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San Diego 2019

October 16, 2019 | The Alexandria at Torrey Pines

Produced by: Life Science Leader
Supported by: OutsourcedPharma.com


Sponsors

ISR Reports

Life Science Leader

Orion Corporation

Outsourced Pharma

Pelican BioThermal

Pfizer CentreOne

Pharmaceutics International Inc.

Recro Gainesville


Exhibitors

Adesis, Inc.

Albemarle

AMPAC Analytical

Asymchem Inc.

Avid Bioservices

Boston Analytical 

Cambrex

Chiral Technologies / DAICEL

Coating Place, Inc.

CordenPharma

DiPharma

Eurofins Alphora

Nitto Avecia Pharma Services

Olon Ricerca Bioscience

PCI Pharma Services

QbDVision by Cherry Circle Software

Regis Custom Pharma

SafeBridge Consultants

Singota Solutions

Therapure Biopharma


Agenda

8:00am
Registration & Networking Breakfast

Collect your badge at registration and head over to our catered breakfast spread to enjoy while you mingle with fellow attendees.

9:00am
Welcome & Conference Chair Opening Remarks

Louis Garguilo, Chief Editor & Conference Chair of Outsourced Pharma, kicks off the morning.

Morning Sessions

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.

9:10am
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

9:40am
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

10:40am
Networking Refreshment Break
11:15am
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.

Panelists

  • Sara McCutchan, Sr. Regulatory Affairs Manager | Aristea Therapeutics
  • Michael Mulkerrin, VP, Head of CMC | ADC Therapeutics
  • Ratna Shekhar, PhD, Head of External Site Operations | Takeda Pharmaceutical Company Limited
  • Brian James, Sr. Vice President of Operations | Rondaxe Pharma(Moderator)
 12:15pm
Networking Lunch

Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.

Afternoon Sessions

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.

1:15pm
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

2:00pm
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

2:45pm
Networking Refreshment Break
3:30pm
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.

Panelists

  • Marilyn Bruno, CEO | Aequor
  • James Mackay, President & CEO | Aristea Therapeutics
  • Matt Wadell, Director, Clinical Trial Manufacturing | Eli Lilly & Company
  • Michael Mulkerrin, VP, Head of CMC | ADC Therapeutics
  • Doug Bakan, Executive Vice President, Technical Operations | Arena Pharmaceuticals, Inc.(Moderator)
4:00pm
Conference Chair Closing Remarks

Louis Garguilo, Chief Editor & Conference Chair of Outsourced Pharma, sums up the day's takeaways.

4:10pm
Networking Reception

You're invited to join us for an open bar reception featuring dinner and desserts! 

6:00pm
Conference Concludes



READY TO ATTEND?