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Vaccine Development & Production Summit

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Disease and Pandemic Vaccine Research, Discovery and Innovation

December 08-09, 2014 · Hilton Boston Back Bay · Boston, MA

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Alternative Language Options:

  • Japanese
  • Korean
  • Taiwanese
  • Chinese

Agenda

Agenda

Monday, December 8, 2014

8:00
Registration and Coffee

8:55
Chairman's Opening Remarks
Patrick A. Ott, MD, Ph.D., Clinical Director, Melanoma Disease Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Assistant Professor of Medicine, Harvard Medical School

Keynote Presentations

9:00
Dr. G.S. Reddy Emerging Vaccine Markets and Their Potential
Emerging markets are playing an increasingly pivotal role in the vaccine space. Emerging economies have huge populations with high GDP growth rates. Opportunities in the emerging markets are opening up due to large number of people are moving into the middle class and they are able to spend more on healthcare. In addition, great advances have been made in developing countries during last decade in expansion of immunization programs and introduction of new vaccines. Emerging markets are in transition and next big vaccine markets are going to be emerging markets.
Dr. G.S. Reddy, Chief General Manager, Indian Immunologicals Limited, India

9:30
Hari Pujar, Ph.D. Vaccine Globalization: Challenges and Opportunities for Bioprocess Development and Biomanufacturing
The last decade has witnessed significant advances in vaccine globalization, ranging from technology transfers to indigenous vaccine development and manufacturing enabled by an ecosystem of accomplished local talent, non-government organizational funding, technological and logistical support. Despite these successes many challenges still remain for more widespread adoption of vaccines. This talk will feature challenges and opportunities in vaccine globalization from a bioprocess development and biomanufacturing perspective.
Hari Pujar, Ph.D., Global Product Leader and Executive Director, Merck & Co

10:00
Networking Refreshment Break in Poster and Exhibit Hall

10:45
Chairperson's Opening Remarks
David L. Narum, Ph.D., Head of Process Development, Laboratory of Malaria Immunology and Vaccinology, NIH

Vaccine Cold Cases

Case StudyNew Data

The session will focus on key infectious diseases where prophylactic vaccineshave, thus far, eluded researchers. Panelists will discuss two "cold case" diseases, where vaccines are currently in development. Several panelists will share new information related to respiratory syncytial virus (RSV) vaccines. Then several panelists will discuss research related to dengue vaccine candidates. The panel will review the 'lessons learned,' the impact new technologies have had on conquering these diseases and examine the recent efforts to develop novel vaccines.

10:50
Chlamydia Vaccines
Ulrich H. von Andrian, M.D., Ph.D., Mallinckrodt Professor of Immunopathology, Microbiology and Immunobiology, Harvard Medical School, and Program Leader, Basic Immunology, Ragon Institute of MGH, MIT and Harvard

11:05
RSV/HSV
Ali Fattom, Ph.D., Senior Vice President of Vaccine Research and Development, NanoBio Corporation

11:20
RSV
Mark Parrington, Ph.D., Senior Director, Sanofi Pasteur

11:35
Dengue Fever
Sean Du, Ph.D., Chief Operating Officer, Altravax, Inc.

11:50
Q&A

12:15
Networking Luncheon followed by Dessert in Poster and Exhibit Hall

1:25
Chairman's Opening Remarks
Kevin Killeen, Chief Scientific Officer, Matrivax R&D Corp.

Conjugated Vaccines and Vaccine Adjuvants

1:30
Case Study
Vaccine Adjuvant Science
This presentation will cover what is an adjuvant; why and when do we need vaccine adjuvants; the general adjuvant mode of action; safety considerations with vaccines formulated with novel adjuvants; and the GSK Adjuvant System families. It will also explore learning and challenges in developing adjuvant system-containing vaccines; the first experience with the malaria candidate vaccine; considerations for use of adjuvanted vaccines in special populations; considerations for future application; and adjuvant vaccine science communication to healthcare providers.
Leonard Friedland, MD, Vice President, Scientific Affairs and Public Health, Vaccines, GlaxoSmithKline

2:00
Case StudyNew Data
Designing the Next Generation of Vaccine Adjuvants
Vaccine adjuvants interact with the immune system, to increase the potency of vaccine antigens. Many of the adjuvants currently available were developed with little understanding of how they worked. Highly pure recombinant antigens are typically very poorly immunogenic due to a lack of exogenous immune activating components such as nucleic acids, lipids, and cell membrane components. The role of adjuvants and the role of adjuvants as delivery systems or immune potentiators is explored in this presentation. The challenges faced by vaccinologists to create the next generation of vaccines can be solved in-part by developing a greater understanding of the impact of delivery, and an appreciation of the key role of pharmaceutical sciences.
Derek T. O'Hagan, Ph.D., Vice President, Global Head of Vaccine Chemistry and Formulation Research, Novartis Vaccines

2:30
New Data
Development of a Malaria Transmission Blocking Vaccine as a Chemically Conjugated Nanoparticle
The current control strategy for elimination of malaria will benefit from the development of an effective malaria vaccine. Our approach is to develop a well-characterized recombinant protein based, chemically conjugated transmission blocking malaria vaccine. The chemical conjugates comprised of Pfs25 and/or Pfs230 with a carrier protein form nanoparticles that significantly enhance immunogenicity in mice and humans, and induce transmission blocking antibodies.
David L. Narum, Ph.D., Head of Process Development, Laboratory of Malaria Immunology and Vaccinology, NIH

3:00
Networking Refreshment Break in Poster and Exhibit Hall

4:10
Chairman's Opening Remarks
Derek T. O'Hagan, Ph.D., Vice President, Global Head of Vaccine Chemistry and Formulation Research, Novartis Vaccines

Vaccine Developments for Emerging and Infectious Diseases

4:15
Case StudyNew Data
Manufacturing a Recombinant Measles Virus For Treating Patients With Multiple Myeloma
A complete clinical response was recently achieved in a patient with multiple myeloma after systemic treatment with a single, high dose of Measles Virus (MV). The large-scale production and purification of MV for human use is particularly challenging since MV is a large, fragile, enveloped virus that requires the use of aseptic techniques throughout virus production and downstream purification. The development of the current MV manufacturing process for oncolytic virotherapy will be discussed.
Mark J. Federspiel, Ph.D., Director, Viral Vector Production Laboratory, Mayo Clinic Comprehensive Cancer Center

Featured Presentation

4:45
Survivor Story: Measles Vaccine Put Her Cancer in Remission
Stacy Erholtz, of Pequot Lakes, MN, battled myeloma, a blood cancer that affects bone marrow. As one of two in a two-patient clinical trial at the Mayo Clinic, the 50-year-old mom discusses her triumphs in this virotherapy story after she was injected with 100 billion units of the measles virus - enough to inoculate 10 million people.

5:15
End Day One

Tuesday, December 9, 2014

8:00
Registration and Coffee

8:55
Chairman's Opening Remarks

Vaccine Enhancement and Delivery Innovations

Featured Presentation

9:00
Vaccines and Melanoma
The potential for therapeutic efficacy of a melanoma vaccine has been evident preclinically for many years. In melanoma patients, vaccines have resulted in the induction of immune responses, although clinical benefit has not been clearly documented. The recent achievements with immune-checkpoint blockade have shown that immunotherapy can be a powerful tool in cancer therapy. With increased understanding of tumor immunity, the limitations of previous cancer vaccination approaches have become evident. Rapid progress in technologies that enable better vaccine design raise the expectation that these limitations can be overcome, thus leading to a clinically effective melanoma vaccine in the near future.
Patrick A. Ott, MD, Ph.D., Clinical Director, Melanoma Disease Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Assistant Professor of Medicine, Harvard Medical School

9:30
Case StudyNew Data
Development of Cellular Immunotherapies to Treat Pancreatic Cancer
Aduro Biotech is developing novel immunotherapies to treat cancers, and our lead program for metastatic pancreatic cancer is a combination of two cellular immunotherapies comprising a prime/boost regimen of GVAX Pancreas and CRS-207. GVAX Pancreas is composed of lethally-irradiated GM-CSF-secreting allogeneic tumor cells, and induces T cell immunity to cancer antigens including mesothelin. GVAX is administered with low dose cyclophosphamide (Cy) to inhibit regulatory T cells. CRS-207 is a live-attenuated double deleted Listeria monocytogenes strain expressing mesothelin, and induces innate and adaptive immunity. Prime/boost vaccination with GVAX and CRS-207 demonstrates synergy in mice. We have recently completed a 90 patient randomized Phase 2 clinical trial in which metastatic pancreatic adenocarcinoma patients who received or refused ≥1 prior chemotherapy were treated with Cy/GVAX followed by 4 doses of CRS-207 (Arm A) or 6 doses of Cy/GVAX (Arm B) every 3 weeks.. No vaccine-related serious adverse events or unexpected toxicities were observed. There was a statistically significant survival benefit for subjects in Arm A versus Arm B demonstrating that the combination of these two novel cellular immunotherapies, when combined, may be a potent immunotherapy regimen. Additional clinical studies are underway.
Justin Skoble, Ph.D., Senior Director, Technical Operations, Aduro BioTech, Inc.

10:00
New Data
Economic and Immunological Rationale for Self-Vaccination using Microneedle Patches
Microneedle patches are in development for painless vaccination by the intradermal route with a potential for self-vaccination. This talk will include a quantitative economic analysis of self-vaccination and recent, pertinent in vivo results.
James J. Norman, Ph.D., Postdoctoral Associate, Chemical Engineering, Massachusetts Institute of Technology

10:30
Networking Refreshment Break in Poster and Exhibit Hall

11:15
Process Characterization of Vaccine Candidates: Where Do We Start?
When we speak of process characterization, we often think of a process in their late phase of clinical manufacture and qualification. Usually, there is a desire to characterize "everything" without really going a systemic methodology of performing characterization. In this talk, we will be looking at some of the ICH guidelines and how we use those guidelines to appropriately stage process characterization. The discussion would cover examples of process characterizing microbial expressed vaccine antigens. The process starts with performing a process risk assessment, performing small-scale model, characterizing unit operations to obtain operating parameters to control your process to meet critical quality attributes.
Tim Lee, Ph.D., Director Process Sciences, Biologics Development, Allergan

11:45
Presentation Sponsorship Opportunity
For more information on presenting a talk on a service, technology or application, please contact Kristen Schott at kschott@ibcusa.com or 508-614-1239.

12:15
Networking Luncheon followed by Dessert in Poster and Exhibit Hall

1:25
Chairperson's Opening Remarks
Tim Lee, Ph.D., Director Process Sciences, Biologics Development, Allergan

Featured Presentation

1:30
Joshua P. Cohen, Ph.D. Measuring Progress in Neglected Disease Drug Development
Increased funding through product development partnerships (PDPs) in neglected disease drug development appears to be yielding results. Approvals and products in Phase III have shown a steady increase since 2000, with nearly a doubling of products in 2009-2013, compared to 2000-2008, in terms of the annual average yield. However, there have only been three newly approved new molecular entities in 14 years. In addition, malaria and HIV (pediatric indications) appear to have benefited most from increased funding, while there has been less success in other diseases. Inclusion of newly approved products on the World Health Organization's Essential Drug List has been slow and limited, with only 44% of new approvals added to the list. Uneven progress suggests funding could be better targeted. And, PDPs could do more to facilitate access, in particular, by working closely with the World Health Organization.
Joshua P. Cohen, Ph.D., Senior Research Fellow/Research Assistant Professor, Tufts Center for the Study of Drug Development

2:00
Case Study
Analytical Characterization of CHIKV VLP as a Vaccine Candidate
Chikungunya virus (CHIKV) is an emerging mosquito-borne alphavirus that causes acute illness including fever, rash and severe arthralgia. Chikungunya virus -like particles (VLPs) could elicit a protective humoral response in animal models and have potential to be used as a prophylactic vaccine. Detailed analytical characterization of CHIKV VLPs and comparison of HEK293 and SfBasic derived VLPs will be presented here.
Sha Ha, Ph.D., Director, Merck

2:30
Case Study
Challenges Experienced During the Approval Process of a Novel Recombinant Influenza Vaccine
There are many advantages of the baculovirus expression vector system for influenza vaccine production, including limited growth potential for adventitious agents that can infect humans and production of authentic antigen that does not require egg-adaptation. This talk will describe the technology we use to produce seasonal and pandemic vaccines and the regulatory challenges encountered during the FDA approval process.
Penny Post, Ph.D., Director of Regulatory, Protein Sciences Corp.

3:00
Networking Refreshment Break in Poster and Exhibit Hall

3:45
Presentation Sponsorship Opportunity
For more information on presenting a talk on a service, technology or application, please contact Kristen Schott at kschott@ibcusa.com or 508-614-1239.

4:10
Chairperson's Opening Remarks
David L. Narum, Ph.D., Head of Process Development, Laboratory of Malaria Immunology and Vaccinology, NIH

4:15
New Data
Formulation of Non-Viral Delivery Systems for Self-Amplifying RNA Vaccines
Nucleic acid-based vaccines such as viral vectors, plasmid DNA, and mRNA are being developed as a means to address a number of unmet medical needs that current vaccine technologies have been unable to address. We have developed multiple non-viral delivery systems for enhancing potency of a self-amplifying mRNA vaccine. Data will be presented to illustrate the potential of a lipid nanoparticle (LNP) and a cationic nanoemulsion for delivery of self-amplifying mRNA. The nanoemulsion technology is based on Novartis's proprietary adjuvant MF59, which has an established clinical safety profile and is well tolerated in children, adults and the elderly. Data will be shown in for a number of prophylactic diseases including influenza, respiratory syncytial virus and HIV in animal models including mice, and non-human primates. Given the demonstration that self-amplifying mRNA delivered using non-viral delivery is well tolerated and immunogenic in a variety of animal models, we are optimistic about the prospects for this technology.
Luis A. Brito, Ph.D., Head Formulation Science, Vaccine Chemistry and Formulations, Novartis Vaccines

4:45
Close of IBC's Vaccine Development & Production Summit