BIO Digital 2020 Highlights: How COVID-19 Will Radically Change Biomedical R&D Across the Globe?

By Sahana Shankar Ph.D. Candidate

At a time when the words pandemic, new-normal, social/physical distancing, vaccines, contact-tracing have entered common parlance, thanks to COVID-19, there is no part of the society, government, or industry that is unaffected by it. It has put into sharp focus the varied responses of governments, need for healthcare infrastructure, research funding, and, most importantly, innovation across different industries and institutions to rise to the occasion.

To address how the COVID-19 has changed the global biomedical industry, Scientific American and Nature Biotechnology co-hosted a virtual session on June 11, 2020, with a diverse group of thought leaders and visionaries in the biotech industry. Moderator Dr. Andy Marshall, Chief Editor of Nature Biotechnology, steered a thought-provoking and insightful conversation on how the current crisis may help accelerate innovation in the public and private sectors and normalize the few changes that have been instituted.

Dr. Andy Marshall, Chief Editor of Nature Biotechnology

The panel comprised of the following distinguished KOLs:

1. William Hait, MD, Ph.D., Global Head, Johnson & Johnson External Innovation, Johnson & Johnson,
2. Karen Heichman, Ph.D., Senior Program Officer, Diagnostic Development, Innovative Technology Solutions, Global Health Division, Bill & Melinda Gates Foundation,
3. Johnsee Lee, MBA, Ph.D., Founder, and CEO, Personal Genomics, Inc.,
4. Jeremy Levin, MB BChir, D. Phil, Chairman of the Board of Directors and Chief Executive Officer, Ovid Therapeutics Inc.,
5. Vicki Seyfert-Margolis, Ph.D., CEO & Founder, My Own Med, and
6. Eric Topol, MD, Executive Vice-President, Scripps Research Institute, Director & Founder, Scripps Research Translational Institute.

Here is a round-up of the critical issues raised by this distinguished panel on how COVID-19 will change our understanding of public health, product development, and manufacturing in the pharma industry, policies, and regulation.

Dr. Jeremy Levin observed adaptability in the biotech industry since the beginning of 2020. At Ovid, he said there had been a sustained effort to review and revise methodologies and capabilities of conducting clinical trials in the face of current restrictions, prioritizing the patients’ health and safety. He thinks that the biotech industry has changed its investment and operational models, the scale of work, and reordered priorities on certain research programs.

Dr. Jeremy Levin, CEO, Ovid Therapeutics Inc.

Speaking of changes in manufacturing processes, Dr. Levin hoped that pharmaceutical companies would invest more in manufacturing innovations such as automation and AI rather than focusing on cheap labor. He mentioned that the success of countries like Taiwan in controlling the pandemic was the implementation of policies from a central command. The US would need a national policy and regulatory framework to bring together the expertise in diagnostics and healthcare industry and make it accessible.

Dr. Johnsee Lee mentioned how Taiwan was successful in limiting the spread of COVID-19 by effective monitoring and testing protocol put in place after the 2003 SARS outbreak. Contact tracing, monitoring of people in quarantine, and at-risk individuals was made possible by a combination of technology and concerted efforts from the federal and provincial governments at the very beginning. He described a pilot program by the CDC in association with Stanford University to assess the risks in trans-continental air travel wherein 500 passengers from San Francisco to Taipei will be monitored before the flight, after arrival, and during quarantine to develop a standard protocol to open Taiwan’s international borders.

Dr. Johnsee Lee, Founder, and CEO, Personal Genomics, Inc.,

Dr. Eric Topol mentioned that the US national response was lacking. Despite the test-trace-isolate protocol, cases have steadily risen. Speaking of the positive changes, he said that wearable technology might help to develop more guided testing parameters for asymptomatic carriers, and Telemedicine has become a mainstay. Since COVID-19 is a new disease, there is a learning curve with developing vaccines and other treatment options.

Dr. Eric Topol, Executive Vice-President, Scripps Research Institute

Structural biology has helped with atomic resolution structures of coronavirus, cellular receptors, and monoclonal antibodies, which will inform drug development. Gilead’s remdesivir has shown significant efficacy from two clinical trials. Neutralizing antibodies and convalescent plasma are promising options too. However, we need to exercise caution in understanding the symptoms and response to certain therapeutic avenues. Early and accurate diagnosis is key to combating infectious diseases.

Dr. William Hait is also a proponent of early disease detection and interception. He said the focus needs to be on more fundamental research into the causes of diseases. There have been numerous partnerships across the globe for vaccine development. At Johnson & Johnson, from four candidates, they have scaled up clinical trials for two, and human trials are expected to end in September 2020. If the trials are successful, Johnson & Johnson aims to be able to produce 1 billion doses of the vaccine by the end of 2021. He also spoke of the JnJ supply chain innovation program, where they work on improving manufacturing processes. A good example is the engineering of the Percy6 cell line to improve viral outputs.

Dr. William Hait, Global Head, Johnson & Johnson External Innovation

Dr. Karen Heichman from the Bill and Melinda Gates foundation emphasized on the importance of diagnostics and the availability of kits. She mentioned how low-cost nasal swabs had improved the scale of testing in South Africa since nasopharyngeal swabs are cost and labor-intensive. Development of self-collection and point of care diagnostic kits will be essential to ensure adequate testing. Public and private funding to scale up manufacturing of these kits will enable a lot of small and medium-sized companies and keep the supply chains going.

Dr. Karen Heichman, Senior Program Officer, Diagnostic Development, Innovative Technology Solutions, Global Health Division, Bill & Melinda Gates Foundation

She said that in the face of a pandemic, we need a paradigm shift in sample collection. High scale manufacturing of diagnostic kits will increase accessibility and availability across populations. It will also help in the early testing of priority populations. She gave the examples of the agro-biotech industry, which uses high-throughput molecular testing for seed genotyping and basic at-home tests like a pregnancy kit at the two ends of the diagnostics spectrum. Borrowing technology from other industries such as food, automotive or agro-biotech, investing in infrastructure, and incentivizing companies may be the way forward.

Dr. Vicki Seyfert-Margolis of Open Med talked about the importance of mobile applications in collecting information on patterns of disease, especially in asymptomatic carriers and developing algorithms to identify disease predictors. In her collaboration with the College of Medicine, Drexel University, Philadelphia, she is trying to work on guidelines for opening the economy. Essential staff at the hospital, medical students, researchers who cannot work from home are people with high potential exposure. Proper guidelines, informed by patient data, have to be in place to prevent cluster infections.

Dr. Vicki Seyfert-Margolis, CEO & Founder, My Own Med

She mentioned that monitoring long term consequences for COVID-19 patients with regular follow-ups is essential because understanding recovery from disease is vital to be able to think of prevention. Addressing health inequities, she said that the current pandemic had stressed the importance of access to healthcare in underserved communities and the need to address the trust deficit in these communities. She mentioned that the CDRH (Centre for Devices and Radiological Health) has classified software as a medical device and defined guidelines for information sharing in the wake of using wearable technology for monitoring health data. Similarly, in Europe, legislation is in place for remote diagnostics. For more regulatory policies for diagnostics, robust controls are necessary.

Going forward, we need to develop a durable diagnostic infrastructure across the world. The panel agreed that healthcare would require a combination of robust diagnostics and digitization. In the coming months, a combination of effective treatment options like neutralizing antibodies, convalescent plasma, repurposed drugs should reduce fatality rates, even if a vaccine takes time.

The pandemic has highlighted the value of science and scientific data to save and improve lives and that the generation of knowledge is important for all humankind. It has put public health in focus with a need to address inequities in healthcare, disease as a population problem. In the biotech industry, COVID-19 has engineered a shift in investment from oncology to a broader distribution of chronic and infectious diseases. It has spurred collaborations across the board (basic research, antibodies, vaccines, diagnostic kits, manufacturing and supply chain pipelines) between industry, academia, public and private sectors, enabling us to be better equipped for the next pandemic. With high costs to pay, COVID-19 presented a unique opportunity to address significant needs in science and society.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: BIO Digital 2020 Highlights: Leveraging Platforms and Partnerships to Develop COVID-19 Vaccines in Record Time

References

https://www.bio.org/events/bio-digital/sessions/666240

Author

Sahana Shankar