San Diego 2019
October 16, 2019 | The Alexandria at Torrey Pines
Produced by: Life Science Leader
Supported by: OutsourcedPharma.com
Life Science Leader
Pharmaceutics International Inc.
Chiral Technologies / DAICEL
Coating Place, Inc.
Nitto Avecia Pharma Services
Olon Ricerca Bioscience
PCI Pharma Services
QbDVision by Cherry Circle Software
Regis Custom Pharma
Registration & Networking Breakfast
Collect your badge at registration and head over to our catered breakfast spread to enjoy while you mingle with fellow attendees.
Welcome & Conference Chair Opening Remarks
Louis Garguilo, Chief Editor & Conference Chair of Outsourced Pharma, kicks off the morning.
Outsourcing Service Models: Which One Is Best For Your Biotech?
There is no shortage of models for biotechs to obtain services from CDMOs – time-and-materials, fee-for-service, FTEs, clinical material agreements, commercial supply contracts, milestones, risk-sharing (to name a few). You’ll learn the definitions and differences among these models, and the criteria needed to make the best decision at the right phases.
Review Of Outsourcing Service Models
What service models are available to you when contracting a CDMO? Should you use a fee-for-service or FTE arrangement for your project? We’ve prepared a list of models for review and preliminary discussion to start our day.
Presenter - Louis Garguilo, Chief Editor & Conference Chair | Outsourced Pharma
A Real-Life Look At The Application Of Service Models
Next we'll turn these traditional service models into living examples, and provide some creative, real-life applications. You’ll learn how small- and mid-sized biotechs are working with CDMOs to expand boundaries and improve sponsor-service provider relationships.
Presenter - Robert Discordia, Ph.D., Chief Operating Officer | Corbus Pharmaceuticals
Networking Refreshment Break
The Grand Transfer: Best Practices For Getting Your Project To Your CDMO
The initial “tech transfer” sets you and your CDMO up for a very successful – or not so successful – implementation and managing of your project(s). Unfortunately, lost time, missing data, and miscommunications can occur … but can be avoided. Our panel of experts will explain best practices in this all-important first step to outsourcing success.
Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.
Domestic & International Outsourcing: The Pitfalls & Possibilities
Now that you understand the services models, you’ll have to determine where you should deploy them. Your options are global. Yet, every region presents opportunities and challenges. Our afternoon is devoted to examining domestic and international outsourcing, with an update on the varying regulatory environments and agencies.
An Outside View On The Patient Impacts Of Outsourcing
Rosemary Gibson, author of China Rx* (an exposé on drug supply chains in China), a winner of the highest honor from the American Medial Writers Association, and advisor to the Hastings Center, will provide attendees with her insights on pharmaceutical outsourcing as it relates to patient perspectives, supply-chain security and quality, and its impact on international relations.
Presenter - Rosemary Gibson, Sr. Advisor at The Hastings Center & Author of China Rx
An Update On The Global Regulatory/Quality Environment For Biopharma Outsourcing
The regulatory and global outsourcing landscape is changing. Each region and country present particular opportunities and challenges. This session will provide you a detailed update of the current regulatory and compliance changes, challenges and opportunities around the world, so you can make more informed decisions before deciding on an offshore solution to your outsourcing needs.
Presenter - Bikash Chatterjee, President & CSO | Pharmatech Associates
Networking Refreshment Break
Where To Outsource And What To Consider
This panel discussion will add real-life examples and explain rationales for smaller biopharma organizations looking for the best outsourcing experience and outcomes. Some key discussion topics include: domestic vs. international, managing partner relationships, and tracking costs.
Conference Chair Closing Remarks
Louis Garguilo, Chief Editor & Conference Chair of Outsourced Pharma, sums up the day's takeaways.
You're invited to join us for an open bar reception featuring dinner and desserts!