"China vs India: Who Will Rule Emerging Pharma”

“A One-Day Seminar with Networking on How China and India are the SAME But  DIFFERENT in Leading the Global Pharma Shift Towards Emerging Regions"

Venue:   Pines Manor, Edison- New Jersey
Address : 2085 Route 27 (Lincoln Highway) Edison, NJ 08817
Date:   July 28th , 2010, 8:30am - 5:30pm
Price: $ 399 per attendee early bird Registration until July16th, $ 459 thereafter – includes Conference Materials, Continental Breakfast, Lunch, Breaks and Networking with your peers and our experts.


08:30 a.m - 09:45 a.m :
   Registration-Continental Breakfast-Networking
09:45 a.m :
   Opening Remarks/Welcome/House Keeping - Mr. Ram Balani,   CEO/Founder  FDASmart Inc.
Session 1:
“Challenges and Opportunities for China and India based Pharma Companies in Regulated Markets (US)”
10:00 a.m -11:00 a.m :
  Lee Kang - Director of Asia Pacific Quality Operations, Perrigo Company
Description :
“China and India both have a large pool of educated and appropriately qualified talent with the ability to run manufacturing plants with some companies matching Western complexity and quality. Though China is renowned for its excellent manufacturing infrastructure, it has weaker (Western style) management that affect quality compliance. On the other hand, while India lacks infrastructure, it makes up this disadvantage with its better record of having the most number of US FDA approved manufacturing plants outside the US.

In this session, Lee Kang will present the strategic forces that are shaping outsourcing decisions for US pharmaceutical companies with products destined for US markets.

Companies need to balance a number of factors, ranging from the forces that are affecting current and future pharmaceutical business models to the opportunities and constraints posed by the dynamics of growth, convergence and divergence at work in the Asia region. Lee will look at how outsourcing in Asia is moving up the value chain, and explore challenges and opportunities posed by China versus India “ Much of the historical impetus for manufacturing outsourcing comes from the economic development gap between Asia and developed pharmaceutical markets like the US as manifested in lower wages and other costs. On the other hand, the gap in regulatory and supply chain quality standards between with China / India and the West has discouraged companies to outsource in the past. Today in India and China, there is a closing of these gaps between East and West with a consequent impact on the cost benefit of outsourcing different parts of the value chain but not without continuing challenges.”

Speaker Background :
Lee Kang is currently Director Asia Pacific Quality Operations of the Perrigo Company. He has held positions in Pharmaceutical R&D (both API and finished products), Regulatory Affairs, and Quality Assurance. Lee has 18 years of direct and managerial experiences in various CMC (Chemistry Manufacturing, and Controls) functions to support global clinical trials and market launches.
Lee has worked in Bristol-Myers Squibb, Wyeth (now Pfizer), and Sanofi Aventis Pharmaceutical Companies in various CMC roles with increasing responsibility. He has been an adjunct visiting professor in School of Pharmacy, State University of New York at Buffalo, New York. Lee received his Ph.D. from the Virginia Polytechnic Institute and State University, Blacksburg, Virginia, and M.B.A. from the State University of New York at Buffalo, Buffalo, New York
Session 2: “Preserving Market Exclusivity: Job 1 for  Big Pharma Globalization”
11:00 a.m - 12:00 p.m :
  Patrick Higgins
Description :
China and India both have an enormous wealth of scientific  talent and development capabilities in the drug-discovery industry but present different challenges to Big Pharma.

Big Pharma seeks small molecule compounds and biopharmaceuticals, at a premium, to fill necessary product development pipelines.  Numerous targets are evaluated in great detail before an exclusive licensing deal or outright acquisition is consummated. 

This session will explore common and varying criteria used by Big Pharma when
shopping for molecules to acquire from companies including those in China or

This session will cover  market exclusivity  as the driving force as well as cover  Strategic Patent Exclusivity, Species, Series, Structural Genera, Compositions,  Methods of use, Dosage and Administration. Also covered will be Relevant Scope, Term, Jurisdiction, Ownership, Validity and Enforceability, Freedom to Operate, Third party Agreements.

 Regardless of China or India – candidate companies need to meet certain
 criteria including:
(AS) Entity needs to occupy a therapeutic niche supplementary/complementary to the the suitor’s therapeutic portfolio; (B) Have an annual prospective market for that entity of at least $200M; and ( C) Have  a credible prospect and likelihood of FDA approval
Speaker Background :
Patrick Higgins' work closely involves building and preserving market exclusivity in the Pharmaceutical industry. His practice focuses on identifying and evaluating discovery assets toward developing, maintaining and enforcing exclusivity employing patent law and FDA regulatory tools.
His practice closely monitors relevant drug substance facts, freedom to operate, IP exclusivity, relevant scope, term, jurisdiction, ownership, validity, enforceability, regulatory issues, as well as the evaluation and control of risk and antitrust exposure in ANDA, litigation, for example.

Prior to joining Eckert Seamans, Patrick was a partner at an international law firm in Princeton. Before that he served as senior patent counsel for a major pharmaceutical company, where he was responsible for strategic portfolio development, risk evaluation and due diligence matters. Before entering law school, he worked as a research scientist at a major
12:00 p.m - 01:00 p.m :
  Lunch /Networking
Session 3:
“China v. India – Regulatory Barriers and Opportunities”
01:00 p.m - 02:00 p.m :
  Jane Earley
Description :
Jane Earley will describe the comparative regulatory environments of China, now engaged in its own health care reform, and India, where regulatory requirements and a new interest in technology have been emerging rapidly.

What implications do these markets have for innovation, investment and business development, and how should they be compared in terms of market entry and transparency?

 More specifically, what do growth trends portend in terms of sector-specific  investment, and what kinds of innovative technology will find hospitable environments

Speaker Background :
Jane Earley is an attorney with 20 years of experience working with new technologies in the biotechnology, biofuels and other innovative sectors. She directs the Health Team of the International Trade Administration’s Office of Health and Consumer Goods, a U.S. Department of Commerce office focused on expanding exports and eliminating market access barriers in the pharmaceutical, biotechnology and medical device sectors.
ITA leads bilateral discussions with China and India on regulatory issues affecting market access and introduction of new technologies in the medical products sector, from intellectual property protection to health information technology.   Jane has worked in both the public and the private sectors, most recently as a partner in Earley& White Consulting, LLC, and as a trade negotiator with the Office of the United States Trade Representative. She received a B.S. from the University of California at Berkeley, and a J.D. from the University of Maine School of Law.
Session 4: "Development Globalization and India: Filtering Reality from the Hype"
02:00 p.m -03:00 p.m :
  Dan McDonald - Excel Life Sciences
Description :
With the globalization of drug development, the clinical trials industry has reached an exciting yet critical crossroads in which success or failure can depend on your knowledge of the various markets and how to survive in them.

India is anything but SIMPLE.

Outsourcing clinical trials to India has its challenges and pitfalls if not done right. Growing in importance is the need to develop strong relationships, especially with hospitals, service providers and other stakeholders. It is also critical to make general and public contributions to the growth of a healthy and successful clinical research enterprise in that region.
This unique session will discuss some of the big picture elements, as well as critical intricacies for consideration when deciding to operate in an exciting market such as India.
 Unique new data regarding clinical research trends from each area will be shared, as well as the benefits and challenges of each. In-depth case studies from India will be shared, including success stories and pitfalls. The session will also include unique new survey data regarding the sponsor companies operating in these regions.
Speaker Background :
Dan McDonald is VP, Business Strategy at Excel Life Sciences. With over 12 years of industry experience working with biopharmaceutical companies to assist them with their global clinical research strategies, patient recruitment and site selection, Dan understands the different challenges the industry is facing and the dynamics that are rapidly expanding its reach across the globe.
03:00 p.m - 03:30 p.m :
  Coffee Break/Networking
Session 5:
“China vs. India: How To Assess The Better Partnering Relationship “
03:30 p.m - 04:10 p.m :
  Mark Rovner - SmartAnalyst
Description :
Pharmaceutical companies recognize the economic value of expanding their presence and their drugs into emerging markets as they are constrained by competitive, pricing and loss of patent exclusivity in developed markets.

While emerging new markets are very attractive and represent exciting new avenues of growth, they have particular challenges in terms of developing appropriate entry strategies and finding and working with the right partner.

As a global advisor to major pharmaceutical companies, SmartAnalyst has developed a checklist of how to evaluate markets and partners and to develop appropriate entry strategies based on a company’s given product portfolio. This checklist and presentation involves approaches to:
  • Understanding therapeutic area/disease and drug issues in specific markets
  • Partner Identification - Analyzing the local market structure and identifying the best partners
  • Communications - Realizing potential communication issues and defining the learning curve in terms of establishing an effective alliance
  • Building strong relationships with partners in emerging markets and attracting strong local talent
  • The presentation will be supported by highlights from the checklist and supported by examples of real work done.  
Speaker Background :
Marc Rovner is Managing Director, SmartAnalyst, a consumer healthcare and life science strategic analysis firm. He was formerly the Vice President of Global New Markets for Johnson & Johnson. He has gone into challenging business situations in the US, Europe and Asia, and achieved successes in Fortune 100 companies (J&J, Pfizer, Unilever, and International Paper) and in entrepreneurial enterprises (Reckitt Benckiser, Renaissance Cosmetics).  
He built an $800mm new products pipeline for Pfizer and freshened every mouth in America with Listerine Pocketpaks. Marc provides pro bono consulting to the American Diabetes Association and to the Oscar Kalb Foundation, a private group that sponsors Save the Children. He earned a BA from the University of Pennsylvania and an MA from the University of Chicago, maintains an intimidating reading list and sometimes catches fishes when he is on lakes and streams. 
Session 6:
Panel Session: “China vs India –  Emerging Biopharma Competitors or Allies”?
04:10 p.m - 05:10 p.m :
Session Topics :
1 - Biopharma R & D – China vs India
2 - IP (Intellectual Property/Patents) – China vs India
3 - Outsourcing – China vs India
4 - Manufacturing & Supply Chain – China vs India
5 - Emerging Domestic Markets - China vs India 
05:10 p.m - 06:00 p.m :
 Post Event  Networking


For more information contact Ram Balani at 516-515-9642 or email at rbalani@fdasmart.com