CPTR 2014 New Drug Development Workshop Report Day 2
Day Two: September 25, 2014
EVALUATING THE IMPACT OF ENGAGEMENT ON TB DRUG DEVELOPMENT
DAY TWO: SEPTEMBER 25, 2014
Objective: Discuss the level of engagement needed for the future TB drug development.
Presenter: Jim Lavery, St. Michael’s Hospital
Jim Lavery shared an overview of the work and goals of the Stakeholder and Community Engagement working group. He also set the stage for the focus of the session with an overview of how stakeholders might think about evaluating the impact of community engagement efforts.
See Jim Lavery’s presentation and video.
- Two New Resources for TB Drug Regimens
Presenter: Colleen Daniels, Treatment Action Group
Colleen Daniels presented an overview of two new resources for TB drug regimens – both guides for activists, with one focused on linezolid and one on delamanid. She emphasized the need for activism and challenged participants to think about how they could increase their role as advocates for new TB treatments.
See Colleen Daniels’s presentation and video.
- Cases from the Field: A Researcher Coordinator’s Perspective on Implementing Community Engagement
Presenter: Steve Wandiga, Kenya Medical Research Institute Centre for Global Health Research (KEMRI CGHR)
Steve Wandiga discussed the importance of building a relationship between researchers/research sites and the stakeholders impacted by research. His key take-away was that better communication leads to increased understanding of the ultimate research goals and allows for more community engagement and ownership.
See Steve Wandiga’s presentation and video.
- Good Participatory Practice: An Investigator’s Perspective on Evaluating Engagement Strategies
Presenter: Kathleen MacQueen, FHI360
Kathleen MacQueen presented on the development on new drugs, new trials and projects with the National Institutes of Health, and the importance of stakeholder engagement.
See Kathleen MacQueen’s presentation and video.
- Piloting Monitoring and Evalutation Research: A Researcher Coordinator’s Perspective
Presenter: Nombuyisela Tshandu, Wits Health Consortium
Nombuyisela Tshandu presented suggested community engagement strategies around clinical trials. She discussed the importance of understanding and addressing stakeholder and community concerns in the research process, so as to avoid misconception, disruption, and closure of trials.
See Nombuyisela Tshandu’s presentation and video.
- Thinking About Community Engagement as an Investigator
Presenter: Maria de Lourdes Garcia-Garcia, Center for Infectious Diseases; Mexico
Maria de Lourdes Garcia-Garcia presented on the benefits of the recent advances in epidemiology, molecular microbiology, functional genomics, immunology and population genetics, and the implementation of new advances in research practices in local communities.
See Maria de Lourdes Garcia-Garcia’s video.
EMERGING ISSUES IN THE REGULATORY SCIENCE OF TB DRUG REGIMEN DEVELOPMENT
Objective: Discuss the impact of emerging issues in regards to the regulatory sciences.
Moderator: Matt Lumpik, Bill & Melinda Gates Foundation
See Matt Lumpik’s video.
- Introduction – Global Regulatory Pathways: Challenges and Opportunities
Presenter: Martha Brumfield, Critical Path Institute
Martha Brumfield presented on the importance of using the experience from countries participating in the early implementation of bedaquiline to share and inform best practices for other countries and for planning the introduction of other new drugs.
See Martha Brumfield’s presentation and video.
- Collaboration Registration of Medicines Prequalified by the World Health Organization
Presenter: Milan Smid, World Health Organization
Milan Smid discussed a new WHO collaborative procedure to facilitate and accelerate national registrations of prequalified medicines, and how the process can contribute to effective regulation. He also shared the benefits of this process for stakeholders, including manufacturers and procurers.
See Milan Smid’s video.
- African Medicines Regulatory Harmonization Initiative: Perspective on Past Experience and Potential Applications
Presenter: Margareth Sigonda, New Partnership in African Development, African Union
Margareth Signoda presented background on the African Union’s African Medicines Regulatory Harmonization (AMRH) Initiative, the AMRH’s vision and goals, and the group’s process for achieving better harmonization, coordination and work sharing among African countries.
See Margareth Signoda’s presentationand video.
- Emerging Issues in Global Regulatory Pathways for TB Drug Regimen Development and Evaluation: Industry Perspective
Presenter: Karin Rombouts, Janssen
Karin Rombouts discussed major regulatory challenges for products addressing global health problems. She examined the case of bedaquiline and posed questions about how the regulatory process might be accelerated and challenges solved in order to make proven drugs more available.
See Karin Rombouts’s presentation and video.
- Emerging Issues in Global Regulatory Pathways for TB Drug Regimen and Development and Evaluation
Presenter: Christian Lienhardt, World Health Organization
Christian Lienhardt presented on the importance of producing policy recommendations for the treatment of tuberculosis. Lienhardt suggested we begin using the World Health Organization’s Policy Package.
See Christian Lienhardt’s presentation and video
Presenter: Uvistra Naidoo, Physician, South Africa
Uvistra Naidoo closed the conference with the inspiring story of his experience as a TB survivor. During his battle with TB, he underwent more than 3 years of treatment – taking more than 20 tablets of treatment a day, and suffering severe side effects. He challenged the group to collaborate and to work together to reverse pessimism and inspire hope in the fight against TB.
See Uvistra Naidoo’s video.
Presenter: Jan Gheuens, Bill & Melinda Gates Foundation
Jan Gheuens noted the evolution and maturation of CPTR in a number of areas, as well as its expanding scope. He summarized several themes of the conference and noted a number of current challenges for the community in their efforts to fight TB.
See Jan Ghuens’ video.