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JOINT SESSION
Protein Therapeutics and
Implementing the Next-Generation of Antibodies

7:00am – 5:30pm Registration

7:30 Breakfast Workshop (Sponsorship Available)

IN THE BEGINNING…

8:15 Chairperson’s Remarks

8:20 Optimizing Antibody Commercialization during Early Stage Development
Adriann Sax, BS, MBA, Executive Vice President, Business Development, King Pharmaceuticals
The commercial success of antibody based therapeutics has created intensified competition in the biologics markets. The Early Stage antibody program in your portfolio today is likely to face competition from fast-followers and overlapping MOA antibodies soon after launch. How do you create the "differentiated scientific story" and maximize the commercial value of your product?

• Developing a robust target product profile for your antibody early and leverage these attributes in your clinical trial design to better document product value.

• Identifying and understanding the market your launching into, including the competitive landscape and impact of payers and other key influencers

• Building important patient insights into registration studies.

• Aligning R&D goals with commercial requirements and creating effective channels for cross-functional input and communication.

• Case Studies will be presented

8:50 Accelerating Identification of High Potential Therapeutic Antibody Candidates using Molecular Interaction Analyses
Marina Roell, Ph.D., Associate Director, Molecular Interactions and Biophysics, XOMA (US) LLC
The ability to quickly identify promising therapeutic candidates allows for increased throughput and deep interrogation of multiple antibody phage display libraries in parallel, as well as rapid evaluation of hybridoma-generated antibodies. Biosensor technologies are powerful tools for analyzing antibodies or fragments in complex media such as bacterial extracts and hybridoma culture supernatants, as well as purified proteins. XOMA accelerates the identification of high potential therapeutic candidates through customized development of target-specific biosensor-based assays in order to evaluate clones as early as possible. Case studies will be presented to demonstrate various screening strategies for therapeutic antibody discovery and development including appropriate consideration of the affinity, epitope, function, and potency.

9:20 Prediction of Immunogenicity: in silico Paradigms, ex vivo and in vivo Correlates
Anne S. De Groot, Ph.D., EpiVax, Brown University, and University of Rhode Island
In the rush to deliver the promise of molecular medicine, biologists have, on occasion, overlooked the well-known implications of protein immunogenicity. To the dismay of drug developers, some protein therapeutics have been associated with adverse events caused by cellular and humoral immune responses. Examples of adverse immune responses include autoimmune thrombocytopenia (ITP) following exposure to recombinant thrombopoietin, and pure red cell aplasia, which was associated with a particular formulation of erythropoietin (Eprex). Since the impact of immunogenicity can be quite severe, regulatory agencies are developing risk-based guidelines for immunogenicity screening. Immunogenicity screening can be performed in silico, with in vitro and in vivo validation. We have developed in silico tools and high throughput methods for immunogenicity validation. This presentation will address the development and application of computational tools for preclinical immunogenicity assessment of protein therapeutics, and validation of those predictions using peripheral blood from exposed subjects or alternative in vivo methods. 

9:50 Coffee Break in the Exhibit Hall

ALONG THE WAY…

10:45 Optimization of Genetically Engineered Monoclonal Antibodies for Desired Pharmacokinetics, Biodistribution and Therapy 
Surinder K. Batra, Ph.D., Professor, Department of Biochemistry and Molecular Biology, College of Medicine, Eppley Cancer Institute, University of Nebraska Medical Center
Genetically-engineered, single-chain, antibody fragments (scFvs) have provided significant new improvements to potentially overcome some of the difficulties caused by normal tissue toxicity, immunogenicity, and relatively poor penetration of intact MAbs into tissues in the clinical application. However, due to a rapid clearance from the blood pool of these 25-30 kDa proteins, the absolute amount of scFv uptake in tumor is limited. The functional affinity is improved by increasing the valency. Consequently, multivalent scFvs show a two-fold advantage: (1) there is a considerable gain in avidity as compared to smaller fragments; and (2) the biological half-life is more compatible with therapeutic requirements. To fully harness their excellent pharmacokinetics for therapeutic efficacy, engineered multivalent fragments, these engineered antibodies can be subjected to further modifications to improve their tumor uptake and penetration. This presentation will address the development and application of multivalent scFvs, pharmacokinetics, physiologically-based pharmacokinetic (PBPK) models for prediction of localization, and biological modifiers that can be modulated to enhance the uptake of antibodies for the optimization of RIT of solid tumors. 

11:15 Anti-CD22-MCC-DM1 and MC-MMAF Conjugates: Impact of Assay Format on Antibody-Drug Conjugate Quantification
Pamela Chan, Ph.D., Senior Research Associate, Assay Automation and Technology
The heterogeneous nature of the antibody-drug conjugates(ADC) creates challenges for accurate pharmacokinetic parameters determination. Various approaches to quantifying total and conjugated antibody revealed that although the total antibody assay format gave similar results, the PK profile for the ADCs appeared significantly different depending on the conjugated antibody assay format. In our example with anti-CD22-MCC-DM1 and MC-MMAF, these differences prompted us to investigate the effect of the drug/antibody ratio on the total and conjugated antibody quantification using multiple assay formats. Our investigations revealed the limitations of some assay formats and highlighted the need to carefully plan the assay strategy for the total and conjugated antibody quantification.

11:45 Improved Protein-Free Methods for the Generation and Screening of Monoclonal Antibodies: Use of Nucleic Acid-Based Delivery and Rapid HTP Infrared-Based Assay
Pirouz Daftarian, Ph.D., Director, Biological Modifier Laboratory, Assistant Professor, Microbiology and Immunology/Translation Research, 
University of Miami
Targeting naturally processed antigens is critical for the generation of therapeutic monoclonal antibodies (mAbs). The generation of mAbs against native forms of antigens is hampered by challenges in protein purification. We have developed/improved methods that negate the need for the purification of protein for immunization as well as for the screening of hybridoma supernatants.

12:15 Close of Morning Session

12:30 Luncheon Workshop (Sponsorship Available) or Lunch on your Own

CASE STUDIES

1:45 Chairperson’s Remarks

1:50 Developing Methods for Characterizing the Polyclonal Characteristics and Biological Activity of Anti-Therapeutic Antibodies in Human Serum
Krista McCutcheon, M.Sc., Senior Research Associate, Antibody Engineering, Genentech, Inc.
Analytical methods characterizing the immunogenicity of therapeutic proteins are useful for monitoring, characterizing and predicting reactions to biopharmaceuticals. Advance investigation of technologies, and real-time experience with surrogate samples and controls provides us with an opportunity to understand assay challenges and the limitations and advantages of methods. Two such investigations that provided valuable assay formats for the characterization of immunogenicity will be presented. First, a multiplexed assay capable of isotyping the specific IgG, IgA, IgM and IgE (IgGAME) antibody responses against a biological therapeutic was demonstrated using a 5 microliter volume of hyper-immune serum. Second, a sample pre-treatment procedure was developed to eliminate non-specific assay interferents in human serum samples. The ability of the pre-treatment procedure to recover serum antibodies neutralizing the functional activity of a therapeutic was demonstrated in a cell-based assay. 

2:50 Proteomic Imaging of Vascular and Caveolar Targets in Vivo: Probes That Penetrate into Single Organs and Solid Tumors
Jan E. Schnitzer, M.D., Scientific Director, Professor of Cellular & Molecular Biology, Director of Vascular Biology & Angiogenesis Program, Sidney Kimmel Cancer Center
Current noninvasive molecular and functional imaging as well as pharmacodelivery by targeting disease biomarkers is challenged by in vivo barriers limiting access. Epithelium and endothelium prevent tissue penetration of many imaging agents, drugs, nanoparticles and gene vectors. Our discovery and validation strategies integrate tissue subfractionation, subtractive proteomics, bioinformatic interrogation, antibody generation, expression profiling, and various imaging modalities to identify quickly the in vivo targetable subset of biomarkers. Mapping proteins in caveolae at endothelial cell surfaces yield novel vascular biomarkers enabling not only tissue- and disease-specific immunotargeting in vivo but also penetration into the tissue. This “organellar proteomic imaging of organ and disease biomarker space” creates opportunities for imaging physiological and pathological functions in vivo as well as treating many diseases 

3:20 Technology Spotlight (Sponsorship Available)

3:35 Refreshment Break in the Exhibit Hall

4:15 Poster Awards in the Exhibit Hall

4:30 Multifunctional Antibodies by the Dock-and-Lock Method for Improved Cancer Imaging and Therapy by Pretargeting
David M. Goldenberg, Ph.D., President, Laboratory Science, Garden State Cancer Center, Center for Molecular Medicine and Immunology 
The Dock-and-Lock (DNL) method, which makes bioactive molecules with multivalency and multifunctionality, has been applied to developing targeting molecules for improved cancer imaging and therapy. DNL has generated several trivalent, bispecific, binding proteins, each consisting of two identical Fab fragments linked site-specifically to a different Fab. As an example, two identical Fabs reacting with carcinoembryonic antigen (CEA) are bound to a Fab reacting with a hapten-peptide that bears a diagnostic or therapeutic radionuclide. Using a two-step, pretargeting method that separates the bivalent anti-CEA antibody targeting of tumor from the delivery of the radioactive peptide that is captured by the second Fab of the tri-Fab construct, this method of cancer imaging and therapy has shown very sensitive and specific targeting of CEA-expressing tumors for either diagnostic imaging, such as with immunoSPECT and immunoPET, or radioimmunotherapy.

5:00 Genetic Engineering, Expression, and Activity of a Chimeric Monoclonal Antibody-Avidin Fusion Protein for Receptor-Mediated Delivery of Biotinylated Drugs in Humans
William M. Pardridge, M.D., Chief Scientific Officer, ArmaGen Technologies, Inc.
Drugs, including siRNA, can be transported into brain across the human blood-brain barrier (BBB) with the combined use of molecular Trojan horse technology and avidin-biotin technology. A chimeric or humanized monoclonal antibody (MAb) against the human insulin receptor (HIR) crosses the BBB via transport on the endogenous BBB insulin receptor. A fusion protein of avidin and the HIRMAb has been engineered and expressed in eukaryotic host cells. The HIRMAb/avidin fusion protein is a universal brain drug delivery system, and carries mono-biotinylated drugs across the human BBB.

5:30 Close of Day 

6:00 PepTalk Dinner, “BuzZ in the Pipeline” 

8:00 Close of Dinner

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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