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Overview | Short
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2 | Day 3 (Joint Session) | Download
Brochure
Creating antibodies and protein-based therapeutics that accomplish their mission of safely delivering efficacious compounds to human targets is a complex challenge. Proteins’ innate qualities make the task difficult, and unforeseen variables typically add additional complications. PepTalk Pipeline 3 covers the challenges and proven successes of antibodies and protein-based therapeutics, addressing why they are such an important – and promising – class of drugs.
The “Protein Therapeutics” meeting showcases the emerging technology and know-how that is leading the way to “Meeting the Challenge of Delivery, Safety and Efficacy,” including novel delivery systems. Leaders from around the world will provide in-depth discussions that reveal innovative approaches to overcoming the hurdles of developing biologics.
The “Antibodies in Translation” joint session explores the tools and strategies that lead to designing successful antibody therapeutics of the future. By looking far ahead from bench research to the needs and challenges of clinical trials, scientists may more effectively design therapeutics to move forward and avoid emerging problems in order to achieve a smooth transition from the bench to the bedside.
In the “Implementing the Next-Generation of Antibodies” meeting, the focus moves a further step into the future of antibody therapeutics that is revolutionizing the biotech and pharmaceutical industry. Increased specificity, novel structures, and improvements in affinity for target antigens are some of the breakthroughs that are leading antibody design into a new and exciting era.
7:30am – 6:00pm Registration Open
7:30 Morning Coffee
PROTEIN THERAPEUTIC FOUNDATIONS
8:45 Chairperson’s Remarks
Keynote Presentation
9:00 The Human Antibodyome – Implications for the Design of Therapeutic Antibodies and Vaccines
Dimiter Dimitrov, Ph.D., Senior Investigator, Protein Interaction Group, National Cancer Institute, National Institutes of Health (NIH)
We have recently initiated a project (the antibodyome project) to sequence large number of antibodies from bone marrow, lymphoid tissue and blood from HIV-1-infected and healthy individuals with a major goal to better understand responses of the human immune system to infectious agents and apply the knowledge gained for design of novel vaccines and therapeutics. Data from the analysis of the first ten thousand sequences from four naïve IgM and six immune IgG libraries will be presented including distribution of somatic mutations in IgM antibodies and pathways of somatic mutational diversification. Implications for prediction of individual immune responses and design of therapeutic antibodies and vaccines will be discussed.
9:50 Nonclinical Safety Assessment of Biologic Therapeutics: Challenges and Strategies
David N. Hovland, Ph.D., Director, Global Regulatory Affairs and Safety, Amgen Inc.
Biotechnology-derived
pharmaceuticals have unique properties that convey certain therapeutic
advantages over small molecules. However, these properties can create
challenges for conducting nonclinical toxicology studies with biologics.
This presentation will discuss salient properties of biologics that impact
the design and interpretation of toxicology studies, and will outline
considerations to help ensure that nonclinical toxicology studies and
programs for biologic therapeutics are informative and effectively address
regulatory expectations.
10:20 Coffee Break
SAFETY & IMMUNOGENICITY
10:45 Strategies for Immunogenicity Assessment
Philippe Stas, Ph.D., Chief Executive Officer, Algonomics
Immunogenicity of protein therapeutics can give rise to loss of drug efficacy and to potentially harmful adverse effects. Therefore, immunogenicity has to be limited and assessed throughout the product life cycle. Strategies to address immunogenicity and risk mitigation will be presented. Special attention is given to the new EMEA guidance on immunogenicity, and to specific case studies.
11:15 Immunogenicity
Prediction: Where Are We and Where Are We Headed?
Theresa
J. Goletz, Ph.D., Director, Medical Sciences, Clinical Immunology, Amgen,
Inc.
11:45 Therapeutic Antibodies Without Helper T
Cell Epitopes
Frank Carr, Ph.D., Director, Biologics Research, Antitope Ltd.
The incidence of immunogenicity in clinical trials of humanized and
fully-human antibodies is generally low, but adverse reactions can still
pose a significant safety risk. Recent clinical data for novel
therapeutic antibodies used in the treatment of cancer (e.g., anti-PSMA)
and infection (e.g., anti-anthrax protective antigen) support the
concept that the avoidance or removal of helper T cell epitopes in
variable regions of therapeutic antibodies reduces the incidence of
immunogenicity. Preclinical immunogenicity data will be presented for a
variety of therapeutic antibodies (chimeric, humanized and “fully
human”) which is based on the frequency and potency of T cell epitopes
present in V-region sequences. These data have been used to provide an
early assessment for the relative risk of immunogenicity between
different antibody therapeutics. Furthermore, in a refinement of this
process, novel humanized antibodies against CD20 and αVβ3 have
been generated in which T cell epitopes in V-region sequences have been
avoided resulting in therapeutic antibodies with reduced immunogenic
potential.
12:15 Close of Morning Session
12:30pm Luncheon Workshop (Sponsorship Available) or Lunch on your Own
INNOVATING DESIGN
2:30 Chairperson’s Remarks
2:35 A Novel Approach to Antibody Design and Selection: From Discovery to Optimization
Peter Luo, Ph.D., Chief Technology Officer, Abmaxis, Inc., A Wholly Owned Subsidiary of Merck & Co., Inc., and Director, Biologics Technology, Merck & Co., Inc.
3:05 RNA as a Cancer Target Using Conjugates of EVadeT Ribonucleases and Polyethylene Glycol
Laura Strong, Ph.D., President and Chief Operating Officer, Quintessence Biosciences, Inc.
The EVadeT Ribonucleases (RNases) are a new class of anti-cancer agent under development at Quintessence Biosciences. Relative to already approved cancer therapies, EVadeT RNases work with a unique mechanism of action, the degradation of RNA. Benefits of polyethylene glycol (PEG) conjugation specific to the EVadeT RNases and their use as cancer therapeutics include: (1) the EVadeT RNases are relatively small proteins (~15 kDa) that are quickly cleared and (2) PEG has been reported to promote accumulation in tumors, which would be a benefit for the already potent, anti-cancer EVadeT RNases.
3:35 Beyond Target-Antigen Binding: Designing the Appropriate Effector Functionalities into Therapeutic Antibodies
Alem Truneh, Ph.D., Senior Vice President & Chief Scientific Officer, Research and Development, NKT Therapeutics
4:05 Refreshment Break
PEGYLATION
4:30 Pegylation, Site-Specificity and More
Keith Powell, Ph.D., Chief Executive Officer, PolyTherics Ltd.
PEGylation is a proven and safe way to extend the half-life of proteins in therapy. Yet there is a need for better ways to site-specifically attach the polymer to the protein or peptide. This talk will describe an exciting advance which allows site-specific PEGylation without the need to engineer unnatural components into the protein. The use of the technology for molecules from antibody fragments to enzymes, hormones and cytokines will be described.
5:00 A Novel and Selective Method for PEGylation of Peptides and Proteins
Joel Van Gelder, Ph.D., Senior Scientist, Drug Discovery, Drug Discovery, InSight Biopharmaceuticals Ltd.
InSight's scientists have invented a novel strategy for PEGylation of proteins. This technique involves reaction of a unique PEG reagent to an amino acid which is not very abundant and only slightly reactive. This amino acid has never been previously conjugated to PEG. A selective PEGylation process has been developed by exploiting the difference in pKa between the different amino acids.
5:30 Welcoming Reception in the Exhibit Hall
7:00 Close of Day
Overview | Short
Courses | Day 1 | Day
2 | Day 3 (Joint Session) | Download
Brochure
For more information, please contact:
Mary Ruberry, Conference Director
Phone: 781-972-5421
E-mail: mruberry@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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