Every month, MassBio spotlights a member company and the great work they’re doing to advance the life sciences industry and support the patients we serve. In June, we spoke with Sarah T. Hogan, Partner at McDermott Will & Emery. Sarah helps companies across the life sciences and digital health industries with structuring and negotiating strategic collaborations, licensing arrangements and other complex commercial transactions that drive their business and mission. She works closely with McDermott’s regulatory lawyers to eliminate roadblocks and help her clients successfully deliver innovative solutions that improve health care.
Tell us about your organization, its mission, and current initiatives.
One of the most exciting things about working at the intersection of life sciences and health care is that the industry is constantly evolving and facing unique challenges. There are no established answers to some of the most pressing questions our clients face, so we dig in with our clients to tackle these issues together.
Data use is one of the most frequent issues our clients in the life sciences industry are grappling with today. Life sciences companies are sharpening their focus on data use practices, with emphasis on how they can use real-world evidence and other data to get therapies to market faster and drive patient adherence. Data use raises a myriad of complex regulatory issues, such as HIPAA and other data protection regulations, FDA and FTC regulatory concerns, and fraud and abuse laws, just to name a few. Our team at McDermott has a finger on the pulse of the ever-evolving regulatory framework in these areas, and as a transactional lawyer, I focus on bringing together the right specialists to develop a fully integrated approach to help our clients navigate these complexities.
How do your organization’s activities help patients now and into the future?
The reason this practice is rewarding is that we partner with companies at the forefront of new therapies as they formulate their business plans. As I previously mentioned, there are a multitude of regulatory challenges that have an impact on how these companies build strategic partnerships and run their businesses. At McDermott, we work across practices including intellectual property, regulatory, transactional, litigation, tax and employment law to help our clients go further. We focus on strategies for clearing the obstacles so that our clients can focus on opportunities to improve health care delivery and patient outcomes, all in service of getting life-changing therapeutics to market sooner.
What do you see as the biggest challenge facing the life sciences industry today?
The health care industry as a whole—including life sciences stakeholders—continues to struggle with implementing a transition from the traditional fee for service model to a value-based care model. Upending the model for our entire health care system in the United States is obviously a considerable challenge, and I think we’ll see the various stakeholders struggle with this for a long time to come. At the same time, this upheaval creates the opportunity for life sciences companies to help shape a new care model that focuses on patient wellbeing. And we’re seeing our clients getting creative in building business models around this goal. That’s where we come in—we thrive on helping companies seize opportunities while navigating the regulatory complexities and minimizing risk.
What’s next for your organization / what are you focused on in the coming year?
As always, we’ll continue to work with our clients to navigate the complex regulatory, business and legal issues that continue to proliferate across the life sciences and health care industries, and fuel the mission of life sciences companies large and small.
We’re also highly focused on engaging with investors early to identify—and mitigate—potential regulatory, compliance and business risks before they arise. When a potential investment target does not have a solid compliance strategy, it can cause serious headaches for the investor down the road. We help investors make sure that the technology they are investing in actually makes it to market.
We’ll also be maintaining our comprehensive global network and focus, which is vital in today’s market, as many larger pharma companies have a global footprint and today’s deals are cross-border more often than not. We have well-established practices in Europe and China, allowing us to deploy integrated global teams to deliver seamless solutions across geographies.
If you’re interested in being featured in MassBio’s Member Spotlight, please see guidelines here.