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Overview | Short
Courses | Day 1 (Joint Session) |
Day 2 | Day 3 | Download Brochure
7:30 am – 4:00 pm Registration Open
7:30 am Breakfast Workshop (Sponsorship Available)
CUSTOMIZATION & SPECIALIZATION OF ANTIBODIES FOR ADDED UTILITY
8:15 Chairperson’s Remarks
Paul Watt, Ph.D., Vice President, Drug Discovery, Phylogica Ltd.
8:20 Engineering Proteolytic Antibodies
Robert Balint, Ph.D., Chief Executive Officer, CytoDesign, Inc.
Proteolytic antibodies have been observed naturally, and certain disease states provoke the formation of antibodies with effective proteolytic activities, suggesting the potential efficacy of proteolytic antibodies in the clinic. A third of the human germline kappa light chain variable domain (Vk) repertoire contain canonical serine protease-like catalytic triads in their complementarity-determining regions (CDR), and some have demonstrated proteolytic activity. We have developed a cell-based system for selecting target-specific proteolytic activities with potentially unprecedented catalytic efficiencies from large designed libraries based on human germline Vk domains. The selection system comprises a proteolytic activity sensor in which an auto-inhibited reporter is linked to the target in such a way that cleavage of the target activates the reporter to confer a selectable phenotype on cells expressing the sensor and any target-cleaving activity. Development of the system and its use for engineering target-cleaving antibodies will be described.
8:50 Probodies: Site-activated Antibody Therapeutics
Nancy Stagliano, Ph.D., Chief Executive Officer, CytomX LLC
Antibody-based therapies have proven effective treatments for some cancers and inflammatory conditions. However, in some cases, toxicities due to broad target expression have limited their therapeutic effectiveness. Increased targeting of antibody to the disease site would reduce systemic mechanism-based toxicities and lead to broader therapeutic utility. Here we describe a method for producing a "ProBody", in which, specificity is achieved by masking its antibody function until it is activated by tumor or inflammatory site-specific enzymes. This method is generally applicable to all antibodies to increase target specificity and therapeutic potential.
9:20 Pre-clinical and Clinical Characteristics of ART621: An Fc-linked Domain Antibody Targeting TNF-Alpha
David S. Wilson, Ph.D., Vice President, Research & Development, Arana Therapeutics Ltd.
Combinatorial methods were used to produce a domain antibody (dAb) with fully human frameworks that neutralizes TNF-alpha. The dAb was then fused to an Fc domain to improve its pharmacokinetic profile. The resulting molecule, ART621, weighs in at only half the size of a full-length antibody but has an IgG-like circulating half-life. ART621 is effective in animal models of rheumatoid arthritis and psoriasis and was shown to be well-tolerated in a phase I clinical trial in healthy volunteers. An update on the development of ART621, which is currently in a phase II clinical trial in psoriasis patients, will be presented.
9:50 Coffee Break in the Exhibit Hall
10:45 Poster Awards in the Exhibit Hall
BUSINESS DEVELOPMENT
11:00 Investing Like An Angel – Innovating and Promoting Innovation
David Bramhill, Ph.D., Director, Gene eXpression Technologies (GXT) Program, Research Corporation Technologies
The following topics will be covered in this presentation: a brief history of innovation and funding through the ages; scientific innovation and peer-reviewed funding; the roles of venture funding and innovators in biotech today; how RCT operates and contributes to the commercialization of innovation.
11:30 Antibody Patents: Getting the Scope You Deserve
Antoinette Konski, J.D., Partner, Foley & Lardner
Recent judicial and regulatory initiatives can limit the breadth of antibody patents. We will review these initiatives and provide strategies for getting the claim scope you deserve in the new legal environment.
12:00 Title to be Announced
Barclay J. Kamb, Partner, Cooley Godward LLP
12:30 Close of Morning Session
12:45 Luncheon Workshop (Sponsorship Available) or
Lunch on your Own
ANTIBODIES, ARRAYS & DIAGNOSTICS
(Combined Closing Session with
PROTEIN Diagnostic Development: ARRAYS of Possibilities)
2:00 Chairperson’s Remarks
Stephen Hewitt, M.D., Ph.D., Clinical Investigator, Center for Cancer Research, NCI
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Keynote Presentation
2:05 A Human Protein Atlas
 Mathias Uhlén, Ph.D., Professor, School of Biotechnology,
Royal Institute of Technology
The latest version of the Human Protein Atlas (www.proteinatlas.org) have been generated with more than 6,000 validated antibodies corresponding to 5,000 human genes (25% of all human protein-encoded genes). The portal contains more than 5 million high-resolution images generated by immunohistochemistry and confocal microscopy. The portal can be used to facilitate studies on the human biology and efforts to find potential protein targets for diagnostics, imaging and therapy.preclinical data for a human CD47-Fc fusion protein.
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2:35 To be Announced
Speaker to be Announced
3:05 Primer on Regulation of Diagnostic Assays
Jeffrey Gibbs, Esquire, Director, Hyman, Phelps & McNamara
Navigating the FDA review process with new diagnostic products presents many regulatory challenges. In order to maximize their chances of success and minimize regulatory delays companies need to carefully develop and implement their regulatory strategy. This presentation will cover some of the key issues that diagnostic companies must consider as they go through the FDA process, as well as some of the pitfalls to avoid.
3:35 Development Experience of Pertuzumab and Trastuzumab-DM1 Targeting HER2: Importance of Aligning the Clinical and Companion Diagnostic Strategies
Lukas Amler, Ph.D., Director, Development Oncology Diagnostics, Genentech Inc.
Pertuzumab, a HER2 dimerization inhibitor and trastuzumab-DM1 a HER2 antibody drug conjugate represent the next wave of molecules targeting the oncogene Her2 in breast cancer and other indications. The identification of patients that might receive the most benefit from treatment with these therapeutics has been a central part of the clinical development strategy employed. Presented in this talk, will be an introduction into the innovative and novel MOA of both antibodies and as well as an update on clinical results with a focus on companion diagnostics.
4:05 Conference Wrap-up
4:30 Close of PepTalk
Scientific Advisory Committees:
Gregory Adams, Ph.D., Fox Chase Cancer Center
Stephen Hewitt Ph.D., NIH NCI
Stephen Hughes, Ph.D., USDA
Volker Schellenberger, Ph.D., Amunix
Paul Watt, Ph.D., Phylogica Ltd.
David Szymkowski, Ph.D., Director, Biotherapeutics, Xencor Inc.
Ryan Darling, Ph.D., Research Scientist, Biotechnology Discovery Research,
Eli Lilly & Co.
William Strohl, Ph.D., Executive Director, Biologics Research, Merck Research Labs – WP
Overview | Short
Courses | Day 1 (Joint Session) |
Day 2 | Day 3 | Download Brochure
For more information, please contact:
Mary Ann Brown, Sr. Conference Director
Phone: 781-972-5497
E-mail: mabrown@healthtech.com
For exhibit and sponsorship information, please contact:
Suzanne Carroll, Manager-Business
Development
Phone: 781-972-5452
E-mail: scarroll@healthtech.com
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