We recently spoke with Mike Ybara, MD of Pharmaceutical Research and Manufacturers of America (PhRMA) about their work in the fight against COVID-19, the importance of developing future medical leaders, and more. PhRMA is a generous Gold Level Member of our Corporate Roundtable and long-standing supporter of the Foundation’s program portfolio, including the Leadership Development Institute.

Dr. Ybarra is the Vice President, Medical Affairs and Strategic Alliances at the Pharmaceutical Research and Manufacturers of America (PhRMA). Dr. Ybarra works clinically as an attending physician in the department of emergency medicine at MedStar Georgetown University Hospital in Washington, DC. and serves as the American Academy of Emergency Medicine’s Chair of the Government and National Affairs Committee. Previously, he was a chief resident in emergency medicine at the Georgetown University and Washington Hospital Center Emergency Medicine Training Program. Dr. Ybarra also served as President of the American Academy of Emergency Medicine Resident and Student Association, and is the past-Chair of the Government Affairs Committee for Young Physicians Section of the American Academy of Emergency Medicine. We thank him tremendously for taking the time to speak with us.

What efforts have PhRMA been leading or supporting in the fight against COVID-19?

“PhRMA is a trade association representing the innovative biopharmaceutical industry. We have a global membership that is committed to beating COVID-19. Things are changing by the minute, in terms of what we know about COVID-19, and the potential medicines and vaccines that may be useful tools in the clinician’s toolbox. We all have one common enemy and are on the same team to defeat this virus that has changed all of our lives. The major roles that the industry is playing can be broken down into a few broad buckets:

• Companies are working with government agencies and diagnostic partners to increase COVID-19 testing capabilities and capacity. As an emergency physician working clinically in a Washington, DC ED, I can say first-hand how critical it is that we have accurate, accessible, rapid testing widely available, and since I started seeing patients with COVID-19 back in March, we’ve made tremendous progress.
• Companies are also screening their vast global libraries of medicines to identify potential treatments and have numerous clinical trials underway to test existing therapies. At my own institution, we are participating in a number of clinical trials to better understand which therapies should form the cornerstone of care for patients with COVID-19.
• Additionally, the biopharmaceutical industry is providing financial support and in-kind donations to organizations and collaborating with global health authorities to combat this global public health emergency. That includes donations of medical supplies, investigational medicines, and personal protective equipment.

When it comes to therapeutic development, I think about the R&D also in a few big buckets: there are antivirals, anti-inflammatories, antibodies, and vaccines. A drug invented by a PhRMA member company is an antiviral medicine that recently received an emergency use authorization for that therapy.  I know that many hospitals are developing treatment protocols, and hopefully, more antivirals will be available soon. There are also anti-inflammatory-type therapies being investigated, for example, IL-6 inhibitors that may have an impact on the cytokine storm that seems to impact patients in the later stages of the disease. Plasma technology is also being deployed to develop antibodies that could be a bridge to vaccine. This builds on the base of knowledge we have from the use of convalescent plasma. And finally, the north star that many are anxiously awaiting are vaccines. Biopharmaceutical companies are exploring a variety of approaches to vaccine technology, including novel approaches like mRNA vaccines. While companies are moving at unprecedented speed, vaccines undergo a rigorous research and development process in order to ensure safety and efficacy, and will continue to be monitored long after U.S. Food and Drug Administration approval.  Many companies have already committed to manufacturing billions of doses of vaccine, even before we know if they work so that we can be ready should one be approved. ”

Are there any plans in the pipeline by PhRMA to address COVID-19 and/or further support various efforts?

“There are numerous initiatives that PhRMA has catalyzed to address COVID-19 and the fallout from the pandemic. One that I’d like to highlight is our partnership with Healthcare Ready. Healthcare Ready is a non-profit that PhRMA (along with other trade associations and the American Red Cross) founded after Hurricane Katrina, in order to help patient’s access medicines after natural disasters. As the outbreak of COVID-19 developed in the United States, we saw a need for the private and public sectors to join forces to find solutions to the issues facing patients and clinicians. We joined forces with Healthcare Ready to ensure financial support and in-kind donations of personal protective equipment, medicines, and critical medical supplies are being provided to areas in need. A number of our companies made significant contributions, for example, of masks to the hardest hit parts of the country. It was inspiring to see my colleagues fight COVID-19 in the emergency department, and my colleagues at PhRMA and in our member companies work to get them the critical supplies they needed, including PPE, while committing scientific expertise to finding the therapies and vaccines that will ultimately beat COVID-19. Healthcare Ready services as a central coordination point between the health care supply chain and government agencies and works to build and enhance the resiliency of communities before, during and after disasters.”

PhRMA is a long-standing supporter of the AMA Foundation’s Leadership Development Institute, why is it important to PhRMA to support this type of programming?

“The Leadership Development Institute is one of the highlights of my year. I really enjoy being with medical students and sharing my perspective as an emergency physician who also works in the biopharmaceutical industry. It’s one of the reasons that I keep working clinically: I love being around medical students, and hearing their perspective on medicine and sharing insights. In particular, the Institute also allows me to try to address some common misperceptions about the biopharmaceutical industry. Many people take for granted the tremendous resources biopharma companies put into research and development, and might assume all research happens at the NIH, for example. We have also had a great dialogue about some of the reforms that we think are needed to ensure that medicines are affordable for patients. I get a lot of questions from the students, and am happy to answer and share our perspectives!”

Why is it important to you, Mike, and/or PhRMA to “*Give Back, and Pay it Forward?” What does that saying mean to you? “Give Back and Pay it Forward.”

“I had so many amazing mentors in medical school who helped in innumerable ways. That’s why I love the Foundation’s work on mentoring as well as the saying “Give Back and Pay it Forward.” The Foundation does it on a massive scale, and it’s so important. The programs, scholarships, and initiatives are incredibly valuable to medical students. However, I take that saying with me on every shift, and love to carve out a few minutes to have a career conversation with students or buy coffee or snacks for the team. I’m also so proud that PhRMA has prioritized supporting these Foundation initiatives like the Leadership Development Institute, and the Excellence in Medicine program before that.”

We again thank PhRMA for being a Gold Level Member of our Corporate Roundtable and all of our generous corporate partners for their support. To learn more about becoming a corporate, foundation, or organizational supporter click here or contact Ivy Gard (Ivy.Gard@ama-assn.org).