Imola Fodor and Ruixiao Lu

The COVID-19 pandemic brought with it many challenges that fundamentally changed the way we live and work. The Bay Area Biotech-Pharma Statistical Workshop (BBSW)—which is a collaborative initiative supported by companies, academic institutions, and nonprofit organizations in the San Francisco Bay Area—adapted rapidly and found new ways to collaborate virtually and advance its mission: to promote connection, leadership, growth, and impact of the San Francisco Bay Area statistics and quantitative science community.

The Bay Area Biotech-Pharma Statistical Workshop (BBSW) held many online events in 2020, including this end-of-year meeting.

While the pandemic prevented a face-to-face event in 2020, two virtual symposiums—both related to COVID-19—were held. The first, with the theme “Embracing Challenges and Opportunities Posed by the COVID-19 Pandemic: A Showcase of Pragmatic Examples by Clinical Trial Statisticians,” took place August 13–14. Cheng Su of BioMarin, BBSW president-elect and conference chair, opened the symposium and delivered the welcoming remarks. Robert Califf of Verily/Google presented the keynote address, “COVID-19 and the Evidence Generation System.” Marcel Wolbers, Chin-Yu Lin, Zoe Zhang, and Xin Li of Roche/Genentech followed with “Statistical and Executional Considerations for Trials Impacted by the COVID-19 Pandemic.” Finally, Tara Maddala of TMbiostats moderated a Q&A session with the audience and panelists.

Whedy Wang of Theravance Biopharma opened the second day, followed by three presentations: “Considerations and Practices in Monitoring COVID-19 Impact” by Priscilla Yen of Amgen; “Safety Assessment for Studies and Submissions Impacted by COVID-19” by Greg Ball of Merck; and “Summaries of COVID-19 Infections in Clinical Trials” by Mary Nilsson of Eli Lilly. Additionally, Julia Varshavsky of Occampoint moderated a panel discussion about how pharma/biotech navigates COVID-19 and what roles statisticians play.

The second BBSW virtual symposium, with the theme “Balancing Speed and Evidence in Developing COVID-19 Therapies,” was held November 5. Peter Bach of Memorial Sloan Kettering Cancer Center presented the keynote, “The Inflexible Paradox of Scientific Research: Urgency Demands Patience.” The rest of the day included the following four talks: “Designing Efficient Clinical Trials During a Pandemic: Some Personal Lessons from the RECOVERY Trial” by Thomas Jaki of Lancaster University; “Statistical Challenges of Designing COVID-19 Therapeutic and Prophylaxis Trials” by Julia Niewczas of AstraZeneca; “Balancing Speed and Evidence in COVID-19 Trials” by Hemal B. Mehta of the Johns Hopkins Bloomberg School of Public Health; and “A Bayesian Design for COVID-19 Trials with Focus on Vaccines Development” by Natalia Mühlemann and Rajat Mukherjee of Cytel.

To enhance the virtual conference experience and community building, a significant investment was made in developing a BBSW mobile app, which participants of both symposiums used to view conference materials, enter a raffle drawing, and interact with others in the BBSW community.

In addition to the two symposia, BBSW organized several virtual meetups throughout 2020 on topics such as using R in the biotech-pharma industry, real-world data, and career development. The goal of these meetups—to increase networking and information exchange—was accomplished.

In the leadership development area, BBSW launched a pilot mentorship program—project YODA—with five pairs of mentees and mentors. Plans are to launch the program more broadly based on lessons learned. A leadership forum also took place that focused on developing data science capabilities in biotech companies.

BBSW has started to build strategic alliances with peer nonprofit organizations such as the San Francisco Chapter of the ASA to increase its collective impact. BBSW co-sponsored several SF ASA events, including the ASA virtual traveling short courses, “Empowering the Statistician with Spark” and “Machine Learning and Deep Learning,” and the 2020 SF ASA holiday celebration. They plan to continue strengthening their partnership with fellow professional associations locally and nationally.

The events in 2020 reached more than 400 participants in the Bay Area.