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Conference Sessions

Sterile Injectables: It’s All About Solutions
Tom Wilson, Senior Director, Alliance Management
September 26, 2013
Pfizer Global Supply (PGS) produces more than 3,000 formulations of our prescription-only medicines, over-the-counter consumer products, and vaccines sold in more than 175 markets around the world. PGS strives to ensure that Pfizer’s complete…  Read More »
The Dose CMO Industry: Size, Structure and Trends
Jim Miller
September 26, 2013
Agenda - Industry definition - CMO characteristics - Market size and shares - Growth drivers - Final thoughts Key Points - Nearly 200 participants and $15 billion in revenues - Many small companies - Market share increasingly concentrated - Organi…  Read More »
Putting the “Quality” in Quality Agreements for Contract Manufacturing Operations
Paula Katz, Acting Branch Chief, Regulatory Policy & Collaboration CDER/Compliance/Office of Manufacturing & Product Quality
September 26, 2013
• Background – Why Outsource? – Legal Framework •Draft Guidance Quality Agreements in Contract Manufacturing – Scope and purpose – Definitions – Highlights and Expectations •Enforcement Perspectives and…  Read More »
Preserving the Partnership: After Signing the Agreement
Steve Walker, Director, Alliance Management and M&A Eli Lilly and Company
September 26, 2013
Opening Comments Section 1 – Orientation – “What type of partnerships are we talking about?” – Continuum of partnerships – Phases of partnership development Section 2 – Challenges in the partnership beyond…  Read More »
Avoiding the Banana Peel: 9 proven techniques to help you avert supplier supervision slip-ups
John Avellanet
September 26, 2013
Six key perils Nine practical techniques Next steps to consider…  Read More »
Path to Rational Quality Assurance
September 26, 2013
Reflections and projections • Human behavior & ‘intention – implementation’ gaps • FDA’s initiative on ‘Pharmaceutical cGMP’s for the 21st Century – A Risk Based Approach’…  Read More »
GDUFA, CMOs and Facility Fees
Mark A. Elengold, President, FDA Strategies LLC
September 26, 2013
No specific authorization until Hatch/Waxman – 1962 amendments required a review of products approved for safety. FDA established the Drug Efficacy Study Implementation (DESI) program. Products found effective were eligible for Abbreviated New…  Read More »
Managing Virtual Manufacturing: The Perspective from a Small Company
Tom Wilson
September 26, 2013
•The views expressed herein are those of the presenter and do not necessarily reflect those of Synta Pharmaceuticals, Corp. •The information presented herein is based upon my 20+ years of outsourcing management from both sides of the spons…  Read More »
Trends in Biopharmaceutical Contract Manufacturing
William Downey
September 26, 2013
- Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2013 - Biopharmaceutical Contract Manufacturing: New Participants, Expanded Services and Emerging Markets Primary research based on interviews and inputs from biomanufacturing direc…  Read More »
Outsourcing Drug Product Development: An R&D Perspective
Gautam Ranade, Sr. Director, Strategic Sourcing Pharmaceutical Sciences
September 26, 2013
- Strategic Context for Outsourcing - Overall Process for Outsourcing Drug Product Development - Roles and Responsibilities for Outsourcing - Supplier Selection and Performance Management…  Read More »
Making Compliance Sexy: Influencing Management to Comply
John Avellanet
September 26, 2012
Since 1973, studies of adult learners have revealed a number of important items relevant to training – especially training for Regulatory Compliance and training on Standard Operating Procedures  Read More »
Trends in Biopharmaceutical Contract Manufacturing
William Downey
September 25, 2012
Definition of Biopharmaceutical Manufacturing The manufacturing of biomaterials proteins, monoclonal antibodies, plasmid DNA, viral products or other biologics from microbial or mammalian cells, or transgenics production methods for therapeutics, diagnostics and vaccines.  Read More »
Global Pharma Outsourcing Industry Trends: A Strategic Network Transformation Approach
Paul Duffy
September 25, 2012
• Provide overview of global industry challenges and impact on pharmaceutical manufacturing • Brief summary of Pfizer and Pfizer Global Supply (PGS) • Highlight critical need for active linkage between global supply network elements • Importance of a strong quality culture  Read More »
Resizing the Global Contract R&D Services Market
Ken Getz
September 25, 2012
Dramatic Increase in Demand for Outsourcing Poor Global Economic Conditions and Sputtering R&D Engine – Rising R&D cost and volume; constrained revenue growth – Downsizing/Consolidation – Inefficient and costly operations  Read More »
When Disaster Strikes: What to do when your CMO goes Bankrupt or Leaves the Business
Kevin M. Koziatek
September 25, 2012
You read a new article that your CMO / CDMO has declared bankruptcy or is exiting the business for one reason or another!  Read More »

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