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THURSDAY, FEBRUARY 26 

7:00 am Registration Open and Morning Coffee

7:20 Plenary Keynote Introduction

7:30 PLENARY KEYNOTE PRESENTATION
Tissue Engineering Strategies for Musculoskeletal Regenerative Medicine in Civilian and Military Applications
Michael J. Yaszemski, M.D., Ph.D., Brigadier General, United States Air Force Reserves; Professor, Orthopedic Surgery and Biomedical Engineering, College of Medicine, Mayo Clinic
Tissue regeneration via tissue engineering strategies requires some combination of cells, a scaffold upon which the cells can attach and express their phenotypic function, and signaling molecules to direct the cells down the desired differentiation path. This cellular component often includes stem cells. This lecture will present current concepts regarding musculoskeletal tissue regeneration and the issues to be considered for its translation to clinical practice, as well as the unique reconstructive challenges encountered in combat injuries. 

USE OF SURROGATE MOLECULES OR ANIMAL MODELS OF DISEASE IN THE SAFETY EVALUATION OF BIOTHERAPEUTICS 

8:25 Chairperson’s Remarks
Jeanine Bussiere, Ph.D., Executive Director, Toxicology, Amgen, Inc.

8:30 Alternative Strategies for Toxicity Testing of Species-Specific Biopharmaceuticals
Jeanine Bussiere, Ph.D., Executive Director, Toxicology, Amgen, Inc.
Surrogate molecules as well as animal models are often used to support the preclinical safety evaluation of biotherapeutics. However, when and how they should be used is not clear and regulatory agencies have different views on the value and appropriateness of these models. A discussion on the pros and cons of the various alternative strategies will be presented.

9:00 Use of Homologous Proteins and Transgenic Animals in Safety Assessments
Tim MacLachlan, Ph.D., Associate Director of Nonclinical Safety Assessment, Genzyme Corporation
As the development of biotherapeutics becomes a more advanced science based challenge, the selection of relevant animal models, utility of traditional species and alternatives to traditional safety approaches are becoming more accepted and in fact, necessary. Alternatives to the traditional safety approach include the use of homologous proteins, transgenic animals, and animal models of disease. The opportunities and challenges for these approaches to advance the science of biotech-nology drugs will be discussed.

9:30 Development of an Anti-Mouse IL-12p40 Surrogate mAb to Support an Anti-Human IL-12p40 Therapeutic mAb
Clifford Sachs, Ph.D., D.A.B.T., Associate Director, Toxicology and Investigational Pharmacology, Centocor R&D
Ustekinumab binds to the 40 kilo Dalton (kDa) subunit of the heterodimeric interleukin (IL) 12 and IL 23 cytokines and neutralizes activity of these cytokines. Pharmacology studies identified cynomolgus monkeys as a pharmacologically relevant species and showed that rodents were not due to lack of binding and neutralization of rodent IL-12/23 by ustekinumab. To identify potential adverse effects of inhibition of IL 12/23 activity on female fertility, an analogous mAb (CNTO 3913) was developed and tested in mice. In contrast to mice, cynomolgus monkeys have a relatively high abortion rate, low conception rate, and only one offspring. No female fertility hazards were identified in the CNTO 3913 mouse female fertility study and the study report supported the ustekinumab BLA submission.

10:30 Poster Competition Refreshment Break & Raffles in Exhibit Hall

11:30 A Cautionary Tale of Two Surrogates 
Suezanne Parker, Ph.D., Director Pharmacotoxicology, Biogen IDEC

12:00 Panel Discussion with the Speakers 
When and how do you decide to use surrogate molecules or animal models of disease in your development programs?
How do you ensure your surrogate is adequate to predict clinical risk? Based on pharmacology, molecular characteristics, PK, etc.?
What do you do when your preclinical models give different answers? Species differences vs molecule differences vs pharmacology differences?

12:30 Luncheon Presentations (Opportunity Available) or Lunch on your own 

1:30 Plenary Keynote Introduction 

1:40 PLENARY KEYNOTE
Engineering Cells to Death
James A. Wells, Ph.D., Chair, Department of Pharmaceutical Chemistry; Professor of Pharmaceutical Sciences, Departments of Pharmaceutical Chemistry and Cellular & Molecular Pharmacology; and Director of the Small Molecule Discovery Center, University of California, San Francisco
Apoptosis, or programmed cell death, represents an ultimate fate decision in cell biology. This process is critical for cellular differentiation and remodeling of tissues, and for anti-viral and anti-tumor defense. The study of apoptotic pathways has important ramifications for determining what is critical for cellular homeostasis, and for the development of potential anti-cancer therapeutics. A distinct molecular feature of apoptosis is the widespread but controlled cellular proteolysis, that is predominantly mediated by eight members of the caspase family of cysteine proteases. These enzymes are like demolition experts that cleave protein targets critical for cellular life. We have designed new enzymes, and antibodies, and small molecules to study and activate individual caspases and the proteins they cleave. For example, a robust proteomic method for global profiling of proteolysis ("degradomics") in cells has been developed. Key to this is an engineered enzyme, subtiligase, that permits selective labeling and enrichment for the protein N-termini created as a result of proteolysis. Using this approach we have already identified >300 caspase substrates from Jurkat cells that were induced to undergo apoptosis by treatment with the chemotherapeutic agent etoposide. The proteins fall into a wide range of functional classes, and reveal much about the molecular components, logic, and timed sequence of events that drive a cell from life to death. We believe these engineered enzymes and proteomic approaches will be useful for characterizing the proteolysis of apoptosis induced by various agents or in different cell types, and will be generally useful for dissecting protease signaling pathways

2:25 PLENARY KEYNOTE 
The Brave New World of Personalized Medicine: The Experimental Man Project, One Man Takes the Ultimate High-Tech Exam
David Ewing Duncan, Chief Correspondent, NPR Talk’s “Biotech Nation” and Best Selling Author “Masterminds”
This focus of this presentation will be on "Creative Disruptions", and will demonstrate the walking scientific response to the question: "Can they really do that?" The most important and controversial topics of today’s scientific research will be discussed, from stem cells and synthetic biology, to rising drug prices and reforming the FDA. Recently, there has been attention on science’s most significant story: a species’ potential to self-evolve. As the founder of the independent BioAgenda Institute for Life Science Studies and, more recently, as the founder of the new Center for Life Science Policy at UC Berkeley, the passion for what comes next after new technologies appear will be explored -- what happens in business, politics, science, philosophy, the media, the arts, and to society as a whole.

3:05 Ice Cream Refreshment Break in the Exhibit Hall with BEST OF SHOW AWARDS (Last Chance for Viewing Exhibits & Posters)

ASSESSMENT OF IMMUNOGENICITY

3:55 Chairperson’s Remarks
Philippe Stas, M.Sc.E. , Chief Executive Officer, Algonomics NV

4:00 Current Trends in Immunogenicity Assessment
Philippe Stas, M.Sc.E. , Chief Executive Officer, Algonomics NV
Immunogenicity of biologics can lead to loss of drug efficacy and in some cases to severe side effects. Therefore, avoiding, minimizing and/or characterizing the expected immunogenicity prior to enter into clinical trials supports the development of safer drugs. This presentation focuses on strategies to minimize and charac-terize immunogenicity in a preclinical setting, with specific focus on the recent industry whitepapers and regulatory guidelines. Selected case studies will be presented.

4:30 Development and Validation of an Immunogenicity Assay for a Biologic
Travis Harrison, Ph.D., Associate Director, Assay Development and Validation, Immunology and Inflammation, SRI International 
Evaluation of immunogenicity is an important step in the development of biologics. This presentation will describe the development and validation processes for an ectrochemiluminescence (ECL)-based immunogenicity assay against a biologic (a human monoclonal antibody). Data will be presented, along with a description of common pitfalls in development of the assay and how to overcome them.

5:00 Challenges of Supporting Immunogenicity Assays During Long Term Clinical Development Programs
Eric Wakschull, Ph.D, Senior Scientist/Group Leader, Bioanalytical R & D, Genentech, Inc.

5:30 Risk Based Assessment Plans
Adrienne Clements-Egan, Ph.D., Principal Research Scientist, Centocor

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