Partnerships in Clinical Trials 2012

Agenda at a Glance

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2012 Agenda Print Out – A quick way to determine your personal schedule in advance of the event
2012 Speaker List - A quick way to review the impressive speaker line-up for 2012
2012 Event Guide - Explore the all new Partnerships 2012 experience

Sunday, March 4, 2012—Women's Clinical Leadership Forum
5:00pm	Early Registration & New Attendee Welcome
6:00	Welcoming Remarks
6:10	Women Leading Change with Impact, FORBESWOMAN
6:45	How the Gobal Pharmaceutical Market and Rise of Multi-National Trials Impacts Work-Life Balance Moderator: RIGEL PHARMACEUTICALS, MILLENIUM PHARMACEUTICALS, PROMETHEUS THERAPEUTICS AND DIAGNOSTICS, ALLERGAN, and RPS
7:15	Women's Clinical Trial Leadership Dinner
8:30	Leaving a Mark in the HealthCare industry: Reforming Ourselves to Transform an Industry

Monday, March 5, 2012—Executive Summit Day and General Session Kick-Off
8:45	Registration for Summits, Sponsored by
9:30	Summits Open
11:00	Break
1:00	Luncheon
3:30	Summits End and Networking Break

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Monday, March 5, 2012—Executive Summit Day and General Session Kick-Off
9:30	Chairperson's Opening Remarks,PFIZER INC.
9:45	Virtual Trials— what are They? - PFIZER INC.
1030	Making a Study Different: What is Truly Innovative About the Virtual Trial Approach? - GENENTECH (ROCHE)
11:00	Break
11:30	Case Study: New Results From Pfizer's Mobile- Powered Virtual Clinical Trial Outsourcing Pilot Program, PFIZER INC.
12:30	Lunch
1:30	Assess the Legal Risks and Considerations of Virtual Trials, GORDON & REES LLP.
2:15	Examine Collaboration of Technology Companies Needed to Support the Virtual Trial Model
2:45	Industry Collaboration: How Should We Approach and Work With the FDA to Create a Regulatory Process for Virtual Trials? - PFIZER INC. AND JANSSEN
3:30	Summits End

9:30	Chairperson's Opening Remarks, BIOGEN IDEC.
9:45		CASE STUDY: Develop a Global Patient Recruitment and Retention Strategy, MERCK
1030		You Ask, They Answer: What Motivates and Attracts a Patient to Enroll in a Clinical Trial and What will Keep Them Interested? - MS CLINICAL TRAILS AND ROCK CF FOUNDATION
11:00	Break
11:30		CASE STUDY: New Results From UCSF'S Pilot Program on Innovative Use of Text Messaging, Mobile Apps, and QR Codes for Patient Recruitment and Retention, UCSF
12:30	Lunch
1:30		CASE STUDY: Use EMR and Social Media to Bolster Patient Recruitment for Postmarketing Trials
2:15		CASE STUDY: Shire's Use of Mobile Health Apps to Boost Patient Recruitment, SHIRE PHARMACEUTICALS
2:45	The Professional Research Subject: Tools to Eliminate Multiple Simultaneous Enrollment in Clinical Trials, ACUMED RESEARCH ASSOCIATES AND CLINICAL RESEARCH OF SOUTH FLORIDA
3:30	Summits End

9:30	Chairperson's Opening Remarks, NYCOMED
9:45	Discovering the Unknown: Is China Really the Next Nirvana? - NYCOMED
1030	SFDA's Update on Regulatory Environment: Latest Clinical Safety and Monitoring Guideline, SFDA
11:00	Break
11:30		You Ask, They Answer: Pharma's Perspective: How to Navigate and Optimize Your Regulatory Strategy in China, MERCK & ATYR PHARMA
12:30	Lunch
1:30		Strategy in Situ: Prevent Supply Chain Disruptions to Ensure Optimal Quality and Improve Clinical Operations, ELI LILLY
2:15	How to Conduct Clinical Rrials in China When You are Not Big Pharma, VDDI PHARMACEUTICALS
2:45	Protecting Your Intellectual Property: Tools for Patent Protection When Conducting Trials in China, PANITCH SCHWARZE BELISARIO & NADEL LLP
3:30	Summits End

9:30	Chairperson's Opening Remarks, NEOVISTA INCORPORATED
9:45	The Big Picture: Does One Size Fit All? A Focus on Outsourcing Trends of Smallmidsize BioPharma Companies, THE AVOCA GROUP, RIGEL PHARMACEUTICALS, C.R. BARD AND REGENERON PHARMACEUTICALS
1030		CASE STUDY: Apply the Large Pharma Model to Small Pharma: What Should You Expect Out of Strategic Partnerships With Your Cros? - HUMAN GENOME SCIENCES, INC.
11:00	Break
11:30		CASE STUDY: Outsourcing Selection and Start up Process for Small Companies Going Global, INOVIO PHARMACEUTICALS INC.
12:30	Lunch
1:30		You Ask, They Answer: Managing Multiple Vendors When You're a Small Shop— Working With Limited Resources, MANNKIND CORPORATION AND ARMONIA CLINICAL RESEARCH, LLC
2:15	Establish a Strong Project Management Function Under the "Do More With Less" Approach, ASUBIO PHARMACEUTICALS, INC.
2:45		CASE STUDY: Get More From Your Key Supplier Relationships —Tips to Infl Uence Required Change Management Within Your Organization, VERTEX PHARMACEUTICALS
3:30	Summits End

9:30	Chairperson's Opening Remarks, FOREST RESEARCH INSTITUTE AND ABBOTT LABS
9:45		Strategy In Situ: Strategies to Ensure Drug Safety in Emerging Markets, GENZYME
1030	Install Risk Minimization and Benefi T-risk Communication Plans that Harmonize U.S. and European Regulatory Codes, ELI LILLY & ROCHE
11:00	Break
11:30		CASE STUDY: Using SPERT Guidelines to Map Your Comprehensive Clinical Trial Safety Reviews Design Your Medication Guide for Improved Effectiveness in Risk Communication, ELI LILLY
12:00	Design your Medication Guide for Improved Effectiveness in Risk Communication, ABBOTT LABS
12:30	Lunch
1:30	How to Use Latestage Clinical Trials as Proper Launchpads for Risk-Minimization Plans, BAXTER HEALTHCARE & CELGENE
2:15	Safety Management and Development Partnerships in Latestage Clinical Trials, TAKEDA PHARMACEUTICALS INTERNATIONAL
2:45		Strategy in Situ: Drug Safety Outsourcing Considerations for Small to Mid-Size Companies: How to Meet Increasing Demands with Limited Resources, FOREST RESEARCH INSTITUTE
3:30	Summits End

9:30-3:30

This is a unique and exclusive forum for senior clinical decision makers and R&D leadership of the biopharmaceutical industry to tackle the biggest challenges facing clinical development and R&D. Participants benefit from a series a mind opening discussions by engaging in an "unconference" format and exchange of ideas with their senior leadership peers around three major themes: Industry consolidation, globalization, and the changing reimbursement paradigm. Participants can expect to walk with new insights into the industry changes need to maintain its long term viability, and the implementation plan to be the leading change agents in the industry.
Moderator: PURDUE PHARMA
Participants: BOEHRINGER-INGELHEIM, SUNOVION PHARMACEUTICALS, CHORUS, IMCLONE SYSTEMS, COVIDIEN, GENZYME, BIOGEN IDEC, PFIZER, BAYER, MEDIMMUNE, HUMAN GENOME SCIENCES, ATYR PHARMA, NOVARTIS, BRISTOL-MYERS SQUIBB, ENDO PHARMACEUTICALS, TEVA
This forum is open to trial sponsors only. To request access or obtain more information, email Danya Burakoff at dburakoff@iirusa.com

Monday, March 5, 2012—Partnerships General Session Opens
4:00	Chairpersons' Opening Remarks, PFIZER INC. and ENDO PHARMACEUTICALS
4:15	Beating the Odds—Not Only Living with Cystic Fibrosis—Rocking It, ROCK CF FOUNDATION and VERTEX PHARMACEUTICALS
5:00-7:00	Opening Reception in the Partnerships Hall
7:15	2nd Annual Partnerships Concert and Celebration

Tuesday, March 6, 2012
7:30-9:00	BioStorage Technologies invites you to the Global Sample Management Breakfast Workshop Click here for more info »
9:00	Chairperson's Remarks PFIZER INC. and ENDO PHARMACEUTICALS
9:15	Disruptive Drug Development: Driving the Necessary Innovation and Change to Pioneer the Next Frontier J. CRAIGVENTER INSTITUTE
9:45	Industry Sit Down: Seismic Shifts in Clinical Development—The Move Towards Tailored Therapeutics and Personalized Medicine Moderator: INNOTHINK CENTER FOR RESEARCH IN BIOMEDICAL INNOVATION Panelists: VERTEX PHARAMCEUTICAL, MEDCO HEALTH SOLUTIONS, J. CRAIG VENTER INSTITUTE; SYNTHETIC GENOMICS INC.
10:30	Networking Break in Partnerships Hall: Speed Networking and Genius Bar

4:00 Track Sessions
Strategic Outsourcing	Operational Excellence	eClinical Technology & Data Management
CASE STUDY : Setting Up a Working Collaboration Across Three Companies in a Strategic CompanyPPD, Parexel, GSK	Track Chair, ELI LILLY Case Study: How to Operationalize Adaptive Trail Designs through the use of Biomarkers IMMUNE TOLERANCE NETWORK	Track Chair, SHIRE PHARMACEUTICALS Using Technology to Improve Quality Management and Proactive Risk Mitigation of Global Trials BAYER VITAL GMBH, COGNIZANT TECHNOLOGY SOLUTIONS
Operational Management of Global Trials	Best Clinical Trial Practices for Your Medical Device Trial	Future Trends in Clinical Research
Track Chair, BIOGEN IDEC Case Study: Roche's Global Task Force to Overhaul the Ex-Us Site Contracting Process GENENTECH (ROCHE), COVANCE	Track Chair, STRYKER Unique Needs for Medical Devices: Choosing the Right Vendors for Your Medical Device Trials BAXTER HEALTHCARE	Track Chair, CELTIC THERAPEUTICS Approved Product Spotlight: Insights into the Strategic Partnerships of Pfizer's Lung Cancer Treatment and Abbott's AlK Gene Test PFIZER INC, ABBOTT MOLECULAR

12:00	Luncheon in the Partnerships Hall
1:30	Crowdsourcing Clinical Development and Medical Innovation AUTHOR, *THE WISDOM OF CROWDS*
2:15	Industry Sit Down: Disrupting the Traditional Drug Development Process - How will Participatory Medicine Drive Innovation in Clinical Research? *THE WISDOM OF CROWDS,* GLOBAL HEALTH LIVING FOUNDATION, DIABETESMINE, and TRANSPARENCY LIFE SCIENCES
3:00	Networking Break in Partnerships Hall: Speed Networking and Genius Bar

11:15 Track Sessions
Strategic Outsourcing	Operational Excellence	eClinical Technology & Data Management
Track Chair, PHARMAPM CONSULTING, LLC Approved Product Spotlight: Insights into the Outsourcing Partnership Involved in Human Genome Sciences' Trials for the Treatment of Lupus HUMAN GENOME SCIENCES, INC	Track Chair, ELI LILLY Strategy in Situ: Strategic Trial Design that Considers Complex Regulatory and Payer Requirements to Drive Efficiencies and Ensure Successful Product Commercialization	Track Chair, SHIRE PHARMACEUTICALS Case Study: Momenta's Application of Social Media in its Pancreatic Cancer Trial MOMENTA PHARMACEUTICALS
Operational Management of Global Trials	Best Clinical Trial Practices for Your Medical Device Trial	Future Trends in Clinical Research
Track Chair, BIOGEN IDEC Case Study: Perform Instead of Rescue: Allergan's Real-Time Management of Global Clinical Trials - The Use of Adaptive Course ALLERGAN INC.	Track Chair, STRYKER Applying Metrics Champion Consortium(MCC) Standardized Performance Metrics and Quality Tools to Medical Device Trials METRICS CHAMPION CONSORTIUM, MEDTRONIC	Track Chair, CELTIC THERAPEUTICS You Ask, They Answer: Virtual Pharma - Show Me the Money! CELTIC PHARMA & CELTIC THERAPEUTICS, CHORUS, ASLAN PHARMACEUTICALS

4:45	Wall Street and Private Equity Perspectives: Economic Outlook on Investment Areas, Growth, Opportunities and the Outsourcing Industry Moderator: BOEHRINGER-INGELHEIM BOARD VENTRURE CAPITAL ASSOCIATION, ROBERT W. BAIRD & CO., FAIRMOUNT PARTNERS, JEFFERIES & COMPANY, INC. and PHARMANET
5:30	2nd Annual Partnerships 2012 Awards Ceremony
5:45	Partnerships International Food & Wine Festival in the Partnerships Hall
6:00	Champagne Roundtables in the Partnerships Hall [All registered attendees will be receiving event update emails starting in January 2012, that will include instructions on how to sign up]
7:00	Close of Tuesday

Wednesday, March 7, 2012
9:00	Chairperson's recap, PFIZER INC. and ENDO PHARMACEUTICALS
9:15	Changing your Game - How Clinical Executives Can Success in the New Leaner Life Science Industry by Increasing Global Competitiveness and Driving Revenue and Profit Growth with Innovation THE GAME-CHANGER: HOW YOU CAN DRIVE REVENUE AND PROFIT GROWTH WITH INNOVATION
10:00	Aligning to Innovate - Sponsors & CROs Partnering to Significantly Improve Success Rates for Clinical Trials *GAME CHANGER,* MERCK, ABBOTT LABORATORIES, RPS, PPD, INC., TEVA
10:45	Networking Break in the Partnerships Hall: Book Signing, Genius Bar & Speed Networking

11:15 Track Sessions
Strategic Outsourcing	Operational Excellence	eClinical Technology & Data Management
Track Chair, PHARMAPM CONSULTING, LLC Case study: Reinventing Sanofi Clinical Development—How to Improve Clinical Operations Efficiency through Strategic Outsourcing and Insourcing (using Flexible, Embedded Model) while Undergoing Comprehensive Transformational Change RPS, SANOFI- AVENTIS	Track Chair, ELI LILLY Proven Tactics to Help you Navigate the Clinical "Bermuda triangle" of Site, Sponsor and CRO Communication TRIFECTA MULTIMEDICAL, AMAG PHARMACEUTICAL, PHARMANET/I3 and MEDPACE,PEIZER	Track Chair, SHIRE PHARMACEUTICALS Case Study: Experimental Operations: Piloting Innovation Without SHIRE PHARMACEUTICALS, ROCHESTER CLINICAL RESEARCH CENTER, PRA
Operational Management of Global Trials	Best Clinical Trial Practices for Your Medical Device Trial	Future Trends in Clinical Research
Track Chair, BIOGEN IDEC Ensuring Ethical Conduct in Emerging Markets HRP CONSULTING, DAIICHI SANKYO PHARMA DEVELOPMENT	Track Chair, STRYKER Strategy in Situ: Completion Expectations for Internal and External Stakeholders for Your Medical Device Trial STRYKER	Track Chair, CELTIC THERAPEUTICS Point, Counterpoint: The R& Path Going Forward: How do we Re-Invigorate Drug Research? INNOTHINK CENTER FOR RESEARCH IN BIOMEDICAL INNOVATION, PFIZER INC

12:00

Luncheon in the Partnerships Hall

1:00 Track Sessions
Strategic Outsourcing	Operational Excellence	eClinical Technology & Data Management
Track Chair, PHARMAPM CONSULTING, LLC The Avoca Group Unveils New Results from its Annual State of Clinical Outsourcing Industry Survey—the Current Realities of the Implementation of New Outsourcing Strategies THE AVOCA GROUP, CUBIST PHARMACEUTICALS, INC, BRISTOL-MYER SQUIBB	Track Chair, ELI LILLY Case Study: Leverage Outsourcing to Grow Individual Value Within your Company OTSUKA PHARMACEUTICALS	Track Chair, SHIRE PHARMACEUTICALS You Ask, They Answer: Determine Your Internal and External Cloud Computing Strategy for Clinical Research
Operational Management of Global Trials	Best Clinical Trial Practices for Your Medical Device Trial	Future Trends in Clinical Research
Track Chair, PHARMAPM CONSULTING, LLC Strategies to Overcome Internal Resistance to Change: Tools to Beat Organizational Challenges when Moving to New Outsourcing Models MILLENNIUM, ICON CLINICAL RESEARCH	Track Chair, STYKER Examine the Regulatory Device Pathway to Improve Current Clinical Trials ABBOTT LABORATORIES	Track Chair, CELTIC THERAPEUTICS You Ask, They Answer: How Comparative Effectiveness Research May Impact Drug Pipelines, Innovation and Patient Care—Can Innovation Survive CER? ACRO, PIPC, and EXPRESS SCRIPTS

1:45	Capture and Navigate New Markets - Reset your Compass for Business Transformation by Profitability Tackling the Challenge of Entering New Markets, Wherever They Are CAPTURING NEW MARKETS

2:30 Track Sessions
Strategic Outsourcing	Operational Excellence	eClinical Technology & Data Management
Track Chair, PHARMAPM CONSULTING, LLC Point Counterpoint: Risk-Sharing: What Does it Look Like and Does it Really Work? NEOVISTA INCORPORATED, ELI LILLY and SHIRE	Track Chair, ELI LILLY Make Your Project More Successful through the Art of Vendor Management PCMG	Track Chair, SHIRE PHARMACEUTICALS You Ask, They Answer: HIPPA demystification—How to use EMRs and Social Networks for Patient Recruitment and Interaction In Line with Proposed Regulations ROYAL SOCIETY OF MEDICINE, COLUMBIA UNIVERSITY MEDICAL CENTER
Operational Management of Global Trials	Best Clinical Trial Practices for Your Medical Device Trial	Future Trends in Clinical Research
Track Chair, BIOGEN IDEC Case Study: Maintaining the Integrity of Clinical Trials and Global Operations in Light of a Natural Disaster Crisis	Track Chair, STRYKER Case Study: How Boston Scientific Managed its Clinical Trial Process to Attain Recent FDA Approval of its Medical Device BOSTON SCIENTIFIC	Track Chair, CELTIC THERAPEUTICS The Future of Medical Device R&D—Shift Your Strategy and Business Model to Create New Dimensions of Performance AUTHOR, CAPTURING NEW MARKETS

3:15	Closing Remarks
3:30	Close of Partnerships 2012
See you next year at The 22nd Annual Partnerships in Clinical Trials, April 22-24, 2013 in Orlando, Florida