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.”

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 

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.

Justin Field, SVP of Government Affairs @nvca explains that the pandemic’s assistance programs were created through a traditional view of the economy and many companies have been “fitting square pegs into round holes” to be able to qualify. #BIODigital

— I Am Biotech (@IAmBiotech) June 11, 2020

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

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

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.

Valerie Paradiz of @autismspeaks: “We need more options for people with #autisim in terms of medications and advancements” #BIODigital pic.twitter.com/MoqnXzRKiK

— I Am Biotech (@IAmBiotech) June 11, 2020

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 

“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:

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.

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

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

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

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

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

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

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

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. 

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!

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." 

“The companies that have been able to pivot to this #WFH and adaptation of technology to enable collaboration are going to be the ones that are going to be able to move into the future” Susie Harborth of @MissionBioCap #BIODigital pic.twitter.com/hesoSaLc3H

— I Am Biotech (@IAmBiotech) June 10, 2020

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

“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

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

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."

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

“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

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.

Meghan Harpole speaks about her ability to advocate for herself when she had #COVID19. #BIODigital #Healthcare pic.twitter.com/Nhxj2cLUPd

— I Am Biotech (@IAmBiotech) June 9, 2020

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.”

“You are the expert of your disease,” Ashley Valentine of @SickCells talking about #patient advocacy at #BIODigital. #Healthcare pic.twitter.com/EWr4VnIM35

— I Am Biotech (@IAmBiotech) June 9, 2020

– Nicole Chardavoyne

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

- Kara Nelson and Cornelia Poku

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.

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)

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

- CORNELIA POKU

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

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

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

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