Trio expands clinical trial and data management and protection capabilities
Linda Malek, Jason Johnson and Blaze Waleski are joining Crowell & Moring’s Health Care and Privacy & Cybersecurity groups and will be based in the New York office.
The team comes from Moses Singer, where Malek served on its Management Committee and led both the Healthcare & Life Sciences and Privacy & Cybersecurity practices. All three lawyers served as leaders of MS Strategic Solutions, a consulting company focused on clinical research, data privacy, digital healthcare and life sciences. At Crowell, they will also join Crowell Health Solutions, the firm’s strategic healthcare consulting firm.
The trio brings a rare combination of experience handling regulatory and compliance issues related to clinical trials for biotech and health tech companies as well as data privacy and cybersecurity matters across the healthcare sector and beyond. They counsel technology companies and academic medical centers on issues regarding patient consent, privacy, state laws governing the use of human tissues, intellectual property, and clinical trial contractual agreements. Outside of healthcare, the group advises a range of industries on data privacy and cybersecurity matters.
In addition, as artificial intelligence advancements continue at a record pace, this team is situated to help guide data custodians through the entirety of their privacy and confidentiality obligations, from customer notifications to algorithm structures to data transfer security.
“This is a huge opportunity to broaden what we can do for our clients in the healthcare regulatory and data privacy space,” said Troy Barsky, co-chair of Crowell & Moring’s Health Care Group and managing director of Crowell Health Solutions. “Any organization working on cutting edge healthcare products or services, whether a technology company, managed care company, academic medical center, or financial insitution, must deal with a myriad of federal, state, and international regulations to bring its product to market successfully. This team is prepared to guide them through those complex processes and requirements.”
The team has extensive background in providing legal counsel to life science companies beyond the clinical trial space, including transactions, FDA compliance, negotiating IP agreements, technology transfer agreements, privacy, advertising and brand promotion, and fraud and abuse compliance. They counsel start-ups, emerging and mature life science, biotechnology, medical device and health tech organizations to support and sustain their healthcare, research and medical device operations around the globe.
“We are seeing a record number of data breaches and ransomware incidents, which confirms what we’ve known for years: data is a commodity, and the healthcare and life sciences space is no exception,” said Jeffrey Poston, co-chair of the firm’s Privacy and Cybersecurity Group. “Linda, Jason, and Blaze are exceptionally well-positioned to assist our clients with ensuring they are set up for success across their clinical trials and data management infrastructures.”
The new team builds on the strategic growth of the firm’s New York office. Over the past five years, the office has more than doubled in size to approximately 170 lawyers and staff under the leadership of Glen McGorty, managing partner of the firm’s New York office.
“We are excited to welcome this outstanding team to our New York office,” McGorty said. “There are strong synergies with their practice and our healthcare transactions group in New York.”
Malek serves as a board member for NewYorkBIO, an advocacy group for the life science industry in New York where she co-founded and co-leads the organization’s DEI initiative. She also previously served on the Education Advisory Board of the International Association of Privacy Professionals. All three members of the team serve as mentors for FirstXFounder, a nonprofit aimed at helping train emerging life sciences companies. Waleski is a member of the board of directors of Mouse, a national youth development nonprofit.
“Crowell delivers top-notch client service, is an innovative market disruptor in the healthcare and data privacy space, and most importantly, a collegial and collaborative place to work,” Malek said. “I am thrilled to have found a place for my team to meet our clients’ growing needs of regulatory guidance in healthcare, life sciences and data privacy and cybersecurity.”
Malek earned her law degree from the University of Virginia School of Law and her undergraduate degree from Walla Walla University. Johnson earned his law degree from Franklin Pierce Law Center and his undergraduate degree from the University of North Carolina, Chapel Hill. Waleski earned his law degree from Rutgers School of Law and his undergraduate degree from Fordham University.
About Crowell & Moring LLP
Crowell & Moring is an international law firm with operations in the United States, Europe, MENA, and Asia. Drawing on significant government, business, industry and legal experience, the firm helps clients capitalize on opportunities and provides creative solutions to complex litigation and arbitration, regulatory and policy, and corporate and transactional issues. The firm is consistently recognized for its commitment to pro bono service as well as its programs and initiatives to advance diversity, equity and inclusion.
