PRE-CONFERENCE TUTORIAL:

This session, led by Greg Kalbaugh and Mak Jawadekar, Ph.D. will assess the impact of these changes.

• What is the current state of IP protection in China and India? Will your IP be adequately protected?

• How is this likely to evolve in the future?

• How should this impact your investment decisions when deciding whether to conduct clinical trials, introduce new products or conduct R&D in China and India?

• How can you leverage the present environment to ensure the greatest protection for your IP?

• Interactive Q&A with audience

	Gregory E. Kalbaugh, Director and Counsel for Intellectual Property, Trade and Labor, US-India Business Council, US Chamber of Commerce
	Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D
	Gregg C. Benson, Assistant General Counsel - Intellectual Property, Pfizer Inc.

11:00 – 11:05 Chairpersons' Introduction
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series, Cambridge Healthtech Institute

Joel S. Marcus, Chief Executive Officer, Alexandria Real Estate Equities, Inc.

KEYNOTE PRESENTATIONS:

12:45 – 2:15 Hosted Luncheon (Sponsorship Available) or Lunch on your own

Special Presentation
How to Create Win-Win Situations with Academic Centers in China and Taiwan

Michael N. Liebman, Ph.D., Executive Director, Windber Research Institute

Significant opportunities exist within China and Taiwan for development of research and development facilities in both China and Taiwan, but issues exist because of regulatory and cultural perspectives that need to be considered in both the planning and execution of such activities, especially as they may differ amongst molecular, clinical and computational research areas.

• How to evaluate risk vs. opportunity in each of the three areas: molecular research, clinical research and computational research

• How to explore partnerships to facilitate success in working in China and Taiwan

• How to manage US vs. international regulatory issues in working in China and Taiwan

Special Presentation
Identifying the Right Partner to Conduct GLP Safety Studies

Ernie Bush, Ph.D., Vice President & Scientific Director, Cambridge Healthtech Associates, former Senior Director, Preclinical Safety, F. Hoffman-La Roche

Preclinical toxicology-safety assessment is a mandatory requirement by global regulatory agencies before new experimental medicines could be tested in humans. The data from preclinical safety studies are used to guide the selection of the starting human dose and a potential maximal dose with an overall plan for safety monitoring. Because of the critical importance of preclinical safety studies in human risk assessment, it is imperative that these studies follow regulations pertaining to ethical use and treatment of laboratory animals and follow Good Practice Regulations (GLP). This session will discuss:

• Animal health and welfare requirements and certifications

• Preclinical toxicology GLP requirements

• Education and experience of the staff

• Confidentiality of studies and data and IP challenges

• High quality study reports

Special Presentation
Short and Long Term Strategic Planning for Clinical Development Operations in Emerging Regions

At this point, clinical development activities in emerging regions are chiefly focused on the trial operations aspects of drug development. One strategy for successful execution of trials in emerging countries includes the initial establishment of a core regional management office manned by clinical trial operations/logistics experts charged with the coordination of site management activities at a limited number of experienced clinical sites in the major markets in the region. After establishing procedures and training to ensure compliance and quality, trial operations groups then gain experience in regional issues related to regulatory submissions (clinical trial applications), drug supply, distribution and storage, site contracting, clinical laboratory, blood/tissue sampling and analysis, safety reporting, etc.

• Utilizing local data to mutually support global and regional applications, while minimizing the need for regional or local clinical trials

• What early discussions with regional regulatory authorities are necessary?

• What is the optimal organizational structure for CDO in the region?
  

How to Build a Shared Risk/ Shared Reward Drug Discovery Collaboration

Steve Bjornson, MBA, Associate Director, Discovery Research Strategy, Wyeth Pharmaceuticals

In an era of intense financial pressures for pharmaceutical companies, Discovery Research organizations must rethink how they approach collaboration. Partnering with external researchers remains a key means of accessing novel innovation and enhancing the early stage pipeline. However, the model of simply paying an Academic to perform research with little/no direct interaction along the way is no longer feasible. Discovery organizations and their respective partners must learn to craft Shared Risk / Shared Reward partnerships.

• How to engage partners and get them interested in “Shared Risk / Shared Reward” collaborations – think like your partner: What is in it for us? What is in it for them?

• Lessons learned in working with European and Asian governments to access novel funding mechanisms for collaborative research

• Gain insight into what a solid collaboration team looks like – make sure you have the right functions and skill sets represented to get the deal signed and off the ground

Opportunities and Challenges of Pharmaceutical R&D and Preclinical Services in China

Chris Song, Manager, Pharmaceutical Segment, Applied Biosystems, former Special Project Manager, AstraZeneca R&D, China

Pharmaceutical R&D management is experiencing unprecedented challenges: increasing R&D costs, increasing drug development timeline and thinning pipeline. China, the fastest growing market, has caught attention of big pharmaceutical companies for not only commercial opportunities but also research and development. The latest developments of pharmaceutical R&D and preclinical services in China as well as opportunities and challenges China presents will be discussed.

The Globalization of Clinical Trials: Where are the Trials Going and Why?

Fabio A. Thiers, M.D., Research Fellow, MIT Center for Biomedical Innovation, Harvard-MIT Division of Health Sciences & Technology

While the participation of individual emerging economies in industry-sponsored clinical research has received much recent attention, reliable quantitative evidence on the extent to which countries and regions are gaining or losing shares of participation in global clinical trials is sparse. We report on research into the changing location of clinical trials since 2002, and document the relatively dissimilar patterns of engagement of Eastern European, Latin American and Asian nations, as well as distinct ways the major pharmaceutical and biotechnology companies are turning clinical drug development into a truly global endeavor. We also report results from an econometric model that depicts how changes in the size of host country’s market, clinical research infrastructure, intellectual property protection, and trial costs per patient have been affecting their participation in global clinical trials since 2002. Finally, we discuss how changes in these same attributes are expected to shape the future global distribution of industry-sponsored clinical research.

AFTERNOON REGULATORY PRESENTATION:

ROUNDTABLE DISCUSSIONS

The close of the first day will consist of a set of concurrent roundtables hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a roundtable of interest to them and become an active part of the discussion at hand.

Roundtable 1:
Intellectual Property Issues, Trends and Strategies
Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D
Gregory E. Kalbaugh, Director and Counsel for Intellectual Property, Trade and Labor, US-India Business Council, US Chamber of Commerce

Roundtable 2:
Partnering and Collaborations

• Overcoming technical and scientific difficulties in international research and development projects
• Understanding cultural differences and their impact on science and business exchanges
• Establishing relationships and communicating effectively in a cross-cultural global collaboration
• Making the most of your partnerships
• Training staff and transferring technology
• Negotiations

Roundtable 3:
Regulatory Landscape and Drug Registration

• Best practices and approaches to the regulatory environment in emerging markets

Roundtable 4:
Accessing, Keeping and Managing Talent

• The product of drug discovery and development involves the intellectual raw materials from specialized disciplines of basic chemical & biological, pharmaceutical, medical and engineering disciplines. The key goal of the educational system in developed and developing nations is to the produce an infinite amount of this intellectual wealth. To this end, a strategic planning is required to access and build this highly valuable talent pool to meet the domestic and international needs of drug discovery and development.
• As the Industry grows, the migration of talent across the companies and across the countries poses both threat and opportunities to the research and development organization. A prospective and balanced recruitment and retention model should be created by the companies to maximize the value of the talent. Especially in the partnering model, the (trans) migration of talent across the countries within a company should be encouraged to build the talent value equilibrium.
• Very little research has been done in developing tools to educate Managers to manage scientists in the science-based business environment. An industry-academy based consortium to be encouraged to develop and introduce skills specific to R&D managers to manage scientists to enhance the productivity.

• What models have been pursued for integrated drug discovery projects in India and China?
• What critical skills are in short supply, and what is being done to address these needs?
• What are the trends for integrated drug discovery in these countries?

Roundtable 6:
New Paradigms for Improving Preclinical Safety Assessment

• Has GLP tox data production/operations become a commodity?
• Can adequate safety assessment for prioritization of candidates be done without in vivo studies?
• Is hERG the right or optimal screen for assessing the potential for TdP?
• What is the "best" way to evaluate the output of pre-clinical safety screens for decision making on the fate of candidates?

Roundtable 7:
Translational Medicine and the Difference in Emerging Regions vs. US and Europe

• Translational medicine: Are there cultural differences?
• Understanding the physician-patient relationship
• Understanding the researcher-physician relationship
• Translational medicine – lab to clinic or clinic-to-lab-to clinic? What is the difference and can it work everywhere?

Roundtable 8:
Global Clinical Trials Operations

• Intersection of IT and Data Management in India Offshore Services
• Experience with Investigative Sites in Various Countries (Latin America, Eastern Europe, India and China)
• Implementing Electronic Data Capture at Global Sites
• Biometrics Services (Statistics and Statistical Programming) in India and China

• Hierarchical determination of the key country attributes that enables effective engagement in global clinical trials
• Gathering of country-specific information on research capacity, cost, and markets potential
• Application of Decision Tree algorithms in the choice of a location for a clinical site
• Ranking of countries in relation to key attributes

5:45 – 6:45 Cocktail Reception Hosted by

View Day 2