Lana Gladstein

#FDA has released its long-awaited draft Platform Technology Designation Program for Drug Development: Guidance for Industry, which could represent a potentially significant shift in the regulatory and commercial strategies for novel drug and biologics products. Our alert looks at the key details. #DrugDevelopment #PlatformTechnology #FDCA

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Read key takeaways from FDA's long-awaited Draft Guidance on its platform technology designation program in our latest Goodwin Life Sciences Regulatory & Compliance team client alert below!

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In our latest issue of Blockbuster Biologics Review, we cover the status and developments of post-grant challenges and patent litigations implicating blockbuster #biologics and legislative proposals related to #biosimilars in Q2 2024. #WeAreMorganLewis

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I pose this question to people in the know, including Shannon Bennett, Karin A. Hughes, Ph.D., Lisa Charter, Joshua D. Levin, Tom Soriano, and Brendan O'Leary. I was on the FDA call with the media regarding LDT regulations. While most people were interested in Grandfathering and NYC review allowance, one question was raised by the media regarding how the FDA viewed the reclassification plan and how many PMAs the FDA expects to review under the final rule. Dr. Shuren answered that they expect reclassification to happen concurrently and that the number of PMAs submitted may be small by the time LDT must start submissions. Reclassification petitions take years. Is there some framework where an entire class of Companions can be down-classified in one swoop? I assume most will be regulated under unique product codes and/or regulations. My regulatory brain says no, but the ex-FDA folks tagged on this message may have some thoughts. Brendan O'Leary, is there an easy way to determine the average time it takes for the FDA to down-classify one IVD (Class)?

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Thrilled to share the latest news on a TetraScience + FlowJo collaboration to streamline cloud-based single-cell analysis workflows! Learn more in the full press release: https://lnkd.in/gq9BBx74 #TetraScience #FlowJo #ScientificAI #ScientificData

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My latest article.

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Attention all manufacturers of laboratory developed tests: #FDA recently issued a final rule significantly modifying its approach to oversight of LDTs, with the phased implementation taking place over the next four years. My colleagues provide an overview of the final rule in the blog post below. #lifesciences #healthcare

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Kelly Gordon, Ph.D., MB (ASCP) is on point as always! As you and I discussed previously, we knew #FDA oversight was coming and #LDT developers have to be mindful in designing their studies accordingly, but there is a lot of opportunity in the oncology space for #CDx and #LDTs with all of the accelerated review channels being provided under the various cancer-related drug, device, and diagnostic development programs. Exciting times in our space! #Boudicca #LDTs #FDA

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While I've attended several fantastic ACI conferences in the past, this is my first time going to the Biologics one! Very excited to connect with my colleagues in the industry. If you're heading there and would like to schedule a coffee or meal, DM me! #bpcialitigation #andalitigation #biologics #iplitigation #pharmaceuticals #pharmalitigation #patents #patentlaw #iplaw

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

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Legal Ops peers - Discussion topic: CLOC vs ACC Legal Ops memberships- 👉 Do you have both? Or just one? 👍 What are the reasons for having both? 💰 Is it worth the cost to have both? I can't be the only curious mind wondering this, so let's dive in and share thoughts (and be kind please!)

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Century Therapeutics Raises $60 Million, Acquires Clade Therapeutics, and Expands Pipeline of Allogeneic, iPSC-Derived Cellular Therapies - https://lnkd.in/ehDg3gC9 Century Therapeutics, Inc (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024. Century plans to pursue additional autoimmune disease indication regulatory filings in 2024. Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors. Concurrently, Century announced pipeline and platform enhancements through the acquisition of Clade Therapeutics, Inc. (“Clade”), a privately-held biotech company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases. “Today’s news signifies a transformative milestone for Century, as we accelerate and broaden our research and development initiatives in autoimmune diseases and iPSC-derived cell therapy on a larger scale. With support from a distinguished group of investors, coupled with the acquisition of Clade, we are poised for continued success,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century. “Under the leadership of a pioneering team of scientists and senior leaders with decades of experience in stem cell biology and iPSC differentiation enabled by significant capital investment from their investors, Clade has established a discovery engine with industry-changing potential,” said Hy Levitsky, M.D., President of R&D of Century. Read more at: https://lnkd.in/ehDg3gC9 #ipsc #cancer #autoimmunediseases

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How can emerging and established life sciences companies build and preserve value by protecting their trade secrets? Listen to MoFo’s new podcast, featuring Kate Driscoll, Nate Mendell, and Jim Krenn, to find out. https://lnkd.in/emESaH-u

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Interesting analysis that my colleagues (Ryan Murr, Karen Alexandra Spindler, Marina Szteinbok, and Artin Au-Yeung) and I drafted of the Delaware Chancery Court’s recent decision on whether a buyer, in the context of a pharmaceutical earnout, used “commercially reasonable efforts” (“CRE”) to achieve certain milestones, and the implications for drafting CRE definitions in the context of license agreements, royalty financings, and merger agreements. #CRE #CommerciallyReasonableEfforts #Earnout #M&A #Licensing #RoyaltyFinance #Royalty #MileStones

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Due to the #FDA's recent draft guidance on maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies, companies conducting these studies should be diligent in ensuring the integrity of the data that is generated and submitted to the FDA. For a complete overview of the FDA's draft guidance, check out the blog post below. #lifesciences #data

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