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June 8-12, 2020

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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

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