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September 17-19, 2019

Parsippany, New Jersey Hilton Hotel

2019 Agenda

Tuesday, September 17, 2019
Track A Track B
Exhibitor Set Up 12:00 PM - 11:00 PM
CMC Workshop 1:00 PM - 4:00 PM
KEYNOTE PANEL: M&A 2018/2019: Trends in Chemistry Services and Contract Manufacturing 4:00 PM - 5:00 PM
What does the M&A Contract Manufacturing marketplace look like in Sept 2019? We will talk about 2018-2019 deals and possible 2020 M&A activity in the contract manufacturing CMO/CDMO markets. We’ll talk about small molecules, technologies, but also biologics whose growth is a driver, such as in Gene/Cell Therapy. We'll look at what investors, like Private Equity, are saying and where capital is flowing. CMO/CDMO are evolving quickly. Contract Manufacturing is growing as our industry brings new technologies to market, globalizes, consolidates, and spawns new companies, large and small. The format will be informal - Q&A and commentary will be welcome throughout the session.
Sean Gallagher
Managing Director, Investment Banking
Janney Montgomery Scott
Mike McCoy (Moderator)
Business Editor
Chemical & Engineering News
Jean-Jacques (John) Mondoloni
Managing Partner
Wombat Capital
Ralf Rempf (Moderator)
Editor-in-Chief
CHEManager International International
Andrew Thompson, Ph.D.
President & CEO
J-STAR Research, Inc. (A member of The Porton Group)
Scott Watson, CFA, MBA
Principal
The C=C Bond Group
David Zimmermann, Ph.D.
Chief Executive Officer
Dipharma-Kalexsyn, Inc.
Casino Night Games & Dinner Party for All Attendees, Speakers, Exhibitors 5:00 PM - 8:30 PM
Wednesday, September 18, 2019
Track A Track B
Registration 07:30 AM
Breakfast in Exhibit Hall 07:30 AM
Exhibit Halls Open 07:30 AM - 5:30 PM
Track A (09:00 AM - 09:30 AM)
Artificial Intelligence, Machine Learning and Predictive Analytics for Synthetic Route Design and Development in API Manufacturing
Jun Li, Ph.D.
Senior Principal Scientist, Chemical Synthetic Development
Bristol-Myers Squibb
Track B (09:00 AM - 09:30 AM)
Continuous Manufacturing of Small Molecule Drugs: Why Isn't Your Company on Board?
Brian Takizawa, MD, MBA
Chief Business Officer
CONTINUUS Pharmaceuticals, Inc.
Coffee & Snacks in Exhibit Hall 09:30 AM - 10:30 AM
Track A (10:30 AM - 11:15 AM)
Integrated CMC Development at Emerging & Virtual Pharma - The Role of Chemical Development and API Manufacturing
Xiaoyong Fu, Ph.D.
Sr. VP API Development and Commercialization
STA Pharmaceutical, a WuXi AppTec company (WuXi STA)
Nick Johnson
SVP, Business Development, Asia
Evotec
Gajanan Joshi,Ph.D.
Director, Chemical Development
Allergan
Stuart G. Levy, Ph.D.
Principal
SGL Chemistry Consulting
Winston Wu, Ph.D.
Vice President, Chemical Development
Lexicon Pharmaceuticals
Track B (10:30 AM - 11:15 AM)
Building Drug Discovery Outsourcing Programs for Virtual and Emerging Pharma
Oleg Michurin, Ph.D.
Project Manager
Enamine, Ltd
Frank Moffatt, Ph.D.
Director of Business Development
NovAliX
Chetan Pandit, Ph.D.
Senior Vice President, Medicinal Chemistry
Aurigene
Jeff Saunders, Ph.D.
SVP, Drug Discovery
Casma Therapeutics
Ashu Tandon
Chief Commercial Officer
Syngene International
Coffee & Snacks in Exhibit Hall 11:15 AM - 12:00 PM
Luncheon in Main Restaurant 12:15 PM - 1:45 PM
Track A (1:30 PM - 2:15 PM)
Phase 1-3 Appropriate Quality Systems For Virtual & Emerging Pharma: How Much Infrastructure Is Necessary?
Cynthia Brysch
Director Of Quality Assurance and Regulatory Affairs
Cancer Genetics
Diane McGuire
Principal
PharmAcumen Consulting Inc.
Michael McGuire
Senior Consultant
Carrowcur Ltd.
Enith Morillo, MS
Senior Quality Consultant
Cadoret Global LLC
Pam Smith
President
PharmIntellect Consulting
Paul Woitach
Managing Partner
Pharmaceutical Advisors
Track B (1:30 PM - 2:15 PM)
Improving Analytics of CRO/CDMO: Augmented Reality & New Technologies
Ian W. Davies, Ph.D.
Department of Chemistry
Princeton University
Jake Janey, Ph.D.
Head of Specialized Designed Experimentation, Chemical & Synthetic Development
Bristol-Myers Squibb
Coffee & Snacks in Exhibit Hall 2:15 PM - 3:30 PM
Track A (3:30 PM - 4:15 PM)
Proper Technical Management of CMO's and Emerging Pharma Outsourcing Drug Substance And Drug Product
Ray E. Forslund, Ph.D., MBA
Vice President, CMC Development & Project Management
Syner-G Pharma Consulting, LLC
Liz Syage, Ph.D.
Consultant
PharmaChem Associates
Stephen Wald
Vice President, Chemistry and Pharmaceutical Sciences
Rgenix, Inc.
Track B (3:30 PM - 4:15 PM)
Choosing and Defending RSM (ICH Q11): Clearing the FDA for Phase 3 Studies and Commercial
Roy A. Swaringen, Jr, Ph.D.
Principal
Pharmaceutical industry Consultant
Coffee & Snacks in Exhibit Hall 4:15 PM - 5:00 PM
Beach Party, Dinner & Fun. Hawaiian Shirts & Sandals Recommended 5:30 PM - 8:30 PM
Networking at Lobby Bar 8:30 PM - 00:00 AM
Thursday, September 19, 2019
Track A Track B
Breakfast in Exhibit Halls 07:30 AM
Exhibit Halls Open 07:30 AM - 4:00 PM
Track A (09:00 AM - 09:45 AM)
Virtual & Emerging Companies: Selecting Early Stage API Development & Drug Product Contractors
William A. Kinney, Ph.D.
Senior VP, Research & Development
Enterin Inc.
Christoph Naumann, Ph.D.
Director, Commercial Operations
WeylChem InnoTec GmbH
Jared L. Randall, Ph.D.
Principal
PharmaChemica CMC Consulting LLC
Alpaslan (Alp) Yaman, Ph.D.
Principal Consultant
Biotech, Pharma & Device Consulting, LLC
Track B (09:00 AM - 09:45 AM)
Preparing for FDA Inspections of CDMO & Emerging & Virtual Pharma
Drew Barlow
Vice President, Regulatory Affairs
Syner-G Pharma Consulting, LLC
Cynthia Brysch
Director Of Quality Assurance and Regulatory Affairs
Cancer Genetics
Diane McGuire
Principal
PharmAcumen Consulting Inc.
Michael Spangler
Principal
Spangler Consulting
Coffee & Snacks in Exhibit Halls 09:45 AM - 10:30 AM
Track A (10:30 AM - 11:15 AM)
How To Limit Spending on CRO/CMO Services at Virtual & Emerging Companies: Discovery Through Late Stage API Mfg
Richard Amitrano
VP Business Development NA
WeylChem Innotec GmbH
Joe Carey
Managing Director
Key Organics
Ray E. Forslund, Ph.D., MBA
Vice President, CMC Development & Project Management
Syner-G Pharma Consulting, LLC
John B. Zucaro, PE
Senior Vice President-CMC
Tyme, Inc.
Track B (10:30 AM - 11:15 AM)
Important Considerations for Virtual & Emerging Pharma in the Selection of a CMO Partner for High Potency Drug Substance & Drug Product
Susan Billings, Ph.D.
Director, Business Development
AMRI †
Sean Diver
Director, Business Development
Lonza
George Rothermel, Ph.D.
Associate Director, Contract Manufacturing Sales
Evonik
Simone Sala
Business Development Manager
Cerbios - Pharma
Claudio Salvagnini, Ph.D.
HPAPI Market Director
Minakem
Allison Vavala
Associate Director, Business Development
Helsinn
Coffee & Snacks in Exhibit Halls 11:15 AM - 12:00 PM
Luncheon in Main Restaurant 12:15 PM - 1:45 PM
Track A (1:15 PM - 2:00 PM)
Roadmap China: Culturally Sensitive Discussion About Drug Safety & Quality
Peter Halkjaer-Knudsen
Executive Vice President
Raybow Pharmaceuticals
Don Hou
SVP, CMC Business & GM
ChemPartner
Michael Santoro
Professor of Management
Santa Clara University
Track B (1:15 PM - 2:00 PM)
API Supplier Oversight & Redundancy: Itís All About Risk Mitigation
Deborah Minor, Ph.D.
President
Drug Discovery Alliances
Coffee & Snacks in Exhibit Halls 2:00 PM - 3:00 PM
Track A (3:00 PM - 3:45 PM)
Process Safety & Risk Mitigation In Contract Development & Manufacturing
James Golden
Associate Process Engineer
CRB  
Peter Halkjaer-Knudsen
Executive Vice President
Raybow Pharmaceuticals
Andrew T. Phillis Ph.D.
VP of Business Development
Raffles PharmaTech
Track B (3:00 PM - 3:45 PM)
Emerging Pharma: How To Fast Track Phase 1-2 Drug Candidates for FDA Approval
James Bruno, Ph.D.
Owner
Chemical and Pharmaceutical Solutions and Chemicals Consultant
2019 ChemOutsourcing Concludes. We hope You Had a Very Productive Meeting! See You in 2020! 4:00 PM