Needham, MA (PressExposure) July 11, 2013 -- Cambridge Healthtech Institute (CHI) announced the final agenda for its Fifth Annual Immunogenicity Summit 2013 to be held on November 11-13, 2013 at the Hyatt Regency on Capitol Hill in Washington, DC.
This year, CHI expanded the scope of the summit to include four concurrent conferences on developing biological drugs with greater safety and efficacy profiles, reduced immunogenicity and a clear regulatory pathway:
Immunogenicity Assessment & Strategies (November 11-12) Conference Highlights:
Keynote Presentation: "FDA Perspectives on Issues Regarding Immunogenicity for Monoclonal Antibodies," featuring Kathleen Clouse, Ph.D., FDA/CDER
Pfizer Case Studies: "Assessment of Neutralizing and Cross-Reacting Antibodies," featuring Jim McNally, Ph.D., Pfizer, and "Immune Complexes without Anti-Drug Antibodies," featuring Deborah Finco, Ph.D., Pfizer
Teva Pharmaceuticals Case Study: V-5010 and Efforts to Modify COPAXONE®: Immunogenicity Impact on Safety and Regulatory Considerations for Complex Drugs
Problem Solving Roundtable Discussions: "Managing the Complexities for Innovators and Biosimilars," featuring Kathleen Clouse, Ph.D., Steven J. Swanson, Amgen, Inc.; Jim McNally, Pfizer, Inc.; Kyra J. Cowen, Ph.D., Genentech; Martin Schwickart, Ph.D., MedImmune, Inc.
PK/PD of Novel Constructs (November 11-12)
Conference Highlights: Keynote Presentation: "Impact of Brentuximab Vedotin in the Treatment of Lymphoma" featuring Ranjana Advani, M.D., Stanford Cancer Institute
Trends in Novel Constructs: "Quality Attributes That May Impact PK or Mechanism of Action," featuring Marjorie A. Shapiro, Ph.D., FDA/CDER
Nonclinical PK/PD of Multi-Specific Modalities Session: "Testing Strategies for the Assessment of Bispecific T cell-engaging BiTE® Antibodies and Their Transition into the Clinic," featuring Benno Rattel, AMGEN Research (Munich) GmbH
Use of Mechanistic PK/PD Modeling Session: Featuring Tamara Van Steeg, Ph.D., LAP&P Consultants BV; Guozheng Liu, Ph.D., University of Massachusetts Medical Center; Nahor Haddish-Berhane, Ph.D., Pfizer; and Rakesh Sindhi, M.D., Children's Hospital of Pittsburgh
Immunogenicity Risk Assessment & Mitigation (November 12-13) Conference Highlights:
Keynote Presentation: "Novel Approach to B and T Epitope Removal from Immunotoxins with Retention of High Cytotoxic Activity," featuring Ira Pastan, M.D., National Institutes of Health
Panel Discussion: "Relevance of Animal Models for Predicting the Immunogenicity of Therapeutic Proteins," featuring Jack Ragheb, Ph.D., FDA/CDER
Risk Considerations for Biotherapeutics Session: Featuring Steven J. Swanson, Ph.D, Amgen; Harald Kropshofer, Ph.D., F. Hoffmann-La Roche Ltd.; and Sally Fischer, Ph.D., Genentech
Problem Solving Roundtable Discussions: "Measures to Reduce Immunogenicity," featuring Steven J. Swanson, Ph.D., Amgen; Harald Kropshofer, Ph.D., F. Hoffmann-La Roche Ltd.; Jack Ragheb, Ph.D., FDA/CDER; and Ira Pastan, M.D., National Institutes of Health
Optimizing Bioassays for Biologics (November 12-13)
Conference Highlights: Keynote Presentation: "New Technologies and Approaches to Bioassays," featuring Max L. Tejada, Ph.D., Genentech
Challenges and Solutions for Optimizing Bioassays Session: Featuring Barbara Hebeis, Ph.D., NDA Analytics; and Surendran Rajendran, Ph.D., Bristol-Myers Squibb
Dinner Short Course: "Developing Potency Assays to Ensure Successful Biologics," featuring Timothy Schofield, MedImmune
Problem Solving Roundtable Discussions: "Bioassay Automation Technology," featuring Alexis Rossignol, Ph.D., Clean Cells SAS; Tina S. Morris, Ph.D., United States Pharmacopeial Convention, Global Science & Standards Division; and Brad Greenfield, Theraclone Sciences
"This greatly expanded Immunogenicity Summit is designed to enable the industry to avoid delays and unnecessary expense, and to produce safe and efficacious products for the clinic and beyond," says Nicole Lyscom, Ph.D., Conference Director & Project Team Lead. "This multi-track event is guaranteed to provide attendees with many valuable take home messages from an experienced faculty. Last year, 300 delegates attended and this year's summit is on track to continue growing."
For more details and to register, visit http://www.ImmunogenicitySummit.com.
Writers and editors are invited to attend. To request a press pass, contact Lisa Scimemi, firstname.lastname@example.org.
Past Delegate Testimonials: "You have succeeded in attracting the very best speaker panel I have ever seen to a meeting of this nature."
- Advisor, NDA Advisory Board
"Congratulations on a very well put together conference." - Assistant Vice President, Pfizer
"I'm glad I attended the PK/PD meeting. Nowhere else could I find a conference entirely devoted to the in vivo activity of novel constructs." - Principal Scientist, Amgen
"Program and participants, first class." - Associate Director, Novo Nordisk
"Break-out interaction with FDA experts was very valuable."
- Associate Director, Alexion Pharmaceuticals Inc.