EVENT
Collaborate
with CMOs,
Owner Companies
and Regulators
CMO Executive Workshop
4 – 5 June 2014
Baltimore, Maryland USA
Hilton Baltimore
Start-up, Selection, Governance, and Delivery
Representatives from Contract Manufacturing and Development Organizations,
Owner Companies, and the FDA, will assemble at the CMO Workshop to
discuss regulatory and operational challenges associated with four phases of
contract manufacturing operations. Through open discussion and debate, key
activities covered at this workshop will include CMO related challenges such as
roles and responsibilities and quality contracts.
Conference Chair
Tim Tyson
Chairman and CEO,
Aptuit, Inc., USA
These FDA officials will be participating throughout the event:
Mike Smedley, Deputy Director, FDA/OC
Rick Friedman, Assoc. Dir., Off. Mfg & Product Quality, FDA/CDER/OMPQ
Paula Katz, Branch Chief (A), Regulatory Policy & Collaboration, FDA/OMPQ
Participate
in 2 days of high-level
discussions around CMO
challenges and expectations.
Keynote Presentations by:
Courtney Billington
VP, Global Pharmaceutical Supply
Chain, Johnson & Johnson, USA
Industry Expectations and
Challenges of Contracted Work
Steve Leonard
Sr. VP of Global Operations,
Catalent Pharma Solutions, USA
CMO Expectations and
Challenges of Contracted Work
Mike Levy
Senior Counsel, Compliance,
DHHS/FDA/CDER/OMPT
The Regulatory Expectations and
Challenges of Contracted Work
Cover the Most Challenging
Components of the
Owner-CMO Partnership
START-UP PHASE
Multi-customer and multi-regulated facilities
Product segregations
Regulatory expectations
CMO due diligence
SELECTION PHASE
Product Approval Inspections
GMP Inspections
Validations
Regulatory expectations
GOVERNANCE
ight level of governance to achieve
R
transparency and accountability
Auditing
Metrics
Risk Management
Regulatory expectations
DELIVERY PHASE
Ongoing development/ manufacturing
Product distribution
Vulnerabilities in the Supply Chain
Control and Visibility in Packaging,
Data Integrity, Shipping
Customs Issues
Regulatory expectations
Register at:
www.ISPE.org/2014-CMO-Executive-Workshop
See last page of CGMP brochure for fees and additional information.
Manage the Rapidly-Changing Global Industry Business Model
and Regulatory Landscape with Speed, Flexibility and Agility
Wednesday, 4 June 2014
07.00 – 08.00 Breakfast Session: Breakfast with the Inspectors
Moderator: Steve Lynn, Director, Office of Manufacturing & Product Quality, FDA/CDER/OC/OMPQ
Inspector Panel Members:
Rachel Harrington, Supervisory Consumer Safety Officer, FDA/ORA/OGROP
Ernie Bizjak, Compliance Officer, FDA/ORA/OGROP
08.30 – 08.40 Opening Remarks
Joe Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical Quality,
Genentech, Inc.
Steve Lynn, Director, Office of Manufacturing & Product Quality, FDA/CDER/OC/OMPQ
08.40 – 09.40 Plenary Session with Q&A: Report of the ISPE Drug Shortages Task Force on Emerging
Strategies for Preventing and Mitigating Shortages
Francois Sallans, VP & Chief Quality Officer, Johnson & Johnson Pharmaceuticals
Doug Throckmorton, MD, Deputy Director, Regulatory Programs, FDA/CDER
Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
09.40 – 10.40 ISPE Drug Shortage Updates
•Operations Working Group Update
Sam Venugopal, Director, PricewaterhouseCoopers
•EMA Overview on Drug Shortage
Sabine Haubenreisser, PhD, EMA Liaison to the FDA, FDA/OC/OGROP/OIP
•EU Working Group Update
John Berridge, PhD, CChem, FRSC, Strategic Advisor, ISPE
•CMC Working Group Update
Karen Hirshfield, RPh, Senior Compliance Specialist, Genentech, Inc.
10.40 – 11.00 Networking Break
11.00 – 12.00 Industry-Regulatory Roundtable: Implications of the Findings of the Drug Shortages Task Force
Moderator: Joe Famulare, Vice President, Global Compliance and External Collaboration,
Pharma Technical Quality, Genentech, Inc.
John Berridge, PhD, CChem, FRSC, Strategic Advisor, ISPE
Sabine Haubenreisser, PhD, EMA Liaison to the FDA, FDA/OC/OGROP/OIP
Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
Larry Kranking, Executive Director, Commissioning Agents, Inc., Invited
Steven Lynn, Director, Office of Manufacturing & Product Quality, FDA/CDER/OC/OMPQ
Francois Sallans, VP & Chief Quality Officer, Johnson & Johnson Pharmaceuticals
Doug Throckmorton, MD, Deputy Director, Regulatory Programs, FDA/CDER
Sam Venugopal, Director, PricewaterhouseCoopers
Fran Zipp, President, Lachman Consulting
12.00 – 13.00 Lunch
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
Courtney Billington, Vice President, Global Pharmaceutical Supply Chain, Johnson & Johnson
13.40 – 14.10
CMO Expectations and Challenges of Contracted Work
Steve Leonard, Senior Vice President of Global Operations, Catalent Pharma Solutions
14.10 – 14.40 The Regulatory Expectations and Challenges of Contracted Work
Michael Levy, Senior Counsel, Compliance, DHHS/FDA/CDER/OMPT
14.40 – 15.00 Question and Answer Opportunity
Moderator: Tim Tyson, Chairman and CEO, Aptuit, Inc.
15.00 – 15.30 Networking Break
15.30 – 17.30 Workshop 1—THE SELECTION PHASE
Leader: Courtney Billington, Vice President, Global Pharmaceutical Supply Chain, Johnson & Johnson
Facilitator: Jim Miller, President, PharmSource
17.30 Workshop Adjourns
Thursday, 5 June 2014
08.00 – 10.00 Workshop 2—THE START-UP PHASE
Leader: Merck Executive, Invited
Facilitator: Jim Miller, President, PharmSource
10.00 – 10.30 Networking Break
An ISPE white paper will
be created following
the meeting to inform
the development of
guidance on this topic.
10.30 – 12.30 Workshop 3—THE GOVERNANCE PROCESS
Leader: Steve Leonard, Senior Vice President of Global Operations, Catalent
Facilitator: Jim Miller, President, PharmSource
12.30 – 13.30 Lunch
13.30 – 15.30 Workshop 4—THE DELIVERY PHASE
Leader: Wes Wheeler, CEO, Marken
Facilitator: Jim Miller, President, PharmSource
15.30 – 16.00 Networking Break
16.00 – 17.00 Debrief and Action Items from Workshops and Closing Remarks
17.00 Workshop Adjourns