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September 17-19, 2019

Parsippany, New Jersey Hilton Hotel

2019 Agenda

Tuesday, September 17, 2019
Exhibitor Set Up 12:00pm - 11:00pm
CMC Workshop 1:00pm – 3:30pm
KEYNOTE PANEL: M&A 2018/2019: Trends in Chemistry Services and Contract Manufacturing 4:00pm – 5:00pm
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.
Jean-Jacques (John) Mondoloni
Managing Partner
Wombat Capital
Scott Watson (Moderator)
Principal
C=C Bond
David C. Zimmermann
Chief Executive Officer
Kalexsyn, Inc.
Mike McCoy (Moderator)
Business Editor
Chemical & Engineering News
Ralf Rempf (Moderator)
Editor-in-Chief
CHEManager International
Andrew Thompson, Ph.D.
President & CEO
J-STAR Research, Inc. (A member of The Porton Group)
Dino Dedic
Director, Global Healthcare Group
Barclays Investment Bank
Rob Maddox
Former President & CEO
PharmaCore (Acquired by Cambrex)
Casino Night Games & Dinner Party for All Attendees, Speakers, Exhibitors 5:00pm – 8:30pm
Wednesday, September 18, 2019
Track A Track B
Registration 7:30am
Breakfast in Exhibit Hall 7:30am
Exhibit Halls Open 7:30am - 5:30pm
Track A (9:00am - 9:30am)
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 (9:00am - 9:30am)
Continuous Manufacturing of Small Molecule Drugs: Why Isn't Your Company on Board?
Bayan Takizawa, MD, MBA
Chief Business Officer
CONTINUUS Pharmaceuticals, Inc.
Coffee & Snacks in Exhibit Hall 9:30am - 10:30am
Track A (10:30am - 11:15am)
Integrated CMC Development at Emerging & Virtual Pharma - The Role of Chemical Development and API Manufacturing
Xiaoyong Fu
Sr. VP API Development and Commercialization
STA Pharmaceutical, a WuXi AppTec company (WuXi STA)
Stuart G. Levy, PhD
Principal
SGL Chemistry Consulting, LLC
Gajanan Joshi,Ph.D.
Director, Chemical Development
Allergan
Winston Wu, Ph.D.
Vice President, Chemical Development
Lexicon Pharmaceuticals
Track B (10:30am - 11:15am)
Building Drug Discovery Outsourcing Programs for Virtual and Emerging Pharma
Jeff Saunders, Ph.D.
SVP, Drug Discovery
Casma Therapeutics
Frank Moffatt, Ph.D.
Director of Business Development
NovAliX
Ashu Tandon
Chief Commercial Officer
Syngene International
Coffee & Snacks in Exhibit Hall 11:15am - 12:00pm
Luncheon 12:00pm - 1:30pm
Track A (1:30pm - 2:15pm)
Phase 1-3 Appropriate Quality Systems For Virtual & Emerging Pharma: How Much Infrastructure Is Necessary?
Diane McGuire
Principal
PharmAcumen Consulting Inc.
Paul Woitach
Managing Partner
Pharmaceutical Advisors
Pam Smith
President
PharmIntellect Consulting
Enith Morillo, MS
Senior Quality Consultant
Cadoret Global LLC
Track B (1:30pm - 2:15pm)
Improving Analytics of CRO/CDMO: Augmented Reality & New Technologies
Jake Janey, Ph.D.
Head of Specialized Designed Experimentation, Chemical & Synthetic Development
Bristol-Myers Squibb
Ian W. Davies, Ph.D.
Department of Chemistry
Princeton University
Coffee & Snacks in Exhibit Hall 2:15pm - 3:30pm
Track A (3:30pm - 4:15pm)
Proper Tech Project Management for Emerging & Virtual Pharma
Raymond E. Forslund, PhD MBA
Vice President, CMC Development & Project Management
Syner-G Pharma Consulting, LLC
Stephen Wald
Vice President, Chemistry and Pharmaceutical Sciences
Rgenix, Inc.
Liz Syage, Ph.D.
Consultant
PharmaChem Associates
Track B (3:30pm - 4:15pm)
Choosing and Defending RSM (ICH Q11): Clearing the FDA for Phase 2 Studies
Roy A. Swaringen, Jr, Ph.D.
Principal
Pharmaceutical industry Consultant
Coffee & Snacks in Exhibit Hall 4:15pm - 5:00pm
Beach Party, Dinner & Fun. Hawaiian Shirts & Sandals Recommended 5:30pm - 8:30pm
Networking at Lobby Bar 8:30pm - 12:00am
Thursday, September 19, 2019
Track A Track B
Breakfast in Exhibit Halls 7:30am
Exhibit Halls Open 7:30am - 4:00pm
Track A (9:00am - 9:45am)
Virtual & Emerging Companies: Selecting Early Stage API Development & Drug Product Contractors
Christoph Naumann, Ph.D.
Direction, Commercial Operations
WeylChem InnoTec GmbH
William A. Kinney, Ph.D.
Senior VP, Research & Development
Enterin Inc.
Jared L. Randall, Ph.D.
Aerpio Pharmaceuticals Inc.
PharmaChem Associates
Alpaslan (Alp) Yaman, Ph.D.
Principal Consultant
Biotech, Pharma & Device Consulting, LLC
Track B (9:00am - 9:45am)
Preparing for FDA Inspections of CDMO & Emerging & Virtual Pharma
Michael Spangler
Principal
Spangler Consulting
Drew Barlow
Vice President, Regulatory Affairs
Syner-G Pharma Consulting, LLC
Michael McGuire
QBD Lead
GlaxoSmithKline
Coffee & Snacks in Exhibit Halls 9:45am - 10:30pm
Track A (10:30am - 11:15am)
How To Limit Spending on CRO/CMO Services at Virtual & Emerging Companies: Discovery Through Late Stage API Mfg
Joe Carey
Managing Director
Key Organics
Raymond E. Forslund, PhD MBA
Vice President, CMC Development & Project Management
Syner-G Pharma Consulting, LLC
John B. Zucaro, PE
Senior Vice President-CMC
Tyme, Inc.
Track B (10:30am - 11:15am)
Important Considerations for Virtual & Emerging Pharma in the Selection of a CMO Partner for High Potency Drug Substance & Drug Product
George Rothermel, Ph.D.
Associate Director, Contract Manufacturing Sales
Evonik
Susan B. Billings, Ph.D.
VP & Global Head, Business Development
AMRI
Simone Sala
Business Development Manager
Cerbios - Pharma
Minakem TBA
Lonza TBA
Helsinn TBA
Sean Diver
Director, Business Development
Lonza
Coffee & Snacks in Exhibit Halls 11:15am - 12:00pm
Luncheon 12:00pm - 1:15pm
Track A (1:15pm - 2:00pm)
Roadmap China: Culturally Sensitive Discussion About Drug Safety & Quality
Michael Santoro
Professor of Management
Santa Clara University
Don Hou
SVP, CMC Business & GM
ChemPartner
Peter Halkjaer-Knudsen
Executive Vice President
Raybow Pharmaceuticals
Track B (1:15pm - 2:00pm)
The Unique Challenges in the Process Development and Validation of Radiochemical Precursors
David W Wilson, Ph.D.
Director, Contract Manufacturing
Avid Radiopharmaceuticals
Coffee & Snacks in Exhibit Halls 2:00pm - 3:00pm
Track A (3:00pm - 3:45pm)
Process Safety & Risk Mitigation In Contract Development & Manufacturing
Andrew T. Phillis Ph.D.
VP of Business Development
Raffles PharmaTech
James Golden
Associate Process Engineer
CRB
Peter Halkjaer-Knudsen
Executive Vice President
Raybow Pharmaceuticals
Track B (3:00pm - 3:45pm)
Emerging Pharma: How To Fast Track Phase 1-2 Drug Candidates for FDA Approval
Jim Bruno
Owner
Chemical and Pharmaceutical Solutions and Chemicals Consultant
2019 ChemOutsourcing Concludes. We hope You Had a Very Productive Meeting! See You in 2020! 4:00pm