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“One area we know we have fallen short is equity in the clinical development ecosystem," said Cartier Esham, PhD, Chief Science Officer of BIO. 

"The lack of diversity in clinical trials is not a new criticism. We know that we need to work to enable diverse participation in clinical trials for all races, genders across all geographies and we must improve our understanding of health outcomes for all patients,” she continued.

Promoting health equity and eliminating systemic inequalities in the biotech ecosystem are priorities of the BIOEquality Agenda.

Dr. Esham brought together a panel of thought leaders and action takers who are helping address health equity in clinical development to meet this goal:

• Cassandra Smith, Director, Diversity & Inclusion in Clinical Trials, Janssen Pharmaceutical Companies 
• Quita Highsmith, Vice President and Chief Diversity Officer, Genentech, a member of the Roche Group
• Elizabeth Ofili, MD, MPH, FACC, Board Chair, Association of Black Cardiologists
• Jeff Allen, PhD, Executive Director, Friends of Cancer Research

Creating a More Inclusive Clinical Development Ecosystem

Quita Highsmith recounted when Genetech was planning a patient summit in 2017 and tried to get a group of underrepresented, diverse patients to share their experiences and they could not find one patient of color who had participated in the clinical trials.

“So we asked ourselves, why is that? What we know is that when we look at the data that less than 10 to 15% of the study participants come from underrepresented groups."

"That led me and a colleague to found Advancing Inclusive Research at Genentech. This initiative is for us to address barriers to clinical research” and understand “what we could do better.”

She recommended looking at many of the protocols around clinical trials that had built-in biases:

• Who are the investigators?
• What sites do we go to?
• Are there barriers in our inclusion criteria?

Education and Engagement

Dr. Elizabeth Ofili spoke about how private practice in the U.S. is designed to treat and move on versus connecting to bring people back to learn about clinical trials.

“The whole process of engaging on an ongoing manner means you have to care about what that patient cares about even before you talk to them about a clinical trial.”

The challenges are not new, but Jeff Allen believes it’s time to look at how we address those challenges differently.

“While education is no doubt an important leg of the stool to support access and equitable trials, that’s got to be just one component of this and it can no longer be an issue of simply prioritizing certain components. It has to be a wholistic approach and this isn’t just about addressing things as related to just patient perception. It has to be to the entirety of the system and actually changing the trials.”

What did we learn from COVID?

According to Highsmith, we need to stop blaming patients of color: “We have to recognize that fact that not all the patients have easy access to medical care and I think it starts there.”

Cassandra Smith said the biggest takeaway is the need to look at the patient holistically.

“It’s truly understanding what it is that’s important to that person as a person, not just a patient, not just as a potential trial participant, but what are the things that are important for them in their lives and that can enable their participation.”

She also found that COVID taught us that it’s not necessarily who won’t participate in clinical trials, but who can’t participate.

While it’s about personal care, Dr. Ofili also touched on how COVID has taught us that it’s also about population health.

What’s Next

BIO will expand on this preview session at the upcoming Sustainable & Equitable Clinical Development Summit to discuss clinical trial design, engaging with patient groups and business strategies to reach underrepresented communities. Registration is free and open to all participants at the June 24-25 summit. 

The COVID-19 pandemic has occupied the global healthcare space for nearly a year and a half. As we see an end in sight, what does that mean for a normal return to care for patients and healthcare providers?

That is what moderator Jan Nissen, Vice President of Patient Innovation and Engagement at Merck discussed with panelists during “Return to Care in a Post-COVID World,” a session focused on how providers can create a safe environment for patients to feel comfortable returning to routine healthcare.

Speaking on the panel are:

• Beth Battaglino, RN-C, Chief Executive Officer, HealthyWomen
• Linda Budzinski, Director of Outreach, Society of Nuclear Medicine and Molecular Imaging
• Marissa Fors, MSW, Director of Specialized Programs, CancerCare

“If you haven’t made your annual #wellness visit, please do so. It’s never been safer.” - @BBCRN of @HealthyWomen #BIODigital #Healthcare #WomensHealth pic.twitter.com/q6JYtBxuV9

— I Am Biotech (@IAmBiotech) June 17, 2021

Return to Timely Care

Nissen outlined how a return to timely care is vital for future healthcare development. “As we all know in order for us to sustain progress in public health and in wellness, it’s really important for people to remain committed to their health… I think most of us are aware the impact that COVID has had on that routine health,” said Nissen.

Battaglino said at HealthyWomen the main goal was to create a trusted source of information that organizations could point to and direct their audiences.

As CancerCare saw drastic drops in routine cancer screenings, they created the Time to Screen campaign, Fors said, to face the problem head-on.

“The goal really is to make things more available, but obviously to do it safely and follow the science and I think medical societies across the board are doing those things,” said Budzinski about what the new normal should look like in healthcare.

Clinical Trial Recruitment and Enrollment

On the topic of clinical trials, Budzinski spoke about the issues around enrollment that continue. She has found that the Society of Nuclear Medicine and Molecular Imaging’s coalition partners are seeing decreases in clinical trial enrollment due to travel and logistics issues. She called for finding ways to make trials more easily accessible. 

How Will Patient Care Return to Normal?

Battaglino is encouraging patients to get back to their normal routine when it comes to their routine visits and screenings.

“If I could use this platform to say if you haven’t made your annual wellness visit, please do so. It’s never been safer… This is a great time to start thinking about you and taking care of you,” said Battaglino.

Next Steps

Fors called for more collaboration across the health care field when it comes to reaching and educating various communities about new treatments, vaccines and therapies.

“We can’t stop now… I say we need to continue this conversation, have discussions like this, and learn from each other, continue to collaborate. The next steps would be to really evaluate what works and what doesn’t work and really use that to strengthen our message and to adapt to the ever-changing world that we’re currently living in and really figure out who have we not collaborated with yet that can strengthen this message?”

As we celebrate Pride Month, BIO invited leaders from across the industry who identify as members of the LGBTQ community to discuss how to cultivate and expand LGBTQ leadership in the biotech industry.

Moderated by Matthew Fust, independent advisor and board member of Ultragenyx Pharmaceutical, Inc., guests on the panel included:

• Paul Hastings, President and CEO, Nkarta Therapeutics
• Todd Sears, Founder and CEO, Out Leadership
• Denice Torres, CEO, The Ignited Company

Where the Industry Was

Torres recounted when she started out in the industry, she was “so afraid of being out.”

But she believes her experience coming out at work gave her a competitive advantage and a stronger sense of empathy.

“All of these experiences gave me an advantage of being able to connect with others because it was so much easier to put myself in other people’s shoes.”

Hastings said his experience in the 80s was much different than "what's happening now in big pharma."

He recalled his experience at one of his first companies before publicly coming out. “The feelings I had were when people outed themselves in an organization like Roche, they ended up in the advertising agency. Somewhere ’creative.’ But I think it was a perception that many of us probably created for ourselves, but it was also probably borne out by hearing statements from people who didn’t know that I was particularly gay.”

The Current Environment for the LGBTQ+ Community in Biotech

Hastings believes the environment today is much better for LGBTQ individuals, particularly younger people.

“I see people that go to our LGBTQ events in their 20s and in their 30s and they want to be future leaders in our industry and being gay has nothing to do with any impediment to getting there in the eyes of these folks,” he shared.

“I’m very proud that our industry has landed there and I think it’s going to get even better in the future.”

“Things have gotten significantly better – and yet they haven’t,” said Sears, pointing to the “onslaught” of legislation in many states aimed at restricting rights of the LGBTQ community. Despite gay marriage being legalized in the U.S., challenges persist both here and globally. 

Hopes for the Future

The LGBTQ community has a responsibility to advocate for other marginalized communities, as members of those communities are also a part of the LGBTQ community, said Hastings.

Torres spoke about how as a community once LGBTQ leaders achieve high levels of success, they should remember how hard is for others who are just starting out, said Torres. The “broken rung” effect prevents many marginalized groups from reaching the top levels of success.

Learn more about the BIOEquality Agenda. 

Avantor is proud to be BIO’s preferred scientific supplier. This unique relationship allows us to address downstream purification challenges with solutions that improve process efficiencies and decrease process time, while enhancing yield and purity. #BIODigital pic.twitter.com/JZnTzXDrTb

— Avantor (@Avantor_News) June 17, 2021

This panel discussion focuses on the new Life Science Workforce Trends report issued by the Coalition of State Bioscience Institutes (CSBI) and TEConomy Partners.

The panel discussion participants are:

• Moderator – Peter Pellerito – Senior Policy Advisor – Federal and State Economic Development – PMP Public Affairs Consulting
• Panelist – Ryan Helwig – Principal and Project Director – TEConomy Partners
• Panelist – Russ Read – Co-Principal Investigator – InnovATEBIO & Executive Director – NCBW, Forsyth Technical Community College
• Panelist – Lori Lindburg – Senior Vice President of Innovation and Inclusion at California Life Sciences (CLS) and President & Chief Executive Officer – CLS Institute

Workforce development is essential: The panelists discussed how education and workforce development are of the utmost importance to the life sciences and biotechnology sector as state and regional governments innovate and address their employment needs, often through public-private partnerships.

Multiple research methods: Helwig, as the lead author of the report, discussed how among other things, the report did the following to come up with its data and findings:

• Conducted both quantitative and qualitative analysis.
• Analyzed industry staffing patterns.
• Surveyed almost 700 Human Resources (HR) and hiring managers across the country for this report.
• Engaged in one-on-one interviews with almost 200 life sciences executives.

Key trends and themes identified in the report included:

• Industry resilience in spite of the COVID-19 pandemic.
• A shift to remote work both necessitated and sped up by the COVID-19 pandemic.
• A greater commitment by life sciences companies to do more in prioritizing diversity, equity, and inclusion initiatives within their organizations.
• The continued importance of industry-academic partnerships.

2020 was a growth year: The report found that the [biotechnology and life sciences] industry “continued to hire and continued to grow” in 2020 according to Helwig, in spite of the economic challenges that many sectors of the economy faced as a result of the COVID-19 pandemic.

Specifically, the industry experienced 1.4 percent growth, in contrast to the private sector as a whole which experienced a 5 percent decline. Ultimately, the industry “continues to bolster city, regional, and national economies” according to Helwig.

“Little to no effect”: This is how Helwig described the effect of the COVID-19 pandemic on hiring within the biotechnology and life sciences sector. In the instances where there was an effect, ultimately there was an uptick in employment within the sector.

STEM, STEM, STEM: The biotechnology sector is five times more concentrated in the STEM workforce relative to other segments of the economy. This has been a part of the rapid growth in hiring of data scientists in the sector.

Education is key to job creation in the life sciences sector: “We need to promote the two-year biotech programs, they’re a good solution to finding these skilled, technical workers and making it work,” according to Russ Read.

Looking ahead: In 2021, there is outsized demand by the life sciences sector for employees to fill high-skilled jobs according to the TEConomy report and that one in three workers in the industry have middle skill occupations such as degrees from trade schools and comparable certifications.

For the full report, click here.

Both the COVID-19 pandemic and a renewed national conversation on systemic racism and inequities have made it clear in the past year just how essential diversity, equity, and inclusion (DEI) initiatives are to create more inclusive organizations. With this in mind, the second-annual Measuring Diversity and Inclusion in Biotech report has arrived thanks to a partnership between BIO and Coqual. This expert panel of executives will give their thoughts on the importance of investing in DEI initiatives to attract the very best talent.

The moderator and panelists are:

•  Moderator – Pooja Jain-Link – Executive Vice President - Coqual
• Panelist – Dr. Ted Love – President and Chief Executive Officer – Global Blood Therapeutics (GBT)
• Panelist – Gisselle Perez – Head of Workforce DE&I and People Relations - Biogen
• Panelist – Andrew Schwab – Founder & Managing Partner – 5AM Ventures

For the full report, click on the following link:

https://www.bio.org/bioequality-agenda/dei

Investing in DEI internally leads to better outcomes for patients and communities externally

“You will have a better, stronger company which makes better decisions if you have diversity,” said Dr. Love and that ultimately “the imbalances we have in our society are due to historical racism and I think we need to correct that to be the country that we really want to be, which is equal to everyone.”

The GBT President and CEO went on to emphasize the importance of spending “a lot of time with the patient community, the advocacy community” so that “when we show up and actually understand them, relate to them, and they relate to us, it’s a healthier relationship.”

Much work remains to be done

Gisselle Perez highlighted how much has changed in recent years and how much remains to be done, stating in part that “things have really changed over time” and that one of the most important changes has been for companies – including Biogen – prioritizing “very intentionally ... listening to our employees.”

Perez stated that her plans regarding the implementation of DEI initiatives changed given “what we saw around the U.S. in [terms of] racial inequities, but also around the world” we saw the world changed last year”.

5AM Ventures’ Andrew Schwab stated in part that while “the venture [capital] industry has been around a long time,” there remains much work to be done so that diversity, equity, and inclusion are key to the industry.

Fostering an open environment at GBT “has benefitted everybody in the company,” said Dr. Love.

To improve DEI efforts in the future, Perez would ideally like to get “more information on our employees”.

What is “the next big wave in DEI?”

The “talent pool” is important, said Schaub. This includes the need to do “a much better job” in ensuring that STEM education opportunities are made available at all stages of education to members of underserved communities.

“Pipelining definitely would be my first [priority],” said Perez, so as to “make sure that we have an equal presentation at the table so that we have an even playing field.” Equally important is “being very transparent with our employees, with our shareholders.”

“We ought to run our business in a way that we’re comfortable that the information is on our website about how we’re performing and meeting these objectives,” said Dr. Love. Corporate social responsibility efforts at the local level are important, too.

We caught up with Nebraska Gov. Pete Ricketts to hear about what's happening with biotechnology and the biosciences in the state.

Biosciences create about 18,000 jobs in Nebraska – and the state government is prioritizing developing human capital and companies.

The state government works with high schools and community colleges to educate young Nebraskans about STEM careers. Southeast Community College in Lincoln offers post-secondary credits for a biotech certificate or a standalone biotech degree, while the University of Nebraska offers $15 million in 2,100 scholarships to help students studying biosciences.

The state generates a lot of patents – 578 between 2016-2019 in fact. The University of Nebraska is among the top 100 worldwide academic institutions that were earning U.S. patents – making it a great place for students to get a career in biosciences, he said. In addition, the Bioscience Innovation Act offers grants for startup and early-stage bioscience companies, which has helped 40 companies grow.

Watch as he discusses the state’s leadership in the biofuels sector and what it means for consumers, farmers, and the planet:

The pandemic highlighted a number of critical concerns. With the climate emergency standing out. In this discussion with key leaders from the U.S. and UK health infrastructure, we explore how governments and industry are confronting climate change by making bold pledges to reduce greenhouse gas emissions and enhancing sustainability more broadly. 

Moderated by Dana O'Brien, Deputy Chief Operating Officer & Chief Sustainability Officer, Biotechnology Innovation Organization

Speakers

• Victor Dzau, MD, President, National Academy of Medicine
• Michelle McMurry-Heath, MD, PhD, President & Chief Executive Officer, Biotechnology Innovation Organization
• Rohin Mhatre, PhD, Senior Vice President, Product and Technical Development, Biogen
• Lord David Prior, Chair, NHS England

“The great similarity between the COVID pandemic and climate change...we know it’s happening, or we know it may happen, but we do nothing about it until it’s right on top of us. And the lack of preparedness...ought to ring a huge wake up call for us all,” said Lord David Prior to open up the conversation. “You need to prepare the roof when the sun is shining,” not during the storm!

The other panelists highlighted that inequity is a big factor as well that was highlighted in the pandemic. 

They discussed the importance of moving quickly to address climate change, not just with the technologies that exist today, but in planning ahead and developing new, inspired methods. 

Rohin Mhatre said that even though Biogen has achieved carbon neutrality and did so many years ago, the real goal is emission-free. “Get away from fossil fuels, enhance and utilize clean energy through the entire operation.”

As Michelle McMurry-Heath noted, many of these solutions are in the biotech sector. 

The health sector is responsible for a large chunk of greenhouse gas emissions, Victor Dzau pointed out. So solutions have to come from this industry coming together, set goals, and develop new strategies. Everyone has to follow the example set by Biogen.

“We need regulatory agencies to prioritize those innovations.” - Victor Dzau, MD, President, National Academy of Medicine.

Dana O’Brien added that it’s important for society to think outside of holding ag and environment companies responsible, but expanding the coalition and reviewing this issue from a public policy perspective.

“When you go back to your companies, start the internal dialogue about how you can do things in a more sustainable way. Don’t wait until tomorrow or next week or next year. Let’s all start today, this week, this month, and have the conversations. Can we do our work in a more sustainable way? Because it’s so critically important to health and that is at the mission and heart of so many of our companies.” - Michelle McMurry-Heath, MD, PhD, President & Chief Executive Officer, Biotechnology Innovation Organization

Dr. Cartier Esham, BIO’s Chief Science Officer and EVP for Emerging Companies, spoke with Dr. Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration.

What were the biggest challenges for the FDA to overcome during the pandemic? 

1. Selecting what agents the government would support amongst the huge number of candidates, particularly on the therapeutics side, says Dr. Woodcock. 
2. Getting clinical trials set up, says Dr. Woodcock, “many of which were done through the act of public-private partnerships and funded through Operation Warp Speed.”

So now that many of those challenges are overcome, how is the FDA prioritizing supply chains and manufacturing capacity? 

“We are working on everything from pharmaceuticals to foods,” says Dr. Woodcock. “For each commodity that FDA regulates, we’re looking at the robustness, resiliency, and redundancy of the supply chain, and supporting U.S. government efforts to increase U.S. manufacturing across these areas.”

Modern technology like computer-controlled systems could help boost manufacturing efforts, says Dr. Woodcock, and having a welcoming regulatory framework will be important to support innovative and advanced manufacturing methods. 

More Tools in the Toolbox: How can the FDA’s Digital Health Center of Excellence help advance clinical development and help inform regulatory decisions? 

“Many would be drug development tools, and therefore would be a part of the qualification process for regulatory acceptance” says Dr. Woodcock.

.@DrWoodcockFDA talks about the potential of the @US_FDA’s Digital Health Center of Excellence, saying digital interventions could be a “new frontier” #BIODigital #Digitization #4IR #FDA pic.twitter.com/YSa4seu6ef

— I Am Biotech (@IAmBiotech) June 17, 2021

How do we increase diverse patient participation in clinical trials and advance health outcomes for all patients? 

“We need to support investigators in all areas of the country,” says Dr. Woodcock. “Right now our clinical trial ecosystem is concentrated in major medical centers and CRO sites,” she explains. 

Building a stronger FDA to meet the challenges of evolving science 

In the short term, the FDA is continuing its work to get the new drug regulatory review process “up to another level of process support,” by streamlining knowledge management and workflow management. 

Long term, Dr. Woodcock hopes there will be many new solutions for patients and “people’s lives will be better because of both the industry’s innovation and the FDA’s ability to manage it and bring it forward to patients.”

New technologies can improve health and tackle critical issues like sustainability and equity, says BIO President and CEO Dr. Michelle McMurry-Heath.

Biogen is prioritizing climate sustainability and equity in its efforts to improve society and overall health – learn more about Biogen's Healthy Climate, Healthy Lives initiative. 

Biogen has been in the news lately following the approval of Aduhelm, a pioneering Alzheimer’s drug. Dr. Michelle jumped right in with the question on everyone’s minds. What did it take to get there?

Preclinical work started in 2007, said Vounatsos. Following the approval last week, Biogen has already begun work on confirmatory studies.

"We aim to deliver more evidence as soon as we can," he said.

“We want this launch to be as equitable as possible,” he continued. “The sustainability of the system is critical.”

The patient journey is very tenuous. They are identifying many bottlenecks to providing access to the drug.

“We stand for a launch that is responsible...that address the right patient, with the right target, at the right pace.," he said. "An equitable launch is very important. I’ve instructed my team to make sure this was front and center.”

And we can't forget this is a historic moment for Alzheimer's patients and their families. “Finally, the science is breaking,” he said.

How is Biogen addressing health equity?

Biogen is reaching out to Black and Brown communities, where we see a higher incidence of Alzheimer's, said Vountatsos.

"It's a societal issue, and we need partners," he added. Biogen is partnering with CVS to find at-risk populations, as well as charitable clinics.

"We will double down there."

What should biotech do to be more equitable and inclusive?

"We all have to recognize we need to do a better job," he said. "It's not an overnight fix."

"It's not an objective in order to be politically correct. It's a mission in order to better perform – in order to better create value."

Biogen set metrics including increasing the number of managers from minority populations by 30%.

While it helps to "put the bar somewhere," we need to address the root cause, specifically the talent pipeline.

"We need to work proactively...with community colleges and more diverse universities" and consciously work on the pipeline "in a sustainable manner." To that end, Biogen has trained more than 250 Black scientists in the Boston area, Dr. Michelle noted.

"Shame on us if we miss the opportunity" to develop new talent, Vounatsos said.

"Science is breaking on many fronts"

"Science is breaking on many fronts" – not just the brain, but cell and gene therapy, digitization and machine learning, better understanding of biomarkers and genomics.

Technology can help make clinical trials more diverse, too, which will lead to better research.

"We need to embrace technology in everything we do, from early research to customer engagement."