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Experimental Medicine for Preventative HIV Vaccines

A three-part event to engage scientists, clinicians, industry, funders and community representatives on experimental medicine to progress HIV vaccine development efforts.

HIV prevention has made substantial progress and conducting large and lengthy trials is becoming more difficult and costly with uncertain chances of success. As such, rapid and iterative improvements may be best achieved in pre-clinical and small-scale trials. In this context, there is a growing interest in experimental medicine approaches where product development is directly informed by human data at an early stage of product development rather than pre-clinical or animal data to support further development. Experimental medicine clinical research, sometimes referred to as Phase 0 studies, can also accelerate the progress of the most pertinent candidates through the development pipeline.

This webinar series aims to: (1) outline experimental medicine research and how the approach can hasten HIV vaccine research and development; (2) discuss current or planned experimental medicine trials of HIV vaccines testing new designs and strategies; and (3) explore the needs, optimal methods and practical approaches for improving knowledge and capabilities of health products that regulatory authorities, agencies and ethics review committees use to assess experimental medicine clinical research. Lessons learnt from other fields of medicine, ethical challenges and community perspectives will also be discussed in the context of research conducted to speed up and streamline the R&D process, the benefit of which will be for other studies and people in the future.

Webinar 01 – What is Experimental Medicine and what are the key challenges?

Key elements of experimental medicine research are discussed against the background of ethical challenges presented by this approach to research and development, with benefits that are not immediate to study participants. It also highlights how to engage communities to achieve support.

Speakers and panellists:

  • Chair: Mark Feinberg, CEO, IAVI, USA
  • Robin Shattock, Professor of Mucosal Infection and Immunity, Imperial College London, UK
  • Christine Grady, NIH, Chief, Bioethics, USA
  • Jerome Kim, Director General, International Vaccine Institute, Korea
  • Carl Dieffenbach, NIH, Director of the Division of AIDS, USA
  • Maureen Luba, Senior Programme Manager, AVAC, Malawi

The webinar will include a presentation, a panel discussion and a Q&A.

Webinar 02 – Experimental Medicine trials for HIV vaccine research

This webinar looks into planned and ongoing experimental medicine trials for the development of HIV vaccines. Strategy, products and trial design will be reviewed and discussed to identify the most promising areas for development.

Speakers and panellists:

  • Chair: Nina Russell, the Bill & Melinda Gates Foundation, USA
  • Bill Schief, Professor, Department of Immunology and Microbiology, Scripps, USA
  • Robin Shattock, Professor of Mucosal Infection and Immunity, Imperial College London, UK
  • Jim Kublin, Executive Director, HIV Vaccine Trials Network, USA
  • Ansuya Naidoo, Medical Director, IAVI, South Africa
  • Brett Leav, Vice President, Clinical Development, Public Health Vaccines, Moderna, USA
  • Stacey Hannah, Director of Research Engagement, AVAC, USA
  • Ann Arvin, Senior Vice President, VIR Biotechnology, USA

The webinar will include a presentation, a panel discussion and a Q&A.

Webinar 03 – Building regulatory and ethics expertise for Experimental Medicine

This webinar explored the needs, optimal methods and practical approaches for improving knowledge and capabilities of health products that regulatory authorities, agencies and ethics review committees use to assess experimental medicine clinical research in high-income and low- and middle-income countries.

Speakers and panelists:

  • Chair: Cathy Slack, Head of the HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, RSA

  • Bartholomew Dicky Akanmori, WHO Regional Office for Africa Regional Advisor, Vaccine Regulation and Safety Communicable and Non-Communicable Disease (UCN) Cluster, Vaccine Preventable Diseases (VPD) Program. Brazzaville, Congo.

  • Eric Karikari-Boateng, Director - Centre for Laboratory Services and Research, FDA, Ghana.

  • Gavin Churchyard, CEO of The Aurum Institute NPC, RSA.

  • Jerome Singh, Adjunct Professor in the Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.

  • Julien Nyombayire, Country Director - Project San Francisco

The webinar concluded with a Panel Discussion.