2009 Agenda
Sunday, September 13, 2009
Monday, September 14, 2009 - Day 1
Tuesday, September 15, 2009 - Day 2
KEYNOTE
9:00 - 10:00
The Pharma Titanic: It's Time to Root for the Iceberg
Stefan D. Loren, Ph.D.
Managing Director
Westwicke Partners
11:00 - 12:15
Reform in the Inspection Process of Foreign Drug Manufacturing Facilities
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Manni Kantipudi |
Jon Brice, Ph.D. |
Charles Calvert |
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Michael N. Eakins, Ph.D. |
Michael A. Santoro, Ph.D. |
Joe Acker |
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1:30 - 2:30
Sourcing Synthetic Route Design and Process Optimization
Remy Angelaud, Ph.D.
Director API Development and Manufacture
Medivation
John Donaubauer, Ph.D.
Senior Project Leader
Abbott Labs
Michael East, Ph.D.
VP Sales North America
Uquifa S.A.
Conrad Hummel, Ph.D.
Associate Director, Business Operations
Array BioPharma
Katherine Kowalczuk, C.P.M.
Sourcing Lead
Pfizer
Jan Oudenes, Ph.D.
President & CEO
Alphora Research
Michael Semo
Outsourcing Consultant, Chemical Product R&D Outsourcing
Eli Lilly & Company
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1:30 - 2:30
Balancing Your Outsourcing Portfolio: What Goes Overseas and What Stays Home
Umar Hayat, Ph.D.
Senior Manager, CMC
Anacor Pharmaceuticals
Ving Lee, Ph.D.
CEO/CSO
Adesis, Inc.
Cheryl Li, Ph.D.
Director, Strategic Sourcing External Manufacturing & New Technology
McNeil/Johnson & Johnson
Peter Meltzer, Ph.D.
President
Organix Inc.
Bhaskar Venepalli, Ph.D.
President
CiVentiChem
Scott Zook
Director of Chemical Development
Neurocrine Biosciences
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1:30 - 2:30
What Is The Future of Big Pharma Outsourcing?
Robert Goodnow, Ph.D.
Global Head, Medicinal Chemistry Outsourcing
Hoffmann - La Roche
David Houser
Assistant Director, Business Development
Asymchem Laboratories
Michael Kolb, Ph.D.
Vice President, Chemical Development
Wyeth
Naren Mallakunta
Chief Executive Officer
LAXAI
Ratna Shekhar
Director, External Supply
Wyeth Pharmaceuticals
Eric Shobe
Director, Scientific Outsourcing
Pfizer
David Stout, Ph.D.
Director of External Services
Merck & Company
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1:30 - 2:00
How Can Pharmaceutical Services Outsourcing Generate A Higher Level of Value?
Manni Kantipudi
President
GVK Biosciences
2:00 - 2:30
Innovation Through Partnerships
Magid Abou-Gharbia, Ph.D., FRSC
Scientific Advisor
LAXAI
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3:30 - 4:30
Risk Management: Logistics, Documentation, Customs, Brokers, Agents, Delays
Charles Calvert
Senior Director, Worldwide Procurement
Pfizer
Luca Parlanti, Ph.D.
Head of Sales & Business Development North America-Custom Synthesis
BASF
H. Barry Robins
President
DavosPharma
Paula Weissberger
Director, New Business Development Life Science Unit
Sumitomo Corporation of America
4:30 - 5:30
Technical Packages for Contract Manufacturing: Quotes, Contracts, and Final Reports
Ravi Garigipati
Research-API
Pfizer Global Research & Development
Conrad Hummel, Ph.D.
Associate Director, Business Operations
Array BioPharma
Violeta Marmon
Director, CMC
(OSI) Prosidion
Sandra Moro
Senior Manager, Business Development
Helsinn Chemicals SA
Bernard Rausch, Ph.D.
Senior Corporate NBD Manager
Boehringer Ingelheim
Winston Wu, Ph.D.
Director, Process Chemistry
Lexicon Pharmaceuticals
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3:30 - 4:30
Will There Be Enough Raw Materials in the Supply Chain?
Kathleen Gabrielski CPM
Strategic Sourcing Manager, Direct Raw Materials
Schering-Plough
John Hollenbach
Vice President and General Manager
Doe & Ingalls of North Carolina
Nalukui Mwisiya
Senior Scientist Sourcing Specialist
Wyeth Research
Stuart Silverman
Pharmaceutical Business Development
Pfizer
Isaac Young, Ph.D.
Director, Supply Chain Operations
BioMarin Pharmaceuticals
4:30 - 5:30
Improving Drug Manufacturing through Controlled Enzyme Evolution
Roger Bakale, Ph.D.
Senior Director, Worldwide Chemical Process R&D
Cephalon, Inc.
Neal Falcone
Global Sourcing Lead, API
Pfizer
Greg Hughes
Associate Director, Process Research
Merck & Co.
Gjalt Huisman, Ph.D.
VP, R & D
Codexis, Inc.
Marc Struhalla
Managing Director
c-LEcta GmbH
Joseph Tessier
Vice President
PCAS-Nanosyn
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3:30 - 4:30
Is Chiral Separation The Best Method to Yield High Purity Compounds?
David Ager, Ph.D.
Principal Scientist
DSM
Joseph Barendt
Chief Operating Officer
Chiral Technologies
Sean Bradley
Director of Business Development
Regis Technologies
James Gage, Ph.D.
Chief Science Officer
Asymchem
Lee Latimer, Ph.D.
Senior Director, Chemical Sciences
Elan Pharmaceuticals
Don Mammato, Ph.D.
Vice President
Novasep Synthesis
4:30 - 5:30
Both Sides of the Fence - The Sourcing Perspective When You Have Worked Both For Suppliers and Pharma
Timothy Fitzpatrick
Site Head
Saltigo, Redmond
Umar Hayat, Ph.D.
Senior Manager, CMC
Anacor Pharmaceuticals
Keith Mackay
Director of Business Development
Codexis
Prashant S Savle, Ph.D.
Director of Sourcing, Chemical and Physical Sciences
Schering Plough Research Institute
Tricia Scialla
Director, Material Operations
Wyeth Research
Steven Tushup
Manager, External Services
Merck & Co.
Isaac Young, Ph.D.
Director, Supply Chain Operations
BioMarin Pharmaceuticals
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3:30 - 4:00
Mergers & Acquisitions in the Chemicals Industry: Recent Trends and Developments
Chris Cerimele
Managing Director & Co-Head, Global Chemicals
Lincoln International
4:00 - 4:30
(CANCELLED) Genotoxic Impurities: The Analytical Challenges Of Impurities At The Parts Per Million Level
Allan R. Moorman, Ph.D.
Senior Director, Medicinal Chemistry
King Pharmaceuticals
4:30 - 5:00
Minimizing European Importer Liability by Communicating New REACH-Mandated Packaging Information
Daniel Sullivan, Ph.D.
Director, Chemical Registration Network (CRN)
Pfizer
5:00 - 5:30
Back to the Future: Pains and Gains that Lead the Way to Effective Outsourcing
Chitra Sharma
Senior Manager, CMC
Vivus, Inc.
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Wednesday, September 16, 2009 - Day 3
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8:30 - 9:30
Finding Good Suppliers In Emerging Markets
Chen Chen, Ph.D.
Senior Vice President Of Chemistry
Sundia MediTech Company
Michael East, Ph.D.
VP Sales North America
Uquifa S.A.
David Harding
Newport Product Specialist
Thomson Reuters
Elut Hsu
VP Business Development
Asymchem
Chitra Sharma
Senior Manager, CMC
Vivus, Inc.
Stuart Silverman
Pharmaceutical Business Development
Pfizer
Surendra Singh, Ph.D.
Director, Chemical Process Research
Sepracor
Winston Wu, Ph.D.
Director, Process Chemistry
Lexicon Pharmaceuticals
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8:30 - 9:30
Finding Good Medicinal Chemistry Partners
Swapan Bhattacharya
Managing Director
TCG Lifesciences
John Ellingboe, Ph.D.
Assistant Vice President, Exploratory Chemistry
Wyeth Research
Mark Sawicki, Ph.D.
Senior Director, Business Development
AMRI
Jerauld Skotnicki, Ph.D.
Senior Director, External Chemistry, Chemical Sciences
Wyeth Research
Tom Sowin, Ph.D.
Senior Project Leader, Global Discovery Chemistry
Abbott Laboratories
Sven Wagner
Vice President Business Development, Discovery Services
GVK Biosciences
David Zimmermann, Ph.D.
Chief Executive Officer
Kalexsyn, Inc.
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8:30 - 9:30
Chiral Synthesis: Early Project Application to Minimize Process Modification
David Fick, Ph.D.
Director, Medicinal Chemistry
Cenomed Biosciences
Lee Latimer, Ph.D.
Senior Director, Chemical Sciences
Elan Pharmaceuticals
Prashant S Savle, Ph.D.
Director of Sourcing, Chemical and Physical Sciences
Schering Plough Research Institute
William H. Tamblyn, Ph.D.
Director, Commercial Development
Johnson Matthey Catalysts
Ton Vries
CEO
Syncom BV
Gary Willingham, Ph.D.
Business Development Director
Solvias, Inc.
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8:30 - 9:30
Biotech Company Outsourcing Culture: Pricing, Timing, Speed, Quality and Frequent Change
Firoz D. Antia, Ph.D.
Executive Director Product Development
Palatin Technologies, Inc.
Brian S. Bronk, Ph.D.
Vice President of Chemistry
Satori Pharmaceuticals Inc.
Curtis Cui
Associate Director, API Manufacturing
Inspire Pharmaceuticals
Bob Edmonston
Associate Director, API Development Sourcing
Alkermes, Inc.
Hui-Yin (Harry) Li, Ph.D.
President
Wilmington PharmaTech
Bernhard J. Paul, Ph.D.
Associate Director, Process Chemistry
CoNCERT Pharmaceuticals, Inc.
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10:45 - 11:45
Peptide Sourcing and Supply: Chemistry, Regulatory, Scale-Up
Firoz D. Antia, Ph.D.
Executive Director Product Development
Palatin Technologies, Inc.
Ralph Di Libero
Business Development
Roche Colorado
Gary Erickson
CEO
CBL Biopharma LLC
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10:45 - 11:45
Sourcing API in Phase II to Facilitate the Commercial Activity
Ian Cottrell, Ph.D.
Director, External Services
Merck & Co.
David Houser
Assistant Director, Business Development
Asymchem Laboratories
Thomas J. Niemeyer, CSCP
API Strategic Sourcing & Planning
Pfizer Global Research & Development
Bernard Rausch, Ph.D.
Senior Corporate NBD Manager
Boehringer Ingelheim
Tricia Scialla
Director, Material Operations
Wyeth Research
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10:45 - 11:45
Scale Up Manufacturing of Hazardous, Difficult, and Potent API’s
Nick Bockovich, Ph.D.
Director of Pharmaceutical Development
GPC Biotech
Trevor Calkins, Ph.D.
Director of Process Development
SAFC Pharma
Scott Miller, Ph.D.
Senior Director, Process Chemistry Pharmaceutical Technologies
Adolor Corporation
J.P. Monteau
Senior Director, Engineering
AMRI
Stuart Silverman
Pharmaceutical Business Development
Pfizer
Inder Pal Singh, Ph.D.
Director, Business Development
SBI Fine Chemicals, Inc.
Sue Wollowitz, Ph.D.
VP, Chemistry and Manufacturing
Medivation, Inc.
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10:45 - 11:45
Small Molecule Bio-Tech Company Approaches to Contracts, IP and Reports
John Chaber, Ph.D.
Senior Director Analytical Development
ARIAD Pharmaceuticals
David Fick, Ph.D.
Director, Medicinal Chemistry
Cenomed Biosciences
Brian Scanlon
Vice President
Cambridge Major Laboratories
Michael Williams, Ph.D.
Director, Pharmaceutical Research & Development
Targacept, Inc.
Shuguang Zhu, Ph.D.
President
Apincon
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1:00 - 2:00
Master Service Agreements: Negotiation, Payment Terms, Acceptance Criteria, Indemnification
Gregory P. Bello
Director, API Sourcing
Alpharma Animal Health
Sean Bradley
Director of Business Development
Regis Technologies
Chris Nuttall
Partner
PA Consulting
Maxwell M. Reeve, Ph.D.
Associate Director, Chemistry Manufacturing Management
Rib-X Pharmaceuticals Inc.
H. Barry Robins
President
DavosPharma
Thomas M Saunders
Of Counsel
Rissman Hendricks & Oliverio
2:00 - 3:00
Int’l Project Teams: Communication, Culture, Personalities, Language, Distance
Gregory P. Bello
Director, API Sourcing
Alpharma Animal Health
Brian S. Bronk, Ph.D.
Vice President of Chemistry
Satori Pharmaceuticals Inc.
Curtis Cui
Associate Director, API Manufacturing
Inspire Pharmaceuticals
Arvind Mathur, Ph.D.
Associate Director, Drug Discovery Chemistry
Bristol-Myers Squibb
Diane McGuire
Vice President Technical Operations and Quality
Oscient Pharmaceuticals
Stuart Needleman
President, API Development and Manufacturing
Aptuit
Chitra Sharma
Senior Manager, CMC
Vivus, Inc.
3:00 - 4:00
Early Stage API Outsourcing and Vendor Management
Hui-Yin (Harry) Li, Ph.D.
President
Wilmington PharmaTech
Michael Semo
Outsourcing Consultant, Chemical Product R&D Outsourcing
Eli Lilly & Company
Bharat Shah, Ph.D.
President
Calyx Chemicals and Pharmaceuticals
Joseph Tessier
Vice President
PCAS-Nanosyn
Richard Toupence
Process Research Sourcing
Merck & Company
Paul F. Vogt, Ph.D.
Vice President, Process Development Services
SiGNa Chemistry, Inc.
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1:00 - 2:00
How Can Suppliers Get Selected? Or De-Selected?
Balreddy Kamireddy, Ph.D.
CRO and Synthesis Research Leader
DuPont Crop Protection
Stephen A. Munk, Ph.D.
President & CEO
Ash Stevens Inc
Balaram Patro, Ph.D.
VP and Head of Medicinal Chemstry
GVK Biosciences
Scott Powers
Business Development Manager
BASF Custom Synthesis
Mark Ralph, Ph.D.
Manager, Medicinal Chemistry
Boehringer Ingelheim
Richard Toupence
Process Research Sourcing
Merck & Company
2:00 - 3:00
Supplier Performance Metrics and Partner Relationship Management
Firoz D. Antia, Ph.D.
Executive Director Product Development
Palatin Technologies, Inc.
Ellen Crawford
Strategic External Resourcing
Novartis Institutes for BioMedical Research, Inc.
Mark Eugenio
Director of Commercial Development
CML
Stuart Hadley
Outsourcing Project Manager
AstraZeneca
Brian Scanlon
Vice President
Cambridge Major Laboratories
Steven Tushup
Manager, External Services
Merck & Co.
Richard D. Wilson, Ph.D.
Associate Director, Medicinal Chemistry
Theravance, Inc.
3:00 - 4:00
Solid State Screening & Characterization of Small Molecules, Polymorphism, Co-Crystallization
Colleen Bleczinski, Ph.D.
Director, Business Development
Aptuit
Joseph Forth
Group Leader, Pharmaceutical Development
AMRI
Paul Hirst, Ph.D.
Director, Business Development
SAFC Pharma
Deborah Minor, Ph.D.
President
Drug Discovery Alliances
Andrei Winkler, MSc, MBA
VP Business Development, North America
Avantium Pharma, Inc.
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1:00 - 2:00
Process Analytical Development in the API Manufacturing Process
Jon Brice, Ph.D.
Director, Business Development
Asymchem
Joseph Forth
Group Leader, Pharmaceutical Development
AMRI
Thomas Scarpa, Ph.D.
Associate Director, Pharmaceutical Development
GPC Biotech Inc.
2:00 - 3:00
Service Providers & IP Concerns
M. Bhupathy, Ph.D.
Executive Director, Chemistry R & D Outsourcing
Amgen
Mike Cruskie, Ph.D.
Vice-President, Business Development, Supply Chain and IRIX Neva
IRIX Pharmaceuticals
John Donaubauer, Ph.D.
Senior Project Leader
Abbott Labs
Thomas M Saunders
Of Counsel
Rissman Hendricks & Oliverio
3:00 - 4:00
Early Drug Discovery Outsourcing: Reference Compounds, Building Blocks, Scaffolds, Route Development, Lead Optimization
Balu Balasubramanian, Ph.D.
Executive/Managing Director, R&D
Bristol-Myers Squibb
Scott L. Dax, Ph.D.
Senior Director and Head of Chemistry, Drug Discovery
Galleon Pharmaceuticals Inc.
Ming Guo, Ph.D.
General Manager, Ascenta (Shanghai) R&D Center; Vice President, Pharma Sciences & Manufacturing
Ascenta Therapeutics, Inc.
Naren Mallakunta
Chief Executive Officer
LAXAI
John J. Masters, Ph.D.
Senior Research Advisor, Discovery Chemistry Synthesis Group
Eli Lilly & Company
Mark Ralph, Ph.D.
Manager, Medicinal Chemistry
Boehringer Ingelheim
Richard D. Wilson, Ph.D.
Associate Director, Medicinal Chemistry
Theravance, Inc.
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1:00 - 2:00
Biotech Small Molecule API Sourcing: CMO Value Proposition vs. Customer Needs
Zhengming (Jimmy) Chen, Ph.D.
Chemistry and API Consultant
Aton Pharma, Inc.
Luca Parlanti, Ph.D.
Head of Sales & Business Development North America-Custom Synthesis
BASF
Michael Sofia, Ph.D.
Vice President, Chemistry
Pharmasset
Peng Wang, Ph.D.
Senior Manager, Process Chemistry
Phenomix Corporation
Ben Yerxa, Ph.D.
Executive Vice President & Chief, Research & Development
Inspire Pharmaceuticals
2:00 - 3:00
I Have to Scale Up to 20 Kilos in 6 Months How Can I Get This Done
Umar Hayat, Ph.D.
Senior Manager, CMC
Anacor Pharmaceuticals
Violeta Marmon
Director, CMC
(OSI) Prosidion
Deborah Minor, Ph.D.
President
Drug Discovery Alliances
Jan Oudenes, Ph.D.
President & CEO
Alphora Research
Brian Scanlon
Vice President
Cambridge Major Laboratories
Andrew Thompson, Ph.D.
President
J-Star Research
3:00 - 4:00
Small Molecule Bio-Tech Vendor Selection Criteria
Srinivasan Babu
Senior Scientist
Genentech
Jim Hamby, Ph.D.
Director of Business Development
Ash Stevens
Stuart Levy, Ph.D.
Director, Chemistry
Magen Biosciences
Stuart Needleman
President, API Development and Manufacturing
Aptuit
Phil Roberts
Senior Director, Manufacturing & Outsourcing
Exelixis
Silvina Garcia Rubio
Senior Manager, CMC Development
Helsinn Therapeutics US, Inc.
Shuguang Zhu, Ph.D.
President
Apincon
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