Next Generation Vaccines 
Event Information
Document Title
Agenda
| Day One Thursday, July 17, 2008 | DISCOVERY & DEVELOPMENT | PRODUCTION & PROCESS DEVELOPMENT | | DAY ONE | DAY TWO | | |
| Plenary Session | |
| 8:30 | Chairperson's Opening Remarks Ronald W. Ellis, Ph.D., Senior Vice President & Chief Technology Officer, NasVax, Inc. |
| Keynote Address | |
| 8:40 | Regulation of Vaccines: Opportunities & Challenges The FDA must be in a position to develop new scientific and regulatory criteria to evaluate new vaccines and new routes of administration for safety and efficacy. Other challenges the FDA faces are how best to facilitate the development of new vaccines targeted for special populations, as well as how best to develop regulatory pathways for the evaluation of vaccines against diseases that are not endemic to the US. There are also challenges evaluating the manufacturing as well as the clinical outcomes of vaccines made with new technologies. Can these technologies be scaled-up, are the resulting products manufactured consistently from lot to lot; are they stable? What endpoints do we use to evaluate these vaccines in the clinic for safety and efficacy? Are there special safety concerns that must be considered when evaluating the benefits versus risks of these products? CBER is in the unique position of being able to address these issues from a research and regulatory review perspective. Norman Baylor, Ph.D., Director, Office of Vaccines Review and Research, CBER, FDA |
| Keynote Address | |
| 9:10 | New Vaccine Introduction in Developing Countries: Perspectives from the Americas Rotavirus, pneumococcus, and human papilloma vaccines are new vaccines that have the potential to prevent thousands of deaths each in developing countries. However, developing countries must undergo a more rigorous analysis of a broader base of evidence if they are going to introduce these vaccines, which are orders of magnitude more expensive than the traditional vaccines, into their national immunization programs. This presentation describes the partnership developed in the Americas to help ensure evidence-based decisions are taken. Jon Kim Andrus, M.D., Lead Technical Advisor, Immunization Unit, Pan American Health Organization/World Health Organization (PAHO/WHO) |
| Keynote Address | |
| 9:40 | Using Genomics to Develop Vaccines for Meningitis Rino Rappuoli, Ph.D., Global Head, Vaccines Research, Novartis, Italy |
| 10:10 | Networking Refreshment Break |
| Discovery & Development | |
| Advances in Adjuvants | |
| 10:40 | Chairperson's Remarks Ronald W. Ellis, Ph.D., Senior Vice President & Chief Technology Officer, NasVax, Inc. |
| 10:45 | IC31® - Driving the Next Generation Adjuvant The hallmark of the next generation vaccines is to optimize the induction of the immune system towards the antigenic composition. IC31®, comprising a peptide and oligonucleotide only, traps the remaining vaccine components in a depot and is fulfilling in many regards the expectations on safety, efficacy and scientific rational that is expected from a state of the art novel adjuvant. Alexander von Gabain, Ph.D., Chief Scientific Officer, Intercell AG, Austria |
| 11:10 | CSL's ISCOMATRIX® Adjuvant and It's Impact on the Development of Next Generation Vaccines CSL's ISCOMATRIX® adjuvant has antigen delivery and immunomodulatory capabilities that combine to provide enhanced and accelerated immune responses. These and other features have led to the use of this adjuvant in a range of next generation vaccines. The results of the clinical trials indicate that the ISCOMATRIX® adjuvant is safe and generally well tolerated and increases vaccine immune responses. Debbie P. Drane, Vice President R&D and Divisional Manager, CSL ISCOTEC, CSL Limited |
| 11:35 | Novel Cationic Liposomes for the Adjuvantation and Formulation of Vaccines Effective vaccination for most new vaccines requires the use of vaccine adjuvants and delivery systems (VADS) to stimulate the optimal and most potent immune responses. Cationic liposomes are promising as a VADS in that they can encapsulate vaccine antigens for effective presentation and adjuvantation and can deliver such antigens both by injection and by the nasal route. This presentation will provide an overview of VADS and one new class of cationic liposomes that is promising for such applications. Ronald W. Ellis, Ph.D., Senior Vice President & Chief Technology Officer, NasVax Ltd. |
| 12:00 | Use of Conserved Influenza Antigens Linked to Immunostimulatory DNA (ISS) to Generate Broad Immunity as a Universal Influenza Vaccine Our universal flu vaccine approach uses highly conserved nucleoprotein and M2e antigens linked to immunostimulatory ODN to induce strong cell-mediated and humoral immune responses that kill virus infected cells. These conjugated antigens should provide heterosubtypic immunity that reduce morbidity and mortality, and serve to adjuvant responses to co-delivered TIV. Debbie Higgins, Associate Director, PreClinical R&D, Dynavax Tehnologies |
| 12:25 | Networking Luncheon |
| Immunogenicity & Immuno-Monitoring | |
| 2:00 | Modulating Vaccine Responses with Innate Immunity The ability of a vaccine to skew the response toward a particular type is of paramount importance, because different pathogens require distinct types of protective immunities. Central to this issue is a rare but widely distributed network of cells known as dendritic cells (DCs). DCs, which have been called 'Nature's adjuvants,' express pathogen recognition receptors, such as the Toll-like receptors (TLRs) and C-type lectins, which enable them to sense and respond to microbes or vaccines. Research in the last decade has demonstrated a fundamental role for DCs in initiating and controlling the quality and strength of the immune response, and emerging evidence suggests an important role for distinct TLRs and C-type lectins in differentially regulating the Th1/Th2/T regulatory balance, by inducing distinct intracellular signaling networks within dendritic cells (DCs). As such, DCs and TLRs represent attractive immune modulatory targets for vaccinologists. This presentation will review the emerging themes in the biology DCs and TLRs, with a particular focus on relevance for vaccine development. Bali Pulendran, Ph.D., Professor, Emory Vaccine Center at Yerkes Primate Research Center |
| 2:25 | Probiotic Lactobacilli Enhance the Immunogenicty and Protective Efficacy of a Live Attenuated Rotavirus Vaccine We evaluated the immunogenicity and protection conferred by the attenuated Wa human rotavirus (AttHRV) vaccine with/without Lactobacillus acidophilus (LA) in gnotobiotic pigs. LA feeding of AttHRV-vaccinated pigs significantly enhanced immune responses to HRV prechallenge and protection against HRV shedding postchallenge, suggesting that LA may be an immunopotentiator for rotavirus vaccines. Lijuan Yuan Ph.D., Assistant Professor, Virology and Immunology, Department of Biomedical Sciences and Pathobiology, Center for Molecular Medicine and Infectious Diseases, Virginia-Maryland Regional College of Veterinary Medicine |
| 2:50 | ImmunoBodies - a Novel Vaccine Approach That Stimulates High Frequency, High Avidity CTL and Helper T Cell, Anti-Tumour Immune Responses ImmunoBody™ are vaccines that incorporate CTL and helper epitopes within the CDR region of a IgG1 human antibody. This allows targeting of CD64 on activated dendritic cells. Upon DNA immunization with ImmunoBody™ mice generated higher frequency and higher avidity epitope specific T-cell responses to antigen compared to whole antigen DNA vaccines, peptides or peptide pulsed dendritic cells. Lindy Durrant, Ph.D., Professor of Cancer Immunotherapy, Clinical Oncology, University of Nottingham, United Kingdom |
| 3:15 | Immunogenicity of Experimental Intranasal HIV-1 or FluDNA/Recombinant Vaccine Candidates with the N3 Cationic Lipid Adjuvant, FliC and/or rGM-CSF In order to increase the efficiency of mucosal DNA vaccines, the intranasal heterologous prime-boost strategy with recombinant proteins, VLPs, peptides or live recombinant virus has proven useful. Since there are today a good number of possible administration alternatives, such as intranasal drop, epidermal creams or bioinjections and electroporations with novel adjuvants, these alternatives will be studied and compared for efficacy. Jorma Hinkula, Ph.D., Professor in Molecular Virology, Clinical & Experimental Medicine, Linkoping University, Sweden |
| 3:40 | Networking Refreshment Break |
| Conjugate Vaccines | |
| 4:15 | Conjugate Vaccines: Present Status and Future Potential Abstract to come. A. Krishna Prasad, Ph.D., Associate Director, Vaccines Research, Wyeth |
| 4:40 | Panel Discussion Emerging Vaccine Technologies: New Immunoassays, Adjuvant, and Delivery Technologies This panel will discuss emerging vaccine technologies that address specific novel areas of vaccine development, including:
Panelists: Martin Cleary, Founder & Chairman, Juvaris Biotherapeutics William Warren, Ph.D., CEO, VaxDesign Corporation Jonathan Smith, Ph.D., CSO, AlphaVax |
| 5:30 | Networking in Exhibit & Poster Hall |
| Production & Process Development | |
| Cost-Reduction Strategies in Vaccine Production | |
| 10:40 | Chairperson's Remarks Eric I. Tsao, Ph.D., Senior Director, Technical Operations, Aeras Global TB Vaccine Foundation |
| 10:45 | Single Use Technology: Can It Reduce Manufacturing Costs? Single use technology is widely accepted in vaccines processing, and is now applicable in a wide range of scale in all manufacturing steps from upstream down to formulation and filling. We will describe using a few examples how it does not only increase manufacturing efficiency but as well decrease manufacturing costs while giving to the vaccine industry the requested level of flexibility. Chris Mach, Marketing Manager, Pall Life Sciences, Inc. |
| 11:10 | Employment of Disposable Membrane Capsules in the Manufacture of Plasmid DNA for Therapeutic and Vaccine Purposes A case study regarding implementation of disposable membrane capsules in the pDNA manufacture for preclinical studies is presented. Two commercially available membrane products were investigated in terms of their DNA binding capacity, contaminant removal and form separation. Advantages and drawbacks of the use of disposables in large-scale production are discussed. Ying Cai, Ph.D., Senior Product Development Engineer, VGX Pharmaceuticals |
| 11:35 | An Automated Approach for Manufacturing Personalized Dendritic Cell Immunotherapies To address the manufacturing challenges of a dendritic cell (DC)-based personalized immunotherapy, Argos has developed working prototypes of equipment capable of automating cellular and RNA processing to increase throughput while lowering cost of goods. These stand-alone RNA and cellular units perform the various processing steps using functionally closed disposables. Tamara Monesmith, Ph.D., Director, Manufacturing & Process Development, Operations, Argos Therapeutics, Inc. |
| Microbial Production | |
| 12:00 | Production of Humanized Therapeutic Glycoproteins in Yeast Engineering of glycans attached to therapeutic glycoproteins in yeast will be described. The topics are related to the production of full length human antibody (H2L2) and glycoproteins for enzyme replacement therapy of lysosomal disease in methylotrophic yeast Ogataea minuta and to the engineering of mucin-type human glycoproteins in budding yeast, Saccharomyces cerevisiae. Yoshifumi Jigami, Ph.D, Prime Senior Researcher, Research Institute for Cell Engineering (RICE), National Institute of Advanced Industrial Science and Technology (AIST) |
| 12:25 | Networking Luncheon |
| Cell Line Development / New Cell Substrates | |
| 2:00 | Embryonic Stem Cells for the Industrial Production of Vaccines ES (embryonic stem) cells have been isolated from chicken and ducks and were used to progressively derive EBx® cells using proprietary procedures. Such cells maintain most of the desirable features of ES cells (ie. High expression of telomerase and stem cells surface markers, long-term genetic stability, indefinite cell proliferation…) but display new industrial- and regulatory-friendly characteristics (ie. proliferation in stirred-tank bioreactors at high cell densities as suspension cells, growth in serum-free media, maintenance of diploidy, absence of in vivo tumorogenicity, high susceptibility to various human and animal viruses, efficient genetic engineering and heterologous protein production…). EBx® cells constitute a unique alternative for the manufacturing of vaccines currently produced in eggs, but also for the production of therapeutic proteins, in particular monoclonal antibodies, with enhanced ADCC (antibody-directed cell cytotoxivity) activity. EBx® cells have already been licensed to over 22 Biotech and Pharma companies worldwide. Majid Mehtali, Ph.D., Vice President, R&D, Vivalis SA, France |
| 2:25 | Scale Up Strategy for a Large Scale Cell Culture Production Process for Influenza Vaccines Abstract to come. Jon S.B. Smith, Ph.D., Directeur Adjoint R&D Projets, Sanofi Pasteur |
| 2:50 | Divergence or Focusing? Using Cell Substrates for Vaccine Production The past years have shown steep increases in the demand for vaccines and subsequently a renewed interest from the Pharmaceutical industry. With that, the use of cell substrates for vaccine production had reached a new innovative level.
Ronald Neeleman, Ph.D., Senior Consultant, Xendo Manufacturing |
| IP Issues in Technology Transfer | |
| 3:15 | Talk TBA |
| 3:40 | Networking Refreshment Break |
| Scale Up & Pilot Production for Clinical Trials | |
| 4:15 | Comparability Strategies for Supporting Manufacturing Scale Up of Merck's HPV Vaccine GARDASIL® To facilitate accelerated approval, a modestly scaled purification facility was initially used to supply Phase III and launch for Merck's HPV vaccine GARDASIL® while larger facilities were being constructed to meet anticipated worldwide demand. This presentation will describe the comparability strategy employed to support licensure of the new facility. Robert D. Sitrin, Ph.D., Executive Director, Bioprocess & Bioanalytical Research, Merck & Co., Inc. |
| 4:40 | Development and Manufacturing of rBCG-Based TB Vaccines Tuberculosis (TB) is the second leading cause of mortality from infectious diseases worldwide. We have developed rBCG vaccines with enhanced immunogenicity based on two strategies: the overexpression of selected antigens and the capacity to escape the endosome to allow improved Class I antigen presentation. Fermentation and lyophilization process development studies aimed at optimizing the process performance will be presented. Eric I. Tsao, Ph.D., Senior Director, Technical Operations, Aeras Global TB Vaccine Foundation |
| 5:05 | Pilot Production of Candidate HIV Vaccines for Clinical Trials - Challenges with Contract Manufacturing cGMP manufacturing of candidate HIV vaccines for evaluation in human clinical trials is an important regulatory requirement. The use of contract manufacturing organizations (CMO) for early stage development is a strategy adopted by the biotechnology industry. Challenges associated with managing a CMO, developing a process and manufacturing these investigational vaccines will be discussed. Eddy Sayeed, Ph.D., Director Vaccine Production, R&D, International AIDS Vaccine Initiative |
| 5:30 | Networking in Exhibit & Poster Hall |
| Day Two Friday, July 18, 2008 | DISCOVERY & DEVELOPMENT | PRODUCTION & PROCESS DEVELOPMENT | | DAY ONE | DAY TWO | | |
| Discovery & Development | |
| Novel Delivery Technologies | |
| 8:30 | Chairperson's Opening Remarks A. Krishna Prasad, Ph.D., Associate Director, Vaccines Research, Wyeth |
| 8:40 | Single-Shot Vaccines: Controlled Delivery by OctoVax Microspheres We are developing single-shot vaccines based on its proprietary OctVAX™ controlled delivery technology. The microsphere matrices can be tailored to facilitate the desired antigen release profiles. Animal studies have shown that this approach can compete with classical multiple injection vaccines, and can thus lead to more attractive vaccines. Bas Kremer, Ph.D., Scientist, Vaccine Development, OctoPlus N.V., The Netherlands |
| 9:05 | Development of New Attenuated Vaccine Delivery Systems Abstract to come. W. James Jackson, Ph.D., Vice President of Technical Support, Emergent BioSolutions |
| 9:30 | Electroporation for DNA/Non-Viral Vector Vaccines New vaccines are needed in the area of immune therapy and infectious diseases. Recently multiple studies have show that short electrical pulses (electroporation) can be used enhance uptake, expression and immunogenicity of gene based vaccines and thereby enable a new vaccine technology to be developed. Inovio and partners were the first company starting clinical trials with this technology and have 5 clinical trials on going with gene based immune therapy delivered by electroporation. An update on the status of these trials will be given. Michael Fons, Ph.D., MBA, Vice President, Corporate Development, Inovio Biomedical Corporation |
| 9:55 | Electroporation Mediated DNA Immunization: Technology Development & Clinical Progress Electroporation (EP) is a potent method for DNA vaccine delivery utilizing the in vivo application of electrical fields to enhance intracellular uptake and resulting antigen expression. In non-clinical studies, the technique has demonstrated induction of robust cellular and humoral immune responses against a broad range of antigens. These encouraging results, have prompted clinical studies EP based DNA immunization for both therapeutic and prophylactic indications. An overview of Ichor's clinical programs for EP mediated DNA vaccine delivery against melanoma and HIV will be provided. Drew Hannaman, Ph.D., Vice President-R&D, Ichor Medical Systems, Inc. |
| 10:20 | Networking Refreshment Break |
| Vaccines for Autoimmune Diseases | |
| 10:50 | DNA Vaccines for Autoimmune Diseases: Clinical Experience DNA Vaccines are a promising method of antigen-specific treatment for autoimmune diseases. We have conducted clinical trials with two DNA vaccines for autoimmune diseases: BHT-3009 for multiple sclerosis and BHT-3021 for type 1 diabetes. The results of these clinical trials will be described. Hideki Garren, M.D., Ph.D., Co-founder & VP of Research, Bayhill Therapeutics, Inc. |
| Advances in Cancer Vaccines | |
| 11:15 | Northwest Biotherapeutics' DCVax Clinical Trial Progress Update Patients with newly diagnosed GBM were treated with autologous dendritic cells loaded with their own tumor biomarkers 3x at 2 week intervals following surgery, radiation and chemotherapy standard of care ("SOC"). Longer term survivors were also administered booster injections at 3 month intervals for 12 months. To date Progression Free Survival was 18.1 months (6.9 month with SOC). Overall median survival was 33.8 months (14.6 months for SOC). Alton Boynton, Ph.D., President and Chief Executive Officer, Northwest Biotherapeutics |
| 11:40 | Development of CTL Epitopes-Based Cervical Cancer Vaccine In this presentation, we present our strategies to develop CTL peptide-based vaccine for human papillomaviru (HPV) associated cancer (i.e. cervical cancer). We have developed a CTL epitopes discovery platform technology to identify novel CTL epitopes in particular focused on the Asian population-dominant haplotype-HLA-A11 and A24, and HPV serotypes 52 and 58. Transgenic mice expressing HLA-A11 and A24 and tetramers are also established as tools to evaluate the functions and cellular immune responses to different CTL peptides vaccines candidates derived from HPV E6 and E7 proteins. The identified CTL epitopes had been tested in a modified TC1 tumor model to demonstrate the efficacy of the CTL peptides-based vaccine candidates in vivo. We are now in pre-clinical studies to complete the CMC section for IND submission. Pele Choi-Sing Chong, Ph.D., Director, Vaccine Research & Development Center, National Health Resesrach Institute, Taiwan |
| 12:05 | Recombinant Viral Vaccines for Cancer Immunotherapy TroVax® is a candidate cancer vaccine which uses MVA as the viral vector to deliver the tumour-associated antigen 5T4. TroVax has been tested in phase I/II clinical trials in colorectal, renal and prostate cancer patients. The presentation will describe lessons learned from these trials and relate measurements of antigen-specific immune responses to clinical benefit. Richard Harrop, Ph.D., Vice President Clinical Immunology, Oxford BioMedica (UK) Ltd. |
| 12:30 | Networking Luncheon |
| Vaccines for Neurodegenerative Diseases | |
| 1:30 | DNA Epitope Vaccine for Neurodegenerative Diseases Antibody-mediated clearance of amyloid-beta holds great promise for treating Alzheimer's disease (AD). Novel second-generation vaccines are now being designed to reduce the potential for adverse events in patients. We have developed a tripartite DNA epitope vaccine that includes: 1) PADRE, a T cell epitope; 2) the first eleven amino acids of amyloid-beta, the B cell epitope; and 3) a "molecular adjuvant", macrophage-derived chemokine that induces a Th2-mediated immune response. New pre-clinical trials may help to develop novel immunogen-adjuvant configurations with the potential to induce therapeutic levels of anti-Aß antibodies, while avoiding the adverse events that halted the first clinical trial in AD patients. David Cribbs, Ph.D., Associate Professor of Neurology, Institute for Brain Aging and Dementia, University of California, Irvine |
| 1:55 | Anti-Aβ Active Immunization for The Treatment of Alzheimer's And Related Disorders Abstract to come. Gene G. Kinney, Ph.D., Director, Head of Integrative Systems Neuroscience, Merck & Co., Inc. |
| Vaccines for Infectious Diseases | |
| 2:20 | Development of Novel Adjuvanted Nasal Inactivated Influenza Vaccine Intranasal co-administration of vaccine with toll-like receptor 3 ligand (TLR3), dsRNA can induce protective immunity for homologous as well as heterologous viral challenge. We applied this technique for a mucosal vaccine directed towards highly pathogenic avian influenza viruses (HPIVs). These results indicate that intranasal administration of vaccine with dsRNA provide significant mucosal immune responses directed towards homologous HPIV as well as protective activity against heterologous HPIVs. Hideki Hasegawa, M.D., Ph.D., Chief Pathology Laboratory, National Institute of Infectious Diseases, Japan |
| 2:45 | Networking Refreshment Break |
| 3:15 | A Phase 1B Clinical Trial to Assess the Efficacy of a Trivalent Influenza PMED™ DNA Vaccine Against a Controlled Influenza Virus Challenge Particle mediated epidermal delivery (PMED) involves the delivery of DNA on gold particles to the epidemis. We have now completed a phase 1b study of a Trivalent influenza PMED DNA vaccine in which subjects were vaccinated then challenged with live virus and protection from disease was monitored. The results of this study will be presented. Peter T. Loudon, Ph.D., Research Director, PowderMed (Pfizer) |
| 3:40 | First & Second Generation Therapeutic Vaccines Against Hepatitis C Virus A few candidate therapeutic vaccines against hepatitis C virus have reached the clinics in the last 4-5 years. While original candidates are based on recombinant protein-adjuvanted or peptide-based vaccines, second generation candidataes involves more sophisticated vaccine vehicles (yeast-based or viral vectored formulations). This talk will present an up-to-date view of this rapidly moving field. Genevieve Inchauspe, Ph.D., Head, Infectious Diseases Department, Transgene France |
| 4:05 | Therapeutic Vaccines for the Treatment of Latent or MDR Tuberculosis China is the country with four million latent tuberculosis (TB) and free treatment of MDR-TB does not include second line anti-TB drugs. In present study, MDR-TB infected monkeys have been treated by DNA vaccines in combination with conventional chemotherapy; and licensed M.vaccae medication has been used to treat latent TB. Zhongming Li, M.D., President & CEO, Shanghai H&G Biotechnology Company, China |
| 4:30 | A Therapeutic Hep B Vaccine Based on the Poly-Epitope Concept: From Preclinical Results to Clinical Trials Thirty cytotoxic (CTL) and 16 helper (Th) T-cell epitopes were selected from multiple hepatitis B virus (HBV) isolates, based on their binding to the most common HLA supertypes and on their conservation amongst HBV isolates. The immunogenicity of a plasmid DNA-based vaccine encoding the epitopes as a single gene product was assessed in vivo and in vitro and subsequently in a phase I study. In order to improve the observed immune response in humans, a heterologous prime-boost immunization with plasmid DNA and recombinant modified vaccinia Ankara (MVA) was evaluated preclinically and resulted in a considerable enhancement of the immunogenicity of the polyepitope vaccine as compared to homologous prime-boost immunization using plasmid DNA only. Clinical studies based on this strategy will be performed to obtain proof-of-concept for a therapeutic HBV polyepitope vaccine. Lydie Meheus, Ph.D., Vice President R&D, GENImmune |
| 5:00 | Close of Conference |
| Production & Process Development | |
| 8:30 | Chairperson's Opening Remarks Peter Latham, President, BioPharm Services Inc. |
| Development and Manufacturing of BioDefense Vaccines | |
| Keynote Address | |
| 8:40 | Emergency Preparedness and Response - How The Development of New Interventions Such As Vaccines Can Play a Major Role Abstract to come. Steve Chatfield, Ph.D., Director, Centre for Emergency Preparedness and Response, Health Protection Agency, United Kingdom |
| 9:10 | Agile Vaccine Manufacturing Abstract to come. Michael V. Callahan, M.D., DTM&H, Program Manager, Defense Science Office (DSO), Defense Advanced Research Projects Agency (DARPA) |
| 9:40 | Rapid Pandemic Response - A Civilian Government Perspective Abstract to come. Jerome A. Donlon, M.D., Ph.D., Chief Science Advisor, Biomedical Advanced Research and Development Authority (BARDA) |
| 10:10 | Networking Refreshment Break |
| 10:40 | In Vitro Immunological Models for Rapid Vaccine Assessment The in vitro MIMIC™ system is a multidimensional interrogation of human leukocytes. It is being developed to simulate a clinical trial including the effect of a vaccine on human population subgroups. This dataset is anticipated to provide better preclinical data and guide the design of rapid and incisive clinical trials. William Warren, Ph.D., President & CEO, VaxDesign Corporation |
| 11:05 | Animal Models in Pre-Clinical Evaluation of Vaccines for Biodefense and Emerging Pathogens This presentation will highlight a few, current animal models for the development of rPA vaccines for anthrax include the use of New Zealand White rabbits and non-human primates, both rhesus (Macaca mulatta) and cynomolgus (Macaca fascicularis) macaques. The presentation will focus on the utility of animal models in preclinical vaccine development and highlight some of the challenges in designing model systems to meet the FDA requirements in accordance with the "Animal Rule". (full abstract on website) Peter Silvera, Ph.D., Program Leader, Vaccine Research, Infectious Disease Research, Southern Research Institute |
| 11:30 | An Innovative VLP-Based Technology for a Rapid and Efficient Pandemic Response Medicago has adapted a rapid, robust and high-yielding vaccine production system based on transient expression in plant biomass to the production of influena virus-like particles (VLP). Results of immunogenicity and lethal challenge studies of our H5N1 influenza VLP-based vaccine will be presented and will show the power of this technology for fast response, dose-sparing and critical surge capacity in an efficient and cost effective manner. Sonia Trepanier, Ph.D., Project Leader, Medicago, Inc., Canada |
| 11:55 | Issues and Challenges Associated with Manufacturing Vaccines for a Biodefense Stockpile Manufacturing biodefense vaccines for the National Stockpile poses multiple challenges for biopharmaceutical companies including: understanding the specific need and developing vaccines accordingly; warm-base manufacturing capability when there is limited turnover of product; uncertainties associated with surge production; and the challenges of working with the US Government. This talk will discuss these topics and offer suggestions for companies interested in this market. Robert V. House, Ph.D., President, DynPort Vaccine Company |
| 12:20 | Networking Luncheon |
| 1:25 | Chairperson's Remarks Bassam Hallis, Ph.D., General Project Manager, Health Protection Agency, United Kingdom |
| Vaccine Production & Challenges | |
| 1:30 | Challenges & Opportunities in Coupling ImmunoBody™ Technology with BEVS in Rapid Vaccine Production ImmunoBiology's two proprietary technologies efficiently delivering antigen to dendritic cells. HspC™ has strengths in multiple antigen presentation, while ImmunoBody™ fuses specific antigen(s) into the CDR region of human antibody, using the Fc region for dendritic binding. ImmunoBody-based vaccine coupled with BEVS has key benefits of speed and yield, exemplified by influenza. Graham Clarke, Ph.D., CEO, ImmunoBiology Ltd., United Kingdom |
| 1:55 | Overcoming Challenges in the Production of Alphavirus Replicon Vaccines AlphaVax is developing a specialized viral vector delivery system for infectious diseases and cancer. Multiple early-stage clinical studies of these alphavirus replicon vaccines are now demonstrating the technology is safe and immunogenic. However, a major hurdle with any new vaccine technology is production and process scalability. This report will highlight a unique approach/solution to alphavirus replicon vaccine manufacture in Vero cells. Todd L. Talarico, Ph.D., Senior Director of Development, AlphaVax, Inc. |
| 2:20 | Thermostable Vaccines CBL's stable suspension technology delivers an instantly injectable product which can be stored, long-term, at room temperature and above. The advantages include: increased shelf-life for thermo labile products, stockpiling with reduced cost of administration and storage, and treatment for patients in the field without the need for refrigeration. We will discuss the technology with examples from our pipeline of vaccine development programmes. Helen Young, Ph.D., Head of Development, Cambridge Biostability Limited, Uniated Kingdom |
| 2:45 | Networking Refreshment Break |
| Biological Assay Development & Analytical Methods | |
| 3:15 | Development and Qualification/ Validation of Biological Assays Biological assays for use in support of vaccine development, manufacture, testing or release and stability must be demonstrated to be sensitive, reliable and reproducible, to give the highest level of confidence in the quality of the data obtained. In order to achieve these aims, the assays are normally qualified and then validated. Qualification/Validation involves demonstrating that a particular method used for quantitative measurement of analytes in a given biological matrix is accurate, precise, specific, sensitive, reproducible and robust. This presentation will review various guidelines for the development and validation of biological assays as well as describing two assays, including a cell-based assay, and their application to vaccine studies. Bassam Hallis, Ph.D., General Project Manager, Health Protection Agency, United Kingdom |
| 3:40 | Validation of Fluorescent Focus Assay: A Case Study of Validation of A Potency Assay The potency assay is the most important lot release assay for biologicals. The potency of Influenza vaccines is measured by Fluorescent Focus Assay (FFA). FFA is a cell - based immunostaining assay which uses virus type and sub-type specific antibodies. A case study will be presented on validation and assessing the robustness of FFA. Kuldip Sra, Ph.D., Senior Scientist, Vaccine Analytical Sciences, MedImmune |
| 4:05 | Potency Assays As Predictors of Vaccine Effectiveness: How Close Can We Get? One of the primary targets in early development of a vaccine is a potency assay. This assay, in its ideal form, is directly related to the clinical assay(s) used to measure the key biomarker(s) that will serve as the surrogate measure of vaccine efficacy. Case studies will be presented to provide examples of both ideal and non-ideal potency assays. John P. Hennessey, Jr., Ph.D., Senior Scientific Director, Bioprocess R&D, Merck Research Laboratories |
| 4:30 | Monitoring Patient Immune Responses and Characterization of Vaccines Using Label-Free Biosensors Label-free biosensors are used to monitor patient immune responses, establish comparability and predict neutralization capability of vaccines. QC and regulatory compliance for analytical instruments will be discussed. Examples from industry for immunotherapeutics and other vaccines will be presented. The objective is to provide examples and strategies for improving R&D productivity. Fredrik Sundberg, Ph.D., Director, Global Pharma Biotech, GE Healthcare, Sweden |
| 5:00 | Close of Conference |
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