Pharma Bio World October 2019

Vol 18 | Issue 03 | OCTOBER 2019 | Mumbai | Total Pages 60 | Price ` 150

www.pharmabioworld.com

PHARMA BIO WORLD Vol 18 Issue 03 oCTOBER 2019 MUMBAI total pages 60

Indian Pharmaceuticals: A Holistic Overview

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PHARMA BIO WORLD R.N.I. No.: MAHENG/2002/8502 Chairman

Maulik Jasubhai Shah

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Mahaluxmivala, Dr Prabuddha Ganguly,

Dr Satish Ravetkar, Utkarsh Palnitkar

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INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

VOL. 18 | NO. 03 | october 2019 | MUMBAI | ` 150

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4 ◄ October 2019

Pharma Bio World

08

interview Today Lasons India’s Export Ranges over 100 Countries across Various Applications Gaurav Aggarwal, Director , Lasons India Pvt Ltd

features 16 Startup Journey: CycaOnco Solutions

Dr Nusrat J M Sanghamitra, CEO, CyCa OncoSolutions Ltd, 20

08

HR Challenges in the Pharmaceutical Industry Sanjeev Himachali, Principal Consultant & Talent Strategist, Ecliptic HR Solutions Private Limited, Chief Curator, HRTales

26 The Evolving Role of Pharmacovigilance

Ketan Zota, Director, Zota Healthcare 29 Unlocking Business Efficiency through Proactive Asset Management

Ben Potenza, VP Marketing, EquipNet Inc. 32 Rational Use of Biomarkers in Oncology Clinical Trials: A Paradigm Shift towards Precision Medicine

Amit Chaudhuri, VP R&D, MedGenome Inc. USA

16

36

Generic vs Branded Drugs Dr Sanjiv Kumar, Director, International Institute of Health Management Research, New Delhi

38

Maximizing the Efficiency of Clinical Trial Supply Chain Sujay Salvi, Head - Clinical Trial Supplies, Management, SIRO Clinpharm Partha Chatterjee, Head - Clinical Research, SIRO Clinpharm

41

Ensuring Effective Safety & Risk Management for Biosimilars Suhasini Sharma, Director, Medical Affairs, Sciformix Corporation

44

Quality and Safety – Especially in Times of Change

Dr Johannes Rauschnabel, Chief Pharma Expert, Bosch Packaging Technology

38 News 48 Press Release

CORPORATE AFFAIRS 52 Products

44

6 ◄ October 2019

56

Events

57

BACKYARD Book Shelf

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CEW Interview

interview

Today Lasons India’s Export Ranges over 100 Countries across Various Applications

With an exclusive interaction with Jayati Mukherjee of PharmaBio World, Gurav Aggarwal walked us through his journey with Lasons India Pvt Ltd. He mentioned about the positioning and competitive edge of the company, its export feature, future invasion plans, quality control (QC), Gaurav Aggarwal Director Lasons India Pvt Ltd

You are with Lasons since 1998. a. Please acquaint our readers with your journey in Lasons starting from your early days. b. How have you experienced Lasons growing during these days? c. How is Lasons positioned in national as well as global market.

The journey since 1998 has been full of adventure and a tremendous learning experience for me as an individual. I was 8 ◄ October 2019

R&D initiatives, innovation, and digital aspiration. He also acquainted our readers with the signature brand of Lasons India – ‘One Life India’.

all but 18 years old and had joined the company on part time basis. The intent was to learn the trade. When I joined, Lasons had almost no exports and was probably the smallest manufacturer of vitamin B3 in India in terms of manufacturing capacity. Soon we realised that we need to grow our manufacturing capacity for our key products Niacin & Naicinamide (Vitamin B3). Therefore, we started focusing our initiatives towards this aim, specifically on increasing capacity and sales in the export markets for the same.

During that period, the domestic market was relatively smaller and the kind of growth levels we were hoping for were only possible to extract from the export markets. Slowly but surely we started expanding our manufacturing facility as per required international standards to ensure we can cater to the requirements of larger users in bigger markets. Today we export our products to more than 100 countries across various applications.

We are also one of the very few vertically integrated producers of Vitamin B3.

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interview Lasons is the premier production house for Vitamin B3 in the country. Not only is that, today about 90 percent of its production being exported to over 30 countries. What’s your present export feature as well as future invasion plan?

Yes, approximately 80 percent of our manufactured products are being exported to more than 100 countries.

Moving forward, we intend to grow the market reach. On boarding new customers and retaining existing customers are two top priority activities for us to focus at this moment.

Quality is the premier aspect for any manufacturing hub, more so in pharmaceutical industry. a. How do you internalize the quality assurance concept? b. What are your best practices in this zone? c. What proportion do you maintain for in-house QA activities and for outsourcing?

You have rightly mentioned that Quality is an extremely crucial parameter for any pharmaceutical company and more so when that’s into manufacturing set up. We have a dedicated 24x7 Quality Control (QC) team with a stringent focus on every step of manufacturing, ranging from raw material to work-in-progress to finished goods. Each individual step is being carefully monitored in our hub. We follow GMP guidelines along with various other rules and regulations, specified by different reputed certifying agencies and organizations. In addition, frequent audits are being carried out ranging the entire value chain on request of various customers. Most of our testing procedures are being carried out in-house.

However, we outsource certain crucial tests, along with a few basic tests, to ensure error-free and high-quality output.

10 ◄ October 2019

What’s your focus on R&D initiatives?

Do you rely on in-house build-up or do you outsource the formulation?

One Life is my baby that was conceptualized in my mind and was brought to life by Lasons.

We have been producing these products for almost 4 decades. That being said, R&D is still an everyday effort for various purposes, process improvement, cost reduction, trial of more efficient and cleaner technology, etc. Technology is constantly changing and upgrading, and it’s extremely important to continue to grow in these areas. Our years of efforts invested in R&D play a pivotal role for our existence as well as growth. Most extent of the R&D initiatives is being done in house; along with, we take help of various technical experts, enlisted with us, from time to time.

Thanks to working with an organization, which is into vitamin production for almost 4 decades, I have been equipped with a fair share of knowledge in the nutrition industry for both animals as well as humans. As the name suggests, we hope to be a part of everyone’s life in their endeavour to live that right. The idea of living life right usually revolves around being a good child to parents and being good parents to child, being a good friend and colleague, etc. Doing the right things, doing good for society, and to do all these things and beyond, the musthave parameter is one’s good health.

We wish to keep people healthy with our products and offerings so that they can focus on the other things that they wish to do to live their life right.

How do you prioritize innovation and integrate that in your business processes?

Our attempt is always innovation centric.

It may not be always in terms of a druginnovation; but, we are into innovating the things that we do every day. Innovation of new ways to do older things is key for any organization to survive, especially when times are difficult; and for sure there are difficult days.

Our aim is to provide adequate and quality nutrition at an affordable price. This is something we arrive for and will continue to work for. We wish to make nutrition tastier, affordable, and enjoyable.

What’s your digital aspiration to enhance productivity and efficiency?

It’s very evident that digital technology has improved efficiency and reduced the scope of human error, specially in crucial manufacturing areas. We use state-ofthe-art technology wherever possible to ensure the upgradation of ourselves as well as the systems.

Your brand ‘One Life India’ is born purely out of passion with a vision of enabling all to live their one life right.

Please acquaint our readers with the conceptualization of the brand and the going forward strategy.

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Startup Journey: CycaOnco Solutions This article gives a brief account of Dr Nusrat J M Sanghamitra’s endeavour towards bringing remedy to cancer patients suffering from the toxicity due to high-dosage drug administration.

Cancer, A Deadly Threat: Chemotherapy is like carpet-bombing, because cancer drugs are toxic if administered in high dosage and useless in low dosage.

During the treatment procedure, cancer cells as well as normal healthy cells are getting killed. Not only is that, the toxic side effects make about 15 million cancer patients (worldwide data) fallen really sick.

Apart from the physiological disruption of the patient, financial and emotional burden – owing to this deadly disease – are also tormenting factors. These two not only just drain the patient, but does so for the entire family. And the massive dosage of drug administration causes significant side effects. Massive dosage is required as because every human cell has a protective cell membrane that does not allow foreign molecules to enter the cell. Drug molecules have to go right into the living cells to act upon and to function properly.

Formation of Startup:

Dr Nusrat J M Sanghamitra CEO, CyCa OncoSolutions Ltd www.cycaonco.com 16 ◄ October 2019

Founded by Dr Nusrat J M Sanghamitra, CyCa OncoSolutions is dedicated to develop efficient as well as nontoxic – both in vitro and in vivo – delivery systems especially for cancer therapeutics (biologics/small

molecules). The vision is to position CyCa OncoSolutions as a high potential innovative molecular drug-delivery device company to make cancer drugs better and safer.

Started its operations from KIIT-TBI, Bhubaneswar in Odisha district, the Startup has recently moved its operations to NCL Innovation Park, Pune. Its Irish branch operates from University College Cork, Ireland.

The journey and the Breakthrough: As a researcher and scientist, since from her PhD days, Nusrat’s primary focus was to lower the dosage as well as the toxicity arising out of the highdose drug administration. She started with

synthesizing

new

water-soluble

copper complexes as an alternative to cisplatin, the most widely used anticancer metallodrug. However, even though this water-soluble copper complex used to kill cancer cells effectively, at the flip-side it was highly toxic. Therefore she shifted her research-focus from chemistry to protein engineering, and then eventually to biophysics and to cell biology. The key breakthrough came when out of serendipity she discovered a new function Pharma Bio World

of an engineered protein USG that works like a molecular nanomachine. USG has similar functionality of computer USB for living cells to transform molecular information. It crosses the living cell membrane as smoothly as one can go across the automatic doors with luggage.

Not only is that, it also carries drugs into the living cell efficiently without damaging the cells. They facilitate the conjugation of USG with Cisplatin, one of the most widely used anti-cancer drug, thus making a new formulation CyPlatin. The equivalent

cancer cell killing ability of cisplatin with 90 percent less dose has been observed than the one being used in lung carcinoma cell model. By making new formulations with USG and known cancer drugs, they aim to – reduce the side effects of cancer drugs, take cancer from mortal to manageable, thus radically improving the quality of life of about 15 million cancer patients worldwide.

Our offerings: The application of USG technology is not limited to cancer drugs only. USG can deliver antibiotics into drug

resistant microbes and beat the superbugs by giving new life to old antibiotics. It also takes part in gene editing machinery CRISPR-cas9 into living cells, thereby becoming the key enabler as a one shot gene therapy toolbox.

In order to validate the delivery efficiency of USG, CycaOnco has developed CyGlo as their first product for the live cell imaging market that is a simple and easyto-use reagent to observe mammalian cells under fluorescent microscope.

Note for Future Entrepreneurs: Entrepreneurship is not a career option.

It’s a way of life. It’s a mindset to strive to make a difference in people’s life in real time and to make a positive impact on society through one’s professional and personal endeavours.

In Dr. Nusrat’s own words, “As an entrepreneur, a key pointer for you to follow is to make your POC (proof of concept) as robust as possible; then the rest will fall into place”.

18 ◄ October 2019

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HR Challenges in the Pharmaceutical Industry This article explores HR aspects in pharmaceutical industry in depth. The author here endeavoured to illustrate the HR challenges specific to the pharmaceutical industry and the methods are being adopted to overcome these challenges by putting emphasis on Workforce Talent.

A

s we usher in industry 4.0, which hinges upon futuristic technologies such as automation, artificial intelligence & machine learning (AI–ML), block-chain, intelligent devices etc, thus leading to digital transformation, the already existing fear that machines will take over human jobs has increasingly been growing stronger. However, rigorous study on talent and HR trends assures that neither this is going to be the case nor this is the complete picture.

That being said, for instance, the World Economic Forum’s Future of Jobs Report suggests that even though 75 million jobs that exist today will be eliminated, 133 million new jobs will be created by 2022 owing to technological advancements and automation. The current jobs that are not displaced by technology will be massively redefined with the elimination of inefficient and low business value generating components.

There is and will be a massive need for reskilling & up-skilling of employees to enable them to become highly valuable resources to the organization and to fit into the jobs in the future of work. So, futuristic technology will make jobs redundant and not the employee per se, according to this report. Futuristic technologies will make the work, the workers, as well as the workplaces more agile & efficient to generate more value.

Sanjeev Himachali Principal Consultant & Talent Strategist Ecliptic HR Solutions Private Limited Chief Curator, HRTales 20 ◄ October 2019

This is the general picture of how technological advancements are affecting HR and talent across the globe and across industries. The trends, patterns, and challenges in each industry will differ drastically. In this article, we will explore the pharmaceutical industry in-depth in this context. We will understand what HR challenges are unique to this industry and

what innovative methods are being used to overcome these challenges.

The Pharmaceutical Industry

The pharmaceutical industry is a thriving industry, but it is also known to be one of those industries with higher levels of inefficiencies and leakages that are eating up the margins, thus causing lower value generation. One of the top causes of these inefficiencies and leakages is the slow pace of technology adoption in the face of global fragmentation of work. Futuristic technologies can help to streamline the industry and infuse higher levels of efficiency, accuracy, and agility into the processes.

For instance, clinical research and drug manufacturing is a complex, globalized process; and this very nature of the process is causing several challenges for the pharma companies. Some of the key challenges are • Globally-dispersed clinical trials • Time-based inefficiencies with a majority of the trials seeing delays in completion • Inability to onboard the requisite number of patients at all the sites equally • Inability to retain patients in the trials for long enough • Considerable patient dropout rates among others With a higher percentage of the pharma company budgets allocated to clinical research and drug development, the globally dispersed workflow, the use of legacy digital systems, and the slow adoption of futuristic technologies have been costing pharmaceutical companies several million dollars of resources. Intelligent automation and the use of AI-ML are known to reduce the time to market. These have, in turn, risen up the global drug prices immensely.

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The emergence of smaller and agile biotech players, who leverage nextgen technologies and use their lack of bureaucratic workflows to respond quickly to the dynamic marketplace, has put the bigger players with higher budgets under significant pressure in this complex global marketplace. For bigger pharmaceutical companies to continue to thrive in the future, the greater financial resources at their disposal or the patents or the product innovations alone are not adequate. They need to massively rethink about their talent/ HR side of things. They are needed to redesign their work, the workers and the workplaces.

Working in the Pharmaceutical Industry

• The nature of work in this industry is challenging-yet-lucrative and fulfilling.

You will find the most interesting projects and opportunities; there is never a dearth of such opportunities in fact. You will be a part of innovative and cutting-edge solutions that save lives and make an impact on the world.

There is, however, a need to eliminate repetitive work as well as manual grunt work; and companies are on their way to achieve this.

• The industry is traditionally very popular for its competitive compensation and perks. Professionals in this space get remunerated well based on their skills, expertise, experience, and educational background.

• The pharma industry is known for its career growth and development opportunities.

Even when certain employees do not get the opportunities for internal mobility, they seamlessly find opportunities in other companies in the space.

• There is a good degree of job security and long-term (if not lifetime) job stability for those in the pharma industry, unlike any other industry.

Critical HR Challenges in the Pharmaceutical Industry 1 Talent crunch in the face of a changing market: The pharmaceutical industry has continuously been evolving and thereby seeing several changes with respect to its processes & functions. For instance, there is an emergence of specialty care in place of primary or general care.

The payers have been becoming the market influencers and thus there is a shift towards more client-focused services. Due to budgetary pressures, the number of sales and marketing personnel in pharma are being reducing and the nature of the existing roles has shifted greatly.

What this means for talent is that the skills and expertise that pharma companies are seeking are now radically different from what they were a few years ago. In the face of the changing market and industry, there is a definite talent crunch caused by the skill-gap. Putting it differently, the skill sets and expertise of the talents are not being changed at the pace of the changes in the industry. This causes a massive skill gap and talent crunch for the employers. In the face of such talent crunch and skill gaps that exist, the war for talent is on in the global market.

2 Building an employer brand is imperative; pharma companies cannot attract talent by default

the World Economic Forum’s Future of Jobs report suggests that even though 75 million jobs that exist today will be eliminated, 133 million new jobs will be created by 2022 owing to technological advancements and automation.

22 ◄ October 2019

anymore:

Traditionally, pharma companies used to attract talent by virtue of their name and used to enjoy the employer-of-choice status for decades owing to their attractive benefits, challenging-yet-lucrative work, and long-term employment stability. Even when one company did not have the scope of internal mobility, talent could move to another employer in a seamless manner in the earlier scenario.

Today, this is not the case. With the changing nature of the talent pool consisting of a large proportion of millennial, the rise of the gig economy and technological advancements that are aiding the creation of virtual workspaces, – attracting and retaining talent is a mammoth yet critical task for HR. HR needs to craft seamless experiences and to engage the globally-dispersed workforce to build a strong employer brand for the company that will make it easier to attract the best-fitting talent with the right skillset and requisite expertise.

3 Traditional talent/HR strategies do not work: As mentioned earlier, the nature of work-worker-and-workplace is being changed in the pharma industry. These days organizations carry multi-generational workforce consisting with millennial, Gen-Xers, and baby boomers; and despite certain similarities, their needs and aspirations from work differ vastly.

Players in the pharma industry cannot afford to stick to the traditional talent strategies and one-size-fitsall HR approach towards employee engagement, benefits, etc.

For instance, the pharmaceutical industry is a slow adopter of the latest technology that could infuse efficiency, accuracy, and agility to improve its value creation. There are inefficiencies in terms of how work is done and also Pharma Bio World

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US FDA regulations CFR 177.2600 for Animal derivative free contact with food Highly advanced auto-curing system USP class VI requirements Excellent heat resistance (-50°C to 250°C) European Pharmacopoeia 3.1.9

in terms of several redundant, lowvalue tasks that employees today perform. Such manual drudgery arising out of repetitive tasks is a big cause of dissatisfaction and disengagement among the employees. Millennial, being digital natives, do not want to work with such employers who do not provide challenging work to them to use their specialized skillsets and keep them involved in unnecessary tasks.

Similarly, they expect greater flexibility in work. If pharma companies fail to provide such work, they will move onto the next employer. And considering that most employees in this industry have transferable skills, they can move on seamlessly.

4 Massive up-skilling / re-skilling challenge: As discussed at the

beginning of this article, there is a massive need for upskilling and reskilling of the existing workforce in the face of the emergence of futuristic technologies. HR experts believe that the best way ahead is to provide learning opportunities for existing employees and to reskill them, rather than laying off the existing employees in the face of the global talent crunch. Such massive re-skilling/ up-skilling efforts require pharmaceutical companies to allocate more funds for employee learning and development endeavours, which often is not concentrated upon.

Best-in-class HR Practices Being Followed in the Industry 1 Focus on positive workplace

culture: Despite the aggressive

competition in the market, the best employers in the pharmaceutical industry these days are focusing on building a positive workplace culture. The smaller and agile biotech companies are frontrunners in this respect as they have lesser bureaucratic bottlenecks to handle, which facilitates creating such a culture.

4 Leveraging

best employers in the pharma industry are investing in making their workplace agile by leveraging the right technology that reduces drudgery and repetitive grunt work for employees, thus enables them to focus on more challenging aspects of their work where they can best apply their skills and expertise. HR is also focusing on crafting seamless employee experience keeping in mind the increasingly fragmented nature of work, emerging gig economy, and rising demand for flexibility among the millennial employees. This, in turn, is helping them to create a strong employer brand.

3 Learning and development opportunities: The best pharma employers are offering invaluable opportunities for learning and professional development to their employees.

These opportunities are starkly different from traditional training programs and workshops. They are leveraging technology to provide customized and personalized learning

the

gig

economy:

An increasing number of pharma companies understand the importance and power of the gig economy; and are tapping it to make up for the skill gap and meet their variable demands and capabilities required at different stages of their functioning. They are balancing the contingent workforce with the permanent workforce well as they grow and evolve. They have sound policies to manage and effectively engage their gig workers.

2 Crafting seamless and cohesive employee experiences: The

For bigger pharmaceutical companies to continue to thrive in the future, the factors viz. greater financial resources at their disposal or the patents or the product innovations alone are not adequate. They need to massively rethink about their talent/ HR side of things. They are needed to redesign their work, the workers and the workplaces.

24 â—„ October 2019

experiences that are immersive and can be seamlessly consumed from anywhere, anytime.

Overall, the best pharma employers are focusing on building a strong employer brand to attract and retain best-in-class talent over the long term.

References: 1.

https://www.proclinical.com/blogs/2019-2/ opportunities-challenges-forpharmaceutical-industry-in-2019

2.

https://www.bamboohr.com/blog/challengesfacing-hr-professionals-healthcare-industry/

3.

https://www.cphi.com/europe/visit/newsand-updates/pharma-outlook-12-trendswatch-2019

4.

http://www.pharmexec.com/reinventingpharma-s-talent-search

5.

h t t p : / / w w w. p h a r m a t i m e s . c o m / magazine/2018/januaryfebruary_2018/ finding_pharm.s_future

6.

https://www.cphi.com/europe/visit/newsand-updates/pharma-outlook-12-trendswatch-2019

7.

https://www.biospace.com/article/whatmakes-life-sciences-professionals-happyat-work/

8.

https://www.businessinsider.in/careers/whypeople-love-working-for-big-pharmaceuticalcompanies/articleshow/21359223.cms

9.

https://www.expresspharma.in/pharma-life/ engaging-the-new-age-employee/22502/ Pharma Bio World

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The Evolving Role of Pharmacovigilance Pharmacovigilance is a critical component for determining the benefit to risk ratio of treatment.

The potential for drug toxicity is determined throughout the lifetime of use of a drug or biological agent, including the development cycle. This includes both the preclinical as well as clinical data. This article defines the science of pharmacovigilance and the process of adverse event reporting and reviews the new directions that pharmacovigilance has taken.

T

he World Health Organization (WHO) defines Pharmacovigilance as "The science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems".

Pharmacovigilance, shortened to PV, is the scientific and detailed study of collecting, monitoring, researching, assessing and evaluating pharmaceutical products. The word Pharmacovigilance comes from Greek and Latin words; Pharmakon (Greek) which means Medical Substances and Vigilia (Latin) which means to keep watch. All the information given by the healthcare providers and patients, are the main key to perform the Pharmacovigilance process.

The main purpose of this in Pharma industry is to improvise patient's care and safety in relation to the use of medicines.

It is very important to understand all the paramedical and medical interventions in order to serve good and safe public health. Pharmacovigilance assesses the beneficial and harmful attributes of the medicines that further indicate about their rational and safe use. It also promotes the clinical training and education involved in it. Thus, it helps in communicating effectively to the public and health professionals.

Ketan Zota Director Zota Healthcare 26 ◄ October 2019

Developed countries are actively involved in using the concept of Pharmacovigilance and the statistics by these countries have indeed focused on the issues and highlighted the benefits incurred. But under developed or lower income countries have major health issues that aren't being rectified because of their major setback. Such countries are in complete need of Pharmacovigilance.

Indulging this concept into the health

infrastructure of such countries will help them generate reliable supply and quality of medicines, trained essential healthcare staff and proper access to its education, communication, and technology.

Pharmacovigilance is very important for every healthcare professional to have an acute knowledge of every drug. Proper data documentation, drug benefits/risk profile, and other practices should be incorporated well in the Pharmaceutical industry. Hence knowing about every step of the Pharmacovigilance Management cycle will be an advantage for every health organization to educate every patient clearly about every drug.

To understand the topic well, there are certain terminologies used and are further categorised according to the health situation.

1. Harm occurred.

Terms and its definitions: • • Adverse Drug Event (ADE)-Harm caused by the use of drug.

• • Adverse Drug Reaction (ADR)-An unintended reaction to a drug taken as a normal dose.

• • Serious Adverse Event (SAE)-An event which is fatal or life threatening.

2. Harm may have occurred.

• • Terms and its definitions: • • Medication Error-A preventable event that may cause harm to the patient.

3. Harm did not occur.

• • Terms and its definitions: • • Potential Adverse Drug Event - Situations that may cause harm by using the drug but does not harm the patient.

The above mentioned terms are frequently used to explain and understand the concept of Pharmacovigilance. It is very essential to deeply understand these terminologies Pharma Bio World

in order to avoid misconceptions. But the main three are ADE, ADR, and Medication Error that sum up the core elements of Pharmacovigilance.

What is Adverse Drug Event (ADE) in Pharmacovigilance and how is it important?

An Adverse Drug Event (ADE) is defined as the harm caused by the overdose or overconsumption of drug. It may also be caused from the use of drug for discontinuing or reducing the dose of any drug therapy. It is precisely defined as an "injury caused by using a drug". This can also be a result of a medication error, but such scenarios hold a rare chance. The study of ADEs in patients during clinical trials must be recorded with the education sponsor or can willingly be given to the local ethics committee as well.

There are types of ADEs:

•• •• •• •• •• •• ••

Serious Non-Serious Expected Unexpected Study-related Possibly study-related Non study -related

Reporting all the types of ADEs plays a major role in Pharmacovigilance. Without these reports it becomes a difficult scenario to conclude the situation. The reporting of ADE involves data entering, triage, assessment, receipt, distribution, and archiving all ADE documentation.

After ADE, it is Adverse Drug Reaction (ADR) that educates about how reactions are caused during the process of Pharmacovigilance.

ADR is defined as the side-effect or adverse reaction after drug consumption.

It is broadly defined as the unwanted, uncomfortable, or dangerous effects that may be caused after consuming the drug.

The toxicity of the drug exceeds than the normal which leads to a situation of ADR. The over-ingestion of any drug reacts

Pharma Bio World

first with the blood levels resulting into an adverse reaction. It is very important for every healthcare provider to have knowledge about all possible risks and benefits of every drug. An ADR can be detected by paying attention to the patient's progress graph after consuming the prescribed drug. The types of ADR are classified as:

•• •• •• •• ••

Type Type Type Type Type

A - Augmented Reactions.

B - Bizarre Reactions.

C - Continuing Reactions.

D - Delayed Reactions.

E - 'End-of-use' Reactions.

The intensity of an ADR also depends on patient's characteristics (age, sex, ethnicity, genetic factors) and drug factors (type of drug, composition, dosage, bioavailability, etc) Apart from ADEs and ADRs, Medication error is another main element of study of Pharmacovigilance. Here the latter is comparatively easier to rectify than the others. The possibility of harm caused is less and can also be prevented at the right time. But a single error can also lead to major harmful situations.

A medication error is further defined as an unorganised prescribing, administration, and dispensing of drugs. It is not an obvious scenario for such errors to cause harm to the patient but the negligence might lead to inappropriate use of the drug by the healthcare provider, and this might cause harm to the patient as well.

Following are the causes that lead to a medication error:

•• •• •• •• •• •• ••

Unavailable Drug Information.

Incomplete Information of Patients.

Inaccurate Recording.

Inaccuracy in Transcribing Orders.

Unclear Labelling of Drugs.

Inadequate Knowledge of Drugs.

Deadline Pressure.

It is very important for every drug developer to consider a Pharmacovigilance plan during its first stage itself in order to

rectify the errors done and possible errors in time. Where Adverse Drug Event, Adverse Drug Reaction, and Medication Error give detailed insight to Pharmacovigilance, there are few other main elements that are equally important to educate every patient and healthcare provider with. Following are the other main elements that create a complete Pharmacovigilance: 1. Individual Case Safety Report.

A report that gives a detailed description of every doubtful adverse reaction by the administration of one or more drugs to an individual patient.

There are four elements of the ICSR An identifiable patient, An identifiable reporter, A suspect drug, and An adverse event. These four elements are important to be determined during the triage phase of a potential adverse event report.

2. MedRA. It is the Medical Dictionary for Regular Activities. MedRA is mapped from WHO-ART, the WHO Adverse Reactions Terminology. It is a medical coding dictionary that is used to convert adverse reactions information into terminology that can be easily analyzed and identified.

3. Clinical Trial Reporting.

Clinical Trial Reporting is the safety information about every drug used while performing a clinical trial. This kind of reporting is also known as Serious Adverse Event (SAE) reporting of clinical trials. The drug's effectiveness on human or in simpler terms drug's safety is the main component to consider while deciding the drug's market approval and presence. Every drug authoriser must have a keen eye on the details of every drug.

4. Aggregate Reporting.

Also known as periodic reporting, aggregate reporting plays a very

October 2019 ► 27

standard that dictates the components of an adequate Pharmacovigilance system or the processes to be engaged in risk management, there is consensus among the major regulators that Pharmacovigilance is necessary and important in the development and commercialization of medicinal products.

important role in safety assessment of drugs. The records of aggregate reporting are a compilation of the safety drug data. These data's can be of a longer time period such as months or years. The main advantage of Aggregate Reporting is that it gives a broader view of drug safety.

Pharmacovigilance process in simpler words is defined as assessing the benefits and evaluating the risk. The evaluation of risks should begin at the preclinical stage of a medicinal product and it should extend throughout the life cycle. There is now added focus on safety and risk assessment after a product has received regulatory approval, when it is placed on the market and prescribed to large populations.

Although there is no international

Risk management in Pharmacovigilance is the main discipline that is responsible for signal detect and monitoring the risks and benefits of every drug profile.

Risk management is a compilation of Risk Management Plans (RMPs) and other aggregate reports such as Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), and Periodic BenefitRisk Evaluation Report (PBRER).

Following are the other few elements under Risk Management that play a key role to carry out the process of Pharmacovigilance with an ease:

• • Causality Assessment.

• • Signal Detection.

• • Risk Management Plans.

• • Risk/Benefit Profile of Drugs.

A drug provider and analyzer should always make the patients and other healthcare providers understand the benefits and risk of every drug. A patient's reaction and effect after consuming any drug should be keenly heard by the drug provider and provide the patients with solutions that can alter the possibility of the harm.

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Unlocking Business Efficiency through Proactive Asset Management This article discusses how the processes of asset redeployment, as well as the buying and selling of surplus and idle laboratory and production instrumentation can benefit the pharmaceutical industry.

T

he global pharmaceutical market is growing 7.8 per cent year on year and is estimated to be worth around USD 1.6 trillion by 2020. As the world's population continues to grow and age, so will this industry 1. At the same time, pharmaceutical companies are facing a range of challenges which are forcing them to reduce both time to market and costs.

For instance, more stringent healthcare regulations are being introduced and payers are putting pressure on companies to adapt their pricing policies and commercial models.

Mergers and acquisitions are becoming more common-place, which means that equipment can fall out of use even though they remain valuable for a variety of uses such as drug discovery, manufacturing, and the packaging of commercially available products. Additionally, new products are constantly being launched across the sector, meaning that instrumentation needs are also evolving.

An Innovative Solution

Ben Potenza VP Marketing EquipNet Inc. Pharma Bio World

An increasing demand from pharmaceutical businesses for low-cost laboratory and manufacturing instrumentation solutions has resulted from the need for companies to focus on leaner production, as well as meeting the fluctuations in demand.

These pharmaceutical companies are now beginning to purchase high-quality, used equipment in order to expand into new production areas, as well as to maximize budget; it is common to save between 50-75 per cent of the cost of new instrumentation.

Furthermore, the advantage with purchasing second-hand equipment is that

it is often available immediately, unlike new instrumentation 2.

In order to obtain returns from surplus machinery, time and expertise is needed.

Many pharmaceutical companies do not have this however and implementing a partnership with a specialist provider can help to execute an asset management strategy. These asset management experts can provide useful information on budgets, specification and risk mitigation (how reputable a supplier is, for example). Industry experts can then guide companies through the purchasing process by helping them to obtain existing warranties on equipment and provide follow-up support allowing an efficient process for the purchaser.

EquipNet provides a holistic approach to surplus asset management for both buyers and sellers and this is illustrated in the EquipNet 'Value Control Model' (See Figure 1 on next page), which is based on time and can be customized using a central tracking platform. This provides communication and workflow tools and ensures the exposure of all assets throughout a business. A variety of disposition channels, which include redeployment, negotiated sales with managed pricing through an online market and competitive auctions can also be used. Other options include clearance, disposal and scrap programs, which can be customized for each specific customer.

To redeploy equipment and keep track of surplus assets, partners should possess a reputable software platform to list assets across a business. A company can then view all equipment across a variety of locations worldwide.

October 2019 â–ş 29

Redeployment Redeployment of instrumentation allows businesses to gain the highest possible value from equipment and is hard to achieve without a central tracking platform. This software allows users to post, track, identify, and then internally redeploy an instrument that is laying idle or not being used in its current location.

Should this not be possible a company can then decide whether the external sale of equipment or the purchase of another instrument is necessary.

A proven example of a tracking platform used within this market is EquipNet's Asset Redeployment Management System (ARMS') platform, which features workflow management and multiple access levels for employees across a business, including plant managers and executives.

ARMS can provide in-depth information on the equipment a business currently owns and which site it is located at.

Looking to Sell?

Should the redeployment of an asset not be possible, a company should then look to sell the instrument. An auction is a reliable way to sell equipment. Dealing with the auction process however is difficult and success depends on a number of factors. An asset management partner can provide advice on how to approach this process for each individual customer.

Figure 1: EquipNet’s ‘Value Control Model’ shows how redeployment, negotiated sales with managed pricing through an on-line marketplace, competitive auction events and clearance programs fit together to deliver a consolidated service. This ensures a ‘seller’ company achieves maximum return and at the same time sees idle equipment become available to a ‘buying’ company. In many cases, a business is both a seller and a buyer at different times

30 ◄ October 2019

Therefore, using a company with specific industry experience and a good reputation is important. Options can include online auctions, live/webcast auction events, sealed bids and private treaty events. Further customized solutions for selling equipment include EquipNet's MarketPlace platform. MarketPlace lists used equipment available for purchase, however, in contrast to auctions, which are scheduled events for selling a large group

Pharma Bio World

of used equipment from client facilities, MarketPlace allows price negotiation for an instrument at anytime.

Should it not be possible to redeploy assets as they have little or no value, clearance by donations, scrap and environmental recycling are the best options. It can be the case that the scrap value of idle equipment can achieve the highest return. It is common for EquipNet to advise clients in this area.

The purchase of second-hand equipment Pharmaceutical companies now face the ever more difficult challenge of meeting rising demand, as well as more rigorous commercial targets. All kinds of businesses are now taking advantage of the savings to be made from purchasing

pre-owned equipment from top-tier manufacturers. This is in contrast to constantly buying new instrumentation.

Buyer companies therefore, often invest in high-quality second-hand instrumentation in order to maintain a low cost-base while continuing to improve company processes and services. Asset management partners can inform businesses of appropriate auctions, as well as how to use negotiated sales platforms such as MarketPlace.

Collection and delivery are all that need to be organized following the purchase of equipment.

Summary As the pharmaceutical sector continues to grow, businesses are keen to further

reduce time to market, as well as costs.

Redeploying and selling equipment with a reliable asset management partner can help businesses obtain the maximum returns on an instrument, as well as ensure operational efficiency. Buyers are also able to purchase unwanted, highquality equipment for a fair price. An asset management partner can therefore provide important solutions for companies looking to redeploy, sell and purchase surplus assets.

Reference PwC-http://www.pwc.com/gx/en/industries/ pharmaceuticals-life-sciences/pharma-2020/ vision-to-decision.html NiceInsight-http://www.niceinsight.com/articles.

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Each monthly edition of PBW covers a separate area of pharma and biotech industry and includes articles from a range of peers, consultants and commentators, interview with industry experts, Market research analyzing industry trends, News Features, News Updates, Product Trends, Events Diary and Bookshelf. Target readers for PBW are Drug manufacturers, Intermediates, Pharma machinery/equipment manufacturers and suppliers, Pharma packaging firms, Research institutes, Academic institutes, Biotechnology firms, Consultants and Government bodies.

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Launched by Chemtech Foundation in 1992, Pharma Bio World (PBW) features contents from Pharmaceutical and Biotechnology industries. PBW provides in-depth information on business practices, latest trends, technologies, research & innovation and processes across the entire industry pipeline.

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Rational Use of Biomarkers in Oncology Clinical Trials: A Paradigm Shift towards Precision Medicine Biomarkers discovered and used in clinical trials have been approved as companion diagnostics and used routinely in making treatment decisions. This article will give an overview of cancer biomarkers, their discovery using traditional approaches and more recently through genomics and proteomics technologies and their validation through clinical trials.

B

iomarkers are biological indicators of early disease detection (diagnostic), disease progression and outcome (prognostic), and response to therapy (predictive). The inclusion of biomarkers in patient selection has led to superior drug response rates and increased overall survival in pivotal clinical trials. Also, use of biomarkers to select drug sensitive patients have greatly improved the quality of life by improving therapeutic efficacy and reducing toxicity.

Biomarkers discovered and used in clinical trials have been approved as companion diagnostics and used routinely in making treatment decisions.

Definition of Biomarkers

Diagnostic

biomarkers:

Diagnostic biomarkers allow disease detection and/or disease staging. Traditionally, diagnostic biomarkers in cancer came from histopathology. The WHO classification of solid and hematological tumors are based on histopathological examination of the tissues and available as monographs, or blue books for consultation (whobluebooks. iarc.fr/). For example, WHO recognizes 30 subtypes of lymphoma based on their histopathology, which has improved the accuracy of patient diagnosis significantly, without impacting drug development, or treatment decisions, because of molecular heterogeneity within the subtypes [1]. For example, gene expression profiling of diffuse large B-cell lymphoma (DLBCL) has identified three distinct molecular subtypes that are treated differently.

Amit Chaudhuri VP R&D MedGenome Inc. USA 32 â—„ October 2019

Other molecular rearrangements have aided in the diagnosis of solid tumors such as ALK-fusion for the diagnosis and therapy of ALK-positive non-small cell

lung cancer. Diagnostic markers in many instances have become both predictive and prognostic. For example, estrogen receptor positive (ER+) breast cancer is a diagnostic marker, as well as a predictive marker for hormone inhibition therapy, and a prognostic marker of good clinical outcome, when compared with hormone receptor negative tumors [2].

Predictive vs prognostic biomarkers: There is considerable confusion in our understanding of what distinguishes a predictive biomarker from a prognostic biomarker. Predictive biomarkers are associated with response to treatment.

Tumors positive for the marker will show differential treatment effects compared with tumors negative for the marker. As an example, in non-small cell lung cancer (NSCLC), tumors harboring activating mutations in epidermal growth factor receptor (EGFR) benefited more from erlotinib (Tarceva) treatment (hazard ratio, HR 0.10) compared to tumors harboring wild-type EGFR treated with erlotinib (HR 0.78) [3] . In this example, both groups benefited from treatment HR <1, however, there was a quantitative difference in benefit between EGFR mutant vs. EGFR wild-type group (quantitative interaction) [2, 4] .

The benefit can also be qualitative, in which case the biomarker positive group benefits from the therapy, whereas there is a lack of benefit to the negative biomarker group including harmful effects from the treatment. For example, use of anti-EGFR monoclonal antibody cetuximab provides benefit to metastatic colorectal cancer patients harboring wildtype KRAS, but patients harboring mutant KRAS fare poorly in the presence of the

Pharma Bio World

drug [5]. This makes KRAS a predictive marker of response to anti-EGFR therapy in metastatic colon cancer. Surprisingly, the status of KRAS is not a predictive biomarker of anti-EGFR tyrosine kinase inhibitor (erlotinib or gefitinib) in nonsmall cell lung cancer [6] indicating deeper biological differences between the two cancer types.

A prognostic biomarker provides information on disease outcome, such as disease progression, disease recurrence or death, independent drug treatment [2].

For example, activating mutations in phosphatidyl-inositol-3-kinase catalytic subunit alpha (PIK3CA) show worse prognosis in women with HER2-positive metastatic breast cancer, regardless of treatment [7,8]. A prognostic biomarker may reveal the underlying mechanism of disease progression and can guide the development of novel therapies.

Biomarker Detection in Clinical Settings

Platform Technologies: Biomarkers are

derived from tumor tissues or other body fluids and detected by histopathological, immunohistochemical (IHC), fluorescence, ELISA, and PCR based techniques.

Tumor tissue-derived biomarkers, such as overexpression of genes are detected by IHC, such HER2 overexpression in HER2+ breast cancer. Chromosomal translocation such as BCR-Abl fusion in Philadelphia chromosome is detected by fluorescence in situ hybridization (FISH). ELISA methods are used to detect proteins in blood or other body fluids such as Carbohydrate antigen 19-9 (CA19-9) from the serum of pancreatic cancer patients. More recently DNA and RNA sequencing have expanded the scope of biomarker detection from limited tissue material. Mutations in EGFR, BRAF, KRAS and other oncogenes are detected by sequencing and is used routinely in clinical settings as predictive and prognostic markers. Similarly, massspectrometric approaches have identified biomarkers in complex body fluids such as serum and saliva. Biomarkers discovered using high throughput proteomics methods

are validated in the clinic using more robust multiplex ELISA methods.

Multi-omics Approaches:

In recent years, technological breakthroughs in genomics and proteomics have resulted in a shift from the use of a single biomarker to multiple biomarkers for disease classification, diagnostics, and prognosis. This is specifically true for oncology indications, where genetic and biochemical heterogeneity of tumor cells and the need to use combination therapies to derive maximum efficacy require a deeper understanding of the molecular features of the tumor and its microenvironment. These molecular features can be accurately assessed by the use of carefully selected biomarkers.

This multi-omics biomarker discovery approach has found extensive application in the area of cancer immunotherapy - a rapidly developing field of cancer treatment, where the host immune response is boosted to elicit an anti-

Figure 1. Biomarkers of response to immuno-oncology drugs combine analysis of tumor cell intrinsic and extrinsic factors. Exome sequencing identifies protein-altering genetic changes in tumor cells that contribute to the generation of immunogenic peptides (T-cell neoepitopes) mediating recognition between tumor cells and cytolytic killer T-cells (CD8 T-cells). Whole transcriptome sequencing provides information on the tumor microenvironment defining the immune reactivity of the tumor. Together, the tumor cell and tumor microenvironment analysis determines response to cancer immunotherapy drugs [9-11]

Pharma Bio World

October 2019 â&#x2013;ş 33

tumor response. The efficacy of immuneboosting checkpoint inhibitors is closely associated with molecular features present in tumor cells and the tumor microenvironment. Both exome and RNA-sequencing analyses reveal critical determinants of drug response. The scope of such an analysis is schematically represented in Figure 1.

Biomarkers Make Meaningful Differences in Clinical Trials A review of clinical trials conducted between 2006-2015 (9985 trials) reveal a low Phase-I to approval success rate for oncology drugs compared to other non-oncology disease areas (5.1% vs.

11.8% respectively) [12]. Further, the success of a biomarker-driven clinical trial was 3-times higher than a trial without biomarkers (25.9% vs. 8.4% respectively) [12] . Therefore, biomarker discovery has become mandatory for the clinical development of therapeutic molecules in all disease areas, particularly in oncology.

Biomarkers have become particularly important for targeted therapies and patient selection during clinical trials. In the early days of cancer treatment, nontargeted therapies, such as chemotherapy, or radiation therapy did not require specific biomarkers for patient selection.

Histopathological examination of tumor tissue helped in tumor staging, which guided treatment decisions. With the advent of targeted therapies, biomarkers for selecting patients who will benefit from treatment became pivotal in designing Phase-II and III clinical trials. In 2005, AstraZeneca's EGFR inhibitor gefitinib was tested in a Phase-III multicenter clinical trial involving 1692 patients.

The trial failed to show improvement in benefit between the placebo and the treated groups, although indications of benefit to certain patient subgroups, such as never smokers or Asian origin were 34 â&#x2014;&#x201E; October 2019

noted [13]. However, follow up molecular studies, investigating the mechanism for the lack of benefit, discovered that only patients harboring activating mutations in EGFR were super responsive to the EGFR tyrosine kinase inhibitors erlotinib and gefitinib [14-16]. These findings resulted in the rescue of the drugs, which have become the standard of care treatment for NSCLC patients harboring activating mutations in EGFR. Similarly, approval of crizotinib against NSCLC tumors harboring anaplastic lymphoma kinase fusion (ALK-fusion) has become the standard of care treatment within four years after the discovery that 3-5 per cent of NSCLC tumors harbor ALK-fusion genes [17] and ROS fusion genes [18]. Such accelerated clinical development was only possible because biomarkers for selecting tumors that will benefit from therapy were well established and FISH assays to detect such fusions were in place.

Biomarkers for Drug Repurposing Drug repurposing or drug repositioning is finding new uses for existing drugs against new disease indications.

Repurposed drugs may be approved for one disease indication, or may have failed clinical development due to inadequate efficacy or unacceptable toxicity. An example of an approved drug repurposed for a totally different indication is the cyclogenase-2 inhibitor (COX2) Celebrex (celecoxib). Celebrex and its generic counterpart celecoxib reduce inflammation and is approved for osteoarthritis, rheumatoid arthritis and acute pain and other indications.

However, the drug has been repurposed for use against colon polyps based on the finding that COX2 overexpression increases the risk of colorectal cancer and a clinical trial to that effect demonstrated a decrease in the risk of additional polyp formation in individuals with colorectal cancer [19]. Drug repurposing requires

identification of diagnostic biomarkers associated with disease mechanisms.

In the example above, the discovery that COX2 is highly overexpressed in colon cancer and inflammation is a key mediator of colon polyp formation led to the repurposing of COX2 inhibitor in this disease indication, which is considered a milestone discovery in colon cancer research. Another example is the use of the Type-2 diabetic drug metformin in preventing cancer. Metformin inhibits mitochondrial complex-I, reducing the generation of ATP, thereby increasing AMP levels that trigger AMPK kinase activation resulting in an increase in glucose metabolism [20]. New discoveries made in the last few years have identified pleiotropic effects of metformin on cellular pathways, such as inhibition of reactive oxygen species (ROS) generation, inhibition of p53-mediated cyclin-D1 expression, inhibition of autophagy and insulin-like growth factor signaling triggering a flurry of over 200 clinical trials in cancer (www.clinicaltrials.gov).

Drug repurposing will rely heavily on the discovery of biomarkers for patient stratification, and for measuring positive effect of drugs in the repurposed disease indications.

Future of Biomarkers in Precision Medicine and Personalized Therapies Biomarker discovery is a critical bottleneck to ensure the success of drugs in clinical trials. The cost of new drug development has skyrocketed in the last decade reaching over 1 billion dollars in discovery/development cost and running clinical trials. The burden of failure in late stage clinical trials results in a significant erosion in company's market value, winding down of future research activities and blunting innovation that small companies bring to the table.

A recent example is the failure of BMS's drug Opdivo (nivolumab) in the first line Pharma Bio World

treatment of advanced non-small cell lung cancer. The results of the failed clinical trial demonstrated that PD-L1, which is used routinely as a biomarker for selecting patients might not be robust enough to ensure approval of BMS's drug. The lack of positive clinical trial data erased 20 per cent of BMS's market cap in a day and prevented the market adoption of its drug to a competing product Keytruda (pembrolizumab) from Merck, which got approved for the same indication.

The Opdivo CheckMate trial and other unsuccessful clinical trials emphasize the need to identify robust biomarkers very early during drug development, and design efficacy and toxicity studies around these biomarkers to evaluate their utility, before transitioning the drug into pivotal clinical trials.

A large number of technological platforms including next generation sequencing and mass-spectrometry are available for the rapid discovery of biomarkers in complex tissues and body fluids [21]. This robustness of these technologies is well suited for clinical adoption and is rapidly gaining momentum with the regulatory authorities. Equipped with multi-omicsbased biomarkers the era of precision medicine will enter into the next phase of delivering personalized medicine, where each patient will receive a tailored therapy at the right time and at the right dose to maximize efficacy and avoid adverse toxicity - fighting cancer and still experiencing a better quality of life.

3.

4.

5.

6.

7.

8.

9.

Brugger, W., et al., Prospective molecular marker analyses of EGFR and KRAS from a randomized, placebo-controlled study of erlotinib maintenance therapy in advanced non-small-cell lung cancer. J Clin Oncol, 2011. 29(31): p. 4113-20.

Khan, S.A., et al., EGFR Gene Amplification and KRAS Mutation Predict Response to Combination Targeted Therapy in Metastatic Colorectal Cancer.

Pathol Oncol Res, 2016.

Song, Q.B., Q. Wang, and W.G. Hu, Anti-epidermal growth factor receptor monoclonal antibodies in metastatic colorectal cancer: a meta-analysis. World J Gastroenterol, 2015. 21(14): p. 4365-72.

6. Hames, M.L., et al., Correlation between KRAS mutation status and response to chemotherapy in patients with advanced non-small cell lung cancer. Lung Cancer, 2016. 92: p. 29-34.

Swain, S.M., et al., Pertuzumab, trastuzumab, and docetaxel in HER2positive metastatic breast cancer. N Engl J Med, 2015. 372(8): p. 724-34.

Baselga, J., et al., Biomarker analyses in CLEOPATRA: a phase III, placebocontrolled study of pertuzumab in human epidermal growth factor receptor 2-positive, first-line metastatic breast cancer. J Clin Oncol, 2014. 32(33): p.

3753-61.

Topalian, S.L., et al., Mechanism-driven biomarkers to guide immune checkpoint blockade in cancer therapy. Nat Rev Cancer, 2016. 16(5): p. 275-87.

and response to EGFR inhibitors. Cold Spring Harb Symp Quant Biol, 2005. 70: p. 419-26.

15. Lynch, T.J., et al., Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-smallcell lung cancer to gefitinib. N Engl J Med, 2004. 350(21): p. 2129-39.

16. Pao, W., et al., EGF receptor gene mutations are common in lung cancers from "never smokers" and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci U S A, 2004.

101(36): p. 13306-11.

17. Soda, M., et al., Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature, 2007.

448(7153): p. 561-6.

18. Rikova, K., et al., Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell, 2007. 131(6): p. 1190-203.

19. Arber, N., et al., Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med, 2006. 355(9): p.

885-95.

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Pryor, R. and F. Cabreiro, Repurposing metformin: an old drug with new tricks in its binding pockets. Biochem J, 2015. 471(3): p. 307-22.

21. 21. Simon, R. and S. Roychowdhury, Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov, 2013. 12(5): p. 358-69.

10. Motz, G.T. and G. Coukos, Deciphering and reversing tumor immune suppression.

Immunity, 2013. 39(1): p. 61-73.

11. Chen, D.S. and I. Mellman, Elements of cancer immunity and the cancer-immune set point. Nature, 2017. 541(7637): p.

321-330.

12. Thomas, D.W., Burns, J. et al., Clinical Development Success Rates 2006-2015.

BIO Industry Analysis, 2016.

References 1. Younes, A. and D.A. Berry, From drug discovery to biomarker-driven clinical trials in lymphoma. Nat Rev Clin Oncol, 2012. 9(11): p. 643-53.

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3968-71.

Pharma Bio World

13. Thatcher, N., et al., Gefitinib plus best supportive care in previously treated patients with refractory advanced nonsmall-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet, 2005.

366(9496): p. 1527-37.

14. Haber, D.A., et al., Molecular targeted therapy of lung cancer: EGFR mutations October 2019 â&#x2013;ş 35

Generic vs Branded Drugs A generic drug may be made and sold by a different company and may have different colour, packaging and inactive ingredients but the active ingredient is the same. The Medical Council of India and the Indian Government have recently accelerated their efforts to promote prescription and the use of generic drugs to bring health care within reach of everyone including the people at below poverty line.

A

ll drugs start as branded drugs.

Pharmaceutical companies spend a large amount of money in research and development of new drugs. In order to recover these costs (average USD 1.2 billion for each drug), the drugs are patented by the companies, which developed it, to prevent anyone else from selling the drug for a defined period of time (eg 10-15 years). After this patent period is over the patent expires and other companies can make and sell this drug, now called generic.

The generic drugs may be prescribed in two ways ie, as generic (only generic name) or generic brand (generic drug with manufacturer name in bracket). Generic drugs are in no way inferior, it is the same drug but at a later stage in the life cycle of a drug. A generic drug may be made and sold by a different company and may have different colour, packaging and inactive ingredients but the active ingredient is the same.

The Governments all over the world promote Generic Drugs to bring down the expenditure on healthcare: In India annually, about 32 million people get pushed below poverty line because of expenditure on medical care. About two thirds of this expenditure is on medicines, making it a major reason of poverty in India (NHSRC estimates). Generic medicines are cheaper than brand-name drugs, hence will substantially reduce expenditure on health.

In the US, the generic drugs that draw a large number of manufacturers average the cost falls to about 20 per cent (US FDA).

Dr Sanjiv Kumar Director International Institute of Health Management Research, New Delhi 36 â&#x2014;&#x201E; October 2019

The world has and is moving towards generic drugs. Let us take examples of two countries, US and Canada. In the

US, generic and over-the-counter drugs account for about 80 per cent of the sale.

In the 2009, the main suppliers of generic drugs (about 40 per cent) in the US were India and China.

In Canada (2011 Canadian Medical Association Journal ) generic drugs accounted for more than three-quarters of all prescriptions, but accounted for only 20 per cent of spending on pharmaceuticals.

The Medical Council of India and the Indian Government have recently accelerated their efforts to promote prescription and the use of generic drugs to bring health care within reach of India's poor. Government is committed to achieve Universal Healthcare and move towards right to health as stated in the recently released 2017 Health Policy.

Promoting generic drugs nationally builds on the rich experience across states especially Rajasthan and Tamil Nadu who are pioneers in introducing generic drugs in public health system. In medical colleges, future doctors are taught about pharmacological compounds (generic drugs) only. They later learn about branded drugs from representatives or promotional activities of the pharmaceutical companies.

According to USFDA : Generic drugs are important options that allow greater access to health care for all Americans. They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Health care professionals and consumers can be assured that FDA approved generic Pharma Bio World

Issues

Challenges

Benefits

Pharmaceutical Companies

Big Pharmaceutical Companies Small companies can manufacture generic drugs that invented the drug will lose business Quality control in smaller manufacturers

Doctors

Lose control over which company product to write. Accountability if the drug dispensed by the chemist is substandard

Do not need to know all brand names of a pharmaceutical compound and not influenced by promotional activity of some companies

Chemist

Decreased profit margins in generics as compared to branded drugs

Get chose different company drugs to dispense (some may be of doubtful quality)

Patients / Public

May run the risk of getting substandard medicines

Reduced patient expenses for medication

Quality of drugs

Quality control standards are the same for all manufacturers. India is the largest manufacturer and exporter of generic drugs which meet international standards.

However smaller companies may not be as robust.

With generic drugs, it is easier to regulate dosage of individual drugs which ins not possible in Fixed Drug Combinations (FDCs) of branded drugs. The government also bans many irrational FDCs from time to time.

Inducements and promotional activities

Those who receive inducements (as pharma companies make less money hence cannot offer inducements)

State and Central Governments : Spend less on reimbursement of medical expenditure on their employees entitled to medical care such as CGHS, Railways, Defence, ESI, RSBY etc.

Access to treatment

Market share of big pharma companies shrinks

Access and affordability of medical care increases benefiting especially the poor.

Table: Challenges and benefits from promotion of generic drugs

drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.

Who loses and who gains with promotion of generic drugs?

It is important to understand who gains and who loses by promotion of generic medicines and to understand the position being taken by different stakeholders in the current debate on generic drugs in India. The challenges and benefits from Pharma Bio World

promotion of generic drugs are summarized in the Table below:

The Government must address the concerns about promotion of generic drugs: Despite convincing scientific evidence that generic drugs are equivalent to branded medicines, there remains an undercurrent of fear towards generics in India. Even with very effective quality control in countries like the US, there have been concerns. A study in the US found that of 43 editorials in scientific journals, 53 per cent expressed negative views concerning generic substitutions for branded cardiovascular disease pharmaceuticals (Kesselheim et al

2008 JAMA) mostly due to advertising by brand companies against generic drugs and some generic drug scandals. In India, the main concern raised by professional bodies is that the quality regulatory mechanism is weak. This may adversely impact on health outcomes.

Large generic manufacturers which have made India - the pharmacy of the world - meet international standards of quality control, but the manufacturers catering to the domestic market may not.

Corruption and inducements that often lead to substandard drugs being sold in the market remains a major concern. Another concern is that the choice of manufacturer of generic drugs will shift to the chemist from the doctor which may affect quality of care if the medicine is substandard. The government needs to strengthen regulatory mechanisms and address corruption and inducements to assure availability of quality generic drugs to the public nationally. The pharmaceutical industry needs encourage all manufacturers to adopt Good Manufacturing Practices, voluntarily or through legal enforcement.

Conclusion The recent decisions by the Medical Council of India and the government to promote generic drugs is welcome and will increase availability of medicines at affordable cost and contribute to reducing poverty. The concerns of the Indian Medical Association and other professional bodies regarding quality of generic drugs need to be seriously addressed by the government.

It is important for the professional bodies to collaborate with the government in improving access to affordable quality medical treatment including medicines. There is a need for the government to engage all stakeholders along in its noble efforts to improve access, affordability, timeliness of high quality medical care to reach Universal Health Care and move towards right to health in the country.

October 2019 â&#x2013;ş 37

Maximizing the Efficiency of Clinical Trial Supply Chain Clinical trials are an essential part of the product development process for both pharmaceutical and biotech companies and if run efficiently can provide the company with a competitive advantage. This article discusses various key factors pertaining to an efficient and effective clinical trial supply management.

F

or a new drug to reach the market it has to undergo a robust clinical trial process which requires considerable amount of investment and can continue in excess of 10 years. The process involves global multicenter trials and recruiting a large number of patients to achieve the trial objectives e.g. safety and efficacy. Different types of clinical trial supplies, from investigational products to ancillary supplies are required to conduct clinical trials. The clinical trial supply chain is an integral part of any clinical trial; it constitutes packaging, labeling, storage, distribution to patients located in different geographic locations, and accountability and destruction of clinical trial supplies.

Below are the examples of Clinical Trial Supplies: • Clinical Trial Drug Supplies: Investigational Product & Comparators, Background / Rescue Medication • Clinical Trial Non Drug Supplies: Equipment & Lab Kits, CRFs, Blinding / Randomization Envelopes The primary goal of clinical trial supply process is to deliver The RIGHT SUPPLIES at the RIGHT TIME to the RIGHT INVESTIGATIONAL SITE for the RIGHT PATIENT

Sujay Salvi

Head - Clinical Trial Supplies Management, SIRO Clinpharm

Partha Chatterjee

Head - Clinical Research SIRO Clinpharm 38 ◄ October 2019

Although the basic principles of logistics apply to Clinical trial supply chain, it is different from Pharmaceutical commercial supply chain due to the following aspects: • Investigational Products are still under testing hence many aspects of the investigational product are still under 'investigation' or in other words the product needs to be administered to a selective group of patients who has consented for the clinical trial. It is, therefore, extremely critical to have a controlled use of such products right from the lab where it is being produced, till the time it is consumed by the patient, while all the extra supplies are accounted for and destroyed.

• Investigational Products are exclusively manufactured and packaged depending on the trial design so they are not available off-the-shelf.

• S o m e i n v e s t i g a t i o n a l p r o d u c t s e g Oncology products are very expensive and available in limited quantity, hence any wastage could affect the fate of the clinical trial.

• Each kit used at the investigational site is accounted for down to the unit level eg tablet, capsule and it needs to be returned to the sponsor for destruction.

• T h e t r i a l d a t a i s s u b m i t t e d t o t h e regulatory authorities for registration hence clinical trial supply chain is prone to regulatory audits and inspections.

• T h e c o m p l i a n c e l e v e l o f t h e investigational product during the trial has a direct co-relation with the final outcome of the trial. If it is not as per the desired level, the entire trial data would be of no use. Hence, one needs to have built-in quality checks in a study design and monitor closely so that the final outcome is achieved.

Therefore, it is imperative to optimize the clinical trial supply chain process with respect to time, quality, safety & integrity, and at the same time, bring in cost efficiencies.

In order to maximize the efficiency of clinical trial supply chain, it's important to know the various challenges associated with the process and the approaches/ techniques to address them.

Geography - Multicenter/ Multinational Trials One of the biggest challenges is the geographical location of the source and sites.

With the rapid growth in the number and spread of clinical trials, there are many multinational & multi-center trials, where Pharma Bio World

Clinical Trial Supply Chain

Site 1 Receipt

Manufacturer

Sponsor's Warehouse

Dispatch

Vendor's Warehouse

Dispensing Site 2

Drugs

Unused

Returned

Drugs

Subject

Site 3

Accountability

Destruction

Monitor/ CRA

multiple countries across the globe and various hospitals in those countries are involved. The clinical trial supplies need to be delivered at these sites from the source e.g. central depot. This could result in longer transit time, for example the central depot could be in USA and the sites in South East Asia.

These situations could result in longer transit time. In case of delays in clearance, there are chances of improper handling of supplies at the custom warehouse which could ultimately compromise the cold chain and affect the quality of the product. There is also a risk of shipments being misplaced resulting in product wastage.

In most of the countries, the drugs cannot be shipped to sites unless necessary approvals from Regulatory and Ethics committee are in place. Hence the clinical trial supplies cannot be sent in advance.

Product wastage can also be caused due to inaccurate forecasting, eg supplying excess investigational product to sites with low or no recruitment, or supplying products with short expiry date. Such incidences will have an adverse impact on the outcome of the clinical trial.

Global Regulatory Requirements Regulatory requirements could differ from one country another and inadequate knowledge about it could lead to delays in customs clearance. In many countries, import license is required to import drugs and the invoice should match the import license. The labels on investigational product kits should be as per country regulatory requirements which could be country specific. For example, expiry date on the kits is not mandatory in USA but it is mandatory in India.

Pharma Bio World

Poor subject compliance can occur if the investigational product is not available as the subject will not be able to adhere to the protocol specified time regime. This will adversely affect the company's reputation as it is the social and ethical obligation of the sponsor to make the investigational product available to the patients at all times during the trial period; this is also a GCP requirement.

Substandard products resulting from improper handling may jeopardize the clinical

trial outcome and there could be chances of data being rejected by the regulatory authorities.

Such issues will also delay the completion of the clinical trial and, in the worst case scenario, could lead to cancellation of the trial all together. The sponsor ultimately could incur heavy losses because of all these issues. â&#x20AC;˘ Based on years of industry experience, here's a checklist which could help in developing the right clinical trial supply chain strategy. Use of a service provider (local depot) The sponsor can appoint local depots in the countries which are participating in the clinical trial. As Clinical Trial Supplies Management is a niche area, many sponsors prefer to outsource it to the experienced partners rather than managing it by themselves. These depots are GxP compliant and provide end-toend service from receipt till destruction of the investigational product. These depots c an be audited and ap p r o v e d b y th e sponsor's Quality Assurance department.

October 2019 â&#x2013;ş 39

This partnership has many advantages, shorter transit time to sites being the most important advantage. The local depot can receive the drugs from the central depot after DCGI approval is received for the trial & import license is in place. Once the ethics committee approval is in place, the local depot can distribute the supplies to various sites.

Shorter transit time also ensures lower courier costs. The drugs can be shipped by the central depot /sponsor to the local depot as a bulk supply instead of supplying in bits and pieces, thus there will be fewer shipments imported for a trial resulting in less frequent customs clearance.

Appointing a local depot will give an added advantage of excellent awareness of local regulatory requirements. The supplies will be always available at the depot and can be dispatched to sites on a short notice. The local depot can provide dedicated resources/ project team handling a particular client ensuring a customer-focused approach and prompt action.

Many clinical trials like Oncology trials require comparators, background or rescue medication. Local depot can also provide support in sourcing the comparators from the local market; this can ease the burden on the sponsor as the sponsor won't have to make arrangements for procuring it centrally and then distributing across the globe. Local sourcing will save time and ensure availability of supplies. By delegating this responsibility to the service provider, the sponsor can increase focus on the investigational product. > Selection of the right courier partner A courier agency with the right experience and expertise is essential for the Clinical Trial Supply Chain to succeed. Sponsor can directly or through the depot partner appoint a courier agency which is focused on the life sciences and has a proven track record in cold chain management. This will ensure ontime and safe delivery of supplies without any transit issues, e.g. excursions, off-loading.

40 â&#x2014;&#x201E; October 2019

Such issues may result in product wastage and add to the overall cost as the product will have to be resupplied to the sites. The courier agency can be audited by Sponsor/ Depot partner. The courier agency should have processes in place for conditioning / preconditioning of gel packs, preparation of insulated shippers. They should always use validated shippers and calibrated dataloggers for the shipments.

The courier agency should track the shipment till delivery and provide the POD and data logger readings to the sponsor/ depot partner upon delivery. They should ensure that the supplies are delivered to the right person. In case of any issue, the courier agency must proactively and promptly inform the client. > Technology and Innovation Technology and innovation play an important role in the optimization of clinical trial supply chain. Multilingual labels or booklet labels are used for multinational clinical trials.

Their main advantage is the flexibility of drug supplies. The supplies can be used in more than one country or redistributed between countries. This minimizes the drug wastage and reduces the overall medication cost.

This hugely helps in trials where drugs are in short supply or expensive, e.g. Oncology trials. Booklet labels also complement the use of IXRS technology and pooled supplies.

IXRS (IWR /IVR) - Interactive Web / Voice Response System is used for forecasting, randomization, drug distribution, Inventory Management etc. This system also tracks the expiry date. As this system is linked to randomization, the drug orders are generated as per the patient recruitment and visit schedule. This minimizes product wastage and ensures the availability of supplies at sites. It also underlines the importance of using a local depot in order to manage the JIT (Just in time) delivery to the site.

Case Study

precious time and co-ordination exercise with an experienced clinical trial supplies vendor.

In a multicentre, randomized, blinded trial number of shipments containing investigational products were sent to the sites. After using these drugs on patients at the sites, these supplies were returned to the depot on an ongoing basis by the sites.

The study had a long duration of about three years. After the recruitment target and all the patient visits were over the sponsor asked the depot to provide the drug reconciliation records. As the depot had not done the reconciliation of investigational product at the time of receipt of the returned supplies they faced lot of issues in the accountability. The depot staff spent no. of days in conducting the drug accountability and found that the documentation received from sites was not adequate, mismatch between the quantities mentioned on the returned documents and the physical returned stock received at the depot. Even after spending considerable time in this activity all the kits dispatched to the sites could not be accounted for and finally sponsor had to report them as missing with a great risk of potential audit and inspection finding. This situation could have been easily avoided if the drug accountability was done on a real time basis and all the discrepancies were promptly reported and resolved.

Conclusion: The number of global multi-center clinical trials is increasing by day. Trial design and dosage regimes are becoming complex, and so are the challenges in clinical trial supply chain. The clinical trial supply chain has evolved over the past few years. The testing phase is over; sponsors nowadays are actively looking to reduce the cost of clinical trial supply chain without compromising the quality and integrity of the trials. The sponsors can achieve this by collaborating with the service providers who are experts in their domain and can provide a customized solution to their clinical trial supply chain requirements.

Here's a case study to help demonstrate the how a sponsor can save much of their Pharma Bio World

Ensuring Effective Safety & Risk Management for Biosimilars The use of biopharmaceuticals has significantly increased in recent decades. Biosimilars are new biopharmaceuticals that are similar but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the products structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. This article will focus on pharmacovigilance and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.

B

iologics have made great contributions to the treatment of many diseases including cancers, and are expected to provide significant therapeutic benefits to many patients.

However, due to their unique source material and complex manufacturing processes, biologics are very expensive, making them unavailable to a large number of patients. Moreover, many biologics are still under patent - contributing to their high price. This scenario is soon to change.

It is estimated that around two dozen biological products with global sales of more than USD 67 billion will go out of patent by 2020. 1

End of patent exclusivity and advances in biotechnology facilitating their manufacture have opened up huge opportunities for follow-on biosimilars. IMS Health forecasts that the global biologics market will reach USD 250 billion by 2020, and biosimilars and non-original biologics will represent 4-10 per cent of that market. 2 The price of a biosimilar is on an average between 10 and 35 per cent lower than the respective reference product. 3 Therefore, growth in biosimilars will drive down healthcare costs and generate significant savings for healthcare systems.

Biosimilars, unlike generic chemical drugs, are similar but not exactly identical to the reference products, and this poses multiple challenges in their development, safety monitoring and regulatory approval process.

Challenges and Solutions in Safety Monitoring and Risk Management for Biosimilars

Suhasini Sharma Director, Medical Affairs Sciformix Corporation Pharma Bio World

Pharmacovigilance: Post-approval pharmacovigilance is of vital importance for a biosimilar as fewer patients are exposed to it during development, since the number/ size of studies required for approval of a

biosimilar is much smaller compared to that for the innovator. Furthermore, because biologics are complex proteins which may stay longer in the body safety concerns may only become apparent outside of the timeframe of controlled clinical trials. 4 Since a biosimilar drug is not a replica of the reference innovator product, the efficacy and safety data generated for the latter cannot be directly and completely transferred to the biosimilar. Hence, compared to a chemical generic there is a bigger need for strict post-marketing product vigilance for a biosimilar in order to correlate its safety profile with that of the reference product, and to detect additional safety issues.

Accurate Product Identification: Despite the fact that a biosimilar and the reference drug can show similar efficacy, the biosimilar can exhibit a different safety profile in terms of nature, seriousness or incidence of adverse reactions. Therefore, when an adverse event (AE) is reported in relation to the use of a biosimilar product, there is a need to clearly identify the product associated with the AE. Product naming therefore becomes an important issue for biologics/biosimilars.

While the EU follows the International Non-proprietary Names (INN), the US Food and Drug Administration (FDA) is still in the process of developing its policy on biosimilar naming. 5 Possible regulatory solutions to aid product identification currently being deliberated include assigning distinct proprietary names to biosimilar products from different manufacturers, adding manufacturing company's name and specific codes to the product labels, and making biological products non-substitutable or noninterchangeable at the dispensing level.

On the part of PV teams, collecting detailed and accurate information on the product October 2019 â&#x2013;ş 41

involved (including the correct brand name, manufacturer's name and even the batch number) when an AE is received is of paramount importance.

Adverse Events Immunogenicity:

Related

to

A n i m p o r t a n t s a f e t y c o n c e r n re l a t i n g to biosimilars is their potential for immunogenicity. Biologics are complex proteins and have the capacity to trigger an immune response that may be humoral or cellular, and could become apparent in a variety of ways such as anaphylaxis, hypersensitivity and infusion reactions, cross-reactivity to endogenous proteins, altered pharmacokinetics of the molecule, or loss or lack of clinical efficacy. 6 In the case of biosimilars, the nature and severity of immunogenicity reactions could vary from those seen with the reference innovator product.

An additional hurdle in establishing immunogenicity of a biologic product could be the variable and often long "at-risk window." Biologics may persist in the body over a long time, resulting in a long, variable period between the intake and appearance of the reaction, making causality assessment difficult. Full characterisation of immunogenicity profile of a biosimilar may not be established at the time of approval. Hence, long term studies as well as continued postmarketing surveillance become crucial for risk management.

Information on the Label: Labelling is critical to the safe and effective use of a medicinal product. When an adverse reaction to the drug is encountered, information in the label is used to decide whether a specific adverse event/safety issue is already identified as a risk or could be a new, potential safety issue.

The general principle of labelling for biosimilars, based on the 2012 EMA 42 â&#x2014;&#x201E; October 2019

guideline, is that the label for a biosimilar medicine has to be consistent with that of the reference medicinal product for the common information applicable to the biosimilar product. 7 However, the unique nature of a biosimilar requires a labelling approach that combines information on both the reference product and the specific biosimilar product, linking each piece of information to the source product. Moreover, there must be "adequate mechanisms" to differentiate between adverse events associated with the biosimilar product and referenced product, including the ability to identify adverse events that have not been previously associated with the reference product.

Risk Management Plan (RMP): Data from pre-authorisation clinical studies are not enough to identify all potential differences between the biosimilar and its reference product. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase, including continued risk-benefit assessment. EMA requires that the biosimilar applicant must submit a risk management plan (EU-RMP) and pharmacovigilance programme with its application. The information must include a description of the potential safety issues associated with the similar biological medicinal product that may be as a result of differences in the manufacturing process from the reference biologic. Thus, the safety specifications in in the RMP of a biosimilar would include both identified and potential risks of the reference product, as well as risks identified from studies on the specific biosimilar product, making the safety profile as complete as possible.

Requirement for Post-Approval Studies: Both EU and the US guidelines require extensive analytical studies to show comparability of the biosimilar to the reference innovator product. Clinical comparability is established by a stepwise procedure with Phamacokinetics (PK)

and pharmacodynamics (PD) studies followed by clinical efficacy and safety trials. PD parameters are selected on the basis of their relevance to demonstrate therapeutic efficacy of the product. If there are several potential indications, the most sensitive disease model to detect differences is chosen in a homogeneous patient population. 8 It is recommended to evaluate safety data within the scope of combined safety and efficacy trials, hence, the size of the safety population evaluated maybe small. Consequently, there is need for additional post-approval studies to establish efficacy in indications not studied during the approval process and long-term safety studies to establish immunogenic potential and other safety issues which may be different from the reference product.

Cohort Event Monitoring: While spontaneous safety reporting is a passive way to gather safety data, it is limited by under-reporting and inadequate details.

Patient/disease registries are a tool for active safety surveillance and are extremely useful for detecting safety issues early in post-marketing user population. New adverse events including rare events or latent onset events can be detected sooner than through spontaneous reporting system and better qualification of known AEs can be done in the cohort being followed.

Summary End of patent exclusivity and advances in biotechnology have unleashed opportunities for follow-on biosimilars to enter the market and serve the needs of patients globally in a cost-effective manner. However, pharmacovigilance (PV) and risk management for biosimilars presents a number of challenges. Routine PV processes may need to be adapted to address these issues and some possible measures include: maintaining a repository of information on biological products available, developing special scripts that would allow for the collection Pharma Bio World

of detailed information on the product associated with the AE, careful medical evaluation of all suspected immunogenicity reports, understanding of "at risk window", implementing frequent aggregate review of safety data and comparison with the safety profile of the reference product, designing an RMP with additional measures to detect/evaluate yet unknown safety issues, setting-up special product/patient registries for cohort event monitoring, conducting adequately powered post-approval efficacy and safety studies in all indications and target populations and having a product label with efficacy and safety information related to both the reference product and biosimilar identified by source.

A number of biosimilars have been available in Europe for more than a decade now and

despite rigorous safety monitoring and tracking, no significant safety issues have been identified with these products. This provides a measure of assurance that safety and risk management for biosimilars can be effectively managed by carefully and diligently following regulatory guidelines and good pharmacovigilance practices.

References 1. GABA Online, 2014 - US$67 billion worth of biosimilar patents expiring before 2020, Generics and Biosimilars Initiative (GaBI), (Internet) http://www. gabionline.net/layout/set/print/content/ view/full/2030, [Accessed 29 May 2015) 2 IMS Health White Paper, 2013 Biosimilars and Non-Original Biologics 3. Joan Rovira, Jaime Espín, Leticia García and Antonio Olry de Labry, 2011. The

impact of biosimilars' entry in the EU market, EMINET. 4. Thijs J Giezen, Sabine MJM Straus, 2012. Pharmacovigilance of Biosimilars: challenges and possible solutions, Generics & Biosimilars Initiative Journa, Volume 1, Issue 3-4, 118-119.

5. Emily A Alexander, The biosimilar name debate: what's at stake for public health, Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(1):10-2.

6.Huub Schellekens, Biosimilar therapeuticswhat do we need to consider? Clinical Kidney Journal, Volume 2, Issue suppl 1, Pp. i27-i36.

7.

Sean Milmo, 2015.

Biosimilars, BioPharm Volume 28, Issue 2

Labeling of International,

8. FDA Draft Guidance, 2012. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

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October 2019 ► 43

Quality and Safety â&#x20AC;&#x201C; Especially in Times of Change The pharmaceutical industry is developing at an unusually rapid pace. Manufacturing companies are confronted with enormous challenges due to high market growth, new medicines and therapy forms, changing regulations and progressing digitization.

Johannes Rauschnabel, PhD, Chief Pharma Expert at Bosch Packaging Technology, casts a glance at some important areas of growth and describes the changes drug producers as well as processing and packaging specialists are facing.

T

he market for pharmaceuticals is growing persistently. According to a current market report by the QuintilesIMS Institute1 expenses for drugs will amount to 1.5 trillion US dollars globally in 2021. This equals an average annual growth rate of between four and seven percent in medication expenses or three percent in doses. Despite political uncertainties regarding general healthcare, the US will record the largest growth, while the so-called pharmerging markets will require about two thirds of the entire drug volume.

The reasons are obvious: global population is increasing (by 1.24 per cent per year until 2030) and ageing at the same time. All in all, the proportion of people aged 65 to 80 will rise to 28 per cent, compared to 22 per cent in 2000. Increasing urbanization and a growing middle class are making drugs available and affordable for more people and also lead to a higher demand for medication.

Megatrend Biologics While the demand for common medication such as pain killers and prescription drugs like antibiotics is increasing in the pharmerging markets, completely new forms of treatment are emerging in industrialized countries thanks to the access to more complex substances.

Accordingly, one of the most important pharmaceutical trends of the past years is extending to more and more people and regions. Groundbreaking changes are occurring in the area of biological agents, for instance regarding the treatment of cancer, autoimmune diseases, as well as rare illnesses which only affect a very small group of patients.

Dr Johannes Rauschnabel Chief Pharma Expert Bosch Packaging Technology 44 â&#x2014;&#x201E; October 2019

In the still relatively new cancer immunotherapy, for instance, the body's

own immune system is stimulated to fight against tumor cells. Monoclonal antibodies attach themselves to the characteristic structures on the tumor surface and mark the cells for macrophages or induce cell death. A further break-through in cancer therapy was achieved with checkpoint inhibitors. To protect the body against autoimmune reactions that would destroy its own tissue, the immune system is equipped with checkpoint molecules which prevent an overreaction of the immune system. By blocking the checkpoints, they open the way for the immune system to fight the tumor consisting of endogenous cells.

A highly promising research and application area deals with antibody-drug conjugates (ADCs). These high-quality biopharmaceuticals connect a certain substance to an antibody, which binds to a target structure such as an antigen on the surface of a tumor cell. This way, cytostatic agents - natural or synthetic substances, which inhibit either cell growth or cell division - can get to the center of the tumor cell like a Trojan horse, and can unfold their chemotherapeutical effect.

Kinase inhibitors also range among the increasingly used targeted cancer therapies. They are able to slow down unrestrained cell growth, for example in chronic myeloid leukemia, by blocking the signal cascade that triggers cell growth.

These molecules are set to become a new therapeutic standard. At the same time, they open up market opportunities for replica products.

Less Expensive Solutions for the Masses For several years, the pharmaceutical industry was awaiting the biopharma patent cliff with a certain concern. Now, the patents of some large biotechnical molecules have expired - and the production of biosimilars Pharma Bio World

Molecular diagnostics serve to identify the genotype of a patient, thus predicting the efficacy and compatibility of each drug. This not only raises effectiveness; it also leads to less side-effects following the adaptation of the dose to a specific genotype.

Changing Role Concepts

has begun. First biosimilars have already been approved during the past two y e a rs , f o r i n s ta n ce f o r t h e t re a t m e n t of neutropenia or rheumatoid arthritis.

Moreover, approximately 15 replicas of the monoclonal antibody Bevacizumab 2 are currently being tested. Patent rights for the reference product will expire in 2019 in the US and in 2022 in Europe.

Targeting Illnesses More Precisely

For patients, this development is a great p ro g re s s , s i n c e m a n y d r u g s a r e n o w produced in larger quantities and are sold at significantly lower prices. Authorities such as the US Food and Drug Administration (FDA) promote the approval of biosimilars to make them available quickly for many people, while reconciling therapeutic advances with cost reductions.

Medicine is also advancing rapidly in the area of vaccines, where targeted campaigns are promoted strongly for instance by the WHO or UNICEF. Pharmaceutical companies are also committed to providing cost-efficient solutions for the development of new vaccines to fight malaria, HIV, Zika or Ebola - diseases which have now also made their way to the industrialized nations. Two aspects are at the center of attention: making these vaccines available for a large population, and simplifying their administration. Untrained staff or patients themselves should be enabled to administer their medicines as effectively and painlessly as possible.

As far as cancer treatment is concerned, the situation is similar in the pharmerging markets.

Here, especially generic cytostatic drugs offer access to therapies that were so far very difficult to obtain or not available at all for the majority of the population. The cost-efficient manufacture of generic cytostatics now also enable these countries to make medicine available for a large amount of patients.

The next step towards an even more targeted treatment consists in the use of stratified medicine. As opposed to cytostatic drugs, which kill both abnormal and healthy cells with a high division speed and can stop hair growth or lead to hair loss, stratified medicine follows a different approach by addressing patient groups with the same genetic preconditions.

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All these pharmaceutical innovations require intensive research and development as well as adequate production environments to ensure a fast time-tomarket. Pharmaceutical manufacturers must adhere strictly to legal requirements, and always be aware of potential changes to existing guidance. They must adapt their production environments to the demands of highly potent substances, while keeping new processes and increasing digitization in mind. Most importantly, they must be able to rely on high-quality equipment.

In the course of these changes, the roles of drug producers and equipment manufacturers have also changed - from a mere business relationship of purchaser and vendor to a partner-like collaboration, where equipment suppliers assume more responsibility. New projects hardly ever focus on a single machine.

In contrast, the trend is towards complete solutions that go far beyond technical or mechanical know-how. Suppliers have advanced to partners, who accompany the entire process with profound market knowledge and technological expertise before, during and after project implementation, thus ensuring a fast timeto-market of new pharmaceuticals.

From Laboratory to Production Before new pharmaceutical products can be introduced to the market, they undergo long and expensive research and development processes. At the same time, producers depend upon a fast market entry October 2019 â&#x2013;ş 45

solid pharmaceuticals, which above all aim at reducing costs and enhancing efficiency.

The Highest Safety for Humans and Products

to make full use of their exclusivity during the limited patent protection timeframe. The keyword for a fast market launch is "scaleup", meaning the transfer from laboratory to production scale. Parameters and recipes must be precisely conveyed from laboratory equipment to larger machines, always in line with Good Manufacturing Practice (GMP). Here, new simulation tools help to calculate the required process conditions and save a significant amount of time.

Biosimilars are produced in both small and large volumes. Whenever frequent product changeovers are on the agenda, pre-sterilized single-use systems offer a solution with hardly any preparation time.

They combine high filling accuracy with maximum safety - and omit the need for time-consuming cleaning, sterilization and validation of product contact parts.

Continuous Processing

Besides scale-up, another trend towards "scale-out" is currently to be seen, especially with small batches of targeted medicine.

Manufacturing capacity is increased by copying existing manufacturing equipment and transferring it to other sites or even contract manufacturing organizations. This requires well defined processes, as well as affordable and robust equipment with a high degree of automation.

The production of complex pharmaceuticals also focuses on cost-efficiency. A concept that favors this approach is "continuous processing", and has already been applied in the food or chemical industry for some years. In contrast to batch production, continuous processing implies the production and processing of materials in a continuous, uninterrupted process.

Speed is especially important for the production of generics in both pharmerging and industrialized nations. The latter are facing constantly rising cost pressure, while the pharmerging markets require affordable medication for a large population.

Prerequisites are sophisticated, robust technologies with easy handling as well as short cleaning and changeover times.

In spring 2015, Dr Janet Woodcock, director of the FDA's Center of Drug Evaluation and Research, repeatedly raised the question why this method was not yet more widely used in the pharmaceutical industry 3 .

Despite a slow development pace, the climate has changed over the past years: leading technology companies are currently working on new continuous technologies for

46 â&#x2014;&#x201E; October 2019

Biologic processes are becoming more complex and guidelines stricter. The highly potent ADCs, which consist of a biologic part (the antibody), a linker and a small active molecule, are toxic to the operator. At the same time, humans also pose the greatest contamination risk to these products. The effective protection of humans and products from each other requires suitable containment technology. In the manufacture of liquid pharmaceuticals, isolators are the enclosure of choice. Vials remain the containers most frequently processed in isolators, while the use of pre-filled syringes has especially risen in Europe.

The development of new pre-filled, sterile primary packaging solutions such as presterilized syringes, vials or cartridges has paved the way for the development of new line concepts.

In order to protect ADCs from external influences such as oxygen, moisture or sunlight, they are mostly freeze-dried in vials after filling. During the lyophilization process, water is removed from the product after it is frozen and placed under vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The substances are preserved until usage and have a much longer shelf life than their liquid counterpart. This requires a very exact integrity test of the packaging material.

New Regulations are Changing the Pharma Industry Container Closure Integrity (CCI) is extremely important to ensure the sterility and stability - and thus quality and safety also of lyophilized products. It requires the inspection of a large number of parameters.

Pharma Bio World

The United States Pharmacopeia (USP) has therefore revised its general chapter 1207 4, demanding more quantitative, nondestructive CCI test methods.

Examples are high-voltage leak detection (HVLD) or headspace analysis (HSA). CCI inspection of sterile products will also be one of many topics during the revision of the "EU GMP Guideline for Manufacture of Sterile Medical Products Annex 1" 5 (Annex 1). This revision will certainly introduce the most significant changes to Annex 1 since its first publication in 1972.

A familiar, high-priority regulatory subject refers to the safety of patients and their protection against counterfeits.

The unambiguous serialization of pharmaceutical packaging not only requires a data matrix code to be printed on folding cartons. A holistic serialization solution should be able to mass-serialize the packaged product, verify the codes and provide the packaging with tamper-evident labels or security seals.

Moreover, the entire process should be consistently controllable and the data accessible at any time. Only this way do manufacturers - and later issuing authorities - have an exact overview of all process steps. A flexible and scalable machine and software concept is the obvious solution.

Pharma En Route Towards Industry 4.0?

Pharmaceutical serialization is a first step towards an increasing connectivity of production processes. State-of-the-art software solutions should not only be able to manage the allocation of serial numbers through to the last aggregation step. They should also connect single components and third-party equipment, packaging lines, own or third-party IT systems and entire production facilities. Compared to other industries, pharmaceutical production is still in a quite early stage - just as it is Pharma Bio World

with continuous processing. However, digitization developments are advancing here, too.

Amongst others, software modules help to control and monitor production and quality data as well as logistic processes flexibly according to customer requirements. Easyto-handle user interfaces not only facilitate the operator's work. The current machine and production status can be clearly visualized from the global level down to a single machine. Drug producers can also obtain fast recipe and count values of a machine. Apps ensure that a transparent overview of machine data is delivered to mobile devices - no matter where the operator or line manager is within the production facility.

These new possibilities help to reduce costs. But most importantly, they also enhance product quality and make it possible to provide patients all over the world with safe medication.

True Line Competence The supplier in his role as partner of pharmaceutical companies, plays a very important part in all these areas. Which regulations must be implemented until when?

Which laws will be changed in the coming years, which effects will they have on the production process? Which technologies are needed to instantly fulfill these requirements - and how can they be seamlessly integrated into the overall process?

providing technology, services, consultancy and profound market knowledge from a single source. This also includes analyzing the market carefully, identifying future demands and implementing customer experience in new developments. The key to highest patient safety, process and product quality lies in the effective combination of all these requirements.

References 1. QuintilesIMS Institute, "Outlook for Global Medicines through 2021", http://www. imshealth.com, December 2016.

2.

Bevacizumab is an angiogenesis inhibitor for the treatment of six different malignant tumors. It is used in combination with chemotherapy. h t t p : / / w w w. e m a . e u r o p a . e u / d o c s / e n _ G B / d o c u m e n t _ l i b r a r y / E PA R _ - _ Product_Information/human/000582/ WC500029271.pdf Brennan, Zachary: FDA calls on 3 manufacturers to begin switch from batch to continuous production; http://www.inpharmatechnologist.com/Processing/FDAcalls-on-manufacturers-to-begin-switchfrom-batch-to-continuous-production, 01.05.2015.

4. h t t p : / / w w w. p h a r m a c o p e i a . c n / v 2 9 2 4 0 / usp29nf24s0_c1207.html 5 http://ec.europa.eu/health//sites/health/ files/files/eudralex/vol-4/2008_11_25_ gmp-an1_en.pdf

Whoever is able to answer all these questions and at the same time provide the corresponding technical solutions is ready to take on exactly this partner-like role.

For this reason, Bosch Packaging Technology has already been concentrating on more than single technologies and machines for quite some time. The focus in all projects is on pharmaceutical line competence and system integration, October 2019 â&#x2013;ş 47

press release Biocon Biologics & Just-Evotec Biologics Signed Licensing Deal for a Biosimilar Asset

Bengaluru, India; Hamburg, Germany; and Seattle, USA: Biocon Limited and Evotec SE have recently announced that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just-Evotec Biologics, wholly owned by Evotec, have entered into a strategic licensing agreement for an early-stage, pre-clinical biosimilar asset.

Biocon Biologics will take this biosimilar asset through end-to-end development, IND filing, and manufacturing & commercialization postregulatory approval under its own label in global markets. Biocon Biologics aims to address the needs of a large patient pool through this differentiated therapy. Through this in-licensing deal, Biocon Biologics has expanded its current therapeutic basket of biosimilars going beyond diabetes, oncology, and immunology.

Just-Evotec Biologics has a unique platform with deep experience in the fields of protein, and process & manufacturing sciences, which it has leveraged to develop this complex molecule. Just-Evotec Biologics has received an undisclosed license fee from Biocon Biologics and will be eligible to receive development, regulatory, and commercial milestone payments.

Dr Christiane Hamacher, CEO, Biocon Biologics, said: “We are extremely confident of the quality of the biosimilar asset developed by Just-Evotec Biologics and this collaboration will provide a head start for Biocon Biologics to commercialize a biosimilar under its own brand.

Leveraging our R&D skills and manufacturing expertise, we aim to take this differentiated therapy from ‘bench to bedside’. This product expands our therapeutic basket and will enable us to address unmet patient needs for a high quality affordable therapy”.

Dr James N Thomas, EVP, Global Head Biotherapeutics & President US Operations at Just-Evotec Biologics, said: “We are excited to enter into this partnership with Biocon Biologics, a multinational company with a strong presence in biosimilars. Just-Evotec Biologics’ optimised product and process platform has generated an excellent early-stage product candidate which we have licensed to Biocon Biologics for further development using their late-stage development, manufacturing and commercial capabilities to bring a compelling treatment to patients.

We look forward to providing support to the Biocon Biologics team as their program advances towards the clinic”. Dr Thomas added, “This is the beginning of a great relationship between Just-Evotec Biologics and Biocon Biologics”.

Under the agreement, Biocon Biologics will now assume all development and commercialization responsibilities for the program. Biocon Biologics will benefit from Just-Evotec Biologics’ vast experience in the process development domain, particularly with respect to optimised manufacturability.

R&D is at the core of Biocon Biologics' journey towards meeting its strategic long-term goal to address the needs of millions of patients worldwide. Biocon Biologics’ scientific expertise and world class R&D and manufacturing facilities have enabled it to bring multiple biosimilar therapeutics to the US and Europe.

Biocon Biologics has a product pipeline of 28 molecules including 11 with Mylan, several with Sandoz, and is developing many 48 ◄ October 2019

independently. The Company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology, and inflammatory diseases.

Nucala is the First Biologic Approved in the US for 6 to 11-year-old Children with Severe Eosinophilic Asthma

London, UK: GlaxoSmithKline has recently announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma. Nucala is the only targeted biologic to be approved for the condition in the 6- to 11-year age group in the US. Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “Children with severe eosinophilic asthma currently have limited treatment choices available to them. We believe this important new indication for Nucala is a significant development for these children and their families”.

Tonya Winders, CEO and President, Allergy and Asthma Network, noted: “As a mother of children who suffer from asthma, I know firsthand the huge impact it has on a family, from the constant worry about your child being hospitalised, to practical issues like arranging time off work to care for them. Having Nucala approved as the first biologic for treating severe eosinophilic asthma in this young age group represents a significant step forward for the asthma community.”

The FDA approval is supported by an open-label study, conducted in children aged 6 to 11 years and suffering from severe eosinophilic asthma, that investigated Nucala’s pharmacokinetics, pharmacodynamics, and long-term safety. Evidence from adequate and well-controlled trials in adults and adolescents also supported approval in this age group. The 52-week long-term phase of the study showed that the safety profile in paediatric patients aged 6 to 11 years was similar to the known safety profile in patients aged 12 years and older.

Dr Daniel Jackson, MD, Department of Pediatrics, University of Wisconsin, added: “Severe eosinophilic asthma in children is a complicated condition that can be extremely challenging to treat.

Nucala has made a difference for many adults and adolescents living with severe asthma. This approval is an important development, giving physicians like me a much-needed option to consider for our paediatric patients”.

Nucala (100mg dose subcutaneous injection) was first approved in 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older. This approval (40mg dose subcutaneous injection) extends the current indication in the US for Nucala to patients aged six to 11 years.

Nucala has been approved for use as an add-on treatment for severe eosinophilic asthma in patients aged six years and older in the EU since August 2018.

Source: gsk.com Pharma Bio World

press release Accutest Biologics Received Global Honour; Trastuzumab Deruxtecan Granted FDA India’s First Standalone Facility Geared Up Priority Review for Treatment of Patients with HER2-positive Metastatic Breast Cancer to Leverage Growing Global Drug Demand Mumbai, India: India’s clinical contract research industry with the current market size of USD 500mn is poised to double over five years and achieve billion dollar market club. As a leading Indian Contract Research Organisation (CRO) Accutest Biologics Private Limited (ABPL) is all set to leverage the growing global demand for Biologics and Biosimilar drugs. The leading CRO for Biochemical characterization and Bioanalytical services, in support of preclinical and clinical development of Biologics and Biosimilars, ABPL has recently received a global honour with the OECD-Good Laboratory Practice (GLP) certification for the next three years.

National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) had conducted a detailed pre-inspection of the test facility located at Navi Mumbai and this year in May, India’s only standalone test laboratory of ABPL received the GLP certification.

The recent Organisation for Economic Co-operation and Development (OECD)-Good Laboratory Practice (GLP) certification for Bioanalytical services, Biochemical characterization and the in-vitro bioassays conducted in its Navi Mumbai facility would act as a powerful catalyst for global pharma companies from the US, Europe, and other emerging markets to get ABPL services.

Dr. Satish Sawant - Founder and CEO, ABPL said, “The Navi Mumbai facility is capable of conducting toxicity studies, mutagenicity studies, and analytical & clinical testing. This significant milestone enables us to advance as the global service provider living up to the biopharmaceutical industry expectations and maintaining high-quality deliverables”.

Rising demand for low cost medicines, growth of R&D sourcing, a large number of biologics going off-patent, growing biologics & biosimilar market, and removal of regulatory bottlenecks for clinical trials are main growth drivers for the sector. As per industry estimates, biologics worth USD 100 billion in sales will go off-patent by 2020 and entail huge pipeline for bio-similar drugs. Asia pacific is expected to capture one-third of bio-similar sales in next 5-6 years.

“The certification places ABPL in the select league of CROs that have been awarded such a global honour. It is a matter of pride and privilege for ABPL not only to serve the biopharma industry with established credibility and also to get recognized in all the OECD member countries for mutual acceptance of the data”, said Dr. Mallikarjun Dixit, Test Facility Management at ABPL. Industry expects the India CRO market to reach around USD 1 billion by 2023 from USD 500 Million in 2017, with a CAGR of 12 percent. India is emerging as a top destination for CRO because of the acceptance of International guidelines and intellectual property rights, Presence of diverse types of climatic conditions thus allowing stability studies to be performed with ease in one destination, highly experienced-educated-and-accessible human resource, presence of diverse ethnic pool thus enabling diverse sample for clinical trials and low operational cost due to cheap human resource.

The CRO services market is valued at USD 36 Billion in 2017 and projected to reach to USD 56 Billion by 2023, at a CAGR of 7.6 percent.

Pharma Bio World

Mumbai, India: AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) have recently announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review.

The Prescription Drug User Fee Act (PDUFA) date for trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic breast cancer, is set for the second quarter of 2020.

José Baselga, Executive Vice President, Oncology R&D, said: “Trastuzumab deruxtecan has the potential to transform the treatment landscape for patients with HER2-positive metastatic breast cancer who have limited treatment options these days. This Priority Review draws on the strength and the consistency of results seen in the Phase I and Phase II trials and is a critical step on the journey to deliver this potential new medicine to patients.”

Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, said: “We are pleased that the FDA has accepted the application and granted Priority Review, as we believe trastuzumab deruxtecan has the potential to redefine the treatment of patients with HER2-positive metastatic breast cancer.

Following the recent regulatory submission in Japan, we look forward to working closely with regulatory authorities to bring trastuzumab deruxtecan to patients in the US and Japan as soon as possible.”

Trastuzumab deruxtecan was previously granted US FDA Breakthrough Therapy Designation and Fast Track designation. The BLA is based on the combination of data from the Phase I trial published in The Lancet Oncology and the pivotal Phase II DESTINY-Breast01 trial. The response rate observed in DESTINY-Breast01, as assessed by an independent review committee, validated the clinical activity observed in the Phase I trial. Detailed data from DESTINY-Breast01 will be presented at the forthcoming San Antonio Breast Cancer Symposium in December.

Source: astrazeneca.com

An Update on US Regulatory Review of PT010 in COPD

Mumbai, India: AstraZeneca has recently announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/ glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD). The NDA submitted to the FDA by AstraZeneca included data from the Phase III trial KRONOS. The Company will now work closely with the FDA regarding next steps, including submitting for review recent results from the second positive Phase III trial, ETHOS, which was not completed at the time the NDA was submitted.

PT010 was approved in Japan in June 2019 as Breztri Aerosphere, a triplecombination therapy to relieve symptoms of COPD. PT010 is under regulatory review in China where it has been granted priority review by the National Medical Products Administration, and is also under regulatory review in the EU. Source: astrazeneca.com October 2019 ► 49

press release GSK and Lyell Immunopharma Joined Forces to Develop the Next Generation Cancer Cell Therapies

London, UK; San Francisco, USA: GlaxoSmithKline Plc has recently announced their five-year collaboration with Lyell Immunopharma, a San Francisco based Biotechnology company, to develop new technologies to improve cell therapies for cancer patients. The collaboration will apply Lyell’s technologies to further strengthen GSK’s cell therapy pipeline, including GSK3377794, which targets the NYESO-1 antigen that is expressed across multiple cancer types.

To date, two cell therapies have been approved for blood-borne cancers, but engineered T cells have not yet delivered strong clinical activity in common solid tumours. Improving the fitness of T cells and delaying the onset of T cell exhaustion could help engineered T cell therapies to become more effective. Combining GSK’s strong cell and gene therapy programmes with Lyell’s technologies may allow the joint research team to maximize the activity and specificity of cell therapies in solid tumour cancers, where there is a high unmet medical need.

Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK said: “We are witnessing significant scientific innovation in cell and gene therapies, transforming the treatment of some blood-borne cancers, but patients with solid tumours are in need of equally effective treatments.

Applying Lyell’s novel approach to counter T cell exhaustion and working with world class scientists, such as Rick Klausner and his impressive team, increases our probability of delivering the next generation of cancer cell therapies for patients with solid tumours.”

Lyell is exploring several approaches to improve T cell function and to increase T cell fitness to enhance initial response rates in solid tumour cancers and to prevent relapses due to loss of T cell functionality. As Lyell addresses inhibition of T cells by the tumour in a fundamental way, there is an opportunity that these technologies can be used as a platform for multiple new cell and gene therapies that can be applied across a broad range of rare and prevalent solid cancers.

Dr. Rick Klausner, founder and CEO, Lyell Immunopharma said: “Our approach is to tackle three of the most significant barriers to T cell efficacy in solid tumours. We are redefining the ways we prepare patient cells to be made into therapies, modulating cells’ functionality so that they maintain activity in the tumour microenvironment, and establishing methods of control to achieve specificity and safety for solid tumour-directed cell therapies”.

Lyell has a scientific management team with a long history in the field of immune cell therapy. Rick Klausner is the former head of the National Cancer Institute (NCI) and co-founder of Juno Therapeutics, and whose lab discovered the molecular engine behind T cell receptor and CAR signalling; Stan Riddell, co-founder and the Head of R&D, co-founder of Juno whose pioneering work over three decades at Fred Hutchinson Cancer Research Center has helped to define the parameters of successful adoptive cell therapy; Nick Restifo, EVP of Science, whose research over 25 years at the NCI defined the properties of the T cells capable of therapeutic efficacy in cancer; and Margo Roberts, CSO, whose work in adoptive T cell therapy includes serving as CSO of Yescarta maker Kite Pharma, administering the first CAR T cell into patients in 1993, and demonstrating the role of co-stimulation in T cells for effective CARs. Next generation engineering that leverages Lyell technologies could further enhance the benefit/risk profile of GSK’s lead 50 ◄ October 2019

programme and other cell therapies in GSK’s pipeline. GSK3377794 uses genetically engineered autologous T cells and is currently in Phase 2, on an accelerated development path.

The collaboration will also build on GSK’s world-leading manufacturing platform and expertise for cell and gene therapy that delivered the world’s first approved ex vivo gene therapy (Strimvelis) for ADA-SCID in 2016. GSK has granted patents and pending patent applications related to its stable cell line technology (SCLT) and has a long-standing collaboration with Miltenyi Biotec to improve quality and scale of output to meet the needs of larger patient populations.

Lyell co-founders also include Crystal Mackall, MD, who has pioneered work on T cell exhaustion, and David Baker, PhD, Director of the University of Washington Institute for Protein Design, whose novel approaches to protein engineering provide technologies to enable enhanced precision, control, and safety in cell-based therapies.

Source: gsk.com

Malaria Elimination Programme Received Mahatma Award for Social Good

Mumbai, India: The Malaria Elimination Demonstration Project (MEDP) started by the Foundation for Disease Elimination and Control of India (FDEC India) was conferred with the Mahatma Award for Social Good 2019 at the 'Mahatma Awards’ ceremony held at Gurgaon, Delhi NCR as part of Mahatma Gandhi’s 150th Birth Anniversary. FDEC India has been established by Sun Pharma as part of its Corporate Social Responsibility initiative. MEDP was started in September 2017 as a Public Private Partnership between FDEC India, the Indian Council of Medical Research (ICMR), and the Government of Madhya Pradesh.

The Mahatma Awards, constituted in 2017 in the United States, are presented annually to honor the good social impact of thousands of individuals and organizations. The awards are given to individuals, NGOs, nonprofits, corporations, and public sector enterprises, who are working towards sustainable development goals set by United Nations.

The goal of MEDP is to demonstrate successful elimination of malaria from 1233 villages of Mandla district in Madhya Pradesh. Within 24 months of operations, FDEC India has achieved 83 percent reduction in indigenous cases in the entire district and 90 percent reduction in high endemic blocks. The project involves robust surveillance through the T4 approach – Track, Test, Treat, and again Track to eliminate malaria.

Japan’s PMDA Issued GMP Certificate to Lupin’s Unit II Mandideep facility

Mumbai, India: Pharma major Lupin has recently announced the receipt of GMP (Good Manufacturing Practice) Certificate from the Pharmaceutical and Medical Devices Agency (PMDA), Japan for its Mandideep API facility (Unit II). The GMP Certificate was issued following an inspection conducted by PMDA between May 14, 2019 and May 17, 2019.The PMDA inspection closed with no critical or major observations. The GMP Certificate issued by PMDA for Mandideep facility (Unit II) will remain valid till September 2024.

Source: lupin.com Pharma Bio World

press release Glenmark Pharmaceuticals Received Tentative ANDA Approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg Mumbai, India: Glenmark Pharmaceuticals Inc. USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Dimethyl Fumarate Delayed-Release Capsules 120 mg and 240 mg, a generic version of Tecfidera1 Capsules 120 mg and 240 mg of Biogen Inc.

According to IQVIA sales data for the 12 month period ending August 2019, the Tecfidera Capsules 120 mg and 240 mg market achieved annual sales of approximately USD 3.7 billion.

Glenmark’s current portfolio consists of 161 products authorized for distribution in the US marketplace and 49 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Lonza Discussed the Benefits of Working with Serum-free Cell Culture Media

Basel, Switzerland: Lonza has recently hosted a free 60-minute webinar that addressed current concerns regarding the use of serum in cell culture media, explored viable alternatives and provided guidance on how to adapt cells to a serum-free environment.

In cell biology, cells are commonly grown in medium supplemented with serum. Serum is a highly variable, undefined product, which impacts the reliability, reproducibility and consistency of scientific results. In order to eliminate these unwanted influences, more and more scientists are considering serum-free cell culturing these days.

Nicole Wellens, Lonza Cell Culture Specialist, threw light on – scientific concerns about cell culturing with serum, case for serumfree cell culture, and how to switch from serum to serum-free culturing with little effort in his disciscussion.

Sun Pharma Launched Drizalma Sprinkle in the US Mumbai, India; and Princeton, USA: Sun Pharmaceutical Industries Ltd has recently announced that one of its wholly owned subsidiaries has launched Drizalma Sprinkle (duloxetine delayed-release capsules) in the US for oral use. Drizalma Sprinkle is a serotonin and norepinephrine reuptake inhibitor (SNRI) designed for the treatment of various neuropsychiatric and pain disorders in patients who have difficulty in swallowing – a problem that is estimated to affect approximately 30-35 percent of long-term care residents. The US Food and Drug Administration (FDA) approved Drizalma Sprinkle on July 19, 2019.

The availability of Drizalma Sprinkle expands Sun Pharma’s portfolio of alternative formulation products designed for individuals with swallowing difficulties, the risk of which increases with age and exposure to age-related diseases and conditions - including Pharma Bio World

depression, anxiety, and pain disorders. Drizalma Sprinkle joins Ezallor Sprinkle (Rosuvastatin) and Kapspargo Sprinkle (metoprolol succinate) extended-release capsules as the third product in Sun Pharma’s US portfolio designed for individuals in long-term care. It is common practice in long-term care facilities to crush medications to ease administration, but crushing tablets introduces additional risks into the administration process. The Joint Commission International Accreditation Standards for Long Term Care urges facilities to dispense medications in forms that require minimal manipulation.

“The launch of Drizalma Sprinkle is an important milestone for people with difficulty swallowing, as this formulation of duloxetine can facilitate treatment of common neuro-psychiatric disorders while preserving the quality of the medicine,” said Abhay Gandhi, CEO, North America, Sun Pharma. “This launch further underscores our commitment to providing a portfolio of alternative formulation products to treat common diseases – especially in long-term care, where 30-35 percent of individuals have difficulty in swallowing.

These patients often encounter medication errors and challenges with medication administration”.

Drizalma Sprinkle is indicated for the treatment of major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients 7-17 years old, diabetic peripheral neuropathic pain (DPNP) in adults, and chronic musculoskeletal pain in adults. It is available in four dosage strengths (20mg, 30mg, 40mg, and 60mg).

Drizalma Sprinkle is the first and only FDA-approved formulation of duloxetine that can be swallowed whole, sprinkled on applesauce, or administered via nasogastric tube. Drizalma Sprinkle carries a boxed warning for suicidal thoughts and behaviors. In clinical trials of Drizalma Sprinkle, the most common adverse reactions (in at least 5 percent of participants and at least twice the incidence of placebo) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.

Lupin Appointed Sreeji Gopinathan as Chief Information Officer

Mumbai, India: Pharma major Lupin Limited has recently announced the appointment of Sreeji Gopinathan as Chief Information Officer (CIO). He will lead the IT function for Lupin globally, based in Mumbai.

Sreeji brings to Lupin over 20 years of significant domain expertise and global experience. Most recently, Sreeji was with Reckitt Benckiser. Prior to that, he was associated with Philips, Procter & Gamble, ISRO, and Asea Brown Boveri. Sreeji holds a Master’s degree in Business Administration from the University of Edinburgh, UK and B Tech (Applied Electronics and Instrumentation) from the University of Kerala.

Commenting on the appointment, Nilesh Gupta – Managing Director, Lupin said, “We have built a very solid Information Technology foundation, whether it pertains to our manufacturing operations, our sales operations or our HR processes. With Sreeji’s joining, Lupin’s IT function will be further strengthened. With his substantial experience and ability to closely work with businesses, he will expand and invigorate our initiatives in digitization, process automation, data management, and analytics which will eventually help improve business results”.

October 2019 ► 51

Qdos Metering Pump Building on its highly successful Qdos Series of chemical metering pumps, Watson-Marlow Fluid Technology Group (WMFTG) offers a version for mobile and remote applications that can be powered by a 12-24 V DC power supply.

The latest Qdos pump will aid any user requiring a precise, closely-controlled metering pump where mains power is not readily available or practical to use.

Qdos pumps boost productivity and cut chemical wastage via more accurate, linear and repeatable metering than conventional solenoid or stepper-driven diaphragm metering pumps. As a result, Qdos users can reduce chemical costs even when metering difficult fluids or when pressure, viscosity and solids content vary. This capability combines with peristaltic technology to ensure precise, continuous, smooth flow for optimal fluid mixing.

Suitable for both remote static and mobile battery-powered applications, typical uses of the new 12-24 V DC version include agricultural seed coating and crop irrigation, remote water treatment/sampling, potable water refining and on-truck pumping operations, to list just a few.

For very remote applications, the pump is able to run from batteries that can be recharged via solar cells, other renewable energy sources or split charge relays. The product is reliable, self-contained and does not require any additional components.

Ultimately, with the addition of this new variant into the existing WMFTG range, Qdos is now the first choice when it comes to accurate chemical metering in applications and locations where there is no practical access to grid electricity.

For more information, please contact: Watson-Marlow India Pvt Ltd S No: 81/7, Opp: JSPM Institutes Pune-Mumbai Bypass Road Tathawade, Pune, Maharashtra 411 033 E-mail: info@wmftg.in

AODD Pumps M-Pump offers the best in the field of air-operated double diaphragm pumps.

Features side-ported design; powder-coated metalic pumps; plastic center section for robust design; PP air valve assembly; single shaft design and low air consumption.

For more information, please contact:

Flowmatic Engg Co HO No: 107, 1 st Floor SIDCO Estate, Tiny Sector Pattravakkam Diary Road Ambattur, Chennai 600 098 Tel: 044-48574900

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Mixing Device without Rotation The FUNDAMIX is a universal device for mixing liquids in open or closed vessels under vacuum or pressure, even in sterile conditions. FUNDAMIX can be operated continuously without overheating or amplitude variations. The electro-magnetic drive operates at 50 to 60 cycles and transmits the vibration via the mixing device or mixer plate attached to a special clamp coupling into the medium. The amplitude resp mixing effect is controlled by a thyristor controller and adjusted by approximately 0 to 3 mm. The flow direction can be adapted to suit the medium and the required mixing effect. Standard mixers are SS-316, but can be manufactured from a wide range of materials including Hastelloy, Titanium and various plastics.

For more information, please contact:

DrM Filter Technology Pvt Ltd Plot 46, 1 & 2, Village Pungam Ankleshwar, Dist: Bharuch, Gujarat 393 020 Tel: 02646-652774 E-mail: info-in@drm.ch

Dry and Wet Discharge The filtered solids are dewatered and discharged by as blow-back. As an alternative, the cake can be reslurried into another liquid. This filter type allows continuous filtration without interruption of flow. The solids are flushed back into the liquid and discharged in slurry form. This filtration process mainly applies for processes where continuous flow is required.

This is a variant of the FUNDABAC design to comply with the high production standards of pharma and biotech industries. Surface finish and design of internals allow effective cleaning of all parts in contact with product.

For more information, please contact:

DrM Filter Technology Pvt Ltd Plot 46, 1 & 2, Village Pungam Ankleshwar, Dist: Bharuch, Gujarat 393 020 Tel: 02646-652774 E-mail: info-in@drm.ch

Multi-stage Centrifugal Blowers/Exhausters With 22 models to choose from and the ability to specify a variety of manufacturing options, one can be assured that the blower or exhauster one order will deliver the performance one expects. In addition to the base models available, customers can choose from a variety of design options such as special coatings, alternative component materials, oil or grease lubrication, special seals, drive couplings and power sources. The Hoffman and Lamson blowers/exhausters one specifies is then manufactured according to ones unique application and requirements.

In water and wastewater treatment, air is provided to water and wastewater aeration systems and air scouring/filter back-washing. Hoffman and Lamson blowers can be specified for coarse/ fine bubble diffuser systems, reactor batch supplemental air, digester gas boosters, grit channels and sludge digestion applications. In the industrial market, their blowers provide air or gas for sulphur recovery, combustion air, process gas boosting, coal mine venting, fluidised bed combustion systems, vapour and gas extraction, composting, sludge incineration and printing systems, to name a few. Gardner Denver Engineered Vacuum Systems are used to pick up, convey and capture a myriad of materials ranging from aluminium granules to corn flakes.

For more information, please contact:

Gardner Denver Engineered Products India Pvt Ltd Gat No: 181, 182, 184 Alandi Market Road, Fulgaon Pune, Maharashtra 412 216 Tel: 020-66782100 E-mail: info.pune@gardnerdenver.com

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O-rings/FEP Encapsulated O-Rings (Silicone/Viton/EPDM/Neoprene/Nitrile) APPL offers its wide range of O-rings from 1.0-mm ID to 600-mm ID from its 5,000 single piece moulds. APPL’s O-rings are manufactured on a hydraulic press with tightly controlled temperature, pressure and time which ensures accurate dimensions, glossy finish and invisible flash line, properly post-cured and absolutely defect-free articles. These O-rings are also manufactured as per the dimensional tolerance specified by the customers and available from Nitrile, Neoprene, Silicone, EPDM, Hapalon, NBR, Viton and Butyl rubber or in any other rubber as per customer’s specification. It is also available in Viton O-rings from 1-mm ID – 3,000-mm ID or in any sizes through step moulding process which gives joint less O-rings of dimensionally accurate, excellent workmanship and finish. APPL’s Silicone, Viton and EPDM Encapsulated O-rings with FEP encapsulation are designed to address the growing problem of sealing in the most hostile chemical and temperature environments. It combines the best qualities of FEP material on the outside with its chemical inertness and an elastomer on the inside for resilience. This unique combination forms a highly effective, long lasting seal for the most demanding applications. These O-rings are comprised of FEP over Silicone, Viton or EPDM and can be used in temperatures from -75°F to +400°F (-60°C to +205°C) depending upon the choice of elastomer core.

There are certain applications which prohibit the use of conventional rubber O-ring seals. The use of hostile chemicals or extreme temperature (both high and low) during various processes can make effective sealing very difficult. The main advantage encapsulated O-rings have over solid PTFE is that it has the chemical inertness whilst with its energising core, the O-ring returns to its original form.

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

Zero Liquid Discharge Zero liquid discharge describes a process that completely eliminates liquid discharge from a system. The goal of any well-designed ZLD system is to minimise the volume of wastewater that requires treatment, process wastewater in an economically feasible manner, while also producing a clean stream suitable for reuse elsewhere in the facility. Interest in zero liquid discharge technology has grown in the industrial manufacturing sector over the past decade.

KEP is providing the turnkey solution for zero liquid discharge, which includes the process like primary treatment, secondary treatment, tertiary treatment and evaporator and dryers. Based on the effluent characteristics KEP will select the process of treatment to recycle 100 per cent water to process.

For more information, please contact:

KEP Engg Services Pvt Ltd 6-A-52, Opp: Park, Nr Vedant International School Apurupa Colony, Jeedimetla Hyderabad, Telangana 500 055 Tel: 040-23096275 E-mail: info@kepengg.com

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Rotary Vacuum Dryer Rotary vacuum dryer offers clean, simple and effective method of drying filtered/ centrifuged wet cakes, wet powders and slurries. Operating under vacuum, the dryer effectively dries heat sensitive materials to very low LOD levels. Solvents are condensed and recovered. Operation is batch and drying time depends on material being dried, amount of solvent or water to be removed, desired LOD level, permissible jacket temperature, etc.

Rotary vacuum dryer is a horizontal cylindrical jacketed shell with hollow agitator, rotating in close clearance. A batch operation, drying is done under vacuum, heating is through jacket. The dryer offers a simple but effective method of drying wet cakes and sometimes slurries. Due to vacuum and agitation, it is possible to dry heat sensitive materials.

For more information, please contact:

Tech-Mech Engineers A-227, 16 th A Road, Wagle Indl Estate Thane, Maharashtra 400 604 Tel: 022-25828749 Telefax: 91-022-25827883 E-mail: info@techmecheng.com techmecheng@gmail.com

Platinum-cured Si Hose Reinforced with Polyester Braiding and SS-316 Helical Wire Imavacfit is platinum-cured silicone hose reinforced with SS-316L helical wire and polyester braiding having better flexibility with high pressure resistance.

Imavacfit is having high burst pressure rating along with high vacuum resistance compared to Imavac. The product is suitable in pressurized fluid transfer application.

Imavacfit conforms to US FDA 21 CFR 117.2600 Food Grade Standard, USP Class VI and ISO 10993-1. It is certified by ROHS and Animal Origin Certification (free of animal derived material), free of restricted heavy metals. It is free of Phthalate/ Bisphenol/Volatile Plasticizer. It has USFDA DMF accreditation #26201. Complete validation package available upon request.

Imavacfit has high burst pressure resistance compared to Imafit and Imavac. It is designed for high vacuum rating applications.

It has anti-static properties to dissipate static electrical charge makes it suitable for highly volatile flammable fluid transfer. It imparts no taste and odour. It is lot traceable. Its temp range is -80°C to 180°C and is available with SS-316 L Tri-clover end. It is sterilizable by autoclave, ethylene oxide gas and gamma radiation.

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

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October 2019 ► 55

events diary CPhI Worldwide

Global Pharmaceutical Biotechnology Summit

Date: 05 – 07 Nov 2019 Venue: Congress Center Messe Frankfurt, Frankfurt, Germany

Date: 20 – 21 Nov 2019 Venue: Toronto, Canada

About the event: CPhI Worldwide is world’s largest pharmaceutical exhibition and the most important fair in the pharmaceutical industry. Source solutions from suppliers in dedicated zones covering ingredients, contract services, machinery, finished dosage, packaging, and more. It combines all the key suppliers and customers in the chemical and pharmaceutical industry.

About the event: In the light of theme, assessment &advancements in the field of pharma-biotechnology, the conference aims to provide a forum for international researchers from various areas of pharmaceutical, biotechnological mastery where academicians: university faculties, pharmaceutical research, biopharmaceutical industry practitioners, manufacturing medical device, and data management companies, private, public investors and government agencies are contributing existing mastery & collaborating to nurture subject knowledge to accelerate innovations by providing a platform for critical analysis of new data, and to share latest cuttingedge research findings and results about all aspects of pharmabiotechnology. This meeting will be a multidisciplinary gathering and present major areas in the field of bio-pharma.

Highlights of the event: • World’s largest pharmaceutical exhibition • Category & type: pharma & medical, packing & packaging • Expected participants: 45000 visitors and 2500 exhibitors Contact: UBM EMEA, UK – a Division of UBM Plc Informa Plc 240 Blackfriars Rd, London SE1 8BF, UK Tel.: +44 20 7921 5000 E-mail: media@informa.com Website: https://informa.com

Highlights of the event: • Hone your aptitudes with new thoughts and methodologies • Category & type: conference on pharma and medical • Expected participants: approximate 1000 delegates

and 50 exhibitors Contact: Organizer: Lexis, Switzerland Communication: https://10times.com/pharma-biotech

CPhI & P-MEC India

BioPharma World Expo 2019 ( South )

Date: 26 – 28 Nov 2019 Venue: India Exposition Mart, Greater Noida, India

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

About the event: CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. Attendees will meet the movers and shakers from India’s pharma machinery, technology, and ingredients industries, giving you a competitive advantage that will help grow your business.

BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/startups connected with pharma machinery, CRAMS, 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.

Highlights of the event: • Source high quality, low cost Pharma solutions • Category & type: pharma & medical • Expected participants: 59296 Visitors and 1509 Exhibitors Contact: UBM India Pvt Ltd Informa Markets India Times Square Unit No. 1 & 2, B Wing, 5 th Floor, Andheri-Kurla Road, Marol, Andheri East, Mumbai, Maharashtra 400059 Phone: +91-22- 6172 7000 https://www.informamarkets.com/en

56 ◄ October 2019

Contact: Jasubhai Media Taj Building, 210, Dr. D.N. Road, Fort, Mumbai - 400 001 Tel: 91-22- 40373636 Email: amrita_patil@jasubhai.com

Pharma Bio World

bookshelf The Future of Pharma – Evolutionary Threats and Opportunities Author: Brian D. Smith Price: ` 3743.00 No. of Pages: 194 Publisher: Routledge About the Book: Pharmaceutical industry makes a notable contribution in Indian economy. Tracing back to history indicates its success so far. Owing to the profits-and-dividends this industry has added and also due to its counter-cyclical stock market trends, investors consider this industry as a relatively low-risk one.

However with significant global implications for employees, shareholders, governments, and patients, this important contribution appears to be petering out due to economic crisis. There are numerous examples indicating the stalling of the pharmaceutical industry. This book – the future of Pharma – throws light on the reasons for this potential decline through an in-depth analysis. It speaks about the emerging landscape, changing marketplace of mass-market consumers, institutional healthcare systems, innovative therapies as the alternate source of commercial value, super-efficient processes, supply chains and operations, closer customer relations, and increasingly tailored health services. The book also has mentioned about various significant long-term and mid-term challenges. The author Brian Smith’s insights are basically the wake-up call and a first step forward for all concerns with the future of this industry.

The Antidote: Inside the World of New Pharma Author: Barry Werth Price: $ 30.00 No. of Pages: 448 pages Publisher: Simon & Schuster About the Book: This book is about a ground-breaking close-up of Vertex – an upstart pharma company. Here in this time-relevant book, the author Barry Werth has leveraged his experiential insights spanning more than two decades and explained the indispensable world of Big Pharma.

The book is about the rise of charismatic Joshua Boger after his leaving Merck, then America’s most admired business. The book takes the readers to the olden days and narrates a real-life story about founding a drugcompany, which eventually challenged industry giants and transformed health-care. The author described the tumultuous early days of the business, the bold endurance, and the eventual success.

FASTtrack: Pharmaceutical Compounding and Dispensing (FASTtrack Pharmacy) Author: Christopher A. Langley (Author), Dawn Belcher (Author) Price: ` 1,711.00 Pages: 217 Publisher: Pharmaceutical Press About the Book: This book has been designed to assist the students in understanding the key dosage forms encountered with extemporaneous dispensing. The book precisely focuses on the comprehensive take-away for the students through providing concise and bulleted information, key points, tips, and all-time important self-assessment sections. The content has been structured through various MCQs, case-studies, sample essay questions, and worked-out examples. It also includes the ultimate lecture notes and is a must-read for all pharmacy students. Readers can even now have an easy access to online videos demonstrating various dispensing procedures.

Pharma Bio World

October 2019 ► 57

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ChemTECH SOUTH WORLD EXPO 2019

International Exhibition and Conferences 4-6 December 2019

                 

Venue: HITEX Exhibition Center, Trade Fair Office Building, Izzat Nagar, Kondapur PO, Hyderabad, India

Chairman, Central Advisory Board LAB & ANALYTIX South World Expo 2019

Concurrent Events:

Technical Chairman, Central Advisory Board WaterEX South World Expo 2019

L AB

&

ANALYTIX

Prof. (Dr) Ashwini K Nangia

Mr. M. K. Srinivas

SOUTH WORLD EXPO 2019

Director, CSIR-National Chemical Laboratory

Director General National Water Development Agency

WaterEX

South World Expo 2019

SOUTH WORLD EXPO 2019

Pumps, Valves & Fittings SOUTH WORLD EXPO 2019

Industry

AUTOMATION

& Control South 2019

SOME CONFIRMED EXHIBITORS 2019 FAAB INDUSTRIES FABEX ENGINEERING FILTROMIX G M ENGINEERING PVT. LTD. G M FLOWLINES PVT. LTD. GALAXY INDUSTRIAL EQUIPMENTS PVT.LTD. GALAXY THERMO PLAST PVT.LTD GMM PFAUDLER LTD GOMA CLEANTECH PVT LTD GRAPHITE INDIA LTD GUARNIFLON INDIA PVT LTD HAVER & BOECKER INDIA PVT LTD HI-FAB ENGINEERS PVT. LTD HORIZON POLYMER ENGINEERING PVT LTD HTC VALVES PVT LTD HYDRO PRESS INDUSTRIES INDO SEALS PVT LTD INFINITY PUMPS AND SYSTEMS PVT. LTD. INSTRUMAX ENTERPRISES ISGEC TITAN METAL FABRICATORS PVT LTD J D CONTROLS JADE ENERGY JAINEX INDUSTRIAL CORPORATION JET VACUUM SYSTEMS PVT LTD. JOYAM ENGINEERS & CONSULTANTS PVT. LTD. KELVION INDIA PVT. LTD. KHOSLA PROFIL PVT LTD KILBURN ENGINEERING LTD KUBER PRECISION TECHNOLOGY LE-BORN TECHNO MECH LEAK- PROOF ENGINEERING INDIA PVT LTD LECHLER (INDIA) PVT LTD LEISTER TECHNOLOGIES INDIA PVT LTD LINET ENGINEERS LLP

MASCOT SYSTEMS PVT. LTD. MAXIMA BOILERS PVT LTD MEGA ENGINEERING MICRO PNEUMATICS PVT LTD MOJJ ENGINEERING SYSTEMS LTD MONIBA ANAND ELECTRICALS PVT LTD NAGA PUMPS PVT LTD NAGMAN INSTRUMENTS & ELECTRONICS PVT LTD NARAYAN OIL & GAS BURNERS COMPANY NATIONAL RUBBER INDUSTRIES OHMKAR EQUIPMENTS ORCHID MATERIAL HANDLING SOLUTIONS PVT. LTD. OSTECH FLUID TECHNOLOGIES PATCO FLAME PROOF PRODUCTS PFEIFFER VACUUM INDIA PVT LTD PH1 INDUSTRIES PVT LTD PHE SEALING SOLUTIONS PVT.LTD. PPI SYSTEMS PRAYAG STEEL & ENGINEERING CO. PRIMA EQUIPMENT PRIME VACUUM PUMPS PROCECA ENGINEERS AND AUTOMATION PVT LTD PROMIVAC ENGINEERS PUNE TECHTROL PVT. LTD QUALITY MECHANICAL SEALS QUANTECH SEALING SYSTEMS PVT LTD RADIANT INDIA RAJENDRA INDUSTRIAL CORPORATION RAPPID VALVES INDIA PVT. LTD. RELIABLE THERMOCRAFT ROKADE ROTOTECHNIKS ROLLIFLEX CABLES PVT LTD S V EQUIPMENTS PVT LTD

S.G POLYMERS S.S. TECHNO LTD. SACHIN INDUSTRIES LTD. SAMTECH ENGINEERING SERVICES PVT LTD SHACHI ENGINEERING PVT.LTD. SHANTI INDUSTRIAL CORPORATION SIFLON POLYMERS PVT. LTD. SMART LABTECH PVT LTD SMITA INDUSTRIES SRI BALAJI PUMPS SRI JAISHANTH AUTOMATION & ENGINEERING SOLUTIONS SSP PVT LTD SUMMITS HYGRONICS PVT LTD SUZALKEM TECHNOLOGIES PVT LTD SWAM PNEUMATICS PVT.LTD. TECHNODRY SYSTEM ENGINEERING PVT. LTD. TEKMAN INDIA PVT LTD TELEFLO STRAINES & PRESSURE VESSELS THERMOTECH ENGG & SERVICES PVT LTD THORAT FILTRATION PVT.LTD. TOSHNIWAL INSTRUMENTS (MADRAS) PVT LTD TRADELINK SERVICES TRINITY FILTRATION TECHNOLOGIES PVT. LTD. UNITOP AQUACARE LTD VACUUM TECHNOLOGIES AND SOLUTIONSS VARUN ENGINEERS VVR INNOVATE MATERIALS PVT. LTD. WAHAL PROCESS TECHNOLOGIES PVT.LTD. WIN GRAPH SEALS YCS TECHNOLOGIES PVT LTD ZIBO GLASSCOAT (INDIA) PVT LTD AND MANY MORE....

Co-Operation Partners

AERZEN MACHINES INDIA PVT LTD AIRA EURO AUTOMATION PVT LTD AIRRO ENGINEERING COMPANY AKASH BLOWERS PVT LTD AMARAMA ENGINEERS AMRL HITECH CITY LTD ANIRUDHA ENGINEERS ANTICORROSIVE EQUIPMENT PVT LTD APPAREILLAGES ET BANCS HYDRAULIQUES CHATELLERAUDAIS PVT. LTD. ARIES FABRICATORS PVT LTD ASTRAL POLYTECHNIK LTD BHAVI PLAST PVT.LTD BLAST CARBOBLOCKS PVT LTD BOHRA METAL & ALLOYS CALICO METAL INDUSTRIES PVT LTD CARBORUNDUM UNIVERSAL LTD CEECONS PROCESS TECHNOLOGIES CENTPRO ENGINEERING PVT LTD CHEMIN ENVIRO SYSTEMS PVT LTD CHEMITEK EQUIPMENTS CHILTON REFRIGERATION PVT.LTD CNP PUMPS INDIA PVT LTD CROZAIR TECHNICEA COUNCIL OF SCIENTIFIC & INDUSTRIAL RESEARCH D-VALVE ENGINEERS INDIA ( P ) LTD DYNAMIC FORGE & FITTINGS (I) PVT LTD DYNAVAC INDIA PVT LTD DYNEMIX INDIA ECONOMY REFRIGERATION PVT.LTD EDWARDS INDIA PVT LTD EGGER PUMPS INDIA PVT.LTD ENLOK ENGINEERS EVEREST BLOWER SYSTEMS PVT. LTD

Organised by

Supported by

Jasubhai Media Pvt Ltd Taj Building, 3rd Floor, 210, Dr. D N Road, Fort, Mumbai – 400 001, INDIA. Tel: +91-22-4037 3636, Fax: +91-22-4037 3635, Email: sales@jasubhai.com Web: www.chemtech-online.com • Ahmedabad - 07238038888 • Bangalore - 09444728035 • Chennai - 09176963737 • Delhi - 09818148551 • Pune - 09822209183 • Vadodara - 09898061072