Agenda

Contracting & Outsourcing 2013 featured a schedule balancing important Conference presentations with time to do business in the Exhibition!

Thursday, September 19
8:30-9:15 Breakfast Sponsored by Norwich
9:15-9:20 Welcome and
Opening Remarks		 Frank Chrzanowski
Moderator
9:20-10:00 Pfizer Keynote:
Outsourcing Trends
and Sterile Injectables		 Tom Wilson
Pfizer Global Supply
10:00-11:15 EXHIBIT HALL OPENS!
Mid-morning Break
in Exhibit Hall		 Sponsored by AbbVie
11:15-noon The Dose CMO Industry:
Size, Structure and Trends		 Jim Miller
PharmSource
noon-1:30 Lunch in Exhibit Hall Sponsored by
JHP Pharmaceuticals
1:30-2:10 FDA Keynote:
CMOs and Quality Agreements		 Paula Katz
FDA, CDER
2:10-2:40 Preserving the Partnership:
After the Agreement is Signed		 Steve Walker
Eli Lilly & Co.
2:40-3:15 Executive Outsourcing
Summit		 Tom Wilson (Pfizer),
Steve Walker (Lilly),
Mike Furlong (BMS),
Tom Wilson (Synta)
3:15-4:00 Break in Exhibit Hall
and Prize Drawings		 Grand Prize sponsored by
Jubilant HollisterStier,
Break sponsored by Pharma Tech Industries
4:00-5:15 Networking Reception Sponsored by
Catalent Pharma Solutions
Friday, September 20
7:30-8:25 Breakfast
8:25-8:30 Day 2 Opening Remarks Frank Chrzanowski
Moderator
8:30-9:15 Avoiding the Banana Peel:
9 Techniques To
Control Your Suppliers		 John Avellanet
Cerulean Associates
9:15-9:45 Rational Approaches to Quality Ajaz Hussain
Insight, Advice & Solutions
9:45-10:00 Mid-morning Break and
$100 AmEx Gift Card Giveaway
10:00-10:30 GDUFA and CMOs Mark Elengold
FDA Strategies
10:30-11:00 Managing Virtual Manufacturing Tom Wilson
Synta Pharmaceuticals
11:00-11:30 Bio-manufacturing Report William Downey
High Tech Business Decisions
11:30-noon Outsourcing Drug
Product Development		 Gautam Ranade
Pfizer Research
noon Closing remarks and prize giveaways:
iPad Mini & $100 AmEx Gift Card
(must be present to win)		 Frank Chrzanowski,
Moderator

EXHIBIT HALL HOURS: 10 a.m. to 4:00 p.m. on Thursday, Sept. 19

This year’s topics include:

2013

  • FDA Keynote: Quality Agreements with Contractors Guidance – Paula Katz • FDA
  • Pfizer Keynote: Global Outsourcing & Sterile Injectable Trends - Tom Wilson • Pfizer
  • The Dose Form Market: Size, Structure and Trends - Jim Miller • PharmSource
  • After the Contract: Preserving the Partnership – Steve Walker • Eli Llly
  • Managing Virtual Manufacturing – Tom Wilson • Synta Pharmaceuticals
  • Bio-Manufacturing Outsourcing Report – William Downey • High Tech Business Decisions
  • Avoiding the Banana Peel: 9 Techniques to Control Your Suppliers – John Avellanet • Cerulean Associates
  • Outsourcing Drug Product Development – Gautam Ranade • Pfizer
  • Executive Outsourcing Summit – Michael Furlong (Bristol-Myers Squibb), Tom Wilson (Pfizer), Seve Walker (Lilly), Tom Wilson (Synta)

Previous years’ topics include:

2012

  • Pfizer Keynote: Global Pharma Outsourcing Industry Trends: A Strategic Network Transformation Approach – Paul Duffy • Pfizer
  • Resizing the Global Contract R&D Services Market – Ken Getz • Tufts CSDD
  • Are CMOs Winning the War Against In-House Capacity? – Jim Miller • PharmSource
  • Defined Contributions: Measuring Alliance Management – David Thompson • Lilly
  • Making Compliance Sexy: Influencing Management to Comply – John Avellanet • Cerulean Associates
  • Trends in Biopharmaceutical Contract Manufacturing – William Downey • HighTech Business Decisions
  • When Disaster Strikes: What to do when your CMO goes bankrupt or leaves the business – Kevin Koziatek • Koziatek Consulting
  • Site Selection Criteria for Contract Service Providers – David Kristjanson • Sweetwater Construction
  • Building a Virtual Pharma Infrastructure – John Peck • Mesa Therapeutics
  • FDA Keynote: Inspectional Trends – Addam Reynolds • FDA NJ Distrcit office
  • What is Rx-360 and why should you get involved? – Linda Evans O’Connor • Teva & Scott Watson • Ampac

2011

  • Pfizer Keynote: Global Pharma Outsourcing Trends – Christine Ayllon • Pfizer, Inc.
  • Consolidation in the Contract Services Market: What It Means to Buyers and Sellers – Jim Miller • PharmSource
  • FDA Keynote: Guidance for Industry Process Validation: General Principles and Practices – Douglas Kovacs • FDA NJ District office
  • The Value of Strategic Alliances in Transforming Pharma R&D – Adrienne Takacs • Lilly
  • Virtual Suppliers – What FDA Expects You to Know and Do – John Avellanet • Cerulean Associates
  • FDA Keynote: Enforcement Update – Joseph McGinnis • FDA NJ District office
  • Restricting Future Growth: The War for Talent – Dave Jensen • Kincannon & Reed
  • Overview of FDA’s Process Validation Guidance – Jim Agolloco • Agalloco & Associates
  • Mapping US-Based Regional CRO Clusters – Stella Stergipoulos • Tufts CSDD
  • Risk-MaPP & Cleaning Validation – Bruce Naumann • Merck & Co.
  • East Meets West II – Carl Accettura • Dainippon Sumitomo Pharma America

2010

  • Pfizer Keynote: Global Pharma Outsourcing Trends – Mac Lynch • Pfizer
  • Roche/Genentech’s Risk-Based Approach to CMO Management – Franco Pasquale • Genentech
  • East Meets West: Japanese Pharma Experience with CMOs for the U.S. Market – Carl Accettura • Dainippon Sumitomo Pharma America
  • FDA Keynote: Compliance Enforcement Updates – Joseph McGinnis – FDA NJ District office
  • Holding Hands in the Dark: How to help your CMOs and CROs pass FDA Inspections – John Avellanet • Cerulean Associates
  • Are CMOs Leading Change? Innovating manufacturing, improving cost & quality and leveraging regulatory flexibility – Ali Afnan • Step Change, Inc. (fmr. FDA)
  • Utilizing Six Sigma to Optimize the Cost of Clinical Trials – Rhonda Griscti • J&J
  • Obtaining Capital for Growth – Michael Martorelli • Fairmount Partners
  • Panel Discussion: Contract Laboratory Criteria
  • Quality/Toxicology: Strategic Considerations when Doing Due Diligence – Damaris DeGraft-Johnson • DJA Global
  • QbD: Fitting the Building Blocks Together – Ronald Snee • Snee Associates

You can download PDFs of the conference sessions from Contracting & Outsourcing 2012 by visiting our download site!