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The exciting new developments we’re seeing in biotechnology must be supported by equally innovative policy, according to Fritz Bittenbender, the new Chair of the Board of the Biotechnology Innovation Organization (BIO), as of June 17.
Bittenbender, who is also Genentech’s Senior Vice President and Head of Public Affairs & Access, now has a greater platform to encourage an environment in which biotech can thrive.
“I’m really excited to be the Board Chair at BIO,” he said. “Biotechnology is at such a critical inflection point for our industry, and BIO is going to be the key catalyst that assures we can continue to grow the biotech industry and make it stronger than ever.”
Bittenbender praised the steady leadership of outgoing Board Chair Ted Love, M.D., whom he called “thoughtful, smart, engaging, supportive of the BIO leadership and staff.” Bittenbender said he was excited to know Love would continue on the Board’s Executive Committee.
This position is Bittenbender’s latest achievement in a 25-year career of forwarding biotech innovation and access through both public and private sector roles.
Formerly the Vice Chair of BIO’s Board, Bittenbender also served as BIO’s Executive Vice President for Public Affairs. Previously, he served as Executive Director of the Council of State Bioscience Associations (CSBA) and, earlier, as President of Pennsylvania BIO (now Life Sciences Pennsylvania). His public service included the position of Secretary of Administration, the chief operating officer for the Commonwealth of Pennsylvania, as well as Deputy Chief of Staff to former Pennsylvania Governor Tom Ridge. Aside from Genentech, his private positions have also included serving as Vice President of Global Public Affairs at Cephalon.
Bittenbender answered questions from Bio.News about the current situation for biotech and the work he sees ahead for BIO.
You’ve worked in biotechnology for a quarter of a century. What are the major changes you’ve seen, and what has remained constant?
As far as constants, I think policymakers, particularly at the state level, still believe in biosciences as an innovative builder of economies. It shows if you look on the trade show floor at BIO 2025 and you look at the states that have booths there, working hard to attract biotech companies and investment. That’s always been the case. So we’re an industry that policymakers believe in, and BIO is a great showcase of that.
One thing that’s changed is the pace of innovation. When I think of just my 25 years in the industry, the number of new medicines that have been developed for patients is remarkable. Certain types of cancers that were a death sentence 20 years ago are cancers that people are living with today. Look at MS, and certain neurologic diseases—diseases that were debilitating, leaving people confined to a wheelchair after a certain number of years. Today, people with those conditions are living healthier, less-assisted lives because of medicines. We’re just seeing innovation growing exponentially.
On the flip side, the policy has not changed as fast as innovation. One of the key challenges for BIO, for now and into the future, is to make sure we stand at the vanguard of innovative policy solutions. We need to lower costs for government and reduce patient out-of-pocket costs by making medicines more affordable. But we need to do it in a market-based way that allows innovation to continue to grow and flourish in our country.
You can achieve all of those things with thoughtful policy based on new, innovative solutions. Doing that requires better, and different, engagement with policymakers on the state and federal level than maybe we’ve had in the past.
What are BIO’s biggest challenges and priorities right now?
I think the biggest challenge is the uncertain policy environment that we’re working in today. You see other countries, and even at times the federal government, talking about reducing intellectual property rights. You see an uncertain reimbursement environment, with policy proposals that would have reimbursement of products in the United States tied to single-payer healthcare systems around the world—instead of using free market reimbursement. When you think about the cuts that are happening in early-stage research, at the National Institutes of Health and other universities and colleges across the country; when you think about staffing cuts in government and funding cuts: How does that impact the industry?
We have to look for the risks and opportunities. For some of the changes, I think there are going to be opportunities. I think there are opportunities to modernize the Food and Drug Administration (FDA), and BIO can play an exciting leadership role in all of that.
But on the risk side, this uncertainty is driving change in our industry, and you’re finding medium- and small-sized companies having a hard time getting funding because of that uncertainty. You have a lot of biotech companies that are underwater. They’re trading below their cash value because people are uncertain about the reimbursement future for their products.
One thing about our industry is it’s so capital-intensive. You know it takes $1 or $2 billion and over 15 years to get a product to the market, and only about 8% of products go from the early preclinical stage to actually make it to a product that patients can use. There’s already so much uncertainty, cost, and risk that you need a certain policy environment to really support that. So I think that’s a key goal for BIO over the next couple of years to help develop a more certain policy environment and take some of the uncertainty and risk out of it for investors. That’s the only way we’re going to continue to deliver for patients and continue to innovate in a way that keeps the United States a global leader in bioscience.
How do you work with government to help develop an improved policy environment?
In the past, we have really focused on protection of our industry, which has made it harder to put energy into really innovative policy solutions, but we are doing more to push those forward. One of the things I really like about BIO right now is we are working with the understanding that biotech is not an industry of “no”: “No, we can’t do that. No, we can’t afford that.”
BIO is at the epicenter of coming up with groundbreaking policy solutions that actually can change the healthcare paradigm in the U.S. Now it’s about “how might we do better?” I think that’s a different conversation than what we’ve had in the past. I think that’s really exciting.
For instance, we can come into a state and talk to a governor about how we might help support Medicaid in their state. We can have conversations about how we might look at reimbursement slightly differently, in order to save the government money while we still continue to grow and protect investments in innovation. This is where BIO is really leaning forward now.
One of the key things we’re excited about is FDA modernization. BIO is taking the lead, with small and mid-sized companies, in a conversation about how we use technology and artificial intelligence to modernize the FDA to meet the needs of our innovative companies in the biotechnology industry today.
We’re an industry that the policymakers should partner with, so we work together on solutions. I look forward to sitting down at the table together and really developing the policies that work for everybody in terms of how we lower costs for government and increase patient access.
