BIO appoints board member Rachel King as interim head during tumultuous time for the industry group
Who: Rachel King, the former CEO of GlycoMimetic and a longtime BIO board member, was appointed as interim CEO of BIO Tuesday after Michelle McMurry-Heath stepped down from the role amid reports of divisions within the organization's leadership.
Background: McMurry-Heath took the helm at BIO in 2020 and carried the industry group through a volatile period marked by the COVID-19 pandemic, the Aduhelm controversy and the passage of major drug pricing reform measures the group had lobbied heavily against. She resigned from the role earlier this week after reports of a “clash over direction” in the organization, specifically over whether the group should address social issues or stay focused on biotech policy advocacy.
As the group searches for McMurry-Heath’s permanent successor, King will need to help right the ship. Having served on BIO’s board for close to two decades, including a stint as chair from 2013 to 2015, King appears well-informed of the needed procedural knowledge. She also has a deep background in drug development as the co-founder of GlycoMimetics, a late-stage company focused on developing glycobiology-based therapies for cancers. King stepped down as CEO of the company — which is preparing to submit its first candidate for FDA approval — in 2021 but is still an active member of its board.
Why it matters: The leadership change comes at a pivotal moment as the group continues to lobby Congress to enact policy measures related to antimicrobial resistance before the end of the congressional session in January. They will also be on top of the HHS as the agency begins to implement drug pricing reforms laid out in the Inflation Reduction Act. Although the industry group lost its battle with Congress over the legislation, it has the power to influence how HHS applies many details of the policy. King’s leadership will be key in these efforts.
Meanwhile, it remains unclear how BIO will address social and political issues. In a statement, King noted that “the strategy of BIO remains on track,” to advance medicine and technology that “touches people of all backgrounds.”
Learn more: The HHS is preparing to release its initial list of 10 drugs for negotiation as early as September 2023. While there is still time to impact how the agency administers the policy, analysts say life sciences companies need to start preparing now. Here’s a look at three ways your company can prepare for the drug pricing policies.
Alvotech brings Sarah Tanksley onboard as chief quality officer
Who: Sarah Tanksley will succeed Reem Malki as the biosimilar company’s chief quality officer starting Oct. 14.
Background: The founder and CEO of her own pharma compliance consulting group, Tanksley has advised Alvotech for years from the outside and will enter the new role with an intimate familiarity of its business practices. Prior to opening her own firm, Tanksley served as a biologist at NIH for seven years and as a consumer safety officer at the FDA for five years, where she gained a firm understanding of Good Manufacturing Practices and other regulatory issues.
Why it matters: Alvotech is focused on developing and manufacturing biosimilar medications, which are copycats of existing biologic medications and could potentially lower the costs across the board. Its pipeline contains eight candidates for the treatment of autoimmune and eye disorders, osteoporosis, respiratory disease and cancer. So far, the company has one biosimilar approved in Europe and Canada — its copycat of AbbVie’s Humira.
If Alvotech succeeds at producing other biosimilar drugs, the impact on industry could be monumental. In 2019, biologic medications accounted for 43% of the U.S. prescription drug spending. A recent report found that biosimilars like the ones Alvotech produces could save the U.S. up to $375 billion a year in pharmacy spending by 2031.
However, challenges remain in the market — particularly with manufacturing. The drugs are often costly and complex to produce, and the road to approval can be tumultuous. To gain FDA approval, biosimilars must meet the same quality standards as the drug they are mimicking. As chief quality officer, Tanksley will be key in ensuring the drugs in Alvotech’s pipeline meet these standards.
“Her familiarity with our operation facilitates a smooth transition and we are excited to benefit further from her experience in regulatory compliance and GMP,” Alvotech CEO Mark Levik said in a statement.
Read more: Earlier this year, PharmaVoice spoke with Alvotech founder Róbert Wessman about why he believes the company is prepared to weather manufacturing and regulatory challenges in the biosims market.
