Alexander Varond

Among the significant matters Alexander Varond has worked on in the past two years are two high-profile public offerings. First, he served as lead company-side FDA regulatory counsel for Intellia Therapeutics, a clinical-stage genome editing company, in its $690 million underwritten public offering. This offering followed the release of clinical data supporting the safety and efficacy of in vivo CRISPR genome editing in humans.

The second matter involved advising BELLUS Health Inc., a clinical-stage biopharmaceutical company, in its $153 million and $200 million public offerings. These offerings required a deep understanding of the company’s pipeline and Varond previously worked with BELLUS on regulatory and SEC matters. The acquisition of BELLUS by GSK for approximately $2 billion further highlighted the significance of these deals.

According to Varond, three prominent trends in the health care field require attention in the near future. The first is the increased difficulty in securing financing. “Life science companies must respond to tighter markets,” he said. “This means looking at creative ways to finance, license, and prioritize. For example, reverse mergers are increasingly being considered. Companies also have to prioritize their pipelines and think critically about their regulatory strategies, including how and when they interact with FDA, EMA and other regulatory authorities.”

The second trend involves the push for regulatory flexibility while maintaining commercial incentives. “Despite recent headlines, controversy around FDA’s accelerated approval program is not new. Dating back to 1992, FDA’s accelerated approval program is a centerpiece of the FDA’s exercise of regulatory flexibility,” Varond said. “And it is important to keep in mind that accelerated approval has always had critics, yet it has been a key force in unlocking seemingly impossible therapeutic areas, like HIV/AIDS in the late 1980s, early 1990s and multiple sclerosis in the 1990s. The current controversy around Alzheimer’s drugs and the effort to withdraw approval of Makena has led to significant changes to and around accelerated approvals. This includes new legislation via the Food and Drug Omnibus Reform Act of 2022 and pricing and reimbursement restrictions. If the pendulum swings too far against accelerated approval, a critical tool in developing and approving drugs for the most dire unmet medical needs would be threatened.”

Lastly, the growing impact of AI in the life sciences industry requires careful regulation and consideration of its potential benefits in areas such as medical device development, drug discovery and research processes. “Although not new, AI is now everywhere. Life sciences companies are increasingly developing medical devices that use AI or machine learning (ML), drug candidates or leads are being developed through AI/ML and increasingly robust AI/ML technology is changing how research, including preclinical and clinical research, is being conducted,” Varond said. “For example, AI/ML may be able to curtail the need for animal testing, whereby increasing speed and reducing cost and ethical concerns. How FDA advances and regulates AI/ML is critical to its adoption and impact.”

In addition to his legal work, Varond is involved in various volunteer activities and professional associations. He serves on the board of the Ogden C.A.R.E.S. Foundation, a patient advocacy group, and engages in pro bono projects such as VoteRiders and the New England Innocence Project. He is an active member of industry groups and bar associations, including the Food and Drug Law Institute and the Drug Information Association.