2010 Agenda
Monday, September 13, 2010
Tuesday, September 14, 2010 - Day 1
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9:00 - 10:00
Integrated Drug Discovery Services:Â The Future of Outsourcing
Rick Connell, Ph.D.
Vice President, WW head of External Research Solutions COE
Pfizer Global Research & Development
John Ellingboe, Ph.D.
Senior Vice President, Discovery Chemistry
GVK Biosciences
Steven Hutchins
SVP, Strategic Business Development
Evotec
Mark Sawicki, Ph.D.
Senior Director, Business Development
AMRI
Tom Sowin, Ph.D.
Associate Director II, Global External Research
Abbott Labs
David Stout, Ph.D.
Director of External Services
Merck & Company
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9:00 - 10:00
Is Chiral Separation the Best Way to Yield High Purity Compounds?
Merrick Almond, Ph.D.
VP, Research
Chimerix Inc.
Sean Bradley
Director of Business Development
Regis Technologies
Kevin Duffield
Regional Director, Business Development
Regis Technologies
Michael Sofia, Ph.D.
Vice President, Chemistry
Pharmasset
Andrew Thompson, Ph.D.
President
J-Star Research
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9:00 - 10:00
Both Sides of the Fence:Â Those Who Have Worked for Both Suppliers and Customers
Curtis Cui
Associate Director, API Manufacturing
Inspire Pharmaceuticals
Ving Lee, Ph.D.
CEO/CSO
Adesis, Inc.
Cheryl Li, Ph.D.
Director, External Technology and Innovation
Johnson and Johnson Consumer Healthcare Products
Harribert Neh, Ph.D.
Head of Production & Technology
Evonik Degussa GmbH
Luca Parlanti, Ph.D.
Head of Sales & Business Development North America-Custom Synthesis
BASF
David Wirth
Group Leader, Chemical Process Development
Targacept
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9:00 - 10:00
International Project Management: Culture, Personalities, Language, Distance
Gregory P. Bello
Director, API Sourcing
Alpharma Animal Health
Ellen Crawford
Strategic External Resourcing
Novartis Institutes for BioMedical Research, Inc.
Nina Dahlstrom
Account Manager for CVGI, GSA and DECS, R&D Procurement
Astrazeneca
Robert A. Goodnow, Jr. Ph.D.
Global Medicinal Chemistry Outsourcing, Discovery Chemistry
Hoffmann-La Roche Inc.
Umar Hayat, Ph.D.
Senior Manager, CMC
Anacor Pharmaceuticals
Nalukui Mwisiya
Senior Sourcing Specialist
Pfizer
Chitra Sharma
Senior Manager, CMC
Vivus Pharmaceuticals
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11:15 - 12:15
Biotech Company Outsourcing: Pricing, Timing, Speed, Quality, and Frequent Change
Jeannie Celiberti
Director, Operations and Facilities
Genocea Biosciences, Inc.
Jim Hamby, Ph.D.
Director of Business Development
Ash Stevens
Corrie Hulten, Ph.D.
Manager, Process Chemistry
BiogenIdec
Ed Olhava, Ph.D.
Scientist/Program Manager - Medicinal Chemistry
EpiZyme
Regan Shea, Ph.D
Senior Director, Chemical Development
Gilead Sciences
Andreas Stolle
Head of Business Line Pharma
Saltigo GmbH
Joseph Tessier
Vice President
PCAS-Nanosyn
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11:15 - 12:15
Particle Design: Bridging the Gap Between Chemists, Material Scientists, and Formulators
Hitesh Bhagat, Ph.D.
Vice President of Formulation
Genzyme
Scott Chadwick, Ph.D.
Director, Chemical & Pharmaceutical Operations
Anthera Pharmaceuticals
Umar Hayat, Ph.D.
Senior Manager, CMC
Anacor Pharmaceuticals
Doug Hecker
Global Director - Particle Design
Hovione
Stuart Silverman
Pharmaceutical Business Development
Pfizer
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11:15 - 12:15
Early Stage API Outsourcing & Supplier Relationships
Vince Ammoscato
Vice President, Operations
Ash Stevens
Michael Kolb, Ph.D.
Vice President, Chemical Development
Wyeth
Mark A. Krook, Ph.D.
Senior Director, API Development - US
Johnson & Johnson, Pharmaceutical Research & Development L.L.C.
Keith Mackay
Vice President, Sales & Marketing - Chemistry
GVK Biosciences
Stuart Needleman
President, API Development and Manufacturing
Aptuit
Jan Oudenes, Ph.D.
President & CEO
Alphora Research
Allen H. Salerno, Ph.D.
Senior Director, Business Development
AMRI
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11:15 - 12:15
Continuous Flow Manufacturing & Process Optimization
Paul C. Collins, Ph.D.
Director - Technology Design and Development
Eli Lilly & Company
Curtis Cui
Associate Director, API Manufacturing
Inspire Pharmaceuticals
Greg Hughes
Associate Director, Process Research
Merck & Co.
Inder Pal Singh, Ph.D.
Director, Business Development
SBI Fine Chemicals, Inc.
Paula Weissberger
Principal
PS LIfeSciences LLC
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Wednesday, September 15, 2010 - Day 2
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11:00 - 12:00
Quality Assurance in Contract Manufacturing
Sean Bradley
Director of Business Development
Regis Technologies
Russ Doughty
Senior Director, Quality
Indotek Pharmaceutical Corp
Daniel Radebaugh
Associate Director, Global Operations, Small Molecule Contract Manufacturing
Biogen idec
Stuart Silverman
Pharmaceutical Business Development
Pfizer
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11:00 - 12:00
Outsourcing Early Drug Discovery
M. Bhupathy, Ph.D.
Executive Director, Chemistry R & D Outsourcing
Amgen
Duncan B. Judd, Ph.D.
Manager, R&D
GlaxoSmithKline
Angus MacLeod, Ph.D.
VP Medicinal Chemistry
BioFocus
John J. Masters, Ph.D.
Director, Discovery Chemistry Synthesis Group
Eli Lilly & Company
Arvind Mathur, Ph.D.
Associate Director, Drug Discovery Chemistry
Bristol-Myers Squibb
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11:00 - 12:00
How Pharmaceutical Companies Select Suppliers of Chemistry Services
Kyle Blair
Sourcing Lead, API Strategy
Pfizer
Brian Bronk, Ph.D.
Vice President of Chemistry
Satori Pharmaceuticals
Cheryl Clark
Project Sourcing Manager, Discovery Sourcing Operations
Merck & Company
Michael Semo
Outsourcing Consultant, Chemical Product R&D Outsourcing
Eli Lilly & Company
Regan Shea, Ph.D
Senior Director, Chemical Development
Gilead Sciences
Winston Wu, Ph.D.
Director, Process Chemistry
Lexicon Pharmaceuticals
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11:00 - 11:30
Our Experience Externalizing Drug Discovery: Sourcing Biological Research Capabilities and Integrated Discovery Programs
Robert Lobell, Ph.D.
Director, Biology Sourcing
Merck & Co.
11:30 - 12:00
Pharmaceutical Contract Manufacturing Choice: India or China?
Yingming Yue
Associate Director, Supplier Management
Nektar Therapeutics
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1:15 - 2:15
Technical Packages for Contract Manufacturing: RFP’s, Quotes, Contracts, Final Reports
Andrew Anderson
Sourcing Lead
Pfizer
Charles Cook, Ph.D.
Associate Director, Process Chemistry
Reata Pharmaceuticals
Scott Miller, Ph.D.
Senior Director, Process Chemistry Pharmaceutical Technologies
Adolor Corporation
Maxwell M. Reeve, Ph.D.
Associate Director, Chemistry Manufacturing Management
Rib-X Pharmaceuticals Inc.
Winston Wu, Ph.D.
Director, Process Chemistry
Lexicon Pharmaceuticals
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1:15 - 2:15
I Have to Scale Up to 20 Kilos in 6 Months
Steve Beagle
Senior VP Sales & Business Development
Rohner Inc.
Sean Bradley
Director of Business Development
Regis Technologies
Ian Cottrell, Ph.D.
Director, External Services
Merck & Co.
Arvind Mathur, Ph.D.
Associate Director, Drug Discovery Chemistry
Bristol-Myers Squibb
Joseph P. Rainville
Sourcing Lead, Global External Supply
Pfizer
Greg Reid, Ph.D.
Vice President of Technology
PCI Synthesis
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1:15 - 2:15
How to Find Excellent Medicinal Chemistry Partners
Scott L. Dax, Ph.D.
Vice President, Chemistry
Galleon Pharmaceuticals
Allan Moorman, Ph.D.
Senior Director, Medicinal Chemistry
King Pharmaceuticals
Richard Soll, Ph.D.
Senior Vice President, Integrated Services
WuXi AppTec
Daniel Warner
Manager, Strategic External Resourcing
Novartis
Lihu Yang, Ph.D.
Director, Medicinal Chemistry, External Discovery and Preclinical Sciences
Merck Research Laboratroies
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1:15 - 1:45
Working with a CRO Partner on Medicinal Chemistry Programs: A Case Study of the EDG5 Antagonist Project at WuxiApptec
Thomas Saunders
Of Counsel
Rissman Hendricks & Oliverio
1:45 - 2:15
Genotoxic Impurities: The Analytical Challenges Of Impurities At The Parts Per Million Level
Allan R. Moorman, Ph.D.
Senior Director, Medicinal Chemistry
King Pharmaceuticals
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2:15 - 3:15
Master Service Agreements: Negotiation, Payment, Acceptance Criteria, Indemnification
Sean Bradley
Director of Business Development
Regis Technologies
Harry Kochat, Ph.D.
Vice President, Process Development & Manufacturing
Bionumerik Pharmaceuticals
David McGee
Associate Director, Pharm Chem Commercial Operations
Boehringer Ingelheim Chemicals
Thomas Saunders
Of Counsel
Rissman Hendricks & Oliverio
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2:15 - 3:15
What Makes a Good Process Chemistry External Partner?
Ravi Garigipati
Research-API
Pfizer Global Research & Development
Conrad W. Hummel, Ph.D.
Associate Director, Business Operations
Array BioPharma Inc.
Surendra Singh, Ph.D.
Director, Chemical Process Research
Sepracor
Richard Toupence
Process Research Sourcing
Merck & Company
Steven Weissman, Ph.D.
Associate Director, Process Chemistry
CoNCERT Pharmaceuticals
David Wirth, Ph.D.
Group Leader, Chemical Process Development
Targacept, Inc.
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2:15 - 3:15
Solid State Chemistry is a Very Hot Topic: Polymorphs, Co-Crystallization
Colleen Bleczinski, Ph.D.
Director, Business Development
Aptuit
Chris Frampton, Ph.D.
CSO
SAFC - Pharmorphix
Noel Hamill
Team Leader - Physical Sciences
Almac Sciences
Ashwini Nangia, Ph.D.
Technical Advisor
Synergia Sciences
Ken Wells, Ph.D.
Principal Scientist, Medicinal Chemistry Drug Discovery
Johnson & Johnson
Gary Wilmingham
Business Development Director
Solvias, Inc.
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2:15 - 2:45
Sourcing Innovative Compounds to Fulfill Drug Discovery Needs
Duncan B. Judd, Ph.D.
Manager, R&D
GlaxoSmithKline
2:45 - 3:15
Managing and Tracking Data in Collaborations with CROs
Christelle Renou
Senior Manager, Medicinal Chemistry Outsourcing
Millennium: The Takeda Oncology Company
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4:30 - 5:30
Chiral Synthesis: Early Project Application to Minimize Process Modification
Joseph M. Barendt Ph.D.
Chief Operating Officer
Chiral Technologies Inc.
Sean Bradley
Director of Business Development
Regis Technologies
Michael Sofia, Ph.D.
Vice President, Chemistry
Pharmasset
William H. Tamblyn, Ph.D.
Director, Commercial Development
Johnson Matthey Catalysts
Andrew Thompson, Ph.D.
President
J-Star Research
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4:30 - 5:30
Get your Suppliers Talking to Each Other! Strategies for Cross-Functional Supplier Integration
Joseph Drost
President
Micron Technologies
Derek G. Hennecke
CEO & President
Xcelience, LLC
Christopher Kavlick
Director, Business Development
Beckloff Associates
Brian W Scanlan
Chief Business Officer
Cambridge Major Laboratories
Michael Semo
Outsourcing Consultant, Chemical Product R&D Outsourcing
Eli Lilly & Company
Richard Slauter, Ph.D.
Senior Director, Drug Metabolism and Pharmacokinetics
MPI Research
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4:30 - 5:30
Sourcing API in Phase II to Facilitate the Commercial Activity
Roger P. Bakale, Ph.D.
Senior Director, Worldwide Chemical Process R&D
Cephalon, Inc.
Jon Brice, Ph.D.
Director, Business Development
Asymchem
Paul Brodfuerher
Project Manager
AMRI
Michael East, Ph.D.
VP Sales North America
Uquifa S.A.
Michael Kolb, Ph.D.
Vice President, Chemical Development
Wyeth
Violeta Marmon, Ph.D.
Director, CMC
OSI Prosidion
Tricia Scialla
Director, Material Operations
Wyeth
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4:30 - 5:00
We Don’t Need No Stinkin’ Patent Attorneys
Lihu Yang, Ph.D.
Director, Medicinal Chemistry, External Discovery and Preclinical Sciences
Merck Research Laboratroies
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Thursday, September 16, 2010 - Day 3
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8:45 - 9:45
Evaluating and Managing Risks in Your Supply Chain
Greg Bello
Director API Sourcing
Alpharma Animal Health
Ping Cao
Associate Director, CMO
Bristol-Myers Squibb
Bill Coakley
Senior Director, Supply Chain Management
SciClone Pharmaceuticals
David McGee
Associate Director, Pharma Chem Commercial Operations
Boehringer Ingelheim Chemicals
Dan Sullivan
Director of Chemical Registration Network
Pfizer
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8:45 - 9:45
Sourcing Synthetic Route Design & Process Optimization
Firoz D. Antia, Ph.D.
Executive Director Product Development
Palatin Technologies, Inc.
Violeta Marmon, Ph.D.
Director, CMC
OSI Prosidion
Scott Miller, Ph.D.
Senior Director, Process Chemistry Pharmaceutical Technologies
Adolor Corporation
Bernhard J. Paul, Ph.D.
Associate Director, Process Chemistry
Johnson Mathey Pharma Services
Andrew Thompson, Ph.D.
President
J-Star Research
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8:45 - 9:45
Phase Appropriate Procurement/Supply Agreements for Small Companies: Raw Materials, API’s, Suppliers
Bill Bennett
Principal
Bennett Pharma Solutions
Scott Chadwick, Ph.D.
Director, Chemical & Pharmaceutical Operations
Anthera Pharmaceuticals
Alan Harris, Ph.D.
Partner
Alacrity Pharma Associates
Stuart Levy, Ph.D.
Principal
SGL Chemistry Consulting
Diane McGuire
Principal
PharmAcumen Consulting
Deb Minor, Ph.D.
President
Drug Discovery Alliances Inc.
Sue Wollowitz, Ph.D.
VP, Chemistry and Manufacturing
Medivation, Inc.
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8:45 - 9:15
What is your Starting Material & API Sourcing Strategy?
Darlene Hall
Principal Scientist / Chemical R&D Global External Supply
Pfizer
9:15 - 09:45
Raw Material Supply Chain for Early Phase API Production
Elizabeth H. Rainbeau
Research Operations Manager, Small Molecule Process & Product Development
Amgen Inc.
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11:00 - 12:00
Sourcing & Manufacturing HPAPI’s
Roger P. Bakale, Ph.D.
Senior Director, Worldwide Chemical Process R&D
Cephalon, Inc.
Trevor Calkins, Ph.D.
Director of Process Development
SAFC Pharma
Brian Haney, Ph.D
Section Head, Commercial Manufacturing
AMRI
Harry Kochat, Ph.D.
Vice President, Process Development & Manufacturing
Bionumerik Pharmaceuticals
Don Mammato, Ph.D.
Vice President
Novasep Synthesis
Stephen Munk
President & CEO
Ash Stevens
Stuart Silverman
Pharmaceutical Business Development
Pfizer
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11:00 - 12:00
Balancing Your Outsourcing Portfolio:Â What Stays Home and What Goes to Asia or Europe
Elizabeth H. Rainbeau
Research Operations Manager, Small Molecule Process & Product Development
Amgen Inc.
Silvina Garcia Rubio
Senior Manager, CMC Development
Helsinn Therapeutics US, Inc.
Neil Sawant
Associate Director, Development Strategic Sourcing
Novartis
Bhaskar Venepalli, Ph.D.
President
CiVentiChem
Bob Waggoner
Sourcing Consultant - New Product Sourcing
Eli Lilly and Company
Angela Zhou
Scientific Manager
Genentech
Scott Zook, Ph.D.
Director of Chemical Development
Neurocrine Biosciences
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11:00 - 12:00
CMC Development & Regulatory Impact for Small & Medium-Sized Companies
Scott Chadwick, Ph.D.
Director, Chemical & Pharmaceutical Operations
Anthera Pharmaceuticals
Charles Cook, Ph.D.
Associate Director, Process Chemistry
Reata Pharmaceuticals
Curtis Cui
Associate Director, API Manufacturing
Inspire Pharmaceuticals
Gene Merutka, Ph.D.
Vice President of CMC
Zelos Therapeutics
Edward A. Narke
Principal and Co-founder
Design Space InPharmatics
Chitra Sharma
Senior Manager, CMC
Vivus Pharmaceuticals
Joseph Tessier
Vice President
PCAS-Nanosyn
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11:00 - 12:00
Sharing Data Securely & Efficiently in Collaborations with CROs
Kellan Gregory
Head of Product Management
Collaborative Drug Discovery, Inc.
Chris Ruggles, Ph.D.
Executive Director, Enterprise Marketing
CambridgeSoft Corporation
Robin Smith
CEO
ArtusLabs
Steven Tushup
Manager, External Services
Merck & Co.
Stefan Walke
Senior Manager, Collaborative Research
Boehringer-Ingelheim Pharmaceuticals
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1:15 - 2:15
Rating CRO/CMO Performance
Ellen Crawford
Strategic External Resourcing
Novartis Institutes for BioMedical Research, Inc.
Michael Kolb, Ph.D.
Vice President, Chemical Development
Wyeth
Cheryl Li, Ph.D.
Director, External Technology and Innovation
Johnson and Johnson Consumer Healthcare Products
Scott Miller, Ph.D.
Senior Director, Process Chemistry Pharmaceutical Technologies
Adolor Corporation
Todd M. Stark, Ph.D.
Business Development Manager
Johnson Mathey Pharma Services
James Tormos, Ph.D.
Director – PharmaTX Research Scientific Services
Pfizer Worldwide Procurement
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1:15 - 2:15
The Future of Big Pharma Outsourcing
Alan Harris, Ph.D.
Partner
Alacrity Pharma Associates
John J. Masters, Ph.D.
Director, Discovery Chemistry Synthesis Group
Eli Lilly & Company
John Mathew MBA, Ph.D.
Head, Discovery Sourcing Operations
Merck & Company
Christoph Naumann, Ph.D.
Director Operations
AllessaSyntec GmbH & Co. KG
Eric Shobe
Director, Scientific Outsourcing
Pfizer
Stefan Walke
Senior Manager, Collaborative Research
Boehringer-Ingelheim Pharmaceuticals
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1:15 - 2:15
Early Phase Clinical Trial Formulation & Dosage Form Delivery
Hitesh Bhagat, Ph.D.
Vice President of Formulation
Genzyme
Jeremy Drummond, Ph.D.
Business Unit Director - Formulated Products
Aesica Pharmaceuticals
Stephen Hannon, Ph.D.
Director of Marketing and Project Management
DavosPharma
Stuart Silverman, B.Sc., MBA
Pharmaceutical Business Development
Capsugel - A Division of Pfizer
Paula Weissberger
Principal
PS LIfeSciences LLC
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