Pharma Bio World July 2016

July 2016 Vol 14 | Issue 12 | Mumbai | Price ` 150 Total Pages 68

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4  July 2016

Pharma Bio World

INTERVIEW 8

“We have been engaging the medical fraternity to enable better practice of precision medicine in the country” - Hiranjith G H, Director, MedGenome

12

Pushing the Frontiers of Genomics Testing in Healthcare...

- Samarth Jain, CEO, Positive Biosciences

FEATURES

12

18

How e-pharmacies could Usher an Evolved Pharmaceutical Future for India - Dharmil Sheth

22

The Digital Wave in the Pharma Industry - Mudit Vijayvergiya

26

Role of the CIO in Making Mergers and Acquisitions Successful - Ram Meenakshisundaram, Rajesh Kuppuswamy

30

The Impact of FDI in the Pharmaceuticals Sector - Bhavik Narsana, Soumyadri Chattopadhyaya

18

36

Putting the Patient at the Forefront of Labelling - Richard Petherick

44

Pharmacogenetics: From Traditional Method to Modern Pharmacogenomics - Ketan Zota

46

Laser Coding and Marking in Pharmaceutical Industry: An Expert Overview - Sascha Ammesdörfer

NEWS UPDATE

22

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Pharma News

59

Biotech News

CORPORATE AFFAIRS 61

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Ad Index Next Issue Focus: Drug Metabolism

6  July 2016

Pharma Bio World

interview

H IRANJITH G H

“We have been engaging the medical fraternity to enable better practice of precision medicine in the country�

8 ď‚ƒJuly 2016

Genomics and precision medicine have made a significant impact in the drug development process, and will continue to shape diagnosis and drug research.

Taking cue from this, MedGenome, a leading provider of genomics research services globally, is partnering with more than 800 doctors and 500 hospitals across the country to enable better practice of precision medicine in the country. Hiranjith G H, Director, MedGenome speaks to Mahesh Kallayil on the importance of genomics in clinical practice, the potential applications of Next Gene Sequencing in oncology and much more. Edited Excerpts: How would you summarize MedGenome's vision & mission and accomplishments to date?

What set MedGenome apart from companies with similar offering?

MedGenome's vision and mission is to improve global health by developing deep insights into diseases at the genetic and molecular level. We have taken the lead in creating awareness and educating the stakeholders about the importance of genomics in the clinical practice. MedGenome is also a pioneer in advancing genomics-based research to understand the underlying genetics behind complex human diseases.

Our advanced technology platforms for Next Generation Sequencing, ability to build novel bioinformatics pipelines to analyse and interpret genomics data differentiates us. Our capabilities to partner with global players helps us to launch the most advanced genetic tests that are relevant in the country. Our research focus applying genetics to complex human diseases help us to be a global player.

MedGenome has the highest throughput NGS lab in South-East Asia owing to the advanced NGS platforms it houses. MedGenome is the only genomics sequencing lab in India validated and verified to run a non-invasive prenatal test. We are a founding member of GenomeAsia 100K, a consortium aimed at sequencing 100,000 Asian genomes. The objective is to gain an understanding of the underlying population genotype in this region and thereby enable drug discovery and research to combat the diseases of high unmet need. We also have a CLIA / CAP certified lab in US offering sequencing services to the research programs.

Could you please explain us the evolving role of clinical genomics and personalized medicine in Indian pharma industry?

The cancer burden in the country is on the rise and we can expect genetic markers to play a vital role in selecting the right drug for the right patient. Apart from Oncology, metabolic diseases, neurology, ophthalmology and cardiovascular diseases, genetics can play a major role in providing targeted drug choices for inherited disorders and rare disorders. With a high birth rate of 26 million in a year and approx. 5 per cent high risk pregnancies, screening for chromosomal disorders in the paediatric population is also an area where genetics can play an impactful role.

Pharma Bio World

interview What are the competitiveness of Indian genomics market against the markets of other countries?

Genomics-based diagnostics in India has seen much higher adoption in the recent years - thanks to increased awareness among the clinicians. Compared to the western world, we are still behind in terms of application of genomics in clinical practice though.

How is the company positioned in the Indian and global market in the field of clinical genomics?

We are a market leader and first mover in clinical genomics in India. We have a pan-India presence with fully supported logistics function to manage sample pickup to report delivery. Our diagnostics test menu has more than tripled in the last 1 year, in line with the demands from our customers - across oncology, neurology, ophthalmology, metabolic diseases, rare disease and pediatric disorders among others. MedGenome has forayed into expanding its offerings to customer bases in South East Asia and the MENA region, where consanguinity levels are high and hence the burden of genetic disorders.

Over the past several years, what are some of the changes that you've noticed in genomic arena, and how has MedGenome responded to these changes?

The most notable change was inquiries for genetics based testing in areas other than Oncology. We responded by developing genetic tests across various diseases areas including neurology, ophthalmology and metabolic diseases. We see a lot of adoption of genetics-based diagnosis in these disease areas. We were also the first to launch a non-invasive prenatal test in a facility in India considering the high number of high-risk pregnancies that are estimated in the country.

With large volumes, we have increased the throughput of our lab in Bangalore. This helps us to work with our research partners as well on large research programs.

10 ď‚ƒJuly 2016

One of the needs was to generate more awareness among the key stakeholders, which has been met by the numerous CME's and seminars we conduct around the year. We have partnered with collaborators across the country to advance both diagnostics and research, thereby helping to advance the practice of precision medicine. Our skilled resources and advisors are available to guide these collaborations for mutual benefit.

condition is identified, the experts are brought in to handle the situation and help the individual. There is a dearth of genetic counsellors who can explain genomics findings to the affected individuals and their families. In addition to this, factors like lack of resources for effective data analysis, cost of technology, lack of baseline genomics data of Indian origin and unclear policies on intellectual property rights also pose hindrances to the industry.

India is a price sensitive market. With in-house capabilities, we are able to offer advanced genetic tests at affordable prices to our customers, which is very important for them to understand the impact it can have on patient's healthcare outcomes.

We respond by utilizing our in-house capabilities to make our tests affordable, providing end-to-end service - right from sample pick-up to clinical report delivery and counselling. Our lab management solutions, infrastructure and powerful big data analytics capabilities allow us to manage the data better. We continue to put in efforts on educational programs and awareness drives to spread the word.

Clinical genomics field is expected to reap the benefits in near future. In what ways are you competing for the same?

MedGenome has been engaging the medical fraternity, thought leaders, academic institutes, research centres and hospitals to enable better practice of precision medicine in the country. In line with the fact that MedGenome currently works with more than 800 doctors and 500 hospitals across the country. We continue to maintain the leadership position through comprehensive test offerings, high throughput, superior test quality and end-to-end service offering.

Currently what are the major challenges you are facing and how are you gearing up?

The future of the industry is promising.

However it brings with it a necessity for better data management and conversion to clinical application. Certain factors like reimbursement from insurance companies may prove to be crucial in determining the growth of this industry. In the western world, insurers have started accepting genomic tests in their formulary as it is expected to reduce the cost of down-the-line treatment.

There is also a great need for clinicians who have a good understanding of genomics and its clinical significance. The patient journey must be well managed so that if a particular

Please appraise us o n y o u r r e c e n t collaborations. How you think these deals going to help MedGenome to strengthen its market presence and R&D realm?

We have collaborations with both government and private institutions to run research programs in key disease areas.

These collaborations help us to leverage our skills along with our collaborators specialty to design research programs that can provide useful insights towards drug discovery and exploratory research.

We are also a founding partner of GenomeAsia 100K, a consortium aimed at sequencing 100,000 Asian genomes.

Kindly apprise us of MedGenome's future plans?

We plan to maintain the leadership position in clinical genomics in India and gain a leadership position in Middle East and South-Asia. We will build more academic collaborations with institutions who are focused on research. Our research solutions will be built further keeping in mind the global pharmaceutical and biotech industry. Our ambition is to be a global player in genomics from India.

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interview

SAM ARTH JAIN

Pushing the Frontiers of Genomics Testing in Healthcare... “The challenge in India, for the faster adoption of personalised medicine or precision medicine, which is the future of medicine, is the lack of awareness of genomics testing, the lack of training needed to analyse genomic test reports,� says Samar th Jain, CEO, Positive Biosciences. In an inter view with Mahesh Kallayil, he further talks on future of genomics in India and Globally.

How would you summarize Positive Bioscience's vision & mission and accomplishments to date?

A genomics company, Positive Bioscience was founded in 2012 to bring to India, the latest technologies in Genomics testing, that is changing the paradigms of healthcare the world over. We offer interpretational analysis of DNA based diagnostic tests for cancer patients and healthy individuals. This analysis helps clinicians personalize the clinical management of cancer and other health conditions. We aim to partner with patients and medical professionals by giving them the tools that genomics testing provides to take informed decisions on health care.

In the area of cancer genomics, we are committed to make a difference in the treatment of oncology and care of cancer patients by empowering the physicians with actionable genomic testing reports. We believe the future of medicine allows patients to receive affordable, personalized and precise care. Our genetic tests are aimed at making this future a reality.

In October 2012, the company was founded and Positive Bioscience was ranked among the top 6 startups globally by amazon.com. In April 2014, Positive Biosciences commercially launched its Cancer Genomics & Personal Genomics products. It also launched India's first Personal Genomics clinic at Medanta, The Medicity Hospital Gurgaon in August 2014 and later launched Mumbai's first Personal Genomics Clinic at Kokilaben 12 ď‚ƒJuly 2016

Dhirubhai Ambani Hospital Mumbai. In August 2015, the company was selected as exclusive India partner of the world's leading genomics company Myriad Genetics.

What set Positive Bioscience apart from companies with similar offering?

At Positive Bioscience, we give utmost importance to the quality of our tests and this sets us apart from our competition. Genomics testing have huge implications on person's life and well-being and it is very important that these tests adhere to the most stringent quality control measures. All our tests are carried out in NABL/ CAP/CLIA accredited laboratories in the USA, Korea, China, while few tests are also done in India. Once we process the genomic data and produce the reports, our genetic counselors help the patients understand the significance of their genetic findings and correlate these with their health history.

In cancer genomics, our tests are provided at a very affordable price. We work with oncologists as their partners, working towards finding the appropriate solution for a cancer patient.

How is the company positioned in the Indian field of clinical genomics?

We launched genomics testing in India, and then more recently introduced Whole genomics testing in India.

We are partners to leading hospitals in India.

Pharma Bio World

interview urrently what are the maor challenges you are facing?

More than our challenge, the challenge in India, for the faster adoption of personalised medicine or precision medicine, which is the future of medicine, is the lack of awareness of genomics testing, the lack of training needed to analyse genomic test reports. But as a pioneer in this field, we accept this as a responsibility and our contribution towards the country's healthcare system.

P l e a s e a p p r a i s e us on y our r e c e nt collaorations and how these collaorations will fit into the company's growth strategy?

Our company has collaboration with world's leading genomics company Myriad Genetics, based in the USA.

And we are its exclusive India partner.

This will indeed help us to take genetic testing in India to the next level. We also have collaborations with Medanta, The Medicity, Gurgaon Kokilaben Dhirubhai Ambani Hospital &Medical esearch Institute, New Delhi Breach Candy Hospital, Mumbai and Saifee Hospital, Mumbai. The response from the doctors across these hospitals has been amazing.

These hospitals are modern and provide the best medical care. or us, our contribution towards saving lives and helping people be healthy is what drives us.

How does the company eep areast with the everchanging trends?

We have collaborations with top global universities doing research in the area of genomics, further, our scientific advisory board has leading scientists and researchers

in the field of genomics and oncology. Our teams are often sent for training across the world. We have partnered with companies like Myriad, which are in the cutting edge of genomic testing.

We also have an entire in-house research team who study and track the latest developments in relevant areas. or us keeping abreast is part of our daily routine. indly outline the future road map of your company?

Our business strategy for future growth is focused on various key initiatives. We are working to grow and expand our existing products and markets. or that, we are developing our business nationally, with tieups with hospitals. We are looking forward to revenue of approximately s 00 crores in the next five years.

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Drug metabolism also known as xenobioticmetabolism is the biochemical modification of pharmaceutical substances or xenobiotics respectively by living organisms, usually through specialized enzymatic systems. Drug metabolism often converts lipophilic chemical compounds into more readily excreted hydrophilic products. Catch our forthcoming issue on Drug Metabolism to know more on the advances in this field.

To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback.

Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.

16 July 2016

Pharma Bio World

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How e-pharmacies could Usher an Evolved Pharmaceutical Future for India The e-Pharmacy business model has been in the news lately for multiple reasons. At one end, consumers are benefitting from the increased transparency, access, affordability and convenience; also the model holds tremendous promise for the regulatory body to tackle the issues of fake medicines since the entire supply chain is well documented and tracked, and also ensures better pharmacovigilance.

Dharmil Sheth Co-founder PharmEasy 18 ď‚ƒJuly 2016

T

echnology has always had a deep impact on human civilisation.

The reason why we as humans have evolved from caves, through initial settlements, to iconic cities boasting highrise buildings was because of our fondness for development, technology, and curiosity for the new. From discovering fire, through invention of wheels, to electricity, the internet, and other modern day marvels, every consecutive technological upgrade has had a tremendous impact on society and human civilisation.

Today, as digital technology is revolutionising every aspect of life, society is moving forward rapidly, eliminating the basic problems that it encountered previously. Now, people can shop online, connect with their peers, watch movies, order groceries, and can even get their laundry done, all from the comfort of their homes! The internet is truly changing the dynamics of all facets of our society. But surprisingly enough, owing to red-tapism and regulatory roadblocks, a vital industry that has the potential to change the face of India's healthcare scenario has been shadowed with clouds of uncertainty. The Indian e-pharmaceutical space truly holds promise to revolutionise the way consumers in the country access healthcare and also make it affordable for them. It is the imminent next step in India's growth story which is unfortunately being impeded from fulfilling its true potential.

Our country has long faced challenges relating to the very significant pharmaceutical sector. The government has found it relatively tough to crackdown on counterfeit medicine circulation in the market that has risked the lives of over a billion people of the country. In many cases, rollback of drugs hasn't been successful as there has been no mechanism to track the entire supply chain efficiently. With the advent of technology, it seemed

possible to trace back all medicines to the manufacturers, creating room for a more systematic law-abiding apparatus.

This apparatus could have helped the government better regulate the country's healthcare scenario. It would have not just bolstered the government's focus on affordable healthcare but would have also contributed to the vision of 'Digital India' wherein e-health is a major component.

Unfortunately, despite the host of advantages that e-pharmacies promise, regulatory units in the country are battering them down. They seem to be unable to understand the potential that these ventures hold and how they can unlock tremendous advantages in terms of access, safety and affordability for the Indian populace.

Here's a look at how e-pharmacies in India are paving the way for a healthier and more medically safe nation: 1. H i g h d e g r e e o f t r a n s p a r e n c y : E-pharmacies have the potential to bring a more transparent system into effect. By employing digital platforms, e-pharmacies can help compile all the industry data and bring it online. Additionally, it will also become much easier to bring the endto-end supply chain online, therefore making it relatively easier to identify the loopholes in the system and analyse the supply and demand in the market to increase efficiency.

2. Eliminates counterfeit medicine: Using the online mechanism enables the system to easily track the source of any medicine. Doing so makes it impossible to supply illicit medicines to the market as everything is welldocumented. The logs can be accessed by the government in order to track an illegal drug consignment, helping the crackdown on counterfeit medicines.

Pharma Bio World

3. Prescription drugs: E-pharmacies help in preventing the sale of prescription drugs over the counter. In order to buy drugs from the e-pharmacies, one has to submit a scanned copy of the drug prescription which can be traced back to the doctor. In case of any suspicion, the prescription is cross-checked by a local doctor to prevent drug abuse and self-prescription of medicines. For chronic diseases, patients are required to furnish the e-pharmacists with a new prescription if the previous prescription has expired, thus ensuring their safety.

4. Monitoring the effects of medical drugs: As e-pharmacies are directly linked to customers with their mobile application and online website, users can instantly report health issues arising after consumption of a particular medicine. A single such complaint can initiate re-examination of the medical drug and all its health implications that previously went unnoticed. Additionally, an e-pharmacy notifies all of its consumers who had been prescribed the same medicine and prevents its further usage. Hence they ensure safety and security of consumers as well as help in enhancing the quality of the healthcare eco-system in the country as a whole.

5. D o o r s t e p d e l i v e r y : I t b e c o m e s much more convenient for patients to order medicines online, thanks to e-pharmacies. Often, ailing consumers may not be in a position to go outdoors to get the medicines themselves. Older patients may need certain drugs on a regular basis which may cause them a considerable amount of inconvenience.

All of these cases can be effectively dealt with by e-pharmacies. Moreover, they enable access to prescription medicines that may not be easily available in the patient's locality.

6. Drug recall: Recently, medicines produced by many major Indian pharmaceutical companies have come under the scanner due to their unsatisfactory quality. If any such case unfolds in the near future, it 20 ď‚ƒJuly 2016

will be much easier for the government and pharmaceutical companies to recall these drugs from the market. With e-pharmacies, it will be relatively simple to track down a batch of medicines due to manufacturer-level issues. This will save thousands of people from health implications that could potentially be caused by consuming a defected batch of medicines.

7. Controlling and tracking sensitive drugs: Schedule X, narcotics, and sleep inducing medicines can only be sold to an individual against the prescription of a registered medical practitioner. Although failing to do so is a punishable offence, yet they can be easily bought at many regular brick and mortar pharmacies today. The e-pharmacy model ensures that this practice is put to an end and the government is given a higher degree of control over the sale of sensitive drugs.

8. S e l f - m e d i c a t i o n : M e d i c i n e s a r e a combination of several distinct elements.

With the slightest change in their chemical combination or chemical reagent can alter their purpose entirely. The reagent can attack a cell that is not desired and can even modify the cellular structure.

Additionally, many diseases have similar symptoms, but require different medicines to cure them. Therefore, it is advisable that a medicine should only be consumed with proper examination and supervision of a medical practitioner.

E-pharmacies ensure that there isn't any self-medication and medicines are being sold only on a valid prescription.

Hence, the e-pharmacy is not merely a technological evolution, but today it has become a basic necessity for each and every Indian. Depriving the needful consumer of India of this facility is not merely unjust, but it will also make it impossible to rein in the nexus of racketeers who are playing with the sensitive and vital healthcare space. The government and regulatory bodies need to wake up to the importance of the e-pharmacy model if India has to truly become a nation ready for a brighter tomorrow. There is an urgent need to ensure the proper functioning of e-pharmacies in the country to fulfil India's dream of being a veritable digital nation which is capable of catering to the healthcare needs of its citizens and also of ensuring a safer and more transparent eco-system at large.

Contact: monica.patel@value360india.com Pharma Bio World

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The Digital Wave in the Pharma Industry This article presents a timeline of digitalization in pharma industry comprising important legal and industry behavioral changes.

P

harma marketing is tricky. It is not only subjected to regulations.

From the very beginning pharma companies have had odds stacked against them in terms of reaching out to their target audience. Pharma industry is perhaps the richest and the most advanced amongst all the industries.

However it is a pity that the remarkable technological advances made by these industries have not percolated down to the ultimate end user.

In the 80s and early 90s, Big Pharma was primarily targeting doctors, because it wasn't realistic to target consumers directly when all of the drug's side effects had to be mentioned in a broadcast or print ad.

Pharma industry has always had a data driven approach its sales and marketing.

Though they have been spending millions and even billions in reaching out to the doctors, pharma companies have never shied away from the using data in its very cruciform to make informed decisions.

The collection of prescription data and big organizations making sense out of those data had a great role to play for the pharma companies especially when they were deploying medical reps in great numbers.

1990-2000 In the later half of the 90's and early 2000's, governments slackened few of the rules and regulations, and hence pharma companies have been trying to adopt the latest medium possible. Within this period arose the new hype. The 24X7 rep. A website that is a reflection of a rep and all the details present there. This one size fits all model was aimed at cutting sales cost and generating higher revenue.

Mudit Vijayvergiya Co-founder Curofy 22 ď‚ƒJuly 2016

However here in lies the problem. The doctors have primarily remained tech aversive. Especially for their social interaction and communication. With the

rise of social sites, Pharma industry was also due for its digital makeover. However it wasn't to be.

2000-2015 This was supposed to be the golden era of any industry. With advent of mobile phones, strengthening of internet prowess, pharma marketing was about to ride the digital wave. However all that hype was futile. Facebook, linkedin or twitter couldn't capture the doctors’ imagination.

And hence cold calling and sms became the only digital medium for the pharma marketers. SMS even today remains a great channel of engagement even today.

Big Pharma employed 72,000 sales representatives and invested USD 15 billion in detailing in 2012. Detailing includes face-to-face promotional activities, sales pitches, meals and gifts targeted at doctors. The industry spent an additional USD 5.7 billion in free samples given to doctors and USD 2.1 billion in educational and promotional meetings for doctors. it is still a pity that an industry so huge would spend so much on marketing, in essence reaching out to the doctors Post 2010 the situation has taken a turn for the better. Especially the pharma industry slowly moving to a closed loop structure and employing multichannel routes to engage end user can be thought of an outcome of doctors making their way online. E Detailing today has become a common technique.

The Future The future however seems bright. Doctors are slowly but surely adopting technology as a means of taking bigger strides in their careers. Today every eminent doctor boasts of strong web presence. They are venturing into niche communities like curofy and earning a name for themselves with their contributions. This is the window that the pharma industry cannot afford Pharma Bio World

Going digital will help the companies not only reduce costs but will also help them gauge the over all feeling about their product. to miss. Because in the next 5 years, everybody will be online. The ones missing out will left behind.

Companies like sermo, doximity, curofy have created communities online that the doctors trust. Hence they are engaged.

Though pharma marketers look at this viable channels, however the ultimate power for engagement lies in the hands of the doctors. He can meet and engage with pharma marketers on his terms.

Going digital will help the companies not only reduce costs but will also help them gauge the over all feeling about their product. Most importantly, the surveys conducted by consulting firm A.T. Kearney 24 ď‚ƒJuly 2016

suggest that even a partial adoption of digital marketing saves costs by 20-50% and provides better results. So does it makes sense to use the most expensive traditional channel when digital marketing ca n prov ide y ou better res ults ? Als o customer engagement will be a new territory for these companies. The chance to engage with the ultimate end user sound too good to pass on. Pharma marketing will become efficient eventually. Its about going that extra yard and trying unexplored channels. The initial results have been very effective so far.

through e-detailing, surveys, webinars. The companies would be spending far less than it is spending today. And the company will deploy much more resources at the initial phases of the drug development cycle.

And the patients or the consumers will reap the maximum benefit out of this highly anticipated scenario.

Contact: sanyab2608@gmail.com

Think of a time when all the 15 lac doctors of the country are online and pharma companies are meeting doctors virtually, Pharma Bio World

Role of the CIO in Making Mergers and Acquisitions Successful Mergers and acquisitions in the life sciences industry, like in other industry sectors, provide opportunities to redefine business models. Understanding opportunities for transformation, and architecting the change through informed decision-making and enhanced standardization and automation make the role of CIOs more significant than ever before.

Ram Meenakshisundaram Senior Vice President and Global Delivery Head, Life Sciences, Cognizant

Rajesh Kuppuswamy Senior Director, Life Sciences Consulting, Cognizant 26 July 2016

T

he last two years have seen significant mergers and acquisitions (M&As) in the global pharmaceutical and medical devices industries. The closed deal value increased from about USD 170 billion in 2014 to about USD 403 billion in 2015. The year 2016 has been relatively slower. Deals initiated until early second quarter of this year totaled about USD 121 billion, returning the pace of M&As to 2013 levels.

This pace is being attributed to volatility in equity markets and developments in the European Union. However, there is another theory that explains the slowdown in M&A activity. Analysts and executives are cautious about the excessive debt-laden financing from previous years and the ability of the merged entities to deliver promised synergies. While there is little that executives

can do to control the volatility in global financial markets, they have a significant opportunity to leverage synergies.

Multiple industry studies have shown that more than 50 per cent of targeted synergies are tied either directly to technology or technology-led/technology-enabled processes. Let us therefore take a moment to focus on the CIO. The CIO's role can be viewed through the prism of the dual mandate: To "run better" via efficient and seamless integration and operations of the joint entity from day one of the merger, and to "run different" by unlocking opportunities to innovate and create value through new technology-led business models.

Streamlining the merged entities and having them operate in unison is table stakes;

M&A Phase

Application Rationalization

Infrastructure Consolidation

IT Organization Design and Vendor Management

Diligence

• Validating the scope of applications • Determining application rationalization objectives

• Conducting current state assessment of infrastructure (end-user computing, servers, networking and data centers)

• Determining current state IT operating model, sourcing strategy and spend

Strategy and Planning

• Data gathering plan/tools • Finalizing scoring criteria and assessment model

• Capacity and performance planning, aligning with application rationalization teams • Planning for data center migration/ consolidation

• Determining future state of all service, software, and procurement contracts & licenses

Execution

• Data gathering and analysis • Developing business case

• Establishing infrastructure command center • Capacity optimization and performance

• Renegotiating or purchasing new contracts or licenses • Defining new interim and final org. structures

Pharma Bio World

Synergy avenue

Role of Technology - Illustrative

Strengthening pipeline

• Bio-marker research to extend beyond analytical markers to pharmacological markers • Integrating early development data from disparate sources to enable better selection and pivotal study design

Extending reach

• Analytics driven decision-making for choice of markets, product portfolio • Social media listening and analytics to build new markets

Drug-device combination for drug delivery

• Automatic trigger to initiate dosing based on pharmacokinetic parameters (automatic dose calibration), aiding medication compliance • Remote communication to HCP enabling dose monitoring and control

Drug-device combination for diagnostics

• Understanding genotype to enable targeted drug delivery • Continual data gathering and analysis for continuous approval for additional indications

companies that fail to accomplish basic performance are at risk of losing value.

The following table summarizes CIO's core "run better" responsibility through major M&A phases.

The "run different" responsibilities are critical to uncover the true value of the merger. Attaining synergies, after paying for restructuring and acquisition premium, requires discipline and changing status quo.

Typical targeted synergies, besides cost takeout or those related to efficiency, include strengthening of pipeline and enhancing reach into complementary markets or existing markets with complementary product portfolio.

Of late, drug and devices are also coming together; companies are trying to uncover synergies in the ability to combine drug-device for better and targeted delivery, and the ability to package diagnostic tests along with the drug product. In any of these (or possibly other) scenarios, the importance of diligence from target screening to close, and then during execution cannot be emphasized enough.

Studies across various industries conducted by multiple industry bodies and consulting companies suggest three predominant reasons for failure to attain targeted synergies: (a) inadequate focus on the integration strategy and preparation, (b) 28 July 2016

is not surprising. Therefore, the role of the CIO and the CIO's team is critical from the outset in shaping the success of any M&A. Each of the scenarios discussed here requires a discerning ability to get the right data at the right time from possibly disparate sources and converting that data into intelligence for enhanced decision-making. The onus of attaining synergies will continue to increase and the need to optimize application value realization will be more relevant. New processes may need to be defined, which are likely to be technology-led, rather than being just technology-enabled. The following table outlines representative means of uncovering value for each of the avenues.

In order to attempt something along the lines of what is suggested here, the CIO

The following figure illustrates the starting point for CIOs in these changing times.

improper execution after deal closure, and (c) organization's inability in executing the change. The underlying theme across these factors is the lack of involvement, participation and ownership of the right individuals or teams at appropriate times. In the life sciences industry, typically about 50% of synergies targeted are related to IT, that is, rationalizing the application portfolio and optimizing the realization of application value to provide enhanced benefits. Based on the synergy avenues discussed here, this finding

organization needs to undergo a radical change. The CIO needs to be empowered and also held accountable. Only then the true value of M&As can be realized. This also means that some of the current core "run better" responsibilities of the CIO must be managed by a separate team from the one that is responsible for innovation and value realization. This requires a rethink of the organization and the operating model.

Contact: balambigai.m@2020msl.com Pharma Bio World

The Impact of FDI in the Pharmaceuticals Sector Projected to become world's third largest market by 2020, the Indian pharmaceuticals sector continues to represent an attractive proposition for foreign investors.

The most recent initiative to open up foreign direct investment (FDI) in brownfield pharmaceuticals up to 74 per cent from the pre-existing government route to the automatic route has triggered debate around the potentially deleterious effects of foreign multinationals 'taking over' Indian pharmaceutical companies.

Preliminary studies assessing the impact of FDI in this sector, where national interest, access to public health and tapping foreign money have been uneasy bed fellows for long, however suggest a largely positive impact.

Bhavik Narsana Partner, Khaitan & Co

Soumyadri Chattopadhyaya Senior Associate, Khaitan & Co 30 ď‚ƒJuly 2016

S

ince the liberalisation of the Indian economy in 1991, the pharmaceutical sector was for the first time completely opened up for foreign investment with certain riders1, in 2001. The ensuing ten year period witnessed unprecedented growth in FDI as foreign firms poured in money to fund acquisitions of Indian pharmaceutical companies including Ranbaxy's acquisition

by Daiichi Sankyo, Abbott's acquisition of Piramal Healthcare's pharmaceutical solutions business, and the Sanofi-Shantha deal amongst others. India was highlighted as a cost effective location for manufacture of drugs and pharmaceuticals compliant with EU, US and other international export requirements and at the same time, to service the local markets. However, the trend was unmistakable: FDI was concentrated in operational businesses or brownfield assets.

In comparison, very little money flowed into development of new or greenfield projects 2.

Clearly, from an investment perspective, an operational business simply made better commercial sense rather than setting up a new project that potentially meant being tangled in red tape and long wait for multiple regulatory approvals.

The spate of acquisitions in the brownfield pharmaceutical space soon becomes a political issue. The potential of foreign investment to destabilise the Indian market by driving up prices and jeopardise the capabilities of domestic players fanned unending debates. Citing national in t e res t in light of c onc erns s uc h as potential to drive up prices of essential medicines, stifling competition in the sector and adversely impacting India's burgeoning pie in the global generics market, in November 2011, brownfield foreign investment in the pharmaceutical sector was made completely subject to the approval of the Foreign Investment Promotion Board (FIPB) in line with the recommendations of the Arun Maira Committee. Subsequently in January 2014, the Department of Industrial Policy

and Promotion declared that non-compete clauses were also to be scrutinized and permitted only in special circumstances.

Bitter Pill or Better Pill?

Between April 2000 and September 2014, the pharmaceutical sector clocked FDI inflows of approximately USD 12,689 million 3 , which is one of the highest in India. FDI is an invaluable source of growth capital that fuels innovation, research and development and productivity. At the same time, it has the potential to stifle access to medicines, one of the cornerstones of healthcare system which is underscored by the consistent availability of new and existing medicines at affordable prices.

This issue is apparent in India given that a very large section of the Indian population is in the low income group and vulnerable to uptick in prices of medicines.

This is compounded by a paucity of government spend on healthcare and lack of penetration of medical insurance.

Consequently, the effect of FDI in the Indian pharmaceutical sector needs to be evaluated with a focus on its impact on access to medicines. The aspirations of any regulatory policy in this sector must delicately balance the need to ensure affordability of medicines and at the same time, provide sustained growth capital for the local industry and thereby continue to attract FDI. As on date, while there have been reports prepared by the Parliamentary Standing Committee that, there has not been any detailed economic study on the impact of the FDI in the pharmaceutical sector to conclusively parse the findings and pave the way for a responsive regulatory policy.

To remedy this, the government has now commissioned a study on the impact of FDI in the pharmaceutical space 4 .

However, over the years, concerns and consternations, particularly against FDI in brownfield pharmaceutical sector have been drummed up. Some of these include: Pharma Bio World

(i) Potential for acquired companies to increase prices of important drugs (ii) Restricting the flow of high-priced speciality drugs (iii) Stifling the generics drugs market (iv) Debilitating the domestic pharmaceutical industry given dominant positions of foreign multinationals with sophisticated drug portfolios and deep pockets (v) Killing the Indian medicine export market Given its critical role, the pharmaceutical sector remains one of the most regulated in India. Further, certain medicines are treated as essential commodities and their prices and supply is also controlled by various Drug Pricing Control Orders.

Additional safeguards in relation to pricing is ensured by the National Pharmaceutical Pricing Authority which has a mandate to monitor prices of not just medicines on the National List of Essential Medicines but also keep prices of decontrolled drugs in check. Since 2012, the FIPB, whilst approving proposals for brownfield investments has consistently insisted that the highest production levels of essential medicines in the last three years as well the highest expense in research and development over a similar period be maintained by the incumbent company post investment for a period of five years.

These are inbuilt safeguards within the sector that ensure access to medicines which acts as a safety valve given the vulnerability of large swathes of the Indian population to price increases. Interestingly, some of the most vociferous resistance to continued price controls have come from the lobby of domestic pharmaceutical players, the Indian Pharmaceutical Alliance. In fact, a result of a study by the Department of Pharmaceuticals found that foreign acquisitions of Indian companies did not result in an increase in domestic drug prices. Indian manufacturers, whether or not controlled by foreign companies would be equally affected by price controls as it ultimately impacts the bottom-line. Prima facie, current research does not seem to 32 ď‚ƒJuly 2016

suggest a correlation between FDI and spike in prices and it will remain to be seen whether FDI really has a direct threat to ensure affordable medicines.

India's share in the global generics market has been pegged to grow at a healthy CAGR of 16.3 per cent as more blockbuster drugs come to the end of patent lifecycles around the world. Global players have also eyed a piece of this lucrative generics pie given robust growth in this sector. Counterintuitively, the concern that an acquirer would takeover to "kill" another player applies equally to domestic players. Given the attractiveness of the Indian market, the acquisition of Indian generics players appears to be driven by manufacturing expertise in generics and strong distribution reach that can only benefit from capital injections.

the target had a higher market share have shown an upward trend.

Further, in terms of availability of medicines, the findings were positive. There has been an increase in both domestic sales as well as exports, the target companies have launched new products in the offering portfolio. Further, the discontinuation of essential medications has also trended downwards. Furthermore, sales of active pharmaceutical ingredients have increased which are important for reducing dependence on raw material inputs.

The study, however, found that investments in research and development were not sustained and decreased postacquisition. Further, while some of the target companies have launched drugs from the global portfolio to address diseases in the local market, overall the

Between April 2000 and September 2014, the pharmaceutical sector clocked FDI inflows of approximately USD 12,689 million, which is one of the highest in India.

Parsing Hard Data In this context, some of the findings from a recent study 5 on the impact of M&A in the brownfield pharmaceutical sector that assessed key impact parameters including being pricing of medicines, availability of medicines, spend of research and development and impact on employment. The study looked at the impact of six recent foreign investments in the pharmaceutical space and studied data for the above parameters and compared the available data for the preceding three year period with the corresponding data for the three year period following the acquisition.

impact on research and development as not been entirely positive. To this end, the FIPB's imposition that investee companies should maintain pre-existing levels of research and development appears justified and is a legitimate safeguard for brownfield investments in India, given the impact on the public. At the same time, let us also bear in mind that research and development may not be the forte for all companies and many prefer to outsource such function or simply inorganically acquire what is needed. Lastly, from a socio-economic perspective, FDI has had a positive impact and has generated employment and new opportunities.

Looking Ahead

The study found that pricing levels decreased across both portfolio as well as therapeutic area. This finding is consistent with the findings of the Department of Pharmaceuticals which also found local drug prices not impacted by FDI inflows.

However, price growth of molecules where

The current proposal to further liberalize the FDI norms in the pharmaceutical space makes the right noises and creates the right incentives for new FDI to flow into the country, at a time where Indian companies are also scouring the Pharma Bio World

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Over the years, FDI inflows in India's pharmaceutical sector has benefitted the country and provided the push for growth and development. As newer and more resistant diseases appear on the horizon as well as various lifestyle diseases set in, drug companies need patient capital to fund breakthroughs and reach out to newer markets. The Indian p h a rm a c e u t i c a l re g u la t o ry f ra m e wo rk has sufficient in-built safeguards in terms of price controls and identification of essential medicines to provide insulation. In terms of maintenance of production of certain essential drugs, from a business perspective, perhaps the correct incentives would work better than hard impositions and elicit sincere compliance. The positive externalities of long term and patient capital from foreign investors will only serve India better, spurring the next level of growth in the Indian pharmaceutical space and thereby creating a more efficient market for pharmaceuticals which will benefit the Indian consumer. While the liberalized brownfield pharmaceutical policy is certainly a step in the right direction, given the criticality of this sector and public health concerns, the need of the hour is perhaps a more nuanced and responsive policy that is premised on achieving dynamic equilibrium between the country's FDI requirements, incentivizes research and development and the ensures access to affordable medicines.

References: 1) Press note 4 of 2001 series. In terms of the rider, activities attracting compulsory licensing or involving use of recombinant DNA technology, and specific cell / tis s ue targeted form ul ati ons s til l required a prior approval from the government.

2) S t u d i e s s u g g e s t t h a t d u r i n g A p r i l 2012-April 2013, more than 90% of FDI inflow was towards brownfield projects e.g. $989 million was brownfield compared to just $87.3 million for greenfield investments.

3) FDI statistics, Department of Industrial Policy and Promotions, Ministry of Commerce and Industry, Government of India available http://dipp.nic.in/English/ Publications/FDI_Statistics/2014/india_ FDI_September2014.pdf 4) Commerce Ministry commissions study to assess impact of FDI on pharma sector available at http://www.zeebiz. com/india/news-commerce-ministrycommissions-study-to-assess-impactof-fdi-on-pharma-sector-1716 5) Impact of Merger & Acquisitions in Indian Pharma on Production, Access and Pricing of Drugs, commissioned

by Government of UK's Department for International Development (DFID) under its Knowledge Partnership Programme available at http://www.ipekpp.com/ admin/upload_files/Knowledge_2_39_ Impact_2575324832.pdf.

6) (i) Ranbaxy's acquisition by Daiichi Sankyo; (ii) Fresenius Kabi's acquisition of Dabur Pharma; (iii) Piramal Healthcare's acquisition by Abbott; (iv) Matrix Laboratories' acquisition by Mylan; (v) Generic Injectable Business of Orchid Chemicals by Hospira; and (vi) Acquisition of Shantha Biotechnics

by Sanofi Pasteur.

HEALTH

globe for acquisitions and expanding their footprints globally. This will only encourage more deal-making in the pharmaceutical space and importantly, drive transactions for smaller stakes in brownfield companies as financial investors will be incentivized to partner with Indian companies without passing through unnecessary regulatory scrutiny.

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Putting the Patient at the Forefront of Labelling The article details on the current method of pharmaceutical products labelling which is paramount importance for the safety, benefit risk and other information to patients and healthcare professionals (HCP) and suggests effective recommendations, if that go hand in hand and implemented together, will take labelling to the next level.

T

he labelling of pharmaceutical products is the primary mechanism for communicating safety, benefit risk and other information to patients and healthcare professionals (HCP).

Yet making sure this information is communicated, accurately, in time, and to the right people, has always been, and continues to be, a significant challenge across the industry.

Assessing the Signals Inadequate maintenance of Reference Safety Information is responsible for 29 per cent of critical inspection findings. This was the headline of the latest Medicines and Healthcare products Regulatory Agency (MHRA) annual pharmacovigilance inspection report, released in November 2015. That's a significant statistic, but isn't surprising. A clear trend has emerged since the MHRA started producing annual inspection reports back in 2010. There have now been six reports and, each year, Reference Safety Information has been the most prevalent area for critical inspection findings in pharmacovigilance (PV).

Why is Reference Safety Information Causing So Many Problems? Number Crunching The key steps in the labelling process are simple enough. If all you had to do was to implement a labelling change for one presentation of one product in a single market, the level of compliance would be good. But, it's rarely that easy.

Things soon get complicated, and the number get big. Each stock keeping unit (SKU) will have multiple packaging components that need updating (carton, label, leaflet, foil). Each market will have differing requirements for your submission and all will have different

Richard Petherick Client Partner Navitas Life Sciences 36 ď‚ƒJuly 2016

timelines for approving your submission.

Once approval arrives, the next batch out the door needs to be with the new packaging, information must be updated on your public domain websites within 10 days, all your promotional materials are updated and any old materials are no longer used, whilst ensuring continuity of supply to the markets.

Signal detection is a complex process in itself. The decision to make a label change may be initiated by PV, but implementation crosses functional boundaries of global regulatory affairs (RA), affiliates, supply chain, and medical affairs. Links with these functions need to be well defined and integrated, to ensure signals are acted upon and variations submitted. There are multiple data sources generating 'big data' volumes of information. You need to harness this information, sort the noise from the quality data, analyse and verify your signals, before deciding what action to take. Once you have made a decision to change the label, the clock starts ticking and the challenge begins. Six months is considered approximately right to effect a change, depending on its severity. These numbers and tight timelines pose a tough challenge to companies.

There is no Communication Safety Net Common MHRA inspection findings include "Failure to identify and submit safety variations", "Significant delays in submitting variations" and "Failure to implement updated Reference Safety Information following variation approval".

The result: your product labelling isn't up to date with the latest information,

The labelling of pharmaceutical products is the primary mechanism for communicating safety, benefit risk and other information to patients and healthcare professionals (HCP).

Pharma Bio World

MHRA Pharmacovigilance Inspection Metrics Report April, 2014 – March, 2016

meaning HCPs and patients may be unaware of significant safety information that is pertinent to the prescription and administration of medical products. This could have a variety of consequences, from ineffective treatments to preventable drug interactions or even deaths. Labelling is the primary means by which the industry communicates medical scientific information to the patient and HCPs. If it's not up to date, there is little in the way of a safety net.

So it is clear why labelling merits focus from the regulators. But it doesn't explain why labelling is such a persistent problem and why industry seems to find it so difficult to get a handle on its labelling processes.

The Move to End to End (E2E) Labelling The concept of E2E labelling is widely accepted across the industry as best practice in labelling, and, rightly so. The principles and intent that drove the design of this process are just as applicable today as when it was developed years ago.

Labelling has many component parts and the common issues do not stem from one part of the process.

Some critical finding analysis conducted by the MHRA2 include: • P o o r c o m m u n i c a t i o n s b e t w e e n P V and RA; • No mechanism to feedback Competent Authority Summary of Product

• •

• • •

Characteristics (SPC) update requests made at the national level to review whether the same change should be applied to other regions; Delays in completion of internal processes; Inadequate tracking systems, and inadequate central oversight of local functions/submissions; Lack of procedures for implementation of updated RSI and no defined timelines; Poor communications between RA and manufacturing sites; Inadequate artwork controls.

These findings are indicative of systemic issues across the process and are all driven by the need to safeguard patient safety and put the patient at the forefront of labelling. E2E labelling encompasses all of the key stakeholder groups from pharmacovigilance to regulatory, manufacturing and artwork, in global and affiliate groups, and provides improved oversight of the process.

The Evolution of E2E Labelling In the wake of the MHRA's most recent report, we have got to ask ourselves if E2E labelling goes far enough. What else can be done to put the patient at the forefront?

38 July 2016

Pharma Bio World

There are three areas that go hand in hand which, when implemented together, will take labelling to the next level: 1. Improve oversight and efficiency by stretching the boundaries of the labelling process 2. Employ a risk-based approach to focus efforts on the changes and actions that will have the biggest impact on patient safety 3. Improve the quality of product labelling and make continuous improvement part of the labelling process

40 ď‚ƒJuly 2016

1. Stretch the Boundaries - Bringing Greater Alignment across the Process The first step to enabling change is to gain greater oversight, alignment and understanding across the process.

That means moving signal detection firmly into the labelling process and getting a better handle on logistics and supply chain, having excellent linkages to your affiliate network, providing you with a sound understanding of the labelling situation in local markets and regions.

With signal detection relocated you now have a direct link into your labelling process, which simplifies decision making and ensures safety signals are acted upon. Similarly, having greater input from supply chain has a number of benefits, from being able to plan more effectively in alignment with stock levels, to having oversight of when the change is on the packed product and shipped.

2. All Products are not Created Equal Take a Risk-based Approach Evidence tells us that managing safety

Pharma Bio World

Making this transition will require quite a bit of forward thinking and a change in mind-set. It’s certainly a challenge, but the result is a labelling process that puts your patient at the forefront. risk via the product information leaflet (PIL) is ineffective. Whilst this is essential, it takes too long for the message to get to its audience through PILs and when it does the customer often doesn't read it. Given this is the primary means of communication, more needs to be done to make sure people are aware of the content in a timely manner. Thus, establishing greater oversight of the elements that impact labelling allows you to start managing your labelling process differently. It gives greater access to and understanding of the information you need to make informed risk-based decisions.

This is important because when it comes to labelling there isn't a 'one size fits all' approach. By understanding your product profile from a prescribing and supply chain perspective you can make informed decisions on your label change strategy at the product level. This could include prioritisation of the change, or mechanisms employed to ensure the end user is aware of the change in a timely manner. Such an approach will mean you put your efforts where they will have greatest benefit rather than applying the same standards to all products.

The result is a risk-based plan for implementing your label change that takes into account all of the variables and criteria. You will then deliver changes that don't just aim to get updated information on the pack, but aim to get the right information to the customer, using the most appropriate method, in the shortest timeframe.

labelling change in the most effective way such as - Is the product over the counter (OTC) or prescription?, Is the treatment for an acute or chronic disease? Etc. Focus on the best way of getting the information to your customer, rather than purely relying on the updated packaging.

3. Improving the Quality

Making this transition will require quite a bit of forward thinking and a change in mind-set. It's certainly a challenge, but the result is a labelling process that puts your patient at the forefront.

Contact: sharanya.gopinath@2020msl.com

Research has shown that the majority of PILs require graduate level literacy.

That means that only 30-50 per cent of a population may be able to understand the leaflet. Ensuring the effectiveness of your risk-based product strategy is vital to enable your labelling process to evolve.

Such an approach is a key element of any quality management system (QMS) so it makes sense to apply this thinking to labelling. To make this work there are some other QMS principles that should be applied. Once you have established the effectiveness you need to take action. A robust Corrective and Preventative Action process should be applied to manage improvements and actions tracked to closure. Of course it's important to correct any immediate issue but, your process will only evolve if you understand the root cause of deficiencies.

The Labelling Cycle

The Most Effective Way

When you make these three changes it makes sense to start thinking of labelling as a cycle, rather than a process that has a beginning, middle, and an end. Ultimately, this will lead you down a route that is more patient-focused and will ensure that labelling is continually improved.

By establishing an assessment framework that answers a number of key questions, market by market, you can build a product profile that will inform how to manage the

Your improved oversight will allow you to make informed decisions on how you manage a labelling change and will ensure you get your message to the HCP

42 ď‚ƒJuly 2016

and patient quicker. This is turn will have a positive impact on compliance and reduce those critical inspection findings.

Meanwhile, having an understanding of the effectiveness of that change will ensure that the message is clear and well understood.

Pharma Bio World

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Pharmacogenetics: From Traditional Method to Modern Pharmacogenomics Pharmacogenetics is the study of inherited genetic differences in drug metabolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects. The article explains on the how the practice of pharmacogenetics has been evolved with the today's advancement in the medical field.

Ketan Zota Director Zota Healthcare 44 ď‚ƒJuly 2016

M

edicines are those external forces that act as a bandage to your illhealth. Earlier times noticed the making of medicines the traditional way but as the years changed with the influence of technology, the scientists since then have been researching on all the possible cure methods for every kind of health issue. The cultural changes have also been a benefit for the medical institutions to grow in terms of adapting new methods with an ease. It is true that a mother's care is the most effective medicine but a well-researched method just cures your ill-health in time without leaving any traces of harmful side-effects. The difference in our health is noticed when there are linked series of chemical reactions occurring within a cell.

Thus, scientists and doctors are using this new technology for a variety of things, one being improving the efficacy of drugs.

Pharmacogenetics is the study of inherited genetic differences in drug metabolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects. Though the field of pharmacogenetic was established in 1950s, the adoption of new tests for the variants of pharmacogenetic has recently become available to the institutions and clinicians that guide pharmacotherapy.

These variants are implicated in interindividual drug response.

Variation within the human genome is seen about every 500-1000 bases. Variation in the N-acetyltransferase gene divides people into 'slow acetylators' and fast acetylators', with very different half-lives and blood concentrations of such important drugs asisoniazid (antituberculosis) and procainamide (antiarrhythmic). As part of the inborn system for clearing the body ofxenobiotics, the cytochrome P450 oxidases (CYPs) are heavily involved in drug metabolism, and genetic variations in CYPs affect large populations. Importantly, CYP2D6 is also prone to copy number variation, including full gene deletion and duplication, which can significantly influence the interpretation of CYP2D6 sequencing, genotyping, and phenotype prediction. Since the initial discovery of CYP2D6 and its important role in drug metabolism, CYP2D6 genotypes have been correlated with four general metabolism phenotypes: ultrarapid, extensive, intermediate, and poor. Now that clinical DNA-basedCYP2D6 testing is available, interpretation of a patient's genotype typically includes one of these predicted metabolism phenotypes.

Pharmacogenetics is largely used in relation to genes determining drug metabolism. The term pharmacogenetics is often used interchangeably with the term pharmacogenomics, the latter being a broader based term that encompasses all genes in the genome that may determine drug response. Health being the greatest of all possessions, one never fails to rely on the doctor and their medications even if they catch cold. The wider use of pharmacogenetic testing is viewed by many as an outstanding opportunity to improve prescribing safety and efficacy.

Talking about its history, the field of pharmacogenetics was not officially recognised until 1959 when the term 'pharmacogenetics' was first published by the German physician Friedrich Vogel.

One of the most influential discoveries for pharmacogenetics and its potential clinical utility was the identification in 1977 of the hepatic cytochrome P450 oxidase that controls debrisoquine and sparteine metabolism. Since then there have been numerous landmarks that have shaped this field of research, and have led to the current wave of interest.

Pharma Bio World

Pharmacogenetics is expensive yet controversial because of its elongated process and the high level of risk involved in resulting out a successful test. Since it is a new topic in the field of medical, the ethics of it are not clear but yet few of them have been addressed with proven solutions.

However, it should be emphasized that this is only a prediction and not based on individual pharmacokinetic measurements. e spend our health in gaining success, respect, money but years down the lane we spend the some money to cure our health. ith the advancement in the medical field, the practice of pharmacogenetics was at a kickstart. The clinical experiments did not only help the scientists and clinicians to analyse the drug compositions accurately but also helped them in formulating effective combination for curing the genetic variations.

One of the earliest tests for a genetic variation resulting in a clinically important consequence was on the enzyme thiopurine methyltransferase (TPMT).

TPMT metabolizes 6-mercaptopurine and azathioprine, two thiopurine drugs used in a range of indications, from childhood leukemia to autoimmune diseases. Another performed test was for the polymorphism near a human interferon gene that is predictive of the effectiveness of an artificial interferon treatment for Hepatitis C. For genotype 1 hepatitis C treated with Pegylated interferon-alpha-2a or Pegylated interferon-alpha-2b (brand names Pegasys or PEG-Intron) combined with ribavirin.

Moreover, highly multiplexed genotyping assays enriched for important pharmacogenetic genes and functional variants have been commercially developed for both research and clinical use, prompting the possibility of providing individuals with a predicted drug metabolism phenotype profile. As the cost per genetic test decreases, the development of Pharma Bio World

personalized drug therapies will increase.

The need to stay modernized along with time is important when it comes to health.

Technology now allows for genetic analysis of hundreds of target genes involved in medication metabolism and response in less than 24 hours for under SD 1,000.

This is a huge step towards bringing pharmacogenetic technology into everyday medical decisions.

Spending on your health to be perfect makes more sense than spending money on junk that ruins your health. Medical field is just witnessing a mode of accelerated growth when it comes to the involvement of technology in their clinical experiments and tests. ith machines and instruments being well-equipped to increasing the knowledge about a particular drug does not only result in a successful test but the scientists also get a green signal to ask the doctors to perform that particular test on patients as well. Still Pharmacogenetics has become a controversial issue in the area of bioethics. It's a new topic to the medical field, as well as the public. This new technique will have a huge impact on society, influencing the treatment of both common and rare diseases.

Pharmacogenetics is expensive yet controversial because of its elongated process and the high level of risk involved in resulting out a successful test. Since it is a new topic in the field of medical, the ethics of it are not clear but yet few of them have been addressed with proven solutions. Pharmacogenetics is a new process that may increase the benefits of medicine while decreasing the risk.

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Laser Coding and Marking in Pharmaceutical Industry: An Expert Overview Pharmaceutical products liable to produce on high throughput lines and often running the same products almost continuously.

Thus coding and marking are needed and laser coders are often favoured due to their ability to run for extended periods of time with little required maintenance. Most cases coding are carried onto cardboard substrates, therefore CO2 lasers are recommended and in rare instances fiber laser may be recommended where boxes have a plastic coating.

The article explicates on the advantages of using CLARiTY Laser Controller for coding and marking in pharma industry.

Sascha Ammesdörfer Laser Business Unit Manager Videojet 46 July 2016

P

harmaceutical products tend to be produced on high throughput lines, often running the same products almost continuously. For coding and marking purposes - a vital element in the production process - laser coders are often favoured due to their ability to run for extended periods of time with little required maintenance.

In most cases, coding will be carried out onto cardboard substrates, therefore CO 2 lasers are recommended. CO 2 is the most cost effective solution in terms of cost for the system and the end result on the product. There are some areas, where boxes have a plastic coating, where a fiber laser may be recommended, but for most high speed production lines CO 2 will be the solution.

The CLARiTY controller used to control the system also has many advantages for high throughput lines. Code assurance minimizes and almost mistake-proofs operator input - a huge benefit in the pharma industry, where accuracy is vital.

If we take expiry dates as an example, only allowable dates can be selected.

For product changeovers a simple set up wizard allows the orientation of the laser to be changed very quickly - you simply access the line set up wizard, change the product side selection, printer and text orientation, use the interface to enter jobspecific details and then place the printer back online. This reduces line setup by up to 33 per cent over legacy controllers.

Clear Advantages for Pharma Industry One of the clear advantages of a laser is that it doesn't have any consumables, which means that there is very little maintenance required. Once in a while - depending on how dusty the operating environment is - manufacturers will have to clean the lens and check and change the filters, but in most cases this is once every three to six months. Other than that, the laser can be switched on and will run happily without further interaction. A Videojet customer once remarked - 'the issue I have with lasers is I have to touch it so infrequently I almost forget how to operate it'. This also makes it easy in terms of predictive/scheduled maintenance.

Manufacturers can plan effectively depending on environment in order to avoid unscheduled downtime on production lines.

In clean room environments, for example, laser systems may not need to be touched for a year or more.

Determining suitability will highly depends on the substrate a manufacturer wishes to code, as this directly affects the material effect achieved. It is advisable to work with an expert to determine which form of laser type and associated parameters are best suited to individual needs. This will ensure the best possible coding contrast on end products.

A CO 2 laser cannot code onto metals as the laser radiation is completely reflected, whereas if a fiber laser is used a very nice

Pharmaceutical products tend to be produced on high throughput lines, often running the same products almost continuously. For coding and marking purposes – a vital element in the production process – laser coders are often favoured due to their ability to run for extended periods of time with little required maintenance.

Pharma Bio World

contrast can be achieved. Then depending on how the laser parameters are set up, it is also possible to create an engraving or an annealing contrast - for medical devices for example. On some substrates it is possible to automatically identify the laser required. A good example is glass.

A fiber laser will go straight through glass, while a CO 2 laser will be absorbed. There are a lot of substrates, such as cardboard, that are suitable for both, but in this instance most will go for CO 2 as the cost is less and the results are of a high quality.

Making the Correct Decision With each and every customer project, Videojet carries out sampling to ascertain the right laser type and also the parameters and the required power settings etc. A very slow line may only need a 10W laser, whereas others may need a 50W laser - the more power you have the faster you can code.

colour. Most plastics are comprised of a base plastic and then a colour pigment is added to the master batch. In most cases the laser doesn't react with the base material, it reacts with the colour additive. In some customer projects we have to ask the customer to add a colour pigment to the base material in order to make it laser codeable, otherwise the base material wouldn't absorb any radiation and therefore could not be coded.

There are many variables to consider when laser coding, which our experts will work in partnership with customers to get absolutely right to ensure the correct solution is installed.

Operating Safely In North America and Europe fume extraction is mandatory, whereas in other regions such as China and South America there are no statutory regulations in place.

Some choose not to do this in order to reduce operating costs, but with every laser unit we install we always offer a fume extraction system and strongly encourage customers to consider the implications of operating without one.

If you are coding onto plastics, for example, the fumes can be harmful to the operators.

Legally it is the customer's responsibility to ensure they have a solution that

The colour of the substrate and the material it is made of can have a direct effect on how the laser reacts when coding so testing is very important. Some customers have the same plastic but in five or six different colours and sometimes it will be the case that five of them will be fine but the sixth one will not work at all because of the base colour. The absorption of the material depends on the Pharma Bio World

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Laser also uses no chemicals at all, so operators are never exposed to potentially harmful substances. The only consumable we have is electrical power. We don't have any elements on the laser that need to be exchanged on a regular basis or any consumables such as solvent.

protects their operators from potentially harmful fumes and vapours that could be generated, but we also take this very seriously in terms of our recommendations.

It is helpful for customers to understand that not only does it protect the operator, but in many areas it also improves product quality. If you code onto a cardboard box and you don't extract the fumes, depending on how much material you are removing you may have dust and vapours that remain on the product that will be detrimental to the look of that box. The extraction units are relatively inexpensive, so too are the filters, so it really is a sensible choice.

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When we install a laser, in most cases we also install a beam shield - a fully integrated solution. This ensures that no laser radiation - either direct or reflected - can harm the operator. With the laser powers that we are using, if you put your hand under the laser you would burn yourself, but it is not powerful enough to take off a limb for example. However, any risk of harm must be avoided. The biggest danger with a laser is to the eyes of the operator, and the level of risk is associated with how you are operating the system. There are two ways; the first is what we call open - without any protection - in which case the operator would have to wear protective goggles.

This, however, is not suitable in industrial environments, so usually the second is adopted, where you build the laser into your production line and around it you

build a plastic or a metal shield, which prevents any radiation from escaping.

As a manufacturer we are very keen for our customers to have beam protection in place. In Europe and America there are regulations in place to ensure this happens, but in other areas there are cases of manufacturers operating systems openly. Laser radiation has the ability to permanently damage the eyes. The Science & Technology Facilities Council, based in the UK, advise that 'retinal eye damage from laser radiation can occur at very low power levels due to the focusing effect of the cornea and lens of the eye and the coherence of laser radiation', therefore operating systems openly is not recommended.

We are in constant contact with our customers to identify their needs and challenges, and therefore are able to react to their requirements on an ongoing basis. Bigger and faster is the theme for the future and as demand and throughputs continue to increase we will continue to develop our systems accordingly.

Contact: sascha.ammesdoerfer@videojet.com Pharma Bio World

marketing initiative

High Quality Rubber Components with Modern Vacuum Technology

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he main products of Datwyler components are stamped, vulcanised, Pharma Packaging Italy Srl. are tested, washed and packed. small rubber components for medical equipment. The output of The moulding process takes place the company's production facility in under high mechanical pressure, at Montegaldella (VI) is primarily rubber temperatures between 175°C and parts for syringe plungers and sealing 180°C, and in a vacuum of 1 mbar (-999 caps for sterile products. Datwyler's mbar). This vacuum level is necessary thermoforming machines rely on to exclude air bubbles from the finished screw vacuum technology by Busch. component, and to remove vapour A vacuum system with four COBRA generated by the high temperature and screw vacuum pumps ensures high pressure of the process. The moulding product quality, as air and gas bubbles machines were originally equipped are removed from the rubber during with oil-lubricated rotary vane vacuum the moulding process. pumps, which soon developed a serious problem: the vacuum pump oil reacted Datwyler Pharma Packaging Italy Srl. with the process vapour, causing is part of the international Datwyler emulsions and greasy deposits to Sealing Solution Group, which is accumulate in the vacuum pumps. These owned by the Datwyler corporation. deposits reduced the vacuum output, so Datwyler Pharma Packaging Italy the required level and pumping speed Srl. operates two production sites in could no longer be achieved. Costly Italy. At the Montegaldella (VI) facility, measures to keep these vacuum pumps components such as stoppers for blood running were attempted, including collection tubes and parts for single- changing the oil every two weeks. In use syringes are manufactured. The 2009 Datwyler signed a maintenance site employs 140 staff and operates agreement with Busch, in which Busch around the clock in a 3-shift system. agreed to carry out third-party servicing The manufacturing process includes of the vacuum equipment. all stages of production, from mixing of raw materials to preparing the finished sterile rubber components for shipment. Datwyler's customers are medical technology companies throughout the world.

The first production stage is the mixing of rubber with additives and chemicals to form strips of base material, which are then coiled. The composition of this base material is dependent on its later application, and is prepared to customer specifications. Two production lines of twelve thermoforming machines each cut the base material strips to size automatically. The trimmed sections are then pressed into a mould under vacuum, after which the individual 50 July 2016

After Busch vacuum specialists had studied the problem in depth, they presented their recommendations to Alessandro Piccoli, the maintenance manager of the Montegaldella (VI) site. Their solution: replace the oillubricated rotary vane vacuum pumps with Busch dry screw technology.

Consequently, a COBRA screw vacuum pump was subjected to extensive testing. These vacuum pumps operate without compression chamber fluids, which means there is no contact between the extracted vapour and any other medium in the vacuum pump. In addition, COBRA vacuum pumps run at a working temperature which allows vapour to pass through the pump without condensing. The COBRA test system proved to be highly satisfactory, so Alessandro Piccoli ordered two COBRA vacuum pumps to supply a line of six moulding machines. Both vacuum pumps incorporated Panda Roots vacuum pumps as boosters. This arrangement permitted the vacuum system to be installed away from the production buildings, with vacuum for the thermoforming machines supplied

Figure 1: Centralised vacuum generation outside of the production rooms

Pharma Bio World

marketing initiative

Figure 4: Rubber plugs

temperature distribution throughout COBRA units Figure 2: Screw vacuum pump COBRA NC

Figure 3: Blood collection tubes

by a pipework system. An upstream For Alessandro Piccoli, whose goal vacuum reservoir ensures that the is maximum energy efficiency, this is required vacuum level and pumping another important argument in favour speed are constantly available. In of COBRA dry screw technology and 2012 two additional vacuum units the centralisation of the vacuum supply. were ordered and installed - also with Plans to extend the vacuum system COBRA fore pumps and Panda Roots to supply all 24 moulding machines booster pumps - to supply a complete have been made, and will be line of twelve thermoforming machines. implemented shortly.

All the vacuum units are equipped with a fully automatic control system, which For Alessandro Piccoli, the Busch monitors the vacuum level and activates solution has brought the following the minimum number of vacuum advantages: pumps required to meet the current demand from the twelve thermoforming • No reaction between extracted vapour and operating fluids, due to machines. This means that all the dry screw vacuum technology vacuum pumps run only when the entire line is operating at maximum capacity.

In everyday use, only three COBRA/ • No accumulation of condensates in the vacuum pumps, due to the even Panda combinations are required.

Pharma Bio World

•

Considerable energy savings, due to vacuum supply centralisation and automatic demand-driven control

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An extremely reliable vacuum supply

•

Significantly reduced maintenance effort and consequently lower costs for servicing, replacement parts and production downtime

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Easy access to the vacuum system even if thermoforming machines are operating, maintenance possible during production

•

No noise emissions in the production building or at workstations, due to external location of centralised vacuum system

Uli Merkle Manager - Marketing Services Busch Dienste GmbH Email: uli.merkle@ busch.de www.buschvacuum.com

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marketing initiative

ETP Keyless Bushes

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eys & Keyways have been an integral part of torque transmission - as long as we can remember. But the difficulties encountered in machining & fitting them remains a perennial & permanent problem. Taper Lock (Tapered Bushes with half threads) were designed to eliminate the assembly problem - but the main culprit - the KEY/KEYWAY still remained.

Locking assemblies were the first to totally eliminate this necessity of keys & keyways. These products with 2 tapered rings provided a real alternative and became very popular - mostly in heavy industries like Conveyors/Gears/Large couplings.

Although the range encompassed shaft

When the screws has been tightened, ETPCLASSIC creates and even surface pressue against the hub and shaft along virtually the entire length.

When the pressure screw is tightened to the recommended tightening torque, the piston has reached the bottom of the bore. ETP-EXPRES R has created a uniform surface pressure against the shaft and hub.

diameters from 6 mm onwards - they were too cumbersome & uncomfortable.

In the 1980's ETP Transmission AB of Sweden designed/manufactured and launched ETP Classic bushes to totally eliminate keys & keyways, for shaft diameters from 15 to 100 mm.

Utilising Pascal's law, ETP Bushes had a 'medium' filled between 2 thin walled cylinders & utilized the hydraulic force to expand/contract & clamp the product (pulley/gear/coupling/sprocket) to the shaft, using minimal forces.

Simultaneously using the same screws to release the pressure & dismantle the product from the shaft.

Now - locations where you needed quick & precise assembly/frequent dismantling/repeated adjustments have a real time solution.

With a commitment to expand this range, ETP developed ETP EXPRESS– with all the benefits of ETP Classic, but WITH JUST 1 SCREW, located radially.

Very quickly ETP Express- R (in Stainless Steel) was introduced - for the Printing/ Packaging/Pharma industries. Now, OEM's/designers have a fascinating product to enhance the capacity of their machines. Maintenance - has become faster/ easier using the ETP range of Bushes.

ETP also offers ETP-Techno (for very low run-out), ETP Power (for high radial loads) ETP-HYLOC (for shaft diameters from 50 to 300, as standard).

HYLOC is widely used in the rolling/tube manufacturing industry - for quicker/ easier changing of dies/rolls.

TRADELINK SERVICES, Chennai offers a wide range of products in the field of Mechanical Power Transmission engineering.

Websites : www.etp.sewww.tradelinkservices.in

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Pharma Bio World

press release BIRAC Initiates GCE-India Programme

                                                                                                                                                                                                                                                           

Liraglutide Reduces the Risk of Major CV Events and Death                                                      54 July 2016

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Positive Bioscience Launches Positive– Academy                                                                                                                                                  Pharma Bio World

22-07-2016 18:21:06

press release Godrej Appliances to Reduce Vaccine Wastage

                                                                                                                                                                                                                                                                                                  

Sanofi Sign Business Swap Deal with Boehringer Ingelheim                                                             

  

Romaco Group Expands Management Team                                 

                                                                                                              Pharma Bio World

Press Release.indd 55

July 2016  55

22-07-2016 18:22:26

press release SRL Diagnostics Champions the Cause of Preventive Healthcare

                                                                                                              

Agilent Introduces InfinityLab Liquid Chromatography Instruments

                                                                  

                          

AstraZeneca India Collaborates with STEMI India

                                                                                      56 July 2016

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KSB Pumps Appoints Rajeev Jain as New Managing Director                                                                        Pharma Bio World

22-07-2016 18:22:26

pharma news Merck Animal Health to Acquire Vallée for $ 400 million Merck Animal Health (known as MSD Animal Health outside the United States and Canada) has executed an agreement to acquire a controlling interest in Vallée SA, a leading privately-held producer of animal health products in Brazil.

Under terms of the agreement, Merck Animal Health, through a subsidiary, will acquire approximately 93 per cent of the shares of Vallée SA at closing, in exchange for a payment of USD 400 million, based on current exchange rates. This agreement is subject to regulatory review and certain closing conditions.

Vallée has an extensive portfolio of more than 100 products spanning parasiticides, anti-infectives and vaccines. The company’s portfolio includes products for livestock, horses, and companion animals. Vallée was founded with the mission of producing a Foot and Mouth Disease (FMD) vaccine for Brazil and has expanded significantly, with distribution centers in Brazil and operations in Paraguay, Venezuela, Mexico and Bolivia.

Takeda, Altos to Develop ATC-1906 for Gastroparesis Treatment Takeda Pharmaceutical Company Limited and Altos Therapeutics LLC have entered into a definitive agreement to further the development of Altos’s proprietary compound ATC-1906. Additionally, the agreement includes an exclusive option for Takeda to acquire Altos beginning on the date of the agreement and continuing for a period of time following the completion of ongoing phase 1 studies of ATC-1906. The parties envision future development of ATC-1906 for the treatment of gastroparesis (GP) and its symptoms.

GP is a chronic gastric motility disorder characterized by delayed gastric emptying. Symptoms include early satiety, post-prandial fullness, nausea, vomiting, and abdominal discomfort. Diabetic gastroparesis and idiopathic gastroparesis have high unmet need.

Altos Therapeutics, a single asset company, is developing the ATC-1906 compound as an oral dopamine D2/D3 receptor antagonist that addresses the symptoms of nausea and vomiting in GP patients. As part of the agreement, Takeda will provide Altos an upfront payment for the option to acquire Altos. If Takeda elects to exercise the option, Takeda would make an additional payment to acquire Altos, and would then assume control over development and commercialization of ATC-1906. Altos would be eligible to receive additional payments linked to clinical development and achievement of key commercial milestones. No further details of the agreement were disclosed.

Pharma Bio World

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In patients with GP, the activation of dopamine receptors drives an emetic response, also commonly known as vomiting. Altos & Takeda will seek to develop ATC-1906 and its dopamine receptor antagonist mechanism of action as an alternative treatment to target the symptoms of nausea and vomiting to relieve patient suffering with an improved safety profile.

Citius Pharma Stop Production of Suprenza Citius Pharmaceuticals, Inc, a specialty pharmaceutical company dedicated to acquiring, developing and commercializing adjunctive cancer care and critical care drug products, announced it was discontinuing Suprenza, its FDA-approved phentermine-based product for weight loss.

Myron Holubiak, CEO of Citius said, “Suprenza no longer meets our core strategic objectives. We are dedicating our focus on our phase 3 asset Mino-Lok and our phase 2b asset Hydro-Lido for hemorrhoids.”

Holubiak continued, “We feel that the obesity and weight management market has shifted and therefore we are devoting our efforts on developing our leading two assets. We anticipate a minimal financial impact to Citius from discontinuation since we eliminate our ongoing regulatory expenses and have not historically received royalties from the product.”

Ritter Pharma Receives US Patent Covering Method of Use of RP-G28 Ritter Pharmaceuticals, Inc, a company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, has been issued US patent number 9,370,532 by the US Patent & Trademark Office.

US patent number 9,370,532 covers methods for treating symptoms associated with lactose intolerance and for overall improvement in gastrointestinal health. Subject to the payment of maintenance fees, this patent will remain in force until 2030.

“We are excited to have received additional patent protection related to RP-G28, our treatment for lactose intolerance which has the potential to be the first FDA-approved treatment for this indication,” commented Michael D. Step, chief executive officer of Ritter Pharmaceuticals. “As announced earlier this year, we gained patent protection for the manufacturing and composition of RP-G28. This new patent will provide us with further protection as we work to bring a safe and effective treatment to patients suffering from lactose intolerance and to achieve long-term value for the company and its shareholders.”

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pharma news Allergan Gets Positive Opinion from Swedish MPA for Belkyra Allergan plc, a leading global pharmaceutical company, has received a positive opinion from the Swedish Medical Products Agency (MPA) for Belkyra (deoxycholic acid).

Belkyra will be the first prescription medicine to be licensed in Europe for the treatment of moderate to severe convexity or fullness associated with submental fat (often called double chin) in adults when the presence of submental fat has a psychological impact for the patient. Belkyra is being evaluated through the Decentralised Procedure, with the Swedish MPA acting as the Reference Member State for 20 other countries in the European Union, as well as Iceland and Norway.

Submental fullness (or double chin) is a concern for many people. In fact, according to data from the American Society for Dermatologic Surgery (ASDS) in 2015, fat under the chin/neck topped the list of most troublesome conditions for patients, with 67 per cent reporting being concerned or bothered about the condition. There is a common misperception that fullness under the chin only appears in those who are overweight, when in reality it can occur in any body type and may be related to aging, genetics or weight gain.

Valeant Pharma, AstraZeneca to Terminate Brodalumab Pact Valeant Pharmaceuticals International, Inc. announced that its affiliate and AstraZeneca have amended Valeant’s license for brodalumab, an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis, to terminate Valeant’s right to develop and commercialize brodalumab in Europe.

In August 2015, AstraZeneca and Valeant entered into an agreement granting Valeant an exclusive license to develop and commercialize brodalumab globally, other than in Japan and certain other Asian countries. Under the terms of the amended agreement, Valeant will continue to hold the license to develop and commercialize brodalumab in the US, as well as the remainder of the territory outside of Europe. As consideration for the termination of the European rights, AstraZeneca will pay to Valeant an upfront payment and certain sales-based milestone payments and, in addition, one of the pre-launch milestones payable by Valeant to AstraZeneca under the original license has been reduced.

With the termination of Valeant’s licensing rights to brodalumab in Europe, AstraZeneca has entered into an agreement granting LEO Pharma the exclusive rights to develop and commercialize brodalumab in Europe.

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On January 25, 2016, Valeant announced that the US Food and Drug Administration (FDA) had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant for brodalumab injection for the treatment of moderateto-severe plaque psoriasis and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016. In addition, the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant’s BLA on July 19, 2016.

UMN Pharma Joins Protein Sciences’ Global Zika Vaccine Consortium Protein Sciences Corporation, manufacturer of Flublok influenza vaccine, and UMN Pharma Inc. (Akita, Akita prefecture, Japan) announced that UMN has signed on as the latest partner of the international Zika vaccine consortium initiated by Protein Sciences.

The consortium, which also includes partners Sinergium Biotech (Buenos Aires, Argentina) and Mundo Sano, a private foundation with activities in Argentina, Spain and Africa, is developing a vaccine to combat the Zika virus based on Protein Sciences’ proprietary technology.

The partners are pooling resources to drive advancement of their vaccine candidate into the clinic as quickly as possible, which is anticipated for later this year. Under the terms of the agreement, UMN will pay an upfront fee to fund the development and manufacture of the vaccine being produced at Protein Sciences.

In return, UMN will receive manufacturing and commercial rights to the vaccine in Japan and other counties to be determined.

Protein Sciences Corporation is saving lives and improving health through the creation of innovative vaccines and biopharmaceuticals.

Hanmi Pharma, Medidata Expands Partnership Medidata, the leading global provider of cloud-based solutions for clinical research, has signed a multi-year enterprise deal with Hanmi Pharmaceutical, one of South Korea’s leading drug makers.

A Medidata customer since 2013, the Seoul-based pharmaceutical company is expanding its technology partnership with Medidata, becoming the first Korean company to incorporate the Medidata Clinical Cloud into all clinical trials across its drug development programmes.

Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics.

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22-07-2016 18:24:24

biotech news AbbVie’s Humira Gets US FDA Nod AbbVie, a global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis.

This approval marks the 10th approved indication for Humira in the United States for immune-mediated diseases.

This month, the European Commission also approved Humira in the European Union for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

Prior to this approval, ophthalmologists and rheumatologists had no FDA-approved treatment options other than corticosteroids.

Humira targets and helps block TNF-a, a specific source of inflammation that can have a role in uveitis. The FDA approval is based on results from two pivotal phase 3 studies, VISUAL-I and VISUAL-II, which demonstrated that adult patients with active and controlled non-infectious intermediate, posterior and panuveitis treated with Humira had a significantly lower risk for treatment failure (a combination of uveitic flare and decrease in visual acuity), compared to placebo. No new safety risks were identified for adult patients with non-infectious uveitis treated with Humira every other week.

In 2014, the FDA granted Humira orphan drug designation for the treatment of certain forms of uveitis, which affect a population of fewer than 200,000 patients. The orphan drug designation provides Humira the potential to be granted seven years of market exclusivity for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

Kiadis Gets EMA Nod to Expand ATIR101 ODD to Include in HSCT Kiadis Pharma N.V., a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, announced that its lead product, ATIR101, has been granted an expansion to its existing Orphan Drug designation (ODD) by the European Medicines Agency (EMA) to include treatment in a hematopoietic stem cell transplantation (HSCT).

Kiadis Pharma was previously granted an ODD for ATIR101 by both EMA and the United States Food and Drug Administration Pharma Bio World

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(FDA) for the prevention of Graft-versus-Host-Disease (GVHD) following an allogeneic HSCT. A further ODD was granted by the FDA for the prevention of Transplant Related Mortality following an allogeneic HSCT and a fourth ODD was granted by EMA for the treatment of acute myeloid leukemia (AML) following an allogeneic HSCT. This latter ODD has now been expanded

by EMA to cover all uses of ATIR101 as treatment in HSCT, regardless of the underlying disease.

The EMA’s ODD is reserved for new therapies being developed to treat life-threatening or chronically debilitating diseases or conditions that are relatively rare in the European Union and for which no satisfactory therapy is available. The ODD designation provides incentives to support development, including fee reductions and a ten-year period of market exclusivity in the European Union after product approval.

For patients suffering from blood cancers, an allogeneic HSCT is generally regarded as the most effective curative approach. During an HSCT treatment, the bone marrow, harboring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells in the graft from a healthy donor. After an HSCT treatment it usually takes the patient at least six to twelve months to recover to near-normal blood cell levels and immune cell functions.

Array BioPharma Seeks US FDA Nod for Binimetinib Array BioPharma announced the submission of a New Drug Application (NDA) for binimetinib in patients with advanced NRAS-mutant melanoma to the US Food and Drug Administration (FDA). The submission is based on results of the pivotal phase 3 NEMO (NRAS MELANOMA AND MEK INHBITOR) study, which found binimetinib significantly extended median progressionfree survival (PFS), the study’s primary endpoint, as compared with dacarbazine.

In the NEMO study, binimetinib significantly extended median PFS at 2.8 months, as compared with 1.5 months observed with dacarbazine [hazard ratio (HR)=0.62 (95% CI 0.47-0.80), p<0.001] in patients with advanced NRAS-mutant melanoma. In the prespecified subset of patients who received prior treatment with immunotherapy, including ipilimumab, nivolumab or pembrolizumab, patients who received binimetinib experienced 5.5 months of median PFS (95% CI, 2.8–7.6), compared with 1.6 months for those receiving treatment with dacarbazine (95% CI, 1.5–2.8).

In addition to improving PFS, binimetinib also demonstrated significant improvement in overall response rate (ORR) and disease control rate (DCR). While there was no statistically significant difference demonstrated in overall survival, the median overall survival (mOS) favored the binimetinib arm.

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biotech news Ligand Gets $ 4 million from Expansion of Two OmniAb Deals Ligand Pharmaceuticals Incorporated, a biopharma company, announced that two recent events relating to its OmniAb platform generated USD 4 million in combined payments due to Ligand.

One event relates to a current OmniAb licensee exercising its option to expand access to the OmniAb platform and the second event relates to Wuxi sub-licensing Chinese rights to an IND-ready antibody it discovered with the OmniAb platform.

In exercising its option, an OmniAb licensee broadened its access to the OmniAb platform by adding OmniFlic, a transgenic rat technology with a fixed light chain used to generate bispecific antibodies. Prior to the option exercise, this licensee’s access to the OmniAb technology was limited to OmniRat. The option exercise triggered a payment to Ligand. Additionally, any approved antibody therapeutics generated utilizing OmniFlic will be subject to milestones and royalties to Ligand.

Under the existing license agreement with Wuxi, antibodies developed using the OmniAb platform and subsequently outlicensed for use in China trigger a payment to Ligand, in addition to potential royalties on product sales. Wuxi recently out-licensed the Chinese rights to an undisclosed IND-ready antibody it discovered with the OmniAb platform and its sub-licensee will be responsible for all future costs related to the program.

Poxel Completes Enrollment in Phase 2b Trial of Imeglimin Poxel SA, a biopharmaceutical company focused on the development of innovative drugs to treat type 2 diabetes, announced that it has completed patient enrollment for the phase 2b clinical trial of Imeglimin in type 2 diabetes patients in Japan.

Imeglimin is the first in a new class of oral anti-diabetic agents targeting mitochondrial bioenergetics and has completed phase 2 development in over 850 patients in the United States and Europe.

The dose-ranging, randomized, double-blind, placebo-controlled phase 2b study in Japan is supervised by Professor Kohjiro Ueki, MD, PhD, Department of Diabetes and Metabolic Disease at the University of Tokyo and been designed to include approximately 300 naïve and pre-treated patients. Following recruitment and a six-toten week washout period, patients are randomized into 24 weeks of treatment. The primary endpoint of the trial is efficacy measured by change in glycated haemoglobin HbA1c concentrations.

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phase 3 development programme in Japan, which Poxel expects to be in the position to initiate during the second half of 2017.

Poxel’s Imeglimin programme in Japan is being supported by a Japanese Scientific Advisory Board (SAB) in diabetes research.

The SAB members have worked with Poxel in guiding the Company’s regulatory interactions and clinical development plans. The members include: Pr. M. Kasuga, President of the National Center for Global Health and Medicine in Tokyo; Pr. K. Ueki, Professor of the Department of Molecular Sciences on Diabetes of Tokyo University; and Pr. H. Watada, Professor of the Department of Medicine, Metabolism and Endocrinology of the Juntendo University in Tokyo.

Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the Glimins. Imeglimin acts on three main target organs involved in glucose homoeostasis: the liver, muscle, and the pancreas.

Yabao Pharma, LFB Biomedicaments Partner to Deliver Vialebex in China Yabao Pharmaceutical Co, Inc., a leading pharmaceutical company in China, and LFB Biomedicaments, a fully-owned subsidiary of LFB SA, a French state-owned company, announced a strategic partnership to deliver LFB’s leading human albumin product Vialebex to China, which is the world’s largest human albumin market with annual growth of 29% from 2010 to 2014.

Under the terms of the agreement, Yabao receives exclusive rights to register Vialebex at the China Food and Drug Administration (CFDA) and further commercialize Vialebex in China. LFB shall exclusively supply Vialebex to Yabao using their specific expertise in bioproduction and biosafety. Financial terms were not disclosed.

“LFB’s Vialebex is a human albumin already registered and marketed in Europe and worldwide. Yabao is honoured to be collaborating with a long-established, global leader in human albumin and plasmaderived medicinal products,” commented Dr. Peng Wang, president of R&D and head of international business, Yabao Pharmaceutical Co., “This ground-breaking commercial partnership with LFB is an important sign of Yabao’s growing commitment to bringing worldclass products such as Vialebex to China. Yabao is pleased to serve the growing need for high-quality human albumin to treat patients suffering from serious diseases in China.”

Dr Philippe Gredy, MD, MSc, executive VP marketing and sales, stated, “We consider Yabao as a very valuable partner and are very pleased to have been chosen for our biopharmaceutical expertise. China is part of our strategy to grow internationally and we will do our best to serve the Chinese patients with high-quality medicinal products.”

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Effervescent Packaging Sanner GmbH offers senior-friendly closure for effervescent packaging. The new FOG 27 closure can be opened in about a third of the time and with 70 per cent less physical effort compared to conventional closures.

Together with the Brilliance Tubes from Sanner, which are decorated using in-mould labelling (IML) technology, customers receive an allin-one solution for highest convenience and attention at point-of-sale.The Brilliance Tubes offer high-quality, photorealistic printing with endless design varieties. The font size can be flexibly adapted to improve readability. Especially expressive motifs attract customers’ attention; sales messages can be conveyed without many words.

 EPP has a wide range of pultruded products from which you can select the perfect product for your industry, according to the existing conditions. Their pultruded products present a secured solution with their anti-corrosive strength. In their wide range of products, they have FRP cable trays, FRP gratings (moulded and pultruded), FRP ladders, FRP profiles, staircase with hand railings and many more. MoC FRP - polyester, vinylester, bisphinol epoxy.

They find application in electrical cable laying, instrumentation cable laying, etc. Sector served includes ports, telecom, power, chemical industries, etc.

For more information, please contact:

For more information, please contact:

Communication Harmonists GmbH & Co KG Poststraße 48 69115 Heidelberg, Germany Tel: +49 (0) 6221 18779-27 | Fax: +49 (0) 6221 18779-11 E-mail: sanner@commha.de

EPP Composites Pvt Ltd Plot No: 2646 Kranti Gate Main Road, GIDC Lodhika Kalawad Road, Metoda, Rajkot, Gujarat 360 021 Tel: 02827-287059, 287060, 287061 | Fax: 91-02827-287063 E-mail: kuwarjoshi@epp.co.in / bd@epp.co.in / vaishalijoshi@epp.co.in

 Lonza offers 4D-Nucleofector LV Unit to its transfection platforms. The new unit expands the proven 4D-Nucleofector System to closed, larger-scale transfection of up to 1x109 cells. Transfection protocols can be established in smaller scale using the 4D-Nucleofector X Unit and smoothly transferred to larger scale without the need for re-optimization.

Transfection is a powerful tool that is used to study and control gene expression by delivering DNA, RNA and even proteins into cells.

Various applications within translational research require the generation of large numbers of transiently modified cell lines or primary cells.

Such applications include modification of cells via genome editing or the generation of CAR-T cells for ex-vivo cell therapies, production of transient proteins or antibodies for construct screening and generation of disease models via genome editing for cell-based assays.

Lonza’s Nucleofector Technology is an improved electroporation technique that has transformed transfection and allowed scientists to achieve results. Unlike classical electroporation, Nucleofection delivers high efficiencies that can be achieved using much lower amounts of substrate with only a moderate impact on viability. Due to its flexibility with different substrates, such as plasmid DNA and mRNA, Nucleofector Technology is being used by renowned scientists and is helping to drive research in numerous cell types and applications, including non-viral iPSC generation via episomal vectors, as well as genome editing using various ZFN-, TALENor CRISPR-related cargo combinations.

For more information, please contact: Lonza International Scientific Support Lonza Cologne GmbH Nattermannallee 1, DE-50829 Koeln, Germany Tel: +49 221 991990 | Fax: +49 221 99199498 E-mail: marcom.lbs@lonza.com

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 Syrris offers the Titan Syringe Pump, a continuous flow chemical processing module.

Suitable for lab, pilot and production scale applications, this extremely chemically-resistant single channel pump combines powerful drive motors, clever valve design and software control to deliver ultra-smooth flow rates from 1 to 250 ml/min.

The Titan Syringe Pump is designed for safe and reliable scale-up. Carefully constructed from long-life materials, it operates effortlessly at pressures up to 20 bar and viscosities up to 1,000 cP, delivering precisely controlled flow rates for extended periods. Removable cassettes allow straightforward servicing of syringes and enable seals to be rapidly changed with minimal tools required.

A built-in backwash feature prolongs seal lifetime and maintains the cleanliness of pistons and cylinders, which also helps to prevent degradation of air-sensitive chemicals and protect users. Process safety can be further enhanced by immersing syringe cassettes in a gas blanket.

The Titan Syringe Pump can be controlled manually via the intuitive Titan Remote Display touch screen or fully automated through PC software, and it is compatible with a wide range of chemical reaction systems.

For more information, please contact: Syrris Scientific Equipment Pvt Ltd 420/421 Corporate Avenue, Sonawala Road Goregaon (E), Mumbai 400 063 Tel: 022-26864410 E-mail: info@syrris.com

 Mettler Toledo CI-Vision offers the V2622 Flex-Lite, a compact smart camera based vision solution. The V2622 offers manufacturers the ability to only take the software and cameras they need, and allows for in-house setup of the system.

These smart cameras have delivered quality results to the pharma industry and are now being brought to other industries for similar applications in package quality, code reading, and graphical identification. Some camera models include liquid lens technology, allowing for adjustments in camera focus to be made with no moving parts.

The system comes in multiple configurations ranging from a single smart camera and patch panel all the way to a two camera system with a dedicated control box and touch screen PC running Inspection Manager, a software allowing control of multiple smart cameras from a centralized interface. Manufacturers can decide which configuration works best for them, or have the vision experts at Mettler Toledo tailor a solution for them.

For more information, please contact: Mettler Toledo India Pvt Ltd Process Analytics Solutions Amar Hill Saki Vihar Road Powai, Mumbai 400 072

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Liquid Ring Vacuum Pumps



Toshniwal leader in vacuum engineering, now provide further solution to your vacuum needs in manufacturing of liquid ring vacuum pumps that offer optimum performance and reliability.

They offer minimal water consumption and an innovative impeller design that assure extremely quite operation and extending its life even under harsh condition the most advanced manufacturing process with the objective to reduce manufacturing time and shortening delivery time.

Hydrotwin a PLC-controlled roots + LRVP package for high vacuum application with total liquid re-circulation. Capacity to 3,900-m 3/hr and max vacuum 2-mbar. Hydro sys a centralized package vacuum unit with total or partial water recirculation.

Capacity to 3,500-m 3/hr and max vacuum 33-mbar.

Toshniwal is counted among the prominent manufacturers, suppliers and exporters of a wide range of roots pumping systems.

international quality standards.

Manufactured using finest quality material, their range is in adherence with

Available in a spectrum of specifications, these systems are used in distillation process, food processing, drying of powder and solids, and transformer evacuation.

For more information, please contact:

For more information, please contact:

Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net

Toshnwial Instruments (Madras) Pvt Ltd 267.Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshwnial.net

Batch Controller Fluidwell offers the new N413 batch controller with receipt printing functionality. This is useful for situations where you need a locally printed ticket as evidence of the delivered quantity like tank and truck (un)loading applications. End-of-batch tickets and reprints can easily be printed automatically or on demand. Even in the unexpected event of an uncompleted batch, it is possible to print a ticket.

The N413 is a versatile and powerful batch controller, with a printer output, 2 field replaceable, heavy duty relays and three configurable transistor outputs. Relay 1 is fixed as main batch control output. Relay 2 and the transistor outputs can be configured as pump control with time delays, 2-stage batch control, and alarm or pulse outputs. This makes the N413 a powerful and versatile batch or delivery controller.

The crystal clear LCD display, provides multiple batch control data simultaneously at a glance, including a graphical indication of the vessel, the batch process and the relay status. The bright back light is standard, ensuring perfect readings in all lighting conditions.

It saves time and cost in installation and programming. It is easy to start, stop, pause or terminate a batch or set a new preset value, especially with the numerical keypad.

Fluidwell designs and manufactures a wide range of flow computers, indicators, totalizers, transmitters, monitors and controllers.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 E-mail: sales@toshniwal.net

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22-07-2016 18:28:38

events diary   

                   

                                              

64 July 2016

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                                                                      

                                           

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bookshelf Biopharmaceutical Drug Design and Development, 2nd Edition (Hardcover) Author: Susanna Wu-Pong (Editor), Yon Rojanasakul (Editor) Price: USD 209 No of pages: 375 pages Biopharmaceutical Drug Design and Development, Second Edition, updates the widely successful first edition, published in 1999. This new, expanded edition investigates the dozens of new biopharmaceutical drugs that have become available since the publication of the first edition. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, such as bioinformatics, DNA microarrays, transgenics, therapeutic gene delivery, stem cells, nucleic acid-based therapeutics, and macromolecular drug delivery.

Authors also study pharmacogenetics in the clinic and changes in biologic drug approval at the FDA. Biopharmaceutical Drug Design and Development, Second Edition, is a worthy sequel in the discussion on the dynamic, exciting field of biotechnology.

Pharmaceutical Marketing (Paperback) Authors: Brent L Rollins, Matthew Perri Price: USD 45.62 No of pages: 282 pages Pharmaceutical Marketing will provide students and new industry professionals with a thorough overview of the general principles of marketing including marketing as a process, marketing effectives in the pharmaceutical environment, and coverage of marketing brand and generic drugs with special emphasis on direct-to-consumer advertising and the impact of social media and technology. Two unique chapters of the text are Chapter 10 Social Media, which addresses exactly what Social Media is, how it is currently being used within the industry, and how it should be used from the manufacturer’s perspective; and Chapter The New 4 P’s of Pharmaceutical Marketing takes a unique look at how the Internet and mobile technology has shaped the pharmaceutical industry and shifted the promotion paradigm to these current “P’s” - Predictive modeling/analysis, Personalization, Peer-to-peer networking and Participation.

Pharmaceutical Marketing examines the current pharmaceutical marketing environment from both an academic and practical perspective with a focus on providing practical applications of all material discussed according to the perspectives of various market segments including industry, community, and institutional pharmacy, as well as the practicing pharmacist.

Principles and Practice of Clinical Trial Medicine (Hardcover) Author: Richard Chin, Bruce Y Lee Price: USD 82.27 No of pages: 560 pages Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

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ad index                             

66  July 2016

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                            

                            

Pharma Bio World

22-07-2016 18:32:44

th R.N.I. month.

Postal R.N.I. No.: No.: MAHENG/2002/08502.

MAHENG/2002/08502. Date Date of of Publication: Publication: 26 26th of of every every month.

Postal Registration Registration No: No: MH/MR/SOUTH-284/2014-16 MH/MR/SOUTH-284/2014-16 th th Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26 th & 27 th of every month. Total Pages:- 56 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26 & 27 of every month. Total Pages:- 68