Pharma Bio world March 2019

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PHARMA BIO WORLD VOL 17 ISSUE 8 MARCH 2019 MUMBAI TOTAL PAGES 62 ` 150

VOL 17 | ISSUE 08 | MARCH 2019 | MUMBAI | TOTAL PAGES 62 | PRICE ` 150

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6 ◄ March 2019

Pharma Bio World

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DEFENCE & FUEL

UTILITY

FEATURES

10

10

Technology and the future of Healthcare Vipul Jain, CEO, Advancells

16

Obsolescence management in the pharmaceutical industry

19

Leadership in Pharmaceutical Industry - A Reflection on Expectations and General Theme Partha S. Mukherjee, Director, Analytical Development at Celgene

25

Technology to optimise pharma talent management

27

Retention of Talent in the Pharma Industry Jessica Pryce - Jones, Joint Founder and Partner, iOpener Institute

30

The Dynamics of a Revolutionary Talent Management Strategy Dr. Soniya Yadwadkar, Managing Director, CerveauSys Strategic Consulting Pvt. Ltd. TECHNOLOGY

16

32

Leverage the Industry 4.0 Revolution to Meet Market Challenges Bob Lenich, Global Life Sciences Director, Emerson Automation Solutions and Michalle Adkins, Life Sciences Consulting Director, Emerson Automation Solutions

35

State-of-the Art Technologies Facilitate the Combating SubStandard Medicines Amit Chopra, Managing Director & VPGM, India and Middle East, Thermo Fisher Scientific

37

How Technology Transform the Pharmaceutical Industry in India Sameer Bhalla, Founder, CEO, HealthIntel Services Private Limited (HSPL) MARKETING INITIATIVES

39

Toshniwal Instruments Provides Solutions for All Your Vacuum Needs

40

HRS India at Chemtech 2019: Heat transfer technology with competitive advantage

42

NEWS

19

CORPORATE AFFAIRS 52 58

Products Events BACKYARD

59 60

Book Shelf Ad Index

25

8 ◄ March 2019

Pharma Bio World

Technology and the future of Healthcare Healthcare changes dramatically because of technological developments, from anesthetics and antibiotics to magnetic resonance imaging scanners and radiotherapy.

Future technological innovation is going to keep transforming healthcare, yet while technologies will drive innovation, human factors will remain one of the stable limitations of breakthroughs.

Mr. Vipul Jain, CEO, Advancells, expounds on the technology and future of Healthcare.

H

ealthcare Industry in India is at its peak of success already, in terms of both, revenue and employment.

Looking at the current world market standards, we are doing fairly well by employing tech-savvy medical devices, clinical trials; outsourcing the best resources; introducing telemedicine and stem cell treatment; and improving the vertical of medical insurance. Overall, the sector is achieving heaps of success due to its broader coverage, improved services, and higher expenditure.

Assuming the current scenario and the fact that consumers are becoming aware, informed and demanding for their own health, it is believed that these predictions shall be fully functional by the end of 2020:

The public as well as the private segment of Indian healthcare delivery system further comprises of limited secondary and tertiary care institutions in cities and metros, tier I and tier II cities, respectively.

1. Patients will take healthcare advice on social media Online networking is rapidly getting to be one of healthcare’s best promoting platforms.

About 90,000 medical practitioners use Twitter for everything from sharing news about their practices to talking about medicines and answering their patient’s concerns. Other social locales, as Facebook, are also increasing their prenence, as live video is changing how specialists and different professionals associate with their patients specifically.

India’s competitiveness can be estimated by the large pool of well-trained medical practitioners. Also, the cost of treatment here is comparatively cheaper than the rest of Asian and Western countries.

In fact, it is believed that the patient outcome and experience data in the future shall include Friends and Family Test, open reviews, Patient Reported Outcome Measures (PROMs) and related measures,

Vipul Jain CEO, Advancells

10 ◄ March 2019

Pharma Bio World

4,000+ m2 of exhibition space

EXHIBITION SECTORS

Analysis

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Measuring & Testing/ Quality Control

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social media life investigation, online activities and feedback.

2. Healthcare will be directly delivered to the homes The health care industry today is confronting difficulties on all fronts.

Patients are stood up to with soaring consultation costs, while health care specialists must need to communicate across their groups, from admission to in-home treatment for enhanced patient consideration and security.

condition and consequently improving cooperation while conveying home care services.

As mobile phones and smart applications will keep on developing, they will be utilized in extra ways, including utilizing the camera, getting to the life on social media, employer portals or health care sites, and connecting to wireless gadgets.

3. Regenerative Medicine will open more windows Albeit stem cell as a field has existed for more than 10 years, shockingly minimal essential research has been done. All together for the field to propel, researchers are exploring the major cellular connections and evolving strategies for cell generation and preservation. As for 2020, some of the scientists have predicted for a healthy environment where stem cells can perform

At-Home Healthcare Agencies of the future shall accommodate the rising interest for consideration with operational expenses. Medical attendants will invest more energy overseeing the patients data, than any time in recent history, to ensure that the diagnosis of illnesses and treatment are provided timely at home.

Portable medicinal services applications will also significantly change the manner in which healthcare offices work. Above all, the patient will get the most ideal consideration, in light of the fact that the staff has the most recent, significant, and important data about every patient’s 12 ◄ March 2019

Pharma Bio World

4. Rise in the use of wearable and mHealth services

therapies for both, patients and industrial research and development.

Some believe that diseases such as macular degeneration, arthritis, ALS, and such could be cured with effective stem cell therapy thus increasing the lifespan and quality of life of individuals. In order to be more efficient, several academic hospitals shall also coach young scientists and medical practitioners the physician training in stem cell-based medicine.

4. Healthcare right on your mobile devices Technology on-the-go, i.e. your smartphone today is capable of a lot of things except for just keeping you connected. But by 2020, this smart device is expected to combine digital health and human interaction by

harnessing technology in a way that patient-centered care facilities are provided on the tip of the fingers. Virtual visits, as it is called, refers to providing facilities such as enabling users to exchange messages with the doctors, book appointments, refill prescriptions, and check their medical records and lab test results, all on their smarter devices.

With the support of an App, the users will be also be able to make self-service transactions while the doctors will have a better way of prevention, health analysis, and health vision. The introduction of Artificial Intelligence to the healthcare is here to ensure accuracy, speed, and cost-effective measures to diagnose health conditions.

Smart devices that can monitor your steps, in activeness, and calories burnt are already very popular today. However, by 2020 these devices are expected to revolutionize healthcare through completely transformed functions such as remote monitoring, disease management, an early inspection of fatal disorders by bio-sensing the vital signs in a human body.

The senors will collect data such as sleep cycle, fall detection, heart rate functioning, body temperature regulation, and the likes.

In future, these wearable will have a capacity to track your glucose levels, hearing quality, medication-intake behaviors, blood pressure, and weight bearing. This data shall help doctors manage a chronic disease.

5. Big Data of 2020 The future of healthcare shall largely depend on the information sources such as electronic health records and patients provided data. This will allow doctors and surgeons access, share, and form diagnosis from anywhere in the world.

This shall not only impact the national economic development of the country but will also bring new capabilities (like data management) and partnerships (like hospital systems) virtually closer; hence, blurring the boundaries between traditional research and modern day development and commercial functions.

However, the pharmaceutical companies will have to become more aware and developed in order to deal with the complexities of different health systems and keep an up-to-date track record of data analysis for day-to-day decision making.

In all, the key to the future of healthcare will be the IT spine that will keep running all through, and incorporates systems, associated information and man-made consciousness to create measured results and amplified quality.

14 â—„ March 2019

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Obsolescence management in the pharmaceutical industry With an annual growth rate of 9.1 per cent between 2016 and 2021, the pharmaceutical industry across Asia is growing rapidly and countries like Vietnam, Sri Lanka and China should all expect strong growth across the sector over the coming years. However, with such significant growth in the region, pharmaceutical manufacturers need to be able to keep up with demand.

Here, John Young, APAC sales director of obsolete industrial automation equipment supplier, EU Automation, explains the importance of obsolescence management in the Industry.

John Young APAC Sales Director EU Automation 16 â—„ March 2019

N

ot only is the native pharmaceutical industry developing rapidly across Asia, but multinational pharma organizations have earmarked the region as a target for the future. So much so, that experts predict that by 2021, the Asia Pacific market will have grown to be worth $277 billion, increasing the lead over Western Europe and making gains on market leader, North America.

However, the manufacturing requirements that will come alongside the research and development innovations will also require careful consideration and development.

Technologically advanced The pharmaceutical industry is considered to be one of the most advanced industry sectors for cutting edge technology.

Whether it is nanotechnology that is

delivering drugs inside the human body, to 3D printing medication pills, it’s safe to say the industry is at the forefront of innovation.

However, for many pharmaceutical manufacturing processes, often very old equipment or technology is still being used. This can result in slow, inflexible and high-risk equipment being relied on for mass manufacturing.

Despite this, many pharmaceutical manufacturers choose to continue to use old equipment because the industry is a heavily regulated sector, with every inch of production and process being required to meet specific industry and geographical standards. By continuing to use outdated or inefficient equipment, it means the rigor of meeting industry regulations, like the ASEAN Common Technical Dossier (ACTD) for Pharmaceuticals, is avoided.

With significant growth across the pharmaceutical industry across Asia, manufacturers need to be able to keep up with demand.

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Failure risks However, in an industry that is so reliant on profit margins, the danger associated with using old equipment is unexpected downtime and system failures when equipment or parts break.

Many manufacturers can’t afford both financial and regulatory approval timescale costs to replace entire pieces of equipment because their outdated system is obsolete. There are also potential implications when it comes to integrating any new machines with existing, older equipment and systems.

That’s why equipment obsolescence management is vital in ensuring the ongoing productivity at your site.

Just because an old motor, pump or other piece of equipment has broken down and a direct replacement isn’t readily available, all is not lost. Suppliers, like EU Automation, which specialize in sourcing obsolete parts or equipment for organizations across the globe, can help to source a replacement part in a flash.

While many organizations can’t afford to keep a stockpile of replacement parts or equipment on site for those ‘just in case’

scenarios, having a trusted supplier on hand to deal with any urgent or unexpected requirements will prove valuable in the long-term.

This will be increasingly important with the rapid growth of the industry across Asia. If the level of predicted investment and development for the region comes true, the manufacturing processes need to be kept up to scratch as well, regardless of whether they are brand new, or old, machines.

FORM IV Statement about ownership and other particulars about newspaper PHARMA BIO WORLD to be published in the first issue every year after the last day of February 1. Place of Publication

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18 ◄ March 2019

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Pharma Bio World

Leadership in Pharmaceutical Industry - A Reflection on Expectations and General Theme Partha S Mukherjee through this article makes an effort to capture the general themes/identify the commonality in leadership expectations that are considered to be the key survival elements in the pharmaceutical industry, in the face of the earlier mentioned challenges.

T

he idea is to share my learning from the various organizations, with the pharmaceutical professionals who may find the article useful as aspiring Leaders, or coming fresh in a leadership role. Different companies may associate different terminology specific to them, with Leadership. But the basic building blocks of a successful Leader are very similar across the industry. This article highlights some of the key leadership competencies, how the leadership expectations have evolved over the past 20 years or so, and current pitfalls in pharmaceutical leadership.

A Leader: Defined Based on my years of working with and for Leaders in various pharmaceutical companies, I have my own vision of a holistic Leader in this industry. Note I mentioned working “with” and “for”. A true Leader will energize people to work “with” him/her wholeheartedly, not just “for” him/her as a formal requirement of the reporting structure.

Partha S. Mukherjee Director Analytical Development at Celgene Pharma Bio World

The common attributes of a Leader irrespective of whether the individual works in branded/ generics/ OTC industry can be summarized in the following statement. A successful Leader is an individual who is ethical (never compromises with quality and safety at any cost), always has patients and consumers in mind as the end-users in all decisions made, visionary, drives performance, leads with humility, credible, excellent communicator, resilient, energetic, fearless (risk-taker), collaborative, respectful, and open-minded. A leader is someone who is empathic, motivator, active listener, decisive, contemporary (has the knowledge of benchmarked competition and possesses current skill sets), embraces the company culture,

and someone whom people will trust and follow during crisis and uncertainty, to pull them through. A Leader can be in a people management role, or an individual contributor.

A long list of expectations – right?.That is what it takes to make a visible Leader leading from front. I worked for a global biopharmaceutical company where there were 16 behavioral competency expectations for an R&D Leader, which eventually was reduced to top 10 by a Task Force that I was part of. Also, the above attributes are not ranked in a priority order. It depends on the role.

For example, communication becomes relatively even more important for a Leader who manages a global team across sites remotely, vs. a Leader who has his/her team present at the same local site. In the former case, the Leader needs to go the extra mile to ensure his/ her message is clearly heard/ understood over phone/IM/e-mails, without the associated body-language.

The relative weighing of a particular Leadership attribute may also vary, depending on whether the individual is in branded/generics/OTC business.

For example, a Supply Chain Leader in an OTC company will have to possess relatively much stronger sense of urgency compared to an R&D Leader in a branded company. This is because if a respiratory category OTC product is not launched during the limited few month time window of cold/flu season, the opportunity to get most consumers/sales will be lost. In comparison, an R&D Leader in a branded development setting may not always be required to have similar intense sense of urgency, as the R&D development phase spans over several years. I would expect March 2019 ► 19

a Project Team Leader in a generics company to possess a more intense sense of urgency, to be the “first to file” in a fiercely competitive generics world, as compared to an R&D Leader in branded company, solely due to the nature of the settings. The focus of a Leader in a pharmaceutical CRO will be mostly on meeting key customer demand to sustain business- much more than any other settings. The key word in all the above examples is “relative”.

In a very approximate term, the pace of development at OTC >generics >branded, as the relative intensity of the drive to bring products into market is based on the nature of the industry. On the other hand, the relative weighted importance of some attributes such as ethics, collaboration, decisiveness, and embracing business culture etc. should be the same across all 3 settings.

In essence, all pharmaceutical companies urge the above-mentioned leadership competencies in their visible (who most employees will recognize by face and or name within the organization), and invisible (who have so much humility that they do 20 ◄ March 2019

not come on forefront but get business goals delivered silently and let their teams take the credit for it) Leaders. These core competencies I mentioned earlier are relevant whether it is the Senior Leadership Team who sets the vision, mission, and strategy for the organization, or an individual contributor Leader who is tasked to deliver an objective for his/her department.

The top 3 key skills for a Leader are Ethical, Excellent Communicator, and Inspirational. These 3 key skills are tied directly or indirectly to majority of the other attributes mentioned above. Organization HR may promote the vision that each employee needs to be a Leader. In reality, there will be a handful of exceptional Leaders in an organization at any given point of time, who will demonstrate all the above qualities.

Types of Leader in pharmaceutical sector There are numerous classifications of Leaders out there. Resources on Leadership at the Crossroads, Leadership in 21st Century etc. will provide comprehensive overview on those. There are tests to identify whether Leaders are people or task oriented, transactional

or transformational, autocratic or democratic, and combinations of some of these. These sets of questionnaire may be a bit simplistic, but they can assist to point someone in the right direction on a career or organizational path.

I particularly feel “The Eight Archetypes of Leadership” as proposed by Manfred F. R. Kets de Vries (Harvard Business Review Dec 20, 2013) are quite applicable to the pharmaceutical sector.

Manfred identified there are mostly 8 recurring patterns of behavior that influence an individual’s effectiveness within an organization. He calls them as leadership “archetypes,” reflecting the various roles Leaders can play in organizations. It is a lack of fit between a Leader’s archetype and the context in which he or she operates is a main reason of team and organizational lack of effectiveness. The types of Leaders include: (1). The Strategist: leadership as a game of chess, (2).The ChangeCatalyst: leadership as a turnaround activity, (3). The Transactor: leadership as deal making, (4).The Builder: leadership as an entrepreneurial activity, (5). The Pharma Bio World

Innovator: leadership as creative idea generation (6). The Processor: leadership as an exercise in efficiency, (7). The Coach: leadership as a form of people development, and (8). The Communicator: leadership as stage management. My own interpretation is you need to have a balanced mix of all the 8 patterns in pharmaceutical leadership, based on the nature of the current industry. For example, if you lack (8), chances of success for a Leader who is a strong (1) or (4), or any other type, will be greatly diminished.

Identifying the types of Leaders you have on your team can be a Key Performance Indicator (KPI) of your effectiveness as a group. It helps you to recognize how you and your colleagues can individually make their best contributions. This will in turn create a culture of mutual support and trust, inclusive working, ease team stress and conflict, and make room for more creative problem solving. It also assists in future talent search or grooming for succession planning: what kinds of personality and skills are you missing?

Pharma Bio World

Tips for successful leadership I would like to highlight some of the key activities I believe a Leader should do, and provide perspectives based on my realization of their importance across all pharmaceutical sectors: • Do an intra-view : Before you embark on a leadership role that came your way, consider doing an ‘intra-view”. Formal self-assessment is done as part of mid or year-end review.

But Intra-view takes it a step higher- it is really looking inside yourself and asking questions such as: do you believe in your heart that can you handle the role and associated challenges, what are the areas you will have to improve, how will it affect your work-life balance etc.

Do your self-analysis of pros and cons.

There are standard sets of questions out there I am sure from various Leadership Development resources. You are the best critic of yourself and you can use that to your own advantage. It is absolutely fine if you decide to choose a path of not to lead, but be led by a highly successful

established Leader. At the end of the day it is your career, so choose wisely what makes you happy, and allows you to enjoy the other gifts of life beyond work.

Successful Leaders always do an intraview in terms of relevant skills required to excel in their roles.

• Proactively seek feedback : Successful Leaders will reach out to peers, direct reports, and stakeholders to proactively seek what things are going well and what are not, and adjust their leadership styles accordingly. Getting feedback is great but meaningless unless you act on those. I believe people are professional enough to provide candid / unbiased feedback to really mean the well-being of others. I have seen a Leader use this very effectively- first providing “raw/uncut” feedback on a weekly meeting to direct reports. Then turning the table, and soliciting feedback from them. The advantage of this approach is often times, the direct report maybe not too happy with the feedback just received will disclose the true feelings from his / March 2019 ► 21

her side about the leadership style of Manager, which definitely open up the areas of improvement for the Leader.

This would otherwise not be possible if both were trying to please each other in a compromising manner.

• Be an active listener : If you just are a good listener but do not act upon the concerns voiced, that is also not desirable, and you are definitely bound to hear about it in feedback. And, if you do not speak often, you are missing out on the most important element of leadership- Communication (verbal, written, and non-verbal).

We are probably all familiar with the approximately correct phrase “The Good Lord has given you one mouth and two ears so you should listen twice as much as you speak”. True, the successful Leader needs to master the art of “Active Listening” or even better “ Emphatic Listening”-where you are not only listening to the other person but putting yourself in his/her shoes to feel the real situation faced by the individual.

22 ◄ March 2019

• Communicate well : Over the years, I got exposed to various communication courses, some with common themes and some with company specific focused ones. My own interpretation of efficient communication by a Leader is “O5CT”: Open, Clear, Concise, Consistent, Correct, Concrete, and Timely. Bottom line is 2- way communication is an absolute necessity across all layers of organization. It is the lifeblood of any organization, where a Leader serves as the interface / conduit between senior management and others.

• Build trust : I like the “Johari Window of Trust” model as it is intuitive, and highly effective to provide visible results if practiced consistently. I have also seen a pharmaceutical organization using a “Trust Equation” to relate trust with credibility, reliability, intimacy, and perception of self-awareness. A Leader will earn respect only through building the trust and credibility (walk the walk), and demonstrated consistent behavior.

A Leader coming on-board from external

source/other site/other function will probably first have to spend a considerable time and effort on building the elements of trust with his/her manager, direct reports, and team members, while navigating the business strategies and getting up to speed on ways of working.

• Have courage to take risks : Have the courage to make decisions on-the-fly without the full picture, taking appropriate risks associated with it, and take accountability for the outcome. Some leaders are tested with decisiveness right after they take up a role, and will have to bank on their prior experience in similar situations, or general broader industry experience, or just by trusting instinct or gut feeling.

• Know where to focus when it comes to people management : Best way to know where to focus is to have a documented or mental chart of where employees (direct reports) stand with regards to their ability and attitude.

Your performance is a function of both.

A Leader will have to spend most Pharma Bio World

Individual Contributor Manager as Leader

time in dealing with employees having negative ability and negative attitude, vs. empowering employees with positive ability and positive attitude. Treat your employees fairly and consistently, but not in identical manner. Companies expect on treating all employees equally.

Here “equally” means with equal respect and transparency, irrespective of their performance level.

• Rely on Human Factor Analysis : I am a strong proponent of the less tangible areas of demonstrated behavior, which can be interpreted accurately by various Human Factor Analysis tools such as HFAT®, HFACS etc. Essentially there is the propensity to include just a single statement as “human error” in technical investigations CAPA (Corrective Action Preventive Action) plans, with remediation measures such as the analyst was trained in SOP etc. That is not sufficient. There should always be the need to analyze the situation from human perspective – what, who, when, and why. The Human Factor Analysis tools guide through flow charts to do root cause analysis.

• Embrace the company culture : One of the Leader expectations is to openly embrace the company culture by being an active proponent of, and encouraging others to practice it. Each company has its own culture, which

Pharma Bio World

varies on the approaches it uses to achieve the company mission and vision. On the other hand, protecting and improving health and wellness is the common deliverable from all. All have commonality in striving to be the best in the industry. What sets apart the companies is how employees embrace the promoted culture, as executed by the Leaders. I am particularly impressed by the OWNIT! Culture from Pfizer, because it has the right message in urging employees to own the culture, and it is easy to comprehend and follow. The culture of “Speak up” and “Straight Talk”, as encouraged by the Leaders in several pharmaceutical companies, are expected from all layers of the organization.

• Show and expect accountability : Not only does the Leader holds others accountable, but also does so for himself/ herself. Meeting or exceeding the clear visible accountabilities consistently allows a Leader to move up in the organization at an impressive pace.

• Motivate : Be an Inspirational Leader who can motivate people by providing the right tools and support for career development, provide extrinsic motivation such as rewards and recognition on a routine basis, and practice inclusive style of working while being a visible Leader.

vs.

People

We are probably all familiar with the 4 Stages of Leadership (Individual Contributor, Novice Manager, Experienced Manager, and Transformation Leader). It is important to realize that an individual contributor can also be a Leader, and be expected to demonstrate the core leadership competencies as a Group Leader. The direct people management skills may not be necessary for an individual contributor. But in some aspect, some of the leadership skills such as influencing and negotiation could be of more challenging for an individual contributor because he/she does not have a direct reporting structure and may have to work across cross-functional peers/ sr leaders to get objectives delivered for his/her own function. Also, if the core Leadership competencies are consistently noticed in an individual contributor, it is a trigger for upper management to evaluate this individual by providing opportunities to progress along the 4 stages.

What differentiates pharmaceutical companies in their relative rates of success?

All top 10 global pharmaceutical companies have more or less similar resource in terms of global presence, skilled people, R&D budget etc. So what differentiates one company from the other? It is basically how many exceptional Leaders a company possesses within the organization, who consistently demonstrate all the core leadership competencies. It is the Leaders who provide the necessary edge to an organization to make it the trendsetter, or set it apart from the rest of the competition in today’s everchanging pharmaceutical arena. Leader is something you become by demonstrating the behaviors, while Manager is a title given by the organization. A Leader can be a Manager but the reverse may not be true always.

March 2019 ► 23

What have changed in pharmaceutical leadership expectations over the years 1. Over the years, leadership has begun to consciously focus on a “Happy and Healthy Workforce”- a paradigm shift that was generally absent 20 years back. This is in alignment with the realization of an aging global population.

2. There is a marked increase in the common theme of expectations from present day Leaders to build energy and resilience to cope with the fastchanging landscape of pharmaceutical environment.

3. With increased globalization, there is increased Leadership expectation to lead diverse global teams, going beyond the previous comfort zone of local and regional teams.

4. Leaders are asked to deliver more with tighter R&D budget, not-so-impressive pipeline, and in a faster pace of time to stay competitive in the pharmaceutical world. This is inevitably leading to more focus on Innovation (Open Innovation/ partnering with key enterprise/ consultancy firms etc).

5. Leaders are being asked to streamline processes and policies more than ever across global sites, to make an organization run in a more efficient and productive manner via harmonization and standardization.

Leaders are also expected to be more IT savvy, or at least be well versed in the relevant areas. Digital Leadership is not an optional part of a CEO anymore (Josh Bersin).

8. Leaders with diverse background (e.g.

- worked in several organizations/ different functions within same organization) are considered an asset to be acquired, as they bring onboard the best practices and diverse knowledge from other organizations.

Their diverse experience also allows them to look at existing practices with a fresh set of eyes, challenge status quo, and implement more efficient and productive ways of working to stay competitive.

9.

Leaders are expected to drive performance with an increased sense of urgency- to do the right thing with the right people in the right time. Leaders today are expected to raise the bar in this area even higher and respond/ remediate the concerns voiced, through demonstration of sense of urgency.

So, the basic leadership attributes have not changed over the years, the expectations have only intensified. And on top of that, the above mentioned 9 areas are demanding more attention from the current Leaders.

6. To stay competitive and find novel medicines are also often challenging the Leaders more to stay up to date with latest technology know-how/ cutting edge/emerging automation technologies. Leaders are expected to be more creative to make better use of existing resources by looking at them from a different outlook.

Final thought Remember, Leadership is not something you practice at workplace only. It also teaches valuable lessons and provides you the tools to improve your quality of life as well. Whether you are an enthusiast embarking on a pharmaceutical career and aspiring for a dream leadership role, or a highly successful Leader getting ready to wrap up a glorious and long pharmaceutical career, it is worthwhile to remember this nice quote from Actor Christopher Walken:

7. With the popularity of Digital Age technology introduction across all phases in Pharmaceutical arena,

“None of us are getting out of here alive, so please stop treating yourself like an after- thought. Eat the delicious food. Walk

24 ◄ March 2019

in the sunshine. Jump in the ocean. Say the truth that you’re carrying in your heart like hidden treasure. Be silly. Be kind. Be weird. There’s no time for anything else.”

Disclaimer: The views expressed in this article are solely based on the Author’s relevant experience, and reflect his own interpretation of the situations encountered during the pharmaceutical career.

Author: Partha S. Mukherjee, Director Analytical Development at Celgene, is an Analytical Chemistry Leader with 23 years of experience in pharmaceutical settings spanning Discovery molecules to Commercial products, and a strong track record in scientific leadership and people management in major pharmaceutical R&D. Broad expertise in various Analytical and Bioanalytical Separation Science techniques and instrumentation. In-depth knowledge of overall drug development process.

High energy level, strong take-charge ability, and follow through. Demonstrated leadership skills in strategic thinking, passion for customers, developing others, collaborative working and driving performance of organization.

Pharma Bio World

Technology to optimise pharma talent management Though pharma deals in data on a daily basis, it needs to apply its rigorous approach to staff management too, in order to ensure that the right person is in the right place at the right time, says Jim Sykes.

T

he pharma sector is undergoing one of its most turbulent and challenging periods. Cuts to government spending globally, patent cliffs, stalling product development lines and now the uncertainty around £8.5 billion of EU funding for UK science generated by a looming Brexit have all combined to give the industry’s leaders more than a few sleepless nights.

Fortunately, there are opportunities for those who can embrace the increasing need for both innovation and agility in their commercial strategies. However, this means having the type of talent which can turn goals from aspiration into reality.

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European pharma sector employs 725,000 people directly, as well as generating three to four times more employment indirectly, both upstream and downstream. However, until recently, the industry has not had to utilise the tools and tactics now needed to attract the right people with the right skills.

In the past, as a cash-rich sector, pharma was able to address any talent shortage simply by offering attractive financial packages. But, with funds now under pressure,organisations need to find smarter ways to attract, engage and retain talent – ways that key competitor industries such as tech, consultancy and financial services are already using.

The CMR International Pharmaceutical R&D Factbook states that total global pharma sales reached $1.1 trillion in 2015, with the sector directing profits into drug discovery and R&D in an effort to bridge patent cliffs. This emphasis has meant high profile redundancies over the last decade, with big pharma shedding staff to manage efficiencies.

New drugs have always faced long odds.

According to EFPIA, in 2015 an estimated €31,500 million was invested in R&D in Europe, with the cost of researching and developing a new chemical or biological entity estimated to be €1,926 million1. In 2015, 44 New Molecular Entities (NMEs) were launched – double the number registered in 2010.

Jim Sykes Client Services Director Alexander Mann Solutions Pharma Bio World

March 2019 ► 25

According to Oxford Economics, the average cost of recruiting a new member of staff is £30,614 per employee. Therefore, redeploying staff where a business needs talent most is much more efficient than hiring and firing at will. Even relatively basic workforce analytics tools can do more than create a static snapshot of an organisation’s people resource, providing a dynamic picture showing the possible movement of staff up, across or even out of the business over a specified period of time.

Staff retention Considering that the development stage of any new drug takes, on average, 12 years and, according to LinkedIn, cost per hire is over two times lower for companies with strong employer brands, shaping and communicating compelling Employee Value Propositions (EVPs), outlining the benefits and appeal of the company, and ensuring ongoing employee engagement, will undoubtedly be key to successful deployment and retention of staff.

But equally, perhaps even more importantly, pharma’s senior managers and HR professionals need to develop effective strategic workforce planning (SWP). Long talked about, yet seldom implemented effectively, SWP is, in essence, the alignment of the people across an

organisation with its long-term commercial strategy. Or, to put it even more simply, ensuring that the right people are in the right place at the right time.

Although regarded as obvious and straightforward by many outsiders, SWP has proved extremely difficult to operate in practice. But now advances in analytics and predictive technologies in the HR field could make it both attainable and effective.

Although still not widely used in the pharma arena, the tools now exist to harness and analyse the data which can allow a company to build an accurate picture of what its workforce actually looks like, as opposed to what it would like it to look like.

In addition, analytics tools can help talent managers understand why and when target individuals outside their business make career moves, thereby making them much more effective recruiters.

The pharma sector is geared towards the rigorous collection, assessment and employment of data, so it should not neglect its analytical strengths when it comes to what may be its most valuable resource – people.

Offering employees individual development, cross-training and redeployment is vital when competing for talent with other high-skill industries. Organisations that embrace and invest in the new technologies are more likely to gain competitive advantage over their rivals by making better and more cost-effective use of their workforces and reducing the need to sustain continuous, expensive and often inadequately-targeted recruitment campaigns.

Furthermore, by offering better and more attractive career options to staff, they will reduce attrition and become more effective at sourcing what talent they do require from the external market.

Reference: 1According to a paper by Joseph A DiMasi, PhD, published in the Journal of Health Economics in 2016.

Author: Jim Sykes is client services director, Professional & Business Services, at Alexander Mann Solutions. Article republished from https://pharmaphorum.com

26 ◄ March 2019

Pharma Bio World

Retention of Talent in the Pharma Industry In a continually unstable economic climate like the pharma industry, the need to retain and foster existing talent becomes more prevalent. Organisations have no desire to invest in the training and coaching of key employees only to see the benefits of that investment being reaped by another employer.

T

he retention of staff applies particularly to Generation Y employees: the demographic cohort born after the early 1980s and before early 2000s. They are today’s 20-to-30-something workforce who have collectively fuelled the socially networked, multi-channel society and represent the management class of the future. This “digital native” generation is the creative engine of the digital economy. Yet they also exhibit a new-found job mobility which, from an employer’s point of view, is a ticking time-bomb of potential cost and disruption to their businesses.

The pharma industry has for some time recognised the need to foster and retain employees, but this does not necessarily mean that significant efforts are being made. A recent survey by RSA of nearly 400 life science executives found that, while over 90% identified talent management as a key priority for 2010, only 26% had an active strategy in place for retaining talent, and 68% had no clear leadership succession plan.

Our new research at the iOpener Institute for People and Performance, which analysed responses from over 30,000 professionals in Europe, the US, Australia, India, China & Africa, has shown the digital generation – Generation Y – values job fulfilment over financial reward. Whilst pay levels are not unimportant to Gen Y (i.e., people are not prepared to be underpaid for their work), there is no significant correlation between increased levels of pay and greater talent retention.

The research analysis also looked at the correlation between job fulfilment and likelihood of quitting. Job fulfilment was measured by the extent to which people stated that they “love their job”.

Here, a very strong correlation emerged, definitively showing that a fulfilling job is what keeps the Gen Y employee on board, not simply throwing money at them. A single point of increase in job fulfilment brings down the intention to leave by 0.8 points. Statistically speaking, job fulfilment (or, rather, lack of it) explains almost 60% of the variance in a Gen Y employee’s desire to leave. This suggests

Jessica Pryce - Jones Joint Founder and Partner iOpener Institute Pharma Bio World

March 2019 ► 27

fines is over $20bn covering the last two decades.These episodes have damaged the sector’s reputation not just among the public but also current and potential employees.

However, as well as focusing on the areas where the pharma industry could improve, it’s important to recognise where it is performing well. For example, employees report feeling that their job has a positive impact on the world (22% more than average across all sectors) and that what they’re doing is worthwhile (14% higher than average). This is in comparison to the food services, mining and accounting industries whose employees report the lowest levels of this attitude. that Gen Y is not inherently interested in jumping ship for the sake of a bigger pay packet. Instead, Gen Y is simply not prepared to stay in jobs that make them unhappy.

This is of particular importance to the pharmaceutical sector, as whilst pay levels are, on average, 20% higher than other manufacturing sectors, analysis of the iOpener database, which includes information from workers across a range of industries including education, health and manufacturing, reveals some areas of job fulfilment where the pharmaceutical sector specifically is underperforming.

Happiness’ and ‘well-being’ are not some kind of soft concept, but can be finely calibrated by assessing the identifiable key components of ‘happiness’ at work:– positive factors such as recognition, respect, and time on task; as well as negative indicators such as likelihood of leaving or sick days off.

For example, contribution is one of the most important factors that influences happiness at work. Contribution is a dual concept: it is not only about what the employee puts in but also what they get out of working. So, as well as feeling that they are achieving goals and contributing 28 ◄ March 2019

to the working of the organisation, the employee also needs to be given feedback, respect and appreciation in return. By analysing the responses of employees in the pharmaceutical sector, we can see that they display 4% less contribution than the average across other industries.

Our research into Gen Y also found that this group, in particular, also needs to believe in the strategic direction that their employer is pursuing. A correlation was noted between the trust that Gen Y employees have in their leaders’ vision, and their intention to leave the organisation. The more Gen Y believes in the leadership’s corporate strategy, the less likely they are to leave.

Businesses are recognising that Generation Y—their up and coming management cohort—is different from the previous generations, especially in terms of job mobility. No organisation wants to invest in the next generation of management only to find that they leave and destroy return on that investment.

While this recognition is shared by the pharmaceutical industry, few companies have strategies in place to retain talent.

Our research, based on the analysis of thousands of responses, clearly demonstrates that simply throwing money at Generation Y will not be enough to retain them. Instead, Gen Y employees

For the pharmaceutical industry, this is an important point. Numerous scandals have occurred over the past few years.

The most notable of which was the $3 billion fine against GlaxoSmithKline - the largest fine ever imposed to a pharmaceutical company by the U.S. Department of Justice. GlaxoSmithKline illegally marketed Paxil and Wellbutrin, antidepressant drugs, while withholding data describing the health risks of Avandia, a diabetes drug. Indeed, GlaxoSmithKline are not alone - the total cost of industry Pharma Bio World

companies would do well to consider this as they formulate a talent retention strategy, fit to nurture their managers of the future.

Author: Jessica Pryce- Jones is joint founder and partner of the iOpener institute for People & Performance which examines the factors that contribute to resilience and how it can be maintained.

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March 2019 ► 29

The Dynamics of a Revolutionary Talent Management Strategy Dr. Soniya Yadwadkar, Managing Director, CerveauSys Strategic Consulting Pvt. Ltd, in her article talks about understanding talent management and the process which essentially leads to acquiring and retaining talent.

O

ne of the major challenges faced by scholars over the years has been about formulating the exact definition and goals of talent management.

As Lewis and Heckman (Authors – Talent management: A critical review) put, “There is a disturbing lack of clarity regarding the definition, scope and overall goals of talent management”. Nevertheless, certain commonly held views have been expressed by authors which sees talent management as a process through which employers anticipate and meet their needs for human capital. If we want to draw a median, we can come to an understanding that talent management is a process that should essentially be centered around acquiring and retaining ‘talent’ aka ‘performing employees’ who display the potential to provide a competitive advantage for the company.

Fundamentally, a good talent management strategy should be in-line with these 3 key outputs: Organizational Goals – Achievement and alignment of business goals and objectives Financial goals– Profit to the organization Customer goals– Maintain and maximize customer satisfaction

So how do you go about building a revolutionary talent management strategy?

In India, it has been observed that companies tend to neglect the subtle signs of initial decay owing to the cultural differences we contest with our rather careful western counterparts. If your business is set up in India, there are quite a few legitimate business strategy consulting firms in Mumbai that can chisel out the perfect talent strategy for you. A perfect case study of an impressive talent management strategy would be Apple Inc. considering it has had its share of bankruptcy until their rise to supremacy. While it is true that Apple predominantly exudes the persona of its founder Steve Jobs, it is also a result of a tightly knit (yet physically isolated) web of highly focused employees. After a detailed research on the working of Apple by Dr. John Sullivan – a leading thought leader from the Silicon Valley, we can identify the recipe for a formidable talent strategy. One of the key qualities that separates Apple from its competitors is its ‘agility’. It started off as a computer company (previously Apple computers), then ventured into tablets and Music with the immensely popular IPad and IPod. Then it swiftly entered into the smartphone sector with IPhone and now

Dr. Soniya Yadwadkar Managing Director CerveauSys Strategic Consulting Pvt. Ltd. Soniya@CerveauSys.com 30 ◄ March 2019

Pharma Bio World

are world leaders with some of the most premium level clients in its loyalty list.

Lessons learnt: Keep it Lean and fast Apple believes in the principle of consuming less while producing more, which spells more profit from less (but highly creative and responsible) employees. Less people means more individual responsibilities.

And when you are working for a company like Apple, there’s very little scope for mechanically motivated employees who enjoy working discreetly. Rather, you have to be on your toes, trying to constantly prove yourselves. Not that all companies have to be an Apple, but certainly they can walk the path towards becoming a potential ‘apple’ with advice from a professional.

Performance rewarding culture Apple is rather infamous among its employees when it comes to treating a special few employees ‘significantly differently’ based on their individual contribution to the work. They reward and promote their best employees much to the dismay of rest of the ‘not so performing’ ones. But then, that’s what is important anyway. That’s how you separate the wheat from the weed.

Set Cogent Goals The senior management at Apple have a clearly defined Vision and mission statement which drives them to work in a predefined direction at full pace. Apple’s innate ability to keep innovating, which in fact finds its roots in the personalities of the founders of Apple, helps to keep it afloat the vast ocean of cut-throat competitors.

What are the takeaways Revolutionary leaders are not just good at appreciating the importance of talent management but are also swift in adopting and implementing practical measures in actuality. If you want to revolutionize the way things work, you have to get likeminded people on board or train the existing ones to match your ideologies. You have to be practical and somewhat ruthless when it comes to implementing some rather unpopular policies if you know they will Pharma Bio World

eventually be good for your organization.

You know nobody really likes broccoli but then a burger never helped you with a healthy and glowing skin. A great talent lodestone is formed by the amalgamation of a qualified HR team and insightful managers who are completely aligned with the company goals. Investing in a well-known strategy consulting firm can go a long way in achieving the desired outcomes.

A Pragmatic Approach to Execute an Effective Talent Management Strategy The core purpose of a talent management strategy is the identification, selection, development, and retention of the best resources for your organization in a longterm association. A company is majorly sustained by its people. The employees shoulder the company to reach its goals.

Thus, having a good plan in place is a prerequisite. Remembering these pointers will ensure your organization is on the right track when it comes to talent management.

Beginning with the End in mind Having clear and concise organizational goals is the first step towards Talent Management. Asking questions like; What are your organizational priorities; Where does your organization see itself in the next 5 years; helps to achieve clarity. Listing them down helps understand where you are headed to. This will help you chalk out the perfect route and manage the talent accordingly. It also helps in Identifying what

kind of talent will be required to transport the company to it’s desired objective. Acquiring the right talent requires clear selection criteria.

Analyzing the Gap The question is, where do you stand today and where do want to be? It’s required to measure the gap between your present self and your future projection. It’s best to have a proper measurement system in place to calculate the arithmetic required to launch your company off the right spot. If your goal is to occupy 15% of the market share and you are currently standing at say 12%, then it would be required to identify the steps needed to bridge the gap.

Allocating dedicated resources at the beginning Once you have identified your goals and set your priorities, you can now have a much better idea of your journey. Before your recruitment team is equipped to hire the right talent, it’s important to hire the right recruitment team. Without a functional team to implement, the best of talent management strategies won’t create the desired impact.

In many organizations, the implementation projects never see the light of the day because the existing HR team has a tough time juggling between their regular jobs and implementing TM strategies. CerveauSys provides dedicated talent management consulting services to custom-fit your requirements.

March 2019 ► 31

technology

Leverage the Industry 4.0 Revolution to Meet Market Challenges The rise of the fourth industrial revolution, or Industry 4.0, which combines digital and physical advanced technologies, can potentially transform the life science industry. This article looks into the extent to which life science companies have positioned themselves in relation to this transformation and the opportunities the switch to industry 4.0 offer them.

T

he Life Sciences industry — with its major investments in research, reliance on complex chemistry, and sophisticated understanding of human biology — is generally regarded as a technologically advanced sector.

However, when it comes to manufacturing technology; the same processes that have been used since the mid-20 th century have remained. Until recently, this has been an acceptable strategy. But with increasing levels of complexity and increased competition in the market, Life Sciences manufacturing is going through a transformation.

Today, Life Sciences manufacturing facilities can take advantage of stateof-the-art digital automation systems and seize opportunities to improve operations. Increasing market competitive pressures demand efficient operations, manufacturing flexibility, and integrated supply-chain management.

Going forward, Life Sciences manufacturing companies must invest in the new technologies that digitization and the Industry 4.0 revolution enable to stay current, competitive, and compliant.

Bob Lenich Global Life Sciences Director Emerson Automation Solutions

Michalle Adkins Life Sciences Consulting Director Emerson Automation Solutions 32 ◄ March 2019

Currently, many companies operate with disconnected and inefficient legacy systems that are challenged to respond to dynamic shifts in manufacturing supply and demand. Companies have increased expectations for real-time release and for more visibility to all the manufacturing activity, data collection, and analysis.

Including the growing requirements from increasing regulatory scrutiny and cyber security means improved quality controls, better system management, and more access to data.

Digital automation solutions hold tremendous potential to help Life Sciences companies address each of these exacting regulatory and market challenges.

The Life Sciences Manufacturing Opportunities The idea and goals behind Industry 4.0 include connecting human resources, data, and physical machines in a cyber physical network. Although the Life Sciences industry is quite advanced in its application of technology, Life Sciences manufacturing operations historically have been very cautious in adopting new technologies. With high costs to re-validate a working, licensed manufacturing process after making a change, the regulatory environment has historically been a major barrier. This alongside other drivers resulted in Life Sciences companies focusing on new product development and sales rather than on optimizing operations.

This traditional mindset is changing rapidly.

The industry is facing strong price control pressures, the historic product lifecycle patent protection window is shrinking, and there are fewer opportunities for blockbuster products targeted at a large,

“Although the Life Sciences industry is quite advanced in its application of technology, Life Sciences manufacturing operations historically have been very cautious in adopting new technologies.”

Pharma Bio World

technology the order) to dramatically reduce this inventory carrying cost.

To provide real-time release, leading manufacturers are: • Moving lab measurements from remote laboratory locations that require slow sample management processes to atline or in-line production points with no time delays. The expanded interfacing capabilities of digital automation systems to new sensors and analyzers make this work possible.

• Using the in-line lab quality information to automatically adjust the production line versus having to wait for lab results, make a “manual” decision, and then deal with all the production that occurred during the wait. Digital automation with embedded advanced control and integrated analytical measurements can help ensure quality.

Source: American Productivity and Quality Center uniform global market. As these pressures grow, manufacturing effectiveness, flexibility, and reliability have become critical enablers for the industry to meet challenges. Digital automation systems have the potential to fundamentally transform manufacturing, enabling stepchange improvements in performance.

A great example is how single-use manufacturing processes and advanced digital solutions dramatically reduce the initial capital spending and improve ongoing manufacturing operations.

To take advantage of opportunities, many companies are developing a strategic manufacturing operations roadmap to inform how they modernize and digitize their manufacturing operations. These multi-year plans can deliver sustainable agile operations as well as improved cost-efficiency and control to provide a competitive advantage ultimately leading Pharma Bio World

to better care for patients. Two core areas offer significant opportunities as companies leverage the new processes and digital technologies: throughput improvements and manufacturing flexibility.

1) Throughput Improvements In addition to having significant warehouse space costs, Life Sciences companies have significant amounts of working capital tied up in inventory.

For example, to manage changing demands today, many companies keep an excess of 90 days of safety stock and have large amounts of intermediate and final product inventory with various quality statuses, but particularly those waiting on QA test results. Top quartile companies utilize real-time release (where an order is proven to meet specifications on completion of

• Adding equipment monitoring and process modeling, so that digital automation systems can predict potential problems to avoid them before they occur.

• Using manufacturing execution systems (MES) to confirm that equipment is properly calibrated and in the correct state, that people are properly trained, and that the proper sequencing of work activity is occurring to avoid deviations.

• Leveraging embedded digital exception handling methods to confi rm that any deviations that do occur have been resolved quickly with no impact on release.

• In addition to working capital savings, these techniques also reduce unit costs. Reductions in quarantined or lost product, reductions of in process material losses, and consistent batch execution all contribute to cost savings.

2) Manufacturing Flexibility Production lead times in the Life Sciences industry typically have been considerably March 2019 ► 33

technology longer than lead times of other industries.

But this is changing. The amount of exclusive time available to a company to produce a new drug is shrinking as generics and bio-similars get faster approvals. As target patient pools get smaller (fewer blockbuster medicines and more niche market medicines), manufacturing must be sized appropriately while also maintaining a global reach. Because the number of new products successfully completing clinical trials is increasing, more new products must go through the same supply chains faster.

Companies are addressing these issues by: • Adding supply-chain complexity via outsourcing to contract development organizations, contract manufacturing organizations, and global logistics organizations to lower capital risks and to make sizing and new manufacturing capital decisions much later in the development cycle.

• Applying advanced planning, scheduling, and modeling techniques across the complete supply chain to optimize in-house facilities and contracted resources for a combination of best cost and faster deployment.

• Utilizing new manufacturing processes like single use or continuous manufacturing with smaller capital footprints, faster deployment, and higher utilization so that a new facility can have footprint 60-70% of a traditional site yet still produce more product in a shorter period.

• Developing modular, standards-based operations so that changing the manufacturing sequence and/or recipe for a new drug doesn’t require new equipment or re-validating the complete process, only what’s changed.

• Ensuring consistent quality standards are maintained across these approaches by integrating the systems and leveraging their new modular standards so that crosssite comparisons can demonstrate consistent performance.

Life Sciences manufacturing leaders are using modern, digitized infrastructure and applications to leverage standard building blocks, to integrate information flow globally, to facilitate planning/ scheduling, and to optimize their supply-chain performance. Using a mix of site-based and cloud-based applications provide the infrastructure to use consistent business processes and reporting to provide sustainable competitive advantages.

Through digitization, including cloud computing, companies can develop global integrated supply-chain networks. Cloudbased networks make it much easier to link all players through a single integrated network, even those with different IT architectures or ERP systems, thus making networks more scalable.

Life Science organizations of all sizes are taking advantage of technological capabilities in manufacturing while incorporating a holistic strategy regarding GxP compliance to ensure the value will be fully realized. Industry 4.0 is here. Companies now can leverage it to modernize technical operations and corporate quality management. Advanced technology solutions and Industry 4.0 can lead to productivity gains and can secure a company’s competitive advantage, while also improving the robustness of product quality and the security of the supply chain to the patient.

We are amid the next industrial revolution and are seeing a radical revamping of technical operations from the inside out. Based on the common principles of Industry 4.0, an innovation initiative can significantly improve agility and productivity issues, and provide quality operations with better tools to enforce product safety and supply-chain security.

Associated improvements in manufacturing flexibility can give real capacity gains. All gains from the existing assets can potentially delay or remove the need for other (more expensive) capacity increase investments.

“Advanced technology solutions and Industry 4.0 can lead to productivity gains and can secure a company’s competitive advantage, while also improving the robustness of product quality and the security of the supply chain to the patient.”

34 ◄ March 2019

Advance Your Operations with the New Industry 4.0 Revolution

Contact: bob.lenich@emerson.com

Pharma Bio World

technology

State-of-the Art Technologies Facilitate the Combating Sub-Standard Medicines Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide.

Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence and the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain.

T

he Indian pharmaceutical sector ranks 3 rd in the world as far as volume is concerned, and is ranked th 13 in terms of value. Being the largest provider of generic drugs globally, India’s share in the global generic drug market is an impressive 20 per cent. As per the World Health Organization, 35 per cent of counterfeit drugs sold in various countries come from India. Also, approximately 25 per cent of medicines sold in India are of substandard quality. The Indian pharmaceutical industry is strong in the field of manufacturing, but it is crucial to improve its ranking in producing approved and quality medicines.

Fraudulent drugs harm or kill millions around the world. Of these counterfeit drugs, the most common are those related to cardiovascular and cancer treatment. Further, there are various counterfeit antibiotics that are produced in large quantity. Additional common counterfeit drug categories include but are not limited to erectile dysfunction medicines, painkiller medicines, weight loss pills, psychiatric medications and medicines that are given during the treatment of various chronic ailments such as HIV, Diabetes, Alzheimer ’s disease, etc.

Amit Chopra Managing Director & VPGM India and Middle East Thermo Fisher Scientific Pharma Bio World

Every stakeholder involved in the pharma business, including the policy makers, can play a pivotal role in putting a stop to this globally alarming issue.

For example, the drug manufacturers need to strengthen their process around security of the manufactured drug -from raw material identification through production, supply to the end-user and destruction of unused/returned/rejected

material including the packaging material.

Players in the supply-chain process should closely monitor the movement of drugs from one point of sale/distribution to the other. Policy makers should frame stringent guidelines/regulations, increase the number of inspections on every stakeholder in the pharma business and drive campaigns that provide insight about counterfeiting and its implications to discourage such negligence.

For many years, pharmaceutical companies have relied on a combination of covert and overt security features in packaging and occasional forensic analysis to identify counterfeit drugs.

However, counterfeiters have found ways to quickly and accurately replicate those features to deceive authorities and patients. While combating through traditional approaches like laboratory tests, random batch checks, routine screens etc., are being carried out, it can, only be used to verify a small fraction of all suspected samples. It becomes imperative for companies to create a robust mechanism to identify counterfeit drugs and loop-holes in the supply chain while making significant contributions to support research and innovation for the pharma industry through state-of-the-art technologies.

It becomes essential to make investments in high-end analytical instruments and consumables to support activities which will accelerate drug discovery, enhance productivity and enable regulatory compliance. By means of right technologies, manufacturers can achieve quality initiatives not just throughout the manufacturing process March 2019 â–ş 35

technology

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

PBW Spotlights »Indian Pharma and Biotech

but also in the market place. There are products available in the market which examines chemical composition of all components of a pharmaceutical dosage and offers non-destructive, rapid and accurate raw material identification respectively. Handheld instruments are designed to detect a variety of applications, including incoming raw material identification, quality control and assurance, counterfeit product screening, process troubleshooting and quantitative analysis. Non-destructive, rapid and accurate raw material identification enabling immediate release of raw materials into production while also meeting the requirements of current good manufacturing practices (cGMP) and 21 CFR part 11 with minimal training required.

coatings to create a unique spectral fingerprint representing the authentic medicine. Such technological solutions enable leading pharmaceutical companies to quickly and effectively identify almost any pharmaceutical material from receipt to release.

Currently, major global pharmaceutical manufacturers and regulatory authorities use such analysers to verify the identity of either raw materials or finished products.

Innovations are allowing brand owners and government agencies to develop new and powerful approaches towards anti-counterfeiting. These products have facilitated the seizure of thousands of counterfeit drugs that would otherwise have entered the supply chain with serious consequences.

Industry Globalisation »Latest Developments in Pharma

Innovation and Technologies »Future Trends of the Industry »Current Indian and International

Corporate News » Novice & Updated R & D

Strategies » In-Depth Market Research »New Product Launches »Event Alerts and Many More……

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Tel.: 91-22-40373636 | Fax: 91-22-40373635 E: industrialmags@jasubhai.com W: www.pharmabioworld.com rd

Raman

spectroscopy

examines

the

chemical composition of all components of a pharmaceutical dosage, including APIs,

excipients,

36 ◄ March 2019

fillers,

dyes

and

Contact: seema@mediavalueworks.com

www.chemtech-online.com

Pharma Bio World

technology

How Technology Transform the Pharmaceutical Industry in India                                      

M

arket in general, has been greatly impacted by the might of technology and the Pharmaceutical sphere is not lagging behind. Catalysts such as Mobile communications, the cloud, advanced analytics, and the Internet of Things has influenced the way pharmaceutical industry operates, with players opening their visions to the disruptive potential. Yet many find it hard to determine what initiatives to scale up and how, making it a precarious yet enriching ally to bring on the table. Here are a few Trends reshaping healthcare: Patients are becoming more engaged In the current digital age, patients are increasingly able to take greater control of their own health, decreasing the blind dependence on prescriptions to a minimal level. They feel empowered by the vast amount of health information available online and on apps. With an array of health and fitness wearables such as FitBit and Apple Watch, consumers have grown confident in their ability to take responsibility for their health, alongside becoming keener to evaluate different healthcare products and services, making it patient engagement a key to the success of any pharma organization.

Digital-centric competitors are moving in

a aa        Pharma Bio World

Insights into clinical pathways are no longer the prerogative of the traditional healthcare establishment, as technology companies such as Apple, IBM, and Qualcomm Technologies moving into healthcare with their vast array of solutions to aid consumers. These are able to engage with patients through apps, health and fitness devices, and online communities, collecting petabytes of data

while capturing valuable insights. Pharma companies need to optimally position themselves for competition/collaboration, while building complementary capabilities .

More information is available about product performance Gone are the days of pharma companies controlling both the generation and dissemination of information as Digital technologies spurred an array of new, independent information channels for sharing and discussing patients’ experiences, advanced data aggregation and analysis to link disparate, complex data sets and generate new insights into drug safety and efficacy. Players are building channels to anticipate these new sources of evidence, and respond efficiently.

Efficiency and agility is improving dramatically Advanced analytics, sensors, and the automation of complex decisions are delivering a remarkable change in the efficiency, speed, quality, and responsiveness of the pharmaceutical operations. Players are deploying nextgeneration technologies to streamline their business processes, through championing real-time transparency of their clinicaltrials and frictionless sales and operations planning, while satisfying new expectations in efficiency and agility from customers, employees, patients, and suppliers.

Personalized care The ability to personalize interactions with stakeholders may have been a fodder for post 70’s science fic fares, but in the present generation, it has risen to March 2019 ► 37

technology

be a key value driver in pharma. This is facilitated through the use of sensors and digital services, providing tailored care on a monitored basis. Medication has become personalized, targeting the needs of each patient with greater precision than before. Advanced data analytics that mine electronic medical records, including diagnostic results, medication history, and genomic, proteomic, and gene-expression data are helping identify optimal therapies, while predict how individual patients will respond to treatment.

Omnichannel conversations physicians and patients

with

Digital-engagement technologies open up a whole new world for marketing, the exchange of information, and recruitment for trials. Pharmaceutical sales reps, medical-science liaisons, and patientservice teams can inform and influence patients, physicians, and caregivers in person or via mobile phones, the Internet, apps, or social media. Virtual care is becoming become increasingly commonplace with specialist virtualcare apps ruling the roost. Consultation through medical portals and social media 38 ◄ March 2019

have become a thing to vouch for as patients to use Skype to call their general practitioners.

Data-driven insight: Advanced analytics to increase pipeline and commercial value Pharma companies are utilizing a wealth of data, usually locked away in different technical and organizational portals, for the growth of their trajectory. Some are already linking and mining their data sets to improve their pipelines, products, and strategies.Insights are being harnessed through use of AI to cull out valuable data that would help conjoin patient’s data to give rise to a well rounded perspective.

Healthcare devices to monitor personal health and robot-assisted surgeries are direct results of successful AI integration, replacing the need for human reviewing.

This in turn, has made operations and diagnosis possible on a much rapider pace, decreasing time taken to recover to a minimum level.

patient outcomes, putting an even greater pressure on pharmacy companies to demonstrate the value of their drugs in the real world to retain market access and premium pricing. In this technologically charged atmosphere, digitally enabled “an extent beyond the pill” solutions, which including not just drugs but also sensors to collect and analyze data to monitor a patient’s condition, have become the season’s favourite. These solutions are driving the adherence to treatment and outcomes that consumers and governments seek, while maintaining a delicate balance between technology and humanity.

Conclusion Although these may be minor changes, but as it takes small ripples to create a storm, these too will usher in a breath of fresh air for everyone to sit up and take notice.

Outcomes-based care is moving to center stage Playersn have adopted a sharper focus on managing costs while delivering improved

Contact: monalisadas@mediamantra.in Pharma Bio World

marketing initiatives

HRS India at Chemtech 2019: Heat transfer technology with competitive advantage

H

RS Process Systems Ltd., (HRS PSL) recently displayed their range of heat exchangers and systems at Chemtech 2019, organized

by Jasubhai Media, at Mumbai from 20th – 23rd February 2019. The exhibition primarily gives an opportunity to connect with process industry and technology experts, to share latest information and developments by the company.

HRS is synonymous with offering innovative heat transfer technology to processing sectors. Our heat exchangers are successfully running at various chemical, agrochem, fertilizers, pharma, specialty chemicals and other process plants. At Chemtech, HRS showcased their flagship ECOFLUX* corrugated tube heat exchangers (CTHE), HRS FUNKE Plate Heat Exchangers (PHE) and range of Heat Exchanger based Systems.

HRS is the pioneer in corrugated technology, backed up with extensive research. ECOFLUX* CTHE is one of the most widely accepted heat exchangers in the market today. Some of the key process concerns of customers of chemical, agrochem, fertilizers, oil & gas, petrochemicals, specialty chemicals,

paint, dyes, textiles, resin, polymers, etc. have been addressed in our stall by our technical team at the exhibition. Many of our esteemed customers like Atul Ltd., Pidilite Industries, Piramal Enterprises, Multiorganics, Aarti Industries, VVF India, Gujarat Organics, Aurobindo, Hetero Drugs, Matrix Life Sciences, Everest Blowers, UPL, Meghmani LLP, Bayer, etc., visited the event.

These delegates from prestigious companies were informed of the advantages of our range of products.

Customized design, application engineering and consistent heat exchanger performance is why customers continue to prefer HRS. Our expertise to understand the customer requirement and supply heat exchangers in a range of regular and exotic material of construction such as SS, Hastelloy, Inconel, Monel, Titanium, Tantalum, Duplex, Super Duplex, etc. give HRS the advantage as a competitive heat exchanger supplier to the industry.

HRS Process Systems Limited Web: www.hrsasia.co.in

Pharma Bio World

March 2019 â–ş 39

marketing initiatives

Toshniwal Instruments Provides Solutions for All Your Vacuum Needs

O

ver three decades of expertise in vacuum technology, Toshniwal offer tailored solutions ranging from individual products to a complete system. Toshniwals’ vacuum products play a vital role in a vast range of technologies.

Toshniwal are manufacturer and supplier of vacuum pumps, vacuum systems and roots pumping system for specific segments in the industry. Toshniwal owe their recognition competence as service providers with our own manufacturing facilities and as partners of high-tech manufacturers all over the world to the innovative methods with which Toshniwal satisfy the highest precision and quality demands.

Toshniwal is one of the leaders in vacuum technology for over 70 years, now provides solutions for your vacuum needs.Herewith is the illustrations of the products manufactured and marketed by the company.

Oil-lubricated Vacuum Pumps Condensors Toshniwal supplies oil-lubricated vacuum The condensor helps in reducing the pumps. This oil-lubricated vacuum process time of drying, distillation, pumps of the TMS Series are single etc, by effectively condensing the stage, oil-lubricated rotary vane vacuum condensable vapours. It has been pumps with oil re-circulation system. The standardised with 1.5 m², 3 m² and lubricant system is rated for continuous 6 m² cooling surface area. The Material operation of high intake pressures of Construction (MoC) can be given in so that the pump may be used in a Mild Steel/SS-304/SS-316 for Shell and versatile manner in most rough vacuum Copper/Cu Nickel/SS-304/SS-316 for the applications. The pumps are used for cooling coil. suction of air also in presence of water vapour and for continuous industrial High Vacuum Pump (Oil Immersed) use. TMS Series pumps are made from high quality materials, has economical features which matches together to achieve: high pumping speed over the range of absolute pressure 1000-0.5 mbar; high water vapour tolerance and low noise level; no pollution; and aircooled: built-in anti-suck-back system.

The pumping capacities available are 17 m 3 /hr, 35 m 3 /hr, 65 m 3 /hr, 100 m 3 /hr and 150 m 3 /hr The GL Series pump is an oil-sealed belt driven pump operating according to the rotary vane principle with gas ballast valve. Oil, which is injected into the pump chamber, is used for sealing lubrication and cooling purpose.

Double stage models from 180 m 3/hr to 300 m 3/hr are available to meet wide range of vacuum needs.

Features Highly reliable ● Guaranteed ultimate vacuum ● Effective gas ballast ● Quieter operation ● Advanced lubricating system ● Easy maintenance ● Compact and sturdy design ●

40 ◄ March 2019

Pharma Bio World

marketing initiatives High Vacuum Pump (72-D Series)

in distillation process, food processing, drying of powder and solids and transformer evacuation.

Features Longer functional life High efficiency Compact design

Over three decades of expertise in vacuum technology, Toshniwal offer customized solutions ranging from individual products to a complete system.

New customer requirements have given rise to further development in Toshniwal Direct Driven Vacuum Pumps, the 72-D Series.

Beyond usual quality and reliability of Toshniwal pumps the 72-D Series pump offers improvement in the areas of quieter operation, smaller size and easy maintenance. Pumping capacities available are 120 to 900 lit/min.

Roots Pumping Systems Roots Pumping System is used where high pumping capacity is required at lower operating pressure. The capacity available ranges from 250 m³/hr to 10,000 m³/hr. Toshniwal also provide appropriate accessories like condensers, filters, etc, to reduce the cycle time, protection of the pumping system. ● Decrease power. Savings in the range 30-40% ● ●

The Roots-type pumps belong to the group of positive displacement delivery pumps.

Two symmetrical pistons having an eight feature, housed in the pump body, rotate in opposite directions with no contact neither between each other, nor with the pump body, meshing continuously. The pistons are driven by a set of gears with synchronised rotation, which guarantees friction-free movement. During rotation, a progressively growing space is created with corresponds to the suction stage: Phases 1 and 2, being gradually decreased Phases 3 and 4, compressing the volume of gas. This cycle is repeated four times per each complete rotation of the drive shaft.

Improve the quality and productivity Have a compact design. Yet easy to service, easy to install

Toshniwal will be providing sales/ service to all over India with Branches in Metro cities such as Chennai, Baroda, Bengaluru, Delhi, Hyderabad, Kolkata and Mumbai.

Roots Pumping Systems

Roots Vacuum Pumps Toshniwal are counted among the prominent manufacturers, suppliers and exporters of a wide range of Roots Pumping Systems. Manufactured using finest quality material, their range is in adherence with international quality standards. Available in a spectrum of specifications, these systems are used

Pharma Bio World

For details contact:

Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net Website: www.toshniwal.net March 2019 ► 41

news Kiran Mazumdar-Shaw Conferred with Varian, Tata Trusts Collaborate for Advanced Honorary Doctorate Cancer Care Solutions Kiran Mazumdar-Shaw, Chairperson & Managing Director of Biocon Ltd, has been conferred with the ‘Honorary Doctorate’ by Deakin University, a leading Global University based in Victoria, Australia.

She has been recognized for her pioneering entrepreneurial role in the field of biotechnology & for her sustained significant contribution to Industry-Academia collaboration between Australia & India. Speaking on the occasion, Kiran Mazumdar-Shaw, said: “I am immensely proud to receive this coveted recognition from the prestigious Deakin University of Australia and feel even more inspired to be presented with this honour in the year when Deakin University is celebrating 25 years of association with India, the longest sustained period of engagement by any Australian University with India.”

Deakin Honorary Doctorates program recognizes eminent individuals who have made an inspiring or significant and sustained contribution to the community aligned to the University's objectives. Past recipients of Deakin University Honorary Doctorates include eminent leaders like Julia Gillard, Australia’s first female Prime Minister.

HRS India at Chemtech 2019: Heat transfer technology with competitive advantage HRS Process Systems Ltd., (HRS PSL) recently displayed their range of heat exchangers and systems at Chemtech 2019, organized by Jasubhai Media, at Mumbai from 20th – 23rd February 2019. The exhibition primarily gives an opportunity to connect with process industry and technology experts, to share latest information and developments by the company.

HRS is synonymous with offering innovative heat transfer technology to processing sectors. Our heat exchangers are successfully running at various chemical, agrochem, fertilizers, pharma, specialty chemicals and other process plants. At Chemtech, HRS showcased their flagship ECOFLUX* corrugated tube heat exchangers (CTHE), HRS FUNKE Plate Heat Exchangers (PHE) and range of Heat Exchanger-based Systems.

HRS is the pioneer in corrugated technology, backed up with extensive research. ECOFLUX* CTHE is one of the most widely accepted heat exchangers in the market today. Some of the key process concerns of customers of chemical, agrochem, fertilizers, oil and gas, petrochemicals, specialty chemicals, paint, dyes, textiles, resin, polymers, etc. have been addressed in our stall by our technical team at the exhibition. Many of our esteemed customers like Atul Ltd, Pidilite Industries, Piramal Enterprises, Multiorganics, Aarti Industries, VVF India, Gujarat Organics, Aurobindo, Hetero Drugs, Matrix Life Sciences, Everest Blowers, UPL, Meghmani LLP, Bayer, etc, visited the event.

These delegates from prestigious companies were informed of the advantages of our range of products. Customized design, application engineering and consistent heat exchanger performance is why customers continue to prefer HRS. Our expertise to understand the customer requirement and supply heat exchangers in a range of regular and exotic material of construction such as SS, Hastelloy, Inconel, Monel, Titanium, Tantalum, Duplex, Super Duplex, etc, give HRS the advantage as a competitive heat exchanger supplier to the industry.

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The Varian ARIA oncology information system and Eclipse treatment planning system will be implemented in a secure network hosted on a private cloud, to assist in elevating the level of care across India. Tata Trusts and Varian announced the signing of a framework agreement intended to increase patient access to advanced radiation therapy treatments in the country. The three-year agreement is focused on worldclass cancer care delivery through the installation of radiation therapy treatment systems across India where Varian has been selected as the preferred supplier by Tata Trusts.

The agreement is part of a program undertaken by Tata Trusts with the goal of creating patient-centric cancer institutions to deliver standardized and affordable care closer to patients' homes in different regions in India, including rural areas where many patients do not have the financial means to access existing care options. Included in the scope of the agreement, is the creation of a significant number of new cancer centers, as well as the installation of advanced radiotherapy equipment in already existing centers in these areas. At its culmination, the program is targeted to bring world-class cancer care to an estimated quarter million patients per year that previously did not have easy or affordable access to treatment options. In addition to the installation of the radiation therapy treatment systems, the Varian ARIA oncology information system and Eclipse treatment planning system will be implemented in a secure network hosted on a private cloud, to assist in elevating the level of care across India. The first systems are estimated to begin installation later in 2019.

Piramal Critical Care announces launch of Mitigo in the US Mitigo is used for management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Piramal Critical Care, a global leader in anesthesia, pain management, and intrathecal therapy, today announced the launch of MITIGO (Morphine Sulfate Injection, USP – Preservative-free) in 10 mg/ mL and 25 mg/mL concentrations in the US market. Piramal Critical Care will continue to work with wholesalers, hospitals, interventional pain doctors, and pain management centres across the country to ensure availability of MITIGO for patients with intractable chronic pain.

Peter DeYoung, Chief Executive Officer, Piramal Critical Care said: “Piramal Critical Care has established itself as the leader in U.S. intrathecal therapy with Gablofen which we have successfully integrated post its acquisition from Mallinckrodt. We are pleased to support intrathecal therapy for pain management with FDA approval and our launch of MITIGO. We continue to expand our leadership in intrathecal therapy through this launch, as well as in inhaled anesthesia and the injectable anesthesia and pain management drugs that we acquired from Janssen. We stay committed to executing on our strategy to expand our portfolio, address patient and customer needs, and deliver high quality critical care solutions to the market.” MITIGO (Morphine Sulfate Injection, USP – Preservative-free) is an opioid agonist, for use in continuous microinfusion devices indicated only for intrathecal or epidural infusion for the management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

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news Fortis Organizes PANFORAnIC on preventing hospital-acquired infections and AMR According to the World Health Organisation (WHO), Ant-imicrobial resistance happens when microorganisms (such as bacteria, fungi, viruses, and parasites) change when they are exposed to antimicrobial drugs (such as antibiotics, antifungals, ant-ivirals and antimalarials). Microorganisms that develop ant-imicrobial resistance are sometimes referred to as “superbugs”. As a result, the medicines become ineffective and infections persist in the body, increasing the risk of spread to others. In addition, Healthcare associated infections or Hospital acquired Infections (HAIs) are the major challenge today for the healthcare industry. As bugs increasingly grow resistant, treating options are also becoming limited. The cost of healthcare for patients with resistant infections is higher than care for patients with nonresistant infections due to longer duration of illness, additional tests and use of more expensive drugs. Globally, 480,000 people develop multi-drug resistant TB each year, and drug resistance is starting to complicate the fight against HIV and malaria, as well.

Fortis Escorts Heart Institute organized PANFORAnIC, the first combined meeting of Anaesthesiologists (PANFORA) and Infection Control (PANFORIC) teams from Fortis hospitals across India on 9-10 March 2019. The primary objective was to discuss infection prevention and control, share knowledge on best practices and recent advances among specialties, taking priority measures and planning exchange training programmes. The event saw participation from delegates from hospitals from across the Fortis network in India.

The conclave witnessed paper presentations, interactive sessions, posters and other collaterals with key messages, quiz and workshops. It brought together specialists, clinicians, microbiologists, anaesthetists, nurses and other support groups to deliberate upon the challenges to successful outcomes around healthcare associated infections, effective strategies for their prevention and control, and some of the complex emerging problems like antibiotic resistance. Identifying “Antibiotic Stewardship” as a major initiative being undertaken by Fortis control to spread awareness about appropriate use of antibiotics, participants called the advent of ‘super bugs’, or ‘ant-imicrobial resistance’, a critical public health issue requiring commitment and action from all stakeholders offering healthcare service delivery. Participants spoke about how they are not only working towards safer outcomes, but also behavioral change on using and preserving antibiotics. This conclave held periodically over the last few years is a necessary exercise for clinicians and key stakeholders to discuss and arrive at most effective measures of infection control.

Without effective ant-imicrobials for treatment of infections, risks during critical medical procedures such as cardiac implants, organ transplants, chemotherapy, diabetes management, caesarean birth deliveries and hip/knee replacements become very high. Coupled with the fact that the microorganisms causing such infections have also developed survival mechanisms, antibiotic resistance is likely to cause or directly contribute to around 20 lakh Indian patients dying of healthcare associated infections by 2050. A report by the Centre for Disease Dynamics, Economics and Policy (CDDEP) 2015 on the State of the World’s Antibiotics has noted that 58,000 new-born babies died in the year 2013 in India due to drug-resistant infections.

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Dr Murali Chakravarthy, Chairman, Central Infection Prevention and Control Committee, Fortis Healthcare said, “The Ant-imicrobial Stewardship (AMS) programme at Fortis Healthcare calls for rational and judicious use of life-saving antibiotics with the unconditional support of Fortis clinicians. The ultimate goal is to address the rising issue of anti-microbial resistance and overall purpose is to bring about a change in the antibiotic prescription patterns with focus on the safety of patients and the larger community.”

Japan 2nd Fastest Pharma Growing Pharma Market in 2019: CPhI Japan Report The Japanese pharma market is expected to grow quickly in 2019 following the release of a new report published ahead of CPhI Japan 2019. The industry executives predict Japan to be the second fastest growing mature market for solid dose drugs in 2019, and even more impressively, the second fastest overall country for biologicals growth – finishing only narrowly behind the United States. The findings represent a sizable year-on-year improvement in outlook for pharma in Japan, with expected growth of solid dose formulations improving by more than 10 per cent (rising to 5.4 up from just 4.75 in 2018), with generic drug classes highlighted as offering strong growth prospects.

Significantly, it now ranks ahead of all EU nations and Korea – finishing only behind the United States of the mature pharma markets. Laura Murina, Brand Manager CPhI Japan said, “Japan’s pharmaceutical industry has long centred on strong innovation and patented drugs, but we are now observing a dramatic increase in generics and biosimilars in the market.”

The outlook for the biologics sector was even more positive, where growth potential for Japan (7.5) was second only to the United States (7.9) – recognising the substantial potential for biosimilars in 2019 and beyond – as a result, the collocated BioPh has become a much larger part of CPhI Japan in recent years. Japanese companies reported renewed confidence in the domestic market, but more significantly, a larger number are also exploring exports than in previous years. In fact, 2019 will be the first year that Japan’s largest pharma companies gain 50% of their sales from overseas – as recently as 2017 this was still well under 50%, but it has grown quickly in recent years.

Crucially, this internalisation is being observed both ways – inbound and outbound. Another industry segment offering opportunities are nutraceuticals and traditional Chinese medicines. The report suggested that the resurgence in international interest is being driven by de-regulation opening-up accelerated approval pathways, coupled with one of the world’s fastest growing generics markets. R&D in Japan also remains at the forefront of global pharma – a result of both the attractiveness of the nation’s medicines market and the strength of local research institutions. The report concludes that Japan is a country ripe for growth across a number of product classes, but the long-term winners of regulatory changes, aging demographics and innovative R&D remain hard to pick. What is clear however, is that the opportunities have widened quickly, and new players would be wise to act fast. In particular there are renewed opportunities for international contract service providers, generics and finished drug manufacturers as well as domestic manufacturers to become the local manufacturing arms of international firms.

March 2019 ► 43

news Cancer Screening from Breath Analysis SniffPhone, currently in its prototype phase, enables early diagnosis of gastric cancer from a person’s exhaled breath. SniffPhone is a small sensor device developed for cancer screening that can be attached to a smartphone. In practice, the user holds the device in front of his or her mouth and exhales onto the sensor to give breath sample. The device measures the contained Volatile Organic Compounds (VOCs) using highly sensitive nanotechnology-based chemical sensors.

The measurements are sent via Bluetooth using a smartphone to a dedicated cloud platform, where they are analysed by the appropriate medical personnel.

The new cancer screening method has many advantages over traditional methods: the device is comfortable and painless to use.

In addition, it provides a simple, fast and cost-effective alternative for screening gastric cancers. In the project, SniffPhone prototypes have been developed and validated by means of, for example, clinical studies. The next step in the project is finding financiers for this kind of novel cancer screening method. Commercialisation of the device is planned to take place through a spin-off company.

VTT’s role as a visionary research, development and innovation partner in the project was the implementation of the platform for transferring data from the smartphone to a cloud-based storage space.

VTT has also been building analysis tools and methods for recognising high-risk patients. In addition, VTT developed a mobile application that guides the user in giving a breath sample and provides the user with a preliminary analysis of the sample. Furthermore, a physician’s analysis tool has been developed to display the analysis results of breath samples. VTT was also in charge of the implementation of responsible research and innovation in the project by such methods as engaging final users and stakeholders in the development work through interviews and workshops and integrating responsible design practices into project operations.

areas across Maharashtra, Telangana, Assam, Odisha, Chhattisgarh, Uttar Pradesh, etc.

Launched in 2007, Wockhardt Foundation’s ISO 9001:2015 approved the programme has been successful in administering free primary healthcare services to people from more than 4072 villages across 20 States of India. Each van services on an average 20 villages in a week.

Each van services close to 25,000 people per year and till now close to 23.27 million people have been treated or directly benefitted through these services.

Sir Dr. Huz was elated with the 200th launch and said, “With the objective of providing quality healthcare services to the masses, we have reached a milestone of 200 medical vans. I am really grateful to all the partners for their immense contribution to this initiative and making this basic facility accessible to the rural population.” The programme is aimed towards creating awareness in rural areas about the basic health requirements in terms of sanitation, hygiene, safe drinking water, anemia, mother and child healthcare, HIV, tuberculosis, diabetes, etc. The vans travel across various villages to provide health screening and free basic health services.

Platform to Digitally Transform Clinical Studies Tata Consultancy Services, has launched a new version of the Metadata Registry and Transformation (MRT) Platform that helps life sciences companies streamline their clinical data management by automating clinical study design and set up and conversion of clinical data into standard formats for greater interoperability across the clinical trial phases. The MRT platform is part of TCS’ Advanced Drug Development (ADD) suite of cloud-based clinical platforms, which are powered by a cognitive engine. The latest version comes with a modernized automation engine and offers significantly enhanced capabilities across both its modules of Metadata registry and Data transformation.

The SniffPhone project is part of the EU’s Horizon 2020 Funding Programme. The project consortium consists of nine partners: the co-ordinator Technion - Israel Institute of Technology (Israel), NanoVation (Israel), Cellix Ltd (Ireland), microfluidic ChipShop (Germany), University of Latvia (Latvia), University of Innsbruck (Austria), Siemens (Germany), JLM Innovation GmbH (Germany) and VTT. Last year, European Commission recognized the project as the Most Innovative Project.

Clinical Metadata Registry helps create and manage a metadata library to accelerate clinical study set-ups and consumption across various study phases. The metadata backbone across clinical trial phases ensures a seamless exchange of information across phases within and outside the company. This enables a seamless cascade of changes in metadata vertically and horizontally across clinical trials. Powered by TCS’ unique code generation engine, the component automates the conversion of clinical data to Clinical Data Interchange Standards Consortium (CDISC) or sponsor-specific standards.

Mobile 1000 Scores Big

TCS has successfully implemented the platform at a leading pharmaceutical company, Boehringer Ingelheim, helping it revolutionize its clinical development process. Andrea Rauch, Head, Clinical Data Standards and Business Capabilities, Boehringer Ingelheim, said, “With the successful roll-out of MRT, we are able to maintain and govern our company, therapeutic area, and project standards using configurable workflows while pushing our study metadata to our EDC system with the click of a button. This is a first step and further releases will offer us an opportunity to revolutionize our clinical development by automating the process of converting study data to submission-ready SDTM data. This implementation is part of Boehringer Ingelheim’s Biometrics and Data Sciences Strategy to set-up and conduct clinical studies and analyze data while supporting our mission of bridging data to solutions.”

Mobile 1000, a social initiative programme by Wockhardt Foundation achieves its next milestone by launching the 200th medical van. The mobile 1000 vans aim at providing professional healthcare delivery to the rural most areas in the country. The launch of the 200th van is significant as it further strengthens the reach of the programme.

The 200th mobile medical van was launched in the state of Karnataka with the contribution from Kotak Life Insurance Co Ltd. Health vans are instrumental in bridging the gap in delivery of health services for the patients who have limited access to these facilities. The Wockhardt Foundation mobile medical vans are already serving patients in rural 44 ◄ March 2019

Pharma Bio World

news Piramal’s Partner Launches Generic Cinacalcet in the U.S. Piramal Enterprises Limited announced that one of its partners for its global pharma businesses - Slate Run Pharmaceuticals LLC. (‘Slate Run’), has launched generic cinacalcet hydrochloride tablets (30 mg, 60 mg and 90 mg) in the United States. Piramal’s subsidiary, Piramal Healthcare (UK) Limited (‘PHL’), has partnered with Slate Run Pharmaceuticals with the goal of developing a non-infringing formulation of cinacalcet hydrochloride tablets. Cinacalcet tablets are indicated for the treatment of secondary hyperthyroidism (‘HPT’) in adult chronic kidney disease patients on dialysis and hypercalcemia in adult patients with parathyroid carcinoma.

“As part of our patient focus strategy, we are working with global pharmaceutical firms, to co-develop products, where our R&D competencies can bring about a differentiated and cost effective value proposition for the global healthcare system. With world class R&D and fully integrated network of manufacturing capabilities across the globe, for both drug substance and drug product, Piramal is uniquely positioned to solve both complex chemistries and formulation challenges in the pharmaceutical domain with innovative solutions for partners,” said Vivek Sharma, CEO – Piramal Pharma Solutions, Piramal Group. PHL received the final Abbreviated New Drug Application (‘ANDA’) approval for its generic abbreviated bioequivalent (‘AB’) rated version of Amgen Inc’s Sensipar (cinacalcet hydrochloride) tablets on August 1, 2018. Piramal received a favourable US district court ruling which holds that Piramal’s generic version does not infringe any of the asserted claims of Amgen’s Patent No: 9,375,405. Amgen has filed an appeal which is currently pending in the U.S. Court of Appeals for the Federal Circuit.

Optimized Safety Assessment Solution to Enable First-in-human Clinical Trials Envigo, a leading provider of non-clinical contract research services and research models, has launched ‘Pathway’ an integrated solution that optimizes non-clinical safety assessment programs to enable first-in-human clinical trials. It is designed to manage the complexity of the entire safety assessment process on behalf of the company’s pharmaceutical and biotechnology customers by integrating safety assessment study types and bio-analytical support with scientific and regulatory consulting, program design and project management. This helps to navigate the increased scientific and regulatory complexity facing advanced therapies going through safety assessment. The intricacy of design and management of these critical non-clinical programs, and the level of interaction with regulatory bodies required, raises the risk of introducing delays and costs to development programs. ‘Pathway’ has been designed to leverage Envigo’s capacity, capabilities and experience in the field to optimize safety assessment programs and deliver translational biology insights to prepare customers for first-in-human clinical trials. “Our deep expertise in the complex fields of biologics and advanced therapies adds particular value to our customers with drug development programs in these growing categories. On our customers’ behalf, we frequently work with regulators to determine the most appropriate interpretation of regulatory guidance as it applies to a specific Pharma Bio World

therapeutic,” commented Lee Coney, Envigo’s Chief Scientific Officer.

The solution makes full use of our beginning-to-end understanding of the safety assessment process, and optimizes the journey to first-inhuman studies. Experience of designing and conducting studies in a wide range of therapeutic modalities, and in working with regulatory agencies around the world, means we are able to anticipate the needs of a program at design stage, plan studies accordingly, and manage an optimal timeline of study execution. With harmonized facilities with AAALAC accreditation in Europe and North America, Envigo further seeks to optimize safety assessment programs by ensuring studies are carried out at centers of excellence and where capacity permits the earliest possible start date for commencing work.

Prashant Nagre Recognised as the Best CEO of the Year Fermenta Biotech’s CEO, Prashant Nagre, has received the Best CEO of the Year award in the prestigious Pride of Maharashtra Award 2018.

The award was under the manufacturing category (Pharmaceuticals).

The award was presented by Dr Raghunath Mashelkar, President of Global Research Alliance & Former Director General of Council of Scientific & Industrial Research (CSIR), at a ceremony held on 21st February 2019. Nagre was responsible for noteworthy transformational activities undertaken at FBL such as capacity expansion, increasing its global footprint, digitization initiatives for operational excellence, customer proximity measures and product quality assurance. Under his leadership, FBL has doubled its turnover to over INR 300 cr over the last financial year, and won numerous prestigious awards such as the India Pharma Awards 2018 in three categories: Excellence in CSR for companies with turnover less than INR 500 cr, Pharma International Excellence, Excellence in Export Promotion as well as National Best Employer Brands 2018 at the World HRD Congress and Hindustan Times Thane Ratna Award 2019.

Novel Treatment for Dry and Wet Age-related Macular Degeneration OliX Pharmaceuticals, Inc, a leading developer of RNAi therapeutics, has announced that it has signed a license and collaboration agreement with Théa Open Innovation, part of the Laboratoires Théa S.A.S (Théa) which is the leading French independent pharmaceutical company in Europe dedicated to ophthalmology, to develop and commercialize OLX301A. Under the agreement, OliX receives a non-refundable and non-creditable upfront payment of 2 million euro and is eligible to receive milestone payments upon achievement of clinical milestones, plus royalty for the development and commercialization. Théa has been granted licensing rights for OLX301A program in EU countries, Middle East and Africa. OliX continues to hold the rights of OLX301A program for US and Asia.

Dong-ki Lee, the founder and CEO of OliX, stated, "OliX's cp-asiRNA platform technology is an RNAi platform optimal for the development of ocular therapeutics, which can circumvent potential side effects arising from the existing siRNA technology. The collaboration with Théa proves that OliX's ophthalmology RNAi platform has been recognized in global pharmaceutical market, and we will continue to expand pipelines for eye diseases."

March 2019 ► 45

news Dr Christiane Hamacher is the CEO Biocon Biologics India Ltd Biocon Ltd Asia’s premier biopharmaceuticals company, announced today that Dr Christiane Hamacher has been appointed as CEO of Biocon Biologics India Ltd, a wholly-owned subsidiary of Biocon Ltd. Dr. Hamacher comes with more than 20 years of leadership experience in both strategic and operational roles across the value chain in global pharma, spanning Asia, Europe and the U.S. She has been with Roche, Basel, Switzerland since 2007 and prior to that spent 10 years at Schering AG, Berlin, Germany.

Dr. Hamacher is an accomplished international C-suite executive with a passion for setting the corporate vision, defining and implementing future-driven strategy and growing businesses through entrepreneurial innovation and patient-centricity. She has robust experience in steering complex, global matrix organizations, quickly building strong, trusting relationships to enable achievement of top-level results. During her long career in the pharmaceutical industry, she has built expertise in the areas of oncology, virology, CNS, cardiovascular, gynaecology, diagnostics, dermatology, rheumatology and rare diseases. She holds a Ph D. in Molecular Biology (Oncology) from the University Clinic Bergmannsheil / University of Bochum, Germany. She also studied Economics at the University of Hagen, Germany.

Kiran Mazumdar-Shaw, Chairperson & Managing Director, Biocon, said: “I am delighted to welcome Christiane Hamacher as CEO of Biocon Biologics India Ltd. Christiane joins us at a critical inflexion point in the business as we build our stature in the large and growing opportunity for biosimilar biologics. I am confident that she will successfully lead the company to become a major global player in the near future. Being a woman leader, I believe she also brings a diversity perspective which is integral to our leadership journey.”

Sanofi Genzyme observes Rare Disease Day in India Sanofi Genzyme, the specialty care global business unit of Sanofi, observed Rare Disease Day on 28th February 2019, in India. Rare Disease Day takes place on the last day of February, a month known for having a ‘rare’ number of days. Sanofi Genzyme has partnered with - Organization of Rare Diseases India (ORDI) for the ‘RaceFor7’ run in Mumbai, Bengaluru, Chennai and New Delhi; and with Lysosomal Storage Disorders Support Society (LSDSS) to raise awareness in Delhi, Chennai, Jaipur and Kozhikode about such debilitating disorders.

Observed every year on the last day of February, Rare Disease Day is an international awareness campaign established by the European Organisation for Rare Diseases (EURORDIS) in 2008. It is globally supported by hundreds of patient organizations. This day provides an opportunity to bring to the fore the impact that these debilitating diseases have on patients and their families.

Given the nature of rare diseases, there is limited awareness of the concept, the existence, the diagnosis and the prevalence of such diseases. This day provides an important opportunity to shed light on the impact that these chronic and debilitating diseases have on patients and their families. Sanofi Genzyme is committed to working with the medical fraternity, the government, scientific bodies, universities and 46 ◄ March 2019

patient advocacy groups to support greater awareness and education for timely diagnosis and access to treatment. Sanofi Genzyme’s humanitarian program is in its 21st year in India and supports over 130 patients diagnosed with four of the treatable Lysosomal Storage Disorders. Through India Charitable Access Program, it provides the treatment totally free of cost to these patients, in a country where treatment access is limited. Sanofi Genzyme in India is focused on treatment for rare diseases, multiple sclerosis and immunology, and is committed to working with key stakeholders to develop sustainable partnership models.

SIRIO Pharma Receives Sports Nutrition Production License Approval Sirio Pharma Co Ltd (SIRIO), the global nutraceutical contract development and manufacturing organization (CDMO) has been granted SC (production license) of sports nutrition food in China. The approval enables Sirio to add special sports nutrition ingredients into products and covers six functional classes for ‘protein supplementary’, ‘speed and power’, ‘endurance’, ‘energy control’, ‘energy supplementary’, and ‘postexercise recovery’. Due to the stringency of regulations and complexity of achieving approval, Sirio is now one of just seven approved license holders in the country.

“In the last few years, sports nutrition in China has grown extremely quickly – at a CAGR of 37% between 2013-2017 – and is forecast to continue to expand at up to 50% per year, easily outstripping growth in the USA and other global market. So it is a huge opportunity not only for domestic companies, but also international brands” commented Rui Yang, CSO of SIRIO Pharma.

Until recently, the barriers to entry for international brands in China were high, and the majority entered the market using cross-border e-commerce. However, Sirio’s new sports license – coupled with its strong formulation capabilities and capacity – now provide the possibility of contract manufacturing these products in China and selling through all distribution channels across the country. Potentially opening-up a far larger customer base. It also enables international brands to start developing customized sports nutrition products that are tailored to local consumer preferences in China. Significantly, the license allows nutra brands to make specific functional claims on sports nutrition product labeling, and will cover popular ingredients including concentrated whey protein, whey protein isolate, soy protein isolate: BCAA, CaHMB, creatine, and many vitamin and minerals.

The consumer demand for sports products in China has exploded in the last few years, in part thanks to the national fitness policy, yet the production and regulatory environment is still maturing. As a result, only a very small number of companies have licenses and, through Sirio, we foresee tremendous opportunities for brand companies to access one of the fastest growing segments of the nutrition industry globally. In fact, we have already had a number of enquiries and we are able to start production immediately. What is more, for established brands who want to build their name in China, by partnering with Sirio, they are now even able to develop completely unique products tailored to the Chinese sports consumer. The new sports production license has been introduced to better regulate manufacturers and combat counterfeit products in China, and involves a rigorous onsite audit covering environmental control, equipment, warehousing and documentation.

Pharma Bio World

news Saridon Exempted from List of Banned FDCs The Supreme Court of India has ruled in favour of Saridon, a heritage brand from the healthcare product portfolio of Piramal Enterprises Limited (PEL), exempting its formulation from the list of banned FDCs (Fixed Dose Combinations). In September 2018, PEL had been awarded a stay order from the Supreme Court on the ban, which allowed it to continue manufacturing, distribution and sale of the FDC. Saridon, amongst the most trusted heritage analgesic brands in India, enjoys strong customer allegiance globally. Commenting on the Supreme Court ruling, Nandini Piramal, Executive Director, Piramal Enterprises Limited said, “We are pleased with the Supreme Court ruling, as it is an affirmation to our commitment to provide effective and safe healthcare solutions that address unique needs of Indian consumers. We were confident that the law would prevail in our favour. Saridon is a heritage brand trusted by customers for the last 50 years in India. This exemption from the banned list of FDCs validates our intent to serve our customers with the highest levels of integrity. We continue to expand our healthcare product portfolio with an aim to be amongst the top three OTC (over the-counter) product companies in India by 2020.”

As per a recent study by A C Neilson, the addressable analgesic market is ~INR 6,450 crores, of which the analgesic tablet market is ~INR 2,050 crores (as of December, 2018). Saridon is amongst India’s most widely distributed analgesic tablets with a strong distribution network across 9 lakh outlets in India. According to Nielsen study conducted in 2017, the popularity of the brand is widespread with 31 tablets being sold every second. Saridon continues to be amongst the most trusted heritage brands in India, that enjoys strong customer allegiance globally.

Blackstone to acquire AYUMI Pharmaceutical Blackstone has announced that private equity funds managed by Blackstone have entered into a definitive agreement to acquire AYUMI Pharmaceutical Corporation, pharmaceutical company in Japan focused on Anti-Rheumatism and Orthopedics, from Unison Capital, an independent private equity firm based in Japan, and M3, Inc, a medical information site business.

Atsuhiko Sakamoto, Senior Managing Director and Head of Japan Private Equity at Blackstone, commented, “We are delighted to announce our new partnership with AYUMI. Under the leadership of its seasoned management team, AYUMI has established a robust foundation as a leading specialty pharmaceutical company in the field of rheumatism and orthopedics – with world-class medical and scientific capabilities.

We look forward to working with the Company to leverage Blackstone’s global footprint and expertise in this sector to help AYUMI meet the growing need for its RA and orthopedic products, invest in new, cuttingedge treatments and products, and continue supporting the Company’s mission of improving patient health.”

Ouchi Hikaru, Representative Director, President and CEO of AYUMI, commented: “It is a great honor to announce our new partnership with Blackstone to further accelerate our growth. Although we have already established a strong platform of growth in partnership with Unison Capital, from orthopedic therapeutic areas to RA areas and further Pharma Bio World

through the new introduction of biosimilar products, we will need more investment for future growth. We have great expectations for our new shareholder in order to further enhance our presence in the Japanese pharmaceutical industry and to continue providing drug treatments that contribute to patients and to society.

The acquisition would mark Blackstone’s first control private equity investment in Japan. The transaction is expected to close in the second quarter of 2019, subject to regulatory approvals and customary closing conditions.

Asia set to lead the way on healthcare but supply chains face complex challenges New biopharma, medical advances and innovative healthcare products largely evolved in developed parts of the world before making their way to emerging markets. These sectors are still dominated by companies in North America and Europe, but a gradual shift has started towards Asia in terms of global innovation. Asia is now poised to lead the way, as a growing patient population and increased investment in infrastructure supports the trend to home-grown biologics and other innovative therapies. This growth in biologics will deem necessity of new supply chain demands. China and South Korea are the most active in Research and Development (R&D) such as clinical trials prompting expansion of healthcare hubs in a thriving innovation ecosystem. Yet the trend from small molecular drugs to a biologics-driven drug creation process is one which is increasingly complex, time-consuming, expensive and risky.

The complexity of these drug materials that FedEx is now transporting every day means there’s a greater need for more sophisticated logistic and distribution solutions. The challenge the company have as supply chain partners is to find that critical balance between the cost effectiveness of shipping active pharmaceutical ingredients (APIs) and formulations to research laboratories, with safety, trackability and regulatory compliance.

A high-risk industry demands highly-differentiated solutions. As a result, customers have identified pain points in the transportation process.

Pharma customers of FedEx in China cite product quality, speed, logistics costs, regulatory compliance, operational quality and end-toend supply chain expertise as absolute must-haves for their Speciality Pharma, Biologics, Vaccines and Clinical Supplies.

In such a competitive climate, highly specialised logistic solutions take on even greater importance – providing fast and professional customs clearance, timely and accurate monitoring throughout the journey, and most significantly, cost-effectiveness.

Solutions like FedEx technology SenseAware controls and monitors temperature-sensitive shipments, provide real-time tracking and visibility into inventory using GPS communications. Building secure and compliant distribution solutions requires stronger collaboration with customers.

FedEx is putting innovation into practice - by integrating technology with transportation and also integrating compliance with the supply chain process. This is raising the overall service level of the supply chain industry to better meet the requirements of biopharma customers, ensuring innovation remains at the heart of everything we do.

March 2019 ► 47

news C2 PHARMA Acquires Digoxin API Portfolio from Nobilus Ent C2 PHARMA s.a.r.l., a Luxembourg-based phytochemical and chemical pharmaceutical manufacturing and distribution group, has acquired the Digoxin API product portfolio of Polish company, Nobilus Ent, self-developed and inherited from Roche/Galenus Mannheim.

Through the agreement, C2 PHARMA is the product owner, and Nobilus is a manufacturing partner and releasing entity for the API. Parallel manufacturing to ensure redundancy is supported by longterm partner, Laurus Labs, an India-based API manufacturer with an impeccable track record.

Since 2014, Digoxin API availability has been frequently and severely disrupted causing shortages of product due to high levels of impurities and an unreliable supply chain. To mitigate the expected future impact of those Digoxin API shortages, C2 PHARMA has taken various actions, including this recent agreement, as well as setting up a fully independent supply chain for digitalis leaves and investing in a brand new, dedicated, state-of-the-art manufacturing facility with Laurus Labs in India.

“While this type of investment is unprecedented for such a niche product, we believe that it is the most responsible path to secure a quality, continuous supply of this complex and essential API,” CEO of C2 PHARMA, Andrew Badrot said. “With existing impurity and supply issues, and as regulatory authorities progressively tighten specifications, this places C2 PHARMA at the forefront of purification technology and process innovation for Digoxin API.” Tech transfer has been completed and validated, and the Digoxin API is currently in production at the Nobilus Ent and Laurus Lab sites.

Purchases can be made directly from C2 PHARMA.

Indian Pharma Industry witnesses new trends introduced by Schott Kaisha Schott Kaisha successfully concluded its 5-city roadshow, bringing together industry experts, R&D specialists, business and sales leaders for discussions on the latest technological advancements and best practices that lead to drug safety. Held over 2 weeks, the events gave participants a clear understanding on the importance of conversion process in tubular glass manufacturing, and showcased Schott Kaisha’s upcoming product portfolio, tailor-made design and development capabilities.

Rishad Dadachanji, Director, Schott Kaisha shared, “the Indian packaging industry is undergoing rapid growth and we have always been committed to address the demands and challenges of our customers. Hence, we always work together with our partners to deliver better integrated lines of solutions and services. We are extremely happy with the response at the roadshow. This has helped us further strengthen our position in the industry as a catalyst of innovation and technology. As a key takeaway, we have decided to work even closer with our stakeholders and meet their demands by investing in yet another manufacturing unit in Umarsadi, Gujarat, as well as plan to set up an entirely new plant in northern India.”

With fresh investments in new sites in Gujarat and North India, expansion and upgradation of existing plants in Daman and Jambusar, Schott Kaisha’s financial commitment will further increase by up to INR 48 ◄ March 2019

500 crores between 2018 and 2020. The increased capacity will cater to the growing demand of ampoules, vials, syringes, cartridges and sterile portfolio. Through this increased production capacity, the company is focussing on catering to the domestic market first, with a current supply to export ratio of 75:25.

Lucence Diagnostics to develop AI tools for treating liver cancer Lucence will be working with Olivier Gevaert, PhD, Assistant Professor of Medicine (Biomedical Informatics) and of Biomedical Data Science at the Stanford University School of Medicine. Lucence Diagnostics, a genomic medicine company focused on personalizing cancer care, has announced a new project to develop AI algorithms for improving diagnosis and treatment of liver cancer. The goal is to combine the imaging and molecular data from liver cancer patients into smarter software tools that help physicians make better treatment decisions.

Having developed LiquidHALLMARK, the world’s first liquid biopsy next generation sequencing test that analyzes the DNA of cancercausing mutations and viruses, Lucence will contribute its genomics expertise and proprietary sequencing technology to this project. This project will evaluate a dataset of over 5,000 patients to identify image changes and patterns that are linked to diagnostic and treatment outcomes in liver cancer.

Everstone-backed Everlife acquires CPC Diagnostics Everlife plans to support CPC’s manufacturing and distribution capabilities within India and South-East Asia, to become the leading IVD distributor in India. The Everstone Group via its pan Asian healthcare platform Everlife, has acquired a stake in Chennai based CPC Diagnostics, to include core in-vitro diagnostics (IVD) segments in its portfolio of medical devices and extend its geographical presence to India, with this first investment in the country.

Founded in 1987, CPC Diagnostics (“CPC”) is a medical devices manufacturer and distributor with presence across India, Sri Lanka and Bangladesh, and exports to countries in Middle East and Europe. It supplies a wide range of products and services to research and clinical laboratories. With this strategic investment, Everlife plans to support CPC’s manufacturing and distribution capabilities within India and SouthEast Asia, to become the leading IVD distributor in India.

The in-vitro diagnostics (IVD) segment is one of the largest within the medical devices market. CPC’s portfolio already overlaps with IVD’s biggest segments, namely the immunoassay, bio-chemistry and haematology segments. The investment would allow CPC to consolidate their position in these core segments while expanding territorial reach.

Everlife also has investments in Malaysia-based Chemopharm Group, a leading provider of products and solutions to laboratory, research and medical facilities in South-East Asia; DV Medika Group, manufacturer and distributor of one of Indonesia’s top brands of hospital furniture and other imported medical equipment and supplies; and Singapore-based Bio-REV Pte Ltd., which specializes in distribution of reagents, media and consumables to the Life Sciences industry.

Pharma Bio World

Single-sided Rotary Press The KTP 590X is an extremely versatile single-sided rotary press which can be used to manufacture both mono-layer and bi-layer tablet formats. It can be switched between mono-layer and bi-layer mode without any modifications to the compression roller set-up. Bi-layer tablets can be compressed at any time on the version with three compression rollers. The tablet press is equipped for this purpose with two standard fill shoe modules, which distribute the powder uniformly in the die. Thanks to the optimised paddle design, even poorly flowing or sticky powders can be processed efficiently and compressed homogeneously. With its three separate compression stations, the Kilian KTP 590X is equally suited for manufacturing effervescent tablets. The powder is tamped initially to prevent the formation of air pockets and capping. Then it is pre-compressed and finally converted into finished tablets in the main compression unit. The dwell time is significantly longer owing to the use of Kilian 28/41 tooling, meaning harder tablets can be made, even at high operating speeds. The Romaco Kilian KTP 590X single-sided rotary press boasts a max output of up to 510,000 tablets per hour, even in bi-layer mode. Low process temperatures, efficient cleaning and changeover and a mature hygiene concept – the KTP 590X single-sided rotary press too, conforms to the design principles of Romaco Kilian’s successful KTP Series.

For more information, please contact: Romaco Group Am Heegwald 11, 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Frequency Inverter NORD DRIVESYSTEMS offers an ATEX-compliant, decentralised frequency inverter that not only is economical in operation but also comes in protection class IP 69K. This guarantees the complete sealing of the housing, even for processing applications which require frequent high pressure cleaning. Many applications do not fully utilise the immense scope of functions of modern frequency inverters. To fill the gap which has resulted between simple motor starters and full featured frequency inverters, NORD DRIVESYSTEMS has developed the NORDAC BASE – SK 180E. This compact frequency inverter concentrates on the essential functions for pumps and conveyor technology (PI/speed control, energy saving, communication with peripherals) and results in significant savings.

The NORDAC BASE includes power ranges up to 2.2-kW and can be mounted decentralised, outside the switch cabinet (mounting to the wall or on the motor is possible). The inverter is flexible with regard to accessories and function, and a great number of communication interfaces make it compatible with all common bus systems. The drive controller offers high precision control. IP 69K offers ultimate protection against the ingress of dust and jets from high pressure water and stem cleaning. The SK 180E is designed to control synchronous and asynchronous motors. Energy-efficient operation is possible due to its energy saving function for partial load operation: the motor power can be adapted to load changes automatically. The NORDAC BASE comes with an integrated PLC. The intelligent drive electronics reduces the load on the higher level system control unit and allows for a modular plant design. Application data can be evaluated in real time by the decentralised PLC, eg, for the optimisation of diagnostic facilities. The SK 180E can be modified for operation in explosive environments. Depending on the area of application (conductive or non-conductive dust), the modifications also include the replacement of the transparent diagnostic caps with a version made of aluminium and glass. This allows the operation of the frequency inverter directly in a hazardous area (ATEX 22-3D).

For more information, please contact:

Getriebebau NORD GmbH & Co KG Getriebebau-Nord-Straße 1, 22941 Bargteheide / Hamburg, Germany Tel: +49 45 32 / 2 89 -0, Fax: +49 45 32 / 2 89 -22 53 E-mail: pl.muthusekkar@nord.com / Joerg.Niermann@nord.com

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HYDROSYS (Liquid Ring Vacuum Pump) With vast experience coupled to the countless installations in the field, Toshniwal offers many types of turnkey packages to meet the customer’s needs.

Pump system Type HYDROSYS include liquid ring vacuum pump, cyclone type air-liquid separator and heat exchanger, and associated accessories all mounted on a fabricated frame.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Roots Pumping Systems Counted among the prominent manufacturers, suppliers and exporters of a wide range of roots pumping systems, Toshniwal provides solution to your vacuum application.

It replaces multi-stage water/liquid ring pumps, steam jet ejectors with compact vacuum packages. Available in a spectrum of specifications, these systems are used in distillation process, food processing, drying of powder and solids, and transformer evacuation. The volume flow is from 180 to 97,000 m 3/hr. There is savings in energy resulting from low motor rating. Booster and rotary may be started at the same time.There is built-in bypass value to protect from overloads.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshwnial.net

Powder Transfer System Toshniwal has expertise in manufacturing vacuum pump of more than three-decades for varied application. The vacuum conveying technology is a proven method of moving dry bulk solids and powders in a range of applications. It is widely used in food, pharma, chemical and industrial environments. Frequently noted benefits of vacuum conveying systems include cleanliness due to the closed conveying lines, reliability, low noise, simple operation, gentle material transfer with dilute to dense phase conveying, easy low-cost maintenance, lower operating cost and safety.The most common vacuum conveying systems use a batch process. The transfer line is sealed, a vacuum pump is activated, and the process material (powder or granules) is conveyed to a receiving vessel. When the batch is complete, vacuum is released and the material is dropped or transferred from the receiving vessel to the desired destination. The system is again sealed, and vacuum is reintroduced to get the product flowing again. The selection of the vacuum pump is one of the most important element of the system design. The vacuum pump needs to be able to quickly evacuate air from the line, pull and maintain enough vacuum to induce product movement, and provide a volume of air that is sufficient to transfer all the material needed in a given time.

For more information, please contact: Toshniwal 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net

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Plunger Type Dosing & Metering Pump / Industrial Metering Pumps SRS Pumps offer qualitative range of plunger type dosing and metering pumps and industrial metering pumps. These pumps are positive displacement pumps and in each cycle of operation displace a particular amount of fluid. The pumping action is created by the reciprocating motion of a plunger. As per the requirements of the customers, SRS Pumps offer their assortment of plunger metering pumps and industrial metering pumps in different models. These pumps have two parts such as drive end mechanism and the liquid-end mechanism. It can be distributed in simplex, duplex or multiple heads for handling various chemicals with a common motor to facilitate the whole operation. Each head is independently connected and the capacities of each head are also independently adjustable. It can achieve flow rates up to 10,000 LPH and delivery pressures up to 400 kg/cm2; steady state metering accuracy of +/-1% of pumps output; and handles corrosive, abrasive or viscous fluids. Flow metering accuracy is almost independent of back pressure of liquid. Discharge flow rate is linear to variation of stroke length. Heating of cooling jackets for liquid head is also available. SRS Pumps offers different types of plunger pumps such as simplex, duplex, triplex and multiplex. MoC (wetted parts) includes: SS-304/SS-316/Alloy 20/Hastealloy B/Hastealloy C, etc.

For more information, please contact: SRS Pumps Chawl No: B, Pitch No: 3, Pimpal Galli, Nr Hindustan Naka Charkop, Kandivli (W), Mumbai 400 067 E-mail: info@srspumps.net / srspumps@gmail.com

Model-Based Systems Engineering Maplesoft offers MapleMBSE, the software that enables companies to employ a Model-Based Systems Engineering (MBSE) approach to their design projects without requiring every engineer on the project to be an expert in complex MBSE tools. The latest release, MapleMBSE 2019.0, further improves the workflow by making it even easier to create and modify many of the structures used to define and analyze the design.

Using an Excel-based interface, MapleMBSE provides a streamlined interface for each task in your MBSE project, such as defining requirements, impact analysis, trade-off studies, and failure mode effects analysis. These streamlined interfaces make these tasks significantly easier to perform, and reduce the time and errors that typically come with using a standard MBSE tool. The new release includes enhanced support for the Systems Modeling Language (SysML) used by many MBSE tools, including MapleMBSE. Increased support is available for a variety of constructs that are used to define requirements, architecture, behaviour, and relationships, including activity diagrams, state machines, and parametric diagrams. By making it easier to create and modify these underlying SysML constructs, the new release further reduces the time and effort required to define the requirements and the relationships between them, analyze the impact of changes, and improve the design.

Other improvements in this release enhance the integration of MapleMBSE with model management systems, including faster model access through Teamwork Cloud. By connecting MapleMBSE to Teamwork Cloud, customers can seamlessly access models created in a number of different tools, including MagicDraw, and Cameo Systems Modeler. MapleMBSE can also be integrated directly with other SysML-based tools, such as IBM Rational Rhapsody.

For more information, please contact: Maplesoft 615 Kumpf Drive Waterloo ON N2V 1K8, Canada

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Tableting Robot

Capture Hood

The Romaco Kilian STYL’ONE Evolution singlestroke press is the ideal solution for laboratory applications, whether for developing new formulations or for scale-up tests. It achieves a max output of 1,750 tablets per hour in configurations for mono-layer, multilayer or core tablets. The compression cycles have been speeded up by more than 60 per cent and the max compression force increased to 50 kN in order to simulate high speed presses. Compression force profiles for all standard rotary presses like the Romaco Kilian KTP 420X can now be determined at full power. ANALIS, the intelligent PAT software, calculates all relevant tableting parameters based on compression force or displacement controlled cycles. The remarkable precision of the test batches means powder properties can be analysed very realistically. The STYL’ONE Evolution can thus also be utilised to optimise processes or troubleshoot errors.

For more information, please contact:

Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

It is an efficient extraction of the fumes in all phases of operation. Energy saving by an integrated furnace cover, air flow control and an optimized design for less false air, less pressure loss. Robust design, easy to maintain custom-made – individually adapted to the furnace, the melting area, charging wagon, ladle, operating process, etc.

Ease of operation – hydraulically-operated, no mechanical interlocks: the hood is moved by the operators or levers in the control booth. Good access and visibility to the melting bath and the furnace spout.

For more information, please contact:

Doo Young Eng Co, Ltd #782-18, Gomo-ro, Hanlim-myeon Gimhae-si, Gyeongsangnam-do, Republic of Korea 50850 Tel: +82-55-346-5178, Fax: +82-55-346-5181 E-mail: dy1542@hanmail.net

AODD Pumps Shanbhag & Associates is the authorised national distributor for the entire range of Dellmeco Products with an all India sales and service network.

The range of Dellmeco pumps includes solid block AODD pumps in PE, PTFE in conductive and non-conductive housings from 1/4” to 3”; SS, CI, PTFE, coated and aluminium housing AODD pumps from 3/4” to 3”; hygienic, zero hold-up sanitary SS-316L AODD pumps from 1/2” to 2.5”; jacketed and high-pressure AODD pumps for applications such as filter press; AODD pumps for powder transfer.

The pumps internals are available in EPDM or with chemically bonded TFM diaphragms and ball valves. Dellmeco AODD pumps are absolutely lube-free; non-stalling in operation and corrosion-free. Air valve body is available in corrosion-free engineered plastics.

There are fewer moving parts and commonly used spares across models and sizes.

Dellmeco pumps find application in industries such as pharma, paint, chemical, clay and ceramics, electroplating/surface treatment, food, dairy and beverages, automotive, glass and fibreglass, oil and gas, marine/shipbuilding, metal and steel treatment, effluenttreatment, aircraft, etc.

For more information, please contact:

Shanbhag & Associates B-50 Nandbhuvan Indl Estate Mahakali Caves Road, Andheri (E), Mumbai 400 093 Tel: 022-40365711, Fax: 91-022-40365712 E-mail: info@shanbhags.com

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Granulation Line The M 100 high-shear mixer for manufacturing wet granules was developed by Romaco Innojet especially for the new IGL 100 granulation line. In combination with the VENTILUS V 100 LE dryer, this technology is ideal for achieving compact granules, which are mainly processed during the production of pharma solids. Innojet now also offers an end-to-end line concept for manufacturing and subsequently drying wet granules. The first version of the Innojet IGL 100 is designed to handle batches of up to 100 litres. In the medium term, the new IGL Series will be capable of processing batches as large as 800 litres. The line concept ships with central process control and can be cleaned using an integrated WIP (wash in place) system. The transfer from the mixer to the dryer is gravimetric. The very short transfer section manages without an external air supply and meets the high requirements for the containment. The wet granules are then dried extremely gently and uniformly in the VENTILUS V 100 LE. The process air for this purpose is introduced by means of the ORBITER booster. Thanks to Romaco Innojet’s patented air flow bed technology, the movement of the product can be precisely controlled, so that the drying process is not only gentle but also very efficient.

For more information, please contact: Romaco Group Am Heegwald 11, 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Real-time Moisture Measurement AMETEK Process Instruments has broadened its AMEVision communication and display system capabilities to include the 3050 Series of moisture analyzers. Originally designed for WDG-V analyzers, the AMEVision system provides real-time moisture measurements and trend data while also detailing a variety of maintenance and troubleshooting information.

Users can now continually monitor the measurement and diagnostic information for up to eight 3050 Series moisture analyzers. AMEVision enables the convenience of on-site calibration and communication with analyzers via Modbus RS485 and Ethernet LAN. The system augments or replaces the 3050 configurator software, providing all the same features and capabilities, including span verification and zero calibration.

Additionally, AMEVision stores the last 10 successful calibrations and all alarms.

The 3050 Series analyzer can be pre-configured at the factory to directly communicate with AMEVision, eliminating the need to set it up, which will ultimately save time in the field. Users can extract data and upload new configuration files directly to the unit via a USB port.

AMETEK Process Instruments is the leader in online analytical instrumentation with the industry’s most extensive product line. The company offers analyzers based upon 11 differentiated technology platforms for use in a variety of markets including oil and gas, power, pharma manufacturing and semiconductor chip manufacturing. AMETEK Process Instruments is a unit of AMETEK, Inc, a leading global manufacturer of electronic instruments and electric motors.

For more information, please contact: AMETEK 1100 Cassatt Rd, Berywn Pennsylvania 19312 U.S.A. E-mail: greg.galiffa@ametek.com

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Magnetic Float Switch Float switch is an electrical On-Off switch, which operate automatically when the liquid level goes up or down with respect to a specified level. The signal thus available from the float switch can be utilized for automatic control of pump or allied elements like solenoid, lamp, relays, etc. These magnetic float switches are available in a wide range according to operating and mounting methods to suit variety of individual application. These are rugged, accurate and reliable operation. These floats are available in verticle type, Horizontal type in PVC, SS, Nylon material depends on application. MRK Engineers can also supply high temperature application, cable type electrical float as well as other than water like oil, sand, granule, salt, wood, etc.

For more information, please contact:

MRK Engineers 15/1A2, Plot III, Lakshmi Nagar Ramamoorthy Street Moondramkattalai (Post) Chennai 600 128 E-mail: ramakrishnan252008@yahoo.com.

Silicone Diaphragms Medical-grade, platinum-cured silicone is widely accepted in pharma and biotech applications and is often used throughout the plant.

Like all of our diaphragm materials, silicone diaphragms meet USP Class VI and FDA 21 CFR 177.2600 Standards.

It is suitable for biomedical/pharma application. All diaphragms meet the standards for quality, purity, lack of toxicity, strength and consistency.

For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

Oxygen Permeation Analyzer AMETEK MOCON offers OX-TRAN 2/40 oxygen permeation analyser for whole package testing of cups, trays, pouches and other forms. AMETEK MOCON offers a new analytical instrument to measure the oxygen transmission rate (OTR) of whole packages under precisely controlled environmental conditions. The new OX-TRAN 2/40 Oxygen Permeation Analyzer for OTR measurements targets package permeation testing for food, beverage and healthcare packaging applications in which knowing the precise oxygen ingress through a package is critical to a product’s shelf life. Applications for the OX-TRAN 2/40 include permeation testing of thermoformed trays, bottles, flexible pouches, corks, caps, and more. Historically, testing the oxygen permeation of whole packages either suffered from poor control of the test gas conditions, since the package was tested in room air, or required cumbersome set up of an independent environmental chamber that was often difficult to use. Adding to the complexity of legacy package permeation testing, package samples needed to be epoxy adhered and heat removed from reusable plates. The OX-TRAN 2/40 utilizes MOCON’s industry-standard coulometric sensor, so no calibration is required, and it complies with ASTM F1307 for OTR measurements.

For more information, please contact: AMETEK Inc 1100 Cassatt Road, Berwyn Pennsylvania 19312, U.S.A. Tel: +1-763-493-7238 E-mail: jamie.durkin@ametek.com

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Innojet VENTILUS V 5 Processing Machine Granulation and coating technologies by Romaco Innojet offers the VENTILUS V 5 processing machine. Biogrund is a supplier of innovative premixes and carriers. The two manufacturers work together closely, especially when it comes to developing hot melt coating formulations for pharma products. The VENTILUS technology is suited for both melt and polymer coatings. The laboratory-scale version of the Romaco Innojet VENTILUS V 5 is used for particle sizes from 10 µm to 2 mm. Only one product container is required for the granulation, drying and coating steps. Due to its special design and enhanced processing efficiency, the VENTILUS V 5 allows up to 85 per cent shorter batch times with hot melt coating applications and up to 25 per cent with polymer coatings. The homogeneous flow conditions inside the cylindrical product container enable extremely gentle intermixing of the batch and hence play a crucial role here. The air flow bed technology ensures accurate control of the product movement and equally precise application of the spray liquids. The process air is controlled by the ORBITER booster, an ingenious container bottom consisting of overlapping circular plates. Together with the ROTOJET, the central bottom spray nozzle, the booster forms an innovative functional unit that meets all the requirements for linear scale-ups.

For more information, please contact: Romaco Group Am Heegwald 11, 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Horizontal Flow Wrapping Machine Hermetic packages protect pharma products from external influences like humidity, oxygen and light. The new Sigpack HML from Bosch Packaging Technology, allows products such as blow-fillseal vial cards, blisters and various medical technology products including pens and inhalers to be reliably hermetically packaged. The Sigpack HML is suitable for the production of both small and large batches. Depending on the desired output volume, the film reels can either be changed manually during short machine stops or with the help of a splicer. The improved splicer fully automatic connects the old and new film to avoid disturbances, such as at the film former.Products are delivered to the flow wrapping machine via a transport chain. The transverse and longitudinal film sealing uses the proven Longdwell heat sealing technology. The machine achieves an output of up to 350 sealed packages per minute. The sealing rolls used for horizontal wrapping can be opened from both sides. This prevents the film from coming into contact with the heated sealing rolls, and from being damaged during machine downtime. For particularly temperaturesensitive products, the cover plates at the sealing station can be cooled. The Sigpack HML is also available with ultrasonic sealing, allowing customers to gently package heat-sensitive products. The Sigpack HML can be equipped with options for additional product protection, such as the “no gap no seal” function. This is especially used for product piles in blister or BFS packages, which is checked once again shortly before it reaches the cross-sealing. If the pile is not in the correct position, the cross-sealing stops. This avoids product rejection or damaged sealing jaws. The optional MAP module (Modified Atmosphere Packaging) offers optimal product stability by removing residual oxygen from the hermetic packages. Sensors precisely monitor and regulate the gas content of the packages.

Based on the Bosch systems competence, the Sigpack HML can be combined with other equipment, like cartoning machines as well as track and trace systems for seamless traceability of the packaged products.

For more information, please contact: Commha Consulting GmbH & Co KG Poststraße 48, D-69115 Heidelberg, Germany Tel: +49 6221 18779-32 E-mail: bosch@commhaconsulting.com

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Mono Flange Valve For connections to the process using connection flanges, the mono flange enables an optimal and compact measuring point assembly. In addition, stress from vibration, potential leak points as well as installation and maintenance costs are reduced. The mono flange is mounted directly on to the axial flange (radial flange on request), allowing the gauge to be kept in an upright position.

The mono flange includes a block valve, a bleed valve and a vent hole.

Clarifiers Clarifiers are extensively used for continuous mechanical removal of settleable solids from water and wastewater.

This assortment is designed to meet client’s requirements and is available in different specifications as per the application.

Technologies involved are high rate solid contact clarifier (HRSCC); tube settler (TSU); and clariflocculator.

It finds application in removal of colloidal silica, colour removal and primary treatment of wastewater.

For more information, please contact: For more information, please contact:

Chintamani Engg Industries India Pvt Ltd 201 New Rahul CHS, Suyog Nagar Chulne Bhabola Road Vasai (W), Dist: Palghar, Maharashtra 401 202 E-mail: info@chintamaniengineering.com

WTE Infra Projects Pvt Ltd 26/6 Apte Colony, B/h Ayappa Temple Pune-Nashik Road, Bhosari Pune, Maharashtra 411 039 E-mail: enq@watertreatmentindia.net

Mobile Dust Extractors Whatever material, dust, chips or fumes you would like to remove or transport from or within the workplace, we have the solutions, even in dangerous environments, such as ATEX zones. With such a wide range available we have developed a diverse customer base, including clients from construction, heavy industry, aerospace and transport as well as the food industry, to name a few. Dustcontrol supplies industrial mobile dust extractors and air cleaners, on-tool suction casings, stand-alone separators and cleaning accessories. This helps companies worldwide achieve cleaner and more efficient production, in addition to improved product quality. All of our mobile vacuums and air cleaners are delivered as standard with Hepa H13 filtration and built to Application Class H for hazardous dusts and the most demanding environments. Their vacuums all feature cyclone-based separation and are fitted with pleated cartridge filters to provide high and consistent performance in the most energy-efficient way. Reverse pulse filter cleaning also means filters can be kept clean without the need for removing them in the workplace.

All machines are designed to be as ergonomic as possible, so they are easy to handle, move around and transport, as well as being simple to maintain. Dustcontrol has over 45 years’ experience in developing high-efficiency dust extraction solutions including machines, capture hoods for hand-held power tools and fixed equipment and a wide range of cleaning accessories.

For more information, please contact: Dustcontrol UK Ltd 7 Beaufort Court, Roebuck Way Knowlhill Milton Keynes MK5 8HL, U.K. Tel: 01327 858001, Fax: 01327 858002 E-mail: sales@dustcontrol.co.uk

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Monitoring Physical Parameters OCEASOFT brings a new dimension to solutions for monitoring physical parameters such as temperature, humidity and more. OCEASOFT worked closely with the Fondation Jean-Dausset-CEPH international genetic research center, France, to carry out preliminary testing and develop a product that truly matches user needs.

OCEASOFT created its new Cobalt X2 system for monitoring physical parameters to meet major challenges faced by life science professionals, including laboratories, hospitals and pharma companies: 1) Cobalt X2 simplifies daily tasks for users by enabling them to acknowledge alarms directly via the module’s colour touchscreen. Cobalt X2 also serves as a data collector and gateway for OCEASOFT’s wireless sensors, further simplifying installation with automatic connection. 2) Integrating LoRaWAN long-range connectivity, Cobalt X2 modules communicate wirelessly over large sites and inside buildings easily, benefiting from completely automated deployment. Cobalt X2 features distinct sensor channels to support any combination of up to four wired Smart-Sensors (with calibration parameters stored directly on-board) or wireless Bluetooth enabled sensors, giving users a cost-effective way to monitor up to four different pieces of equipment with a single module. 3) Cobalt X2 includes features designed specifically to respect applicable sectorrelated regulations: 21 CFR Part 11, EN 15189, and good practices guidelines (GxP). To ensure optimal service to customers, OCEASOFT has its own sensor calibration laboratory, accredited according to the ISO 17025 standard.

For more information, please contact:

OCEASOFT 250 Phillips Boulevard, E-Wing, NJ 08618, U.S.A. Tel: +1-609-589-1668, +33 (0)4 99 13 67 30, Fax: +1-609-589-1669 E-mail: P.Besson@oceasoft.com

Process Oxygen Analyzer Barben Analytical offers OXYvisor, its second-generation process oxygen analyzer, which optically measures oxygen in either the gas or liquid phase. In the gas phase, the analyzer measures from trace (0.5 ppmv) to % level oxygen, and in the liquid phase, it measures dissolved oxygen from 1 ppb to ppm. The OXYvisor can be used for continuous oxygen measurement for a wide range of industrial process and laboratory applications. It detects oxygen in flare gas, nitrogen headers, and hydrocarbon and other process streams. It is commonly used to detect oxygen to prevent the corrosion of capital equipment and to ensure product quality. Typical applications include vapour recovery systems, annealing furnaces, produced water, enhanced oil recovery waterfloods, tank blanketing systems, and upstream to midstream natural gas processes. The analyzer uses a proven optical luminescence technique that offers high accuracy, dependability and low maintenance. Its optical technology contains no membranes, which are susceptible to fouling, or electrolyte, which can poison or fail. The unique, industrialized optical oxygen sensing technology is based on proven quenched luminescence measurement principles. The OXYvisor provides supervisory-type monitoring capabilities with advanced diagnostic, auto calibration and remote validation capabilities. This functionality allows users to take significant process actions on alarm conditions at remote locations with high confidence, while significantly reducing maintenance and calibration needs. OXYvisor can be used in conjunction with Barben’s BOSx Series, FiberSense, FlexSense and SafeTap sensors. It has been tested and approved for direct use in Zone 2, Group IIC and Class I, Div 2 Groups A, B, C, D hazardous areas. It is NEC- and CECcertified for North America and has ATEX and IEC global certifications.

For more information, please contact: Barben Analytical 5200 Convair Drive Carson City, NV 89706, U.S.A. Tel: +1 775-883-2500 Fax: +1 775-883-6388 E-mail: sales.barbeb@ametek.com

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events diary       

   

Date: 4-6 December, 2019 Venue: HITEX Exhibition Centre, Hyderbad

Date: 19 – 21 September, 2019 Venue: HITEX, Hyderabad

BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/ startups connected with pharma machinery, CR AMS, CROs/CMOs, packaging, logistics, exports, APIs, generics, biotech, regulatory affairs, etc . It offers a unique opportunity to meet, network and establish business partnerships.

The concurrent conference tracks would highlight latest technological developments, market trends, investment opportunities and challenges facing the industry. The technical sessions would cover pharmaceutical technology, biosimilars, green chemistry, compliance, etc.

The laboratory and analytical market is growing at an exponential rate due to the recent investment plans initiated by the government; which is furthermore complemented by the industry bodies to capitalize on the growth projection. More and more pharma and R&D projects have been commenced leading to increased demand for laboratory and analytical instruments. In order to capitalize on this growth opportunity, Messe Muenchen India is organizing the 13 th edition of India Lab Expo, the leading trade fairs for laboratory technology, analysis, biotechnology and diagnostics at Hyderabad.

 Jasubhai Media Taj Building, 210, Dr. D.N. Road, Fort, Mumbai - 400 001 Tel: 91-22- 40373636 Email: amrita_patil@jasubhai.com

 Messe Muenchen India Pvt. Ltd. INIZIO 507 & 508, Cardinal Gracias Road, Opp. P&G building, Chakala, Andheri (E), Mumbai - 400 099, India.

Tel : +91-22-42554710 Email: info@mm-india.in

 

   

Date: 10 – 12 April, 2019 Venue: Helipad Ground, Gandhinagar

Date: 19-21 April 2019 Venue: Parade Ground, Chandigarh

iPHEX is an exhibition that brings together the drugs, pharmaceutical and healthcare industry- all under one roof.

It is one of the largest showcase of Indian pharmaceutical products and technologies to a global audience. The show will offer the industry majors from India and all across the world a great platform to connect and do business. iPHEX provides visitors and exhibitors with an opportunity to meet new and existing customers actively looking for new suppliers, or looking to assess the current progress of existing projects.

PharmaTech Expo 2019 & LabTech Expo 2019 is an exhibition related to pharma and packaging machinery in addition to analytical and lab equipment. This year the focus is on pharma manufacturing and processing technology, pharmaceutical services, formulations, nutraceuticals and ayurveda. There is a strong local and global opportunity in North India for the manufacture of pharmaceutical & biotechnology products, cosmetics and ayurvedic items. According to industry estimates there are approximately 3000+ manufacturing units in nearby states adjacent to Chandigarh (i.e. Himachal Pradesh, Haryana, Uttrakhand, Punjab, Delhi etc.). The strong growth prospects of the pharmaceutical exports segment and increasing demand from the domestic market is bound to further fuel growth in the pharmaceutical machinery sector, which will be present in large numbers at the show as exhibitors along with other segments of the pharma and biotech industry.

 Pharmexcil 101, Aditya Trade Centre, Ameerpet, Hyderabad - 500038 Tel: +91-40-23735462 Email: sales@iphex-india.com

58 ◄ March 2019

Contact: PharmaTechnologyIndex.Com Pvt. Ltd. 302, Shails Mall, C G Road, Ahmedabad – 380009 Tel: +91-79-40306340 Email: expo@pharmatechnologyindex.com

Pharma Bio World

bookshelf Pharma Resource Book 2019-2020 Author: Cole-Parmer India Price: Free No of pages: 336 pages Publisher: Cole-Parmer India About the book: Cole-Parmer, a leading manufacturer and supplier of laboratory and industrial products, instrumentation, and supplies, recently launched its biggest Pharma Resource Book 2019-20, dedicated to meet application needs of pharmaceutical and biopharma customers. For biopharma product development, the pharma resource book addresses the pain areas of the customers such as compliance, SOP concerns, customized solutions, validation support and much more, in addition to offering numerous unique and new products, as well as returning favourites, making it the biggest Pharma Resource. Whether it is a lab set-up or scale-up, the book has everything pharmaceutical and biopharma customers need - a wide range of laboratory essentials, cleanroom and safety products, fluid handling products, lab equipment, electrochemistry, test and measurement, cell culture, and chromatography products. The products and specifications meet many pharmaceutical industry standards. Cole-Parmer’s close association with the pharmaceutical industry has enabled them to develop products and solutions to meet Industry’s stringent requirements for testing and manufacturing. Their application knowledge and expertise combined with in-depth understanding of customers’ needs enables them to provide integrated solutions that address their customer’s requirements. Cole-Parmer today is seen as a substantial, superior value, one-stop package of innovative products, quality service and technical support. Leading pharmaceutical companies rely on them for comprehensive solutions for their research to production. The company aims at continuous growth and has added many renowned brands in the last three years to widen it’s pharma solutions – Kinesis®, Jenway®, Stuart®, Traceable®, Electrothermal®, Argos Technologies, VapLock®, and Ismatec® to name a few. The latest products from these brands are added in the book, making it a biggest Pharma Resource for the customers. It all adds up to a promise that Cole-Parmer as ‘Scientific Experts’ works to fulfil every day: delivering solutions customers trust and therefore is considered as a preferred partner for end-to-end solutions to the Pharmaceutical Industry. To request your copy of Pharma Resource Book, contact 022-61394444 / response@coleparmer.in or visit ColeParmer.in/catalog

Leachables and Extractables Handbook Editors: Douglas J Ball, Daniel L Norwood), Cheryl L M Stults and Lee M. Nagao Price: $70.00 No of pages: 700 pages (Hardcover) Publisher: Wiley; (1 st Edition) About the book: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) - such as metered dose inhalers, dry powder inhalers, and nasal sprays - pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product.

Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, etc.

Talent Wins Authors: Ram Charan, Dominic Barton and Dennis Carey Price: $16.74 No of pages: 192 pages (Hardcover) Publisher: Harvard Business Review Press About the book: Most executives today recognize the competitive advantage of human capital, and yet the talent practices their organizations use are stuck in the 20th Century. Typical talent-planning and HR processes are designed for predictable environments, traditional ways of getting work done and organizations where lines and boxes still define how people are managed. As work and organizations have become more fluid - and business strategy is no longer about planning years ahead but about sensing and seizing new opportunities and adapting to a constantly changing environment - companies must deploy talent in new ways to remain competitive.

Turning conventional views on their heads, talent and leadership experts provide leaders with a new and different playbook for acquiring, managing and deploying talent - for today’s agile, digital, analytical, technologically driven strategic environment - and for creating the HR function that business needs. Filled with examples of forward-thinking companies that have adopted radical new approaches to talent, as well as the juggernauts and the start-ups of Silicon Valley, this book shows leaders how to bring the rigor that they apply to financial capital to their human capital - elevating HR to the same level as finance in their organizations. Providing deep, expert insight and advice for what needs to change and how to change it, this is the definitive book for reimagining and creating a talent-driven organization that wins.

Pharma Bio World

March 2019 ► 59

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Pharma Bio World

RNI No. MHENG/2003/13269. Date of Publication: 1st of every alternate month.

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