Main Conference Day 1: Tuesday, May 11, 2010

7.45 Registration And Coffee

8.30 Welcome Address And Chairpersons’ Opening Remarks

8.45 Opening Keynote: Industry Overview - The Current Shape Of The Contract Manufacturing Industry

  • Discussing the direction the contract manufacturing market is heading
  • Changing environment & dynamics of contract manufacturing opportunities and commercialisation
  • Evaluating in-house vs external manufacturing options
  • Examining the emergence & challenges of domestic and overseas outsourced manufacturing
  • Considering manufacturing opportunities for small biotechs and start-ups
  • Discussing new strategies and creative partnerships for improving success

Jim Browne
Director, Contract Manufacturing, Europe

Effective CMO Sourcing and Relationship Management

9.30 Panel Discussion: Analyzing The CMO Market: Tools For Choosing A Preferred CMO

  • Understanding the scientific background and capabilities of tentative CMOs
  • Addressing a CMO's experience developing a biologic product from early clinical stages through regulatory review and commercialization
  • Assessing a CMO's necessary facility, equipment and personnel infrastructure for successful commercialization of a biologic drug product
  • Examining the importance of quality agreements
  • Assessing the potential of a CMOís global reach with regards to manufacture, supply channels, quality/regulatory requirements
  • Compiling a data set in order to rank and risk assess potential CMOs

Jim Browne
Director, Contract Manufacturing, Europe

Franco Pasquale
Senior Manager
Roche Contract Manufacturing Operating Unit

Alex Badal
Director, Global Strategic Sourcing Supply
Valeant Pharmaceuticals

Adam Sabouni, Ph.D.
President & CEO
PharmaArtz, Inc.

10.15 Morning Networking Break

11.00 Biogen Idec’s Approach To Vendor Selection And Capacity Utilization Rationalization

  • Displaying how Biogen Idec has revamped its business model for how external vendors are selected
  • Understanding how capacity utilization amongst back-up vendors are determined
  • Discussing how the overall business decision making process is conducted and documented
  • Highlighting the process that is being utilized and the impact it's made on overall business operations

John Kuczek
Associate Director, Contract Manufacturing
Biogen Idec

Thomas Holmes
Associate Director, Contract Manufacturing
Biogen Idec

11.45 Successfully Organizing And Adapting Your Internal Structure To Effectively Handle A CMO

As big pharma sheds its in-house manufacturing sites, more and more companies are turning to Custom Manufacturing Organizations (CMOs). A successful collaboration involves harmonizing many different activities. This panel discussion will discuss a number of the key drivers for success in a relation with a CMO.

  • Successful selection of a CMO: What to look for in a partner
  • Technology transfer: The elements for speed, accuracy and success
  • Process chemistry and route scouting: When a CMO has a good idea
  • Quality: Who's in charge; harmonizing SOPs
  • Contracts and reports: Understanding and reaching customer expectations

Justin D. Noll
Senior Vice President, Plant Manager
Cherokee Pharmaceuticals LLC

12.30 Networking Lunch

1.30 How To Salvage A Bad Contract Relationship

  • Using Metrics and Data: Demonstrating actual performance as opposed to perceived or emotional type performance
  • Developing a combined plan to fix the issues and metrics
  • Discussing relationship Counseling for the resistant: Performance management ties and right person in the right position
  • Evaluating communication: Picking the appropriate way to communicate, not just the fastest way
  • Examining international cultural norms and the contract
  • Breaking up: Knowing when to walk away

Jeannie Celiberti
Operations and Facilities, Genocea Biosciences, Inc.

Diane McGuire
PharmAcumen Consulting Inc.

Operational Benefits of Post-CMO Collaboration

2.15 Using Your CMO As A Resource To Tap Into A New Innovative Product Market

  • Gaining the competitive edge on manufactured products through CMO-utilized tools and technologies
  • Identifying novel product design and re-launch technologies from your CMO
  • Unveiling novel product revamping technologies for post patentexpired products
  • Optimizing your marketed product pipeline with innovative drug delivery and manufacturing capabilities from your CMO
  • Extending product lifecycle through new product launches

Adam Sabouni, Ph.D.
President & CEO
PharmaArtz, Inc.

3.00 Afternoon Networking Break

3.45 Due Diligence With In The Selection Process Of Your CMO

  • Reviewing the internal J&J due diligence process for CMO selection
  • Examining key points critical for future success
  • Managing risk with CMO – Developing an aligned approach to benefit both parties
  • Maximizing product lifecycle with an aligned approach with a “likeminded” CM
  • Developing the future due diligence relationship for a CMO from both a business and compliance angle

Jim Damon
Regional Director, External Manufacturing
Johnson & Johnson Consumer Healthcare

4.30 Maximizing Innovation: Addressing The Importance To Small Biotech’s And Start-Ups

  • Identifying successful strategies in order to go about finding/locating/attracting a suitable CMO
  • Unearthing the breakdown of manufacturing costs: How to locate cost-saving solutions and techniques within your outsourcing supply chain
  • Locating the correct CMO geared to working with small-scale/ startup companies
  • Discussing the importance on focusing on your pilot projects from start to finish
  • Discussing case study examples

Michael Ramsay
Contract Managing Expert
Biopharmassist, Inc

5.15 Chairpersons’ Closing Remarks And End Of Day One