BIO Interim Leader Rachel King: Stabilizing the Organization, Focusing on IRA and Accelerated Approval Are Top Priorities

Rachel King had fully embraced retirement. After stepping down as CEO of GlycoMimetics, the biopharmaceutical company she co-founded over 20 years ago, she became a grandmother for the first time during the pandemic and was at a stage in life where she wanted to "spend more time with family."

However, her retirement lasted only about a year before she was invited to serve as interim CEO of the Biotechnology Innovation Organization (BIO). The organization is hosting its annual International Convention in Boston this week.

"There are very few things that would get me out of retirement," she said with a laugh. "But this is one of them."

When King took the helm in November, the biotech industry group was navigating a turbulent few years, dealing not only with the COVID-19 pandemic but also the aftermath of the sudden departure of former CEO Dr. Michelle McMurry-Heath in October. Against this backdrop, King sought to stabilize the situation, reaffirm BIO's commitment to policy advocacy, and refocus attention on priorities such as the implementation of the Inflation Reduction Act (IRA) and patient access to medicines.

"Initially, stabilizing the organization was critical," she said. "People have been through a lot over the past few years. The first priority is to get us back to normal, back to what BIO does best: policy advocacy, innovation, and (providing) affordable access to the innovations the industry delivers."

Her strategy going forward is to deliver a clear and focused message. "I have to continue to reiterate our focus and, as part of the team, work to embody good communication, transparency, and mutual respect," she said.

Although BIO has not stated the specific reasons for McMurry-Heath's departure, both The Wall Street Journal and Politico reported that it was related to conflicts with BIO's board. When PharmaVoice sought comment from BIO on this, the organization declined.

King is a logical choice to lead the organization through the transition. For the past 19 years, she has been a familiar face at BIO, serving in various roles on the board, including chair. "Whenever there's a leadership change, people speculate, right? My advantage is that I already know a lot of people. I'm still on the board," she said. "From day one, I knew the senior team, and they knew me. That gives us a good foundation."

King declined to say whether she is vying for the organization's permanent leadership position, but noted that BIO has hired organizational consulting firm Korn Ferry to conduct the search for a new CEO.

Although it remains unclear how much longer she will be at the helm, King is currently focused firmly on the biggest challenges facing the biotech industry.

Pushback on the IRA

King said BIO is currently addressing several key priorities, including IRA implementation and ensuring that drug price negotiation is transparent, fair, and considers the value the drugs provide to patients. In the long term, they will also consider whether "there are legislative opportunities to actually change certain aspects of the IRA." (Merck sued the U.S. government over the law on Tuesday, attempting to block its enforcement.)

"I don't think we'll see any changes in this Congress, but we want to make sure we continue to build our supporters on Capitol Hill and educate people about the impact of this legislation, so that over time, we can ensure we have the most innovation-friendly environment possible," King said. "We believe some provisions in the IRA don't achieve that."

"As a society, at a high level, it's very important for us to think about what we want to incentivize entrepreneurs and investors to do."

For example, one of the IRA provisions BIO is most concerned about is "the difference between small molecules and large molecules in terms of exclusivity periods." Specifically, current IRA policy states that government pricing will begin seven years after a small-molecule drug receives initial FDA approval, while for large-molecule drugs, it begins after 11 years.

"This provides a disincentive for the development of small-molecule drugs relative to large-molecule drugs, and that's a problem because many innovative therapies are still small molecules," she said. King noted that diseases like Alzheimer's could eventually be addressed by small-molecule drugs "that can cross the blood-brain barrier."

"We don't want anything to dampen the incentive for those long, expensive, and high-risk drug development efforts," she said. "This disparity between small molecules and large molecules is a real concern for us."

Defending accelerated approval

BIO is also focused on supporting the FDA's accelerated approval pathway, which has come under fire from critics who argue its standards are lower than traditional approval, leading to delays in confirmatory trials and slower removal of drugs from the market that have not been proven effective.

However, King believes accelerated approval is important for many indications, such as rare diseases with small patient populations, diseases where efficacy is judged by biomarkers, or diseases where final clinical outcomes take a long time to achieve, so surrogate endpoints are used in the meantime.

Furthermore, she said losing the accelerated approval option would create financial barriers to innovation for small companies, especially if payers decide not to cover quickly approved drugs. "If initial approval is delayed by many years, I think many small companies won't be able to get there," King said. "There's so much hope riding on reaching that stage to generate revenue."

Other areas of focus for BIO include capital formation issues, particularly for small companies that may face heavy regulatory burdens in the public markets; building a diverse workforce; and ensuring legislators, policymakers, and the public understand the role of pharmacy benefit managers (PBMs) and pushing for more transparency in how they operate.

Leveraging industry connections

Despite stepping in as interim CEO at a challenging time for BIO, King's long history with the industry means she knows firsthand the situations members face in their day-to-day operations. In addition to serving as co-founder and CEO of GlycoMimetics, she has also held roles such as senior vice president at Novartis, CEO of Genetic Therapy, and entrepreneur-in-residence at New Enterprise Associates.

The 2013 PharmaVoice 100 honoree said all these experiences have taught her that "the ecosystem matters" when it comes to biopharmaceutical innovation and advocating for BIO's goals.

"I've been through all of this... It's not theoretical to me. I've been through the process of raising money from venture capital firms. I've been through the process of taking a company public," she said. "As a society, at a high level, it's very important for us to think about what we want to incentivize entrepreneurs and investors to do."