March 20, 2010

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Day 1

DAY ONE: THURSDAY, MAY 29, 2008

7:30 AM Coffee and Conference Registration

8:25 Organizer’s Welcome and Chairpersons’ Introduction
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series, Cambridge Healthtech Institute

Balu Balasubramanian, Ph.D., Executive Director, Research and Development, Bristol-Myers Squibb Co.

INTRODUCTORY PRESENTATIONS:

8:30 Developing a Global Strategy to Further Innovation

Ross Horsburgh, Regional Medical Director, Asia Pacific & Head CRR-APAC, AstraZeneca

9:15 Assessing Which Regions are Most Attractive and Why: A Perspective

Balu Balasubramanian, Ph.D., Executive Director, Research and Development, Bristol-Myers Squibb Co.

10:00 A Critical Evaluation of Preclinical Testing in China: A Case Study

Dr. Diana Galer, Vice President, Strategic Management Group, Pfizer, Inc.
It is now widely recognized that there are expanding opportunities for the growth of pharmaceutical industry and related businesses in China and other emerging markets. A case study of an evaluation of preclinical testing capabilities in China, based on the implementation of a pilot toxicology testing program, will be presented. This will include a critical appraisal the current state of the testing industry in China, including the physical capacity, technical capabilities and needs, talent development, as well as educational and training gaps. A number of new collaborations between preclinical laboratories in China and Western CROs and pharmaceutical clients may yield near-term improvements. Additional approaches that could yield more long term development of these capabilities will be presented.

10:45 – 11:15 Networking Coffee Break

BREAKOUT GROUP A: DISCOVERY	BREAKOUT GROUP B: DEVELOPMENT
11:15 – 11:20
Chairperson’s Introduction Balu Balasubramanian, Ph.D., Executive Director, Research and Development, Bristol-Myers Squibb Co.	Chairperson’s Introduction Ross Horsburgh, Regional Medical Director, Asia Pacific & Head CRR-APAC, AstraZeneca
11:20 – 11:50
Outsourcing Lead Generation Activities in China, India, and Russia Deborah S. Hartman, Ph.D., Vice President, Lead Generation, AstraZeneca Access to high quality, low cost CRO’s in emerging regions such as China, India, and Russia has provided a rich source of chemical and biological resources for the early phases of drug discovery. A wide variety of partnership models have been used by pharmaceutical companies to establish effective processes across distance, time, and cultural differences. There are also growing opportunities to access both scientific and technological innovation to support R&D. This presentation will describe the AstraZeneca experience in Outsourcing large scale chemical library synthesis to enhance the compound collection, with the challenge of coordinating efforts between China, India, and Russia Taking a decentralized approach to Discovery outsourcing driven independently by Research Area teams, and the challenges of efficient management and knowledge sharing across these teams Developing a recent China-focused externalisation strategy to enhance efficiency and effectiveness of global Lead Generation, and the challenges in project management of multidisciplinary approaches	Differences and Similarities Between USA and China in New Drug Application Procedures and Regulations Lee Jia, Ph.D., Project Manager, Toxicology and Pharmacology Branch, DTP, National Cancer Institute/NIH Regulatory agencies throughout the world are becoming more homogeneous in accepting and approving new drugs as we are approaching pharmaceutical globalization. The mechanics involved in the drug approval process have had a tremendous impact on how new drugs are developed globally. Consideration of the rules, regulations, and guidances in the new drug approval development process must become part of a company’s strategic plan in bringing these products to market. This presentation will address differences and similarities between USA and China in the investigational new drug (IND) application procedures and regulations, and compare in parallel the related data acceptability and facility.
11:50 – 12:20
Build a World Class R&D Organization in China Samantha Ying Du, Ph.D., CEO, Hutchison MediPharma Ltd. The capital- and time-consuming nature of drug R&D has become a huge problem for the healthcare industry. That coupled with the high attrition rate has threatened to dampen the enthusiasm for the industry to make large investments from earlier discovery to proof of concept. However, the recent ascent of China in the world economy created opportunities for the industry to re-think its strategy in reducing time and cost by taking advantages of China resources. This presentation will share HMPL’s R&D strategies and how to best manage R&D operations in China to maximize productivity. The author will also describe the opportunities and risks in investing in China. This presentation will: Highlight a successful story of a drug R&D company growing from a start-up to a leading R&D company in China and also an int’l public company within five years Provide a real case study by analyzing China strategies and best ulitizing China resources for the successful global drug development Share first-hand experiences in drug R&D development and company management in China	Translational Medicine and Biomarker Development Collaborations and Partnership in China Jingsong Wang, Ph.D., Director, Clinical Discovery, Bristol-Myers Squibb Translational Medicine and biomarker development is becoming an area of rapid growth across biopharma industry. Multinational biopharma companies are starting to look for China to set up translational medicine research collaborations; such collaborations have great potential but have unique challenges as well. Challenges include: Identifying suitable sites Accessing top talent pool Interacting with existing clinical study infrastructure Protecting IP Following SFDA regulations on biosample processing These challenges can be overcome by utilizing a systematic and integrated approach. In this presentation I will: Familiarize attendees to the landscape for translational medicine in China Teach attendees how to access the talent pool of translational medicine in China Offer attendees strategies on how to overcome obstacles unique to translational research collaboration in China

12:20 – 1:50 Hosted Luncheon and Roundtable Discussions

LUNCHTIME ROUNDTABLE DISCUSSIONS:

During lunch, tables will be labeled with a specific topic. Attendees will join a table with their peers and a moderator to enjoy a meal and discuss some of the more poignant questions facing the industry. It’s an informal yet informative format that allows attendees to learn from each other and make some new contacts.

Partnerships, Collaborations and Joint Ventures Leading to M & A Activities
David W. Moskowitz, MD, MA (Oxon.), FACP, Chairman, CEO & Chief Medical Officer, GenoMed, Inc.
&
Mak Jawadekar, Ph.D., Director, WWPPM, Pfizer Global R & D

The pharmaceutical industry in the 21st century
Funding sources
Massively parallel drug discovery & development
Pros & Cons of 'Partnering & Collaborations'
Partnering Models (e.g. FTE vs. Project based): Pros & Cons
M & A activity by/with CRO/CRAM firms in Asia (India/China): Metamorphosis & Regression, A crystal Ball
Leveraging: Partnering & Licensing within 'Partnering & Collaborations' umbrella
Ideas on how Big Pharma could expand its market- share within Asia through 'Partnering & Collaborations'

Regulatory Landscape and Drug Registration
Donald Swankie, Director, Neeman Medical International
&
Frank J. Malinoski, MD, Ph.D., Senior Vice President, Medical and Scientific Affairs, MedImmune, Inc.

What does the regulatory environment look like currently in [these emerging markets, i.e. India?]
What changes might be ‘in play’ in 2008-2009 within Government and Regulatory bodies one need be aware of?
How and when do the regulatory bodies evaluate current trials efforts in US, EU, UK and any impact on ‘in country’ approval?

Deals, Licensing, and Risk-sharing in China Today
Dr. Ying Luo, CEO, GNI, Ltd. and Shanghai Genomics, Inc.

Talent and its Management in a Competitive and Evolving Environment
Navaneetha K. Rao, M.S., Sc.D., Vice President, Clinical Research and Development, Vicus Therapeutics

What is Talent Management?
Talent identification…Who, how, categorizing and interpreting CVs in India, titles vs. experience
Talent recruiting...Who, how, cost, what to expect in the near and long term from wage inflation
Talent retention…How, long-term strategies, training, losing people to pillaging and job jumping
Talent utilization and development...Project assignment, cross-functional training, sabbaticals
Examples of some best practices
Examples of lessons learned

International Project and Team Management
Dhanapalan Nagarathnam, Ph.D., Director, Medicinal Chemistry, Pharmasset, Inc.

What are the effective tools to manage these projects and teams, and to produce good results?
Is language a barrier? If so, how to deal with it?
What are the challenges? How you solved them? Are there pending/ongoing unresolved issues?

Toxicity Issue Resolution: How to go About a Clinical Hold
Gopala Krishna, PhD, DABT, MBA, Senior Director and Head, Preclinical Candidate Evaluation, Supernus Pharmaceuticals, Inc.

Challenges of Performing Complex Discovery Biology with International Partners
Col. Aizen J. Marrogi, M.D., Department of Pathology and Area Laboratory Service, Walter Reed Army Medical Center

Successfully Identifying CROs and Conducting Pre-Clinical Research & Development in India
M. (Ken) Kengatharan, Ph.D., MBA, Vice President, Scientific Affairs, CoMentis Inc.

How to identify the right CRO partner for the project
How to protect intellectual property when outsourcing research activities?
How to cost-effectively manage the research project from a distance?

Translational Medicine and Biomarkers
Jingsong Wang, M.D., Director, Discovery Medicine & Clinical Pharmacology, Bristol-Myers Squibb
&
Sudhir Borgonha, M.D., Chief Executive Officer, Translational Medicine India

Translational medicine and biomarker discovery collaborations with academics
Fulfill regulatory requirements and align clinical program timeline
Biomarker and bioanalytical service: Local vs. Global

Clinical Trials in CEE and CIS: All One Big Area?
Pavle Vukojevic, Medical Director, Pharm-Olam International
&
Elena Barmanova, Deputy Director, Office for Registration of Drugs and Medical Devices, Federal department for Surveillance in Healthcare, Roszdravnadzor, Russia

Running Clinical Trials in EU and non-EU countries: what are main differences?
Central and Eastern Europe: does this as an entity exists anymore?
CIS – A Commonwealth of Independent states can they be grouped together?
EU/Non EU CEE Countries. Are there any non EU countries in CEE left and what does their future hold?

Allocation of Trials of Different Therapeutic Areas
Fabio Thiers, M.D., M.Sc., Ph.D., Research Associate, MIT Center for Biomedical Innovation, MIT

Does the clinical site allocation decision-making vary substantially across therapeutic areas?
Are all oncology trials allocated according to the same decision-making paradigm? What about cardiology, neurology, or psychatric trials?
What are the most prominent determinants of the country allocation decisions for conditions like diabetes, hypertension, Alzheimer's, breast cancer, or schizophrenia?
Are any of the emerging countries preferred destinations for trials on specific conditions? If so, why?
When is it more desirable to keep the trials in traditional countries?
How is the allocation decision influenced by mandates of regulatory agencies or increased scrutiny on specific therapeutic classes, like COX-2 inhibitors?

Ethical Issues in Multinational Clinical Trials
Art Gertel, Vice President, Clinical Services, Regulatory, & Medical Writing, Beardsworth Consulting Group, Inc.
When conducting multinational clinical trials, there are factors in play that may bring to bear ethics considerations. These factors may be social, geographic, bureaucratic, or economic. Discussions at this roundtable will touch on a number of these in raising ethics awareness of the participants.

Exploitation of 3rd-world populations? What do they get out of the pharma clinical trials in which they participate?
Is it all about geography? Cultural vs. Geographic differences of environment. Healthcare infrastructures.
Is Informed Consent a guarantee of a subject being an informed consenter? Language barriers, surrogacy, the power of the caregiver.

Current Challenges and Opportunities for Clinical Development and Operations in Brazil
Alberto Wainstein, M.D., Ph.D., Chief Medical Officer, Biocancer Clinical Research

How to establish long-lasting and successful partnerships
What are the peculiarities of clinical development in Federal Universities, Public Hospitals and Private Research Centers? Understanding limitations and unique opportunities of each of these venues.
How to improve results in a Latin America country. How to decrease the distance from the Sponsor / Medical Protocol Chief to the site / investigator. Which tools could be employed through CRO and CRAs in order to get higher adherence, appropriate recruitment, low queries and commitment from local research teams?

BREAKOUT GROUP A: DISCOVERY		BREAKOUT GROUP B: DEVELOPMENT
1:50 – 1:55
Chairperson’s Introduction Balu Balasubramanian, Ph.D., Executive Director, Research and Development, Bristol-Myers Squibb Co.		Chairperson’s Introduction Ross Horsburgh, Regional Medical Director, Asia Pacific & Head CRR-APAC, AstraZeneca
2:00 – 2:30
Drug Discovery Strategy in China to Reduce Cost and Improve Outcome: Case Study Dr. Ying Luo, CEO, GNI, Ltd. and Shanghai Genomics, Inc. Although outsourcing-related research has been a hot area of growth, drug discovery has been the focus of overall strategy of the Chinese pharmaceutical industry. After combining with GNI in 2005, Shanghai Genomics has become one of the very few biotech companies who has adopted a hybrid model of both developing novel therapeutic drugs in China and providing contract research to western pharma. Our experience of how to manage research collaboration, licensing, clinical trials, production and sales is a good example for biotech companies in emerging regions of the world.		Case Study: Conducting a Complete Development Program Integrating Preclinical Animal Toxicology and DMPK Gopala Krishna, PhD, DABT, MBA, Senior Director and Head, Preclinical Candidate Evaluation, Supernus Pharmaceuticals, Inc. A generalized preclinical candidate selection model Key questions to be answered for First In Man trial [global IND, for example] Reasons and strategies for conducting a complete development program in India, one that includes preclinical development Integrating a preclinical development program Key questions to be answered from a “preclinical” perspective for NDA or marketing authorization package
2:30 – 3:00
International Collaborations: Overcoming the Challenges of Time and Space Apart Kelly P. Longo, Director, Strategic Alliances, Pfizer Inc. In this session we will discuss the global pressures on the biopharmaceutical business as well as general principles for establishing and managing collaborations. We will touch on the challenges that long distance partnerships face including people, communication and geographical separation. We will then review a couple of academic case studies – this includes creative business structures and challenges that each partnership may have encountered. The need to Collaborate What we seek in a partner Challenges Examples of partnerships, some successful, others not Considerations in multi academic, biotech/pharma relationships, and Consortia Summary		Case Study: Conducting Proof of Concept Clinical Programs in India Sudhir Borgonha, M.D., Chief Executive Officer, Translational Medicine India Assessing investigators, medical centers, and practice of medicine in India Working with the DCGT and understanding the regulatory environment Conducting translational research in India Evaluating the costs and time frames of conducting POC programs
3:00 – 3:45 Afternoon Refreshment Break
3:45 – 4:15
Outsourcing Chemistry for Success: Assessing and Optimal Utilization of Contract Research Organizations Dhanapalan Nagarathnam, Ph.D., Director, Medicinal Chemistry, Pharmasset, Inc. There are many CROs to provide chemistry support. The critical element is on how to find the right partner(s) for your needs. In addition, every CRO has their strengths and weaknesses. How to identify and evaluate these CROs? Do you need a single vendor or multiple vendors? How to use them effectively based on their capability? How to get high quality support for small biotechs? How to avoid problem CROs? Identify short and long term needs for CROs Evaluate cost, timeline, and risks Evaluate the capabilities of CROs Determine criteria and set clear expectations Monitor progress and get optimal results		Country Selection for Global Clinical Trials: Business Analysis Outcomes from a Collaborative Project Between Johns Hopkins University and Emergent BioSolutions Cris Howard, MBA, MEd, Senior Manager, Clinical Operations, Emergent BioSolutions India, China, Poland, Russia, Argentina, and Australia were countries included in a collaborative effort between Emergent BioSolutions and Johns Hopkins University Carey Business School MBA Fellows program to conduct a business analysis of the risks versus benefits of conducting global clinical trials. The analysis included risk, opportunity, cost and timeline while considering influencing variables such as subject recruitment, health care climate, cultural considerations, market maturity, regulatory landscape, available suppliers, distribution channels, and potential partnerships. This presentation will share the outcomes of this analysis and will recommend considerations for clinical trial country selection.
4:15– 4:30
Solution Provider Presentation (Sponsorships available, contact Arnold Wolfson at awolfson@healthtech.com or 781.972.5431)		CASE STUDY: Challenges and Key Learnings in Placing Early Phase I and II Studies in India Edward J. Brennan, Jr., MD, FACS, President and CEO, IndiPharm LLC
4:30– 5:15
INDUSTRY-PROVIDER JOINT PANELS:
Partnering for Medicinal Chemistry, Pharmacology, Animal Models, and GLP Tox Beyond chemistry and biology outsourcing, what can be done outside of the US and Europe? What are the true possibilities, costs, constraints and efficiencies in: Medicinal Chemistry Pharmacology Animal Models GLP Tox Animal Supply Discovery Biology *Moderator:* Kelly P. Longo, Director, Strategic Alliances, Pfizer Inc. Balu Balasubramanian, Ph.D., Executive Director, Research and Development, Bristol-Myers Squibb Co. Dhanapalan Nagarathnam, Ph.D., Director, Medicinal Chemistry, Pharmasset, Inc. Samantha Ying Du, Ph.D., CEO, Hutchison MediPharma Ltd. Deborah S. Hartman, Ph.D., Vice President, Lead Generation, AstraZeneca Elena Barmanova, Deputy Director, Office for Registration of Drugs and Medical Devices, Federal department for Surveillance in Healthcare, Roszdravnadzor, Russia Please submit topics and questions for the panel to: mlieberman@pharmaseries.com, subject: discovery (panel A).		Partnering for Clinical Trials in Emerging Regions It is agreed upon that there are patients and treatment naïve populations outside of North America and Europe who can benefit from research as well as greatly enhance the speed of trials for industry. However, what are the challenges in: Patient Recruitment Site Management Clinical Trials Supply PoC Trials *Moderator:* Ross Horsburgh, Regional Medical Director, Asia Pacific & Head CRR-APAC, AstraZeneca Jingsong Wang, Ph.D., Director, Clinical Discovery, Bristol-Myers Squibb Donald Swankie, Director, Neeman Medical International Zili Li, M.D., M.P.H., Director of Clinical Research Operations-Asia Pacific/Head of China Regulatory Policy, Merck Sudhir Borgonha, M.D., Chief Executive Officer, Translational Medicine India Alberto Wainstein, M.D., Ph.D., Chief Medical Officer, Biocancer Clinical Research Please submit topics and questions for the panel to: mlieberman@pharmaseries.com, subject: clinical (panel B).