Clinical Research India 2008 Agenda

Preconference Workshop — Sept. 23
Navigating the Waters of the Clinical Trials Application Process in India
Ira Gupta, M.D., Director, Clinical Development, Oncology Medicine Development Center, GlaxoSmithKline
Vijai Kumar, M.D., President and Chief Medical Officer, Excel Life Sciences, Inc.
Michael Eckstein, President, Topaz Clinical Services

This full-day workshop is the perfect primer to outsourcing your clinical trials to India. The process is drastically different than what you know in North America.  This day of study will be well spent as you learn:

  • What to expect when submitting your application to the Drugs Controller General of India office
  • Timing of application process
  • What types of trials are accepted and applicable in India

Day 1 — Sept. 24
9:00 a.m. – 9:30 a.m.
Conducting Clinical Trials in India: Potential and Pitfalls
Falguni Sen, PhD, Professor of Management, Fordham University and Pharmaceutical Industry Consultant

Clinical research is growing at an exponential rate in India. This session will kick off the conference by exploring some of the nuances of conducting clinical trials in India. A discussion of limitations will provide a cautionary look into the realities of the market and provide suggestions on reducing the risks. Keynote speaker Falguni Sen is an expert on this topic and has worked closely with India's regulatory bodies and other stakeholders to help develop informed legislation and procedures.

9:30 a.m. – 10:15 a.m.
Does India Have the Bandwidth and Qualifications to Effectively Conduct Your Clinical Trials? What You Need to Know to Move Forward
Vijai Kumar, MD, President and Chief Medical Officer, Excel Life Sciences, Inc.

This valuable “how-to” session will highlight the array of issues to examine when considering India as a clinical research resource. An overview of culture, population, epidemiology, medical community, infrastructure and regulatory landscape will be covered.

10:15 a.m. – 11:15 a.m.
Critical Business Issues Roundtable Discussions: Building a Solid Framework to Tackle Your Questions About India
Susan Kling Finston, President, Finston Consulting, LLC
Diana Anderson, PhD, President & CEO, D. Anderson & Company
Dinkar Saran, Principal, PRTM Management Consultants

The goal of each roundtable discussion is to provide you with new, practical information that will enable you to better manage your clinical research initiatives for India. In a fast-paced roundtable discussion format, you will bring together knowledge, ideas and proven methods for evaluating, entering and succeeding in India. Industry leaders will facilitate these empowering roundtable discussions. 

NOTE: More facilitators coming soon!

11:15 a.m. – 11:45 a.m.
Networking Break

11:45 a.m. – 12:30 p.m.
Evaluating Key Emerging Markets for Improved Strategy: Regulations, Growth Trends, Leaders and Challenges Panel Discussion
Mak Jawadekar, Ph.D., Director, WWPPM, Pfizer Global R&D

India is only one of several emerging markets experiencing rapid growth because of increased initiatives from clinical research sponsors. Central and Eastern Europe, Latin America and China are also becoming top destinations for sponsors looking to speed the drug development process and reduce costs. This panel discussion aims to evaluate the evolution of each market with questions such as:

  • Which emerging markets are hottest today?
  • Which markets are next?
  • What makes each market unique?
  • How do markets compare?
  • What are the challenges and risks of each market?
  • Who is operating in each market?
  • And more!

12:30 p.m. – 2:00 p.m.
Benchmarking Your Knowledge of India - An Interactive Luncheon

Find out what you really know versus what is a misperception about India through an interactive game, designed to demystify this critical market. Put yourself to the test — it could make all the difference to your success!

2:00 p.m. – 2:45 p.m.
What is the FDA’s Perspective and Expectations on U.S. Companies Conducting Research in India?
Wayne Pines, President of Regulatory Services and Healthcare, APCO Worldwide

None of this information matters if the FDA has issues with U.S. companies conducting clinical research in India. This critical session will delve into navigating the regulatory environment in the U.S. and how to weave this knowledge into your strategy.

2:45 p.m. – 3:00 p.m.
Networking Break

3:00 p.m. – 3:45 p.m.
Sponsor Real-World Case Study I
Eddy Anglade, M.D., Chief Medical Officer, Lux Biosciences, Inc.

Instead of theorizing about what is likely to enter the India market, learn from a sponsor who has gone through the paces and can report on the rewards and challenges of outsourcing clinical research to India.

3:45 p.m. – 4:30 p.m.
Inside India Sites — Surprising Facts You Need to Know
Saurendra Das, M.D., Country Head and Director of Operations, Excel Life Sciences

Learn unexpected details about how equipped India really is to handle your clinical studies. This explorative session takes you on a tour of sites in India, including video footage, photos, interviews and common perceptions. Get a first-hand look at how sites operate and excel in this dynamic and fascinating market.

5:30 p.m. – 7:30 p.m.
Networking Reception

 

Day 2 — Sept. 25

9:00 a.m. – 9:45 a.m.
Understanding the Patient and Cultural Considerations for Conducting Studies in India … NEW DATA REVEALED from an informed consent survey of India patients!
Dan McDonald, Vice President, Business Strategy, Excel Life Sciences

Responsible conduct of research is on everyone’s mind, especially when considering a naïve patient population of study volunteers. Media have reported on patient exploitation and improper consenting practices as a challenge. Balance skepticism and oversight through knowledge of the patient pool by comparing and contrasting characteristics of both North American and Indian patient populations. New data will be presented from a survey of Indian patients who participated in clinical trials.

9:45 a.m. – 10:45 a.m.
Global Studies and Emerging Markets — Considerations for Success: Sponsor Case Study II
Jennifer Carothers, MBA, ScD, Associate Director, Clinical Management,
Ortho-McNeil Janssen Scientific Affairs, LLC

Learn from a sponsor who has the experience and insight into conducting clinical research in an emerging market such as India. The dynamics of clinical research will be discussed along with a winning model for success.

10:45 a.m. – 11:00 a.m.
Networking Break

11:00 a.m. – 12:15 p.m.
Avoiding Mistakes in Selecting an Outsourcing Partner to Conduct Clinical Trials
Dinkar Saran, Principal, PRTM Management Consultants

India presents a range of opportunities, and with opportunities come opportunists. Cut through they hype and learn how to evaluate service providers to avoid choosing the wrong one. India is a host to reputable, reliable suppliers. This talk will provide tips on what to look for in order to make the right decision and avoid major, costly mistakes.

12:15 p.m. – 1:00 p.m.
Understanding the Impact of Increased Regulatory Oversight on Clinical Trials in India
Linda Horton, Partner, Hogan & Hartson, LLP

Now that you have learned how to enter into this rapidly growing clinical research market, what considerations are you making about the patients and your study outcomes to achieve success? India provides an abundance of opportunity and cost savings, but it is not a good fit for all therapeutic categories. Through an understanding of the epidemiologic profile, you will gain knowledge of whether or not India is right for your studies.

  • What U.S. and EU requirements affect trials outside their borders?
  • The U.S. DHHS Office of Human Research Protections (OHRP) has gone global--what impact in India?
  • Sponsors are encountering denials and delays in marketing approval applications--what implications for trials?
  • Sponsors can choose whether outside-the-U.S. sites are under INDs -- what factors influence choice?
  • Sponsors want to reduce risks of non-compliance, safety problems, and unreliable data in trials--how?

1:00 p.m.
Main conference conclusion

1:00 p.m. – 5:00 p.m.
Postconference Workshop
Understanding India's Regulatory Bodies Governing Clinical Research
Sandeep Athalye
, M.D., Director, Translational Medicine, Exploratory Development, Novartis Pharmaceuticals Corp

One of the most important, yet confusing elements to conducting clinical research in India is making sense of the ever-changing regulations. This workshop will help you understand:

  • What regulatory bodies exist in India
  • How to begin the application process
  • Where to turn when something goes wrong
  • The ways the U.S. FDA interrelates to India’s regulatory system