September 19-21, 2016
Parsippany Hilton

2016 Agenda

Print agenda

Sunday, September 18

8:00pm - 11:00pm
Exhibitor Set Up
6:00pm - 8:00pm
Welcome Reception & Dinner (Dress Business Casual)
8:00pm - 10:00pm
After Hours Socializing at the Lobby Bar

Monday, September 19, 2016 - Day 1

8:00am - 11:00am
Breakfast All Attendees in Exhibit Halls
8:00am - 10:00am
Exhibitor Set Up
8:00am - 8:00pm
16 Private Meetings Rooms Open (Use online portal to set up meetings)
8:00am - 6:00pm
Exhibit Halls Open
12:00pm - 5:30pm
Afternoon Snacks & Refreshments in Exhibit Halls
4:15pm - 5:00pm Keynote
Development Anecdotes: Hindsight from a Failed Drug Development Program

A discussion of past pharma experiences navigating mid-stage development obstacles around loss of efficacy, payer value propositions, pricing in multiple indications and patient compliance. This includes the problems we did not expect and the technical solutions we innovated in our attempts to rescue the program.

Khanh Ly, MS, JD
Director, Global Innovation and Pipeline
AbbVie
6:00pm - 9:00pm
Welcome Reception & Dinner For All Attendees
9:00pm - 11:00pm
After Hours Socializing at the Lobby Bar

Tuesday, September 20, 2016 - Day 2

7:00am - 6:00pm
Exhibit Halls Open
7:00am - 8:00pm
16 Private Meeting Rooms Open (Use online portal to set up meetings)
7:00am - 5:00pm
Networking & Snacks in Exhibit Halls
7:30am - 10:00am
Breakfast in Exhibitor Halls
10:30am - 3:30pm
Exhibitor Presentations Track C
Track A Track B Track C

9:00 - 09:45 Panel Discussion
Sourcing Strategies to Mitigate Supplier Risk
Jay A. Cadieux, Ph.D., PMP
Director, CMC & Intellectual Property
Xenon Pharmaceuticals Inc.
Zhengming (Jimmy) Chen, Ph.D.
Senior Director, Pharmaceutical Sciences
Shionogi Inc
Roger Hanselmann
Director Process Research and Development
Akebia Therapeutics
Evan Hecker, Ph.D.
Director of API Development
Spero Therapeutics
James Kanter
Director of CMC
Portola Pharmaceuticals
Mark A. Krook, Ph.D.
Senior Director, Portfolio Management
Janssen, A Johnson & Johnson Company
Deborah Minor, Ph.D.
President
Drug Discovery Alliances
Maxwell M. Reeve, Ph.D.
Director Drug Substance Development
Melinta Therapeutics

9:45am - 12:15pm
Networking & Refreshments in Exhibit Halls
12:15pm - 1:45pm
Luncheon
Track A Track B Track C

2:00 - 3:00 Panel Discussion
Pharmaceutical Co. Hosted Roundtables for 4 Minute Supplier Speed Meetings
Participants, just show up. No presentations, just business cards, and a 4 minute chat, then move to next table you want to visit


Takeda Pharmaceuticals
Medicinal Chemistry/Discovery

Lycera Corporation
API development, Phase 1/2
Process Development
Raw materials suppliers
Custom synthesis, cGMP API

Pfizer
Chemistry development services, clinical scale manufacture of custom raw materials, intermediates, API

Celgene Corporation Table #1
Medicinal Chemistry/Discovery

Celgene Corporation Table #2
Early Development

Merck Table #1
Discovery/Medicinal Chemistry

Merck Table #2
Process Research & Development

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

Boehringer-Ingelheim Pharmaceuticals
CRO's with expertise in synthesis of small amounts (50 mg to 10 g) of organic heterocyclic compounds. Excellent communication skills and Project management essential. Experience in advanced separation and purification techniques (prep. HPLC/MS; SFC; chiral separation), advanced analytical techniques (COSY; HMBS; HSQC; NOE etc...). The successful CRO partner will aim to keep the TATs < 8 weeks

Genentech
For Clinical Supply Manufacture: High Potent API Manufacturing, including milling Preparative Chromatography capability CMOs with both API and DP capability (one-stop shop)

Gilead Sciences
Commercial cGMP manufacturing, Bulk Contract Manufacturing
API, GMP intermediates, Raw Materials
High Potency APIs, Clinical phase Process development
High hazard chemistry, Fluorination

Neurocrine Biosciences
GMP, custom starting materials, small molecule APIs

Rexahn Pharmaceuticals
Rexahn is interested in API synthesis (both clinical and commercial scale), drug product manufacture (both clinical and commercial) and formulation services, including work to increase bio-availability.

Ironwood Pharmaceuticals
I expect to meet CMOs with both GMP and non-GMP capabilities. The CMO profiles: ISO intermediates, APIs, cGMP, FDA inspected, early phase process development, process validation, Phase 3/Commercial capability

Spero Therapeutics
Interested in Peptide manufacturing and fermentation development, peptide purification development, I.e. Resin screening, UF/RO, small molecule antibiotics chemical development, GMP manufacturing, Beta lactam API and oral tablet facility

Biogen
Chemical process R&D support, cGMP drug substance manufacture support, Material solubility measurements, Impurity purification, reference standard and impurity synthesis

Concert Pharmaceuticals
Early phase process development, including route scouting
Later phase process development and scale-up; commercial
GMP Starting Materials, Raw material procurement services
Drug product: roller compaction and high shear wet granulation

NattoPharma
Menaquinone-7, Napthoquinone derivatives
Farnesol & isoprenoids (terpenes)
Early development, cGMP toll manufacturing

2:00 - 3:00 Panel Discussion
EXHIBITOR SHOWCASE

2:00pm - 5:30pm
Networking & Snacks in Exhibit Halls
Track A Track B Track C

3:00 - 3:30
Development and Piloting of High Potent API Processes
Thomas Cleary, Ph.D.
Principal Site Manager, External Development Collaborations
Genentech

6:00pm - 9:00pm
Evening Reception, Dinner & Casino Games Party
9:00pm - 11:00pm
After Hours Socializing at the Lobby Bar

Wednesday, September 21, 2016 - Day 3

7:30am - 5:00pm
Exhibit Halls Open
7:30am - 10:00am
Breakfast in Exhibit Halls
7:00am - 5:00pm
16 Private Meeting Rooms Open (Use online portal to set up meetings)
9:00am - 3:30pm
Exhibitor Presentations Track C
Track A Track B Track C

9:00 - 09:45 Panel Discussion
Establishing Successful Raw Material and Intermediate Supply Chains for API Development
Silvina Garcia-Rubio, Ph.D.
Senior Director, Technical Operations
Veloxis Pharmaceuticals
Hui Kim
API Sourcing Lead
Pfizer Chemical R&D
Stuart G. Levy, Ph.D.
Principal
SGL Chemistry Consulting
Tim Maher
Associate Director, Custom API and Intermediate Sourcing
Merck & Co.
Michael Markey, Ph.D.
Principal Scientist, Small Molecule Process Development
Radius Health, Inc.
Surendra Singh, Ph.D.
Director, CMC
Verastem, Inc.

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

11:00 - 11:30
Virtual Drug Discovery and Development: Strategies for Successful Projects with Limited Budgets
Daniel Levy, Ph.D.
Principal Consultant
DEL BioPharma

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

2:00 - 3:00 Panel Discussion
Pharmaceutical Co. Hosted Roundtables for 4 Minute Supplier Speed Meetings
Participants, just show up. No presentations, just business cards, and a 4 minute chat, then move to next table you want to visit

Neurocrine Biosciences
GMP, custom starting materials, small molecule APIs

Veloxis Pharmaceuticals
Large scale API (GMP), fermentation, potent compounds, analytical, late phase development

Eli Lilly
API Crystallization Development and optimization
Chemometric Modeling
Late phase process optimization with data integrity
GMP High Potency API manufacture

Gilead Sciences
Fluorination process R&D, raws and intermediates, and small-molecule process R&D

Melinta Therapeutics
API Development and Raw Materials

2:45pm - 5:00pm
Networking & Snacks in Exhibit Halls
Track A Track B Track C
5:00pm
Event Concludes

See You at Ocean Place in Long Branch, NJ MAY 1-3, 2017!