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Short Course 3: Emerging Partnership Models between Emerging Companies, CDMOs, and Big Pharma

Short Course

8:00 AM–3:30 PM Nov 12, 2017

San Diego Convention Center - Room 24BC

Description

Moderators:

  • Anil Kane Ph.D., M.B.A.
  • Carson L. Swink B.S.

Proposal Description:

An additional fee is required to attend this short course. To register, visit www.aaps.org/AMRegister

Increasing pressure in the industry to develop new products and therapies requires small, emerging, specialty, and big pharma companies to develop strategies to take the successful candidates from discovery through clinical to commercial stage with speed and the right investment by the right partners. The development of small molecules and biologics by contract development and manufacturing organizations (CDMOs) on behalf of small to emerging companies that eventually are planned to be licensed out to larger pharma companies as sponsors have required a shift in collaborative and partnering models for a variety of reasons, chemistry, manufacturing, and controls expertise, investment or financing programs, and the ability to take the products to the market quicker. The need to go through due diligence with multiple partners and the knowledge lost in the process demands a new model of partnering earlier in the clinical development phase—well before planning for regulatory approvals and commercial launch.

Learning Objectives:
•Development of a clinical and outsourcing strategy for early to late phase development and clinical manufacturing and selection of a right partner with capabilities
•CMC partner selection criteria and bringing in speed to clinical and market avoiding multiple due diligence exercise
•Learnings from novel partnering and collaborative models that have been successful – case studies from emerging companies/sponsors, CMC service providers and big pharma/new marketing sponsors

Sub-Sessions
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Short Course

Welcome and Introductions

8:00 AM–8:15 AM Nov 12, 2017

San Diego Convention Center - Room 24BC

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Short Course

Beverage Break

9:45 AM–10:15 AM Nov 12, 2017

San Diego Convention Center - Room 24BC

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Short Course

Buffet Lunch (Short Course Attendees only)

11:45 AM–12:45 PM Nov 12, 2017

San Diego Convention Center - Room 24BC

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Short Course

Beverage Break

2:15 PM–2:30 PM Nov 12, 2017

San Diego Convention Center - Room 24BC

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Short Course

Moderated Round Table

2:30 PM–3:15 PM Nov 12, 2017

San Diego Convention Center - Room 24BC

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Short Course

Wrap Up

3:15 PM–3:30 PM Nov 12, 2017

San Diego Convention Center - Room 24BC

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