Rachel King had fully embraced retirement. After stepping down from her role as CEO of GlycoMimetics, the biopharma she co-founded more than 20 years ago, King became a first-time grandmother during the pandemic and was at the point in life where she wanted to “spend more time with family.”
But her retirement only lasted about a year before she was tapped to become interim CEO of the Biotechnology Innovation Organization (BIO), which is hosting its annual International Convention in Boston this week.
“There were few things that I would unretire for,” she laughed. “And this was one.”
When King came on board last November, the biotech trade group was in the midst of a rocky few years, coping not only with COVID-19, but the sudden departure of its former CEO Dr. Michelle McMurry-Heath in October. In the wake of that tumult, King sought to steady the ship, reaffirm BIO’s commitment to advocacy and re-focus its attention on priorities like IRA implementation and patient access to medicine.
“Initially, it was important to stabilize the organization,” she said. “People have been through a lot over the past few years. Job one was to get us back to normal, and get us back to the things that BIO does so well, which is advocacy, innovation and (providing) affordable access to the innovations that the industry delivers.”
Her strategy moving forward was to deliver a clear and focused message.
“I had to continue to reaffirm our focus and to try, as part of a team, to embody good communication, transparency and mutual respect,” she said.
Although BIO did not specify a reason for the change in leadership in the wake of McMurry-Heath’s exit, both the Wall Street Journal and Politico reported that it was due to clashes with BIO’s board. When PharmaVoice asked BIO to comment on this, it declined.
King was the logical choice to lead the organization through the transition. She’s been a familiar presence, having held several roles on BIO’s board over the past 19 years, including chair.
“Whenever there's a leadership change, people wonder, right? I had the advantage that I already knew a lot of people. I was still on the board,” she said. “On day one, I already knew the senior team, they knew me. That gave us a good foundation.”
King declined to comment on whether she was in the running to take the reins of the organization permanently, but noted that BIO had hired the organizational consulting firm Korn Ferry to conduct its search for a new CEO.
Although it’s unclear how much longer she’ll be in charge, King, for now, is keeping a steadfast focus on biotech’s biggest challenges.
Pushing back on the IRA
King said BIO is currently addressing several key priorities including IRA implementation, and ensuring drug price negotiations are transparent, fair, and consider the value that the drugs in question provide to patients. In the longer term, they’ll also be considering whether there are “opportunities, legislatively, to actually change some aspects” of the IRA. (Merck & Co. on Tuesday sued the U.S. government over the law, seeking to block it from being enforced.)
“I don't think we're going to see any changes in the current Congress, but we want to ensure that we continue to build our champions on the Hill so people understand the impact of the legislation so that over time, we can ensure that we have the most productive environment to support innovation,” King said. “And we think the IRA has some provisions that don’t do that.”
“As a society, it is really important for us, at the high level, to think about what we want to incentivize entrepreneurs and investors to do.”
For instance, one part of the IRA that BIO is most concerned with is the “discrepancy between small molecules and large molecules in terms of the period of exclusivity.”
Specifically, IRA’s policy currently states that government price-setting will start seven years after initial FDA approval for small molecule medicines and after 11 years for large molecules.
“It provides a disincentive for the development of small molecules relative to large molecules, and that's a problem because a lot of innovative therapies are still small-molecule drugs,” she said.
King noted that diseases like Alzheimer's could eventually be addressed with small-molecule drugs, “which are able to penetrate the blood-brain barrier.”
“We don't want any disincentives for the long-term, very expensive and highly risky development that goes into drugs like those,” she said. “That discrepancy between small and large molecules is something that we're really concerned about.”
Defending accelerated approval
BIO is also focused on supporting the FDA’s accelerated approval pathway, which has come under fire from critics who say it has lower standards than traditional approvals, results in delayed confirmatory trials and leads to slower market removal for drugs that aren’t proven effective.
However, King argued that accelerated approval is important for many indications, such as rare diseases with smaller patient populations, ones that rely on biomarkers for efficacy or ones where the ultimate clinical outcomes can take a long time to realize and surrogate endpoints are used in the interim.
In addition, she said losing the accelerated approval option would create a financial barrier to innovation for small companies, especially if payers decide not to cover fast-tracked drugs.
“If that initial approval was years in the future, I think we'd see many small companies that are just not able to get there,” King said. “There's a lot riding on getting to that point to capture revenue.”
Other areas of focus for BIO are issues around capital formation, especially for small companies that might face heavy regulatory burdens in the public market; building a diverse workforce; and ensuring that legislators, policymakers and the public understand the role of pharmacy benefit managers (PBMs) and pushing for greater transparency around how they operate.
Tapping industry connections
Despite stepping into the interim CEO position at a challenging time for BIO, King’s long history with the industry means she knows firsthand what its members face in their day-to-day operations. In addition to being the co-founder and CEO of GlycoMimetics, she served as senior vice president of Novartis Corporation, CEO of Genetic Therapy, and Entrepreneur in Residence at New Enterprise Associates, among other roles in the industry.
The 2013 PharmaVoice 100 honoree said all of this experience taught her that “the ecosystem matters” when it comes to biopharma innovation and advocating for BIO’s objectives.
“I've lived through it all…it's not theoretical to me. I've lived through going to venture capital firms and raising money. I've lived through taking a company public,” she said. “As a society, it is really important for us, at the high level, to think about what we want to incentivize entrepreneurs and investors to do.”