There is ample scientific data and evidence in the safety and efficacy of Covid-19 vaccines. Unfortunately, in the era of so-called alternative facts and widespread misinformation, we’ve seen that science and data alone may not be enough to combat hesitancy among certain populations. In this panel, experts discuss key drivers of vaccine acceptance, confidence, and the role of government, industry, scientists, health professionals, and more in getting shots in arms.

This insightful discussion is moderated by Hannah Kuchler, the pharmaceutical correspondent for Financial Times. Speakers include:

• Priya Agrawal, MA, MPH – VP, Global Commercial Leader - HPV Vaccines at Merck
• Heidi Larson, PhD – Director at The Vaccines Confidence Project
• Joe Smyser – Chief Executive Officer of The Public Good Projects
• Reginald Ware Chief Executive Officer of BlackDoctor.org

#vaccine messaging is “the ultimate example of personalized #publichealth” says @Merck’s @priya_agrawal #BIODigital pic.twitter.com/Xm7F4RGJRw

— I Am Biotech (@IAmBiotech) June 14, 2021

Ware gives historical context to mistrust and distrust in health systems among minority communities and discuss current challenges in keeping communities of color-safe from Covid-19:

• “We knew going in that we had this monumental challenge of how do we get people to trust the vaccine to the point where not only will they do it, but they’re also going to talk to other people in a favorable fashion about getting the vaccine,” he says.
• On strategies to social distance and work from home to reduce Covid-19 spread, Ware notes, “only 10 percent of [the Black population] have jobs where we can work from home … how do we go to work every day and stay safe?”
• “We’re smart by not underestimating the power of misinformation […] Coming away with ways to attack the misinformation is going to be really really important.”

Kuchler notes the messenger can be just as important as the message in efforts to build vaccine confidence. Larson discusses the role of health professionals to engage hesitant communities:

• She notes how official vaccine websites – such as the Centers for Disease Control and Prevention – don’t always answer everyone’s questions.
• “We need to engage where people are – and there’s been a real gap.”

Agrawal speaks to the role of industry in bringing vaccines and therapies to the public and convincing them of their safety and efficacy:

• “Addressing vaccine hesitancy hinges largely on building trust … we have a massive role to play… not only in the actual vaccines, but in the scientific processes” used to create vaccines.  
• “Communicate to converse rather than convince … having that conversation… not necessarily going in to convince them to take the vaccine […] but to really understand concerns and make sure they have the relevant information.”
• “We are terrible with jargon. We have a lot to learn from the Anti-Vax community because their communication is simple, easy to understand, it’s personal stories, and messages in a way that taps into people’s emotions.”

Smyser gives insight into the role of community leaders in boosting confidence:

• He hopes the silver-lining to this pandemic is “the recognition that we need to allow space for community leaders and community organizations to actually have a role in public health.”
• “Government agencies around the world need to open up and they need to have more of a two-way dialogue with the public.”
• “People in communities need to be speaking to public health, not the other way around.”

Kuchler transitions to asking speakers what they think key messages are in boosting confidence:  

• Ware speaks to his personal approach and says, “let’s just have a conversation. I’m not going to tell you what to do. I’m just going to give you all the information […] you can make a decision for yourself.”
• Discussing her “building-confidence-to-convince” approach, Larson says, “We’re all dealing with uncertainty […] it’s about self-confidence and convincing yourself” that getting vaccinated is right for you.” 
• Agrawal speaks to the personal element of getting vaccinated: “As industry we talk a lot about personalized medicine … this is a great example of personalized public health.” 

Kuchler ends the panel by asking viewers to take a minute and think of our own role in ending this pandemic.

A Turning Point:

Dr. Fauci discusses how his transition to working on infectious diseases when HIV/AIDS began to enter into public consciousness was something that greatly interested him given his background as someone who is board-certified in the study and treatment of infectious diseases.

Dr. Gerberding takes a moment to reflect on the early, dark days of the HIV/AIDS epidemic and thinks of her patients back then as “teachers” who as advocates for themselves and their communities, oftentimes knew more about what was going on with their bodies and their communities than many physicians did at the time.

Dr. Fauci recalls the “high” and “low” that came with the hope of AZT, followed by the realization that many patients were getting sick again since the importance of measuring a patient’s viral load was not understood at the time.

1996 was a “transforming” year for HIV/AIDS research at the “Vancouver Meeting” where “stunning” results were presented of a “durable control” of the virus. This became known as “the Lazarus effect”.

Dr. Gerberding states that a colleague of hers at the time died from their illness as a result of not being eligible to join a treatment trial but that his partner was able to join a three drug treatment trial and is alive to this day.

According to Dr. Fauci “we’re in very good shape” in the United States regarding COVID-19 vaccine distribution but it is important to recognize that “a global pandemic, requires a global response” and that President Biden is taking “a major step” at the G7 regarding vaccine purchases and donations.

On the potential for an HIV vaccine and what COVID-19 researchers are learning from HIV research:

Regarding the potential for an HIV vaccine, Dr. Fauci states that “the body doesn’t make a good response to HIV”.

Dr. Fauci notes that Coronavirus researchers have partnered with structural biologists who have long experience in HIV research and learned from them how you stabilize a molecule in its pre-fusion, highly immunogenic form by doing certain mutations.

Dr. Fauci says that it is "the best I’ve ever seen” right now in terms of cooperation between academic institutions, research entities, the federal government, and the private sector in confronting COVID-19 and it has been “highly, successful”.

Dr. Gerberding states her belief that HIV should be referred to as a pandemic since there are still 38 million people living with HIV and 1.7 million newly infected every year.

Dr. Fauci says “we have the tools” to prevent HIV infection but that ultimately it’s “all about implementation” and that “we can meet the goal of ending HIV by 2030,” even if we do not have a vaccine yet.

On acknowledging and confronting disparities:

According to Dr. Gerberding, “You know, sometimes I think people forget about the importance of the social determinants of health as HIV distributes itself globally but also in the United States, that especially today, it’s obvious that the areas where the hotspots of HIV transmission [is] occurring are very often overlapping with the hotspots where we are seeing the high degree of Coronavirus transmission but also the unusually high hospitalization and death rates.”

Dr. Fauci remarks on healthcare disparities and compares the HIV epidemic to the COVID-19 pandemic.

Dr. Fauci states that comorbidities in certain underrepresented communities are not racially determined, rather, they are socially determined, hence the importance in addressing healthcare disparities. Addressing these disparities is “a decades’ long commitment”.

On the importance of activism:

Dr. Fauci explains the importance of not only working with advocates and activists but becoming one to more effectively conduct innovative research on behalf of patients in need.

On prophylaxis:

The development of prophylaxis as preventative treatment was a major breakthrough according to Dr. Fauci and that the risk of resistance was much lower than the risk of someone dying from the infection you were trying to prevent.

On PEPFAR:

Dr. Fauci discusses why he believed as it was being planned, that the President's Emergency Plan For AIDS Relief (PEPFAR) would work in decreasing the spread of HIV/AIDS.

What are three things – excluding a vaccine – that would help reach the 2030 goals for HIV prevention?

According to Dr. Fauci, they are:

• Community mobilization,
• Implementing existing treatments,
• Advancing research to improve treatment.

This session was sponsored by Merck.

Grab a glass and check out some of our favorite tweets from Day 1 of BIO Digital...

Our work starts where science begins — with discovery and innovation. We are a proud sponsor of #BIODigital 2021, where Avantor's Dr. Ger Brophy will introduce tomorrow's keynote between @IAmBiotech’s Dr. Michelle McMurry-Heath and @pfizer’s Dr. Albert Bourla. #AvantorStrong pic.twitter.com/bju79st0Q9

— Avantor (@Avantor_News) June 13, 2021

The COVID-19 pandemic showed the power of international collaboration in overcoming a crisis, but highlighted weaknesses in the process. How will the world prepare for the next global health crisis? What lessons should we learn? Phyllis Arthur, Vice President, Infectious Diseases and Diagnostics Policy for BIO, was joined by the following to discuss:

• Stanley Erck, President & CEO, Novavax, Inc
• Amanda Glassman, Executive Vice President, Chief Executive Officer, CGD Europe and Senior Fellow, Center for Global Development
• Dr. Richard Hatchett, CEO, Coalition for Epidemic Preparedness Innovations (CEPI)
• Dr. Rajeev Venkayya, President, Global Vaccine Business Unit, Takeda Pharmaceuticals America, Inc.

What have we learned so far?

Glassman spoke about the importance of scale and speed of public financing that is available for the rest of the world, outside of the U.S. and the U.K.

“We have to set norms and expectations around access and before the next pandemic amongst the most powerful actors in this movie, “said Dr. Venkayya.

How did COVAX work, and in what ways will it need to improve?

“This plane was built while flying,” Glassman said. According to her, the initial funding for COVAX was insufficient from most countries. As a solution, she offered an increase in visibility for the governments involved, as well as finding ways for middle- and low-income countries to get involved.

“It’s the best bargain ever for finance ministers,” Dr. Hatchett added. “Not only did we build it while we were flying it, we also learned how to fly it in the air!”

What can we do, “in peace time,” to ensure that supply and manufacturing needs are where they need to be in case of a crisis?

The speakers pointed to the supply chain as a critical need to address – both from a manufacturing standpoint and international trade.

“One thing that could help the supply is that we don’t close our borders, so that there’s free flow of goods,” Erck added.

“There’s a struggle in building up manufacturing globally, specifically in areas that are ‘manufacturing poor.’ These manufacturing hot zones have left areas like South America and, especially, Africa very dependent on vaccines being transferred from other regions,” said Dr. Hatchett.

How does the issue of intellectual property (IP) around vaccines fit into the larger discussion on supply and availability?

“If you waive a patent, it’s not like a company can then go and work around to redevelop the process,” led Dr. Venkayya. “Is it physically possible? Yes. Will it happen in a year or two years? No, it’ll take much longer. Many of these stances are being proposed by people who haven’t spent any time in vaccine manufacturing.”

“It is so complex that that just transferring IP isn’t the issue at all. It’s transferring the technology and working with sophisticated groups of people who are already trained. That’s how you get your vaccines,” Erck added. “As long as it’s taken us, it would take somebody fresh two years to just access our IP and do something about it, it just is not the answer for this problem.”

“It does send an important signal right now to everyone that, because we’re in a crisis, business as usual is not sufficient,” said Dr. Hatchett.

Novavax CEO Stanley Erck today addressed @BIOConvention and discussed why transferring intellectual property doesn't get vaccines to the world faster. Get the recap on the live blog: https://t.co/IAi9Cwa1Z0 #BIODIGITAL pic.twitter.com/4oI4e6FYuC

— Novavax (@Novavax) June 14, 2021

How do we address vaccine hesitancy?

“During this pandemic, we had a toxic mix of social media and research findings being reported in real-time through press releases, so the public was getting different messages,” Dr. Venkayya said. “In many countries, frankly, there was also a failure in leadership to get behind the science.”

“I think vaccine hesitancy has been overblown because of the U.S. and U.K., because we’re seeing many developed countries that have high rates of acceptance,” said Glassman. “Yes, address it, but don’t let it stop us from moving forward as quickly as we possibly can.”

Just like at BIO Digital 2020, Alkermes Chairman and CEO Richard Pops moderated this year’s FDA Town Hall. His guests were two leaders of the U.S. Food and Drug Administration, one of the most critical federal agencies for the biotechnology industry:

• Dr. Peter Marks, Director of the Centers for Biologics Evaluation and Research (CBER)
• Dr. Patrizia Cavazzoni, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER)

The three discussed how the FDA is dealing with its heavy workload, balancing approvals related to COVID alongside other treatments and therapies (such as cell and gene therapies), and how the FDA plans to return to in-office work.

Back to Work

Just like workplaces everywhere, the FDA is contemplating how to return its staff to the office. Dr. Cavazzoni, who noted how proud she was of the FDA staff during the pandemic, said that “when it comes to inspections, we are tied to our ability to get to certain places.” She noted that the center hopes the situation will “increasingly normalize if things continue to progress as they have been with vaccinations.”

Dr. Marks offered an interesting take, saying that FDA staff have a heavy workload, but expects to ease back into the office as “going back to work and commuting would actually take time away and destabilize things.”

Meetings and Efficiency

“We like in-person conversation but the [virtual] format frees up time, particularly for the sponsors.” Dr. Marks cited conference room limitations that make it hard to find a conference room, whereas being virtual may make things more flexible and available and help work-life balance. He noted the trade-offs.

Clinical Trial Diversity: Carrot, not a Stick

Both FDA officials said that industry and the FDA have the same goal when it comes to clinical trial diversity and need to continue working together to find the best way to accomplish it.

Dr. Marks stressed the importance of using the U.S.’ diversity as an asset that could be translated across geographies and countries. He made a clear point that “we want to get there with a carrot rather than a stick.”

“We recognize the anxiety among drug developers about taking too rigid of an approach. We don’t want to slow down development. We are giving that a lot of thought and must land on a pragmatic and sensible approach,” said Dr. Cavazzoni.

What about delays?

Both regulators agreed that the FDA was doing everything that they can. Dr. Marks talked about bringing in, if only temporarily, people with relevant experience to help and said, “Only a minority of applications require us to go into the facility and travel.” Both empathized with company sponsors that had to wait.

Specifically related to cell and gene therapy applications, Dr. Marks noted that there was “no remission” in terms of the number of applications. “We went from 243 in 2019 and we had 237 in 2020. So very, very stable despite the fact that there were all sorts of issues with getting gene therapy trials up and running.”

Restructuring advisory committees

At the end, Pops asked an interesting question about refreshing the structure, purpose, and operation of advisory committee meetings – and mentioned that BIO has input to offer on this topic.

Dr. Cavazzoni said “such feedback is valuable” and that they need to look at “advisory committees that don’t seem to have experts in the field.” She stressed the importance of “removing the emotional under- or over-tones in committees” and “getting back to the substance.”

“These are important scientific decisions. Can’t be swayed by emotion in the face of very hard facts to the contrary, she said.” Pops agreed and said industry wants to help.

One thing's certain in this time of uncertainty: markets have taken notice of biotechnology.

David Thomas, BIO’s VP for Industry Research, presented new analysis of funding and deals for 2020/2021 and launch a new clinical development pipeline tracker—and we got a sneak peek ahead of the session.

There were 64 R&D-stage biotech IPOs in the U.S. and 35 outside the U.S. in 2020, which raised $10 billion and $6.7 billion, respectively—far exceeding IPOs and funding in 2019. 

VC firms have been a key driver of increase funding for life sciences and biotechnology firms in 2020, having raised $17.9 billion for the industry in the U.S. and $11.5 billion outside the U.S—also an increase from 2019.

Who’s leading the clinical pipeline in 2021? Hats off to smaller biotech firms, which account for 5,006 ongoing programs (out of 6,506 total), representing 77% of clinical programs this year.

Looking ahead…COVID-19 is likely to be far less of an issue in the U.S. in 2021 compared to 2020, but emerging companies will likely continue to raise capital and close deals. 

Read the whole thing.

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How do we fix the economics of antibiotic development? Jenelle Krishnamoorthy PhD, Interim Vice President Global Public Policy at Merck, led a conversation with U.S. Senator Michael Bennet (D-CO) and Dr. Henry Skinner, CEO of the AMR Action Fund. The speakers discussed what is needed to accelerate the development of novel antibiotics - before it’s too late.

The Antimicrobial Resistance (AMR) Crisis:

Senator Bennet highlighted a few key lessons learned working on health issues over the years and also living through this pandemic:

1. Global collaboration is “absolutely critical” to address public health crises. “We can't sit on our hands and wait for the next crisis to arrive. We need to anticipate that crisis and act now."

2. Infections don’t care about borders. “We need a coordinated international approach to keep us safe from global threats to public health.”

3. Health inequities must be kept in mind and addressed as underserved communities are hit hardest by health crises such as the COVID-19 pandemic.

Dr. Skinner noted the impact that antibiotics have had on humanity. “It is the most important class of drugs we’ve ever developed for the greatest benefit to humanity. We've lived in a golden age, but that golden age is coming to an end."

Dr. Krishnamoorthy described the importance of antibiotics and the crisis right now. “The resistance is outpacing the development of new novel antibiotics,” she said.

The AMR Action Fund will invest $1 billion to bring two to four new antibiotics to patients to cure these drug-resistant infections by the end of the decade.

The Challenges of Research and Development

“The challenge is really quite extreme right now, and fundamentally, we have too few drugs in development and the reason for that is that the market’s broken for antibiotics,” said Dr. Skinner.

"We have seen multiple antibiotic companies successfully develop antibiotics only to go bankrupt in the last 5 years. And the consequence of that is there is even less investment and less willingness to invest in this space.”

Dr. Krishnamoorthy spoke about a “valley of death” for many small biotech companies doing research and development for new antibiotics.

“They get to the point of possible approval by FDA, but there is no market incentive to pull them through and actually get them to the public,” she said.

Supporting the Development of Novel Antibiotics

Senator Bennet said “we have to rethink how to encourage development of the innovative antibiotics we need.”

He explained legislation called the PASTEUR Act that would have HHS communicate to pharmaceutical companies that they will support the development of the next generation of antibiotics through a subscription contract.

“It's sort of like Netflix. We're giving you a guaranteed return for your product, but we're going to compensate you for value, not volume,” he added.

The bill will spell out "favored characteristics" to describe the type of antibiotic that HHS will pay for. The emphasis is on "novelty" so as to spur innovation. If the bill passes, pharmaceutical companies must provide these antibiotics to patients with public health insurance at no cost.

In addition, this bill would help create better partnerships on global development.

If AMR is unaddressed, it "will become the leading cause of death," said Sen. Bennet. "Not cancer, not heart disease, not malaria, but infections. We can't continue speaking about resistant infections becoming the leading cause of death in 20-30 years and not do anything about it now."

Dr. Skinner added that “AMR is a smoldering pandemic. It's under-appreciated."

"We've taken antibiotics for granted given the benefit they’ve given to us over the last 70 years. But this is an entirely foreseeable crisis and it is an entirely preventable crisis. We just need to act and to stay in front of it.”

Lessons Learned from COVID-19

“We live in this world together. This is a global problem and it's going to require global solutions,” said Dr. Skinner. “We see how quickly an infectious disease will spread around the world and how quickly a pathogen will mutate and endanger us all. Time is of the essence.”

“The COVID-19 recovery has been costly and we shouldn't follow through that same playbook for AMR,” said Senator Bennet.

Private sector contributions to progressing on confronting AMR are "so vital," concluded Sen. Bennet. He is "hopeful" Congress will address AMR "through appropriations." He committed to "pushing for" AMR to continue to be a part of the public conversation and for the PASTEUR Act to be adopted into law.

This session was sponsored by Merck.

Biotech reacted to the pandemic with remarkable speed, helping to change the course of history and the biotech industry itself in the process. 

BIO’s Dr. Michelle McMurry-Heath digs into the story in the new BIO Digital preview episode of the I AM BIO Podcast.

Guests include:

• Dr. Cartier Esham, BIO’s Chief Science Officer
• Dr. William Karesh, EVP for Health and Policy at the EcoHealth Alliance
• Aaron Soto, Chief Scientific Officer of Twist Bioscience
• Ron Faucheux, Chief Analyst at Certus Insights

Listen to the whole thing here. You can also get the episode via Apple, Google, or Spotify.

This episode of the I am BIO Podcast is brought to you by FUJIFILM Diosynth Biotechnologies.

As COVID-19 spread across the globe, companies worked on many different types of therapeutics to treat patients.

Phyllis Arthur, Vice President, Infectious Diseases and Emerging Science at BIO, led a panel on COVID-19 therapeutics and the work we’ve done to prepare for the next pandemic.

Speaking on the panel were:

• Arpa Garay, President, Global Pharmaceuticals, Commercial Analytics & Digital Marketing, Merck & Co., Inc.
• John Redd, Chief Medical Officer, HHS Office of the Assistant Secretary for Preparedness and Response
• George Scangos, PhD, President, Chief Executive Officer & Director, Vir Biotechnology, Inc.
• Brad Wilken, Deputy Director Product Development Operations, Bill & Melinda Gates Foundation

Coordination and Collaboration

When COVID-19 hit, Merck looked at what they had already developed to see if any of those approaches would work against COVID.

“The first step we took when the pandemic first hit was looking at all of our assets and testing them for activity against COVID-19 so we had a close collaboration with multiple partners in the public space as well as the academic space to see if there was any existing drug or therapeutic that could work," said Gray. 

Ultimately, the company collaborated with Ridgeback Biotherapeutics on a potential therapeutic, molnupiravir.

The Gates Foundation worked to coordinate and aggregate funding, science and clinical trials through the COVID-19 Therapeutics Accelerator, a philanthropic collaboration that supports efforts to research, develop and bring effective treatments against COVID-19 to market quickly and accessibly.

Implementing and Leveraging Therapeutics

“The administration of the antibodies has been a significant limitation because of the fact that they’re IV-administered," said Scangos. "That’s a limitation in the U.S., but a bigger limitation in other parts of the world.”

The goal is a single, low-dose injection that can be administered easily and be easily accessible.

Ensuring Access

Access is critical and making sure people have equitable access is the right thing to do.

What Have We Learned?

Preparedness is critically important.

We know the viral families that most likely could lead to a pandemic. Dr. Scangos believes we should have antibodies ready broadly across those families so that we’re not caught flat-footed.

“We should have them ready so the next time there is an outbreak caused by one of those viral families, we will have therapeutics ready to contain it that will minimize and contain that infection until the vaccines are available some number of months later.”

A few more things that could help: sharing data faster and earlier, clinical conduct, broad antibodies that treat whole viral families, genetic surveillance and a robust system to share it.

This session was sponsored by Merck.

BIO President and CEO Dr. Michelle McMurry-Heath sat down with Dr. Tony Coles, CEO and Chairperson of the Board of Directors of Cerevel Therapeutics, to discuss everything from how Cerevel is discovering "how the brain works" and developing a better understanding of neuroscience diseases, to the importance of diversity and inclusion in biotech.

“Tony holds a special place in my heart," said Dr. Michelle to begin the session. "He was the architect of the United Negro College Fund and Merck partnership that gave me as a young scientist the financial support and confidence to forge a career that I sought. That fellowship changed my life."

Lessons Learned from the COVID-19 pandemic

Dr. Tony Coles refers to the COVID-19 pandemic as a “cycle extraordinaire.”

“We’ve had a significantly disruptive event with the pandemic."

This shifted conversations about the industry.

“The world at large was asking the biopharmaceutical industry how we could help," he said. "Now, we have a society that is grateful, thankful, appreciative of the speedy work, the innovation, everything that we’ve done to try to address this once in a lifetime crisis."

"That brings us into a much more balanced and perhaps nuanced conversation about the strength of the industry, what it is that we do on an ordinary basis, how we treat these spectacular events, but also the things that we’ve done for the more mundane things, the things that have become chronic diseases.”

But the industry shifted, too: "We, as an industry, have to do our part as stewards and step up and always ask ourselves what’s the right thing to do at the intersection of innovation, pricing, affordability, availability, and continuing to challenge ourselves to look for new solutions."

As China and Russia have engaged in vaccine diplomacy worldwide, the United States biotechnology industry must be "at the table" and "in the room" where decisions are made regarding U.S. policy.

How the U.S. will respond is essential since it is "the source of biotechnology innovation."

On intellectual property

IP "has really been the lifeblood of our industry – the ability to ensure an appropriate payback to investors and stakeholders for their investment in technologies and to do so for an IP-protected period of time."

He is "especially thoughtful and concerned about developing countries" regarding vaccine distribution.

But there's an important question. If intellectual property protections are stripped away, "does it end with vaccines"? 

In the context of neuroscience diseases, it's worth understanding "the risk to the investment model" that proposals to transfer IP would cause. While it may sound like "good policy," it should first be carefully studied and understood.

On advancing diversity, equity, and inclusion

Dr. Coles discussed his role in the Black Economic Alliance and launching the Center for Entrepreneurship with Spelman College and Morehouse.

“One of the things we wanted to do was to figure out a way to increase the amount of capital that could become available to Black innovators and Black entrepreneurs," he said.

Cerevel has "put practice into action" and made a commitment to the Board of the company to increase the hiring of Black Americans. This includes building and recruiting for a Black student internship program and increasing the number of minority vendors and suppliers to the business as well as the number of investors and funders as potential shareholder targets for the company. 

One Health – the concept that animal, human, and environmental health are interconnected – has been made readily apparent by the recent COVID-19 pandemic. 

Catherine Machalaba, PhD, Senior Policy Advisor and Senior Scientist at EcoHealth Alliance, led a discussion with experts in this space:

• Casey Barton Behraesh, MS, DVM, DrPH, DACVPM, Captain U.S. Public Health Service, Director, One Health
• Timothy Bouley, Co-founder & Chief Executive Officer, BioFeyn
• Mahesh Kumar, Senior Vice President, Zoetis, Inc.
• Eddie Sullivan, President & CEO, SAB Biotherapeutics

SAB Biotherapeutics' CEO Eddie Sullivan kicks off the discussion by highlighting the importance of One Health.

“There is this tremendous dynamic that happens between animal health and human health and certainly the environment," he said.

"All of these things can work together, and biotechnology is the technology that really brings this together in a unique way.”

SAB was able to pivot to respond to the pandemic: "SAB responded by going from essentially concept to clinic with a polyclonal antibody produced in these unique animals in 128 days.”

“I think it’s really critical as a company—as a biotechnology industry—that we really keep in mind this connection [One Health] and that we work together as veterinarians, as physicians, as scientists in the field of biotechnology in developing new ways to protect the planet. To protect the health of animals and humans the critical infrastructure that really exists within life sciences and within life."

Zoetis, Inc.—a company that develops animal health products—was working on vaccines for COVID-19 in companion animals like dogs and cats. They pivoted after hearing that transmission of the virus from minks to humans was compounding the pandemic and creating new variants.

“Let’s pivot the program to mink and see what we can do,” says Zoetis SVP Dr. Mahesh Kumar. They shipped vaccine to mink producers last week; zoos are now requesting vaccine, as well.

“One Health is a team sport—it's very important, there’s no single organization, sector, industry that can address One Health alone,” adds the CDC's Captain Casey Barton. “It’s vital that we work together to protect the health of people, animals, and plants living in our shared environment.”

Timothy Bouley with BioFeyn jumps in and explains the interesting connection between his work with fish and protecting against the next pandemic—further accentuating the importance of the One Health concept.

“Sampling fish tissues and pathogens can really help us understand outbreaks and apply pressure at the right points in the supply chain to prevent and stop transmission.”

Did you think there should be a fundamental shift to focus on One Health and where should the scope be?

“Expanding the surveillance networks around the world is going to be very important for us,” says Dr. Kumar. “I think knowing ahead of time what is happening and having the information be public is also important.”

“Ample surveillance is critically important for helping us find problems early and it should apply to all types of animals, not just traditional livestock,” adds Captain Casey Barton.

The next pandemic "could happen tomorrow," said Sullivan. He explains how we should prepare:

“No one’s safe until we’re all safe”

Pfizer intends to get their vaccine out to the world as soon as possible. According to Dr. Bourla, “We will have enough doses, not for the Americans and the Europeans, not for the rich or the poor, but enough doses for all. From day one, we understood that everyone needed to be protected. Equity doesn’t mean that you give everyone the same; equity means that we give more to those who need more.”

On COVID variants and booster shots

“We are always learning new things about these variants,” he said. “But speaking to what we know so far, with the variants that have emerged, we have tested against almost all of them. There’s no variant that escapes the protection of our vaccine.”

“As for the boosters, the data currently says a third dose is necessary in 8-12 months, but we are still finalizing the studies to confirm. I think it is a very likely scenario, but we are ready for it.”

Scientific and Strategic Priorities for the Future

Dr. McMurry-Heath brought up the future of public-private partnerships, a passion point for Dr. Bourla, and the unprecedented collaboration between these organizations to bring the vaccine to the public. “It’s not about the partners, it’s about the partnership. It’s not about who takes the credit for what we did, it’s about the outcome of this partnership,” Dr. Bourla said. “In a partnership, the best outcomes come when the partners focus on what they know how to do best.”

Dr. Bourla also believes that the mRNA technology used to develop this vaccine could change lives of patients around the world that have proved so challenging to treat for so long. “We believe that we have barely scratched the surface for what we are able to powerfully and dramatically demonstrate in the middle of a crisis. We have already started on other applications for this technology, and I think that will be a great contribution…We will see great things from this technology.”

What does the future of biotech look like?

“Beyond the specificity of the technology, I think we can do things differently and be faster and more successful in the future,” Dr. Bourla added regarding the future of the industry and lessons learned from the COVID-19 pandemic.

Dr. Bourla believes the future is bright for the biotech industry, coming out of the COVID-19 crisis. “I see it every day with the amount of people applying to Pfizer, truly great talents, that might not have before this crisis. People want to go into biotech because it’s really what saved the world.”

This session was sponsored by Avantor.

The last year tested all of us – but biotech has risen to the challenge.

Veteran journalist Brooke Baldwin (formerly of CNN) led a discussion on what's next for the industry with BIO President and CEO Dr. Michelle McMurry-Heath, BIO's new chairman Paul Hastings of Nkarta Therapeutics, and outgoing chairman Dr. Jeremy Levin of Ovid Therapeutics.

"We developed safe and effective COVID vaccines with unprecedented speed. And we know what drove it: biotechnology and the bio-revolution," said Dr. Michelle.

However: "We have a long way to go. Millions of people continue to suffer. Much of South America is in crisis and the toll in India is difficult to fathom. COVID has exposed the shortcomings of health and socioeconomic systems in the U.S. and worldwide."

What lessons do we want to take with us? Dr. Michelle outlined four things:

1. We have learned critical lessons about our shared humanity. Our borders are porous, our distinctions slight, and our shared vulnerability great. We are – quite literally – all in this together. We must keep this lesson close at hand as we move forward.

2. We need to construct more flexible, family-forward workspaces.

3. While we have learned so much about our similarities, we have also become more comfortable discussing our differences. Our innovative biotech companies will lead the way in showing how we can build more inclusive work cultures moving forward.

4. We now know we can never be satisfied with pre-COVID R&D timelines.

So, where are we now?

“We’ve closed a very important chapter, but we haven’t finished the book,” said Dr. Michelle. It’s fantastic to see the progress and the U.S. reopening – but “we have to be incredibly mindful that there are so many corners of the globe that are still waiting to see the fruits of the science.”

“We are going to have another pandemic,” said Dr. Levin. “We knew one was coming, we had some of the plans in place to deal with them, and unfortunately, we didn’t implement the plans.”

“In order to prepare for what’s coming, we have to look back over the last 18 months," in the U.S. and internationally – because “these viruses don’t know borders.”

How will the industry change post-COVID – and how do we prepare for the changes?

Diversity in clinical trials is critically important, said Hastings. In the COVID vaccine trials, companies enrolled diverse participants so everyone could feel comfortable and know “that they can be safe when they are being given the vaccine.” This is a priority for BIO going forward. 

“People need to be able to see themselves in the data” – not just in clinical trials, added Dr. Michelle. We must bring the public into the science and make it accessible and relatable.

Annnnd we're back!

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It's Monday, June 14 – and it's a busy day. Here's what we're covering:

9:15 AM ET - Breaking Barriers in Biotech: COVID-19 and the Future of Biotech feat. BIO's Dr. Michelle McMurry-Heath and BIO leaders Paul Hastings of Nkarta Therapeutics and Jeremy Levin of Ovid Therapeutics

10:05 AM ET - Conversation with Pfizer CEO Dr. Albert Bourla

11:05 AM ET - One Health Preparedness and Response feat. the CDC and EcoHealth Alliance

11:55 AM ET - Fireside Chat with Dr. Tony Coles, CEO of Cerevel

12:00 PM ET - COVID-19 Therapeutics: Modality, Efficacy and Implications for Access feat. HHS, Merck, and Vir

2:00 PM ET - Emerging Therapeutic Company Investment, By the Numbers

2:00 PM ET - Fixing the Economics of Antibiotic Development—Before It’s Too Late feat. the AMR Action Fund and U.S. Sen. Michael Bennet (D-CO)

3:00 PM ET - Global Pandemic Preparedness...it takes a globe! with CEPI and Novavax

3:00 PM ET - FDA Town Hall

4:00 PM ET - Building Vaccine Confidence: Evidence & Emotion

4:00 PM ET - Dr. Anthony Fauci and Merck's Dr. Julie Gerberding on Ending the HIV/AIDS Epidemic

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Already registered? Head to the BIO Digital Hubb to plan your day!