Drug Discovery Partnership:
   Filling the Pipeline
   Integrating Private-Public Efforts to Treat Severely
      Unmet Medical Needs

October 28-30, 2009
Hyatt Regency Boston, Boston, MA
 PAST Conference Agenda (as of 10-19-09)   

2009 Attendees:

Licensing Liaison, Technology & Business Development, Mount Sinai School of Medicine
Director, NHGRI Technology Transfer Office, National Institute of Health
Director, Biomarker Consortium, National Institutes of Health
Program Director, Innovative Molecular Analysis Technologies (IMAT) Program, National Cancer Institute
Executive Director/Technology Transfer, Northwestern University
Sr. Business Strategy & Licensing Manager, Partners Healthcare System/ Massachusetts General Hospital
VP, Clinical Research Head for the Indications Discovery Units, Pfizer
Director, Research and Development Alliances, Pfizer Canada
Senior Director, External Research Solutions, Pfizer Global Research & Development
Senior Scientist, Progenra Inc
Scientific Advisory Board, Pyxis Discovery
VP, Research & Development, Quebec Consortium for Drug Discovery
President, CEO, Quebec Consortium for Drug Discovery
Assistant Director, Chemical Library, Sanofi Aventis
Director, New Lead Discovery, Schering Plough Research Institute
Assistant Director, Stony Brook University
Licensing Associate, Stony Brook University
Licensing Specialist, Stony Brook University
CEO, Sygnature Chemical Services Ltd.
VP, Business Development, Sygnature Chemical Services Ltd.
Director, The Nanotechnology Commercialization Group (NCG)
President, The Scheye Group Ltd.
Director, Syracuse University
Research Professor, Syracuse University
Business Analyst, Technology Transfer, The Wellcome Trust
Business Development Manager, Technology Transfer, The Wellcome Trust
Wistar Scientist, The Wistar Institute
President, Tiger Pharmatech
Portal Director, Tufts Clinical Translational Science Institute, Tuft Medical Center
Associate Director, Office of Technology Licensing and Industrial Collaboration, Tufts University
Senior Manager, Business Development, Tufts University Office of Technology Licensing and Industry Collaboration
Licensing Associate, Tufts University Office of Technology Licensing and Industry Collaboration
Office of Patents and Licensing, UMDNJ University of Medicine and Dentistry of New Jersey
Director, Patents & Licensing, UMDNJ-Robert Wood Johnson Medical School
Industry Relations and Business Planning Officer, University of California Davis Center for Biophotonics Science and Technology
Associate Director, Chemistry, University of California , San Francisco
Licensing Associate, University of California-San Francisco
Research Contracts & IP Services, University of Cape Town
Assistant Director, University of Florida
Manager Technology Commercialization, University of Iowa Research and Foundation Ventures and Licensing
Executive Director, Commercial Ventures and Intellectual Property, University of Massachusetts
Director, Advanced Technology & Manufacturing Center, University of Massachusetts
Assistant Professor, University of Massachusetts
Licensing Officer, Commercial Ventures & Intellectual Property Office of Techno, University of Massachusetts Amherst
Licensing Officer, University of Massachusetts Medical School
Licensing Officer, University of Massachusetts Medical School
Licensing Officer, University of Massachusetts Medical School
Assistant Director, Life Sciences, University of North Carolina at Chapel Hill Office of Technology Development
Chief Scientist, Structural Genomics Consortium, University of Oxford
Associate Director, University of Rochester Medical Center
Senior Business Development and Licensing Associate, University of South California Stevens
Associate Professor, University of South California Stevens
Senior Director, Business Development, Vivo Biosciences Inc.
Director of Technology Transfer, Wake Forest University Health Sciences
Business Development Director, Washington University in St. Louis Office of Tecnology Management
Senior Attorney, Wilson Sonsini Goodrich & Rosati
Leader, Lead Discovery for Drugs for Infectious Tropical Diseases, World Health Organization
Research Scientist, Wyeth
Assistant Vice President, Wyeth Research
Director of Technology Licensing, Yale Office of Cooperative Research
Director of Strategic Corporate Partnerships, Office of Cooperative Research, Yale University
Director of New Ventures, Office of Cooperative Research, Yale University
Technology Licensing Assistant, Yale University
Licensing Associate, Yale University / OCR
Business Development and Technology Transfer Consultant

Evolution of Drug Discovery Partnership Focus Day: Wednesday, 28th Oct 2009

12:30p

Registration and Box Lunch

1:00p

Workshop A: Achieving Effective Alignment through Project Management, Contracts Negotiation, and Choosing the Right Partners

This interactive workshop will examine the challenges of forming drug discovery alliances. A client’s decision to form R&D partnerships has important underpinnings that figure into a successful research and development outcome. For this reason, the most effective relationships are built on early definition of operational and research requirements that are strategically aligned with stakeholder expectations. Selection of your R&D projects should be based on a rigorous evaluation process. Our pre-conference focus day will critically examine the WHERE, WHY, WHAT, and HOW when choosing the right R&D partners for your next project; as well as getting project management and contract negotiation tips.

Lars J.S. Knutsen, MA, Ph.D., FRSC
President
Discovery Pharma LLC

2:05p

Workshop B: Scripting the Early and Key Steps for a Drug Discovery Program: Scientific and Practical Matters

The early design and optimization steps for a drug discovery program are critical and they determine the fate of the program going forward. Ironically, most of the work in a drug discovery program happens ahead (in design and optimization) and behind (in validation) of the automated and robotic high-throughput screening execution. Our company, DiscoveryBioMed, Inc. (DBM), specializes in these early and formative steps of the drug discovery program. We also are facile at establishing commercial-academic partnerships, where secondary validation assay are scripted between the academic client and DBM to identify the most potent lead compounds early and often. There is currently frustration within facilities that perform HTS that the assays that they are handed to perform are not sufficiently optimized. Topics to be discussed within this Workshop include:

• Acquiring or engineering the human cell line as the biological- and/or disease-relevant platform for a drug discovery program. Why not screen on a relevant human cell platform because the end goal is to give the end drug product to a human patient?

• Building biostatistical power into the assay optimization and the primary HTS bioassay. Is single well-single compound screening or batch screening wise or should new and different formats be considered? When should miniaturization occur in a program?

• Determining adequate signal-to-noise. Because physiology and biology often have subtle endpoints, is boosting the expression of a molecular target and its signal by over-expression and other means wise or ambigious?

• Performing cheminformatics on the validated ‘hits.’ Should cheminformatics occur continually during the screening program or at the end of a large-scale program?

Dr. Erik M. Schwiebert, Ph.D.
CEO, CSO and Director
DiscoveryBioMed, Inc.

3:10p

Workshop C: Chemonaut: A Web-Based Compound Database and Search Tools Applied for the Identification of Potentially Blood-Brain Barrier Permeable Beta-Secretase Inhibitors for Alzheimer’s Disease.

Chemonaut is a web-based structure-searchable compound database of >5 million high quality commercially available compounds. It is the world’s largest database of leadlike and druglike compounds that are readily available for screening. Compounds in the collection are sourced by a consortium of the most dependable vendors and expert query and search support are available on request. This session will feature a demonstration applying the Chemonaut tools to locate compounds that possess beta-secretase inhibitor pharmacophore elements and also the physiochemical properties potentially enabling blood-brain barrier permeability.

How You Will Benefit:

• Search and source capabilities of Chemonaut
• Expert query and search support
• New lead discovery approaches
• Structure-activity relationship approaches
• Physiochemical property-directed searching

Gilbert M. Rishton, Ph.D.
Scientific Advisory Board
Pyxis Discovery

4:15p

Workshop D: BioFocus: Your research partner of choice

BioFocus offers a comprehensive suite of discovery products and services. These are available separately or as an integrated drug discovery solution, backed by a centralized project management system and a team of skilled drug discovery scientists . We provide target discovery, assay development and screening, structural biology, medicinal chemistry and ADME/PK services as well as compound management services. Our ability allows the target to candidate drug discovery cycle time to be minimized, enabling programs to progress rapidly. By working with BioFocus, you have access to these specialized skills without incurring your own fixed costs or sacrificing any of your intellectual property. You can operate in a dynamic, flexible manner that suits the competitive commercial environment of drug discovery. With a client base that spans the major pharma, biotech and the not-for-profit sector, BioFocus has the experience to successfully deliver on project like preclinical candidates.
The talk will focus on:

• How partnering with BioFocus will help your programs to be industry standard
• How our flexibility help non profitable organization in their program
• Case study:
    o NIH Compound Management
    o Hit to lead collaboration with university

Nathalie Joly,
Director Business Development, North America,
BioFocus

Todd Blewett,
Director Business Development, East Coast USA,
BioFocus

5:15p

End of Focus Day

Conference Day One: Thursday, 29th Oct 2009

7:30a

Continental Breakfast & Registration

8:15a

Organizer’s Welcome

THEME: Possibilities in Academia-Industrial Partnership

8:20a

Opening Remarks: A No IP Policy can Facilitate Science and Target Discovery, by Enabling Open Partnerships: Pooling of Resource, Expertise and Capabilities

Dr. Chas Bountra
Chief Scientist, Structural Genomics Consortium
University of Oxford

8:45a

Keynote Panel: Building Understanding between Academia & Industry

• Understand the conflict of interest and its significant in science and medicine
• How to overcome unfair competitive issues?
• Explore new paradigm for drug discovery to address the severely unmet medical needs

Moderator:
Shawnmarie Mayrand-Chung, Ph.D., J.D.
Program Director for the Biomarkers Consortium
Program on Public-Private Partnerships
National Institutes of Health

Panelists:
Dr. Solomon Nwaka
Lead Discovery for Drugs: Business Line Leader and Innovation Research Coordinator
Special Program for Research and Training in Tropical Diseases (TDR)
World Health Organization

Damian O’Connell
VP, Clinical Research Head for the Indications Discovery Unit (IDU)
Pfizer; Chairman, Board at Molecular Medicine Ireland

Ralph Marcello
Senior Manager
Deloitte Consulting

Max Fehlmann
CEO
Quebec Consortium for Drug Discovery

9:45a

The NIH Roadmap for 21st Century Translation Research

• Historical underpinning for congressional support of applied research in academic
• Triple helix of inflection points behind massive paradigm shift in academia
• “Halftime Scorecard”
• Transformative models for pre-competitive collaboration between industry and academia needed

Melvin Reichman, Ph.D.
Director LIMR Chemical Genomics Center (LCGC)
Lankenau Institute for Medical Research

10:15a

Morning Refreshment and Networking Break

10:45a

Case Study: University-Industry-Government Partnerships in Translational Medicine Research Collaboration (TMRC)

• Discuss Government collaboration with Scotland as a model for Academia/ Industry/ Government collaboration
• Understand the objectives behind and hear best practices and strategies to achieve the mission

Giora Feuerstein, M.D.
Assistant Vice President
Head, Discovery Translational Medicine
Wyeth Research

11:15a

Panel Discussion: In Whose Best Interest? Finding Common ground to Patenting
• Academic freedom and NIH requirement Vs. Protecting IP to develop

Moderator:
Gregory N. Tew
Assistant Professor
Polymer Science and Engineering
University of Massachusetts

Panelists:
Dr. Erik M. Schwiebert, Ph.D.
CEO, CSO and Director
DiscoveryBioMed, Inc.

Claire T. Driscoll
Director, Technology Transfer Office
National Human Genome Research Institute (NHGRI)
National Institutes of Health

Andrew K. Gonsalves
Patent Attorney
Heslin Rothenberg Farley & Mesiti P.C.

Peter F. Corless
Partner
Edwards, Angell, Palmer, Dodge LLP

12:00p

Keynote Luncheon

Dr. Solomon Nwaka
Lead Discovery for Drugs: Business Line Leader and Innovation Research Coordinator
Special Program for Research and Training in Tropical Diseases (TDR)
World Health Organization

THEME: Strategic Alliance

Track A

Track B

1:00p

Integration in Early Stage Drug Discovery

Track Chairperson:
Melvin Reichman, Ph.D.
Director LIMR Chemical Genomics Center
Lankenau Institute for Medical Research

Insider Tips to a Successful Partnerships

Track Chairperson:
Dr. Erik M. Schwiebert, Ph.D.
CEO, CSO and Director
DiscoveryBioMed, Inc.

1:15p

Leveraging NIH Resources to Help Bridge the Chasm between Basic Research Activities and the Commercialization of a Drug

• Tips on how to successfully enter into productive
research collaborations with NIH intramural scientists
• Overview of NIH research resources – including but not
limited to: Computational and data mining tools • Clinical
trial networks • In-vitro and in vivo screening programs
(including assay development and high throughput drug
screening resources) • Pharmacokinetic and animal
toxicology testing • Clinical-grade gene vector
repositories • Human tissue and cell repositories •
Animal model repositories • Research reagent
repositories (including biodefense-related materials) •
Genetic and genomic resources • small molecule libraries
• Overview of some select NIH grant programs including
Small Business Research Funding Opportunities
(SBIR/STTR) – an important funding source for start-up
biotechnology companies
Claire T. Driscoll
Director, Technology Transfer Office
National Human Genome Research Institute (NHGRI)
National Institutes of Health

Panel Discussion: Funding Early-Stage Start-Ups

Early stage start-up projects are the main victims of the "valley of death" funding gap between innovations and commercial viability. Venture capital, which was moving downstream even before the economic downturn, now needs to invest in their portfolio companies due to the lack of an IPO market. Plus they can buy clinical-stage assets cheap as public companies run out of cash. Where does a start-up go for funding?

• Pharma venture funds - strategic focus, interest in
platforms and early stage projects
• Government sources - beyond SBIR/STTR - ATP (now
TIP), DARPA, BRDG-SPAN and more
• Disease and other foundations - leveraging their dollars
for clinical results, not basic science
• Academic sources - internal funds for early stage results
• Public-private partnerships

Moderator:
O. Prem Das, Ph.D.
Business Development and Technology Transfer Consultant

Panelists
Shawnmarie Mayrand-Chung, Ph.D., J.D.
Program Director for the Biomarkers Consortium
Program on Public-Private Partnerships
National Institutes of Health

Dr. Richard Aragon
Program Director, Innovative Molecular Analysis Technologies (IMAT) Program
National Cancer Institute

Jill O’Donnell-Tormey, Ph.D.
Executive Director
Cancer Research Institute

1:45p

Panel Discussion: Target Identification, Assay Development, Screening

• What fruit has been picked and what remains on the tree?
• Can a pre-competitive model involving academia and
industry accelerate target validation?
• How can redundancy in effort be minimized?
• When does a candidate truly become a target?
• When are assays really ready to eat?
• Are there objective methods to classify best candidate
molecules identified from screens to be used as probes
for ultimate target validation?
• How should information from screens be disseminated in
order to assure quality?

Moderator:
Marcie Glicksman, Ph.D.
Sr. Director Leads Discovery and Assistant Professor
Harvard NeuroDiscovery Center
Department of Neurology, Brigham and Women’s Hospital
Harvard Medical School

Panelists
David Schultz, Ph.D.
Wistar Scientist
Director, Protein Production, Libraries & Molecular Screening Facility
The Wistar Institute

Dr. Frederick Monsma
Director, New Lead Discovery
Schering-Plough Research Institute

Rick Hammar
Director, Compound Management, Chemistry and Screening Services
ASDI Inc.

2:30p

Afternoon Refreshments and Networking Break

3:00p

Panel Discussion: Hit-to-Lead

• How to fund in vitro ADME and in vivo DMPK studies in
academia-based drug discovery
• Division of labor in research collaborations between
academic and industrial groups
• Target/project selection for academic drug discovery
groups

Panelists:
Adam Renslo, Ph.D.
Associate Director, Chemistry
Adjunct Assistant Professor of Pharmaceutical Chemistry
University of California, San Francisco

Caroline Shamu, Ph.D.
Director, ICCB-Longwood
Harvard University Medical School

Dr. Kelvin Lam,
Director of HTS, Harvard University,
Harvard Stem Cell Institute

Jose Perez,
Manager HCS Assay Development,
Broad Institute

Panel Sponsored by CyBio

Panel Discussion: Identifying Outsourcing and Partnership Opportunities for Both Small and Large Life Science Companies R&D Projects

• What are the risks/ rewards?
• How to form collaboration?
• What to look for in your potential partners?
• Are you looking at the right partner?
• What are the components to a successful collaboration?
• What are some of the lessons learned from successful/ unsuccessful collaborations?

Moderator:
Ian Hanegraaff,
General Manager,
CyBio US

Panelists:
David H. Donabedian, Ph.D., MBA
VP Strategic Alliances, US CEEDD
GlaxoSmithKline

PJ. Anand
Executive Vice President, Corporate Development
Arsenal Medical

Reid J. Leonard, Ph.D.
Executive Director, Licensing & External Research
Merck Research Laboratories

Dr. James Chafouleas
Head of Global Licensing Virology & Business Development, R&D Division
Boehringer Ingelheim Laval, Canada

3:45p

Panel Discussion: Optimizing Integration in Early Stage Drug Discovery

• High Value Compound Libraries: Looking Beyond the Initial Screen
• Computational Chemistry - How much can this help?
• Drug Discovery 2010 - Using IT and Database Management to Facilitate Pre-Competitive Research
• Compound Management - Efficiently Managing a Compound Library to Facilitate Initial and Follow Up Screens

Moderator:
Mark Parisi
Executive Director
ASINEX Corporation

Panelist:
Sean Ekins
Collaborations Director
Collaborative Drug Discovery

John McGrath
Compound Manager
Broad Institute of Harvard & MIT

Nouri Neamati,
Ph.D., Associate Professor, Department of Pharmacology and Pharmaceutical Sciences,
University of Southern California School

IP Value and the Scope of Claim

• Balancing IP value with strategy to determine the scope of claim
• Insider tips on claimed subject matter and when to narrow the scope
• Prosecution strategy
• Respond to office action

*Speaker and sponsorship opportunities available. Please contact kye@opalevents.org for more information

4:30p

Roundtable Best Practice Discussions

During each roundtable, the facilitator will present a short case study as a benchmark for a 30-minute discussion and question session. Attendees will be allowed to attend (2) table discussions within this hour and get comprehensive review of the surrounding issues, technical capabilities and differing stakeholders’ views. Attendees will also get answers to many questions and innovative ideas to take back and apply to your drug discovery projects.

Table 1: Discovery of the Potential Best-in-Class c-Met Inhibitor by Truly Virtual Company
Junhu Zhang
President
Tiger Pharmatech

Table 2: Compound Management Outsourcing: Project or Task Based?
Rick Hammar
Director, Compound Management, Chemistry and Screening Services
ASDI Inc.

Table 3: Chemical Compound Library Technology

• Natural Product Bias
• Fragment Based Screening
• Medicinal Chemistry Expertise

Mark Parisi
Executive Director
ASINEX

Table 4: Academic Screening Programs: Good Leads, Good Tools, and Good Probes… One in the Same
Gilbert M. Rishton, Ph.D.
Scientific Advisor
Pyxis Discovery

Table 5: Topic TBD
Ian Hanegraaff
General Manager
CyBio US Inc.

Table 6: “Meeting needs in Preclinical Oncology Drug Discovery with 3D Mini-tumor Assay Collaborations”
Raj Singh, Ph.D.
President and CSO
Vivo Biosciences, Inc.

Table 7: Accessing Early Discoveries from Academic and Nonprofit Organizations
Ryan M. Dietz,
Director, Office of Technology Development,
Immune Disease Institute/ Program in Cellular and Molecular Medicine at Children’s Hospital Boston

5:30a

5-minute Speed Networking: Connecting People with Innovations and New Products

A lot can happen in 5 minutes. There’s a great way to meet new people, new projects, and discover where the next big innovation is!

Instructions: A series of round tables will be arranged in a circle, there will be six stations at each table, with two different colored place markers. Once the session begins, participants will have five minutes to network. At the end of the five minutes a moderator will ask participants standing in front of a designated colored place mark to shift to the table counter clockwise to them. The process will be continued until the end of the speed networking session.

6:30p

Cocktail Reception

Conference Day Three: Friday, 30th Oct 2009

7:30a

Continental Breakfast & Registration

8:15a

Organizer’s Welcome

THEME: Partnerships/ Opportunities Showcase

8:20a

Opening Remarks: Open Innovation - GSK’s New Approach to Sharing R&D Knowledge

• Patent pooling to stimulate research into neglected diseases
• New models of academic industry interaction such as the GSK ‘academic incubator’ which allows university researchers who are leaders in their field to become directly involved in early clinical development
• Hear GSK’s novel approaches in the pre-competitive research space

Dr. Jacqueline Hunter
SVP Science Environment Development
GlaxoSmithKline

9:00a

The Changing Face of What And Whether An Invention Is Patentable Subject Matter

• Post-KSR decisions on obviousness
• Patent eligible subject matter- In re Bilski, LabCorp v. Metabolite Labs., Inc., Prometheus Labs. v. Mayo

Dutch Chung, Ph.D., J.D.
Senior Attorney
Wilson Sonsini Goodrich & Rosati

9:30a

Bridging Untapped Source of Ideas and Compounds through the Phenotypic Drug Discovery Initiative (PD²)
• Utilize Lilly’s developed disease-state assays and web portal to evaluate therapeutic potential of compounds
synthesized from universities and biotech laboratories
• Explain how researchers can access PD²
• Discuss potential collaborations and licensing agreements

Dr. Thomas Engler
Senior Research Advisor
Discovery Chemistry Research and Technologies
Lilly Research Laboratories
A Division of Eli Lilly & Co.

10:15a

Morning Refreshment and Networking Break

10:45a

Emerging Charity Based Strategies in Support of Innovative Drug Discovery

• Exemplification of the Wellcome Trust’s ‘Seeding Drug Discovery’ model
• What’s expected: pro’s and con’s
• Case studies

Richard Davis, Ph.D.
Business Development Manager, Technology Transfer
The Wellcome Trust

11:30a

New In Vitro Preclinical Drug Discovery Platform Collaborations: Addressing Needs with 3D Mini-Tumor Bioassay Systems

• Advantages of 3D bioassays
• Oncology, leveraging preclinical collaborations to minimize downstream failures
• Addressing collaborators’ preclinical drug testing needs with the 3D HuBiogel™ Assay Platform

Raj Singh, Ph.D.
President and CSO
Vivo Biosciences, Inc.

11:50a

Topic TBD

Kathleen Rigaut, Ph.D., J.D.
Attorney
Dann, Dorfman, Herrell, and Skillman

12:15p

Networking Luncheon

Commercial-Academic Drug Discovery Partnerships - Powerful Synergism

Dr. Erik M. Schwiebert,
Ph.D., CEO, CSO and Director,
DiscoveryBioMed, Inc.

1:15p

Probe Discovery and Development in the Public Domain

• Probe (tool compound) discovery and development at Broad Institute, coupling complex biology with novel chemistry
• Open-access data sharing to facilitate research in both academia and pharma
• Examples from both the NIH Roadmap’s MLPCN probe pipeline and the Broad pipeline

Nicola Tolliday, Ph.D.
Manager, Screening Outreach
Broad Institute

2:00p

What Have You Done for Me Lately? Discussion on Vendor-Customer Partnerships

Marcie Glicksman, Ph.D.
Sr. Director Leads Discovery and Assistant Professor
Harvard NeuroDiscovery Center
Department of Neurology, Brigham and Women’s Hospital
Harvard Medical School

2:45p

Afternoon Refreshments and Networking Break

3:00p

Lesson Learnt from a Startup: Advantages in Forming Academic Collaborations

• Explore what technologies a small Startup have to offer for academia
• Understand how you can utilize their compound bank as probes to advance the science in drug discovery
• Hear case studies in collaborating on Pre-clinical development

Seth J. Goldenberg, Ph.D.
Senior Scientist
Progenra, Inc.

3:45p

Interactive Q&A Session

The conference will wrap up with a facilitated Q&A session to ensure attendees depart with all their burning questions in forming academia-industrial partnerships answered.

All speakers and participants are invited to join this discussion.

4:15p

Closing Remarks and End of Conference