Interaction with Industrial Coalitions and Professional Organizations

1
Interaction with Industrial Coalitions and
Professional Organizations

• Fernando Muzzio
• Director, ERC-SOPS
• December 1, 2006

2
Current Membership 27 partners

• Growing pool of members
• Level 1 Strategic Partners
• Pfizer, Lilly, Abbott, GSK, Novartis, JJ,
  Pepsico, Schering Plough, Merck, BMS, Amgen,
  Wyeth
• Level 2 Tactical Partners
• Niro, Sepracor, Conformia, PG , KTron, FDA
• Level 3 IP Partners
• Fitzpatrick, Tyco, Tunnell, Allergan, Gericke,
  Schenk-Accurate, Patheon, Accelerys

3
Problem Statement

• Have been approached by multiple collective
  entities
• Industry Technical Consortia (CAMP, IFPRI)
• Advocacy Groups (CHPA, PQRI)
• Professional Organizations (ISPE)
• Issues can be challenging
• Wide constituencies
• Different goals than individual companies
• Different culture than individual companies
• Double dipping
• IP rights?
• How do we interact with these entities?

4
Industry Consortia

• Consortium for Advancement in the Manufacturing
  of Pharmaceuticals (CAMP)
• International Fine Powder Research Institute
• Desire to provide input and guidance (excellent)
• Scouting on behalf of members (good thing can
  bring new members)
• Portfolio management to avoid duplication (mixed
  blessing)
• Lower cost access to IP (forget about it)

5
Advocacy Groups

• Consumer Health Product Association (CHPA)
• Product Quality Research Institute (PQRI)
• Desire to provide input and guidance (excellent)
• Scouting on behalf of members (good thing can
  bring new members)
• Desire to influence the process have impact on
  scientific/regulatory discussions with members
  and with FDA (risky)
• Access to teaching and training materials (good
  avenue, but requires careful quality control)

6
Professional Organizations

• International Society of Pharmaceutical Engineers
• Desire to influence the process have impact on
  scientific/regulatory discussions with members
  and with FDA
• Access to teaching and training materials (good
  outreach avenue, but requires careful quality
  control)

7
Some thoughts

• Steering committee is given a role in helping
  decide how to bring consortia on board
• IP rights and confidential information cannot be
  passed to consortia constituents
• Consortia are not Level 1 (strategic) members.
• Educational content needs to be licensed
• Influence issues are carefully managed