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June 8-12, 2020
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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

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