Overview | Day 1 | Download Clinical Risk Management Brochure
7:30am Morning Coffee
8:15 Chairperson’s Remarks
Philip M. Arlen, M.D., President & Chief Medical Officer, Neogenix Oncology
8:20 Keynote Presentation
Vaccine Safety Surveillance in the 21st Century: Lessons Learned and Challenges for the FutureRenata J.M. Engler, M.D., Colonel, Army Medical Corps, Director, Vaccine Healthcare Centers Network, Walter Reed Army Medical CenterImproving our understanding of rare but serious adverse events following drug or vaccine administration remains a major medical challenge. This is true for the clinician on an individual patient care level, but also for the vaccine manufacturers, the Food and Drug Administration (FDA), and public health, particularly where large healthy populations are targeted for prophylactic drug/vaccine therapy. This presentation will focus on detailing the lessons learned from past vaccine programs, from Lyme and influenza to anthrax and smallpox vaccines with a focus on challenges for the implementation of 21st century post-licensure safety surveillance programs. The increasing role of immunogenetics in the evaluation and study of risk for more serious side effects as well rare but serious adverse events will be addressed in the context of myopericarditis and immunizations. Individual variability in vaccine efficacy and the role of dose response relationships to side effect severity remains an additional challenge in the environment of “one size fits all” that has permeated the vaccine world.
9:05 Progress in the Active Immunotherapy of Prostate Cancer: Case Study of Sipuleucel-T (Provenge)David Urdal, Ph.D., Senior Vice President and Chief Scientific Officer, Dendreon Corporation
Sipuleucel-T is an investigational active cellular immunotherapy for prostate cancer. It is composed of autologous peripheral blood antigen presenting cells (APC) pulsed with PA2024, a recombinant Prostatic Acid Phosphatase (PAP)-cytokine fusion protein and is designed to stimulate an immune response to the patient’s tumor. Results from a double blind, placebo-controlled phase 3 trial (D9901)showed that asymptomatic patients with metastatic, androgen-independent prostate cancer, who received sipuleucel-T, had a median survival of 25.9 months compared to 21.4 months for patients in the placebo arm, a 4.5 month improvement (p-value = 0.01, hazard ratio = 1.7). The development history of sipuleucel-T, clinical trial results and regulatory milestones will be discussed.
9:35 The STEP Trial for an HIV-1 Vaccine Test-of-Concept: How Well Was the Cell Mediated Immunity Hypothesis Tested?Danilo R Casimiro, Ph.D., Director, Vaccine Basic Research, Merck Research Labs
10:05 Networking Coffee Break
10:45 RiskMAP Evaluation Process for FluMist Clinical TrialsFrank Malinoski, M.D., Ph.D., Senior Vice President, Medical and Scientific Affairs, MedImmune, Inc.The expanded licensure of FluMist (Live, attenuated influenza vaccine) for children less than 5 years of age in 2007 gave MedImmune and the FDA the opportunity to negotation of the first Risk Management Action Plans (Risk-MAPs) for a pediatric vaccine. This presentation explores the rationale for applying Risk-MAPs to vaccines, the role of the product label in Risk-MAPs, the negotiations and types of commitments that were made for FluMist as a result of those negotiations, and the unique requirements in implementing a plan for a vaccine that is used on a seasonal basis and is reformulated each year.
11:15 Assessing Safety & Immunogenicity: High Resolution Monitoring of Cell Mediated Immunity Enables Early Decision Making during Pre-Clinical and Clinical Stages of Vaccine DevelopmentMagdalena Tary-Lehmann, M.D., Ph.D., Chief Scientific Officer, Cellular Technology Limited
An increasing number of new vaccines aim to elicit a response from the cellular components of the immune system, in addition to the classical establishment of an antibody-based immunity. Recently, the U.S. Food & Drug Administration (FDA) emphasized the need for better predictive models and the establishment of correlates of protection for novel vaccines that aim to elicit cellular immunity, and in particular T-cell immunity. Based on its proven utility, the FDA now encourages the use of validated GLP-compliant ELISPOT assays for immune monitoring of new vaccine candidates at all stages of development. A careful choice of test systems and cytokines to be monitored is crucial for detecting relevant responses early. CTL pioneered the transition of the ELISPOT technology from a basic research tool to a GLP-compliant high-throughput capable immune monitoring technology. Together with the NIH/NIAID and its partners, CTL has developed, qualified, and validated novel test methods for its clients in various test systems which significantly aid the progress of new vaccines through the pipeline by providing crucial immunogenicity and safety information.
11:45 Addressing Regulatory Issues in Creating Culturally Appropriate Recruitment Tools Targeting High Risk MSMDavid E. Garcia, MPH, Community Education Coordinator, HIV Vaccine Trials Unit, Fred Hutchinson Cancer Research CenterClinical trial units need to be proactive with their local IRBs to educate them about the necessity of culturally appropriate advertisements to reach the MSM community. Examples of MSM targeted research recruitment materials, magazine advertisements, and online banners currently used within the community help to explain what type of advertising are culturally appropriate tools for recruiting MSM in Seattle, WA. These successful recruitment tools contributed to an enrollment of 117 MSM in Seattle for the Phase IIb vaccine trial.
12:15pm Enjoy Lunch on Your Own (Lunch Workshop Sponsorship Available)
1:45 Chairperson’s Remarks
Frank Malinoski, M.D., Ph.D., Senior Vice President, Medical and Scientific Affairs, MedImmune, Inc.
1:50 Testing Adjuvant Systems for the Design of Prophylactic & Therapeutic VaccinesNathalie Garçon, Pharm.D., Ph.D., Vice President, Head of Research and North America R&D, GlaxoSmithKline BiologicalsOver the past decade, it has become clear that new strategies are required for vaccines where classical design approaches are insufficient in order to tackle unmet medical needs (e.g., optimal protection for specific populations or against challenging diseases). One of those strategies, based on adjuvantation, has shown its potential in various areas of vaccinology, going from prophylactic vaccines against viruses or parasites, to new therapeutic approaches. Adjuvant Systems (AS), a combination of adjuvants, must be rationally developed, extensively characterised and systematically tested pre-clinically and in the clinic in order to analyse their ability to safely enhance the protective effects of target antigens. Additionally, the safety evaluation of AS containing vaccines continues after the vaccine registration. We will present the various stages that have been followed for the safety evaluation of one of GSK Adjuvant Systems.
2:20 Combinatorial Therapies Utilizing Cancer Vaccines Philip M. Arlen, M.D., President & Chief Medical Officer, Neogenix Oncology
Preclinical and clinical investigations currently underway are employing novel strategies for combining vaccines with conventional and experimental anticancer therapies. To date, the FDA has not approved a therapeutic cancer vaccine. However, the results of recent investigations suggest an increasing role for vaccines in new models of combination therapy for many types of cancer. Clinical strategies are now employing vaccines in combination with local radiation, chemotherapy, hormone therapy, as well as other novel therapeutics. Preclinical studies have shown that certain anticancer agents have immune modulatory effects that result in up-regulation of surface expression of MHC molecules, tumor-associated antigens, or Fas on malignant cells, rendering them more susceptible to immune destruction. Preliminary results of clinical studies using combination strategies have demonstrated a post vaccination antigen cascade, prolonged time to disease progression, and improved overall survival. Several larger randomized trials are ongoing, and more are required to support these findings.
2:50 Networking Refreshment Break
3:30 Plenary Panel Discussion:
The Critical Business Challenges Associated with Vaccine TrialsIssues to be addressed:
5:00 Close of Clinical Risk Management & Safety for Vaccines conference
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