BioCentury
ARTICLE | Politics, Policy & Law
BioCentury & Getty Images

Politics, Policy & Law

BIO challenging its members to walk the talk on social justice

Drug developers have made statements of solidarity; now BIO is launching an agenda to help them take action

August 6, 2020 1:03 AM UTC

Outrage over the killing of George Floyd prompted biopharma leaders and companies to look up from their work developing molecules to consider their companies’ roles in advancing social justice. Now BIO is challenging its members to put their commitments into practice -- and the trade association is laying out an action plan.

BIO has formulated a BIOEquality agenda that charts a path for companies to both change themselves and help improve the life sciences ecosystem. The aspirations range from diversifying the biotech workforce to ensuring that clinical trials reflect the societies they serve.

The agenda, according to BIO, “aims to attack the systemic inequality, injustice and unfair treatment of women and communities of color through the positive force of biotechnology.”

The week after Floyd’s murder, biopharma CEOs and VCs issued statements that went far beyond the boundaries of typical corporate speech, expressing unity, concern and compassion with the Black community (see “Biopharma Community Joins Calls for Solidarity”).

“Statements are one thing, actions are another.”

Michelle McMurry-Heath, BIO

The statements were “reassuring” but insufficient, BIO President and CEO Michelle McMurry-Heath told BioCentury at the time. “Statements are one thing, actions are another.”

Over the past 10 weeks, BIO has identified the kinds of actions it and its members could take that reflect both their values and the responsibilities of biopharma companies to patients and society, McMurry-Heath told BioCentury. “We spent a lot of time trying to unpack what are the pieces of the racial justice pie our industry can address and that are firmly in our wheelhouse, that if we made progress in those areas we could say with pride we have made progress.”

The BIOEquality agenda has three legs: promoting health equity; investing in the next generation of scientists and entrepreneurs of color; and demanding expanded opportunity for women, Blacks and other minority populations in the growing biopharma economy.

The agenda “will challenge our companies, the government, and yes, even ourselves, to make ‘diversity’ more than just a word or a program but a part of who we are and what we stand for,” McMurry-Heath said in a statement.

Health equity

The lack of diversity in trial enrollment contributes to inequities in health outcomes, both because trials can provide early access to effective therapies and because it is less likely that treatments and regimens will be optimized for populations in which therapies are not studied.

Statistics from FDA provide some insight into the problem.

About 46,000 people enrolled in trials of the 48 novel drugs approved by FDA’s Center for Drug Evaluation and Research in 2019, and the overall demographics are encouraging -- 72% of participants were women, 9% were Black or African American, 9% were Asian and 18% were Hispanic.

A closer look, however, reveals wider disparities.

The numbers are skewed by trials for sickle cell disease, which predominantly affects the Black community, and a small number of other trials that focused on Black patients, which means that across other health priorities, Black patients are underrepresented (see “Real World Data’s Power to Increase Racial Diversity”).

For example, only 4% of the participants in trials of the 11 new oncology drugs CDER approved in 2019 were Black or African American.

Black and African American participation was 3% or less in 22 of the 44 trials that reported racial composition.

Biopharma companies largely rely on CROs and academic investigators to enroll trial participants, but they can influence recruitment activities, McMurry-Heath told BioCentury.

The BIOEquality agenda includes partnering with institutions that serve minority communities and with CROs that specialize in finding diverse patients and urging trial sponsors to prioritize incentivizing enrollment of minority populations.

McMurry-Heath suggested that CROs will respond to priorities set by biopharma companies, and that sponsors can prioritize enrollment of diverse populations over speed of trial completion. Reflecting on her experience overseeing clinical trials for the medical device unit of Johnson & Johnson (NYSE:JNJ), McMurry-Heath noted that drug “companies decide on the success criteria for clinical trials and they decide what factors they will slow trials to address.”

Ending the reliance on academic medical centers is only part of the solution. Industry must earn the trust of populations that have been exploited by medical researchers, for example in the notorious Tuskegee study in which Black men with syphilis were left untreated. Education and engagement are part of the BIOEquality agenda, McMurry-Heath said.

In addition to working to diversify clinical trial enrollment, BIO will “make sure we are doing everything we can to ensure equitable access of the fruits of the research,” she said.

This will include pushing for zero patient cost-sharing for COVID-19 vaccines and therapeutics.

Investing in talent

BIO and its member companies will invest in educational and training programs aimed at increasing the number of minority students who are qualified to staff biotech companies.

It will also launch initiatives to increase the visibility of qualified Black and Latino job candidates, including by building on programs that are already in place.

“We have a huge number of companies that have a long tradition of investing in STEM education and career development for minority populations,” but these programs haven’t fed into recruitment pools, McMurry-Heath said.

She cited the example of Biogen Inc. (NASDAQ:BIIB), which has trained more than 250 minority scientists in the Boston area over the past decade. There is no easy way for biopharma companies to find and consider recruiting these scientists.

That’s a gap BIO wants to fill, either by creating an entity like LinkedIn for qualified minority candidates or by integrating the capability into existing platforms.

Expanding opportunities

The economic activities of biotech companies should be used as an avenue to expand opportunities for women and minorities in the biopharma ecosystem, McMurry-Heath said.

“We are trying to harness the power and influence of the purchasing activities of our companies,” she told BioCentury. Even small companies have large supply chains, she noted. “We want to make sure as often as possible they are patronizing minority-owned and women-owned businesses.”

The BIOEquality agenda will include making suppliers “that have good records on diversity visible to our companies,” she said.

BIO will also push NIH to do far more to include minority-owned companies in its Small Business Innovation Research (SBIR) program, which provides early-stage capital to small businesses for technology commercialization.

In 2014, less than 2% of NIH SBIR awards went to minority-owned businesses, according to a National Academy of Sciences report. NIH hasn’t published more recent data, but McMurry-Heath said current figures for minority SBIR awards are “disturbingly low.”