Richard Zall

Read key takeaways from FDA's long-awaited Draft Guidance on its platform technology designation program in our latest Goodwin Life Sciences Regulatory & Compliance team client alert below!

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Check out this great summary of the new FDA guidance on “platform” technologies from Goodwin partners Julie Tibbets, Susan Lee and Steven Tjoe.

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Listen Here: https://lnkd.in/gXjq6VJR In this episode, Alan Condon, Editor-in-Chief at Becker's Healthcare, discusses current healthcare trends with Scott Becker, including challenges in hospital mergers, notable acquisitions like Kaiser’s purchase of Geisinger, and CMS's financial aid for Medicare providers impacted by the Change Healthcare cyber attack. He also highlights the FTC's increased antitrust enforcement in the healthcare sector. For more information about Becker's Healthcare, please contact Jessica Cole or Scott Becker. #podcast #healthcare #leadership

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A panel discussion on #capitalmarkets at #ausmedtech2024 moderated by Bronwyn Le Grice with Steve Burnell Elyse Shapiro Chris Nave and Jo Chaturvedi- Durant : 📉 the heights of investment and valuations in 2021 and the fall-off in 2023 didn’t necessarily affect #medtech 📈with record numbers of FDA approvals of medical devices last year the sector is hopefully positioned for uplift 💭 funds have been holding on to capital and channeling it to their existing portfolio 🩺 medical devices may be a simpler investment proposition but investors can still experience shocks with problems in reimbursement for example 💰potential acquirers are waiting for companies to generate revenue rather than buying on good clinical results 🏹 we have the money here; we need to convince the super funds to unlock it➡️the more wins we have (which requires international capital at this point) the more evidence we have to persuade them 🤝 being partnered with big medtech is accretive in the eyes of investors 🚛 one challenge with the ASX is the lack of specialist analysts and specialised investors 💥 differing views on whether debt is attractive or a deterrent for investors 💰 be aware of non-dilutive funding opportunities here (eg MRFF) and overseas (eg BARDA) 🩺 lay the groundwork for bringing in specialist investors from US/EU by bringing in KOLs from there #venturecapital #asx #capitalraising

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The latest on private equity-backed healthcare services: WSJ's initial article in a three-part series delves into the Steward Healthcare bankruptcy and the United States v. U.S. Anesthesia Partners antitrust case in Texas. Stay informed on the evolving landscape. #foleyandlardner #privateequity #healthcaretransformation #antitrust #bankruptcy #hospitals #healthsystems #healthcareprivateequity.

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Learnt a great deal about pharmaceuticals branding in the U.S. from this podcast featuring my fabulous colleague Candice Kwok. Nothing short of enthralled by how she managed to weave in all of that science, intellectual property law, and regulatory requirements needed for an effective go-to-market strategy, without for a second becoming overly technical. Do have a listen, and enjoy! #pharmaceuticals #usa #branding #ip #law #intellectualproperty #fda #trademarks #patents #regulatory #podcast https://lnkd.in/gQ_Kb_nK

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More from the #AHLA Healthcare Transactions Conference. The session "We Are Never Ever Getting Back Together: Strategies to Create Lasting Relationships and Avoid Heartbreak in your M&A Deals" was enchanting - particularly for a healthcare transactions attorney and father of an 11-year-old Swifty. So, please bear with me as I "Shake It Off" and share some "Love Story" vibes from our discussion. In the world of healthcare transactions, it's all about crafting relationships that are "Fearless" and built to last. Key Highlights from the session and materials: "Begin Again": 2023/2024 saw a resurgence in health system transactions, with a "Wildest Dreams" scenario of 65 deals. That's a leap from 53 the previous year, proving that "Everything Has Changed." "The Story of Us": Strategic investments are on the rise, with 566 healthcare transactions noted in 2023, up from 475 in 2022. It's clear we're not in a "State of Grace" — we're in a state of growth! "Blank Space": Emerging technologies, especially Generative AI, are the new "End Game," offering innovative ways to streamline operations and enhance patient care. "Delicate" Situations: With increased regulatory scrutiny both federally and at the state level, navigating these waters requires a "Calm Down" approach and innovative strategies. Strategies for Success: "Call It What You Want", but early engagement with legal and antitrust counsel is your "Getaway Car" from potential deal hurdles. "You Need to Calm Down" and remember the "why." Keeping your vision and goals aligned can help you "Stay Stay Stay" on course, even when the "Winds of Change" blow. "I Knew You Were Trouble": Anticipate regulatory scrutiny and plan your integration strategies like you're writing "The Last Great American Dynasty." As we look towards the "Evermore" of healthcare transactions, let's embrace the spirit of collaboration, innovation, and strategic foresight. After all, in the quest for successful partnerships, we aim for "All Too Well" outcomes, not "We Are Never Ever Getting Back Together" breakups. Let's continue to "Speak Now" and share insights, because together, we can navigate the complexities of healthcare transactions and "Begin Again" towards a brighter, more integrated future. Now, back to our regular programming! #HealthcareTranactions #SwiftieLawyers #AHLA2024 #StrategicInvestments #HealthcareInnovation #TaylorSwiftLyricsInLaw #HealthcareRealEstate #GirlDad #ShakeItOff #BeginAgain #LoveStory #WildestDreams #EverythingHasChanged #TheStoryOfUs #StateOfGrace #BlankSpace #EndGame #Delicate #CalmDown #CallItWhatYouWant #GetawayCar #StayStayStay #WindsOfChange #IKnewYouWereTrouble #TheLastGreatAmericanDynasty #Evermore #AllTooWell #WeAreNeverEverGettingBackTogether #SpeakNow

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I’m leaving #MIGlobal feeling hugely inspired by visionaries like my fellow PE panelists Peter Stavros of KKR, Jonathan Sokoloff of Leonard Green, Joe Baratta of Blackstone, and Patrick Healy of Hellman & Friedman, who are giving employees a stake in their companies and a voice in their day-to-day business operations, and facilitating employment opportunities from a broader cross-section of talent pools to create value for their investors. These concepts have me reflecting on my role as co-chair of Dechert, where stewardship is a core prong of our firm’s strategic growth plan, and where we strive to build an inclusive culture where everyone is trusted and empowered to do their very best.   What I learned💡: The premise of the employee ownership model is that giving employees a vested interest in their companies will motivate them to work harder and smarter, which will in turn maximize their company’s success. As Pete said, “ownership is really an ethos, it’s a mindset.”   How it impacted me 🌠: Law firm partners already are vested in the firm as owners, but our responsibility toward our business doesn’t end when we achieve that title. Each of us has a responsibility to develop deep relationships inside the firm and out, and to bring out the best in each other for the good of our clients, as well as to continue the firm’s growth. It’s also crucial to our sense of community that we look beyond the partnership ranks to ensure that all lawyers and employees are incentivized to build a stronger firm. One way we do this each year is by recognizing and rewarding employees who are making significant contributions in areas that align with Dechert’s core values, including DEI, innovation, and mentorship.   How I’ll pay it forward ⏩: Heading out of #MIGlobal, I’m looking forward to exploring this concept further, and thinking about more ways we can empower our employees to shape a shared future and maximize our clients’ success and, consequently, Dechert’s success.   Milken Institute

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On the latest episode of the NextGen VC #Podcast, partner Amy Simmerman discusses the legal nuances of serving as a biotech company board director, exploring duties of care and loyalty, conflict of interest management, and more.

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The FTC has recently made a groundbreaking decision to invalidate non-competition clauses in employment contracts, transforming the legal landscape for organizations and employees alike. This change, aimed at boosting job mobility and innovation, exempts senior executives but affects virtually all other levels of employees. As professionals in healthcare recruiting, where competition for top talent is fierce, it’s crucial to understand how this shift could reshape talent retention and recruiting strategies. We can expect a more dynamic job market where clinicians and professionals may feel more empowered to transition between roles without the hindrance of non-compete clauses. Click below to read the full article for a deeper dive into the implications of this ruling and how it might influence your business strategies and employment practices.

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Read our Goodwin Life Sciences Regulatory & Compliance team's LDT update below!

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Next from the AHLA Healthcare Transactions Conference - "Stronger Together: When a Nonprofit Health System Contributes Post-Acute Assets to a Joint Venture with a For-Profit Operator" Key Highlights from the session and materials: Driving Forces: The push and pull factors leading health systems towards these ventures were dissected, from the challenges of low margins and the need for improved patient outcomes to the benefits of reducing unnecessary hospital visits and fostering value-based care arrangements. Structural Insights: Transaction structures revealed the typical formation of joint ventures as LLCs, with non-profit health systems and for-profit operators contributing assets and cash respectively, aiming for equity stakes that balance financial and operational goals. Negotiating & Valuation: The session provided knowledge on navigating negotiations, understanding valuation considerations, and the intricacies of pricing within these complex transactions. Impactful Takeaways: The importance of ensuring a joint venture aligns with both the strategic objectives and the cultural values of the entities involved cannot be overstated. The session underscored the critical role of due diligence, not just in terms of financials, but also in aligning with community health goals and ensuring the long-term viability and success of the joint venture. The discussion around management services agreements, contribution agreements, and operating agreements offered a blueprint for establishing clear, effective governance structures. A Path Forward: Collaboration between non-profit and for-profit entities represents a promising frontier for addressing the challenges and opportunities within our healthcare systems. #AHLAConference2024 #HealthcareInnovation #JointVentures #HealthcareCollaboration #StrategicPartnerships #HealthcareRealEstate

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Listen Here: https://lnkd.in/gjqpbsED This podcast explores the surge of private equity acquisitions in physician practices. We discuss the current transaction environment, key trends, and the impact on healthcare professionals. We’ll also delve into recent regulatory developments and their potential effect on private equity activity in the future. #podcast #businessleadership #businesstrends #healthcarenews Scott Becker Private Equity and Healthcare Podcasts -Scott Becker Becker's Healthcare McGuireWoods LLP Becker Private Equity and Business Podcast Lukas Recio, CPA VMG Health

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Congrats to firm client Andreessen Horowitz on their recent investment in Talkiatry's $130 million Series C! Two significant barriers to delivering high-quality mental healthcare are (1) limited access to psychiatrists and (2) the lack of technology that can improve both the quality and efficiency of care. Talkiatry addresses both of these barriers for the acute end of the behavioral health market—psychiatric care—by offering virtual treatment covered by patients’ insurance. By employing providers directly and embedding into their workflows, Talkiatry standardizes the quality of physician care and influences patient outcomes over time. In a study of over 1,800 patients, 65% of patients with anxiety or depression no longer have clinically significant symptoms after visiting Talkiatry for an average of five sessions.

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On the latest episode of the NextGen VC #Podcast, partner Amy Simmerman discusses the legal nuances of serving as a biotech company board director, exploring duties of care and loyalty, conflict of interest management, and more.

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More from Day 3 at the #AHLA Healthcare Transactions Conference. Session - What's Old is New Again: Hospital/Physician Affiliation Models in an Age of Private Equity shed light on pivotal trends reshaping healthcare affiliations. Key takeaways from the presentation and supplemental materials: Private Equity's Role: The session underscored private equity's attraction to healthcare due to its unique economics, scalability, and the vast potential for operational efficiencies. This interest forms a backdrop against which hospitals and physicians navigate their affiliations, fostering a climate ripe for innovative models. Alignment Models Explored: A variety of alignment models were discussed, including Clinical Co-Management/Administrative Services Agreements, Gainsharing, Recruitment, Medical Director, and Management Services Agreements, each with its own set of benefits and challenges. The Master Affiliation Agreement (MAA) was highlighted as a flexible framework that accommodates evolving partnerships. Guiding Principles and Legal Framework: Critical to these discussions were the guiding principles for business owners and legal parameters for healthcare counsel. Emphasis was placed on ensuring that payments to physicians are for bona fide services, meet fair market value (FMV), and avoid any potential conflicts with regulations such as the Stark Law and Anti-Kickback Statute. Commercial Reasonableness and Red Flags: A valuable part of the session focused on the importance of commercial reasonableness and identifying potential legal red flags in affiliation arrangements. This discussion is crucial for navigating the complexities of healthcare transactions while ensuring compliance and ethical practices. #HealthcareLaw #AHLAConference #PrivateEquity #HealthcareInnovation

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Listen Here: https://lnkd.in/gBFQuycS In this episode, Alexandra (Lexie) Schwartz,FACHE,MBA,MS,RD, Vice President of Operations at OSF HealthCare, shares her background and provides insights into OSF HealthCare. She discusses the innovative healthcare technology trends she is following, gives an overview of staffing across Illinois and Michigan, and more. For more information about Becker's Healthcare, please contact Jessica Cole or Scott Becker. #podcast #healthcare #womensleadership

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