Clinical Supply Chain Round Table

Theme: “KNOWING WHAT YOU DO NOT KNOW
& PITFALLS IN CLINICAL TRIALS”

Thursday, October 21, 2021; 5:30 pm – 8:30 pm

San Mateo Marriott San Francisco Airport, 1770 South Amphlett, San Mateo, CA

A drug development initiative is a multi-billion-dollar investment spread over 3 to 10 years and has a success rate of less than 7%. 56% of products made for Clinical Trials are wasted. There is something fundamentally wrong with this reality which we must change. The success achieved with Operation Warp Speed with COVID-19 vaccinations demonstrates that we must continue to transform Clinical Trials at an accelerated speed.

This social network event with drinks, appetizers, mingling with peers and two short panel discussions will address some of the following critical issues:
  • How can IRS help the clinical supply chain improve their forecasting, inventory management, just in time replenishment, and perform drug accountability and reconciliation?
  • How do you optimize Randomization schemes where global randomization makes it difficult to predict the number of active vs placebo drugs required per country, forcing you to either send too much of both, and rely on a fast turn-around time?
  • How do you enhance Excel Spreadsheet management of Clinical Trials with information from Distributors?
  • How do you navigate the many options for shipping from their place of manufacture to patients in S. America, Asia, Europe, etc.
  • Should you ship directly from the US to a patient site (“direct ship”), establish a regional depot (e.g., Singapore for all of Asia), establish depots in the country where the patient is located (e.g. Argentina, Brazil, Chile vs Brazil for all of S. America), etc.? 
  • Is it worth opening up a depot in a country that only has 1-5 patients when it can cost over $100,000 to establish a depot?
  • How do you manage storage and shipping of the drug when shipping to Asia and Africa is risky?
  • How do you manage the Customs in countries with long clearance cycles?
  • How do you process requirements of countries who insist their own depot be used or have their own QP requirements, such as Israel?
  • How do you set up JIT labeling where country-specific regulations exist?

Our Agenda

THEME: “KNOWING WHAT YOU DO NOT KNOW
& PITFALLS IN CLINICAL TRIALS”

5:30 pm – 8:30 pm Event (PST)

 

Sponsorship:
Contact Pamela Gardner,
VP, Sponsor Sales, (P: 858-349-8375)

05:30 – 6:15 am | MEET & GREET—Drinks, Appetizers, Networking 

06:15 – 06:30 pm | WELCOME ADDRESS

Clinical Supply OptimizationDevendra Mishra, Executive Director, BSMA

The Services Available for InnovationDr. Gregory Theyel, Director, Biomedical Manufacturing Network

Challenges of Clinical Trials ResearchDr. Prasun Mishra, Founder, American Association of Precision Medicine

06:30 – 07:15 pm | First Panel: Avoid Pitfalls When Using IRT andAchieve Clinical Drug Accountability and Reconciliation

Dr. Ravi Kiron, Bio Pharma External Innovation, Head, EMD Serono
Stacy Anderson, Director, Almac
Dan Silva, Partner, Tenthpin Management Consultants
Jon Paras, Vice President, Strategic Solutions, YPrime
Moderator: Bill Coakley, Executive Vice President of Clinical and Com-mercial Supply Chain Management, BSMA

07:15 – 07:30 pm | NETWORK BREAK

07:30 – 08:15 pm | Second Panel: Optimal Site Selection of Country or Region-specific Depots for Clinical Drug Distribution and JIT La-beling & Packaging

Emily Calimquim, Manager, Clinical Supply Chain, BioMarin
Bill Coakley, Executive Vice President of Clinical and Commercial Supply Chain Management, BSMA
Scott Bailey, Senior Director, Clinical Supply Chain, BeiGene
Moderator: Dan Silva, Partner, Tenthpin Management Consultants

White Paper: “How to Industrialize Strategic Sourcing of Raw Materials and Supplies?”

08:15 – 08:30 pm | WRAP UP & NETWORKING

 

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Panelist Sponsors

Event Sponsors