Mialeeka Williams

With regulators watching off‑label communication more closely than ever, understanding what’s permissible has never been more important. My colleague Kyle Faget will explore these boundaries at ACI’s FDA Boot Camp, outlining how to keep scientific exchange, HEOR, and payer conversations compliant. Learn more about her panel on March 26 and register: https://lnkd.in/g6TaHaEj

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Many growing companies hit the same point: legal work is piling up, outside counsel spend is rising, and internal teams are stretched - but bringing on in‑house legal support still feels like a big step. I work with public and private companies, nonprofits, education institutions, healthcare systems, and mission‑driven organizations across the DC-Metro area who are navigating that exact moment. What I’m seeing most often: • Contracting bottlenecks slowing revenue • Compliance demands outpacing capacity • Outside counsel invoices blowing past budgets • Leadership spending too much time on legal work Teams often tell me it helps to work with someone who understands both the legal work itself and what it takes to build a right‑sized legal function. That perspective shapes how I support organizations at every stage - from first in‑house counsel to GC. If you’re hiring legal talent this year - whether it’s your first attorney or your next senior leader - I am always glad to be a sounding board. No pressure, no pitch. Just practical, honest insight to help you make the right decision. #RobertHalf #InHouseLegal #WashingtonDC #LegalJobs Robert Half

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If you’ve been following the GSK v. Teva skinny-label saga, it’s finally over. The parties settled and dismissed the case in Delaware. My colleague, John Cox, walks through the procedural history and how it came full circle.

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The timing of clinical trial disclosures can make or break a patent. My colleague Cara Mosley explores how to leverage U.S. and international grace periods to maximize patent term and maintain protection. Check out her insights in her latest article: https://lnkd.in/g3a7vjU5

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What is the latest legal news in the life sciences industry? Read Jones Day's Innovative Insights newsletter to learn about what the pharmaceutical industry can do to mitigate supply chain risks in the face of tariffs, innovation and investment in women's health, recent executive orders and policy updates affecting the life sciences industry, and more. Click here to read the Firm's newsletter: https://ow.ly/vKCF50X3Vu0 #lifesciences #healthcarelaw #pharmaceuticaltariffs

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Thanks to Arushi Pandya and Julian Klein for recapping the recent CDRH policy changes. Ultimately, these changes—and those that have been teased for the future—reflect a clear policy shift for the agency in providing an environment for companies to bring products to market faster and at lower cost. Companies looking at strategic investment in these areas, especially AI-enabled tools in the CDS space, should take a close look at the guidances to assess whether these new policies could further—or hinder—prospective operational decisions. https://lnkd.in/ejH_Jbai

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We are pleased to have supported three drug companies: Biophore, Natco, and Deva in its US Supreme Court amicus brief relating to the MSN vs. Novartis cert petition. MSN seeks Supreme Court review to clarify the scope of Section 112 - written description and the effect of "after arising" technology. Our amicus brief discusses the need for predictable, certain, and fair interpretation of the patent laws. Businesses (patent holders and competitors) make huge investments in R&D, consume lots of time and effort, and therefore need certainty about what is onside versus offside when it comes to patents.

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The FDA’s shift to publishing letters denying drug and device applications raises the stakes for public companies navigating SEC disclosure obligations.

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Our most recent post analyzes yesterday’s LabCorp ruling by the U.S. Supreme Court and how it sets the stage for a future showdown on the issue of whether federal courts can grant class certification where members of the class suffer no legal injury https://lnkd.in/e3VgHGS3

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A recent New Jersey court ruling on non-compete agreements serves as a crucial reminder for employers and employees alike: these agreements are still powerful, enforceable tools in the Garden State. In my latest blog post, I dive into the details of the recent PTC Therapeutics v. O'Keefe case and explain the legal standards courts use to determine if a non-compete is enforceable. I also break down common pitfalls and offer guidance for both sides. Staying on top of this evolving legal landscape is a necessity. Give it a read to understand your rights and liabilities. https://lnkd.in/eDeydmTr #EmploymentLaw #NonCompete #NewJerseyLaw #Compliance

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Between the FDA Human Foods Program reorganization, changes in leadership, the MAHA initiative with its increased focus on chemical safety, and (albeit slow moving) MoCRA implementation, 2025 was a year to keep your eyes peeled on FDA activities. Our FDA in Focus report breaks down what changed, what didn’t, and what to expect in 2026. Download the FDA in Focus report. https://lnkd.in/ewrDsiK6 Reach out if you’d like to discuss how these changes may impact your organization. #FDAinFocus #FDATrends #LifeSciences #RegulatoryStrategy

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With compounded GLP‑1s back in the spotlight, new questions are emerging about what the FDA might do next. In its coverage of Hims’ brief Wegovy copy launch, my colleague Nathan Beaver shared that the FDA could escalate enforcement by inspecting Hims’ prescription records, potentially with state pharmacy regulators, to assess documentation and compliance. Learn more in the full Reuters article featuring Nathan’s insights: https://lnkd.in/ge3XFnUp

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Hey #InHouseCounsel, are you up on the latest developments on Privilege and Work Product protections? If not, check out this episode of #TheLegalDepartment with white collar defense partner and privilege expert Diana Feinstein of Gibson Dunn. In this episode, Diana shares these tips for guarding privileged information in-house: 🤫 Legal advice is privileged, business advice is not 🤫 Label communications in a way that shows a judge "this was legal advice" 🤫 Be careful when including disclaimers in legal training materials 🤫 Tips for guarding the privilege when using AI 🔗 Link in the comments

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The Senate IP Subcommittee, led by Sens. Tillis and Coons, will hold tomorrow (Oct. 8) a hearing on the #Patent #Eligibility Restoration Act (S.1546)—a bipartisan effort to rewrite § 101 and clarify patent eligibility. Witnesses include former USPTO Directors Iancu and Kappos, among others. The session may signal Congress’s direction on eligibility reform across AI, diagnostics, and software. https://lnkd.in/e9wVWadU

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💬 Talking Community, Collaboration & the Future of In-House Law 💬 I recently sat down for an interview with GC Connected to reflect on how the UK General Counsel community has evolved, and why connection matters more than ever. When I first moved in-house, opportunities to gather with peers were few and far between. Today, London’s GC scene is buzzing with free conferences, webinars and meet-ups where knowledge is shared rather than guarded. It’s a remarkable shift. Why does that matter? Because the GC role can be lonely. We make complex, high-stakes decisions with no obvious internal sounding board. Expanding our networks gives us the chance to learn from others who’ve faced similar challenges, whether scaling a team, navigating regulatory change, or influencing the board. By collaborating, we elevate the profession and reinforce the strategic value in-house lawyers bring to business. I’d love to hear from fellow GCs and senior in-house counsel: ➡️ What’s the most valuable conversation you’ve had with a peer recently? ➡️ Where do you see our community heading next? Link to full article in post below. #FractionalGC #GeneralCounsel #InHouseLaw #LegalLeadership #Networking #AI #ESG #LegalOps #CareerGrowth Salunke Solutions Limited

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