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Friday, June 12
6:00 AM
Thanks for joining us!

The Good Day BIO Team would like to thank you for joining us for BIO Digital!

The Good Day BIO Editorial Team

Photo: The Good Day BIO convention editorial team during our daily morning meeting. Top (L to R): Theresa Brady, Connor McKoy, Molly McNulty. Bottom (L to R): Cornelia Poku, Samantha Sault, Andrew Segerman, Rufael Seyum. 

Of course, 55+ blog posts, hundreds of social media posts and video clips, and twice-daily editions of Good Day BIO could not exist without our entire team of writers, editors, digital and video experts, and social media mavens. Thanks to all of our contributors (alphabetical order): Beth Anthony, Theresa Brady, Nicole Chardavoyne, Joe Hansen, Jeremy Isenberg, Keelan Kunda, Cassie McKay, Connor McKoy, Molly McNulty, Kara Nelson, Cornelia Poku, Rose Ramseth, Samantha Sault, Andrew Segerman, Rufael Seyum, Cresonia Wong, and everyone at 5:00 Films.

Want more? Sign up for Good Day BIO, the only daily newsletter at the intersection of biotech, politics and policy—and you can read it in just five minutes per day, promise.

We hope to see you next year!

3:00 AM
Heal our social genome.

Yesterday, BIO’s President and CEO Dr. Michelle McMurry-Heath led a discussion with Black CEOs of biotechnology companies and BIO leadership: Dr. Tony Coles, CEO and Chair of the Board of Cerevel Therapeutics LLC; Dr. Ted Love, President and CEO of Global Blood Therapeutics; and Dr. Jeremy Levin, CEO of Ovid Therapeutics Inc. and Chair of the Board of BIO. 

We encourage you to watch the whole thing—it's available here.

But we want to leave you with one takeaway in language the biotech community can best understand, in the words of Dr. Coles:

We talked about the origins of this, dating back to 1619, when the first enslaved people were brought to this country and the dehumanization that was involved to consider someone else as less than a person. And we even codified that in law, it was the Three-Fifths Compromise… 

But think about what that dehumanization actually does to the psyche of the person who is dehumanizing the other. It actually mutated our social DNA as a human race. And that mutation—let’s just say it was 1619—that mutation we’ve been trying to treat with all sorts of chemotherapy, or non-specific therapies. I’m just putting it in language that we understand as a community… 

We actually thought we had targeted therapies to treat this social DNA—this mutation in the mind—called the Voting Rights Act, or the Civil Rights Act, or the anti-lynching laws, all the laws that dismantled the Jim Crow South. When, in fact, what we really needed to do was CRISPR that mutation out of our social DNA.

So, we don’t need to be embarrassed. We need to be embarrassed if we don’t do anything now, now that we understand that we were wired—and white people in particular were wired—deep in the sub-conscious in the social recess, in the social DNA that has made up America in the society that we know. You can’t help it. You didn’t even know it. We don’t walk around thinking about our genes. 

But what we should do, now that we understand this distinction—we should be embarrassed if we don’t fix it. – Dr. Tony Coles

As Dr. Michelle said, we need to heal our social genome.

– Good Day BIO Editors

2:00 AM
What We Learned on Day 4 of BIO Digital

1. We weren’t prepared for this pandemic—but we can learn from it, so we’re prepared in the future.

“If I were to make a plea to the investment community, your return on investment in innovative manufacturing technologies could be quite dramatic,” said Jeremy Levin, Chairman of BIO’s Board and CEO of Ovid Therapeutics Inc., in today’s session on how COVID-19 will change biomedical R&D across the globe. 

The medical professionals on the panel had a fascinating conversation on the shortcomings of the US and Europe’s response to the pandemic and how at-home diagnostics and manufacturing is likely the key that made Asia’s response so swift and strong.

2. And that future pandemic could come sooner than we think. During this morning's town hall, Dr. Peter Marks, Director of FDA’s Centers for Biologics Evaluation and Research (CBER), talked about the agency’s COVID-19 priorities and how the pandemic will shape the new normal.

“At the end of the day, we better be putting things down in our pandemic playbook," said Dr. Marks. 

“Believe it or not, we have to be ready for the fact that a second wave could get worse,” he concluded. “If we want to do our jobs right, we have to think through all the possibilities here.”

Want more like this? Get Good Day BIO in your inbox every morning!

– Good Day BIO Editors

Thursday, June 11
11:50 PM
ICYMI: BIO's Dr. Michelle on NBC Nightly News

 

9:00 PM
Nature Biotechnology and Scientific American WORLDVIEW: Whiplash! How COVID-19 Will Radically Change Biomedical R&D Across the Globe

 

In this fascinating session with respected medical professionals, Andy Marshall, Chief Editor at Nature Biotechnology Journal navigates the multiplicity of issues facing the biotech industry in the wake of the pandemic and after it passes.

In discussion about what the world has already faced, Johnsee Lee, Founder and CEO of Personal Genomics, Inc. shared how Taiwan was able to contain the virus; suffering only seven deaths in a population of 23 million. After the SARS outbreak, they acted early, testing people since January, and immediately implemented lessons from the previous SARS outbreak.

Why did the US and Europe struggle so much?

“The US response to the pandemic has just been pathetic as opposed to Taiwan, as Johnsee reviewed, and several other countries that had just a fantastic performance,” said Eric Topol of Scripps Research Institute

Karen Hickman, a Global Health Division Senior Program Officer at the Bill & Melinda Gates Foundation mused that it might be because of the culture of taking healthcare systems for granted. However, she also spoke on the lack of at-home diagnostics capabilities for a number of infectious diseases. 

Why diagnostics matter

William Hait, a Global Head at Johnson & Johnson shared two comments on Heichman’s point about diagnostics, First, he made the economic argument: “We know the earlier you diagnose cancer, the better the outcome, and the differences in outcome are a huge cost saving; the same with infectious diseases.” Second, Johnson & Johnson created a diagnostics leg that they simply view as a cost of manufacturing, a business model other companies might seriously consider.

Of course, most pharmaceutical companies don’t have those types of resources, but that’s why small biotechs are so important. They have to have a “compelling case” and find those niche areas that will attract investors. 

But what are tools without policy and community structural change

As Jeremy Levin, BIO Chairman and CEO of Ovid Therapeutics Inc. pointed out, much of this conversation about diagnostics is moot without strong policy. “It really doesn't matter how good the diagnostics are, it really doesn’t matter how wonderful the digital is. At the end of the day, it will require that we have intent and a purpose and a set of mechanisms and policies that put this in place in the medical system that we have, otherwise we are going to revisit this again.”

Vicki Seyfert-Margolis, CEO & Founder of My Own Med talked a little bit about why lower-income and poor communities are hit harder by the pandemic and why the next phase of pandemic can’t happen without addressing it. “There's a number of different issues. One of them of course is access to healthcare, another is trust and cultural context. I think in the use of our digital technologies we can't overlook building trust and having the right people that are part of the interface and part of the communication strategy for the deployment of these tools. What we're seeing is that if you aren't working with people who are trusted in the community, who understand the culture of the community...You can't be successful. Even with the latest, greatest technologies.”

5:30 PM
Access to Personalized Medicine Drives Utilization of Genomic Tests and Targeted Therapies

Personalized medicine rests on the assumption that genomic profiling can aid in treatment management decisions, yielding both clinical value for patients and economic value for the system. However, genomic profiling technologies are relatively new and their integration into clinical care has been limited. 

The healthcare ecosystem needs to discuss and address barriers to access, coverage, and clinical implementation of genomic testing as well as examine opportunities in strategic partnerships between biopharma, data providers, and payers that can advance personalized medicine.

Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition, moderated a discussion on these topics with the following panelists:

  • Mandy Bazile, Director, Government Affairs, Public Policy & Reimbursement, Genentech

  • Erick Lin, Medical Director, Medical Affairs Lead, Blue Cross Blue Shield Association

  • Ammar Qadan, Bpharm, Vice President & Global Head of Market Access, Illumina Inc.

  • Daria Salyakina, PhD, Director, Personalized Medicine and Health Outcomes Research, Nicklaus Children’s Hospital

     

 

After providing the foundation of the discussion on patterns of use, coverage, and access to cancer, prenatal, and rare & undiagnosed disease genomic testing across the U.S., the panel took a deep dive into the issues. 

It’s important to have shared beliefs among collaborators. In an ideal world, the utilization of innovative genomic technologies should result in 1) improved outcomes, 2) reduced costs and 3) improved patient experience. 

Success that brings benefits for patients, innovators, and the healthcare system has incredible promise, but there must be evidence that it works. 

The discussion circled around the fundamental challenge for improving access issues for genomic technologies being the lack of evidence for the clinical utility of these technologies. Without that, it will continue to be an uphill battle for these incredibly exciting and innovative tools at our disposal. 

 

Overall Takeaway

Focusing on patient access and coverage of genomic testing utilization can reveal important implications for pharmaceutical, diagnostic, and data platform development, as well as market penetration.

- Jeremy Isenberg 

4:30 PM
Federal Economic Recovery Efforts for Small Biotechnology Companies

Have the federal assistance programs benefited small biotechs during the ongoing economic crisis? What can these small companies do if they need support?

Cameron Arterton, BIO’s VP of Tax Policy and Emerging Companies, sat down with a few experts to provide some timely advice to the small companies developing the big science we need right now. The panelists included:

  • Marc L. Belsky, CFO and Secretary of Kezar Life Sciences
  • Erin Estevez, Special Counsel of Cooley LLP
  • Justin Field, SVP of Government Affairs for NVCA

What programs are available for coronavirus-related assistance?

The government has created a lot of programs to help American business through the pandemic:

  1. Paycheck Protection Program for companies with fewer than 500 employees. This program allows for loans for up to 2.5x monthly payroll. The first eight weeks are forgivable, essentially turning the loan into a grant. After eight weeks, companies can apply for forgiveness.
  2. Mainstreet Lending Program provides a liquidity alternative for companies not eligible for the PPP loan. Companies with fewer than 15,000 employees or less than $5 billion in annual revenues. All loans are required to be repaid along with other restrictions.
  3. Employee retention credit for companies that did not receive a PPP loan. This refundable employment tax credit is for employers whose operations were disrupted due to orders from the government related to the pandemic or had a significant decline in gross receipts.
  4. Payroll tax deferral for companies that did not receive a PPP loan. This referral allows employers to defer the deposit and payment of the employer’s share of social security tax, with 50% of what is deferred due December 31, 2021, and the remainder due December 31, 2022.
  5. Unemployment insurance for furloughed workers. Furloughed employees who are eligible for unemployment may be eligible for an additional amount of unemployment for 2021 to pay for medical costs, too.
  6. Emergency leave employer credit. Eligible employees may take up to two weeks of emergency paid sick leave for qualified conditions related to coronavirus, up to a certain salary cap. It allows an employee to take up to 12 weeks for paid family medical leave due to conditions related to coronavirus, up to a certain salary cap.

Have small biotechs benefited?

Many companies have met requirements for financial assistance. Some simply cannot prove the loans are “necessary.” Smaller companies are now competing with larger companies for assistance. And many pre-revenue companies do not fit into loan categories, creating obstacles for small biotechs.

Many companies are finding it hard to plan a way to pay back Mainstreet Lending Program funds. Others burned through cash thinking they were guaranteed the PPP loan, but did not qualify. The panelists agreed the government must keep assistance simple.

However, some businesses have benefitted greatly from unemployment insurance for furloughed workers.

Pending legislation

Proposed legislation would change the PPP forgiveness provision to allow businesses with a 60% payroll cost and 40% operating cost eligible for loan forgiveness.

What else can be done?

  • Monetize R&D credits
  • Include the Orphan Drug Credit

And particularly for companies working on COVID-related activities:

  • Double R&D credits for U.S. venture capital startups in the biotech industry
  • Workplace indemnification – make companies not liable for COVID cases if they have shown a process of compliance with social distancing and sanitation requirements

– Cassie McKay

 

 

3:30 PM
Fireside Chat with Dr. Jeff Settleman, Pfizer's Chief Scientific Officer for Oncology Research and Development

Dr. Jeff Settleman leads all oncology research at Pfizer Inc., from the beginning stages of discovery to proof-of-concept clinical studies.

An internationally recognized leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, Dr. Settleman discussed the biggest challenges in cancer drug development and what’s in Pfizer’s cancer pipeline. He also provided some practical advice on the importance of partnerships and how biotech companies can effectively work from home during the pandemic.

The importance of external partnerships

“While our internal R&D engine is producing high-quality programs, the external biopharma enterprise is substantial and there’s plenty of innovative science being pursued,” he said.

“We’re always looking for the best science. We’re looking for high quality in programs. We’re looking for the most promising opportunities to find programs that have the potential to impact substantial patient populations, and to complement, again, our internal efforts,” with different approaches and new technologies.

Workplace and culture in the era of COVID-19

It’s not feasible to stay on top of all the science, so Dr. Settleman relies heavily on the leadership team to ensure they’re pursuing the best possible science—“while also recognizing that we can’t do everything.” Sometimes, you have to make difficult decisions when you prioritize resources.

R&D continues, even though COVID-19 is far from over, he added.

“These are interesting and challenging times for us, and it is especially important that we stay connected with each other.” In-person, daily interactions with colleagues are important, but it’s possible to maintain engagement and connectivity, with things like virtual meetings and town halls, video updates on the science, and twice-weekly virtual coffee chats with small groups of colleagues. Pfizer also has an internal website to post comments, photos, and videos to share experiences and tips, like working remotely or online educational tools for employees’ kids.

“We’re actually now connecting with each other in ways that are more personal,” which is somewhat of a silver lining.

The importance of mentorship

Mentorship is extremely important, especially in the biopharma industry, he said.

“We frequently fail, even with lots of really smart scientists working very hard on these problems because biology is extremely complex and still relatively poorly understood. In mentoring my colleagues, I emphasize the importance of scientific rigor and good decision making to improve our chances of success.”

“If we don’t keep the bar for rigor as high as possible our task becomes even more difficult.” And part of this includes knowing when to terminate projects, he said.

How do small biotechs know if they’re ready for Pfizer?

Good scientific thinking, strong execution, and substantial quality “is what it’s all about,” he said.

“We certainly recognize it when we see it.”

– Samantha Sault and Andrew Segerman

12:05 PM
Digital Health: Innovation Meets Regulation

Wearables, apps, sensors and smart tech products hold vast potential to transform the way sponsors develop medicines and positively impact patients. The excitement about deploying these tools in medicine is tempered, however, by the uncertainty in the regulatory environment. 

But, as Baku Patel with the U.S. Food and Drug Administration's Center for Devices and Radiological Health explains in a one-on-one chat with Genentech's Rasika Kalamegham, "the need for digital health is evolving." And as the need and technology advances, there must be a regulatory system that can allow innovation to thrive.

FDA's Center for Devices and Radiological Health Division of Digital Health may not serve as the regulatory body for these technologies, but the office is tasked with envisioning a system that will allow advancement to continue to evolve rapidly while ensuring safety.

"The problem we're trying to solve is, what does regulations 2.0 look like and how are we able to provide that high level of confidence in safety, effectiveness, efficacy, and at the same time not become the hurdle in the way."

Patel even pointed to the groundbreaking work being done at other federal agencies, including TSA's pre-check process, as an example of how evolutions in technology can be built into the regulatory framework.

In FDA's vision, a digital health app store complete with all necessary compliance information for each digital health product is ideal.

Overall, the agency believes that through "appropriate regulation" that is both beneficial to the company, consumers, and the government, a 21st-century framework will "drive to a level of excellence, instead of compliance."

- Connor McKoy

12:00 PM
Leading Through Crisis: Speaking Up and Out on Equity, Diversity, and Inclusion

On Memorial Day, the senseless death of another unarmed African American man touched off days of national protest against racism and police brutality. George Floyd's death also sparked an urgent debate in our country about the unequal treatment of Americans from communities of color.

BIO’s President and CEO Dr. Michelle McMurry-Heath led a first-of-its-kind discussion with Black CEOs of biotechnology companies and BIO leadership:

  • Dr. Tony Coles, CEO and Chair of the Board of Cerevel Therapeutics LLC
  • Dr. Ted Love, President and CEO of Global Blood Therapeutics 
  • Dr. Jeremy Levin, CEO of Ovid Therapeutics Inc. and Chair of the Board of BIO

They have a frank and honest conversation about what these events mean for society and our industry, how we can advance diversity in our companies and in clinical trials, and what’s really behind the disproportionate impact of COVID-19 on the African American community.

We encourage you to watch this conversation in full, so we’re making it available right away below:

 

You can also follow along at @DrMichelleBIO and #BIODigital.

11:00 AM
Patient-Centric 2.0: Are We Ready for Decentralized Trials?

The intersection of digital technology and the life sciences has been growing exponentially. As telehealth has seen rapid adoption during the COVID pandemic, the reality of this new clinical trial framework appears closer than it has ever been.

Rasika Kalamegham, Group Director of U.S. Regulatory Policy at Genentech leads the conversation on the promise and pitfalls of creating a new paradigm for designing clinical trials using digital applications. She spoke with:

  • Wade Ackerman, JD, Partner, Covington & Burling
  • Valerie Paradiz, PhD, VP of Services and Supports, Autism Speaks 
  • Isaac Rodriguez-Chavez, MHS,MSc,PhD,FDA

The panel represents the four important corners of drug development: a biotech company (Genentech), a regulatory agency (FDA), the law firm (Covington) and the patient (Autism). Each bring their own perspectives to explaining the many challenges and opportunities of growing beyond the traditional clinical trial—while not giving it up completely.

Valerie Paradiz of Autism Speaks, speaks from the perspective of being, herself, on the autism spectrum and explained why autism patients might be much more willing to participate if they were not required to go to a physical trial site. “I know that as a person with autism working as a professional in the field, that we need more options” she explained.

Decentralized clinical trials could add more patients to the trial because they are not required to go to travel to one site. Technology is used to communicate and have remote interaction with the participants. It is exciting and promising but is not without its pitfalls. Digital application requires both training and compliance on the part of the patient. 

As the FDA’s Isaac Rodriguez-Chavez noted in response to Kalamegham’s disclosure that she was often careless when it came to keeping up with her food intake app, “The reason why your electronic recording of your food intake failed is because you were not trained and you were not proficient in that technology and in decentralized clinical trials, it is vital that after participants are screened and selected, that the inclusion criteria also stipulates proficiency in the use of the technology, otherwise it is a futile exercise.”

The FDA is in the process of developing a new guidance on decentralized clinical trials. The agency recognized that these new ways of collecting clinical data and adding convenience to participants will ultimately advance drug development and the approval of new medicines. At the same time, FDA wants to ensure that the same safety standards and rigor of data quality and integrity are maintained. 

Resistance to change the way that clinical trials are conducted is both practical and stubborn. Wade Ackerman of Covington noted, “there is a tried and true pathway for doing clinical trials and does any one sponsor want to take the risk of having the FDA believe their data is not reliable?”

It seems inevitable that decentralized clinical trials may one day be a part of drug development. Integrity is key and when that is assured, they can become a reality.

- Theresa Brady 

 

9:00 AM
Bioethics Through the Lens of a Pandemic

The pace of a medical crisis can leave little time for consideration of ethical issues that underpin our healthcare system. 

Is “trying something” always better than “doing nothing?”

To try to figure it out, Kenneth Moch, Advisor of Cognition Therapeutics and Chimerix, leads a panel with US and international healthcare experts, including:

  • Paul Aliu, Global Head Medical Governance, Chief Medical Office at Novartis Pharma AG
  • Alison Bateman-House, Assistant Professor, Division of Medical Ethics at NYU School of Medicine
  • Arthur L. Caplan, Professor and Head of Division of Medical Ethics at the NYU School of Medicine
  • Dr. Joseph Kim, President, Chief Executive Officer and Director of Inovio Pharmaceuticals
  • Dr. Joanne Waldstreicher, Chief Medical Officer at Johnson & Johnson

“Ethics has moved front and center”

From enforced quarantines to wearing masks to scarce medical resources to research surrounding vaccines, we must consider ethics, said Caplan.

While we hope for a vaccine at warp speed, challenges and ethical hurdles like public trust, mandates, and clinical trials can arise, he explained.

"I have a moral obligation to try something"

Bateman-House looks at two areas: access to investigational medicines and clinical trials, and how to treat patients, looking at the moral obligation of how to treat patients when we don’t have an approved therapeutic or standard of care. 

She’s seen situations in which doctors knew they didn’t have validated evidence for a specific treatment, but believed they had a moral obligation to do something--even if their own institutions had policies against it. 

Daily during the COVID crisis, professionals are facing ethical discussions around trials, data, analysis, patients, protocols, and efficacy.

Follow the science, be transparent, and collaborate globally

Follow the science, said Aliu. It’s important to understand the science when discussing “compassionate use” requests outside the approved label. For example, science has guided Novartis on decisions about which studies to participate in.

Dr. Waldstreicher added the need to be transparent. Johnson & Johnson created a bioethical framework specific to COVID-19 in the face of an unproven benefit – “a bioethical framework on how to allocate our supply in the face of no proven efficacy and safety, but only in the face of either biologic hypotheses or in vitro data.”

Dr. Kim emphasized the need to collaborate globally and prioritize vaccine research. Inovio is prioritizing its candidate COVID vaccine research while also prioritizing patient safety versus speed and urgency.

Learn more about Inovio’s vaccine:

INOVIO beyond imagination

Continue the conversation

  • As COVID develops and bioethics heighten, it’s important to continue conversations surrounding:
  • The need to bolster the peer review system.
  • Transparency around potential conflicts of interest.
  • Vaccine distribution.
  • The need to develop communicators who can present information to the public.
  • The role of public health to help make decisions about vaccine distribution for different population groups.
  • The need to let science lead.
  • Exploring opportunities for partnerships and collaboration.
  • Not cutting corners in vaccine development – “If you cut corners you hit walls”.
  • The crisis of public trust.
  • Equity in access and who is involved in research.
  • How to justify work on COVID-19 to other patient groups. 

During the Q&A, Bateman-House shared this resource on how to prepare potential COVID-19 study participants.

8:00 AM
Biotechnology in the Time of COVID-19: Commentaries from the Front Line
Biotechnology in the Time of COVID-19 – Free on Amazon Kindle

Are you looking for your next summer read?

Edited by Dr. Jeremy Levin, BIO's Chair and CEO of Ovid Therapeutics, Biotechnology in the Time of COVID-19: Commentaries from the Front Line (Rosetta Books) is a collection of 47 essays by industry thought leaders, including many of BIO's leaders.

Through the end of the week, the book is available to download for free on Amazon Kindle!

Check out a few excerpts on STAT News:

A pandemic, a funeral, and a chance to help heal the world by Dr. Michelle McMurry-Heath, President and CEO of BIO

What being stricken with Covid-19 taught a biotech CEO by Cedric François, CEO of Apellis

 

6:00 AM
FDA Town Hall

We're here bright and early for the U.S. Food and Drug Administration (FDA) town hall, focusing on the agency's COVID-19 priorities and how the pandemic will shape the new normal.

Alkermes, Inc. Chairman and CEO Richard Pops is spending the morning chatting with Dr. Peter Marks, Director of the Centers for Biologics Evaluation and Research (CBER), and Dr. Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER).

(Yes, that's a lot of Peters and acronyms, but we'll try to avoid confusion!)

 

They started by talking about the "restructuring" at FDA; read more about that in STAT News if you need to catch up.

Status of COVID-19 diagnostics

There has been a "heavy burden of work coming in" on diagnostic tests, said Dr. Marks. But we are starting to have antibody and diagnostic tests that people are confident in.

Status of COVID-19 therapeutics and vaccines 

CDER is working towards a “cohesive approach” on trials, said Dr. Stein, working with NIH, academics, and industry to make “tremendous progress in terms of developing strategies.”

“In a short period of time, a number of trials are moving towards development and even the execution phase,” he continued.

CDER is focusing on “drugs that are most readily available now, which are repurposed drugs” as well as rapidly developing trial capacity for monoclonal antibodies, then identifying the next drugs that are most promising.

“What we’ve been trying to do is make sure we have an organized approach in how we are managing the huge increase in submissions.” They have created a pathway to “triage” and distribute work across divisions within the Office of New Drugs.

The centers are trying to stay aligned so there’s consistency, added Dr. Marks.
“We’re trying to be very fair about how we prioritize things, not favoring one sponsor over another,” but of course, certain drugs “rise to the top.”

 

How does FDA prioritize which products to review first?

"This is really about being a good portfolio manager," said Dr. Marks. "We need to make sure what’s coming up front and what's very urgent gets taken care of, while keeping an eye on the fact that there are some things that may take longer to get there that may turn out to be very important products."

"You just can't dismiss things" based on where they are in development right now, because they may be very important later. 

"We intend to be as broad was we can," added Dr. Stein, to find compounds that might have potential and move quickly if they are effective.

The importance of combinations

For therapeutics, combinations will need to be considered thoughtfully, said Dr. Stein.

The pandemic has led to greater efficiencies

FDA's virtual work environment "has worked out surprisingly well," said Dr. Stein. The agency has had large weekly staff meetings and figured out best practices across the organization.

Industry meetings have gone smoothly as well, he said.

Dr. Marks said they've been able to "shave months off" guidance practices.

"Paradoxically, some of the guidance that we’ve gotten out during this crisis is better guidance. It’s concise, it’s clear, it’s to the point, it contains the scientific information that it needs to. It’s better than guidance that we spent months to years getting out," added Dr. Marks.

"We shouldn’t be as scared of that, because industry likes guidance," he continued. "Maybe isn’t so bad if we streamline how we do it.”

However, the speed may not be sustainable, he said, unless they add staff.

"The per-unit output of staff" has increased 20-30% as they work from home. 

"We can't continue this for the long haul."

We have to learn from this pandemic

“At the end of the day we better be putting down things in our pandemic playbook," said Dr. Marks. "Some of these are things we should have known, but some of them are things that are just unanticipated because of the enormity of this."

“Right now, at least as a regulator, what keeps me up at night…the journey has only really begun.”

“I’m very aware of the fact that we have a long way to go here, and at FDA, part of what we have to do now is we can’t get complacent.”

“Believe it or not, we have to be ready for the fact that a second wave could get worse,” he concluded. “If we want to do our jobs right, we have to think through all the possibilities here.”

– Samantha Sault

5:30 AM
Day 4 of the BIO Digital Live Blog
BIO Digital Program Highlights

It's the last day of BIO Digital, and we're starting bright and early today! Here's what we'll cover here on the blog:

9 AM ET/6 AM PT – FDA Town Hall

10 AM ET/7 AM PT – Bioethics Through the Lens of a Pandemic 

1 PM ET/10 AM PT – Patient-Centric 2.0: Are We Ready for De-Centralized Trials? (Sponsored by Genentech)

2 PM ET/11 AM PT – Digital Health: Innovation Meets Regulation 

3 PM ET/12 PM PT – Leading Through the Crisis: Speaking Up and Out on Equity, Diversity and Inclusion Issues 

4 PM ET/1 PM PT – Protecting Our Long-Term Commitment to Care in a Post-Pandemic World (Sponsored by Sanofi)

6:30 PM ET/3:30 PM PT – Fireside Chat with Dr. Jeff Settleman, Chief Scientific Officer for Oncology R&D, Pfizer Inc. (Sponsored by Pfizer Inc.)

6:30 PM ET/3:30 PM PT – Federal Economic Recovery Efforts for Small Biotech Companies 

7:30 PM ET/4:30 PM PT – Access to Personalized Medicine Drives Utilization of Genomic Tests and Targeted Therapies (Sponsored by Genentech)

7:30 PM ET/4:30 PM PT – Nature Biotechnology and Scientific American WORLDVIEW: Whiplash! How COVID-19 Will Radically Change Biomedical R&D Across the Globe

4:50 AM
ICYMI: BIO's Dr. Michelle on Yahoo! Finance

 

1:00 AM
What We Learned on Day 3 of BIO Digital

The big takeaway? You can say goodbye to business as usual.

1. COVID-19 has changed how we do science. Okay, technically, this happened at the end of the day yesterday—but it’s still important to note.

“We do think the pandemic has changed how we do our science. So, when you’re in quarantine, self-isolation, staying at home for an extended period of time, it allows all of us to reflect on what matters most,” said Sharon Chan, Head of JLABS @ Shanghai, Johnson & Johnson Innovation

“It emphasizes the need for collaboration,” she continued. “We’ve always said no single company has a monopoly on innovation—and no single company can do it alone. We need partners.”

2. The pandemic has accelerated the use of digital technology in health care. During a panel sponsored by Merck, patient advocates spoke about how telehealth has broadened access to medical care, including clinical trials, which Nicholas Brooke, Executive Director of Patient Focused Medicines Development, said he hopes will become the norm rather than the exception. 

In a fireside chat with BioCentury, Dr. Mathai Mammen, Global Head of R&D for Janssen Pharmaceutical Companies of Johnson & Johnson, talked in more detail about how technology has transformed trials by allowing opportunities for remote evidence collection via video or home health visits, home delivery of medication, and iPad-based monitoring. 

The industry would’ve ended up there eventually, he said, but COVID-19 “kicked us into high gear” and got us there quickly.

3. We can’t forget mental health care. COVID-19 has exacerbated mental health challenges—especially for health care workers, as Michelle Williams, Dean of the Faculty at Harvard T.H. Chan School of Public Health and Harvard Kennedy School explained. 

“The pandemic has shined a bright light on a pre-existing burden of mental illness that exists across the globe,” she said. “Front line health care workers are particularly at high risk, largely because of the massive amount of physical and emotional strain that they are under as they move forward to help protect the population from this evolving pandemic.” 

4. The bottom line: say goodbye to business as usual. In a fireside chat with Meg Tirrell, CNBC Senior Health and Science Reporter, Pfizer’s Chief Business Officer John Young said, “When the scale of the pandemic really became apparent, we saw that this is not business as usual. We realized this is not a time to think about a typical ROI or how we would prioritize our R&D investments in a way that would bring the greatest/biggest return in capital. Frankly, the world needs a number of safe and effective vaccines and certainly effective treatments for patients who contract the virus.”

Pfizer’s primary concern has been speed, but they’re also in active conversations around pricing efficiencies and how to help patients pay their co-pays.

Want more like this? Get Good Day BIO in your inbox every morning!

– Good Day BIO Editors

Wednesday, June 10
4:30 PM
Diversity and Inclusion in Biotech’s Explosion

There is a growing appreciation and recognition in the biotech industry that diversity and inclusion are important. It is equally important to go beyond talking and start doing.

Editor of FierceBiotech Amirah Al Idrus moderates a panel discussion exploring how to take that next step. She spoke with:

  • Paul Hastings, CEO of Nkarta Therapeutics and BIO's Vice Chair
  • Ramsey Johnson, VP Operations Phoenix Tissue Repair and Chair of “Out BIO” 
  • Helen Torley, CEO of Halozyme and Chair of BIO’s WDDI Committee
  • Sharon Labreche, VP of Talent Acquisition for Alnylam

Perception vs. Reality

Helen Torley says that there is a perception at the highest levels in companies that their company does focus on diversity and inclusion. However, at the manager level, that perception erodes.

A recent study showed that while at least 70% of executives thought they had a diverse and inclusive culture where people could speak their minds, employees were only at 36%.

“It’s not as easy as you think to create a culture of diversity and inclusion,” Torey said. “CEOs think they have it, but they don’t. It takes dedication and practice to create an environment that attracts diverse candidates but also keeps them.”

Ramsey Johnson echoed Torley’s thoughts. “Often CEOs believe that because they have some diversity on their boards, they are diverse and that it’s translated down through the organization but that isn’t necessarily always the case. Most don’t even realize that they could do more,” he said.

Inclusion is key.

Diversity, alone, is not enough to make an impactful change within an organization. Inclusion is key to that change. People need to feel that what they say will be heard, even if it goes against the grain.

“As a CEO of an organization, if you go to all the trouble and time to have a diverse board and management team but the communication is only top down and not really allow project teams or others in the organization to have a say, then you’ve got a diverse executive team but not an inclusive environment. It takes time, attention and effort to make sure this doesn’t happen,” says Paul Hastings.

The bottom line? It has to come from the top.

The commitment and the work to make people feel included is something that has to come from the top or the goal to be a diverse organization will never happen.

- Theresa Brady

 

3:25 PM
Fireside Chat with FDA Commissioner Dr. Stephen M. Hahn

Cartier Esham, EVP of Emerging Companies at BIO spoke with FDA Commissioner Dr. Stephen M. Hahn to discuss collaboration and COVID-19 response efforts. 

“There is an extraordinary amount of collaboration, scientific endeavors, and work happening in the medical research community with patient organizations, doctors, clinicians, government, biopharmaceutical companies, all resulting in over 500 unique compounds under development working to bring forward vaccines and treatments for COVID,” said Esham to start the discussion.

And Dr. Hahn agrees: “There’s no question. This is unprecedented. I know we use that term a lot but what’s been remarkable about this is the speed with which this pandemic came upon us and the significant number of unknowns, but how remarkable the response has been from the biopharma community in collaboration with regulators and the FDA." 

"It shows what we can do and really is a roadmap for some of the things we can do together moving forward in a non-COVID environment," he continued. 

On the development of therapeutics, Dr. Hahn touches on the FDA’s expedited approval process and efforts to prioritize science-based solutions with a “rolling” approach.

“We engaged early with developers and manufacturers, and did a serial process of exchange of information so that when the final application came in, there had been already a lot of input [allowing us to] easily, readily, and quickly look at that application and make decisions.” 

 

To meet the demands of a pandemic like COVID-19, public-private partnerships are important.

“It’s been truly an all-of-America approach,” said Dr. Hahn.

“There has been incredible alignment, collaboration, and cooperation among...the private sector. This is usually a very competitive environment but what I’ve seen is a really significant lean-in of industry to work together in sharing information."

Post-COVID clinical development will be “very different.”

We should consider domestic manufacturing for medical products, said Dr. Hahn. To do that, “we must understand what the supply chain looks like, and we can only do that by working hand-in-glove with industry.”

Dr. Hahn also calls attention to the effect COVID-19 has on existing clinical trials. “We can do all the regulatory flexibility we want in the middle or backend, but if we can’t get the clinical trials done because we don’t have the flexibility around how those visits occur, we’re not going to be able to move things forward.”

The takeaway: trust the expertise and approach the FDA has used in the past.

There is an enormous amount of pressure to operate in this new territory, bringing many changes and developed process. Dr. Hahn emphasized the FDA “will continue to prioritize data and science.”

– Cassie McKay and Andrew Segerman

2:30 PM
Nothing Stops Innovation

Seema Kumar, President of Innovation and Global Health & Policy Communication at Johnson & Johnson Innovation sat down with Anvita Gupta, CEO of AINovo Biotech Inc. and 2020 BioGENEius Hall of Fame Awardee and the 2020 Bio Genius Finalists to discuss the BioGENEius program and how students have adapted to COVID-19.

 

Inspiring young women to pursue science

Anvita Gupta, CEO and Founder of LITAS For Girls, believes in the “social good” of the industry and aspires to bridge the gap of women within the higher levels of science and technology. As she watched her female classmates drop out and give up on science, she started litas4girls.org in the 10th grade to inspire girls to pursue science through the leadership of strong female role models and the idea that computer science can have a huge impact on the world. This led Anvita to the creation of her company, AINovo Biotech Inc. 

Champions in science

"You need to have champions in science who are committed to the truth and not just swaying people one way or the other," Anvita said. "I think it’s great that scientists like Dr. Anthony Fauci have become so well-known because people really find scientists to be a source of comfort in these times. In a world with so much uncertainty, decomposing everything to the scientific method and applying those skills help you gain control and helps students feel better about the world.”

COVID through the eyes of youth

BioGENEius 2020 finalists explained the challenging and uncharted territory of COVID-19. These young scientists believe COVID has taken a large role in student life and research. Although social isolation and social distancing remain obstacles to learning and connection, communication hasn’t stopped, but it is very different than before.

The positive side of quarantine has allowed these finalists more free time for self-discovery and development of entrepreneurship. Many students have formed study groups and established other avenues of learning to stay focused. Some students have proposed technologies such as virtual reality to help students catch up.

Advice from an industry leader

Johnson & Johnson Innovation leader Seema Kumar gave the young scientists several pieces of advice:

  • Realize the need for our society to be one of health rather than sickness and think about how we can transform the health industry to focus on preventive measures and diagnoses.
  • “Button up” on subject matter expertise.
  • Reword your purpose from “in five years I want to" to “in five Years I want to cure/discover/solve."
  • Market and partner with someone who does not have competition.
  • Combine forces within the industry to create something powerful

- Cassie McKay and Molly McNulty

2:00 PM
Fireside Chat with John Young, Pfizer's Group President and Chief Business Officer

Meg Tirrell, Senior Health & Science Reporter for CNBC sat down with John Young, Group President and Chief Business Officer of Pfizer to talk about Pfizer’s strategy in the race to a COVID-19 vaccine, what they are doing to manage supply, and how they are responding to social issues.

Pfizer is refocusing its approach to biotechnology around data and science.

One of the ways the company has worked to expand its toolbox is to partner with like-minded companies, putting great minds together and expediting the process of creating revolutionary biotechnology.

 

One of the significant partnerships Pfizer has established is its relationship with BioNTech.

The teams at Pfizer and BioNTech have spent about two and a half years researching messenger RNA (mRNA) technology and how it can expedite vaccine development. Traditional vaccine technology takes a long time to develop so the biotech industry has found it difficult to create a strong and focused vaccine to defeat a fast-moving and mutating flu virus.

The focus on mRNA technology is based around its ability to significantly speed up the process of vaccine development.

Luckily, Pfizer and BioNTech had already completed work on the mRNA process of developing a vaccine construct that can adapt quickly once COVID became a threat.

Once COVID-19 became a global pandemic, Pfizer pivoted all company operations toward developing an effective vaccine and supply chain to manufacture at a critical scale. Pfizer is independently funding its vaccine development and will not receive government financial assistance, as the company believes this may slow down development.

Pfizer's primary concern has been speed, but they know drug pricing is something it must also address and are in active conversations around pricing efficiencies and the ability for pharmaceuticals to help patients pay their co-pays.

While our world battles a global pandemic, many social issues also are at the forefront of Pfizer’s focus. Pfizer believes they have a responsibility to address current issues of institutional racism and understands it has a significant role to play as an advocate of change for those affected by COVID-19 and who feel unsafe while battling racial bias.

– Cassie McKay and Cornelia Poku

1:05 PM
How COVID-19 Has Impacted the Global Psyche

Lockdown and isolation, fear, economic turmoil. COVID-19 is placing significant stress on mental health for people around the world.

Seema Kumar, Vice President of Innovation, Global Health and Policy Communication at Johnson & Johnson Innovation, is here to talk about it, with the following panelists:

The World Health Organization identified mental illness as the most disabling illnesses in the Western world. And the World Economic Forum says mental illness as the costliest disease, hitting individuals when they’re relatively young with life-long illnesses.

“We entered the epidemic against a backdrop of a mental health crisis that already exists globally,” said Dr. Manji.

We continue to learn more every day about COVID-19, including whether there’s a direct brain effect of the coronavirus and the potential for some of the immune responses of the virus to trigger or worsen depression. When you consider some of the key psycho-social stressors like acute and prolonged distress, loss of a loved one, economic distress, and social isolation, this pandemic has undoubtedly affected mental health.

 

Health care workers are at high risk of mental health challenges

“Front line health care workers are particularly at high risk, largely because of the massive amount of physical and emotional strain that they are under as they move forward to help protect the population from this evolving pandemic,” said Williams.

Burnout for health care workers in the US was a big issue even before COVID-19. We were losing an equivalent of seven graduating classes of medical-trained doctors per year.

And the pandemic has only heightened the problem. Stress about lack of personal protective equipment, treating infected colleagues, and fears about infecting one’s family have manifested in anxiety, stress, and PTSD-like symptoms for frontline health workers. Reducing stigmas and barriers for them to take care of their own mental health is critical.

Companies should invest in mental health care

Staglin spoke about “neuro diversity celebration” and the role companies play in supporting their employees. The pandemic has likely affected everyone’s “brain health” due to uncertainty, anxiety, and social distancing.

A Tufts University study found that for every dollar invested in workplace mental health, companies will get $3-5 in return from reduced absenteeism, higher productivity, improved morale, ability to thrive, and less self-medicating.

Is there a silver lining to the pandemic?

It might be compassion. We need to increase awareness to care for those who need support to ensure the mental health effects of COVID-19 don’t outlast the virus.

And now may be the time.

“We’ve never seen more openness, more opportunity for people to talk about this and the understanding that this is a physical condition. It’s chemicals, not character,” Staglin concluded.

 

This session was sponsored by Johnson & Johnson.

– Nicole Chardavoyne

11:00 AM
Fireside Chat with Dr. Mathai Mammen, Global Head of R&D for Janssen Pharmaceutical Companies of Johnson & Johnson

BioCentury VP and Editor in Chief Simone Fishburn is leading a conversation with Mathai Mammen, MD, PhD, Global Head, Research and Development at Janssen Pharmaceutical Companies of Johnson & Johnson about R&D in the age of COVID-19.

The COVID R&D Consortium

Right away, heads of R&D across the industry were doing "gut checks" with one another, to see what they were doing about the pandemic, forming the COVID R&D Consortium to share information. (Read more about it in BioCentury.)

"Any action we took, or any inaction, would be remembered," he said. The industry moved quickly to see what they could do about therapeutics, focusing first on "molecules that existed already."

Data and information was freely shared between these companies in an inclusive way, he said. 

"I'm hoping much of the spirit does stick," after COVID he said, but there are legal issues.

"None of us are really going to make a dime off these products" for COVID and they're not excluding any parties, so there's less of an issue at the moment.

After COVID, we have to "make sure that we're doing this in a way that's all proper."

Pooling information about the history of the disease is most important, he continued.

Dr. Mathai Mammen of Janssen

What kinds of IP should companies protect?

Anything to do with "composition of matter" should be protected and not just shared.

"That's part of the competitive advantage that makes the entire system healthy." 

The pandemic is accelerating digital tech in health care

Patients have a lot of fear about going to clinics, so we're quickly pivoting to remote evidence collection, through video or home health visits, home delivery of medication, iPad-based monitoring, etc. This is an area that could get a lot of attention.

We figured this out in a matter of weeks, he said. We would've ended up there eventually, but COVID-19 "kicked us into high gear" and got us there quickly.

How will the industry "reboot" after COVID-19 plays out?

Watch what he said:

 

How do we incentivize preparedness?

The government invests in preparing for a meteor, but not a pandemic, he said. Here's what we need to do:

 

– Samantha Sault

10:00 AM
Global Patient Advocacy in the COVID Era

The biopharma industry and patient advocacy groups have collaborated with a lot of success in recent years—but COVID-19 is making everything more complex.

Dr. Julie Gerberding, former CDC Director turned EVP and Chief Patient Officer at Merck & Co. Inc., is leading a panel on how to continue successful biopharma-patient collaboration, especially when so many things are going digital now.

She's speaking with three powerful patient advocates:

  • Nicholas Brooke, Executive Director at Patient Focused Medicines Development
  • Ratna Devi, Chair at International Alliance of Patient Organizations
  • Eva Maria Ruiz de Castilla, Latin America Patient Academy

How are they continuing their work during the pandemic? What do they hope to do with the biopharmaceutical industry in the “new normal”? How are we going to pull organizations and patients out of this emergency? Let’s find out.

Merck's Dr. Julie Gerberding
Patient Advocacy in the COVID Era

How are patient groups coming together during COVID-19?

"Patient organizations have joined forces," said Dr. Devi. COVID has unified organizations across verticals or therapies, to share resources, contacts, even transportation.

The importance of telehealth

The pandemic is forcing the industry to start implementing telemedicine. Brooke is hopeful the industry will be able to capitalize on what we’ve learned in recent months and make telehealth more of the norm instead of the exception.

COVID-19 affects everything, from trials to costs

Even if there are enough people willing and meeting the criteria for COVID-19 trials, it's usually health care providers who make the final call on trials, said Dr. Devi. Patients need more information about the trials and especially why they were rejected from trials.

Brooke said they are developing a global system to distribute information about trials. Trials are out there, but access is a big challenge.

The cost of care has gone up primarily due to the cost of PPE, Dr. Devi added. "We understand the PPE is very important," but patients should not bear the entire burden.

How can the industry better support patient advocacy groups?

We need more coordination, said Brooke. 

We need to go faster, said Ruiz de Castilla. We need to get patients' the right information, on time. 

It's also important to improve basic digital literacy, said Dr. Devi. The industry could invest in large coalitions to share resources, and country-level repositories of information that are easy to access.

We need to address health disparities, including in the United States

"Access to medicine broadly is a huge and growing challenge," said Dr. Gerberding.

But we also see motivation for "transformational innovation," she added. COVID-19 presents an opportunity for biopharma and patient advocates to really help.

So, how do we use the crisis to accelerate transformation?

We need to design care from the patient perspective, said Brooke. 

8:20 AM
ICYMI: BIO Digital and Dr. Fauci on The Today Show

 

8:10 AM
Day 3 of the BIO Digital Live Blog
Fireside Chat with Dr. Mathai Mammen of Janssen

We're gearing up for Day 3, with a couple not-to-be-missed fireside chats among the sessions in our lineup. Here's what we'll be covering:

1 PM ET/10 AM PT – Global Patient Advocacy in the COVID Era: What Is the Future of Patient Advocacy Around the World? (Sponsored by Merck & Co. Inc.)

2 PM ET/11 AM PT – Fireside Chat with Dr. Mathai Mammen, Global Head of R&D, Janssen Pharmaceutical Companies of Johnson & Johnson

4 PM ET/1 PM PT – Fireside Chat with John Young, Group President, Chief Business Officer, Pfizer Inc.

4 PM ET/1 PM PT – How COVID-19 Has Impacted the Global Psyche (Sponsored by Johnson & Johnson)

5:30 PM ET/2:30 PM PT – Nothing Stops Innovation 

6:30 PM ET/3:30 PM PT – Fireside Chat with FDA Commissioner Dr. Stephen M. Hahn

7:30 PM ET/4:30 PM PT – Diversity & Inclusion in Biotech's Explosion: ERG and Non-Profit Perspectives

And don't forget to follow along at #BIODigital on Twitter!

2:00 AM
What We Learned on Day 2 of BIO Digital

1. In the vaccine race, there won’t be just one winner. “The idea isn’t to pick a winner; it’s to have multiple shots on goal,” said Dr. Mark McClellan, Director of the Duke Margolis Center for Health Policy.

“Everyone will need to work together,” added Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research. “This is really a global issue where we're all connected.” 

Dr. Fauci likewise said he expects “more than one winner” in both vaccines and therapeutics.

2. The pandemic has shown just how interconnected global biotech R&D has become. During the international plenary, Amgen's Christophe Bourdon pointed out the importance of investing in science before a second outbreak occurs: “We know it’s going to come, and we cannot be taken by surprise.” 

“Science is a global enterprise and we need to bring together the best and brightest minds, wherever they are, across borders and across sectors,” echoed the National Academy of Medicine’s Dr. Margaret Hamburg during the vaccine plenary.

3. But we have to think about the vaccine supply chain, too. During the third and final part of the vaccine plenary, panelists said scaling up manufacturing is equally important as developing the science. In fact, Moderna is already investing in manufacturing space, equipment, and raw materials.

If investing in manufacturing now before we have an approved vaccine saves even two weeks in delivering an eventual vaccine, we’ll save even more in terms of human lives and the economy, added CEPI’s Dr. Richard Hatchett.

4. Everything we do now will help us prepare for the next pandemic. "Developing a safe and effective vaccine in a global pandemic is a daunting challenge," said John Markels, President, Global Vaccines at Merck, while discussing his company’s experience with Ebola. "We need to be better prepared in the future, and I do think all the things we're doing now will put us in a better position.”

Want more like this? Get Good Day BIO in your inbox every morning!

– Good Day BIO Editors

Tuesday, June 9
4:45 PM
Fireside Chat with Dave Ricks, Chairman and CEO of Eli Lilly

How is COVID-19 affecting the biopharmaceutical industry? What exciting products does Eli Lilly have in the pipeline? 

For one thing, Eli Lilly dosed the very first patients with the very first therapeutic developed specifically for COVID-19, a drug they developed in just three months.

In this fireside chat, Dave Ricks, Eli Lilly's Chairman and CEO, talked about COVID-19 and the outlook for biotech with Margaret Anderson, Managing Director at Deloitte Consulting LLP.

This is just one example of how COVID-19 is going to completely change the industry.

"The time scale here has been totally collapsed," he said. "Anything that is more than five months is no longer as good as we can be.

Here's what he had to say about the outlook for the industry.

Remember this moment

"If I had one wish for my company, BIO, and the industry, it's that we can all remember what it feels like right now to work in this industry that’s essential for the world," said Ricks. 

"I think we kind of lose that at times and i think when we have that, it creates clarity but also so much positive-forward energy."

Time is currency

“Time is the currency of our industry. Our patients who rely on us for chronic medicine or an acute one like for COVID-19 are all up against the clock," Ricks continued.

"It’s such an important variable for all that we do.” 

This session was sponsored by Eli Lilly.

– Andrew Segerman

4:30 PM
How an Innovation Ecosystem Enables Growth During Times of Crisis and Beyond

Toshio Fujimoto, MBA, MD, General Manager of Shonan Health Innovation Park, Takeda Pharmaceutical Company Ltd., led this discussion looking at innovation ecosystems, including what makes them successful and, more broadly, what the future of biotech innovation looks like. The first mixed-model science park, Shonan iPark is a dynamic community of nearly 100 companies and 2,000 residents/innovators, including big companies and startups, academia and government.

Speakers included:

  • Sharon Chan, MBA, MPH, D. Phil, Head JLABS @ Shanghai, Johnson & Johnson Innovation
  • Rajeev Dutt, President, CEO, and Co-Founder of AI Dynamics Inc.
  • Susie Harborth, Chief Financial Officer and Administrative Partner, Mission BioCapital
  • Maggie O'Toole, Chief Operating Officer, Executive Vice President, LabCentral
  • Dr. Mary Walshok, Associate Vice Chancellor for Public Programs and Dean of Extension at the University of California, San Diego
  • Dr. Andrew McKee, CEO and President, Headland Strategy Group

 

What makes a successful incubator?

According to Dr. Walshok, incubators must be characterized by:

  1. Openness, a willingness to talk about failures as well as successes.
  2. Talent.
  3. Diversity of ideas and solutions. This includes rewarding performance.

Dr. Sharon Chan discusses the success at JLABS @ Shanghai - a no strings attached incubator where over 70% of the residents are first-time entrepreneurs. The goal of JLABS is the discovery and advancement of the best science in the world so that innovators can deliver to patients.

Current biotech industry trends

Dr. McKee notes the level of disruption COVID-19 has had on biopharma companies:

  1. Companies that already had vaccine experience are able to marshal resources quickly to focus on COVID.
  2. Companies with less-active infectious disease activity, but may have had immunological asset, will adapt ongoing business while contributing to COVID.
  3. Small to medium companies outside infectious diseases are the most stressed.
  4. Companies with less than a year of cash runaway are the most challenged and viewed as a risky investment.

Susie Harborth says the pandemic has changed science and put an emphasis on the need to collaborate. 

Rajeev Dutt discusses one of the problems AI is trying to solve - the timeline of the drug discovery process. “One of the problems that we are trying to solve is the fact that drug discovery currently takes about $2.5 billion over 12 years on average.  One of our central premises – and this is something shared by a number of pharmaceutical companies around the world – is that discovery of new drugs and therapeutics will be driven by AI,” he says. 

Susie Harborth says the companies that have been able to adapt to the work from home environment will be the ones that will move into the future and work in a "seamlessly virtual environment." 

4:25 PM
Advancing Rare Disease Diagnosis and Drug Development Through Partnership

Did you know that, in 2019, just under half (44%) of new FDA approvals went to orphan drugs?

The biotech ecosystem is clearly moving toward the development of novel orphan drugs to treat rare diseases, and there remains clear unmet need; 90% of the 30 million Americans living with rare diseases are still without a designated treatment.

BIO’s own Danielle Friend moderated an excellent panel with:

  • Gregory DiRusso, MD, Vice President, Medicine Team Lead, Hemophilia, Pfizer
  • Robert Iannone, MD, Executive Vice President, Research and Development, Jazz Pharmaceuticals
  • Ted Love, MD, President & Chief Executive Officer, Global Blood Therapeutics
  • Sara Nayeem, MD, Partner, New Enterprise Associates (NEA)

     

The most important elements when trying to find an R&D partner

Dr. Ted Love, CEO at Global Blood Therapeutics succinctly summarized three principles when evaluating partnership opportunities: 1) financial capability to provide capital 2) strategic advantage, particularly in a specific therapeutic area, for development or commercialization 3) tackling problems at scale.

Overcoming challenges with external partnerships

Dr. Sara Nayeem pointed to the challenges of meeting milestones and aligning on a time frame when moving a project forward. While approaches may vary, communication is critical as obstacles are encountered along the way.

The role of patient organizations in the context of partnering for rare diseases

Relationships with patient advocacy organizations are critical in the rare disease space. Companies benefit from collaborating with these organizations to establish desirable clinical outcomes for that patient population. Companies are increasingly hiring staff specifically devoted to engagement with patient organizations.

Best practices for engaging with patient organizations

“I would say early and often,” Jazz Pharmaceutical’s Robert Iannone noted.

How partnerships have changed given the pandemic

The formation of new partnerships has been difficult given the pandemic, but that hasn’t completely ceased the work that is being done. Gregory DiRusso highlighted Pfizer’s focus on working with regional guidelines in moving forward or pausing clinical trials. He also pointed out that for many clinical trials, direct data capture allows patients to circumvent appearing at sites to report making it easy for trials to continue in an era of social distancing.   

Overall Takeaway

The sharing of expertise and capabilities between internal R&D teams and external partners plays a vital role in advancing rare disease diagnosis and drug development more quickly, efficiently, and effectively – and remains a cornerstone of the industry.

This session was sponsored by Jazz Pharmaceuticals

-Jeremy Isenberg

2:50 PM
Fireside Chat: Rep. Jim Greenwood and Dr. Michelle McMurry-Heath

We say hello to an incredible new President and CEO, Dr. Michelle McMurry-Heath, but also say goodbye to another: Rep. Jim Greenwood, who led BIO for 15 years. The two sat down for a chat about what's next for the industry, and for Jim.

Fireside Chat with Rep. Jim Greenwood and Dr. Michelle McMurry-Heath

 

“I do think we’re at an inflection point. You can always say that the science is getting better—that’s the nature of science, it builds upon itself," he said.

"But where we’re at now, with cell therapy, and gene therapy, immunoncology, and all that’s coming forward through gene editing opportunities, I think the pace is going to pick up – unless the politicians mess things up.”

"We're at a low point for how we're perceived," but we'll overcome that.

Fun fact: Jim loves birds.

He started birdwatching in college, and he's a board member of the National Audubon Society!

And in his next chapter, he'll focus on climate change.

“I think climate change is dire," he said.

"It’s an existential threat to the planet. Few things are: nuclear war, climate change, a horrible pandemic, far worse than this one. But climate change trumps them all, in my opinion, because it goes to the issue of inhabitability of the planet, not only by all of the species but by our species, so that’s what I want to focus on.”

"We can solve this problem, but only if the US leads," he said. 

But we won't lead if there are too many climate deniers in Congress.

He's created a Super Pac, Fight for Earth.

"We have to have a movement," he said. 

The science is clear. Climate change will destroy the economy, and the economic opportunities to confront it 

– Good Day BIO Editors

1:30 PM
Realizing the Promise of Gene Therapies for Patients Around the World: A Year of Progress

The gene therapy industry has seen a lot of momentum, bolstered by recent Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals.

Bob Smith, Senior Vice President, Global Gene Therapy Business, Rare Disease, Global Innovation Pharma at Pfizer, Inc., led a discussion about the future of gene therapy, and how COVID-19 has affected it.

Dr. Peter Marks, Director of the FDA’s Centers for Biologics Evaluation and Research, joined him, along with industry changemakers:

  • Dr. Katherine High, Visiting Professor at Rockefeller University; Co-Founder and Former President and Head of R&D at Spark Therapeutics 
  • Natalie Holles, President and CEO of Audentes 
  • Dr. Albert Hwang, Managing Director of Healthcare Investment Banking at Morgan Stanley
  • Debra Miller, CEO and Founder of CureDuchenne 

Recent challenges and opportunities for gene therapy

Holles spoke about the importance of being able to commercialize a one-time therapy and creating that valuable framework from the start—even before clinical trials begin. It’s important to show transformative value throughout the journey to approval.

Commenting on the path to approval, FDA’s Dr. Marks emphasized the need for a standardized clinical protocol and a framework to streamline the development of more gene therapies.

 He also spoke to the recent impact COVID-19 has had on gene therapy reviews, reinforcing the agency’s commitment to move forward submissions as fast as possible despite hiring challenges in the current environment.

The importance of large-cap companies

Dr. Hwang noted the importance of large-cap companies, such as Novartis, Roche, Astellas, Pfizer, etc., which have been investing in independent, public gene therapy companies, such as Spark, Audentes, and Avexis in the last few years.

 Holles agreed, saying an acquisition from Astellas was like “rocket fuel” for the company. 

How gene therapy can serve patients’ needs

While many patients remain hopeful about gene therapy, Debra Miller offered a compelling patient perspective. She wants the industry to consider those who may not qualify for gene therapy clinical trials or treatments due to their age or possessing existing antibodies.

 Other panelists agreed we must look beyond gene therapy and the typical adeno-associated virus (AAV) vector delivery methods. What other methods exist, or can we create, to properly serve patient needs? 

Overcome manufacturing issues early

When considering delivery methods, companies must also consider manufacturing capabilities and the need to develop manufacturing experience early on in the process. As Miller noted, delivery is important especially in Duchenne Muscular Dystrophy as corrected genes need to be delivered to muscles all over the body, so this requires a lot of vectors to be produced.

 Overcoming manufacturing issues early is critical in establishing safety and effectiveness, both Dr. Marks and Dr. High confirmed. And most importantly, clinical success fuels better investment. 

What can the gene therapy industry learn right now?

Holles said the gene therapy industry should see the lack of diversity as an opportunity to bridge the opportunity gap and broaden the type of people recruited within the biotechnology and gene therapy industry.

 “This industry has always thrived on doing the right thing and I think we’ve got a real opportunity imposed upon us.” 

– Rose Ramseth

12:33 PM
Global Solutions for Vaccine Implementation: From Scale-Up to Worldwide Access

Our plenary wrapped up with Amanda Glassman, EVP of CGD, CEO of CGD Europe and Senior Fellow, Center for Global Development, leading a discussion on how we get these vaccines to people. 

She was joined by:
• Stephane Bancel, CEO of Moderna
• Dr. Seth Berkley, CEO of The GAVI Alliance
• Dr. Richard Hatchett, CEO of Coalition for Epidemic Preparedness Innovation (CEPI)
• John Markels, President, Global Vaccines at Merck
• Dr. Vivien Tsu, Clinical Professor, Global Health at the University of Washington

What's it going to take?

"Developing a safe and effective vaccine in a global pandemic is a daunting challenge," said Markels, discussing Merck's experience with Ebola.

"The scale is 1,000 or 10,000 times more than it was in the case of Ebola."

Merck is identifying platforms that will enable scalability, and the potential to have efficacy and reasonable durability with a single dose.

"We need to be better prepared in the future, and I do think all the things we're doing now will put is in a better position," he said.

It's important to think about the last step, said Dr. Tsu.

We have to start thinking now about how the vaccine is going to roll out.

How is Moderna managing scaling up?

Bancel said the company did not have the budget to go so fast at this scale at the start of 2020. To build capacity, you need space, equipment, raw materials, and people.

Moderna partnered with Lonza to build capacity to produce 1 billion doses per year.The team is working on scaling up process at the same time – how much can you do in one week? They are also investing in raw materials. 

He's the most worried about raw materials, in particular, scaling up raw materials.

Raw materials matter

There is potential for a scramble and pressure on raw materials, said Dr. Hatchett – for example, there's a global glass shortage. Globally, we're not going to have oversupply of vaccine," he said. That supply could be further constrained by raw materials shortages.

"If we're going to have vaccine as quickly as possible," we need to invest in this, said Dr. Hatchett.

If you could move vaccines up by even two weeks, we'll have a positive financial impact, explained Berkley. This is why we need to invest in manufacturing now.

"The kitchen sink"

The vaccine industry is more or less running at capacity pre-COVID, said Merck's Dr. Markels. 

"What are we doing? It's the kitchen sink," he said. We're doing whatever we can to get more capacity and scale manufacturing.

You're building a factory based on what you think the vaccine is going to be, he said. But you don't quite know yet.

In the end, there probably will be unused capacity, but investing in a portfolio approach makes sense.

"It would be impossible to overinvest if ultimately you were able to support a successful candidate, or two, or three."

11:30 AM
Leveraging Platforms and Partnerships to Develop COVID-19 Vaccines in Record Time

In the second part of our all-star vaccine plenary, Dr. Mark McClellan, Director of the Duke Margolis Center for Health Policy, is leading a panel to talk about how the biotech industry is developing vaccines SO quickly. 

He's joined by: 
• Dr. Gregory Glenn, President of R&D at Novavax
• Dr. Margaret Hamburg, Foreign Secretary, National Academy of Medicine
• Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research
• Dr. Gary Nabel, Chief Scientific Officer at Sanofi
• Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at  Johnson & Johnson

"The idea isn't to pick a winner; it's to have multiple shots on goal," said Dr. McClellan.

Winning the War on COVID-19 through Vaccines Part 2 Panel

So, give us an update on what you're doing.

Novavax's spike protein vaccine is showing "a very strong immune response." It's a platform based on a flu product. The Phase I trial began in May, and results should come in July. 

Sanofi is working on two vaccines: one based on recombinant protein expression, and the other based on an mRNA program. In addition, they are working with GSK on adjuvants. Sanofi's also working on an anti-inflammatory drug; it doesn't appear to be effective in earlier phases, but may be effective in the later stage. 

Johnson & Johnson, which has experience in vaccines against Zika, Ebola, and HIV,  has a vaccine ready for animal testing, with human trials expected later this year. They're also working on extensive manufacturing upscaling.

On the federal government side, FDA is expediting development and availability of a vaccine. "It's a once-in-a-lifetime event," in terms of the speed at which everyone is trying to work to stave off a second wave. 

"Everyone will need to work together," said Dr. Marks. "This is really a global issue where we're all connected." Until it's wiped out, we'll all have issues.

What does global collaboration look like?

"Everybody recognizes that as long as this virus persists anywhere in the world, we all remain vulnerable," said Dr. Hamburg.

"Science is a global enterprise and we need to bring together the best and brightest minds, wherever they are, across borders and across sectors."

Collaboration with companies and regulators is critical to make a difference, said Dr. Nabel.

 

How can we ensure we have adequately sized, well-designed trials against an unpredictable virus?

We're confronted with challenges in terms of where, when, and the numbers, said Dr. Stoffels. We need between 30,000-100,000 people to get to a clear answer on efficacy.

We need collaboration between industry and government on a global basis to get these vaccines tested, he continued.

Perceptions that we have moved too quickly will make us vulnerable to anti-vaccine rhetoric, said Dr. Hamburg. This is why good trials matter.

Don't forget the supply chain!

A lot of these products will use a lot of the same essential ingredients that have never needed to be scaled in this way before, said Dr. Nabel.

– Samantha Sault

11:00 AM
Winning the War on COVID through Vaccines Part 1: Interview with Dr. Fauci

It's the moment we've all been waiting for: our three-part blockbuster plenary on COVID-19 vaccines, sponsored by Johnson & Johnson. (And according to the chat box, we have attendees from California to Kansas to Italy to Vietnam, where it's almost 1 AM!)

The began with an interview with Dr. Anthony Fauci, Director of NIH's National Institute of Allergy and Infectious Diseases–basically the Brad Pitt of the pandemic, right?

BIO President and CEO Dr. Michelle McMurry-Heath asked him how this pandemic is different from other virus outbreaks, like HIV, SARS, and Ebola.

“Those other outbreaks had a degree of containment and finiteness to them from the very beginning," he said.

"The entire world never felt threatened by any given disease," he added. 

Dr. Fauci's worst nightmare

 “The emergence of a brand-new infection that likely jumped from an animal host, respiratory born, high-degree of transmissibility and significant degree of morbidity or mortality.”

We’ve had outbreaks with one or two of those characteristics—but never all four.

COVID-19 meets the criteria for "his worst nightmare."

He was surprised "how rapidly it just took over the planet," he said. "This took about a month to go around the world." And it's not over yet.

The industry response to COVID-19

 

“I’m very heartened by the fact that the industry has stepped to the plate—very much differently than what we saw with SARS.”

“The industry is not stupid—they figured it out!”

He expects “more than one winner in the vaccine field, because we will need vaccines for the entire world—billions and billions of doses.” The same with therapeutics—multiple different kinds of therapeutics, from direct antivirals to medicines that treat hyper-inflammatory response.

The federal government has partnered with biopharmas to “de-risk” involvement in manufacturing the doses before completion of trials, financing production of doses so it’s ready. They’re also giving companies access to clinical trial sites built in the past.

We've never seen this extent of collaboration between industry and federal government, he added.

What's the latest knowledge on how COVID attacks the human body?

We're still learning about that, he said.

"I thought that HIV was a complicated disease," he continued. "It's really simple compared to what's going on with COVID-19." There's a huge range in terms of the severity of coronavirus symptoms.

"We're at almost the beginning of understanding" COVID-19, especially the long-term effects. We don't have any idea what will happen to people who recover, because we've only been studying this disease for four months.

The African American population "is getting hit with a double whammy"

Dr. Fauci talked about why COVID-19 disproportionately affects African Americans. COVID-19 shines "a bright light" on health disparities in the United States. 

Watch him talk about why COVID-19 disproportionately affects African Americans, and what we can do about it:

 

So, how does Dr. Fauci relax?

"The one thing I've made sure I do is to get some sleep." 

"I unwind mostly by exercise," he added. He's been running with a mask on!

Last question: What was his wife's reaction to having Brad Pitt play him on Saturday Night Live?

"If you start taking that kind of stuff seriously...you're really in trouble," he laughed.

"I'm not as good looking as Brad Pitt and no matter what you do to me, I'm never going to be as good looking as Brad Pitt."

Now there's one thing we disagree with Dr. Fauci on...

– Samantha Sault

10:00 AM
Understanding the Voices of Patients: Unique Perspectives on Healthcare

The patient perspective is so critical in drug development and treatment.

Paul Hastings, President and CEO of Nkarta Therapeutics, led a discussion on how we can better incorporate patients’ perspectives to ensure innovation is patient-centered and equitable.

The speakers included:

  • Julie Eller, Director of Patient Centered Strategies at the Arthritis Foundation
  • Meghan Harpole, a nurse and COVID-19 patient
  • Ashley Valentine, Co-Founder of Sick Cells

Julie Eller, a long-time arthritis patient, spoke about living with a chronic disease from age seven.

For 20 years, Julie’s morning routine consists of stretching to get her joints warmed up.

“All of those things were small lifestyle changes,” she said. “The pain is a reminder of why it’s so essential to share your story and why it’s so essential to take action.”

The ER nurse turned COVID patient

An ER nurse for 21 years and a COVID-19 survivor, Meghan Harpole talked about how her experience as a nurse helped her advocate for herself when she was a patient and also for her son when showed symptoms of the virus.

After 20 days of symptoms, she received treatment at the hospital where she works.

“The saddest part about it was I was just so happy to be around people because I hadn’t been around people in 20 days—to talk to people who touched me.” The personal connection helped her feel safe, and relieved some of the stress and anxiety she felt while she had the virus.

While she was able to advocate for herself as a patient, she worries other COVID-19 patients may not be able to speak up as much as she did, given that most COVID-19 patients are alone in hospitals.

 

Why doctors need to listen to patients

Ashley Valentine’s brother suffers from sickle cell disease. “With chronic conditions, invisible pain is really subject to whether that provider believes you. Or not.”

Patients need to educate themselves, too: “You have to know more about the diseases than the providers, than the insurance companies, than the legislators. You, ultimately, are the expert of your disease.”

 

– Nicole Chardavoyne

 

9:56 AM
International Plenary: How are Global Leaders Collaborating to Combat the Pandemic?

The COVID-19 pandemic has brought into sharp relief how interconnected global biotech R&D has become. There is need for greater global collaboration and communication among researchers, healthcare systems, government agencies, NGOs, and the public at large.

We brought together an all-star panel including some of our international sister organizations:

  • Dr. Ami Appelbaum, Chairman of the Israel Innovation Authority and Chief Scientist at Israel's Ministry of Economy and Finance
  • Steve Bates, CEO of UK BioIndustry Association (BIA)
  • Christophe Bourdon, Vice President and General Manager, Oncology at Amgen Inc.
  • Honorable Greg Hunt, Minister of Health for Australia
  • Her Excellency Agnès Pannier-Runacher, Secretary of State to the Minister of Economy and Finance of France

Chris Smith, host of the Naked Scientist podcast, moderated a conversation with a large panel of global health and government leaders. Smith appeared fully clothed. 

It is through dialogue and collaboration, particularly leveraging public-private partnership, that we will be best prepared for the second-wave of this and future pandemics.

Despite the varying healthcare systems around the world, all systems are being tested and forced to adapt. It's a bit of a health care revolution.

Australian Health Minister Greg Hunt noted that this urgent health crisis also pushed world governments to move and act quickly in a way that didn’t seem necessarily possible. 

It makes us wonder why our governments don’t take such quick action on everything!

Israel’s Innovation Authority & Chief Scientist of the Ministry of Economy and Industry shared how the pandemic has taken its toll on tech in his country, including making investors far more reserved.

But just because some investors are zipping up their wallets, doesn’t mean there’s no hope. As we’ve seen all over, evolutions in telehealth, AI, and data technologies are critical to improving access for patients.

Amgen's Christophe Bourdon said that the industry is committed to investing right now because we know a second wave is coming.

“We know it’s going to come and we cannot be taken by surprise,” so that means continuing with research, testing, and leveraging private-public partnerships.

Ultimately, this pandemic is an opportunity to share what science is about with the public. Fostering science at the grassroots level will positively shape this ecosystem and shape outcomes for patients. There will be disappointments along the way, but given recent efforts, we are encouraged about the future.

This session was sponsored by: Amgen

8:00 AM
State of Emerging Therapeutic Investment, Deals, and Pipeline

It’s been a wild ride for the biotech industry market since 2009, said BIO VP of Industry Analysis Dave Thomas during a session on emerging company investment and deal trends.

We’ve seen a 40% drop in the index since COVID-19—but now an unprecedented 80% rally for biotech stocks.

We’re looking at a healthy year for R&D follow-on offerings.

IPOs in 2020:

  • 10 in the United States—6 clinical, 4 pre-clinical
  • 7 outside the United States—primarily in oncology from Phase III all the way down to pre-clinical.

2019 was a record year for dollars, with 34 companies acquired, the most in a few years. 2020 is a different story, with 10 in the first half. It’s likely to be a down year.

In terms of digital health deals, 40% are service agreements that the biopharma is accessing, 50% are software and analytics to investigate clinical trials.

 

The COVID-19 pipeline

The COVID-19 pipeline is strong, with 550 drug programs in 20 weeks. Visit www.bio.org/covidpipelinetracker to learn more. 

The US has over 50% of total COVID-19 drug programs (280) followed by China (39) and Switzerland (26). Of these, 60% are pre-clinical/discovery phase—basically, just a press release with no evidence.

Amazingly, however, there are 216 clinical-stage compounds (40%).

We’re seeing a lot of repurposing: 93% of therapeutics and 80% of antivirals/antibodies are repurposed, but just 3% of vaccines are repurposed.

“In terms of the number of shots on goal, this bodes very well…for success in getting something to the market,” said Thomas.

Check out the full report here.

Want more data? Visit www.bio.org/iareports for all BIO Industry Analysis reports.

 

 

5:50 AM
Day 2 of the BIO Digital Live Blog
Dr. Fauci - Tuesday June 9 at BIO Digital

It's Day 2 of BIO Digital. Here's what we're covering today:

11 AM ET/8 AM PT – State of Emerging Therapeutic Company Investment, Deal-Making, Pipeline

11:30 AM ET/8:30 AM PT - International Plenary: How Are Global Leaders Collaborating to Combat the Pandemic? (Sponsored by Amgen)

1 PM ET/10 AM PT – Understanding the Voices of Patients: Unique Perspectives on Healthcare

2 PM ET/11 AM PT - LIVE PLENARY: Winning the War on COVID through Vaccines feat. Dr. Anthony Fauci (Sponsored by Johnson & Johnson)

4:30 PM ET/1:30 PM PT - Realizing the Promise of Gene Therapies for Patients Around the World (Sponsored by Pfizer Inc.)

4:30 PM ET/1:30 PM PT - Realizing the Promise of Gene Therapies for Patients Around the World (Sponsored by Pfizer Inc.)

5:45 PM ET/2:45 PM PT - Fireside Chat with the Hon. Jim Greenwood and Dr. Michelle McMurry-Heath

6:30 PM ET/3:30 PM PT - Advancing Rare Disease Diagnosis and Drug Development Through Partnership (Sponsored by Jazz Pharmaceuticals)

7:30 PM ET/4:30 PM PT - Fireside Chat with Dave Ricks, Chairman and CEO of Eli Lilly (Sponsored by Eli Lilly)

7:30 PM ET/4:30 PM PT - How an Innovation Ecosystem Enables Growth During Times of Crisis and Beyond (Sponsored by Shonan iPark)

1:00 AM
What We Learned on Day 1 of BIO Digital

1. Trials for COVID-19 therapeutics are moving along—quickly. From Vir Biotechnology Inc., which is expecting to start trials on its antibodies this summer, to Regeneron starting clinical trials for its antibody cocktail therapy any day now, biotechs are moving with unprecedented speed on R&D for COVID-19 therapeutics. 

2. It's time for new cell and gene therapies. Be patient with the U.S. Food and Drug Administration (FDA) as they push COVID-19 approvals, Dr. Wilson Bryan, Director for the FDA’s Office of Tissues and Advanced Therapies, told attendees. The FDA will be responsive, but processes may be slower than normal, meetings may be pushed back, or the format of dialogue may require written responses rather than a normal video conference.

3. Pandemics are not isolated. Jeff May, Vice President, Global Public Policy, Merck & Co., Inc. discussed the severity of pandemics during a session titled International Trade in the Time of COVID-19. “They are not isolated,” he explained. “There is an interest in ensuring good health around the world. We need to support an innovative ecosystem to ensure we are effective in our response.”

4.  Collaboration is key for health care systems to adapt post-COVID. “It is key to work together to sustain patient access...especially for highly innovative treatments that do come with a high price tag," said Fabien Berkemeier, Director, Value and Access Strategy, IGES Institut GmbH. "Both payers and companies want patient access to treatments. It is going to be about working together at a time when there are budget constraints.” 

Want more like this? Get Good Day BIO in your inbox every morning!

– Good Day BIO Editors

Monday, June 8
5:26 PM

We keep hearing that there are several dozen COVID-19 vaccines in the pipeline, but we also keep hearing that there is little to no structure for rapidly developing and distributing the billions of vaccines that will be needed.

Greg Theyel, Program Director at Biomedical Manufacturing Network, led a discussion with four supply chain experts:

  • Mo Heidaran, Consultant at Parexel International and FDA expert
  • Sue Behren, Professor at Keck Institute
  • Eric Fallon, Global Head of Manufacturing at Genentech
  • John Erickson, Acting Technology Officer at the National Institute for Innovation in Manufacturing Biopharmaceuticals

 

5:25 PM
Next Generation Orphan Drug Incentives

Natasha Bonhomme, Chief Strategy Officer at Genetic Alliance and moderator of this session, set the stage. So much progress has been made in orphan or rare disease, but there is still so much that needs to be done and many people who are still waiting. Success for 5-10% of rare diseases is great, but more can be done. 

Jim Shehan, Chair of FDA Regulatory Practice at Lowenstein Sandler law firm, talked about where we’ve been with orphan drugs, including a brief history of the Orphan Drug Act passed in 1983. Since then, we've seen about 503 orphan drug approvals for 731 different orphan indications! 

In a personal anecdote that perfectly illustrates the real-life impacts of the Orphan Drug Act, Bonnie Schneider shared the personal story that led her to start the IGA Nephropathy Foundation of America and how that move has led to inspiring change. 

"In the biotechnology ecosystem, patients tell us what is needed, the FDA guides us on science and regulations, but eventually the decision to invest in rare disease clinical research takes place in the boardroom," said Laura Clague, Retrophin’s CFO. She then talked briefly about how important it is for boardrooms to make decisions about investing in clinical research and how policy can incentivize them.

Nick Leschly, Chief Bluebird at bluebird bio, posed the question, how do we get patients more access and have a system that doesn’t crater under the weight of “a continued rush of therapies?” Leschly walked the audience through bluebird’s strategies to make sure patients have increased and affordable access to medicines with a new payer structure that holds companies more accountable and creates relief for the patient.

Although every session today has been fascinating, this one was particularly touching because it recenters the very people we do all of this for: our patients. 

This session was sponsored by: Retrophin

3:33 PM

We talk a lot about the need to forge partnerships to get through this pandemic—but how can those partnerships be successful?

Dan Sullivan, Amgen’s Executive Director of U.S. Value Strategy and Marketing for General Medicine, hosted a panel called Reinventing Partnerships to Deliver Value to Patients and Society, which brought together health care experts to discuss how partnerships can provide value for patients—and solve some of our most pressing health challenges.

Why is partnership important? 

Health care is “just too expensive,” said Rob Allen, Senior Vice President and Chief Operating Officer of Intermountain Health Systems, an integrated health delivery system providing hospitals, health plans, direct care, and telehealth to more than 900,000 people around Salt Lake City, Utah.

“Partnerships give us a unique opportunity…to address this in new and hopefully impactful ways.”

3:30 PM

Over the last 20 years, cell and gene therapy have gained popularity within the industry. But as we move into the future, many expect cell and gene therapies to dominate the industry.

Simone Fishburn, Ph.D., Vice President and Editor in Chief at BioCentury, talked with three pioneers advancing the next generation of medicine: 

  • Federico Mingozzi, Chief Scientific Officer at Spark Therapeutics 
  • Harlan Robins, Ph.D., Chief Scientific Officer and Co-Founder at Adaptive Biotechnologies
  • James Sabry, M.D., Ph.D., Global Head of Pharma at Roche

All three agreed that the potential of these therapies can address complex biologic issues in a unique and novel way. For example, when examining the viral vectors used to transfer genetic material into cells, Dr. Mingozzi looks at the possibility that gene therapy will move beyond monogenic diseases to treat complex genetic diseases in a specific and efficient manner.

2:15 PM

There’s a misconception out there that all medicine comes from “big pharma,” but the truth is much of the innovation comes from small, scrappy biotech companies, many of them hoping to get the financial backing and name recognition of a larger pharmaceutical company. 

That’s where mergers and acquisitions come in.

Elizabeth Mily, Executive Vice President of Strategy and Business Development at Bristol Myers Squibb, led three lifesciences entrepreneurs through questions about the buyer and seller environment, how to build an attractive biotech company, and how the pandemic has affected acquisitions.

 

1:00 PM
Science on the Front Lines and on the Front Page

The COVID-19 pandemic has brought science front and center for the general public.

Seema Kumar, Vice President of Innovation of Global Health and Policy Communication for Johnson & Johnson Innovation, is leading a supersession that brings together experts in research and journalism to discuss why investment in science is important and strategies to boost public trust and engagement in science.

 

How COVID has changed the way people engage with science

According to science reporters Joe Palca, Correspondent for the Science Desk at NPR and Clive Cookson, Science Editor for The Financial Times, COVID-19 has piqued interest in science around the globe. 

“Interest level in science rocketed upward," said Palca. He also noticed an inverse relationship between interest and understanding around COVID-19: interest has been the highest when we’ve had the least amount of information, but as we’ve been able to report more information and better understand the virus, interest has fatigued.

Cookson spoke about the true interest readers are showing in science: “I think it has engaged people in medical science not just because they want to know what’s going on and they’re worried about getting infected or worried about loved once who are infected. I think there has been an increase in the science as science.”

COVID’s impact on policy

When asked about the impact on funding and advancing public policy for science, Mary Woolley, CEO and President of Research!America, spoke about the lack of preparedness we’ve now seen as a result of the pandemic: “What we’re finding out, policy makers and the public, is that science has been understaffed for quite a long while. When the pandemic arrived, it’s been revealed that we weren’t ready and we don’t have answers.”

In looking at funding and preparedness, Wooley sees an interesting parallel to 9/11. After the attack, the U.S. created the Department of Homeland Security, which now has a budget of around $80 billion a year. Compare that to the CDC’s budget, which focuses on health security, which is not even $8 billion a year.

Shifting the national dialogue around science

When asked about her perspective around public perceptions of science, BIO President and CEO Dr. Michelle McMurry-Heath pointed to the importance of making science interesting, approachable, understandable, and relevant to people’s daily lives. “The amazing thing about the moment we’re living through right now is that it’s never been more clear how relevant or the lack of science is to people’s lives.”

She views science as a social justice issue. “Science is the tool that our societies can use to solve the most vexing problems we still face today," she said.

Science up front

There’s a need for scientists to engage more with the public and work with younger scientists to create a Peace Corps approach – find out from the community what they need and show how science can meet those needs.

When asked about Dr. Anthony Fauci and his ability to communicate, Wooley said it shouldn’t be one or two scientists who can speak to the public, but “the norm of science” that scientists are taught in school how to communicate with the public.

Adding to that, McMurry-Heath spoke about how scientists are sometimes afraid to talk about the process. She spoke of how Dr. Fauci has been willing to talk about the ups and down, which adds to his credibility.

We’re all in this together

When discussing the growing nationalism around the world, Cookson noted that the scientists he’s spoken with have all advocated for collaboration. More than ever, it’s critical to keep communication and collaboration going.

What do the panelists hope the world will look like post-COVID-19?

McMurry-Heath hopes "we remember that science was critical to getting out of the crisis because no matter how the crisis ends, it is a given that science will pave the only road out.”

Cookson said he hopes we don't waste all the research we’ve done on coronavirus like we did with SARS and MRSA. The panelists agreed that we need to take what we are learning and put it to better use.

This session was sponsored by Johnson & Johnson.

– Nicole Chardavoyne

12:33 PM
Brave Innovations: Public and Private Solutions to Advance Alzheimer’s Therapeutics and Diagnostic in a Risk-Averse Climate

Alzheimer’s disease (AD) and AD-related dementias (ADRD) affect more than 5 million Americans and are expected to impact 13.8 million people by 2050. These diseases devastate families globally, while costing the U.S. health care system over $1 trillion.

Despite a risk-averse environment due to clinical trial failures, significant investments and innovations that extend beyond traditional research paradigms to effectively treat and prevent AD/ADRD are needed. No disease-modifying treatments currently exist to treat AD/ADRD, and there is a lack of low-cost, blood-based diagnostic tools for early detection of AD/ADRD.

So, how do we advance AD/ADRD therapeutics and diagnostics in a risk-averse climate? How can entrepreneurs and researchers in the AD/ADRD space access and leverage available support?

Funding Opportunities

NIA Office of Small Business Research (OSBR) Chief Dr. Todd Haim discussed seed funding through the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs that can spark innovation in AD/ADRD.

  

More details on the SBIR/STTR Programs and funding opportunities can be found here.

The Alzheimer’s Disease Discovery Foundation (ADDF) also provides funding opportunities to accelerate drug development for Alzheimer’s and related dementias. Over the last 20 years, ADDF has invested over $150 million in companies and academics, funded more than 625 programs in 19 countries, and has 110 active programs and 32 active clinical trials, according to Dr. Alessio Travaglia, Scientific Program Officer of ADDF.

 

 More information on ADDF funding opportunities can be found here.

How Public-Private Partnerships Accelerate the Development of Novel Innovations

Johnson & Johnson has a commitment to neuroscience and neurodegeneration, with interest in disease-modifying activity, symptomatic treatment of cognitive impairment and neuropsychiatric conditions, and biomarkers and diagnostics. ­J&J is continuing to discover and engage with external partners to conquer AD and neurodegeneration, believing that partnerships can help “early innovation be accelerated and find its way to the hands of patients in the most optimal way,” Dr. Michal Preminger, Head of Johnson & Johnson Innovation says.

C2N Diagnostics focuses on developing unique technologies to better diagnose, monitor, and treat Alzheimer’s disease and other progressive neurodegenerative disorders. C2N’s primary platform, APTUS™-Aβ42/40, has shown promising data for predicting the presence of brain amyloid pathology. The blood test is offered commercially for use in clinical trials and is expected to be available under CLIA in the near future. Dr. Joel Braunstein, CEO of C2N Diagnostics, says external partnerships have allowed the company to get where it is today, saying one significant way C2N has been able to foster great collaborations is through the “willingness to be held accountable for achieving important milestones.”

Cognition Therapeutics is currently advancing its lead candidate, CT1812 (Elayta™), which has shown potential in early clinical studies to reduce synaptic damage in Alzheimer’s patients. Dr. Susan Catalano Co-Founder and CSO of Cognition Therapeutics, says “public-private partnerships are absolutely critical to advancing therapeutics in the AD/ADRD field,” adding that the company has received vital support from the NIA and ADDF to support discovery and advancement of CT1812 into Phase 2 trials.

– Molly McNulty

12:20 PM
International Trade in the Time of COVID-19

In responding to the COVID-19 pandemic, many governments have placed export and other trade restrictions on medical supplies and resources. What's the impact on international trade?

Moderator Brian Pomper, Partner at Akin Gump Strauss Hauer & Feld LLP, asked what have we learned from the current crisis and what steps should we take? Here's what the speakers had to say.

Jeff May, Vice President, Global Public Policy, Merck & Co., Inc.: We need to take pandemics seriously, They are not isolated. There is an interest in ensuring good health around the world. We need to support an innovative ecosystem to ensure we are effective in our response.

Wendy Cutler, Vice President and Managing Director, Washington, D.C. Office, Asia Society Policy Institute: We are still in learning mode. There are essential goods and services that we need to pay more attention to in order to reduce vulnerabilities. Resisting trade protections and barriers is important; countries that to implement trade protections should make them as temporary as possible. Coming out of this, we need to recognize international cooperation is key. A global pandemic requires a global solution.

Keith Rockwell, Director, Information and External Relations Division and Spokesman, World Trade Organization (WTO): No country can address this problem on its own. Part of the solution is adapting greater agility. Consider the best practices from countries around the world. If you restrict supply, you create a difficult situation for solutions

Scott Paul, President, Alliance for American Manufacturing: We need to have solutions that will be applicable to situations we haven’t imagined yet. Instead of legislating backward, we need to be looking forward as well.

– Kara Nelson

10:30 AM
LIVE Plenary: Leveraging Innovative Technology to Treat COVID-19 Patients

When will we have COVID-19 treatments? BIO's Phyllis Arthur, VP of Infectious Diseases and Diagnostics, led a panel with some of the biggest names in the battle against the coronavirus:

  • George Yancopoulos, Co-Founder, President, and Chief Scientific Officer of Regeneron
  • Julie Kim, President of Plasma-Derived Therapeutics Business Unit at Takeda
  • George Scangos, CEO and Director of Vir Biotechnology, Inc.
  • Eddie Sullivan, President and CEO of SAB Biotherapeutics
  • Gil Van Bokkelen, Founder, Chairman, and CEO of Athersys, Inc.

Yeah, that's quite a lineup.

So, what are they doing?

Julie Kim said Takeda launched a cross-functional working group within the company to look at research and repurposing products, data and information sharing, partnerships, and work on a non-branded immunoglobulin plasma therapy.

Dr. Scangos said Vir has three approaches: antibodies, a collaboration with Alnylam on RNAi technology, and cellular genes and proteins that, when inhibited, can block the ability of SARS-CoV-2 to replicate in cells. Vir is bringing all three forward; the antibodies are the leading program right now with trials expected to start this summer.

Eddie Sullivan talked about SAB's technology, which uses cows to produce fully human polyclonal antibodies. Watch to learn more:

 

SAB's clinical trials will start very soon.

Athersys is working on a cell therapy treatment for Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19. It's already in Phase III clinical development.

Collaboration is critical

The speakers agree: collaboration and partnership has allowed these treatments to move so quickly.

"As a small biotech it's important for us that we have a network of collaborators that we're working with, and in particular being able to work with multinational companies as well," said Sullivan.

"We are thinking big in terms of the scale of our production," said Dr. Scangos. 

The scale of the need before a vaccine, and even after a vaccine, could be very large, added Dr. Yancopoulos, which is why treatments are so important.

While speakers expressed some differences in terms of what types of antibodies and treatments have the best chances, they agreed: there's a lot of precedent, and a lot of emerging data, to show that the antibody approach can serve as a bridge to a vaccine, and benefit those who are already infected.

The bottom line? The science is robust!

Pivoting to COVID

Phyllis Arthur asked how companies were able to pivot from non-COVID research to COVID-19. Athersys' Bokkelen said it wasn't necessarily a pivot, but applying their specific expertise and approaches they were already working on to the new disease. 

Most companies aren't looking for a return on investment; they are looking to make a difference, he continued. There won't be a single magic bullet; all of these innovations complement one another. And the approaches we're talking about today have different points of intervention. 

Diversity in COVID-19 trials

Here's a good thread from STAT's Kate Sheridan:

How are you working with regulators?

Takeda is doing a single clinical study, a single master protocol, and has been very transparent with FDA. Through that process, they have been able to accelerate the timeframe.

SAB's Sullivan says it's been critical to think of ways they can do "multiple things in parallel" to move as quickly as possible.

Dr. Yancopoulous said the FDA has been "extraordinary" in dealing with the pandemic and accelerating "without cutting corners," as they're also dealing with other diseases, too. "There's not unlimited capacity out there. Everyone is making choices. I think the FDA is doing a great job," but other things might suffer.

Dr. Scangos added that the agencies have done "a remarkable job with balancing speed with safety," and have not done anything to jeopardize patient safety but have also recognized the urgency. "I'm impressed," he said. "Our interactions have been incredibly positive.

What's the key thing you've learned working on this pandemic that will help us respond faster to the next one?

Collaboration is foundational, said Takeda's Kim. We learned so much after SARS, but we didn't put that information into play as this pandemic emerged. "What I hope that we can apply and learn beyond this is once we get through to the other side of this pandemic is that we don't have short-term memory loss." We need to collaborate and share.

SAB's Sullivan agreed: "Shame on us if we don't learn lessons." 

Athersys' Bokkelen said this is the most vivid illustration of how capable, committed, and passionate the industry and health care workers are. "The broad commitment we all share is really remarkable and shouldn't be overlooked or forgotten."

Regeneron's Dr. Yancopolous said society has forgotten the importance of science, but we can use this moment to remind everyone of the difference science can make and deliver solutions for the world, "that can result in an entire change of how we're viewed as an industry, but more importantly how science and technology is viewed."

The final word from Dr. Scangos: "You can actually function efficiently working from home."

–Samantha Sault

10:07 AM
The Bioscience Economy

In partnership with TEConomy, BIO has published a new report that studies the state of the U.S. bioscience industry and its associated innovation ecosystem at the national, state, and metropolitan area levels. The report also analyzes the significant role of small- and mid-sized companies and the industry’s response to the COVID-19 pandemic.

Hear from BIO President & CEO Dr. Michelle McMurry-Heath, President & CEO of BIONJ Debbie Hart, and from the reports lead author, Ryan Helwig with Teconomy Partners.

 

Check out the full report and state-by-state data at www.bio.org/jobs.

 

 

9:50 AM
How will healthcare systems adapt to the post-COVID-19 world?

COVID-19 is here to stay and will be an added stress to already strained healthcare systems and global economies.  But how? We brought together these experts to discuss:

  • Fabian Berkemeier, Director, Value and Access Strategy, IGES Institut GmbH

  • Helen Chen, Greater China Managing Partner, L.E.K. Consulting, LLC

  • Alan Eisenberg, Vice President, Global Government Relations and Public Policy, Alnylam Pharmaceuticals, Inc.

  • Stefan Neudoerfer, Senior Director, Head Market Access Europe, CSL Behring

  • Patty Wu, Vice President and Managing Director, Crowell and Moring International (Moderator)

What is clear: There are a number of grim realities as to how countries will not only address financial implications from COVID-19, but also the existing challenges of sustaining patient access especially for highly innovative treatments that do come with a high price tag. It is critical that we consider innovative ways of financing innovation.

“It is key to work together to sustain patient access...especially for highly innovative treatments that do come with a high price tag," said Fabien Berkemeier. "Both payers and companies want patient access to treatments. It is going to be about working together at a time when there are budget constraints.” 

“There is a need for all those in the ecosystem – including government, payers, many biotech companies – to be innovative and agile during this time” added Patricia Wu.

– Kara Nelson

9:15 AM
It's time for new cell and gene therapies. ⏰

The cell and gene therapy is an exciting space, rife with promise and potential. However, as with any new and uncharted ground, there are both opportunities and challenges.

In Race Against the Clock: Bringing New Cell and Gene Therapies to Market, we learned about the challenges of advancing a brand new science. 

FDA Director for the Office of Tissues and Advanced Therapies Dr. Wilson Bryan chats with three industry experts: 

  • Marlin Frechette, Corporate Compliance & Quality Officer at Fujifilm Irvine Scientific

  • Heidi Marchand, PharmD, RPh, Global Head, Regulatory Policy and Intelligence at Gilead Sciences

  • Snehal Naik, PhD, Associate Director, Global Regulatory Affairs, Regenerative Medicines and Advanced Therapies, CAR-T and Microbiome, Janssen Research and Development 

 

 

Be patient with the FDA as they push COVID-19 approvals. According to Dr. Bryan, the FDA will respond, but processes may be slower than normal, meetings may be pushed back, or the format of dialogue may require written responses rather than a normal video conference.

When it comes to cell and gene therapy manufacturing, start with the end in mind. If you track how changes may impact the final result, companies have a better chance of saving time and investment, said Naik.

Last, but not least, collaborate and communicate - not just within our industry, but also with key regulators and manufacturers. Dr. Bryan believes others can benefit from the real-world experience you have to share. Currently, there are many different interpretations and definitions of terms within the cell and gene therapy industry, but as we meet, network, and share, we will see enhanced harmony and convergence. 

– Cresonia Wong

8:55 AM
You are BIO. I am BIO.

The COVID-19 pandemic has shown the world the importance of science and biotech breakthroughs—and in the coming weeks and months, we’ll be working hard to change the dialogue about science in the country.

That’s why we’re launching the I am BIO campaign. This campaign will show how biotechnology innovation is leading the charge to get the world back on track and put a face to biotech by showing the hidden heroes in our labs.

Watch:


We kick off the campaign by showcasing researchers at Merck and IMV, a high school student finding a way to reuse gray water for irrigation, and a seventh grader who did a research project on video games and depression and plans to become a vet.  

Who we’ll feature: people who are making an impact on society with science, as well as those whose lives have been changed because of scientific breakthroughs.

Who we’ll share them with: patients, consumers, lawmakers, media, and even our critics, so everyone can understand how biotech employees are innovators who are changing the world. 

But we need YOU to share your story! We developed an easy-to-use app to allow Apple and Android users to record short videos and send them to us. From there, our team will edit the video, work with you on changes, and distribute them. (And don’t worry, you’ll be able to review it before it goes public!) 

Visit www.bio.org/iambio to learn more and share your story!
 

8:00 AM

It’s heeeere!

BIO Digital launched with a special plenary with BIO's leadership, including our new President and CEO Dr. Michelle McMurry-Heath, discussing why this is the moment for the biotech industry to shine. 

Dr. Jeremy Levin began by expressing condolences for those who have lost loved ones and jobs during the COVID-19 crisis against a backdrop of unacceptable racism and social unrest in America.

Speaking from his cattle farm in Connecticut, he talked about the positive impact of the biotech industry. Our job is not merely to combat disease, create better foods, or clean up the environment. “I challenge us, as well, to advocate for and exemplify the standards and values we believe in,” to advance global health as well as social welfare, he said.

Before we dive into the week’s discussions, we want to celebrate the Honorable Jim Greenwood, BIO’s outgoing President and CEO, a “towering figure in the biotechnology industry.” Under his 15-year leadership, the industry has seen tremendous progress and growth—including twice as many employees and over 500 FDA-approved drugs.

Thanks, Jim!
7:00 AM
Welcome to Day 1 of the BIO Digital Live Blog.

Welcome to Day 1 of the BIO Digital Live Blog. We start at 8 AM PT (11 AM ET) with BIO’s leadership, present and (very very recent) past:

Here’s our full coverage agenda for today:

  • 11 AM ET/8 AM PT – Biotech’s Finest Hour
  • 12 PM ET/9 AM PT - How Will Health Care Systems Adapt to the Post-COVID World? 
  • 12 PM ET/9 AM PT - Race Against the Clock: Bringing New Cell and Gene Therapies to Market 
  • 1:30 PM ET/10:30 AM PT - Leveraging Innovative Technology to Treat COVID-19 Patients
  • 3 PM ET/12 PM PT - Brave Innovations: Public and Private Solutions to Advance Alzheimer’s Therapeutics and Diagnostic in a Risk-Averse Climate 
  • 3 PM ET/12 PM PT - International Trade in the Times of COVID-19
  • 4 PM ET/1 PM PT - How to Get Acquired: What Companies Look for When in Acquisition Mode 
  • 4 PM ET/1 PM PT - Science on the Frontlines and on the Front Page 
  • 6:30 PM ET/3:30 PM PT - Reinventing Partnerships to Deliver Value for Patients and Society 
  • 6:30 PM ET/3:30 PM PT - The Next Generation of Medicine: Cell Therapies, Gene Therapies, and Beyond
  • 7:30 PM ET/4:30 PM PT - Discover/Develop: But How Will You Manufacture Your Therapeutic?
  • 7:30 PM ET/4:30 PM PT - Next Generation Orphan Drug Incentives 

See you soon!

– Good Day BIO Editors

Sunday, June 7
8:00 AM
Testing, testing…is this thing on? 🎙

Welcome to the BIO Digital Live Blog!

The team behind Good Day BIO will be here all week, June 8-12, 2020, to bring you news and highlights from BIO Digital—in real time as the virtual educational sessions are happening. 

Whether you’re registered and want more context, on another time zone and need to catch up on what you missed, or didn’t register (why!?), come here for quick recaps, the best quotes, and more fun stuff. We’ll also be taking over the @IAmBiotech Twitter account, so follow along there too #BIODigital. 

Until then, we’ll leave you with the BIO Digital trailer to get you pumped up:

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