MAIN CONFERENCE

4:00 – 6:00pm        Main Conference Pre-Registration

MONDAY, APRIL 6

7:00am    Registration and Morning Coffee

ADDRESSING THE NEEDS

8:30         Chairperson’s Opening Remarks

9:10         AMG 479, A Fully Human IGF-1R Antibody Therapeutic for Cancer

Frank Calzone, Ph.D., Executive Scientific Director, Oncology Research, Amgen, Inc.

9:40         Integrating Modern Biology and Liquid Handling into Conventional Hybridoma Discovery

Fred Kull, Ph.D., Manager, Hybridoma Group, Biologic Reagents and Assay Development, GlaxoSmithKline

Modern hybridoma discovery work integrates recombinant target expression, robotic liquid handling, and exquisite hybridoma selection methods that reveal the richness of the murine antibody repertoire.  Various interventions such as choice of strain, target conjugate, use of Bacmam, and robotic selection/characterizations will be illustrated that concertedly improve the efficiency and robustness of hybridoma work.  Examples from the druggable target classes and biomarkers will be given.

10:10       Grand Opening Coffee Break in the Exhibit Hall

ANTIBODY STRATEGIES—Regulations & Planning

11:10       The Importance of Planning for Preclinical and Clinical Development

Suzanne M. Sensabaugh, M.S., M.B.A., Vice President, Regulatory Affairs, Panacea Pharmaceuticals

Prior to devoting resources to preclinical and clinical development of an antibody, a development plan should be put in place. This can be a challenging task, especially for an emerging company with limited resources. This plan should focus on final product labeling and the necessary studies to achieve this labeling. Scientific and regulatory considerations and best practices will be discussed.

11:40       Novel Pre-Clinical and Clinical Strategies for Two First-in-Class Antibodies

Mark R. Alfenito, Ph.D., Executive Vice President, Corporate Development, KaloBios Pharmaceuticals, Inc.

To validate our Humaneering™ Technology, which is embedded in both of its clinical leads, and to validate the efficacy of both of these first-in-class targets, KaloBios has employed novel pre-clinical and clinical strategies.  KB001 is an anti-Pseudomonas antibody directed against the PcrV protein of the Type Three Secretion System of Pseudomonas.    KB002 and KB003 are chimeric and Humaneered™ antibodies, respectively, directed against Granulocyte Macrophage Colony Stimulating Factor (GM-CSF).  Preclinical and clinical strategies and data from both programs will be presented.

12:10pm Species Selection: The Foundation of the Nonclinical Toxicology Program

Marque Todd, Ph.D., Regulatory Strategy Lead, Drug Safety R&D, Pfizer Inc.

Species selection is a key element in the nonclinical testing strategy for therapeutic antibodies.  This presentation will cover the regulatory definition of a relevant species and the scientific data that must be gathered to support the selection of a relevant species.  Situations for which acceptable relevant species are not available will also be addressed.

12:40       Luncheon Presentation I (Opportunity Available)

1:10         Luncheon Presentation II (Opportunity Available)

1:40         Break

ANIMAL MODELS--TOXICOLOGY AND SAFETY PHARMACOLOGY

2:00         Chairperson’s Remarks

2:05         Preclinical Toxicology Studies to Support the Development of Monoclonal Antibodies: Scientific Issues and Challenges

Barbara Mounho, Ph.D., DABT, Scientific Director, Toxicology, Amgen­­­­­­­­­­­­­­­­­

The complex nature of therapeutic monoclonal antibodies gives rise to their distinctive characteristics, making these molecules fundamentally different from tradition (small molecule) pharmaceuticals.  Thus, in conducting preclinical safety studies for therapeutic monoclonal antibodies, many scientific challenges can develop due to the unique properties of these molecules.  Additionally, conventional preclinical toxicity testing applied to small molecule pharmaceuticals is often not appropriate for monoclonal antibodies. This presentation will review the types of preclinical toxicology studies that are applicable to monoclonal antibodies, as well as provide an overview of the scientific challenges, such as species specificity and immunogenicity, that can arise when conducting toxicology studies with monoclonal antibodies.

2:35         The Surrogate Approaches in the Development of Monoclonal Antibodies

Mohammad Tabrizi, Ph.D., Director, Global PK-PD and Bioanalysis, MedImmune

Therapeutic monoclonal antibodies exhibit exclusive specificity for the target antigen.  This unique characteristic discriminates antibodies from other therapeutic modalities such as the traditional small molecule drugs.  However, when cross-reactivity of the lead antibody across the species is limited, the antibody development program will require generation of surrogate antibodies or surrogate animal models that are necessary for the conduct of preclinical pharmacology and safety studies.  Although the surrogate approach allows examination of pharmaco/toxicodynamic properties in a potentially relevant species, it undoubtedly would enhance the complexities and challenges encountered during the course of antibody development process.  During this presentation, the application of surrogate molecules, and surrogate animal models in the development of antibodies will be evaluated.

3:05         Refreshment Break in the Exhibit Hall

3:45         Challenges and Opportunities in the Design of Nonclinical Safety Programs to Support First in Human Dosing

Laura Andrews, Ph.D., Vice President, Pharmacology & Toxicology, Genzyme Corp.

Nonclinical development programs that are designed to support the safe clinical use of biotherapeutics, and in particular, those considered to be high risk, have considerations that can be very different from traditional small molecule development programs.  These compounds require strategies that use case-by-case scientific assessments to create a highly integrated program and rationale that effectively utilizes all available pharmacological, chemical, toxicological, drug disposition and pharmacokinetic knowledge.  The objective of this session is to highlight the principles, strategies and applications that are necessary for the successful development of these challenging compounds.  Case histories illustrating some unsuccessful and successful examples will be presented.  Emphasis will also be placed on how nonclinical studies and techniques can be appropriately used to best determine the risk and ensure the safety for the subjects in the clinical trials that receive new high-risk biotherapeutics.

4:15         First-in-Man Dosing in the Post-TGN1412 Era: Points to Consider in the Development of TRX518, an Anti-human GITR Monoclonal Antibody

Lou Vaickus, Ph.D., Chief Medical Officer, ToleRx Inc.

Development programs leading up to a decision strategy on first-in-man (FIM) dosing for monoclonal antibodies (Mab) have become more complicated and extensive in the post-TeGenero world.  Some regulatory agencies seem to treat all Mab in the superagonist category and are demanding more justification for FIM doses. However, in many ways the path is easier because it is clearer and we know more now about what to do and not to do.  This presentation will be based on experience gained with two Mabs now in the clinic, one in Phase 3 (otelixizumab), and will focus on the considerations for a successful first-in-man dose for TRX518, a novel, humanized, aglycosyl anti-GITR (glucocorticoid-induced tumor necrosis factor receptor family related protein) Mab.

4:45         Problem Solving Break-Out Sessions

5:45         Networking Cocktail Reception in the Exhibit Hall

6:45         Close of Day

For more information, please contact: 
Mary Ruberry
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5421
E-mail: mruberry@healthtech.com