2011 Agenda
Monday, September 12, 2011 - Day 1
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3:30 - 4:30
Late Stage API Development, Manufacturing, and CMO Relations
Enrique Dilone, Ph.D.
Vice President, Technical Operations
Amicus Therapeutics
Michael Humora, Ph.D.
Principal Investigator
BiogenIdec
Jeff Marra, Ph.D.
Principal Investigator
Purdue Pharma LP
Gene Merutka, Ph.D.
Vice President of CMC
Zelos Therapeutics
Luca Parlanti, Ph.D.
Head of Sales & Business Development North America-Custom Synthesis
BASF
Richard Toupence
Process Research Sourcing
Merck & Company
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3:30 - 4:30
Management of Early Stage Drug Discovery Chemistry Partnerships
Kay Brickmann, Ph.D.
Global Programme Manager, R&D, DECS
AstraZeneca
Scott L. Dax, Ph.D.
Vice President, Chemistry
Galleon Pharmaceuticals
Kevin Fang, Ph.D.
Director, Medicinal Chemistry
Sunovion Pharmaceuticals
Rattan Gujadhur, Ph.D.
Senior Manager Chemical Development, Strategic Outsourcing
Gilead Sciences
Yong-Jae Kim, Ph.D.
Research Operations Senior Manager
Amgen
Christelle Renou
Medicinal Chemistry Outsourcing Manager
Millennium Pharmaceuticals
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3:30 - 4:30
What CRO’s and CMO’s Need from Their Customers: Communicating Process Change, Material Requirements etc.
Niranjan M. Deo, Ph.D.
Director, Business Development and Strategic Marketing
Covenance
Kurt Hoeprich
Business Manager, Custom Services
Albemarle
David Pulham, Ph.D.
Chairman Compliance Board, Sr VP
Siegfried Ltd
Jeff Samuel
Manager, Sales & Marketing
Chemie Uetikon
Joe Tessier
Vice President
PCAS America, Inc.
Ronald G. Yarger, Ph.D.
Director, Business Development
Adesis, Inc.
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3:30 - 4:00
Our Clinical Development Compounds and How We Integrate Internal & CRO Activities
Mike Sofia, Ph.D.
Vice President, Chemistry
Pharmasset
4:00 - 4:30
Development Strategies for Virtual Companies
Stefan Proniuk, Ph.D.
Senior Director Product Development
Arno Therapeutics
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Tuesday, September 13, 2011 - Day 2
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9:30 - 10:30
Management of the Importation of Intermediates, API’s, and Other Materials from Asia
Raymond Dagnino Jr.
Executive Director of Business Development
Agno Pharma USA
Conrad W. Hummel, Ph.D.
Associate Director, Business Operations
Array BioPharma Inc.
Peter Pinto
Licensed Customs Broker, Certified Customs Specialist
World Courier, Inc.
Neil Sawant
Associate Director, Development Strategic Sourcing
Novartis - US
Michael Semo
Sourcing Manager / Virtual CMC Team
Eli Lilly & Company
Bhaskar Venepalli, Ph.D.
President
CiVentiChem
Winston Wu, Ph.D.
Senior Director Chemical Development
Lexicon Pharmaceuticals
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9:30 - 10:30
Technical Packages for Contract Manufacturing: RFP’s, MSA’s, Quotes, Contracts, Final Reports
Rattan Gujadhur, Ph.D.
Senior Manager Chemical Development, Strategic Outsourcing
Gilead Sciences
Frank Roschangar, Ph.D.
Senior Associate Director, Chemical Development
Boehringer Ingelheim Pharmaceuticals
Stuart Silverman, B.Sc., MBA
Pharmaceutical Business Development
Capsugel
John A. Walling, Ph.D.
Vice President, Manufacturing Operations
Reata Pharmaceuticals
Steven Weissman, Ph.D.
Associate Director, Process Chemistry
CoNCERT Pharmaceuticals
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9:30 - 10:30
Where is the HPAPI Business Going?
Jason Brady
Director, Sales & Business Development
Lonza Inc.
Robert Discordia, Ph.D.
Group Director Chemical Development & Head, External Partner Management Group
Bristol Myers Squibb
Kevin Haehl
Director of Manufacturing
Evonik
Raj Iyer, Ph.D.
President
Arch Pharmalabs (USA), Inc.
Jan Oudenes, Ph.D.
President & CEO
Alphora Research
Michael Quirmbach, Ph.D., MBA
Senior Manager Sales and Business Development
Dr. Reddy’s Laboratories
Larry Zeagler
Executive Director, Product Management
AMPAC Fine Chemicals
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9:30 - 10:00
Control of Genotoxic Impurities in APIs
Stephen Raillard, Ph.D.
Executive Director, Chemical Development
XenoPort, Inc.
10:00 - 10:30
Drug Discovery Sourcing
Stefan Oberboersch, Ph.D.
Head, Combinatorial Chemistry
Grunenthal GmbH
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11:30 - 12:30
API Scale-Up Challenges: Controlled Crystallization, Solid State, and Other Complex Chemistries
D. Scott Coffey, Ph.D.
Director, Chemical Product Research and Development
Eli Lilly and Company
Jan-Olav Henck, Ph.D.
Site Director
SSCI, a division of Aptuit
William Leong, Ph.D.
Senior Director Process Chemistry
Celgene Corporation
Mahmoud Mirmehrabi, Ph.D.
Principal Scientist, Salt Selection & Polymorph
Johnson Matthey
Bingidimi (JP) Mobele, Ph.D.
Founder and President
Okapi Chemtech, Inc.
Ken Wells
Principal Scientist
Johnson & Johnson
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11:30 - 12:30
Data Exchange Needs Between CRO’s & Customers
Mary Bosard, Ph.D.
Senior Fellow
Nektar Therapeutics
Ellen Crawford
Strategic External Resourcing
Novartis Institutes for BioMedical Research, Inc.
Nina Dahlstrom
Global Account Manager
Astrazeneca
Vince Kalish, Ph.D.
VP, Chemistry
Cardioxyl Pharmaceuticals
Mark A. Krook, Ph.D.
Senior Director, Portfolio Management
Johnson & Johnson
Violeta Marmon, Ph.D.
Senior Director, CMC
OSI Prosidion
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11:30 - 12:30
2011 Risks in the Pharmaceutical Supply Chain
James Bruno, Ph.D.
President
PharmaChem Magazine
Allan Coukell
Director, Medical Programs
Pew Health Group
Darlene Hall
Principal Scientist
Pfizer
Lindsay Purdie, Ph.D.
Sourcing Project Manager
Astrazeneca
Dan Sullivan
Senior Manager of Regulatory Support
Worldwide Chemical Registration Services, LLC
Scott Watson
Executive Director Sales and Marketing
AMPAC Fine Chemicals
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11:30 - 12:00
Application of Biocatalysis
Tom Moody
Head of Biocatalysis
Almac Group
12:00 - 12:30
Implementation of PLM Software to Enable Integrated Collaboration and Vendor Oversight for CMC Activities
Michael Semo
Sourcing Manager / Virtual CMC Team
Eli Lilly & Company
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Wednesday, September 14, 2011 - Day 3
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11:30 - 12:30
Outsourcing of API Formulation & Characterization
Cheryl Li, Ph.D.
Director, External Technology and Innovation
Johnson and Johnson Consumer Healthcare Products
Michael Semo
Sourcing Manager / Virtual CMC Team
Eli Lilly & Company
Scott Silaika
Director, Business Development
Aesica Pharmaceuticals
Stuart Silverman, B.Sc., MBA
Pharmaceutical Business Development
Capsugel
Scott Zook
Senior Director CMC API
Neurocrine Biosciences
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11:30 - 12:30
Are Integrated Drug Discovery Partnerships the New Pre-Clinical Outsourcing Model?
Eric Martin
Senior Account Manager, R&D Procurement
AstraZeneca
Jeff Naroian
Vice President Business Development
Evotec Inc.
Thomas Sowin, Ph.D.
Associate Director II, Advanced Technology
Abbott Laboratories
James Tornos, Ph.D.
Director Scientific Procurement
Pfizer
Stefan Walke, Ph.D.
Director/Corporate Research Networking
Boehringer-Ingelheim Pharmaceuticals
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11:30 - 12:30
Has Continuous Flow Technology in R&D and Manufacturing Finally Come of Age?
David Ager, Ph.D.
Principal Scientist
DSM
James Bruno, Ph.D.
President
PharmaChem Magazine
James M. Hamby, Ph.D.
Vice President
Ash Stevens, Inc.
Dirk Kirschneck, Ph.D.
Managing Director
Microinnova Engineering GmbH
Marc Winter
Application Engineer/Reactor Technologies
Corning Reactor Technologies
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11:30 - 12:00
SOCMA's Bulk Pharmaceutical Task Force: 2011 Progress Report
Lawrence Sloan
President
SOCMA
12:00 - 12:30
What You Need to Know Before You Sign the Contract
Jennifer Trevor
Senior Business Development Manager
Ferro Pfanstiehl
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2:15 - 3:15
Project Management of Critical Path Deliverables from CMO’s
Vince Ammoscato
Vice President, Operations
Ash Stevens
Robert Blanks
Vice President of Chemistry, Manufacturing, and Control
Flexion Therapeutics
Geoff Evans, P.Eng., MBA
Vice President, Business Operations
Alphora Research Inc.
Maxwell M. Reeve, Ph.D.
Associate Director, Chemistry Manufacturing Management
Rib-X Pharmaceuticals Inc.
Paula Weissberger, Ph.D.
Principal
PS LIfeSciences LLC
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2:15 - 3:15
Synthetic Route Design: How Can Medicinal & Process Chemists Do This Better?
Merrick Almond, Ph.D.
Vice President, Medicinal Chemistry
Chimerix Inc.
Leping Li, Ph.D.
Vice President of Chemistry
Presidio Pharmaceuticals
Don Mammato, Ph.D.
Vice President
Novasep Synthesis
Scott Miller, Ph.D.
Senior Director, Process Chemistry
Adolor Corporation
Sriram Naganathan, Ph.D.
Director, Chemical Development
Exelixis, Inc.
Jeff Raggon
Senior Principal Scientist
Pfizer
Chris Teleha, Ph.D.
Research Fellow
Johnson & Johnson PRD
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2:15 - 3:15
Biotech & Emerging Pharma Early Development API Sourcing: Things for Suppliers to Bear in Mind
Steve Beagle
Senior VP Sales & Business Development
Rohner Inc.
Jean-Luc Girardet, Ph.D.
Vice President, Research Ops / Process Chemistry
Ardea Biosciences
Corrie Hulten, Ph.D.
Contract Manager, Chemical Process R&D
BiogenIdec
Vince Kalish, Ph.D.
VP, Chemistry
Cardioxyl Pharmaceuticals
Chitra Sharma
Principal
CMC Consultant
Michael Thompson, Ph.D.
Senior Director, Chemical Development
FibroGen, Inc.
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2:15 - 2:45
Evolution of the AstraZeneca Compound Collection: Collaborations with Partners in China and Russia
Kay Brickmann, Ph.D.
Global Programme Manager, R&D, DECS
AstraZeneca
2:45 - 3:15
Effective Business & Supplier Management for Chemical Intermediates and Starting Materials
Younes Bekkali
Associate Director, Global Strategic Sourcing
Boehringer Ingelheim Pharmaceuticals
Frank Roschangar, Ph.D.
Senior Associate Director, Chemical Development
Boehringer Ingelheim Pharmaceuticals
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Thursday, September 15, 2011 - Day 4
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1:30 - 2:30
Both Sides of the Fence: Insights from Those Who Have Worked for Both Pharma and a CRO/CMO
Paul Deutsch, Ph.D.
Head, Chemical Process Development (CPD)
UCB Pharma SA
Don LaFerle
President, Sales & Marketing
IRIX Pharmaceuticals
Yuelie Lu, Ph.D.
Vice President
Shanghai Chemspec Corporation
Philip Ma, Ph.D.
Managing Director
Global Pharma Sourcing, LLC (GPhS)
Patricia Van Arnum
Senior Editor
Pharmaceutical Technology
Dix E. Weaver
Advisor - Supply Chain, Health & Nutrition
Evonik Exclusive Synthesis & Amino Acids
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1:30 - 2:30
Outsourcing Analytical Methods Development
Mary Bossard, Ph.D.
Senior Fellow
Nektar Therapeutics
Gene Merutka, Ph.D.
Vice President of CMC
Zelos Therapeutics
Antonio Scatena
Scientist
Gateway Analytical
Chitra Sharma
Principal
CMC Consultant
Stuart Silverman, B.Sc., MBA
Pharmaceutical Business Development
Capsugel
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1:30 - 2:00
The Importance of Face-to-Face Interactions When Outsourcing Process R&D
Scott Miller, Ph.D.
Senior Director, Process Chemistry
Adolor Corporation
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1:30 - 2:30
Limiting Genotoxic & Carcinogenic Impurities in API Formulation & Manufacturing
Violeta Marmon, Ph.D.
Senior Director, CMC
OSI Prosidion
Stephen Raillard, Ph.D.
Executive Director, Chemical Development
XenoPort, Inc.
Andrew Thompson, Ph.D.
President
J-Star Research
Florian Weighardt, Ph.D.
Associate Editor
Chemica Oggi / Chemistry Today
Scott Zook
Senior Director CMC API
Neurocrine Biosciences
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