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BIOTECH CONNECTOR SPEAKER SERIES: MAY 2019
May 9, 2019 @ 7:30 AM – 9:00 AM
TOPIC : VACCINES
Cell Culture-Based cGMP Production of Innovative Phase I Clinical Trial Vaccines for HIV and Influenza
[David Lindsay, Ph.D. – Frederick National Laboratory for Cancer Research]
The Vaccine Clinical Materials Program (VCMP) at the Frederick National Laboratory is a pilot plant engaged in cGMP production, testing and release of novel vaccine candidates destined for evaluation in early phase human clinical trials. The disease targets are infectious diseases of global significance including HIV/ AIDS, Ebola, Influenza, Malaria, RSV, Tuberculosis and Zika.
Dr. Lindsay will provide an overview of the pilot plant design and layout, key capabilities/capacity and role this organization plays in the vaccine product development cycle in support of NIAID’s Vaccine Research Center (VRC). Additionally, case studies describing unique aspects of tech transfer, cell culture-based bulk manufacture, analytical and stability testing, and formulation/filling of drug product, will be presented based on experience with two novel, innovative structure-based vaccines developed by VRC: (1) HIV “Env trimer” subunit vaccine and (2) Flu “HA stabilized stem” ferritin-based nanoparticle vaccine.
Safe and Effective Vaccines for Emerging Viruses
[Peter Pushko, Ph.D. – Medigen, Inc.]
Dr. Pushko will discuss the development of vaccines for emerging and tropical viruses such as Pandemic/Avian Influenza, Chikungunya, Lassa, and VEE viruses. Rational vaccine design and novel technologies have been used for vaccine development, such as virus-like particles and rationally designed attenuation mutations. Protection against emerging pathogens has been demonstrated using animal models.
Use of DNA to Develop Active, Passive, and Active-Passive Vaccines Targeting Lethal Viruses
[Jay Hooper, Ph.D. – U.S. Army Medical Research Institute of Infectious Disease (USAMRIID)]
The Virology Division of the Molecular Virology Branch at USAMRIID is currently using DNA to develop candidate medical countermeasures targeting hantaviruses and other lethal viruses of military importance. Approaches include the use of DNA as 1) an active prophylactic vaccine, 2) as a means to develop neutralizing antibodies for use as a pre- or post-exposure prophylactic (passive vaccine), and 3) as a means to launch therapeutic monoclonal antibodies in vivo (active-passive vaccine). These three approaches will be described using data from ongoing discovery, translational, and clinical research.
HIV Vaccine Manufacturing and Enabling Strategies for Acceleration and Development
[Shyam Rele, Ph.D. – Vaccine Translational Research Branch, National Institute of Allergy and Infectious Diseases]
The Vaccine Translational Research Branch (VTRB) at Division of AIDS] is a unique venture within NIH extramural program with the mission to enable, facilitate, operationalize and translate vaccine concepts into current Good Manufacturing Practice (cGMP) manufactured and vialed HIV vaccine products for HIV clinical trials. VTRB manages & supports a broad product portfolio of HIV vaccine assets ranging from complex envelope HIV protein immunogens, adenovirus vectors, virus-like particles, DNA and mRNA vaccines antibodies & adjuvants. VTRB’s strategy also involves capacity building initiatives, development of platforms to expedite HIV vaccine manufacturing (cell line development, upstream and downstream purification), and advancing nanoparticle-based immunogen delivery systems. Dr. Rele’s talk will provide a brief overview of (a) GMP manufacturing of gp140 Env trimer using transient transfection and immunoaffinity purification, (b) comparing gp120 Env product attributes produced from stable cell, stable pool & transient transfection; (c) nanoparticle vaccine product concept development.
S U P P O R T
One exclusive sponsorship is available for this event. Benefits include logo with link on event webpage; signage at event; distribution of marketing materials at event; able to display one pop-up banner at event; mailing list of registered attendees. REGISTRATION
Registration check-in will begin at 7:30 a.m. so that you can be seated for the presentation to begin promptly at 8:00 a.m. Please be aware that you must have a current government issued ID for entrance into the building. Allow yourself enough time to be processed through security prior to the event. Parking will be along Progress Drive as the ATRF is a secured facility and parking is limited to those with gate access. It is a very short walk from Progress Drive to the front of the building but please give yourself some extra time to allow for the walk.