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

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.

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 India.

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:
(A) 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

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 company where he was awarded the Global Director of Research Award.

We have  heard this many times by now:
  “China and India are moving up the pharma/biotech value chain.”

Truth be told—this sounds like a cliché to most  of us until one digs deeper and  discovers that indeed, in China, great strides and progress are being made which  a few years back would not have been possible.

In this session where Larry Wang  takes a  deep-dive into antibody therapeutics and mAb development , you will hear and learn how one US based company, GenScript in New Jersey , is leveraging China’s scientific talent pool,  American VC capital and good old Asian immigrant know-how to prove this  to be TRUE.

Larry Wang, President  and Co-founder of GenScript will describe  how is company is leveraging West-East strategic advantages to help drive China’s pharma prowess up the innovation ladder. In the past, we have seen limited outsourcing in discovery biology, namely target identification and assay screening and development, largely due to intellectual property related issues. As China/India CROs become more mature in IP protection, more biology-related work are being outsourced to China/India.

Larry’s  talk will discuss some of GenScript’s   state-of the-art antibody drug development outsourcing capabilities  at   the GenScript owned captive facilities in China making good on the promise from “Made in China” to “Discovered in China”

Dr. Larry Wang is the co-founder and President of GenScript, a biology CRO company based in New Jersey, USA with manufacturing sites in Nanjing, China.  The CRO service of GenScript is focused on early drug discovery.  GenScript provides services ranging from molecular biology, protein expression, peptide synthesis, antibody production, assay development to antibody drug development.

Prior to GenScript, Dr. Larry Wang worked as a Senior Principal Scientist in Bioinformatics Group of Schering-Plough from 1996 to 2002. He is one of the key inventors on the target discovery work for Zetia, which advances the understanding of intestinal cholesterol pathway. His scientific achievement has been recognized with a presidential award by Schering-Plough, and Gallo Award from Cancer Research Institute of New Jersey.
Prior to Schering-Plough, Dr. Larry Wang got his Ph. D. from Rutgers University in 1996, and his BS degree in Biochemistry from Shandong University, China in 1991.
Dr. Larry Wang has over 20 publications in leading scientific journals.

More and more pharmaceutical and biotechnology companies in the USA are outsourcing their Research & Development (R&D), including pre-clinical pharmacology & Toxicology, clinical research, and Manufacturing to offshore locations in Asia such as India and China. India is considered to be particularly important because of long standing historical awareness of FDA regulatory requirements, reasonable cost and the wide range of contract research & manufacturing organizations in that country.

This presentation will discuss some of the key features focusing on the drug development outsourcing. Furthermore, some of the hurdles of offshore outsourcing and ways to mitigate such hurdles to bridge the gap between expectation and actual deliverables... 

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.

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.

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:

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).