9.05

An update on universal healthcare legislation and its possible effects on the pharmaceutical industry, and vaccine R&D specifically

• Public funding and pricing strategies for new vaccine programs as part of a refocus on prevention and wellness in healthcare
• Will this create a new wave of opportunity for vaccine R&D based on non-traditional, non-routine-use targets?
  • If so what are the funding, reimbursement and commercialization models?
• What is the impact of new health delivery systems? What is their impact on innovation of new products?

Michael J. Werner, Partner, Holland & Knight

9.25

Questions & discussion

9.30

CDC update: What changes are afoot on the back of the healthcare reform package?

• How is the immunization schedule being impacted by the new administration?
• Are we moving towards real recommendations and vaccine schedules for the adolescent vaccine sector? If so, which diseases?
  • HPV has opened the door for this new age group – what’s next?
  • Potential booster strategies for meningitis, varicella and pertussis
  • Potential demand for innovation in combination products
• Given the ageing population, what role could and should vaccines play in reducing the healthcare burden in this target group?
• How will the increasingly crowded vaccine schedule be managed?
  • What might be the impact on vaccine manufacturers?

Melinda Wharton, MD, MPH, Acting Director of National Centre for Immunization & Respiratory Diseases, Centers for Disease Control & Prevention

9.50

Questions & discussion

9.55

Update on the National Vaccine Plan

• Neglected diseases / tropical diseases are in the spotlight as a result of the stimulus package
  • How will the funds be allocated – what are the targets?
  • Will the funding open the door for truly neglected diseases, eg Dengue fever?
  • Which targets are feasible yet under-funded?
• What is needed on the technical side to effectively utilize the increase in funding?
• Should there be a list of prioritized vaccines?

Dr Bruce G. Gellin, Director, National Vaccine Program Office, Office of Public Health & Science, Office of the Assistant Secretary for Health, US Department of Health & Human Services

10.15

Questions & discussion

10.20

Vaccine programs for the adult market: Putting the infrastructure in place

• What incentives need to be put in place to stimulate demand for uptake of adult vaccines?
  • Performance measures across healthcare
  • Rewarding physicians for immunizing this age group
• How are discussions in the US progressing on the creation of an adult vaccine entitlement?
  • How to build the infrastructure with insurers
• Quantifying the health economic value of vaccines for 18+
  • What data is available on lifetime value and price?

Isabelle Claxton, Director, Public Policy & Advocacy, GlaxoSmithKline Vaccines

10.40

Questions & discussion

10.45

Never assume anything: Successfully developing vaccines for US government customers

• Requirements vs. expectations, risks vs. benefits
• Building a successful team that includes the USG
• Managing risks in medical countermeasure development (where Murphy's Law reigns)
• Laying the groundwork for future success

Robert V. House, PhD, President, DynPort Vaccine Company LLC, A CSC Company

11.05

Panel discussion
What other vaccines are being prioritized?

• Making sure the vaccine pipeline addresses diseases for older populations: Clinical design and reformulation for pneumococcus, influenza, pertussis, RSV, nosocomial infections
• Are there any vaccine priorities besides influenza that are 'stockpileable'?

11.30

Morning coffee in the exhibition area

Case studies of second-generation DNA vaccines

• What are the data that say that DNA vaccines work well enough in the clinic to become licensed products?
• How much promise do they hold for reducing development time versus traditional antigen-based vaccines?
• How might new delivery technologies help to ensure that the DNA vaccine is delivered properly in the right place to control dosage?
• Electroporation
  
• How is industry rallying against the perceived safety issues with DNA vaccines?
• What role might recombinant DNA vaccines have in the development of the universal flu vaccines?

12.30

Electroporation mediated DNA vaccination for influenza: Assessing the feasibility of seasonal, pandemic, and universal immunization strategies

• Characterization of cellular and humoral immunogenicity in animal models
• Synergy with conventional immunization modalities
• Analysis of protection against influenza challenge
• Issues associated with clinical implementation

Drew Hannaman, Vice President, R&D, Ichor Medical Systems, Inc

12.50

Questions & discussion

12.55

Delivery systems and adjuvants for DNA-based vaccines: Development of prophylactic and therapeutic vaccines

• Nonclinical development of a therapeutic poloxamer-formulated CMV DNA vaccine, TransVaxTM
• Interim Phase 2 clinical data of TransVaxTM in hematopoietic stem cell transplant patients
• Nonclinical development of Vaxfectin®-adjuvanted pandemic influenza DNA vaccines
• Phase 1 clinical data of pandemic influenza vaccine

Dr Alain Rolland, Executive Vice President, Product Development, Vical

1.15

Questions & discussion

1.20

Buffet lunch in the exhibition area

Case studies: Universal influenza vaccine – the holy grail

• What’s in the pipeline? What human data is available? Why do these companies feel they will succeed where others have failed?
• What do you target? How do you choose the strain? How do you neutralize a virus whose neutralization target is changing every day?
• What are the pros and cons of different approaches? How confident are they of finding correlates of protection of immunity? Can the response ever be too good?
• What are the issues around safety, and what are the potential regulatory pathways?

2.30

Challenges and the potential promise for universal influenza vaccines

• What is the potential of conserved epitopes for inducing broadly neutralizing antibodies?
• Is antibody-dependent cytotoxicity (the basis for M2-directed protection in animals) relevant to human disease?
• Can a vaccine based on inducing T cell immunity provide sufficient protection without an HA-inducing antibody component?
• What is the potential role for a vaccine that is effective against more severe disease but less so against moderate disease?

Dr Jan ter Meulen, Executive Director, Vaccine Basic Research, Merck Research Laboratories

2.50

Questions & discussion

2.55

rDNA (protein based) HA vaccine

• How can we break out of the "flu virus grown in eggs" paradigm that has dominated thinking for 60 years?
• What kinds of data will be required to support a new approach based on HA?
• How has the swine flu pandemic revealed the weaknesses in the current system?
• If a global supply of flu vaccine was available, how would we distribute it?

Dr Alan Shaw, President & CEO, Vaxinnate Corporation

3.15

Panel discussion

• Can the universal influenza vaccine really slow down transmission and prevent infection or does it just ameliorate disease? In which case is it simply a therapy for the individual rather than resulting in herd protection?
• Is combination with the seasonal vaccine the ultimate answer?
• Could the universal influenza vaccine be used as a model for other viruses?
  
• The role of antibodies for treatment of pandemic influenza: How viable a concept is it in terms of both scientific principle and health economics?

3.35

Chair’s closing summary

3.40

Close of session and of the Phacilitate Vaccine Forum Washington 2010, followed by afternoon tea

Malaria vaccines: Case studies from those furthest ahead in R&D

• What is the commercial promise and what is the latest clinical data?
• Regulatory and clinical pathway for novel adjuvants: What can be learned from the malaria vaccine trials?
• What is the regulatory pathway for T-cell mediated vaccines?
• What are the issues around how widespread the protection would be?

12.30

The RTS, S malaria vaccine candidate: Getting closer to the goal

• A synthesis of salient phase 2 data
• The ongoing phase 3 trial: Design, status and expectations
• The regulatory pathway and strategy leading to licensure
• Getting ready for implementation: what needs to be done?
  • Demand forecast and commercial manufacturing
  • Policy decisions at the global and national public health levels
  • Planning for vaccine procurement
  • On-the-ground readiness

Dr Joe Cohen, Vice President, Emerging Diseases & HIV Vaccines, Research & Development, GlaxoSmithKline Biologicals

12.50

Questions & discussion

12.55

Progress toward development of an attenuated sporozoite (whole organism) malaria vaccine

• What is the profile of a vaccine that could be used to eliminate infection from a geographic area?
• What are the challenges to developing such a vaccine?
• Making progress with a metabolically active, non-replicating malaria vaccine – addressing:
  • the manufacturing challenges
  • the logistical delivery challenges
  • the vaccine administration challenges

Stephen L. Hoffman, MD, Chief Executive & Scientific Officer, Sanaria Inc

1.15

Questions & discussion

1.20

Buffet lunch in the exhibition area

Flavivirus vaccines: Case studies from those furthest ahead in R&D

• Latest results from the clinic
• What are the pros and cons of the different vaccine technologies adopted?
• Use of chimerization as a means of generating live attenuated viral vaccines

2.30

Development of recombinant subunit vaccines for Flaviviruses

• Challenges in flavivirus vaccine development
• Application of recombinant subunit approaches to address challenges
• Update on recombinant subunit vaccines in development
• West Nile virus
• Dengue
• Tick-borne encephalitis virus

Dr Beth-Ann Coller, Senior Vice President for Research & Development, Hawaii Biotech, Inc

2.50

Questions & discussion

2.55

Case study
Next generation Flavivirus vaccines

Harry Kleanthous, PhD, Senior Director & Head, Discovery USA, sanofi pasteur

3.15

Questions & discussion

3.20

Panel discussion
Addressing the challenges associated with development of vaccines for developing countries - learning from the pioneers in the malaria and flavivirus fields

3.35

Chair’s closing summary

3.40

Close of session and of the Phacilitate Vaccine Forum Washington 2010, followed by afternoon tea

12.20

Panel discussion

• How are vaccine biotechs faring in the current economic downturn?
  • Do VCs and private equity view them differently from biotech working in other modalities?
  • How are the risks weighed up?
• What are VCs / private equity looking for in a company / technology and at what point do they find something compelling enough to provide seed or expanded funding?
• How attractive are biotechs with a business based on potential pandemic outbreak?
  • How do you put a value on any vaccine enabling technology aimed at pandemic?

Panellists:
Vic Schmitt, Venture Partner, Bay City Capital
John Clerici, Partner, McKenna Long & Aldridge
Chris Varma, PhD, Partner, Flagship Ventures

Small company / big company interplay: How does it all connect around manufacturing, supply chain, and the need for dose sparing?

• To what extent are big pharma really interested in working with smaller companies: What are they looking for?
• How much product variation are big pharma looking for in their pipelines?
  • To service 1st, and 3rd world needs – particularly for adjuvants and delivery systems
  • How much are big companies dependent on dose sparing – do they see a real need for it?
• When and how should they work together? How are goals aligned?
• Building sustainable partnerships for global pandemic and seasonal influenza vaccine needs
• What are the potential knock-on effects to be aware of when products are licensed to multiple partners?

12.55

Case study

Dr Rahul Singhvi, President & CEO, Novavax, Inc

1.15

Questions & discussion

1.20

Buffet lunch in the exhibition area

2.30

Case study

Eric Victory, Associate Director, Business Development, MedImmune

2.50

Questions & discussion

2.55

Case study
Development of a novel technology with worldwide manufacturing capabilities

Dr Vidadi Yusibov, Executive Director, Fraunhofer USA Center for Molecular Biotechnology

3.15

Panel discussion

3.35

Moderator’s closing summary

3.40

Close of session and of the Phacilitate Vaccine Forum Washington 2010, followed by afternoon tea