CONFERENCE DAY ONE – TUESDAY 27 MARCH 2012 |
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| 08.30 |
Registration and refreshments |
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| 09:00 |
Opening remarks from the Chair |
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REGULATORY SCENARIO |
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| 09:10 |
Clarifying the latest Indian biosimilars regulatory guidelines
to remove ambiguity and fast track the development of
biosimilars in India |
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- Understanding the current Indian regulatory position and clarifying the
approval and registration process for biosimilars
- Determining the regulatory requirements for pre-clinical and clinical trials
including in-vitro and in-vivo studies
- Evaluating the regulatory protocols to establish effective comparability studies
for successful development of biosimilars
- Determining the export guidelines to gain speedy entry into international
markets
- Outlining the government’s incentive plans to encourage the development of
biosimilars in India
- Examining the government’s perspective on the future direction of the Indian
biosimilars market
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V.P. Kamboj,
Former Director, CDRI, Lucknow
Former Chairman, BIBCOL,
Bulandshahr
Former President, The National Academy of Sciences, India, INSA
Honorary Scientist, Biotech Park, Lucknow |
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Bobby George,
Assistant Vice President and Head, Regulatory Affairs
Reliance Life Sciences |
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| 09:40 |
Devising robust approaches to overcome complexities in
biosimilars to develop a global biosimilars programme |
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- Determining the range of complexities for biosimilars and understanding
specification setting for biosimilars
- Assessing the reference product selection process for the development of
successful biosimilars programme
- Understanding the critical issues in clinical trials to meet the expectations of
regulators from different countries
- Evaluating different interchangeability and switchability issues to develop a
global biosimilars programme
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Sriram Akundi,
Associate Vice President, Quality and Regulatory
Biocon |
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| MARKET OPPORTUNITIES |
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| 10:10 |
Comparing the future potential of biosimilars in India with
other emerging markets such as China, South Korea, Asia
Pacific, South East Asia, Middle East and Thailand to capitalise
on biosimilar opportunities |
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- Overview of biologic regulations in international markets such as China,
South Korea, Asia Pacific, South East Asia, Middle East and Thailand
- Identifying the key drivers and resistors in these markets to increase the
potential of biosimilars
- Examining key biosimilars in the market and in the pipeline to identify new
uses and opportunities
- Identifying key biosimilars players in these markets and predicting the next
steps and opportunities for long term sustainability of Indian biosimilars
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Ajit Mahadevan,
Partner Life Sciences Practice
Ernst & Young |
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KV Anantharaman,
Principal Analyst, Healthcare, Research and Analysis
Datamonitor |
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| 10:50 |
Corporate address by PPD |
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| 11:00 |
Morning refreshments and networking |
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| COMMERCIALISATION OF BIOSIMILARS
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| 11:10 |
PANEL DISCUSSION: |
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Developing practical strategies to overcome commercialisation
challenges related to the development of biosimilars in
semi-regulated markets like India and regulated markets like
the us and europe |
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While a lot has been said about science and regulatory hurdles with biosimilars, the ultimate
truth is the market opportunity and the "Billion $" question is what kind of market shares can
one anticipate ? Given that emerging and developed markets are unique, the challenges are
quite different in respective markets. Hear from people who have been there and done that.... |
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- Reviewing the current commercialisation strategies of the various companies to enter
markets like India, US and Europe and lessons learn from them
- Overcoming barriers to market entry and ensuring rapid take up of the products in these
markets
- Forecasting the effects of frequently changing market and regulatory environments in
these and how it can be used in our advantage
- Formulating practical and robust strategies to increase the market penetration and
strengthen the future development of Indian biosimilars products
- Examining real-life case studies and lessons learnt from them to leverage the business
potential of Indian biosimilars
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Moderator:
Hareesh Parandhaman,
Assistant Director Business Development
Lupin Pharmaceuticals |
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Ritha Chandrachud,
Senior Vice President
Dr Reddy’s Laboratories |
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Purvish M Parikh,
Managing Trustee
Indian co-operative Oncology Network |
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Paul Thomas,
General Manager,
Business Strategy and Program
Management, Biosimilar mAbs
Biocon |
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| 12.20 |
Applying the next generation chemically defined supplements to effectively develop media for production of biopharmaceuticals |
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- Understanding the next generation chemically defined and animal -free supplementation for the biopharmaceuticals production
- Evaluating the various application of the chemically defined supplements in media development
- Assessing improved lot-to-lot consistency and cost-in use analysis
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Matthias Brand,
Market Development Manager Advanced Bioprocessing
BD Biosciences, Singapore |
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| 13:00 |
Corporate Address by |
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| 13:10 |
Lunch and networking |
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| 14:10 |
ROUNDTABLE DISCUSSIONS: |
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During this session the group will split into a number of smaller discussion groups, each focused on a specific theme arising from the day's presentations, and led by one of the speakers of the day. This is the perfect opportunity for delegates to bring their live challenges to the table, and benefit from the combined experiences and know-how of the roundtable leaders as well as fellow delegates. Come armed with your most challenging questions and leave with a toolkit of practical implementable solutions. |
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| 15:00 |
Identifying and securing attractive sources of investment to
drive biosimilar projects in India |
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- Understanding the current regulatory framework for domestic and
international investments to drive biosimilar projects
- Evaluating the various incentive schemes to maximise the R&D developments
of biosimilars in India
- Determining the pros and cons of various funding options available today
and currently in development
- Exploring the risks associated with funding biosimilar projects and identifying
ways to protect the interest of investors and biopharma companies
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Purnima Sharma,
Managing Director
Biotech Consortium India Limited (BCIL) |
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| CHARACTERISATION CHALLENGES |
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| 15:30 |
Understanding characterisation guidelines in us, europe and
India for effective development of biosimilars |
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- Pinpointing the present definition and characterisation guideline status in US,
Europe and India
- Evaluating various kinds of analytical tests required for characterisation of
biosimilars
- Overcoming challenges for the effective development of biosimilars when the
following tests are performed on:
- Peptides
- Glycated Proteins
- Non-Glycated Proteins
- Monoclonal Antibodies
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Ranjan Mogre,
Director
Analytical Solutions |
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| 16:30 |
Corporate address by GE Healthcare Life Sciences |
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| 16:30 |
Establishing robust approaches to overcome analytical
challenges in the development of biosimilar drugs |
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- Determining techniques for method readiness to establish effective process
development
- Developing analytical method considerations for comparability exercises
- Establishing various methods for effective characterisation of biosimilars
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Mahesh Bhalgat,
Vice President
Biological E |
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| TOOLS AND TECHNIQUES |
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| 17:10 |
Applying fundamentals of process analytical technology
(pat) in bioprocessing to effectively design and control the
manufacturing process |
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- Navigating the principles of PAT and requirements for using PAT in your
manufacturing process
- Leveraging the usage of PAT and how it can be used in the QBD paradigm
- Determining the advantages of PAT to improve the quality of your biosimilars
product
- Case studies involving usage of PAT
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Anurag S. Rathore,
Consultant
Biotech CMC Issue
Professor
Department of
Chemical Engineering, Indian Institute of Technology, Delhi |
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| 17:50 |
Close of conference day one |
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