5th biosimilars congregation 2014

KEY SPEAKERS:-

Rohit Arora, Associate Director - Medical Affairs & Strategy Implementation,

Anita Krishnan, Senior Research Scientist,

Pravin Ghadge, Head-Medical Writing & Pharmacovigilance,

Debolina Partap, AVP & Head Legal,

Siddarth S. Chachad, Head - Clinical Development,

Ashwani Pandita, Head Quality Management & Training,

Chirag Trivedi, Director & Head of Clinical Study Unit,

Ashima Bhatia, Vice President Global Clinical Research & Development,

Suresh Maroli, Head Clinical Pharmacology,

Sofi Joseph, Head – Regulatory Operations,

Yasmin Shenoy, Director - Regulatory Affairs,

Milind Antani, Head - Pharma LifeSciences group,

Tej Krishen Bazaz, Director,

Sanofi

Lupin

Reliance Life Sciences

Wockhardt

Cipla

Glenmark

Sanofi

Wockhardt


Pfizer

Sanofi Aventis

Nishith Desai Associates

Thermo Fisher Scientific

Plus Many More...

Conference Hashtag - #VI_Pharma

ORGANIZED BY

ASSOCIATE PARTNER

SUPPORTED BY

5th Biosimilars Congregation 2014

10th September 2014, Kohinoor Continental Hotel, Mumbai, India

BRONZE PARTNER

CONFERENCE INTRODUCTION:-

The biosimilar industry had a tough 2013 driven by the Indian economy having to experience one of its most turbulent times. Indian bio-pharma sector deceleratedto 5.2 per cent in 2013 from an average growth of 12 percent in the previous year. Adverse policy moves like the foreign direct investment (FDI), drug pricing,clinical trials and compulsory licensing made the matters worse. An overactive US FDA hauled up several leading Indian pharma companies for non-compliance. Allthese negative developments together turned 2013 into an 'Annus Horribilis’ for the Indian bio-pharma sector. The global biosimilars market is expected to be worth$19.4 billion by 2014, growing at a Annual Growth Rate (CAGR) of 89.1% from 2009 to 2014.The American products Follow-on protein market (including NorthAmerica and Latin America) is expected to account for nearly 35.3% of the total income in 2014. By 2015, the sales of biosimilars is expected to hit USD 3.7bn, anear exponential increase from USD 378 million back in 2011.

There are currently more than 80 biosimilars under development worldwide and this market could potentially become the only fastest-growing biologics sector by2020. So, where did all this momentum come from? Why does biosimilars suddenly display an accelerated growth potential? And how have market dynamicsreceived and encouraged this growth? If Indian biopharmaceutical players are to compete effectively on the global scale and capture 10% of the global biosimilarsmarket by 2020, India’s private sector will have to invest a considerable amount of capital in building the necessary manufacturing capacity and skills base. At thesame time, the Government of India will also have to provide the necessary enabling environment. India’s biopharma sector consists primarily of monoclonalantibodies, vaccines, recombinant proteins and diagnostics, and the guidelines for biosimilars are already in place.

Almost 50 biosimilars have already reached the Indian market, and they are sold at discounts of as much as 85%, putting them within reach of the masses. Demandseems likely to grow considerably, as India becomes more affluent. US investment bank Goldman Sachs estimates that the number of Indians with annual incomesof between $6,000 and $30,000 may increase by 250-300 million during the next decade alone. The global biosimilars market has even more potential for the mostefficient Indian biosimilars manufacturers, as the market will be characterised by price competition, even when there are only a less number of rival products. It issaid, the manufacturers of branded products are likely to use second-generation products with more convenient administration schedules as a means of defendingtheir territory. Few of these manufacturers may also try to crowd out the competition by producing their own biosimilars. So the competition is likely to be intense.One of the most critical problem faced in India is the inaccessibility to healthcare. To address this issue, the government needs to not only relook at its public healthpolicy but also bring in various regulatory reforms including a smarter approval of pathway that cuts the cost of drug development to allow affordable innovations.Regulatory reforms also need to address issues related to intellectual property and also clinical trials. Use of technology for procurement and distribution will alsoenable better access to the drugs

This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.Hence, this 5th Biosimilars Congregation 2014 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinicaldevelopment, to the legal and economic aspects. This Biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliversafe, biosimilar products to the marketplace. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. Thisevent will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting Biosimilars development.

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 5th Biosimilars Congregation 2014. I wish and pray that all our efforts will bebeneficial to our industries folks at large.

WHY SHOULD YOU ATTEND:-

broader scope bringing the whole communications value chain together?dedicated networking drinks time,meet the leading international vendors

Expand your knowledge

Get more from the event, with a Enjoy and make the best outof our showcasing the products of tomorrow in the co-locatedexhibition. of the latest business models and strategies in the high-level conference. Whether you are on the brandedor generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be thefirst to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers toentry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margin

KEY THEMES DISCUSSED AT THIS SUMMIT:-

•••••••••••••••••••

Commercialization and development strategies to gain a competitive advantageCalculating possible revenue streams from biosimilar productionHow should the pharma and generics industries approach the quickly emerging and developing biosimilar market?What is the future of next generation Biosimilars?The commercial challenges and opportunities to develop BiosimilarsThe growing importance of biobetters over biosimilarsGain in-depth knowledge on role of technology transfer - How does this affect market access?How do policy makers shaping the contours of this new generic frontier, what implications they have for present biologic drug development & patent protection?Next generation monoclonal antibody development and clinical challenges faced with biosimilar drug developmentTechnical case study for analytical and clinical comparability strategiesThe Legal/IP for BiosimlarsHow to maximise strategic partnerships to enter into the biosimlar marketNew frontiers in cell line development and opportunities in biosimilarsHow to reach the target audience more effectively and quickly.Evaluating the key criteria that has to be considered to gain speedy entry into Biosimilar marketHow global pharmaceutical market is turning to be more specialized & precise?Identifying the experience on follow on biologics, generics and biosimilars has been so farGain up to date insight about the regulatory landscape and how it is effecting the industryBoost your industry knowledge and relationships by networking and learning from key industry and academic leaders

WHO SHOULD ATTEND:-

CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:Biopharmaceuticals/ Biotherapeutics, Follow on Biologics/Follow on Proteins, Biologics/Biotechnology/ Biogenerics, Legal Affairs, IntellectualProperty, Health Economics, Pricing and Reimbursement, Clinical Immunology, Principal Scientist, Chief Scientific Officer, Process Control andAnalytical Technologies, Analytical Characterisation, Regulatory Compliance, Pharmacovigilance, Drug Safety & Risk Management, Quality Affairs/Quality Control, New Product Development, Process Science, Portfolio Management, Research & Development, Business Development, BusinessOperations, Scientific Affairs, Commercial Affairs



11:40 – Substitution And Interchangeability Of Biosimilars AndBiologics

• Regulatory aspects of interchangeability in biologics, includingbiosimilars

• Issues with regard to substitution in the case of multiplebiosimilars

• Clinical aspects of substitution in biosimilars• How will you demonstrate the higher standards of

interchangeabiity?

08:30 – Coffee and registration

09:30 – Morning Chair’s opening remarks

09:40 – Similarity in Biosimilars

10:10 – Strategic Choices ForBiobetters And Biosimilars

10:40 – Morning Coffee/Tea & Networking

• The need for similarity in analytical, biological and preclinicalaspects

• The challenges faced in achieving similarity• Steps in assessing similarity• Case study of a failed technology transfer for a biosimilar product

• Today’s biosimilar market and expectations for the future• Commercial attractiveness for Antibody Drug Conjugate• Antibody Drugs Conjugates – developing the therapeutic windows• Leveraging the biosimilar development expertise into biobetters

Morning Keynote Address 1:

Morning Keynote Address 2:

Afternoon Chair’s person

14:00 – The Science and Business of Reference Standards

14:30 – Safety Evaluation in Biosimilars

15:00 – Afternoon Coffee/Tea & Networking

15:20 – Evaluating the potential revenue streams achievablefrom biosimilar production

15:50 – Updates on current regulatory landscape

• Investing on Biosimilar: what to expect for a return on investment(ROI)

• Profit margins in production of biosimilar• Presentation of a biosimilar sales forecast from a manufacturing

view• Evaluation of biosimilar in unit floor prices in a hyper-competitive

market


Pravin Ghadge, Head - Medical Writing & Pharmacovigilance,

Rohit Arora, Associate Director - Medical Affairs & StrategyImplementation,

Lupin


Sanofi

(http://www.linkedin.com/pub/anita-krishnan/11/bb9/28)

(http://www.linkedin.com/pub/dr-pravin-ghadge-

md/15/835/1a4)

(http://www.linkedin.com/in/drrohitarora)

MARKET ANALYSIS

CHALLENGES & OPPORTUNITIES

12:10 - Panel Discussion: Strategies to Improve Sponsor, Site,and CRO

Moderator:

Panellists:

• Overview of recent trends in clinical research• Cultural considerations for a successful partnering• Effective biosimilars clinical study designs for india• Identifying the role of each stakeholder

Chirag Trivedi, Director & Head of Clinical Study Unit,

Tej Krishen Bazaz, Director,

Ashima Bhatia, Vice President Global Clinical Research &Development,

Ashwani Pandita, Head Quality Management & Training,

Sanofi

Thermo Fisher Scientific

Wockhardt

Glenmark

(http://www.linkedin.com/pub/dr-chirag-trivedi/21/b0/344)

(http://www.linkedin.com/pub/dr-tej-krishen-bazaz/17/776/612)

(http://www.linkedin.com/pub/dr-ashima-

bhatia-md/15/945/728)

(http://www.linkedin.com/pub/ashwani-pandita-rqap-

REGULATORY



11:00 – Panel Discussion: Challenges And Opportunities ForBiosimilars In Emerging Markets

Moderator:

Panellists:

• Market size of biosimilars in the emerging market• Selling of biosimilars in the emerging markets having government

protectionism• Competition concentration of biosimilars in the emerging market• Emerging markets that are highly attractive for biosimilars in india

Siddarth S. Chachad, Head - Clinical Development,


Suresh Maroli, Head Clinical Pharmacology,

Cipla

Lupin

Reliance LifeSciences

(http://www.linkedin.com/pub/anita-krishnan/11/bb9/28)

12:50 - Networking - Take your discussionsfurther & build new relationships in a relaxed

& informal setting...

luncheon

17:00 – Chairperson’s closing remarks and end of conference

17:10 - 18:00 Networking Drinks - Take your discussionsfurther & build new relationships in a relaxed

& informal setting...

16:20 – Panel Discussion: Regulatory Updates andDevelopment

Moderator:

Panellists:

• Clinical approvals for biosimilars• Regulatory differences between the DCGI, FDA, EMA and local

agencies in india and other emerging markets such as china & SEA• How to demonstrate the process consistency and its requirements• Updates on Biosimilars guidelines in indian market• Regulatory demand for demonstrating biosimilarity

Debolina Partap, AVP & Head Legal,

Milind Antani, Head-Pharma LifeSciences group,

Yasmin Shenoy, Director-Regulatory Affairs,

Sofi Joseph, Head–Regulatory Operations,

Wockhardt

Nishith DesaiAssociates

Sanofi Aventis

Pfizer

(http://www.linkedin.com/pub/debolina-partap/1b/388/424)

(http://www.linkedin.com/pub/milind-antani/2/69a/5b5)

(http://www.linkedin.com/pub/sofi-joseph/12/307/632)



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