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September 16-18, 2019

Ocean Place Resort, Long Branch, NJ

2019 Agenda

Tuesday, September 17 2019
Exhibitor Set Up 12:00pm - 11:00pm
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.
Dino Dedic, CFA
Director, Global Healthcare Group
Barclays Investment Bank
Jean-Jacques (John) Mondoloni
Managing Partner
Wombat Capital
Scott Watson (Moderator)
Global Business Development, API’s
Thermo Fisher Scientific
Mike McCoy (Moderator)
Business Editor
Chemical & Engineering News
Ralf Rempf (Moderator)
CHEManager International
Casino Night Games & Dinner Party for All Attendees, Speakers, Exhibitors 5:00pm – 8:30pm
Wed & Thurs, Sept 18 & Sept 19
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)
Gajanan Joshi,Ph.D.
Director, Chemical Development
Stuart G. Levy, PhD
SGL Chemistry Consulting, LLC
Winston Wu, Ph.D.
Vice President, Chemical Development
Lexicon Pharmaceuticals
Virtual & Emerging Companies Should Select Early Stage API Development & Drug Product Contractors
Christoph Naumann, Ph.D.
Direction, Commercial Operations
WeylChem InnoTec GmbH
Jared L. Randall, Ph.D.
Director of Development Chemistry
Aerpio Pharmaceuticals Inc.
William A. Kinney, Ph.D.
Senior VP, Research & Development
Enterin Inc.
Alpaslan (Alp) Yaman, Ph.D.
Principal Consultant
Biotech, Pharma & Device Consulting, LLC
Preparing for FDA Inspections of CDMO & Emerging & Virtual Pharma
Michael Spangler
Spangler Consulting
Drew Barlow
Vice President, Regulatory Affairs
Syner-G Pharma Consulting, LLC
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.
PharmaChem Associates
Phase 1-3 Appropriate Quality Systems For Virtual & Emerging Pharma: How Much Infrastructure Is Necessary?
Diane McGuire
PharmAcumen Consulting Inc.
Pam Smith
PharmIntellect Consulting
Paul Woitach
Managing Partner
Pharmaceutical Advisors
Virtual & Emerging Pharma: Selection Criteria for a CMO Partner for HPAPI & High Potency Drug Product


How To Pace & Control 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