In early spring, over 100 vaccines began their journey through development and testing. The severity and magnitude of the global COVID-19 pandemic catalyzed an unprecedented race of innovation to develop novel vaccines with the goal of suppressing a growing public health crisis. As summer turns into fall, top candidates have entered phase 3 clinical trial testing. This race is not purely scientific, but also political. Recent decisions by the FDA, CDC, and other government agencies have raised concerns about veiled interests and hasty decisions. As the public looks for objective decision-making and clear communication, trustworthiness continues to degrade leaving people skeptical of quickly advancing vaccine developments. How can we ensure that those in charge of regulating data and deliverables remain shielded from politicization and reestablish trustworthiness?

Within weeks of the formal pandemic declaration, scientists began applying for newly established funding opportunities, pivoted their research focus towards COVID-19 questions, and began freely releasing their data. This fast pace was facilitated in part by the widespread adoption of preprint servers and motivated by a drive to understand and fix a growing public health crisis. Across diagnostic innovation, vaccine development, and contact tracing, advanced technologies were quickly moving out of labs and into testing. How do we balance speed and safety? Who controls the flow of information and where does responsibility reside during an unprecedented pandemic and beyond.

In this BERGIT meeting confronted the questions, what can we learn from the history of rogue stem cell clinics in the US? What contributed to the creation of commercial stem cell clinics peddling unsubstantiated claims? Are there attributes of genome editing technologies that may predict a similar future? Or protect against one? What are the regulatory and enforcement limits that contribute to these negative outcomes? And perhaps most critically, how can the genome-editing field guard against a similar future?

With the announcement of a $1.8M price tag for Bluebird Bio's gene therapy treatment for beta-thalassemia, the latest in a string of shocking prices assigned to new gene therapies, concerns mount over prospects for the affordability of CRISPR therapies. This BERGIT meeting examined the question of price and accessibility from three experts in diverse fields. 

Professors Roth, Rohlfs, and Obasogie led a discussion focused on the technical, legal, and ethical consideration of law enforcement access to commercial DNA databases such as 23andMe or MyHeritage.

This meeting continued the previous conversation. As scientific advances like CRISPR have accelerated the time from discovery to application, what role should education in ethical, legal, and social implications take in future life science training? What kind of ethical knowledge and capacities are essential in the future?
Prior to this meeting, an electronic, updated questionnaire was sent to all members and IGI as a whole and some of the results of that questionnaire were discussed.

This meeting built on a topic that came up in our meeting following the announcement of the first CRISPR babies born. Participants raised the point that the researcher who led this experiment was trained at some of the best scientific institutions, and here in the USA. What can we learn from this? How should we be training future generations of researchers, particularly in Bioethics? Will the future of biological research require a different training approach? Jodi Halpern and researchers Sharon O'Hara and Lex Owen put together a questionnaire to prompt discussion in the group about what kind of ethics training do current researchers in the life sciences receive.

On the eve of the Second International Summit on Human Genome Editing, reports emerged that the first CRISPR-edited babies had been born, spurring widespread condemnation and controversy. This BERGIT meeting will provide a forum for discussion about this revelation and the conditions under which the experiment happened. The meeting will be structured starting with a few short presentations, followed by open discussion. We intend to use the majority of the time for discussion.

This meeting focused on the recently released Draft Guidances for Gene Therapies from the FDA. These guidance documents describe how the FDA will be regulating gene editing therapies (as a subset of gene therapy), and were open for public comment until Oct. 10. Their release presented an opportunity for us to discuss if and how regulation of gene editing therapies should differ from the regulation of classic gene therapies. Separately, Lea and Ken led an effort to collect comments for submission to the FDA. This meeting of BERGIT was not be an official part of this effort, but helped shape it. To facilitate discussion, Lea and Ken provided an overview of what is in the guidance that may warrant consideration, and then opened the floor to discussion from the group.