CMO Executive Workshop
Chairman: Tim Tyson, Aptuit
Co-Chairs: Steve Leonard, Catalent, Courtney Billington, J&J and Paula Katz, FDA
Dates: 4-5 June 2014
Location: Baltimore, MD
Wednesday, 4 June 2014
Start
Time
7:00
8:30
8:40
End
DRUG SHORTAGES PROGRAM
Time
Speaker's Name
8:00
Moderator:
Thomas Cosgrove, JD, Director
Inspector Panel Members:
Inspector Panel Members:
Rachel Harrington, Supervisory
Consumer Safety Officer
Ernie Bizjak, Compliance Officer
8:40
9:40
Breakfast Session: Breakfast with the Inspectors
Drug Shortages Opening Remarks
Plenary Session - w/Q&A
Joe Famulare
Vice President Global Compliance
Thomas Cosgrove, JD, Director
Tim Tyson, Chairman and CEO
Moderators:
Joe Famulare, VP, Global
Compliance and External
Collaboration , Pharma Technical
Quality
Francois Sallans, VP & Chief Quality
Officer, Pharmaceutical
Speakers:
Doug Throckmorton, M.D., Deputy
Director, Regulatory Programs
Gerald Heddell, Director, Inspection
Enforcement and Standards Division
9:40
ISPE Drug Shortage Updates:
Report of the ISPE Drug Shortages Task Force on Emerging Strategies for Preventing and
Mitigating Shortages
• Operations Working Group Update
10:40 • EMA Overview on Drug Shortage
• EU Working Group Update
• Drug Shortages: The Inter-Association Prevention Project
• EU Working Group Update
• CMC Working Group Update
10:40
11:00 NETWORKING BREAK
6/3/2014
Sam Venugopal, Director
Sam Venugopal, Director
Sabine Haubenreisser, Ph.D., EMA
Liason at the FDA
John Berridge, Ph.D., CChem,
FRSC, Strategic Advisor
Karen Hirschfield, R.Ph., Senior
Compliance Specialist
Speaker's Company
FDA/CDER/OC/OMPQ
FDA/ORA/OGROP
FDA/ORA/OGROP
FDA/OHHS/ORA/OGROP
Genentech and Rapporteur, ICH
Q10
OMPQ/OC/CDER, FDA
Aptuit, Inc.
Genentech Genentech Genentech
Genentech Genentech Genentech
Genentech Genentech
Johnson & Johnson
Genentech
FDA/CDER
FDA/CDERMHRA
FDA/CDER
MHRA
MHRAeMHRAeMHRAeMHRAeMHR
Aenentech
Pricewater houseCoopers
European Medicines Agency at
PricewaterhouseCoopers
European Medicines Agency at
FDA
ISPE
Genentech
Genentech
CMO Executive Workshop
11:00
Industry-Regulatory Roundtable:
Implications of the Findings of the Drug Shortages Task Force
• John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg.
• Sam Venugopal, Director, PricewaterhouseCoopers
• Larry Kranking, Executive Director, Commissioning Agents, Inc., Invited
12:00 • Thomas Cosgrove, JD, Director, Office of Manufacturing and Product Quality, FDA
• Francois Sallans, VP & Chief Quality Officer, Johnson & Johnson Pharmaceuticals
• Doug Throckmorton, M.D., Deputy Director, Regulatory Programs, FDA/CDER
• Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
• Sabine Haubenreisser, Ph.D., EMA Liason at the FDA
• Fran Zipp, President, Lachman Consulting
12:00
13:00 LUNCH
Joe Famulare, Moderator
Genentech and Rapporteur, ICH
Q10
End
CMO WORKSHOPS
Time
Speaker's Name
Speaker's Company
13:00
13:10 Welcome and Introduction
Tim Tyson, Chairman and CEO
Aptuit, Inc.
13:10
13:40 Industry Expectations and Challenges of Contracted Work
13:40
14:10 CMO Expectations and Challenges of Contracted Work
14:10
14:40 The Regulatory Expectations and Challenges of Contracted Work
14:40
15:00 What makes Contracted Manufacture Successful?
15:00
15:15 Question and Answer Opportunity
15:15
15:30 NETWORKING BREAK
Start
Time
Courtney Billington, VP Global
Pharmaceutical Supply Chain
Steve Leonard, Senior VP of
Global Operations
Michael Levy, Senior Counsel,
Compliance, FDA/CDER/OC
Gerald Heddell, Director,
Inspection Enforcement and
Standards Division
Tim Tyson, Moderator
Johnson & Johnson
Catalent Pharma Solutions
FDA/CDER/OC
MHRA
Aptuit, Inc.
Workshop 1
15:30
17:30
THE SELECTION PHASE
Leader: Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson
Facilitators: Jim Miller, President, PharmSource
Mike Smedley, Deputy Office Director, FDA/OMPQ
Rick Friedman, Associate Director of Risk Science, Intelligence and Prioritization, FDA/OMPQ
Mike Arnold, Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies
George Millili, Senior Principal Technical Advisor, Genentech
Lisa Hawkins, Compliance and Regulatory Affairs Services, Commissioning Agents
17:30
TRACK ADJOURNS
CMO Executive Workshop
Thursday, 5 June 2014
Start
Time
End
CMO WORKSHOPS
Time
Workshop 2
8:00
10:00
10:00
10:30
10:30
12:30
12:30
13:30
13:30
15:30
15:30
16:00
16:00
17:00
17:00
THE START-UP PHASE
Leader: Craig Kennedy, SVP Supply Chain Management, Merck
Facilitators: Jim Miller, President, PharmSource
Mike Smedley, Deputy Office Director, FDA/OMPQ
Rick Friedman, Associate Director of Risk Science, Intelligence and Prioritization, FDA/OMPQ
Mike Arnold, Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies
George Millili, Senior Principal Technical Advisor, Genentech
Lisa Hawkins, Compliance and Regulatory Affairs Services, Commissioning Agents
NETWORKING BREAK
Workshop 3
THE GOVERNANCE PROCESS
Leader: Sridhar Krishnan, VP, Global Operations, Catalent Pharma Solutions
Facilitators: Jim Miller, Mike Smedley, Rick Friedman, Mike Arnold, George Millili, Lisa Hawkins
LUNCH
Workshop 4
THE DELIVERY PHASE
Leader: Wes Wheeler, CEO, Marken
Facilitators: Jim Miller, Mike Smedley, Rick Friedman, Mike Arnold, George Millili, Lisa Hawkins
NETWORKING BREAK
Debrief and Action Items from Workshops and Closing Remarks
CONFERENCE ADJOURNS
6/3/2014
Tim Tyson
Aptuit, Inc.