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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System CEO Panel: Strategic Business Priorities

by McDermott Will & Emery | Jan 29, 2021 | Hospitals & Health Systems, Life Sciences

Our panel included a discussion on what is ahead for 2021 and how the challenges of COVID-19 will lead to lasting changes for hospitals and health systems, with Lloyd Dean (CEO, CommonSpirit), Melinda Estes, MD (President and CEO, St. Luke’s Health System) and Jaewon Ryu, MD (President and CEO, Geisinger). These top healthcare leaders discussed the short- and long-term impact of COVID-19 on hospitals and health systems and their strategic business priorities in 2021 and beyond with moderator Kerrin Slattery (Partner, McDermott Will & Emery).

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System CEO Panel: Strategic Business Priorities, click here to access the full webinar.

Access the PDF here.

HOW 2020 PRIORITIES WILL SUSTAIN AND PROVE HELPFUL IN 2021 AND BEYOND
For hospitals and health systems, 2020 began and was primarily focused on issues like cost and payment models, Medicaid expansion and the wellbeing of clinical providers, including physicians, where statistics cite 40% are burned out. SinceCOVID-19, hospitals instantly pivoted to healing their communities and their staff, as well as rejuvenating the delivery system. “I was very pleased to chair a task force on COVID-19 pathways to recovery that produced a dynamic document [...]

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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum

by McDermott Will & Emery | Jan 28, 2021 | Digital Health, Life Sciences

Top industry executives BJ Moore, Executive Vice President and Chief Information Officer, Providence St. Joseph Health; Dr. Ali Parsa, Chief Executive Officer, Babylon Health; and Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health, discussed the evolving doctor-patient relationship and the digitized data and technology convergence with healthcare delivery and payment along with moderators Dale C. Van Demark, Partner, McDermott Will & Emery; Rachel S. Hall, Partner, Digital Health Leader, EY; Stephen W. Bernstein, Partner, McDermott Will & Emery; and Lisa Schmitz Mazur, Partner, McDermott Will & Emery. They also provided insight into 2021’s regulatory considerations affecting healthcare innovation and its solutions.

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum, click here to access the full webinar.

Access the PDF here.

CARE OF THE FUTURE
We are only seeing the beginning of the decentralization of care through information technology; but that shift is how scalable solutions to our health care challenges will develop. “Care delivery at home, where we can send patients home and remotely monitor them—eventually that will evolve to things like wearables -IoT devices- that we may have in our clinical settings. We’re seeing the [...]

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

by McDermott Will & Emery | Dec 11, 2020 | Digital Health, Life Sciences

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 McDermott Will & Emery | Dec 11, 2020 | Digital Health, Life Sciences

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 McDermott Will & Emery | Dec 11, 2020 | Digital Health, Life Sciences

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 McDermott Will & Emery | Nov 6, 2020 | Health M&A, Health Private Equity, Life Sciences

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 McDermott Will & Emery | Nov 6, 2020 | Health M&A, Health Private Equity, Life Sciences, Uncategorized

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 Karen Owen Gibbs | Oct 8, 2020 | Hospitals & Health Systems, Life Sciences

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.

After the Curve Podcast: Focus on Life Sciences

by McDermott Will & Emery | Oct 8, 2020 | Life Sciences

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 Sharon Lamb and Bella North | Sep 18, 2020 | Digital Health, Hospitals & Health Systems, International Health, Life Sciences

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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