DETAILED AGENDA:
Speakers & Topics for iiBIG’s 4th Annual GLOBAL CLINICAL TRIAL PARTNERSHIPS are now being confirmed. For information on how you can become involved as part of our executive speaking faculty for this event, please contact the event organizer:

Don Buford, CEO, iiBIG at 212-300-2521 or donb@iibig.com

Day One – Monday, March 1, 2010
7:30 – 8:30	Registration & Networking
8:30 - 8:40	Welcoming Remarks from our Chair Dianne Kikta, PhD, MBA, Vice President Global Clinical Strategic Resourcing, Pfizer
8:45 – 9:30	Keynote: State of the Industry-Remaining Competitive and the Future of the Biopharmaceutical and Medical Device Industry Industry trends–the vector Current state of pharma and biotech Emerging trends in therapeutics, technology and globalization Compete for the future and winning in the coming decade Christopher C. Gallen, MD, PhD, Executive Vice President of Research & Development, CombinatoRX
9:35 – 10:20	Regulatory UPDATE: Pharmaceutical regulations, the Medical Device Directive, Generics and more… Receive an update on the Medical Device directive in Europe and in the US The PIP regulation and impact on global development The various CTA “pre Clinical Trial Application procedures available: Scientific Advices, Pre assessment Review for FTIH, VHP procedure Update on the ongoing discussion and proposal for the next update of the EU directive 2001/20/EC. Assess generics and biosimilars approval procedure process Kim Townsend, MBA, JD, CPA, Senior Counsel & Director of Government Affairs, Welch Allyn, Inc. Stephan Reynier, MSc, Project Director Drugs & Biologics, Voisin Consulting
10:20 - 10:50	Refreshments & Networking
10:55 - 11:40	Best Practices: Effective Governance & Optimizing Clinical Operations to Achieve Quality, Time and Cost to Market Redefining your company’s business strategy to determine what needs to be outsourced Best practices for optimizing clinical operations and implementation Using effective governance to optimize quality, time and cost Successful techniques for supporting the sponsor/ CRO teams to identify issues and overcome obstacles Effectively managing 10, 20 or more CROs and partners Panelists: Michael Schwartzman, Associate Director Outsourcing Alliance Management, Daichii Sankyo Lawrence Florin, Section Director US Clinical Outsourcing, AstraZeneca Mark Tulchinsky, MD, MBA, General Manager & Medical Director North-Eastern Europe, Medpace
11:45 - 12:25	Effectively sharing operational risk with sponsors & or CROs to develop strategic partnering for win-win partnerships Divulging what information to share with sponsors or CROs Methodologies used for developing this partnership Developing a deliverable budget together Strategic partnership: factoring accountability, quality and timeline into the equation Devising strategic plans to work with smaller budgets and to increase efficiencies Panelists: Dianne Kikta, PhD, MBA, Vice President Global Clinical Strategic Resourcing, Pfizer Diana Gáler, President, Gáler Coaching for Excellence
12:30 – 1:45	NETWORKING LUNCHEON
1:50 – 2:35	Emerging Markets: Analyzing the Issues and Controversial Ethical Questions to Determine the Long-Term Implications of Running Clinical Trials Responsibilities of the sponsor and investigator Informed consent and the language used Understanding cross-cultural barriers for patient recruitment Defining legal and ethical issues in the emerging market Accessing and recruiting talent Luis Rios-Nogales, MD, Phd, MBA, Regional Medical Director ISMO Latin America Head, MCCD Clinical Research Region, AstraZeneca Latin America Ryan Nichols, Partner, Excend Consulting Group
2:40 – 3:30	Case Study: Involving CROs in the Early Phase of Development to Have Transparency and Effectively Reduce Wait Time for Beginning Clinical Trials Determining the successful strategies for integrating the CRO in the planning stages of drug development Developing an oversight model to determine the roles of the sponsor & the CRO to avoid micromanagement Developing agreeable benchmarks and a timeline to adhere to for a successful sustained relationship Archana Sah, BPharm., MS (Pharm.), PMP, Global Clinical Project Manager, Cell Therapeutics Inc. Art Gertel, Vice President, Strategic Regulatory Consulting, Medical Writing and QA, Beardsworth
3:30 – 4:00	Refreshments & Networking
4:05 – 4:50	Developing a Successful Global Feasibility Study to Determine Where to Do Your Clinical Trials to Reduce Development Times and Clinical Trial Costs Determining what region(s) and or countries to run your trials in- Latin America, Asia, India and or China Examining patient recruitment and standards of care Assessing local regulatory updates and requirements for import and export Obtaining good feasibility data to develop informed planning and logistics Discovering the benefits of utilizing data across regions Panelists: Ross D. Pettit, MBA, Vice President Operations, ARIAD Pharmaceuticals Ginny Payeur, Vice President Business Development, PSI Raymond Panas, PhD, Director of International Clinical Development, Sucampo Pharmaceuticals
4:55 – 5:55	Leveraging Technology to Lower Drug Development Costs Hear from leading solution providers and the sponsors who use them to reduce time to market. Panelists: Jovianna DiCarlo, Global Clinical Development Director, Immunomix, Inc. Vito Losito, MSc, PhD, CEO & President, EntraLogix Systems Group Inc. Lori Shields, VP Data Operations, Medidata Worldwide Solutions Ying Jiang, Director of Client Operations, TTC, llc
6:00 – 7:30	Evening Networking Reception Meet & Network with your Fellow Outsourcing Colleagues
Day Two: Tuesday, March 2, 2010
8:30 – 9:15	Networking & Registration
9:15 – 10:00	Case Study: Latest global patient recruitment strategies Strategies for minimizing recruitment failure Reducing cycle time to recruitment launch Applying performance data to maximize recruitment return on investment Establishing accountability for performance; timelines and cost management Panelists: Graeme Currie, PhD, Vice President Clinical Operations, Sepracor Christian Milliet, Senior Manager Clinical Operations, Novartis Diana L. Anderson, PhD, President & CEO, D. Anderson & Company
10:05 – 10:50	Focusing on Asia: Receive the Latest Updates on Outsourcing, Regulatory Issues, Site Selection, Service Providers and What Should be Developed in Each Country and More Examining patient enrollment and trial execution rate Cost differentials for site selection Examining country specific regulations for doing business in Asia Identifying the challenges of outsourcing in China and possible solutions Successful strategies to protect intellectual property rights Examining the latest lucrative partnerships and why they were successful Moderator: Alexander P. Woollcott, Esq., Chair, Global Sourcing & Procurement Practice, Thompson Hine LLC Panelists: Joanne Jiang, VP, Business Development and International Project Management, Fountain Medical Development Andrew C. Chang, PhD, Executive Director, PharmaNet Consulting
10:50 – 11:20	Morning Break & Networking
11:25 – 12:10	Case Study: Lessons Learned and Conquering Operational Challenges When Conducting Multi-Regional Clinical Trials Effectively overcoming the challenges of selecting the appropriate countries, sites and investigators Ensuring the quality of the clinical research from MRCTs (e.g., ensuring quality of on-site monitoring and data collected) Examining the potential impact of differences in standard of care on study outcomes and potential methods to control Panelists: David Facklam, Senior Director, Global Development Operations, Astellas Pharma Global Development, Inc. Miklos L. Schulz, Ph.D, President & CEO, SciAn Services, Inc. John Strony, MD, Section Head Thrombosis/Cardiovascular, Merck Research Laboratory
12:15	End of Conference: Thanks for "Thinking iiBIG"