As Reported to the: 2014 African Vaccine Regulatory Forum Annual Meeting

Transcription

1 Satellite Session at 2014 HIVR4P in Cape Town: Addressing Regulatory Challenges Associated with HIV Vaccine Trials in the Evolving World of Standards for Treatment and Prevention As Reported to the: 2014 African Vaccine Regulatory Forum Annual Meeting R4P Satellite Host Institutions: Canadian HIV Vaccine Initiative (Health Canada, the Public Health Agency of Canada and the Alliance Coordinating Office) in collaboration with WHO, Global HIV Vaccine Enterprise and the Bill & Melinda Gates Foundation

2 Participants and format: Regulators (e.g. Malawi, Mozambique, South Africa, Tanzania, Zambia, Zimbabwe, Canada, USA) Sharing experiences and Break-out sessions HIV Principle Investigators & HIV related NGO representatives Over 70 participants including more than 40 representatives from African Regulatory Agencies & Ethics Boards

3 Objectives of the Satellite session are: Share lessons learned from past HIV vaccine trials, the impact of non-vaccine HIV prevention strategies as well as other ethical issues; Identify current challenges from the regulator s and researcher s perspectives; Discuss the path towards addressing these challenges.

4 Agenda: 1. Prevention Trials: Challenges and Approaches Regulatory Landscape: presenters from South African Medicine Control Council, US FDA CBER & WHO African Regional Office Current Vaccine Trials and What is in the Pipeline; presenters from HIV Vaccine Clinical Trial Network & Imperial Collage London Evolving Standards For HIV AIDS Treatment and Prevention: (as above) 2. Breakout Groups on Addressing Regulatory Challenges 5 Break-out sessions formed and discussed twothemed questions

5 Break-out sessions discussed: Theme 1: National regulatory frameworks versus international guidance (FDA, EMA, WHO, ICH) and the dialogue between the regulator and the sponsors of clinical trials; Theme 2: Strategies to enhance the expertise available to support regulatory review in resourcelimited environments

6 Highlights of Break-out sessions: Challenges/Gaps (some identified previously are still a concern): - African NRAs have different regulatory processes in different countries, which makes it difficult to encourage regional cooperation - Difficulties in dealing with the conflicting laws in different countries from perspectives of the NRA and the Sponsor - There is a need for guidelines to deal with pre-submission meetings and NRA/Sponsor engagement. Roles and responsibilities are often not clear and the process and commitments can be difficult to follow from both sides.

7 Highlights of Break-out sessions cont d: - Standard of care, including PrEP/PEP, is critical for HIV trials. Concern that after a clinical trial, the quality of care can decline but it needs to at least be maintained at the same level. - For HIV Clinical Trials, NRAs are largely focused on adverse drug reaction monitoring/management and adequate community engagement by the Sponsor as we ll as sustained availability of testing and support for Vaccine-Induced Seropositivity (VISP). - Continued regulatory capacity building is crucial for low and middle income countries (limited capacity delays everything). - Continued regulatory training is needed for the members of the Ethics Committees was also sited.

8 Highlights of Break-out sessions cont d: - Technological infrastructure is limited (e.g. even availability of adequate computers and internet connectivity is a problem for some NRAs). - It was noted that other African NRAs could learn from EMA s regional collaboration as the EAC has. - There was an active preliminary discussion on the potential for the use of so called trusted third party reviews to support for an NRA s regulatory decisions. This discussion could be continued in other forums to further explore this approach with NRAs. - AVAREF's potential for providing a useful framework for implementation of regional regulatory capacity building as well as regional cooperation/convergence with regulatory decisions was recognized.

9 Summary and Next Steps: - The engagement by participants in this half-day event was excellent and the benefit of such inter-agency discussion on these issues was clear. More time to explore the issues raised would have been beneficial. Other opportunities to continue this dialogue will be explored. - The presentations and related materials will be posted on the CHVI Alliance Coordinating Office web site soon ( and a report for the Satellite meeting will also be posted after internal review. Participants will be notified as this progresses.

10 Acknowledgments: - Dr. Dean Smith & Dr. Miga Chultem (Health Canada/BGTD) - Dr. Ulrich Fruth, WHO (presenting at AVAREF for HC) - ACO (Alliance Coordination Office of CHVI) - HTVN (HIV Vaccine Trials Network) - And especially all presenters and participants!