HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
Digital Health
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After the Curve Podcast: Focus on Life Sciences

by | Oct 8, 2020 |

In this time of crisis, the life science industry has demonstrated remarkable speed, innovation and resilience. In this episode of the After the Curve podcast, our life sciences partners join us to discuss the most promising areas of drug discovery and device development that are emerging from the pandemic and the outlook for the industry in a post-COVID-19 world. McDermott’s Chief Marketing Officer, Leslie Tullio, is joined by Stephen Bernstein and Kristian Werling to discuss key topics impacting the life sciences industry today, including:

  • The reasons behind the immunity of life sciences to slowed investments
  • Why more investors are focusing their equity in healthcare and life sciences
  • Promising areas of drug discovery and device development emerging from the pandemic
  • Critical considerations for life science companies regarding rapid regulatory changes
  • Tactics for moving developments forward at an increased speed
  • The importance of Collaborative Transformation to the life sciences industry

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After the Curve Podcast: Focus on Health Policy

by | Oct 6, 2020 | ,

COVID-19 led to major policy changes impacting how healthcare is delivered and reimbursed, but only some of these new policies will endure in coming years. On this episode of the After the Curve podcast, our colleagues from McDermott+Consulting join us to discuss how the pandemic has changed the conversation leading up to the November presidential election and how key policy issues will evolve in the months and years to come. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Eric Zimmerman, Mara McDermott and Jessica Roth to discuss topics surrounding the pandemic-induced policy shifts, including:

  • The most impactful regulatory telehealth changes that have resulted from COVID-19
  • A look beyond telehealth to a paradigm shift in the broader digital health landscape
  • The impact that a more refined data exchange pathway could have on treatment during the next wave of COVID-19 or future pandemics
  • Meaningful collaborations that are currently happening in the digital health space
  • A look at innovations that are emerging from the demands of post-COVID-19 healthcare
  • Legal and regulatory compliance steps that still need to be taken to allow these telehealth programs to continue in the future

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What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

by | Jul 27, 2020 | , ,

In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott partner Dr. Stephan Rau and industry experts Karthic Jayaraman of TPG Capital, Max Müller of Bayer, Ben Faircloth of L.E.K. Consulting and Dr. Ulrich Wandschneider, former CEO of Asklepios AG, currently at Trilantic Capital Partners and Supervisory Board member of BioNTech SE, the Nasdaq-listed developer of COVID vaccine, headquartered in Germany, discussed the impact that COVID-19 and the government measures to address it have had on investments in healthcare and life sciences in Europe.

“I think it’s about as interesting a time as any in my last 20 years investing,” said Jayaraman. “People are beginning to focus a lot more on innovation, the speed of innovation and how innovation is brought to market. I think the question is, “How can we continue to reward innovation, both by simplifying the process by which it’s made possible and how we value it?”

“New developments in digital health have become more and more attractive as people have had faster access to care and governments have understood that some of their regulations needed to be adjusted,” added Müller.

Jayaraman agreed. “There has been an acceleration of the provision of care through telehealth services and any kind of remote administration of care. It’s probably been an acceleration of two-plus years collapsed into months. I also think we’re going to see some vigorous [...]

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European Healthcare Innovation & Investment in a Post-Pandemic World

by | Jul 6, 2020 | , , , ,

As part of McDermott’s HPE Europe 2020: Where Do the Opportunities Exist for Investment in the Healthcare Sector? webinar, McDermott London Managing Partner Hamid Yunis moderated a panel of industry experts including; Dr. Michelle Tempest of Candesic, Dr. Joanne Hackett of IZY Capital, Dr. Charles Niehaus and Professor Karol Sikora of Rutherford Cancer Centres, who collectively shared their perspectives on healthcare innovation and investment in a post-pandemic world.

The panelists agreed that COVID-19 has served as a catalyst for change and which has revealed important prospects for the future.

“There has been this zest for change which we’ve been talking about for a long period of time, and this has finally been that breakthrough,” said Dr. Tempest. “Both the professionals and the consumers have suddenly woken up to this new dawn.”

“What I’ve actually seen in the past couple of months is a lot of innovation that we were really wanting to accelerate are now actually happening,” agreed Dr. Hackett. “And it’s because we’re finally able to look to the future and think about future proofing to make sure that our healthcare system is actually going to deliver. I see positivity.”

Dr. Niehaus emphasized that, the real opportunity at the moment is to take the technologies many people were resistant to pre-COVID now acceptable, and use the shift as a “springboard to actually move forward.”

“We struggle with the cumbersome nature of a nationalized system that doesn’t really encourage entrepreneurism,” Professor Sikora cautioned. “The entrepreneurial skills are there — in [...]

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FDA 2019 Year in Review

by , , and | Jan 13, 2020 | ,

2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir served as acting interim commissioners following Commissioner Gottlieb’s resignation. On December 17, Congress swore in Commissioner Stephen Hahn, a radiation oncologist and former chief executive of MD Anderson Cancer Center.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year, and offers insight into the agency’s 2020 priorities and expected actions in a number of areas, including:

  • Digital health;
  • Streamlined product approvals;
  • Evolving evidentiary thresholds for product approvals;
  • Strategic enforcement;
  • And much more.

Click here to read the full report. 



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Five Questions with a Health Lawyer: Marshall E. Jackson, Jr.

by | Oct 10, 2019 | ,

Marshall E. Jackson, Jr.
Associate
Office: Washington, DC
Year at Firm: 4

What is your favorite part about practicing healthcare law at McDermott? 

My favorite part of practicing healthcare law at McDermott is working with clients that are out in front tackling very interesting and unique issues. The healthcare industry continues to evolve, and our clients are at the forefront. The changes in the industry have required clients to navigate areas of uncertainty, and our clients look to us to help them navigate that uncertainty. I have been blessed to sit shoulder to shoulder with a dynamic McDermott team helping our clients tackle new and unprecedented issues. No day is a dull day.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

Many of our clients face the challenge of balancing the need to deliver affordable, quality healthcare to people when and where they need it, while maximizing return on investment for their business within a hot healthcare market. While one side seems provider-centered and the other investor-centered, providers and investors alike grapple with this balancing act. In addressing this balance in the context of an ever-changing industry, our clients are seizing opportunities to embrace new ways to deliver healthcare, and forming strategic partnerships and collaborations to strike the balance. We are increasingly [...]

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Five Questions with a Health Lawyer: Anisa Mohanty

by | Jul 11, 2019 |

Anisa Mohanty
Associate
Office: Washington, DC
Years at Firm: 3

What is your favorite part about practicing health care law at McDermott? 

I started out pre-med in college, but I quickly realized what excited me was the intersection between science, medicine, policy and law. Many of our clients are at the forefront of shaping policy in the life sciences space through their innovations, and the quality of our health care practice means we have the opportunity to partner with and support them in really exciting projects. I am grateful for the breadth and depth of knowledge and experience of my colleagues—it pushes me to be a better, smarter and savvier lawyer.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

Because our clients are addressing some of the most complex challenges in healthcare and healthcare delivery, often there aren’t straightforward regulatory paradigms for their businesses. Our clients want to do the right thing, but that can be challenging because their regulators haven’t yet articulated how they will enforce the law as it applies to their services and solutions. Digital health is a great example of this and there’s a lot of opportunity to advocate for our clients so that regulators can take industry perspectives into account when finalizing regulations.

What kind of client work [...]

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