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FasterCures Quarterly Update: October 2022

Newsletter
FasterCures Quarterly Update: October 2022

In This Issue:

Advancing Health Equity in Biomedical Research
FasterCures Roundtables Recap
Policy Update
FasterCures COVID-19 Treatment and Vaccine Tracker Sunsets
Apply Now to Join The Research Acceleration and Innovation Network (TRAIN)
New Resources for Building Nonprofit Capacity
Watch the LeadersLink Capstone Videos
Subscribe to the FasterCures Advances in Science Webinar Series
FasterCures in the News
Welcome New Staff Members
Join Us at the 2022 Milken Institute Partnering for Patients Forum and the Future of Health Summit

The FasterCures team is making great strides in our mission-driven work to address the challenges and opportunities facing biomedical innovation.

Leading up to the 2022 midterm elections, FasterCures took a firm stance on several key issues of merit for bipartisan Congressional action, including the reauthorization of the Food and Drug Administration’s (FDA) user fee programs and the PREVENT Pandemics Act, which includes the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH). We also supported legislative efforts to improve the FDA’s accelerated approval process so that it remains a mechanism for fast-tracking access to treatments for patients with serious conditions. For more information, please read the Policy Update.

Our portfolio of work to advance health equity and diversity in clinical trials continues to grow. In a follow-up to the first-ever Milken Institute Health Equity Forum, FasterCures released our latest issue brief, A Call to Action for Health Equity: Solutions from the Front Lines for Local and National Efforts. It outlines four key issues and recommendations for action to address health equity, including best practice examples shared during the Forum.

Our nonprofit capacity-building programs have several new resources available, and recruitment is underway for The Research Acceleration and Innovation Network (TRAIN). If your patient-driven organization is not already part of TRAIN, I encourage you to learn more and apply today to take advantage of exclusive access to our events, mentoring programs, and more.

This summer, FasterCures hosted several roundtable discussions with distinguished speakers on a range of topics, including cell and gene therapy, early warning systems, and patient engagement.

More recently, I moderated a discussion at the Milken Institute Asia Summit about the innovations and health tech that came from the COVID-19 pandemic. Leaders reflected on the solutions that came out of the pandemic they are most optimistic about, what new issues have emerged, and what they see on the horizon for health care and biomedical research. You can view the session recording here.

At the White House Summit on the Future of COVID-19 Vaccines, I was honored to join a group of esteemed colleagues to discuss the next generation of vaccine development and production, as well as opportunities to advance vaccine equity. The White House released its first annual report on progress toward the American Pandemic Preparedness Plan. FasterCures advises taking lessons learned from COVID-19 to prepare for the next pandemic, such as creating an early warning system for pandemics and building community-based infrastructure for inclusive research.

Early in the COVID-19 pandemic, we created the FasterCures COVID-19 Treatment and Vaccine Tracker to help policymakers, the scientific community, and the public track the progress of research and development. Since its debut, there have been over 1 million visits from users around the world. Now, as we sunset the tracker, read this celebration of collaboration and innovation in the race for treatments.

Finally, I hope you will join FasterCures at event opportunities through the remainder of 2022, including our Advances in Science webinar series and the Future of Health Summit/Partnering for Patients Forum in Washington, DC, December 6–8.

Regards,

Esther Krofah
Executive Vice President, Health, and Executive Director, FasterCures and Center for Public Health
Milken Institute

Advancing Health Equity in Biomedical Research

FasterCures advances system change within biomedical research to focus on and value health equity as well as diversity and representation within clinical trials. This summer, FasterCures hosted the first-ever Milken Institute Health Equity Forum in collaboration with the National Civil Rights Museum in Memphis, Tennessee. Learn more about the Forum experience.

Our latest issue brief, A Call to Action for Health Equity: Solutions from the Front Lines for Local and National Efforts, summarizes the information and best practices shared during the Forum. It outlines four key issues and recommendations for action to address health equity, including partnerships, data sharing, workforce diversity, and accountability.

Later this fall, FasterCures will release a report on implementing strategies discussed at this event in other regions nationwide. As part of this ongoing work, FasterCures will also host a series of topic-specific workshops this fall and winter focused on enacting the recommendations from our action plan to address diversity across clinical trials and biomedical research.

FasterCures Roundtables Recap

Our team worked with a diverse set of thought leaders to curate and co-host the following roundtables this summer:

  • A Conversation about Gene Therapy Development with FDA and NCATS: Peter Marks, director of the Center for Biologics Evaluation and Research of the FDA, and PJ Brooks, acting director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS) of the NIH, joined members of the FasterCures community for a discussion of the current landscape of cell and gene therapy manufacturing and policy. Marks and Brooks provided an overview of the goals of the Bespoke Gene Therapy Consortium and expectations for how this initiative could advance the development of gene therapies, particularly for rare diseases. (To learn more about cell and gene therapy, visit our Advances in Science page for a recording of the September 29, 2022, webinar with guest speaker PJ Brooks).

  • Early Warning System Roundtable: A Collaboration with Market Access Africa: FasterCures collaborated with Market Access Africa, a health-care organization that convenes experts on issues relevant for access to health technologies and quality health services in Africa, to host a series of roundtables to discuss the key considerations for an early warning system. In the roundtables, we brought together scientists, researchers, policy experts, and on-the-ground experts to discuss the Milken Institute’s efforts to advance an early warning system as well as understand their experience and feedback to bring needed perspective to how we further this initiative in a manner that is inclusive. We look forward to sharing a summary of these discussions with you later this year.

  • Patient Engagement Roundtable Summary: As part of FasterCures’ ongoing efforts to advance the Science of Patient Input and support our partners in their efforts to engage patients in research, we convened a select group of industry leaders to discuss the metrics, measures, and frameworks that stakeholders are using to assess the impact of their patient engagement activities and initiatives. Panelists shared strategies employed by their organizations, including constituting a cross-functional team to help identify the right points to engage patients and increase internal buy-in for patient engagement efforts, leveraging evaluation data to demonstrate value and return on investment to get the needed support and overcome challenges with building and sustaining investments and commitments to patient engagement, and developing processes with metrics that are relevant to internal stakeholders, including patients. We are working on a report on the current state of the Science of Patient Input for release later this year.

Policy Update

FasterCures supported several important legislative issues before Congress, including:

  • The Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act): FasterCures urges passage of PREVENT Pandemics Act. The legislation will: 1) strengthen public health and medical preparedness and response systems and 2) take action steps to inhibit shortages of medical products. Read our letter of support.

  • User Fee Reauthorization: FasterCures expressed support for reauthorizing the FDA’s user fee programs (PDUFA, MDUFA, GDUFA, and BsUFA) in advance of the September 30, 2022, reauthorization deadline. User fee reauthorization presents an opportunity to make crucial improvements to enhance FDA’s capabilities. Read our letter of support.

  • Accelerated Approval: The FDA’s accelerated approval program allows for early approval of innovative therapies for serious conditions with little-to-no treatments. But the program has also been criticized over controversial approvals and incomplete trials after the approval of products. Policymakers have proposed various ways to reform the accelerated approval pathway. Any potential reforms to the program should strengthen the program to meet its original goals and respond to how scientific knowledge is evolving. Read and share our LinkedIn article.

FasterCures COVID-19 Treatment and Vaccine Tracker Sunsets

In March 2020, FasterCures launched a comprehensive COVID-19 Treatment and Vaccine Tracker. Since that time, much scientific progress has been achieved; in total, 332 treatments and 276 vaccines were tracked, and today there are more than 24 vaccines in use. As such, FasterCures decided to sunset the tracker. While it will no longer be updated, it remains available on our website at covid-19tracker.milkeninstitute.org. Read and share this LinkedIn article celebrating this resource and the innovation that was accomplished in the race for treatments.

Apply Now to Join The Research Acceleration and Innovation Network (TRAIN)

Are you looking to advance your research efforts, make new connections with other patient foundation and R&D leaders, and have more opportunities to be at the forefront of efforts that impact change across the R&D landscape? If so, join the more than 130 organizations participating in TRAIN. There is no cost to apply nor participate in TRAIN. Learn more and submit your TRAIN application here.

New Resources for Building Nonprofit Capacity

FasterCures seeks to strengthen the ability of patient foundations and nonprofit organizations to support, advance, or conduct research that can lead to new therapies for patients. Here are two new resources:

  • TRAIN, in coordination with NCATS, convened a workshop to examine how patient-driven foundations actively support translational research from pre-clinical development to clinical implementation. View video recordings of the panel discussions and related resources as part of the TRAIN Toolkit library.

  • TRAIN and IQVIA led a discussion exploring the power of patient registries to generate real-world insights. Participants heard leaders within the patient data and patient organization communities discuss modern operational challenges and opportunities for patient registries, and how to leverage the modern patient registry to generate real-world data and insights in support of patient advocacy efforts. View the recording and accompanying summary.

For more information about TRAIN, check out the September 2022 TRAIN e-newsletter.

Watch the LeadersLink Capstone Videos

Established in 2020, FasterCures’ LeadersLink is a capacity-building program to support the development of an emerging cadre of leaders of nonprofit organizations that fund or conduct biomedical research. Over the 18-month program, participants work closely with mentors and other leading experts on achieving goals geared toward building their organizational research capacity and addressing their individual leadership needs. Learn about the accomplishments and progress made over the course of the program from the inaugural cohort in this video series.

Subscribe to the FasterCures Advances in Science Webinar Series

You are invited to join our “Advances in Science” webinars to hear the latest scientific and public health advances and engage with scientists and senior leaders to achieve innovation in health. Please subscribe here to receive invitations and updates on the upcoming webinar schedule, which includes:

  • Thursday, October 27, at noon ET—Lessons Learned from the HIV/AIDS Pandemic Applied to COVID-19

  • Tuesday, November 15, at noon ET—The State of the World’s Antibiotics

Previous session recordings are available here.

FasterCures in the News

  • Esther Krofah, FasterCures executive director and executive vice president of health at the Milken Institute, was quoted several times in a Bloomberg Law article about Anthony Fauci’s departure opening the door for the next generation of biomedical leaders. She said, “Now is the time to re-examine the portfolio and look for the kinds of leaders that can tackle the next generation of problems that will be emerging.”

  • As part of the Bridge Initiative, FasterCures Senior Director Sung Hee Choe co-authored a systematic review on drug repurposing in the BMC Health Services Research Journal.

  • Yasmeen Long, FasterCures director, was quoted in the Modern Healthcare article, Retail Pharmacies Look to Disrupt Clinical Trials. "So these new retail pharmacy models, as well as using digital resources, digital technologies, is a great way to not only modernize but really increase the diversity that's been lacking," Long said.

  • Henrietta Awo Osei-Anto, FasterCures director, was quoted in an MM+M Online article about accelerated approval reform as part of user fee reauthorization legislation. “The FDA needs bipartisan congressional support in order to be able to make any meaningful changes to the process and strengthen it,” Osei-Anto said. “We still have a ways to go, but this is an important opportunity to address some of the components that are controversial right now and ensure that we’re moving forward with a process that benefits patients and multiple stakeholders.”

Welcome New Staff Members

Please join us in welcoming two members to the team:

  • Katie O’Connor is a senior associate at FasterCures, a center of the Milken Institute, providing research support on various workstreams, including health equity and oncology. Prior to FasterCures, O’Connor worked as a research associate at Truth Initiative, where she advanced health outcomes and health communication research in the context of tobacco and e-cigarette use. In addition to health equity and oncology, O’Connor’s interests lie in maternal and child health, mental health, and substance use disorder research. O’Connor received her master’s degree in public health with a concentration in global health epidemiology and disease control from the George Washington University and a BS in psychology and a minor in neuroscience from the University of Pittsburgh.

  • Rachel Perkins is an associate at FasterCures, a center of the Milken Institute, providing research support and content development for core programmatic focus areas. Prior to joining FasterCures, Perkins was a health-care policy fellow at DC-based Leavitt Partners, where she assisted with health-specific research to advance client and alliance-focused work. Perkins also served as a graduate research assistant at the Georgetown Center for Global Health Science and Security, where she supported the development of the COVID Analysis and Mapping of Policy site as part of the Georgetown Infectious Disease Atlas. Perkins has a BS in health sciences from Furman University and is pursuing her MS in global health at Georgetown University with a concentration in global health governance.

Join Us at the 2022 Milken Institute Partnering for Patients Forum and the Future of Health Summit

This year’s three-day Future of Health Summit will kick off with our Partnering for Patients Forum, shining a light on the latest biomedical innovation advances, needs, and ideas generated by and for the patient community.

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