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Boston Agenda | Tuesday, May 7, 2019

State Room | 60 State Street, Boston, MA

 

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.

9:15am
Weighing Your CDMO Outsourcing Model Options

This session will present exclusive research data on service and business model options when contracting with CDMOs. You’ll also learn how companies apply these models at the different phases of development and manufacturing. A final Q&A allows drug sponsors and service providers to outline the best models for your programs and company.

Presenter - Kate Hammeke, VP Market Research | ISR Reports

10:00am
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

10:45am
A Real-Life Look At The Application Of Service Models

Find out how traditional service models can be applied in both traditional and “creative” ways. You’ll also hear how small- and mid-sized biotechs are working with CDMOs to expand the boundaries of those traditional relationships.

Presenter - Robert Discordia, Ph.D., VP, Pharmaceutical Development & Manufacturing | Corbus Pharmaceuticals

 12:00pm
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

1:45pm
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

2:15pm
Networking Refreshment Break

Continue the conversation as you fill up on locally inspired treats!

 3:00pm
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

  • Steve Goodman, Head of Drug Product Manufacturing | bluebird bio
  • Thomas Holmes, Global Head, Supply Chain | AMYLYX Pharmaceuticals
  • Vincent Kosewski, Sr. Vice President, Manufacturing & Supply Chain Management | Kala Pharmaceuticals
  • Todd Mabe, Director Drug Substance Quality | Merck
  • Mark Butchko, Sr. Director, Quality Assurance - Development | Eli Lilly & Company (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! 

*Attendees can receive signed copies of China Rx as we celebrate a day of learning with music, good food and adult (and other) beverages.

6:00pm
Conference Concludes

 

Agenda topics and speakers subject to change