Pre-Conference Workshop Day, Monday, March 19, 2012
2:00 PM Pre-Conference Workshop
Successfully Dealing with the Challenges of Forecasting and Managing Global Trials

Led by:

Steve Jacobs, Chair, GLOBAL CLINICAL SUPPLIES GROUP

5:00 PM Workshop Concludes

 

Conference Day 1, Tuesday, March 20, 2012
8:00 AM Registration and Continental Breakfast for Conference Attendees
9:00 AM Welcome and Chairperson’s Introduction

Steve Jacobs, Chair, GLOBAL CLINICAL SUPPLIES GROUP
9:15 AM Building a Clinical Supply Chain Project Management Core Competency

Scott Wong, Senior Systems Analyst, CELGENE
10:00 AM Developing an Effective Site Supply Strategy from Demand Forecasting Techniques

Brad Graves, Manager, Clinical Research Pharmacy Services, MEDIMMUNE
10:45 AM Morning Networking Break
11:15 AM Examining Quality by Design (QbD) & Quality Risk Management Approaches for the Clinical Supply Chain

Ken Schiff, Former Director, Quality Assurance / Quality Risk Management, F. HOFFMANN LA ROCHE & President
QUALITY RISK MANAGEMENT ASSOCIATES, LLC
12:00 PM Factoring and Mitigating Risk Regarding the Sustainability of Conducting Global Clinical Studies within Emerging Markets

Mark Walls, Director, Clinical Pharmacy, HUMAN GENOME SCIENCES
12:45 PM Networking Lunch
1:45 PM Maximizing the Potential of IVRS and Supply Chain Analytics to Ensure the Efficient Management of Investigational Materials

V. Mark Kothapalli, R.Ph., PhD, Supply Chain Manager, Investigational Materials Supply, GLAXOSMITHKLINE
2:30 PM Maintaining an Efficient and Balanced Supply Strategy Through The Use of IWR Data

William Hillman, Associate Director, Clinical Supply Systems, JOHNSON AND JOHNSON
3:15 PM Networking & Refreshment Break
3:45 PM Panel Session: Complying with United States Prerequisites for Importing Clinical Trial Materials

Moderator:

Frank J. Reale, Associate Director, Global Regulatory Operations Global Regulatory, Strategy, Policy & Safety, MERCK & CO.

Panelists:

Roopal Patel, MBA, Manager, Import/Export, TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.

Ted Poplawski, Director, Division of Import and Export Operations and Policy, FDA

Pamela Diedrick Simpson, PhD, Senior Veterinary Medical Officer, National Center, Import – Export, USDA
4:45 PM Flexible Biotech Planning/Forecasting and the Definition of Success

Daniel Kropas, Senior Manager, Clinical Drug Supply and Logistics, Clinical Development & Regulatory Affairs, REGENERON
5:30 PM Close of Day One
  Cocktail Reception Sponsored By:

 

Conference Day Two: Wednesday, March 21, 2012
8:50 AM Chairperson’s Recap
9:00 AM Enhancing the Relationship Between You and Your CRO to Optimize Your Clinical Supply Chain

Adam Sabouni, Ph.D, Chief Development Officer, NOVAN THERAPEUTICS, INC.
9:45 AM Panel Session: Minimizing Drug Supply Issues during a Global Clinical Trial

Moderator:
Steve Jacobs, Chair, GLOBAL CLINICAL SUPPLIES GROUP

Panelists:
Brad Graves, Manager, Clinical Research Pharmacy Services, MEDIMMUNE

Carol Haddad, Manager, Oncology Therapeutic Area, Global Clinical Supply, MERCK & CO.

Rick Mann, Associate Director, Product Development, Clinical Supplies and Logistics, SUNOVION

Ram Narayanan, Associate Director, Planning and Development Operations, BIOGEN IDEC

Wendy Xia, Senior Program Manager, MERCK & CO.
10:45 AM Networking & Refreshment Break
11:15 AM IRT and GMP: Using Technology to Optimize the GMP Processes of Production and Distribution in Clinical Trials

Anthony Frankland, Global Head, Sales & Marketing, CENDUIT, LLC
12:00 PM Predictive Patient Recruitment and Supply Modeling to Ensure Successful Completion of Clinical Trials

Beatrice Basso, Clinical Supply Trial Expert, Novartis Pharmaceuticals Corporation
12:30 PM Lunch
1:30 PM Evaluating Sourcing, Packaging and Using of Comparator Products

Peter Orosz, PhD, Head of Clinical Supply Chain Management, Oncology, BOEHRINGER INGELHEIM
2:15 PM Streamlining Review and Approval of Label Text for Clinical Studies

Sashin Bhuta, R.Ph, MBA, Drug Supply Manager, BRISTOL-MYERS SQUIBB
3:00 PM Conference Concludes

 

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