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

 

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

 

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

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

Why did the US and Europe struggle so much?

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

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

Why diagnostics matter

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

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

But what are tools without policy and community structural change

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

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

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

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

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

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

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

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

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

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

     

 

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

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

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

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

 

Overall Takeaway

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

- Jeremy Isenberg 

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

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

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

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

What programs are available for coronavirus-related assistance?

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

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

Have small biotechs benefited?

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

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

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

Pending legislation

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

What else can be done?

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

And particularly for companies working on COVID-related activities:

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

– Cassie McKay

 

 

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

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

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

The importance of external partnerships

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

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

Workplace and culture in the era of COVID-19

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

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

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

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

The importance of mentorship

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

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

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

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

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

“We certainly recognize it when we see it.”

– Samantha Sault and Andrew Segerman

12:05 PM
Digital Health: Innovation Meets Regulation

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

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

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

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

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

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

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

- Connor McKoy

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

- Theresa Brady 

 

9:00 AM
Bioethics Through the Lens of a Pandemic

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

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

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

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

“Ethics has moved front and center”

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

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

"I have a moral obligation to try something"

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

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

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

Follow the science, be transparent, and collaborate globally

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

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

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

Learn more about Inovio’s vaccine:

INOVIO beyond imagination

Continue the conversation

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

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

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

Are you looking for your next summer read?

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

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

Check out a few excerpts on STAT News:

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

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

 

6:00 AM
FDA Town Hall

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

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

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

 

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

Status of COVID-19 diagnostics

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

Status of COVID-19 therapeutics and vaccines 

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

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

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

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

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

 

How does FDA prioritize which products to review first?

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

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

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

The importance of combinations

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

The pandemic has led to greater efficiencies

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

Industry meetings have gone smoothly as well, he said.

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

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

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

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

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

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

We have to learn from this pandemic

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

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

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

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

– Samantha Sault

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

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

9 AM ET/6 AM PT – FDA Town Hall

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

– Good Day BIO Editors

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