Overview | Day 1 | Day 2 | Day 3 | Download Brochure | Breakout Discussions

MAIN CONFERENCE 

WEDNESDAY, FEBRUARY 25

7:15 Registration Open and Morning Coffee

8:45 Plenary Keynote Introduction 
Kathryn Lowell, Deputy Secretary, Life Sciences, California Business Transportation & Housing Agency

8:55       Plenary Keynote
Therapy Development in a Networked World
Jay M. Tenenbaum, Ph.D., Chairman and Chief Scientist, CollabRx, Inc.
A new paradigm for translational research will be described that combines the integrative and collaborative power of the Internet with personalized molecular analysis to slash the time and cost of therapy development. A key element is the creation of Health Commons, an open web-based ecosystem of researchers, clinicians, patients, pharma/biotechs, and service/technology providers that can be rapidly mobilized to develop targeted therapies for disease subclasses. This ecosystem will stimulate the same radical increase in efficiency for therapy development that ecommerce brought to business in the 1990s, ushering in a new age of collaborative, personalized medicine where every patient can afford custom therapies and discovery is driven by collectively interpreting the outcomes across all patients.

9:40 Grand Opening Refreshment Break in the Exhibit Hall

PROOF OF CONCEPT/PHARMACOLOGY

11:00 Chairperson’s Remark
Matt Devalaraja, D.V. M., Ph.D., Director, Pharmacology, PK and Toxicology, Human Genome Sciences

11:10 SESSION KEYNOTE
Understanding the Value Environment: Biomarkers in an age of Evidence-Based Medicine
Joseph V. Ferrara, President, Boston Healthcare Associates
As the cost of care increases and the population ages, financial risk for the adoption of innovative medical technology will be distributed more widely among health care stakeholders. When stakeholders are increasingly employing clinical and economic evidence to make adoption decisions, what tools can biopharmaceutical innovators use to examine the value potential of these development stage technologies? And further, how can innovators deploy an understanding of this value environment to prioritize R&D investment?

11:40 Overview of Biologics and Unique Preclinical Development Challenges
Giuseppe Ciaramella, PhD, Executive Director, Head of Biotherapeutics, Pfizer
A variety of technology platforms are enabling multiple biotherapeutic modalities, which bring unique challenges in both preclinical and clinical development. The development path for each and every biologic can be distinct and situation dependent. Inherently, it is apparent that the preclinical development of biologics is quite a contrast from small molecules. This presentation will provide an overview of the primary differences between the two approaches in their preclinical valida-tion, development and human dose projection strategies and project paths for emerging biologics. 

12:10 Challenges In Early Clinical Development of Biologics
Gilles Gallant, B.Pharm. Ph.D., Vice President, Clinical Oncology, Human Genome Sciences
The early clinical development of new biologics for the treatment of patients with advanced malignancies can be quite complex. The production of a complete pre-clinical data package is not always predictive of a rapid Phase 1 study initiation and/or duration. A partnership between government regulatory agencies, industry and clinical investigators is necessary for the success of the early clinical development of biologics. Potential approaches to accelerate and possibly shorten the duration of the initial single-agent Phase 1 studies of new biologics will be discussed.

1:10 Walk and Talk Luncheon in the Exhibit Hall

2:15 Chairperson’s Remark

2:20 The Next Generation of Vaccines for the Prevention and Treatment of Infectious Diseases
Sue Clarke, CIBiol, Head of Project Management, Development, ImmBio
This case study will present the inter-disciplinary, pre-clinical development of ImmBio’s novel ImmunoBody influenza vaccines. Particular emphasis will be placed on the critical role of analytical development describing the range of assays - haemagglutination (HA), size exclusion (SEC), flow cytometry (FACS), ELISA, SPR (BiaCore) and cytokine release - used within this development phase to define the product integrity, biological activity and immunogenicity. The establishment of a murine influenza challenge model will also be described.

2:50 Development of an Improved Insulin Product (Nasulin T) for Type 1 and 2 Diabetes Treatment 
Fred Feldman, Ph.D., Senior Vice President, Chief Scientific Officer, Research and Development, CPEX Pharmaceuticals
A novel platform for delivery of peptide therapeutics has been developed that permits administration of products for chronic treatment by nasal administration. PK data in a mini-pig model with insulin predicted a unique time-action profile that mimics the action of insulin as released by a normal pancreas. Toxicology studies in two animal species administering the product as a nasal spray three times daily for three months verified safety in chronic use. Preclinical studies of the peptide and the delivery device allowed approval of an IND for Phase 2 human studies in type 1 and 2 diabetes.

3:20 Development of Antibody-Maytansinoid Conjugates for the Treatment of Cancer
Robert Lutz, Ph.D., Executive Director, Preclinical Development, ImmunoGen, Inc.
This presentation will discuss the establishment of preclinical proof-of-concept for antibody-maytansinoid conjugates in oncology. The critical determinants for mov-ing forward into clinical development, the preclinical packages to support INDs and the questions raised by and responses given to regulatory agencies regarding these preclinical packages will also be reviewed. Lastly the recent clinical results for the lead candidates will be presented.

3:50 Pre-Clinical Development Program of an ACE2 Enzyme Substitution Therapy
Manfred Schuster, Ph.D., Chief Scientific Officer, Apeiron Biologics
Angiotensin converting enzyme 2 (ACE2) is a promising candidate for an enzyme substitution therapy to treat acute cardio-vascular, pulmonary and inflammatory diseases. It is a highly N-glycosylated Zink-metalloprotease expressed on lung, kidney, heart and liver cells whose expression is down-regulated in several life-threatening diseases. This talk will focus on the outcome of our meetings with regulatory agencies in Europe and USA and presents the strategy we have adopted to produce, to formulate and to characterize our protein therapeutic, and summarize the pharmacological properties of ACE2 and the results of our toxicology and safety pharmacology program.

4:20 Reception in the Exhibit Hall 

5:00 Break-Out Discussion in the Exhibit Hall
Pre Clinical Development of Vaccines - Experiences in Developing the Next Generation of Vaccines for Infectious Diseases
Moderator: Sue Clarke, CIBiol, Head of Project Management, ImmBio

• Understanding your product mode of action – Heat shock protein complexes and Fc fusion proteins

• Complex products – defining a draft specification

• Rationales for efficacy and safety testing

• Surrogate molecules and end points

• New paradigms – regulatory “buy-in”

Non-Clinical Safety Development Program 
Moderator: Lauren Black, Ph.D., Senior Scientific Advisor, Navigator Services, Charles River Laboratories

Points to Consider When Selecting Animal Models for Use in Discovery Research
Moderator: Richard G. Peterson, Ph.D., EVP Research and Development, PreClinOmics, Inc.

• Animal size-amount of drug available to do the experiment and amount of blood available for analysis

• Endpoints that need to be measured-amount of blood/tissues needed, availability of assay, and ability of a CRO/collaborator to measure

• Appropriate disease models for efficacy work

• Appropriateness of non-disease models for efficacy work

• Costs of the animals and experiments

6:00 Close of Day

Overview | Day 1 | Day 2 | Day 3 | Download Brochure | Breakout Discussions

For more information, please contact:
Leslie C. Lilly, BSN, RN 
Conference Director
Cambridge Healthtech Institute
250 First Avenue, Suite #300
Needham, MA 02494
Phone: 978 371 5942
Fax: 781-972-5425
email: llilly@healthtech.com 

For sales information, contact:
Carol Dinerstein
Tel: 781-972-5471 
email: Dinerstein@healthtech.com