[Note: There s a pdf called "About Pandemic Flu" here:
www.novavax.com/download/File/pandemic_for_web.pdf If anyone could copy the text and post it, that would be super cool.thanks]
NOVAVAX
http://www.novavax.com/Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary virus-like particle (VLP) technology. The Company produces these VLP based potent, recombinant vaccines utilizing a new and efficient manufacturing approach.
Our world-class scientific team is using virus-like particle (VLP) technology to tackle influenza viruses – including avian strains that have the potential to cause a pandemic outbreak. Our team has created vaccines designed to protect against various circulating strains of avian influenza as well as seasonal flu, Respiratory Syncytial Virus (RSV) and Varicella Zoster Virus (VZV). We have validated our approach in animals and are now in clinical testing with our pandemic and seasonal influenza vaccine.
Our vision is a holistic approach to controlling the spread of disease. Using a unique portable manufacturing system that allows for rapid mass production, our long-term goal is to be able to rapidly deliver a customized vaccine in the midst of a pandemic.
Novavax plans to apply its particle-based vaccine approach to other viral diseases beyond influenza.
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Board of Directors
John Lambert, Chairman
Former President of Chiron Vaccines, current director of J.G. Solutions Ltd.
Gary C. Evans, Lead Director
Chairman and Chief Executive Officer and founder of Green Hunter Energy, Inc., Owner and co-founder, Wind Hunter, LLC, Retired Chairman, President and Chief Executive, Magnum Hunter Resources, Inc.
John O. Marsh, Jr.
Distinguished Professor of Law, George Mason University, Former Secretary of the Army and U.S. Congressional Representative
Michael A. McManus, Jr.
President, Chief Executive and Director, Misonix, Inc.
Thomas P. Monath, M.D.
Partner, Kleiner Perkins Caufield Byers
Rahul Singhvi, Sc.D.
President and Chief Executive, Novavax, Inc.
James B. Tananbaum, M.D.
Managing Director, Prospect Venture Partners
The chart below describes the structure of Novavax's Board of Directors and its committees. Audit Committee Compensation Committee Corporate Governance Committee
Gary C. Evans X Chairman
John O. Marsh X Chairman X
Michael A. McManus Chairman X
Thomas P. Monath X X
Rahul Singhvi
James B. Tananbaum X X
John Lambert, Chairman
Chairman of the Board of Directors of Novavax since March 2007. President, Chiron Vaccines, a biopharmaceutical company, from 2001 to 2005. President, Aventis Pasteur MSD, a vaccine joint venture established between Aventis (now Sanofi) and Merck Vaccines, 1998 to 2000. Currently the Vice President of the Conseil d’Administration of Farmaprojects S.A. (Spain), Non-Executive Chairman of Cambridge Biostability Ltd. (U.K.) and Non-Executive director of Acambis plc (U.K.).
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Gary C. Evans, Lead Director
Gary C. Evans is the Chairman and Chief Executive Officer and founder of GreenHunter Energy, Inc., an alternative energy company involved in wind, biofuels and biomass power production listed on the American Stock Exchange. Mr. Evans is also a principal in Global Hunter Holdings, L.P., the parent of Global Hunter Securities, LLC., entities active in both direct capital investments and investment banking activities for numerous high growth Chinese based enterprises.
During the prior twenty years until April 2005, Mr. Evans served as Chairman, President and Chief Executive Officer of Magnum Hunter Resources, inc. (a New York Stock Exchange listed company) and Chairman and Chief Executive Officer of all the Magnum Hunter subsidiaries since their formation or acquisition dating back to 1985. Mr. Evans founded the predecessor company, Hunter Resources, Inc., that was merged into and formed Magnum Hunter Resources Inc., until its merger with Cimarex Energy, Inc. (NYSDE: XEC) during 2005.
Mr. Evans currently serves as the Lead Director of Novavax, Inc., a NASDAQ listed pharmaceutical company. Mr. Evans serves as an Individual Trustee of TEL Offshore Trust, a NASDAQ listed oil and gas trust. Mr. Evans was recognized by Ernst & Young as the Southwest Area 2004 Entrepreneur of the Year for the Energy Sector and was recently inducted into the World Hall of Fame for Ernst & Young Entrepreneurs.
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John O. Marsh, Jr.
Co-Chair of Independent Review Group for Walter Reed Hospital and Bethesda Navy Medical Center since 2007. Visiting Professor, George Mason University Law School, since 2001. Visiting Professor, Virginia Military Institute, 1998. Interim Chief Executive Officer of Novavax from July 1996 to March 1997 and Chairman of the Board of Directors from July 1996 to February 1997. Secretary of the Army from 1981 to 1989. Counselor with Cabinet rank to the President of the United States from 1974 to 1977. Assistant for National Security Affairs to Vice President of the United States, 1974. Assistant Secretary of Defense from 1973 to 1974. U.S. Representative in Congress from 1963 to 1971.
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Michael A. McManus, Jr.
President, Chief Executive Officer and Director of Misonix, Inc., a medical, scientific and industrial provider of ultrasonic and air pollution systems, since 1998. President and Chief Executive Officer of N.Y. Bancorp from 1990 to 1998. Assistant to the President of the United States from 1982 to 1985. Currently a director of LQ Corporation, Inc., American Home Mortgage Holdings, Inc. and A. Schulman Inc.
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Thomas P. Monath, M.D.
Partner, Kleiner Perkins Caufield & Byers. Chief Scientific Officer and Executive Director, Acambis Inc., 2003 to 2006. Vice President, Research & Medical Affairs, Acambis Inc. 1992 to 2003. Director, Sanaria Inc. 2005 to 2006. Medical Advisory Board, Symphogen A/S 2005 to 2006. Scientific Advisory Board, Transform Pharmaceuticals, 2005 to present, IAVI 2007 to present. Consultant to Acambis Inc., specifically for smallpox vaccine 2006 to 2007. Currently a director of two private life science companies — Juvaris BioTherapeutics and Xcellerex, Inc.
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Rahul Singhvi, Sc.D., M.B.A.
Dr. Singhvi is a recognized vaccine specialist, manufacturing expert and business leader in the pharmaceutical industry. Since assuming his current position, Dr. Singhvi has restructured Novavax to focus on product innovation and development, in particular influenza vaccine development using the company’s novel virus-like particle and Novasome® paucilamellar vesicle technologies.
Before joining Novavax, Dr. Singhvi headed vaccine manufacturing operations at Merck & Co., where production increased by 25 percent at the two plants he oversaw.
Dr. Singhvi received his M.S. and Sc.D. degrees in Chemical Engineering from the Massachusetts Institute of Technology. He also holds an M.B.A. from the Wharton School.
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James B. Tananbaum, M.D.
Managing Director of Prospect Venture Partners II and III, LLC, a dedicated life science venture fund group which he co-founded in 2000. Chief Executive Officer of Theravance, Inc., a biopharmaceutical company, from 1997 to 2000. Partner, Sierra Ventures, a venture capital firm, from 1993 to 1997. Senior Product Manager of Merck & Company, Inc. from 1991 to 1993. Currently a director of Jazz Pharmaceuticals, a private biopharmaceutical company and the following publicly traded biopharmaceutical companies: Critical Therapeutics, Inc., Vanda Pharmaceuticals, Inc. and Infinity Pharmaceuticals, Inc.
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Management Team
President and Chief Executive Officer
Rahul Singhvi, Sc.D., M.B.A.
Senior Vice President, Commercial Operations
Raymond J. Hage, Jr., M.B.A.
Vice President, Development and Chief Medical Officer
Penny M. Heaton, M.D.
Vice President, Vaccine Development
Gale Smith, Ph.D.
Vice President, Technical and Quality Operations
James Robinson
Vice President, Strategy
Thomas S. Johnston, B.S., M.B.A
Biographies
President and Chief Executive Officer
Rahul Singhvi, Sc.D., M.B.A.
Dr. Singhvi is a recognized vaccine specialist, manufacturing expert and business leader in the pharmaceutical industry. Since assuming his current position, Dr. Singhvi has restructured Novavax to focus on product innovation and development, in particular influenza vaccine development using the company’s novel virus-like particle and Novasome® paucilamellar vesicle technologies.
Before joining Novavax, Dr. Singhvi headed vaccine manufacturing operations at Merck & Co., where production increased by 25 percent at the two plants he oversaw.
Dr. Singhvi received his M.S. and Sc.D. degrees in Chemical Engineering from the Massachusetts Institute of Technology. He also holds an M.B.A. from the Wharton School.
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Senior Vice President of Commercial Operations
Raymond J. Hage, Jr., M.B.A.
Mr. Hage is an experienced pharmaceutical marketer who has overseen the marketing of several major drugs over the past 15 years. Mr. Hage oversees business development and marketing strategy. Prior to joining Novavax, Mr. Hage held marketing positions at Eli Lilly & Co. and Cephalon, Inc.
Mr. Hage received a B.S. in Business and Economics from the University of Kentucky and an M.B.A. from Ohio State University.
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Vice President and Chief Medical Officer
Penny M. Heaton, M.D.
Dr. Heaton is responsible for all medical and regulatory affairs at Novavax including the preclinical and clinical development programs for the company’s pandemic and seasonal influenza vaccines. She joined Novavax after a seven-year career at Merck & Co.’s Research Laboratories, where she served as senior director of vaccines clinical research. While at Merck, she oversaw all aspects of the global development of RotaTeq®, the company’s vaccine against rotavirus, which has been filed for licensure in more than 100 countries and is currently recommended for all infants in the United States.
A graduate of the University of the Louisville School of Medicine in Kentucky, Dr. Heaton began her career at the U.S. Centers for Disease Control and Prevention Foodborne and Diarrheal Diseases Branch where she served as a medical officer in the Epidemic Intelligence Service. She was responsible for investigating disease outbreaks as well as conducting surveillance and epidemiologic studies. Dr. Heaton is a member of the Pediatric Infectious Diseases Society and a fellow of the American Academy of Pediatrics.
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Vice President of Vaccine Development
Gale Smith, Ph.D.
Dr. Smith is a leader in vaccine technology and holds numerous patents for the baculovirus-insect cell expression system, influenza vaccines and adjuvants. At Novavax, Dr. Smith has developed the first known commercial, scalable process for the manufacture of virus-like particle vaccines for influenza. He also has collaborated with the U.S. Centers for Disease Control and Prevention in testing a virus-like particle vaccine to protect animals against the H9N2 influenza. Prior to joining Novavax, Dr. Smith led a team at Protein Sciences Corp. that developed the first experimental vaccine for HIV approved by the U.S. Food and Drug Administration for testing in the United States. Dr. Smith also collaborated with the National Institute of Allergy and Infectious Diseases and the National Institute of Health to produce the first experimental vaccine tested in man against the H5N1 avian influenza.
Dr. Smith did graduate work at the Baylor College of Medicine and has a Ph.D. in Microbiology from Texas A&M University.
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Vice President of Technical and Quality Operations
James Robinson
Mr. Robinson is responsible for process and analytical development, clinical manufacturing, QC and QA for Novavax. His team has developed a process for manufacturing recombinant virus-like particle influenza vaccine using insect cells that will use 100% single-use systems. Mr. Robinson joined Novavax after more than 20 years at sanofi pasteur, a division of the sanofi aventis group, where he most recently served as Vice President of Industrial Operations. In that capacity, Mr. Robinson was responsible for all aspects of sanofi's US sterile manufacturing operations including quality control, production planning, engineering, warehousing, outsourcing, and strategic planning.
Mr. Robinson began his career at G.D. Searle & Co. as a pilot plant manager in the company's NutraSweet Division. In 1986 he joined sanofi as a vaccine production supervisor. He held various positions in manufacturing, engineering, and product development before being named vice president in 1998. He is a graduate of Lehigh University, where he earned Bachelor's and Master's degrees in chemical engineering.
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Vice President of Strategy
Thomas S. Johnston, B.S., M.B.A.
Mr. Johnston is responsible for managing Novavax’s corporate strategic planning process, evaluating potential strategic opportunities and managing select initiatives, including the GE Healthcare collaboration, for development through to proof of concept. Prior to joining Novavax, Mr. Johnston served as an executive level strategic consultant in a number of industries including biotech, financial services, and electronic security, with clients such as Novavax, RBC Bank and the U.S. Department of Homeland Security. Earlier in his career, Mr. Johnston held varying senior-level positions with a number of organizations such as Comcast, Microsoft, and Schlumberger. In each role he was able to apply a unique combination of corporate strategy, marketing and finance skills with product level and often technical skills. Tom holds an M.B.A. from The Wharton Business School and a Bachelor of Science degree in Computer Science from Arcadia University.
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Events & Presentations
World Vaccine Congress 2009
Washington, D.C.
April 20, 2009 3:20 pm
Panel Session Speaker: Dr. Rahul Singhvi
April 23, 2009 11:20 am
Presentation: Ray Hage
Commercialisation of virus-like particle vaccines using disposable manufacturing systems
April 23, 2009 12:10 pm
Panel Session Speaker: Ray Hage
No webcast for these sessions
Novavax, Inc., Annual Shareholder Meeting
9920 Belward Campus Drive
Rockville, MD
May 13, 2009 10:00 am
2009 BIO International Convention
Atlanta, GA
May 20, 2009 4:00 pm
Panel Presentation:
"Blockbusters Aren't Dead: They're Just Called Vaccines"
Panel Speaker: Thomas S. Johnston
Presentation will be available here
Phacilitate Vaccine Forum Barcelona 2009
Barcelona, Spain
June 22, 2009 9:05 am (CST)
Panel Session Speaker: Dr. Rahul Singhvi
June 23, 2009 9:05 am (CST)
Panel Session Speaker: Dr. Rahul Singhvi
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R&D Programs
Influenza Vaccines
Novavax is targeting its research efforts initially on various strains of viral influenza. These include H5N1 pandemic influenza, often referred to as “bird flu,” and seasonal influenza, the flu strain that circulates each year. Novavax’s pre-clinical data show the company’s VLP vaccines provide broad protection against a variety of influenza viral strains. Human clinical studies using Novavax' s pandemic VLP vaccine began mid-2007.
Novavax’s collaborators on the influenza vaccines programs include the University of Pittsburgh and the Southern Research Institute, which is one of a handful of U.S. research facilities approved to handle live H5N1 avian influenza virus.
Flu Facts
Varicella Zoster Virus Vaccine
VZV is responsible for over 1 million cases of herpes zoster (shingles) in the US each year.
Primary complication is post-herpetic neuralgia (PHN), which occurs in ~65% of affected patients.
Large market with only one vaccine supplies:
Government has issued a universal recommendation for all US citizens >60 years of age to be vaccinated against VZV
Current vaccine provides ~50% efficacy against shingles and ~39% efficacy against PHN.
Potential advantages of Novavax’s VZV vaccine:
Broad immune response
Potential safety advantages because of lack of replication
Manufacturing efficiencies: live VZV not needed for process
Vaccine is currently in discovery/preclinical development
HIV
Novavax has created a VLP-based vaccine to protect against human immunodeficiency virus (HIV), the virus that causes AIDS, with funding support from the National Institutes of Health. Scientific collaborators at Harvard Medical School, Emory University and the University of Alabama - Birmingham, have conducted pre-clinical testing using the vaccine. Further evaluation is under way.
Other Vaccine Opportunities
Novavax’s VLP approach has many potential applications and could be used to address a number of other common infectious diseases.
For more information about clinical trials with Novavax influenza vaccines, click here.
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Flu Facts
Seasonal Influenza is a viral infection that attacks the respiratory tract including the nose, throat and occasionally the lungs. The infection, which usually lasts about a week and is highly contagious, is characterized by fever, headache, muscle aches, cough and sore throat.
Each year epidemic (seasonal) influenza infects between three million and five million people worldwide and results in 250,000 to 500,000 deaths. Most of these deaths are associated with complications from pneumonia. The elderly are the most vulnerable.
Influenza Virus Particle
This flu particle has a spiny coat made of proteins that encapsulate its segmented RNA, the genetic material
Avian influenza is a virus that normally affects only birds. However, sometimes influenza viruses that infect animals may adapt to infect people. In 1997, the first case of H5N1 avian influenza to infect humans was documented in Hong Kong. Since then, the H5N1 virus has spread across Asia, has mutated and has infected hundreds of people, killing approximately half of those infected. Avian influenza in humans is characterized by an unusually high mortality rate, including otherwise healthy people of all ages, and is believed to have pandemic potential.
The H5N1 avian influenza virus is rapidly evolving into antigenically distinct clades, or families. H5N1 clade 1 flu viruses were identified in Vietnam in 2003; by 2005 a second clade was identified in Indonesia. Novavax scientists have succeeded in making a vaccine candidate designed to protect against the H5N1 clade 2 influenza virus.Recent Avian Influenza Strains That Have Infected Humans
H5N1 Identified in 1997 in Hong Kong, since detected in Cambodia, China, Indonesia, Thailand and Vietnam
H7N7 Identified in 2003 in the Netherlands
H9N2 Identified in 1999 in Hong Kong
H7N3 Identified in 2004 in Canada
Influenza pandemics are rare but typically recur every 10 to 50 years. A pandemic occurs when:
A novel subtype of influenza infects humans who are immunologically naïve to the virus
The virus causes severe mortality in humans; and
The virus spreads efficiently from human to human Influenza Pandemics of the 20th Century
1918 The Spanish flu caused approximately 40 million deaths
1957 The Asian flu caused approximately 2 million deaths
1968 The Hong Kong flu caused approximately 1 million deaths
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