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
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Life Sciences Dealmaking Symposium: As the Dust Settles: Post-Election Update and Impact on the Life Sciences Industry

by | Dec 11, 2020 | ,

How will the election affect life sciences in 2021 and beyond? What’s ahead for the regulatory and policy environment? In this session, our elite group of policy analysts reviewed the election results and the far-reaching effects for dealmakers, executives and investors.

Eric Zimmerman, global head of McDermott’s Health Industry Advisory Practice Group, moderated this discussion that featured insights from Susan Van Meter, executive director at AdvaMedDx; Rodney Whitlock, PhD, vice president at McDermott+Consulting; and Brian Fortune, senior managing director at Farragut Square Group.

Below are the top takeaways for Life Sciences Dealmaking Symposium: As the Dust Settles: Post-Election Update and Impact on the Life Sciences Industry, click here to access the full webinar.

Access the PDF here.

President-Elect Biden’s legislative experience likely will help him reach across the aisle and engage with Republican congressional leadership to advance policy goals. “Biden spent his whole career on the Hill before he became vice
president, so he really understands how his colleagues tick, and he particularly understands the process of how the Hill makes sausage,” Mr. Fortune said. “That’s something that you can’t really say about either President Obama or President Trump. So, not surprisingly, you saw that when they had all the majorities lined up in their favor, they could move stuff, but when they didn’t, it became a little harder.”

With only a narrow projected majority in the US House of Representatives, Democrats will need to work together more effectively and reach [...]

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Life Sciences Dealmaking Symposium: Powering through the Pandemic: Trends in Early-Stage Investment

by | Dec 11, 2020 | ,

The pursuit of progress during these unprecedented times has led to a surge in life sciences investment and funding for early stage companies. Investors are on the lookout for the next big innovation while also navigating new ways of sourcing and managing portfolio companies. Our panel of experienced early-stage investors discussed the top trends in this push for advancement, including sectors attracting the most dollars in today’s challenging business landscape, key issues that early stage investors are watching as they source and vet new investment opportunities, steps that executives of early-stage companies can take to articulate their value and attract investors, and more.

McDermott partners Todd Finger and Joanna Lin moderated this discussion featuring Eric Aguiar, MD, partner at Aisling Capital; Dr. Andrew ElBardissi, partner at Deerfield Management; and Marian Nakada, vice president of venture investment at J&J Innovation.

Below are the top takeaways for Life Sciences Dealmaking Symposium: Powering through the Pandemic: Trends in Early-Stage Investment, click here to access the full webinar.

Access the PDF here.

COVID-19 fundamentally changed the process for evaluating new investment opportunities, Dr. ElBardissi said. “Meeting face-to-face with the management team, kicking the tires, touring the facility—those are intangible factors
that are very difficult to replace in this corporate environment,” he said. “Candidly, the bar has gotten significantly higher, as you think about our inability to conduct diligence the way we would like and as you think about all the constraints in the current environment.”

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Life Sciences Dealmaking Symposium: New Factors in the Mix: Diligence in the Time of COVID-19

by | Dec 11, 2020 | ,

Navigating the ever-changing global life sciences deal landscape has become more challenging in the post-pandemic world. Conducting virtual inspections and examining security and privacy risks for remote working and new operating procedures will be central to evaluating current and future collaboration partners and targets. Thinking quickly yet carefully is essential for successfully adapting to this new normal. This panel explored the critical issues that executives and investors should watch out for in a post-COVID-19 world.

McDermott partner Michael Siekman moderated this discussion featuring Tom Brida, general counsel and chief compliance officer at Invitae; Dr. Anna French, partner at Qiming Venture Partners; Chuck Wilson, president and CEO of Cogent Biosciences; McDermott attorney Jennifer Bock; and Laura Jehl, global head of McDermott’s Privacy and Cybersecurity Practice Group.

Below are the top takeaways for Life Sciences Dealmaking Symposium: New Factors in the Mix: Diligence in the Time of COVID-19, click here to access the full webinar.

Access the PDF here.

The COVID-19 pandemic has forced dealmakers to conduct due diligence virtually, using tools such as videoconferencing and virtual data rooms more than ever before. In some ways, this shift has actually made the due diligence process more efficient, the panel observed. With the complications of travel replaced with the convenience of videoconferencing, some aspects of the process are moving along more quickly than before the pandemic shutdown.

Despite increased efficiencies, lack of in-person interactions may impact deal pipelines long-term as investors move from doing deals [...]

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HPE New York 2020: Big Bankers Breakfast Discussion

by | Nov 6, 2020 | , ,

In this lively panel session, global heads of healthcare at top banks analyzed the current market climate for healthcare services investing and provided their invaluable insights on hot sectors, growth strategies and the dealmaking outlook for 2021. McDermott counsel Charlie Ditkoff moderated this panel featuring Daniel Decelles, global co-head of healthcare investment banking at Jefferies; Matthew McAskin, senior managing director at Evercore; Jim Forbes, vice chairman of Morgan Stanley; Mark Francis, managing director and head of the healthcare group at Houlihan Lokey; and Cheairs Porter, head of the healthcare and life sciences group at Harris Williams.

Below are the top takeaways for HPE New York 2020 half day session: Big Bankers Breakfast Discussion, click here to access the full webinar.

Access the PDF here

The public markets have recovered remarkably from the lows of March and April 2020 and are currently seeing unprecedented deal activity, Mr. McAskin said. However, amid that activity, “there is no one solution that is working,” he said. “We are seeing financing work, we are seeing creative transaction structures work, and we’re seeing a resurgence of initial public offerings and special purpose acquisition companies like we have not seen for years or for decades. It’s a very confusing time for a lot of people, because we’re seeing these micro-cycles occurring very quickly.”

As might be expected in light of the Coronavirus (COVID-19) pandemic, valuations for tech-enabled healthcare businesses have risen significantly this year, and that trend will likely continue into 2021. “I [...]

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HPE New York 2020: The Impact of COVID-19: What’s Hot, What’s Not

by | Nov 6, 2020 | , , ,

In the wake of COVID-19 some health sectors have emerged as hot while others are troubled. Our panel of active investors discussed where the dollars are going and offered insights on why in relation to the events of 2020. McDermott partner Jerry Sokol moderated this dynamic panel featuring Paige Daly, partner at Harvest Partners; Chris Gordon, global head of healthcare and co-head of North America private equity at Bain Capital; Geoff Lieberthal, partner at Two Sigma Impact; and Rob Wolfson, executive managing director and head of H.I.G. Advantage Fund and U.S. Healthcare.

Below are the top takeaways for HPE New York 2020 half day session: The Impact of COVID-19: What’s Hot, What’s Not, click here to access the full webinar.

Access the PDF here.

COVID-19 has revealed weaknesses in the healthcare system and in healthcare delivery in particular. “One of the most fundamental things that we as healthcare investors all should be thinking about is investing in businesses that are making things better for the entire system—for patients, for providers and for payors,” Ms. Daly said. “That means we should be both raising quality and lowering costs.” These principles are driving some of the most exciting innovation today, particularly in payor services, physician practice management (PPM) and healthcare IT.

Healthcare IT generally and telemedicine specifically are areas of major investment. Dramatically accelerated patient and payor adoption of telehealth has created [...]

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DEA Proposes Regulations for Emergency Medical Services Agencies

by | Oct 8, 2020 | ,

On October 5, 2020, the US Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking establishing a registration category for emergency medical services (EMS) agencies and more generally implementing the requirements of the Protecting Patient Access to Emergency Medications Act of 2017.
The majority of the proposed regulations closely track the Act. For example, the proposed rule would:

  • Add EMS agencies as a new category of DEA registrants
  • Allow an EMS agency to obtain one DEA registration for each state where the EMS agency operates (regardless of number of locations within a state)
  • Allow hospital-based EMS agencies to operate using the hospital’s DEA registration.

The DEA also exercised its authority to implement the purposes of the Act more broadly with additional proposed regulations, including:

  • Requirements around notice to the DEA prior to delivery of controlled substances to unregistered locations of the EMS agency
  • Requirements (and options) regarding storage of controlled substances
  • Requirements associated with documentation of individual EMS professionals’ authorization to dispense controlled substances
  • Recordkeeping requirements relating to deliveries of controlled substances among all locations of the EMS agency
  • Recordkeeping requirements associated with controlled substance acquisition, administration and disposal.

Comments on the notice of proposed rulemaking are due by December 4, 2020.



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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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Regulating Medical Devices Post Brexit

by and | Sep 18, 2020 | , , ,

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.

The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.

This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.

Existing law to continue
The rules that currently regulate medical [...]

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What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?

by | Jul 29, 2020 | , , ,

In the second installment of McDermott’s webinar series, HPE Europe 2020: What are the Life Science Transaction Trends in the Wake of the Sanitary Crisis?, moderator and McDermott partner Emmanuelle Trombe and industry experts Joseph El Khoury of Natixis, Cédric Garcia of EY’s Life Science Group, Dr. Erich Tauber of Themis Bioscience and Daniel Teper of CYTOVIA Therapeutics shared lessons learned from the first half of 2020, when COVID-19 changed the world. The panelists also discussed the outlook for life sciences transaction trends in the second half of the year and beyond.

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What Impact has Coronavirus had on Doing Healthcare Deals?

by and | Jul 28, 2020 | , ,

In the fifth and final installment of McDermott’s HPE Europe 2020 Summer Webinar Series, McDermott partner Tom Whelan hosted a discussion with Marc Benatar of Apax Partners, Markus Peterseim of Alvarez & Marsal, and fellow McDermott partner Dr. Nikolaus von Jacobs to examine how the Coronavirus (COVID-19) pandemic is affecting deal making in the healthcare industry.

Whelan led the group through a wide-ranging conversation centered on five key pandemic deal impact areas: pricing, process, timing, regulation and future prospects. Read on for discussion highlights, and click here to access the full webinar.

Pricing

“You’ve clearly seen a polarization,” Benatar said. “Nonessential businesses were hit hard by the lockdown effect and remain impacted, while those that were related to essential elements of healthcare were hit but started to experience a catch-up at the beginning of May and are already getting close to the normal run rate volume. I think that businesses that demonstrated that they are related to an essential part of the healthcare offering and that they can survive this type of crisis have almost strengthened their value. Those businesses that we know have experience with this first wave and those that are getting even more prepared for the next one will probably attract the highest valuations.”

COVID-19 has had a significant impact on the due diligence process, Peterseim noted. “When you’re advising investors on commercial or operations due diligence, there are always questions such as, ‘What will be the new normal of profitability? Will it be a swift [...]

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