Legal and Regulatory Issues, Challenges, and Opportunities in the Era of COVID-19

Dr. Wansheng Jerry Liu, 2019-2020 SAPA President, opened the session and welcomed speakers and audience


Dr. Wansheng Jerry Liu, 2019-2020 SAPA President, gave a brief introduction to the Legal session. After the opening remarks, Michael Druckman, former FDA lawyer, started his talk by asking the audience how long the vaccine development used to take before COVID-19. After stressing the significant speedup from ten-plus years to less than one year, he credited the unprecedented speed advancement to the FDA’s emergency use authorizations (EUA). He pointed out that on one hand, the practice of EUA awards the first runner, but on the other hand, the rapid vaccine EUAs and approval put strains on FDA at the same time – the expectation to get approval with limited evidence was one example he cited. Michael ended his talk by clarifying that mRNA and AAV vaccines are not categorized under gene therapies.

FDA Regulatory Issues in Fighting COVID-19 by Michael N. Druckman


Next, Dr. Joanna Wu, an experienced in-house counsel, shared her personal experience as General Counsel for HiFiBiO Therapeutics during the pandemic. The pandemic has brought many challenges as well as opportunities. When the pandemic hit, HiFiBiO Therapeutics, at the company level, need to not only maintain its essential R&D business, but also respond in a timely manner to frequent policy changes. Because HiFiBiO is a multinational biotech company, at a personnel level, its employees face the challenges of communication between employees from multi-time zones and long-term remote working. She specifically highlighted the importance of communication during the pandemic. She concluded her talk by sharing her thoughts on the opportunities the challenges have brought at both the company level and personal level.

COVID Policy Changes, Telecommuting and Communications in the Pandemic by Dr. Joanna Wu


Followed by Joanna, Jingxi Chu, as 3rd speaker of the session, is Director of IP Affairs & Deputy General Counsel of Nanova that is a medical device start-up. She started her talk by pointing out the conflicting policies Nanova faced between the State of Missouri and the town of Columbia – the most progressive town in Missouri– where Nanova is headquarted. Then she introduced the policies Nanova company-wide adopted and modified. In terms of quarantine practice, Nanova developed its own practice based on local quarantine guidelines. Regarding “work from home” practice, in addition to talking about its pros and cons, she brought up a fairness concern: should the salary of the work-from-home employees be adjusted? After discussing the feasibility of the vaccine mandate, she concluded her talk by mentioning that adopting policies to a company’s daily practice involves many compromises, frequent revisits, and lots of employee education.

Practical Challenges and Strategies in Managing a Start-up in a Red- State During COVID by Jingxi Chu


Last but not the least, Elizabeth Litten, one of New Jersey’s leading health care attorneys, and Kenneth A. Rosenberg, experienced counsel for solving labor and employment issues, both from Fox Rothschild LLP, gave us an informative presentation about legal considerations for the return to work. Employers cite the need to service increased business activity, improve customer service and responsiveness, enhance employee supervision, rebuild corporate culture and values, boost creativity and morale, and address operational difficulties caused by remote work. The growing number of businesses seeking to bring employees back to the workplace face challenges: the prevalence of the delta variant, employee preference leaning toward working from home, and evolving regulations have complicated the process of returning to work. On vaccine mandates, they talked about some scenarios such as employees’ refusing to get the vaccine; the legality of employers requiring employees to provide proof of vaccination and suggested employer accommodations to these specific issues.

Legal Considerations for the Return to Work by Elizabeth Litten and Kenneth A. Rosenberg


Group photo of session speakers and moderators

Public Health Challenges and Implications

Session moderator Dr. Yong Guo welcomed speakers and audience to the session


Dr. Yong Guo from Fairleigh Dickinson University gave a brief opening remark of Public Health session, and then welcomed Dr. Margaret Fisher who is a special advisor to the Commissioner of Health of the New Jersey Department of Health. She discussed COVID-19 vaccines from the perspective of a public health issue. Dr. Fisher first talked about the challenges that the pandemic presents to the public health system, and then efforts and strategies for getting vaccines delivered to all people, especially in the state of New Jersey. As a pediatric infectious disease specialist, she also emphasized the importance of safety in schools. She introduced several risk mitigation practices for both students and employees, including wearing masks and maintaining social distance indoor, vaccinating all eligible people, segmenting young people into cohorts, contact contracting and isolating infected people, and quarantining unvaccinated close contracts.

COVID-19 Vaccines as a Public Health Issue by Dr. Margaret Fisher


Manan Shah, Vice President and Head of Global Public Affairs at LEO Pharma and Adjunct Assistant Professor of Public Health at Fairleigh Dickinson University, continued discussions of COVID-19-related topics. He gave a talk regarding the impact of COVID-19 on public health policy. His talk started by referencing the health policy in this time of a global pandemic, including the immediate and long-term responses. Then he provided a thorough introduction of the mental health approach in response to the pandemic. He suggested that we need a comprehensive mental health strategy, expanded mental health focus before going back to school and work, a larger public health work force, and a plan for prolonged and severe stress rates. Mr. Shah also gave us insight on the COVID-19 pandemic from the perspective of the pharma industry.

The Ripple Effect: COVID-19’s Impact on Public Health Policy by Manan Shah


Last but not least, Dr. Bojana Beric-stojsic, as the 3rd speaker of the session, is an associate professor and program director of MPH Program at the School of Pharmacy & Health Sciences, Fairleigh Dickinson University. Her talk focused on public health professional preparation. She first reviewed the current situation of professional preparation in public health, health promotion and education. She emphasized that public health graduates have a wider range of professional options than liberal arts as well as clinical science students, and that teachers and educators should proactively provide effective and meaningful practice for future public health practitioners under COVID-19 pandemic circumstances. Dr. Beric-stojsic also discussed current barriers and opportunities and introduced new directions of professional preparation as potentially effective pedagogical practice.

Professional preparation in the time of COVID-19: Pedagogical Challenges and Opportunities by Dr. Bojana Beric-stojsic


Group photo of session speakers and moderators


Career Development Spotlight: “BE ON!”

Anyone can learn HOW TO BE ON! by Julie Campbell

Dr. John Sun, SAPA President, gave a brief opening remark welcoming all the speakers and guests to Career Development session. Julie Campbell, the Founder of Center Stage Connections, shared her experiences on stage and talked about how she translated that to career stages on communication and storytelling. She made a parallel comparison between an actress on stage and a professional during meetings. Professionals should think like actors, specifically, they should project presence and authenticity and should foster curiosity and clarity for deeper engagement. Consider phone calls and meetings as a stage. Professionals should invest themselves entirely into the story and performance. When on stage, the actor pays attention to both performance and the audience. Similarly, professionals should pay attention to both the presentation and the reaction from the audience to ensure that there is an established connection. One way to improve the engagement between the presenter and the audience is to be authentic and vulnerable, so the audience can understand and relate to you.

Group photo of session speakers and moderators


Healthcare Investment Trend and Transformative Deal Cases

Dr. Xiaodong Chen, SAPA President, opened the session and welcomed speakers and audience. 

Dr. Jack Wu from Antengene introduced the session agenda.


Xiaodong Chen, SAPA President, and Dr. Jack Wu opened the session and welcomed speakers and audience. The first speaker was Dr. Jonathan Liu, CEO of BeiGene Bio-Island Innovation Center. He said that innovative drugs are predicted to be the biggest growth driver of the pharmaceutical industry in China, with the total market increasing from $247 billion in 2019 to $507 billion in 2029. Dr. Liu believes there are huge opportunities to fuel early-stage innovations in China. Dr. Liu also introduced BeiGene’s patients first mission. In addition, BeiGene has been building a global ecosystem of cost and speed competitive advantages, together with extensive collaborations. This great endeavor includes the launch of BioIsland Innovation Center in the vibrant Greater Bay Area of China. Toward the end, Dr. Liu answered the audience question that BeiGene is recruiting talented individuals, especially those with leadership, communication skills and scientific expertise.

Embracing the Changing World with Innovation by Dr. Jonathan Liu


Dr. Vincent Xiang is the Founding Managing Partner of 7G BioVentures. Dr. Xiang introduced 3 example investments which he orchestrated on both sides of the Pacific Pond: VielaBio, iTeos Therapeutics and Angitia BioPharma. Moreover, Dr. Xiang used Softbank Vision Fund as a case study to demonstrate the investment opportunities in health sciences. In 2 years since its onset, Softbank Vision Fund has made 8 deals in health sciences out of 44 total deals. Dr. Xiang gave a comparative analysis of US vs. China healthcare venture capital markets in 2020. In both markets, 2020 was a record year for investment activities. However, he highlighted that very few healthcare specialist investors are experienced in both US and China healthcare markets. Dr. Xiang concluded his talk with opportunities and threats in cross-border healthcare VC investments.

Recent observation in biosciences by Dr. Vincent Xiang


Dr. Fang Zhang is the Executive Director of China Business Development at Bristol Myers Squibb. Dr. Zhang shared her insights from working in business development in BMS. She described how business development is central to BMS. Within BMS, there is a close partnership between BD and R&D. Dr. Zhang highlighted a few recent BMS BD successes since 2020, after the acquisition of Celgene. Dr. Zhang also introduced the BMS’ long-term aspiration for China 2030, as well as thoughts on leveraging external opportunities to support this aspiration. BMS is in the process of expanding and accelerating the global innovative portfolios to address high unmet patient needs in China. At the end of the talk, Dr. Zhang and the audience discussed the possible strategies for cultivating early-stage innovations in China.

Partnering to Speed Transformational Medicines to Patients by Dr. Fang Zhang


Dr. Chong Xu is Partner of F-Primer Capital Partners. Dr. Xu first introduced F-Prime Capital and its investment in all healthcare subsectors around the globe. F-Prime has a long history of successful investments in China, where it holds more than 40 active portfolio companies. Dr. Xu guided the audience through the past two decades of continued innovation in the US and the EU markets. In China, biotech and CRO/CMO have also experienced rapid growth over the past 6 years. Even so, China as a developing and aging country still has plenty of room to grow. Dr. Xu believes that China now has many of the key “ingredients” needed from a strong healthcare industry. In the end, Dr. Xu shared his observations of the bullish private market being interlinked with the bullish public market for the past decade.

Current Investment Trends between the US and China by Dr. Chong Xu


The panel discussed challenges and opportunities in US-China cross-border deals post-pandemic and under geopolitical tensions. There was still optimism in China-to-US foreign direct investment and cross-border licensing deals. For the China market for healthcare and biotech investments, the panelists observed great growth potential and a fast-increasing number of sophisticated investors. More and more “me-better” and “me-best” advancements were expected to originate from Chinese companies thanks to government administrative support and increasing talent supply. On the other hand, a global vision has become a necessity for Chinese companies. Entrepreneurs on both sides of the Pacific pond were advised to pay attention to local implementation teams for cross-border investments and evaluate if their current corporate structure provides proper flexibility for their business model.

Panel discussion moderated by James Early


Stephen Xue as one of session moderators gave a closing remark. He first acknowledged the teamwork from all the speakers, panelists, sponsors and volunteers. He emphasized that the mission of SAPA is to build platforms and supporting systems for our members and friends. As for the next to come, the 5th SAPA healthcare investment forum and roadshow will be held at Columbia University on June 25th, 2022. It has always been one of the most anticipated SAPA event, and so early registration is highly encouraged.

Group photo of session speakers and moderators


At the end of the presentations and panel discussions, SAPA also planned a series of interactive network breakout sessions to provide opportunities for the conference attendees to participate in conversations with the speakers and panelists. Please stay tuned to our media platforms for more upcoming reports on parallel sessions!