September 14-17, 2015
Ocean Place Resort & Spa

2015 Agenda

Print agenda

Monday, September 14, 2015 - Day 1

12:00pm - 11:00pm
Exhibitor Set Up
12:00pm - 8:00pm
Private Meetings Rooms Open (Use online portal to book)
5:00pm – 8:00pm
Reception & Dinner

Tuesday, September 15, 2015 - Day 2

7:30am - 10:00am
Full Hot & Cold Breakfast in Exhibitor Halls
9:00am - 3:00pm
Exhibitor Presentations Track C
7:00am - 6:00pm
Exhibit Halls Open
7:00am - 6:00pm
Private Meeting Rooms Open (Use online portal to book)
Track A Track B Track C Track D

9:00 - 09:45 Panel Discussion
Trends in Late Stage Clinical API Sourcing, Commercial API Manufacturing & CMO Partnerships
Vince Ammoscato
Vice President, Operations
Ash Stevens
Kuo-Hsi Cheng, Ph.D.
President
ScinoPharm(Changshu) Pharmaceuticals
Angelos Dovletoglou, Ph.D.
Executive Director of Preclinical Development Sciences
Epizyme
Surendra Singh, Ph.D.
Director, Drug Substance
Verastem, Inc.
Ephraim Vidal, Ph.D.
Senior Manager, API Development and Manufacturing
Receptos
Andrew Warmington, Ph.D.
Editor
Special Chemicals Magazine
Winston Wu, Ph.D.
Vice President, Chemical Development
Lexicon Pharmaceuticals

9:00 - 09:45 Panel Discussion
Trends in Drug Discovery Chemistry, Medicinal Chemistry & CRO Partnerships
Sean Chen, Ph.D.
Director of Business Development & Project Management
Beijing Laviana Pharmatech Co
Paul Clewlow, Ph.D.
Senior VP, Business Development
Sygnature Discovery Ltd
Paul Doyle, Ph.D.
Chief Operating Officer
Peakdale Molecular
Vincent J. Kalish, Ph.D.
SVP, Chemistry and Pre-Clinical Development
Cardioxyl Pharmaceuticals
David Perry, Ph.D.
Associate Research Fellow, ERS
Pfizer
A.M. Venkatesan, Ph.D.
Director
TCG Lifesciences

9:45am - 11:00am
Networking & Snacks in Exhibit Halls
Track A Track B Track C Track D

11:00 - 11:45 Panel Discussion
Scouting New Synthetic Routes for Scale Up & Process Optimization of API’s
Michael Cannarsa, Ph.D.
Director, Business Development
Almac
Andre H.M. de Vries, Ph.D.
Director DSM InnoSyn Route Scouting Services
DSM Chemical Technology R&D BV
Julien Hugon
Business Director
Provence Technologies Group
Andrew Thompson, Ph.D.
President
J-Star Research
Bhaskar Venepalli, Ph.D., MBA
President
CiVentiChem
Goran Verspui, Ph.D.
Director of Process Research
Mercachem Process Research BV

11:00 - 11:45 Panel Discussion
When to Audit Suppliers and How to Identify Warning Signs
Sean Bradley
Director of CMC
OnTarget Laboratories
Zhengming (Jimmy) Chen, Ph.D.
Senior Director, Pharmaceutical Sciences
Shionogi Inc
Tom Eckrich, Ph.D.
Founder and Principal
Eckrich Consulting Services
Hans Hiller, Ph.D.
Managing Director
Central Glass Germany
John A. Walling, Ph.D.
V.P. Quality Operations
Reata Pharmaceuticals

11:00 - 11:45 Panel Discussion
EXHIBITOR SHOWCASE
Panelists TBA

11:45am - 12:30pm
Networking & Refreshments in Exhibit Halls
12:30pm - 1:45pm
Luncheon in Main Restaurant
Track A Track B Track C Track D

2:00 - 3:00 Panel Discussion
Pharmaceutical Co. Hosted Roundtables for 3 Minute Supplier Speed Meetings
Participants, go to either Exhibit Hall A or B. No presentations, just business cards, and 3 minute chat, then move to next buyer


Intrexon Corporation
API Development

Celgene Corporation Table #3
Technical Affairs

Gilead Sciences
No Suppler Profile Preference
"We Prefer it to be a Spontaneous Event!"

Eleison Pharmaceuticals
Late Stage Anti-Cancer Drug Development
API, DP Mfg., Release and Stability Testing

Eli Lilly & Co.
API Development

Pfizer, Inc. Table #1
CRO/CMO, Development, Intermediates,
APIs and Contract Manufacturing

Blueprint Medicines
Late Discovery Through Clinical Validation
Chemistry, Formulation, Strong Analytical

Novartis
DS, Formulation Development and Manufacture,
including Analytics

Verastem
Drug Substance, API, Development & Manufacturing
of intermediates & cGMP API for oncology drug candidates

Merck Table #2
Process Research & Development

United Therapeutics
Raw Materials/Starting Materials,
Intermediates, Scale-Up, Analytical Method
Development, Polymorph Screening

Melinta Therapeutics
API Development and Raw Materials

Epizyme
API & DP Development; Regulatory Strategies for Phase 1

2:00 - 3:00 Panel Discussion
Pharmaceutical Co. Hosted Roundtables for 3 Minute Supplier Speed Meetings
Participants, go to either Exhibit Hall A or B. No presentations, just business cards, and 3 minute chat, then move to next buyer


Takeda Pharmaceuticals
Medicinal Chemistry/Discovery

Sumitomo Dainippon Pharma Co., Ltd.
Medicinal Chemistry-Support Synthesis Services

Pfizer Table #2
Discovery & Medicinal Chemistry

Boehringer-Ingelheim Pharma
Medicinal Chemistry/Discovery

Celgene Corporation Table #1
Medicinal Chemistry/Discovery

Dermira, Inc.
Integrated Discovery-to-Phase I Capability
No Pure-Play API or MedChem

Celgene Corporation Table #2
Early Development

Merck Table #1
Discovery/Medicinal Chemistry

Receptos, Inc.
GMP manufacturers with Process Development Capabilities
Analytical Development Group and Stability Program

AbbVie, Inc.
Large volume GMP production with Containment
Small Volume, Highly Potent GMP production
API Solids Processing
Regulatory Starting Materials

Newron Pharmaceuticals
CRO/CMOs for API, Drug Product, Analytical and
Clinical Supply Chain Management. On API,
Small Molecules and Biologics

Sanofi-Aventis
CRO/CMO; Process R&D ; Intermediates
Everything for early clinical phases up to proof of concept

Tolero Pharmaceuticals
API and drug product CMOs Pre-IND to commercial
phase appropriate development, including solid state API
studies and QbD in support of process validation.

X-Rx Discovery, Inc.
Need CMO to scale up 40-100kg of API. Also need a new
discovery focused CRO for early stage programs

2:00 - 3:00 Panel Discussion
EXHIBITOR SHOWCASE

2:00pm - 3:00pm
Networking & Snacks in Exhibit Halls
Track A Track B Track C Track D

3:00 - 3:45 Panel Discussion
QbD: What Pharma Expects of its Suppliers
Nagraj Bokinkere, Ph.D.
Technical Director
Kodak Specialty Chemicals
Roger Hanselmann
Director Process Research and Development
Akebia Therapeutics
James Springer, Ph.D.
R&D Manager
Albemarle
Scott Zook, PhD
VP, CMC Development
Neurocrine Biosciences

3:00 - 3:45 Panel Discussion
Small Molecule Biotech & Emerging Pharma: The Need for Speed
Scott Duncan, Ph.D.
Director of Chemistry
Stealth Biotherapeutics
James Mencel, Ph.D
‎Director of CMC
Galleon Pharmaceuticals
Edward Price, Ph.D.
President
PCI
Robert E. Redfern
Managing Director
High Force Research Ltd
Silvia Garcia Rubio, Ph.D.
Senior Director, Technical Operations
Veloxis Pharmaceuticals
Jeff Samuel
Senior Business Development Manager
Regis Technologies

3:45 - 4:30 Panel Discussion
EXHIBITOR SHOWCASE
Panelists TBA

3:45pm - 4:30pm
Networking & Snacks in Exhibit Halls
4:30pm – 5:15pm
Happy Hour in Exhibit Halls
5:30pm – 8:30pm
Beach Party, BBQ, Free Bar & Bonfire

Wednesday, September 16, 2015 - Day 3

7:30am - 6:00pm
Exhibit Halls Open
7:30am - 10:00am
Full Hot & Cold Breakfast in Exhibit Halls
7:00am - 6:00pm
Private Meeting Rooms Open (Use online portal to book)
9:00am - 5:00pm
Exhibitor Presentations Track C
Track A Track B Track C Track D

9:00 - 09:45 Panel Discussion
Transition from Early API Development (I-IA) to Commercial API Manufacturing (Phase IIB-III)
Kenneth Drew, Ph.D.
Director
Flamma S.p.A.
Geoff Evans
SVP & COO
Alphora Research Inc.
Sriram Naganathan, Ph.D.
Senior Director
Dermira, Inc.
Jeff Slocum
Business Development Manager, API Services
Piramal Enterprises
Jegadeesh Thampi, Ph.D.
Research Director and Head Chemical Development
SYNGENE INTERNATIONAL, LTD

9:00 - 09:45 Panel Discussion
Technical Packages for Contract Manufacturing - RFP’s, Quotes, Contracts & Final Reports
Susan Billings, Ph.D.
Director, Business Development
AMRI
Stuart Levy, Ph.D.
Principal
SGL Chemistry Consulting
Jane Meyer
Associate Director, Sales & Key Account Management
Corden Pharma
Brian Swierenga, Ph.D.
Chief Operating Officer
Pharmacore
Michael Thompson, Ph.D.
Senior Director, Chemical Development
FibroGen, Inc.

9:00 - 09:45 Panel Discussion
EXHIBITOR SHOWCASE
Panelists TBA

9:45am – 11:00am
Networking & Snacks in Exhibit Halls
Track A Track B Track C Track D

11:00 - 11:45 Panel Discussion
Value Versus Cost: The Strategic Relationship with Your CRO/CMO
Magid Abou-Gharbia, Ph.D., RSC
Professor of Medicinal Chemistry
Temple University
Curtis Cui, Ph.D.
President
Hongene Biotechnology USA, Inc.
Joseph DAntuono, Ph.D.
Key Account Director
Evonik
Matthew J. Hanson
Director of Global Strategic Marketing
SAFC Commercial Markets
Marc Janes, Ph.D.
Director
NuChem Therapeutics

11:00 - 11:45 Panel Discussion
API & Intermediates Manufacturing & Commercialization in China
Jon Brice, Ph.D.
Senior Director Business Development - Generics
Asymchem
Greg Reid, Ph.D.
Principal
ChemDev Solutions
Stuart Silverman
Director
Global Pharma Sourcing
Peng Wang, Ph.D.
Site Director
JM Research and Development Company (Yantai, China)

11:00 - 11:45 Panel Discussion
EXHIBITOR SHOWCASE
Panelists TBA

11:45am – 12:30pm
Networking & Snacks in Exhibit Halls
12:30pm - 1:45pm
Luncheon in Main Restaurant
Track A Track B Track C Track D

2:00 - 2:45 Panel Discussion
Selecting Suppliers for Discovery Chemistry, Early API Development & Commercial API’s
Yann Bethuel, Ph.D.
Senior Technology Manager, Chemistry
Novasep
Curtis Cui, Ph.D.
President
Hongene Biotechnology USA, Inc.
Jason Moss, Ph.D.
Sr. Director, Process Chemistry & Manufacturing
Progenics Pharmaceuticals

2:00 - 2:45 Panel Discussion
Trends in Chiral Chemistry - Synthesis, Process, Separation & Purification
Garrett Hoge, Ph.D.
Business Development Director - Sciences
Almac
Lisa Newton
Director, Sales
Chiral Technologies, Inc.
Rina K. Rina K. Dukor, Ph.D.
President
BioTools, Inc.
Paula Weissberger, Ph.D.
Senior Director Business Development
Novasep

2:00 - 2:45 Panel Discussion
EXHIBITOR SHOWCASE
Panelists TBA

2:45pm - 3:45pm
Networking & Snacks in Exhibit Halls
Track A Track B Track C Track D

3:45 - 4:30 Panel Discussion
Advice for New Sourcing Managers in Discovery, Development & Commercial Actives
Curtis Cui, Ph.D.
President
Hongene Biotechnology USA, Inc.
Martha Kelly, Ph.D.
Senior Director
Madrigal Pharmaceuticals
Sameeh M. Salama, Ph.D.
Vice President
NAEJA Pharmaceutical
Paula Weissberger, Ph.D.
Senior Director Business Development
Novasep
David Zimmermann, Ph.D.
CEO
Kalexsyn, Inc.

3:45 - 4:30 Panel Discussion
EXHIBITOR SHOWCASE
Panelists TBA

4:30pm - 5:15pm
Happy Hour in Exhibit Halls A & B
5:15pm - 8:45pm
Casino Night Party, Gaming, Karaoke, Dinner & Open Bar

Thursday, September 17, 2015 - Day 4

7:30am - 9:30am
Full Hot & Cold Buffet Breakfast In Exhibit Halls
Track A Track B Track C Track D

9:00 - 09:45 Panel Discussion
Continuous Flow Manufacturing & Process Optimization
Steve Baric
Director, North America
APC
James Bruno, Ph.D.
Contributing Editor
PharmaChem Magazine
Andre H.M. de Vries, Ph.D.
Director DSM InnoSyn Route Scouting Services
DSM Chemical Technology R&D BV

9:00 - 09:45 Panel Discussion
Both Sides of the Fence: Insights from Those Who Have Worked in Both Pharma Sourcing & CRO/CMO’s
Praveen Baradi, Ph.D.
Director Research and Development
Alberta Research Chemicals Inc.
Ray Forslund, Ph.D., MBA
Senior Director, Project Management
Laurus Synthesis, Inc.
Stuart Garmon
Director, Business Development
Kalexsyn, Inc.
Mark Herbert
Senior Director, BD
STA, WuXi AppTec
Simon Tyler, Ph.D.
Commercial Director
CatSci Ltd

9:00 - 09:30
Elemental Impurities: ICH Q3D finalized - New Implications for Manufacturers of Drug Products, APIs and Excipients
Bethany Walls
Regulatory Affairs Specialist I
Global Regulatory Management | Pharma Food Materials

7:30am – 12:30pm
Networking
7:00am - 12:30pm
Private Meeting Rooms Open (Use online portal to book)
12:30
Event Concludes

See you in 2016!