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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

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