Salamandra, LLC

Genome editing modalities are advancing rapidly, placing greater emphasis on robust, standardized safety assessments. FDA’s April 2026 draft guidance outlines expectations for the detection and characterization of genome-wide editing outcomes, supporting more consistent regulatory approaches.   👉 Explore the highlights from this guidance below. #GeneTherapy #Nonclinical #NGS #RegulatoryScience 

✈️ 𝗦𝗮𝗹𝗮𝗺𝗮𝗻𝗱𝗿𝗮 𝗶𝘀 𝗵𝗲𝗮𝗱𝗲𝗱 𝘁𝗼 𝗟𝗶𝘀𝗯𝗼𝗻 on 5-8 May for the 2026 Regulatory Affairs Professionals Society (RAPS) Euro Convergence! Crystal Murray, RAC-US, our Associate Senior Consultant, Global Regulatory Affairs, will be attending and looks forward to hearing the latest developments shaping regulatory strategy across Europe and the globe. Crystal will be connecting with peers and following key discussions, including:  • EU pharmaceutical legislation updates  • Implementation of the new UK Clinical Trial Regulations  • International reliance pathways  • The expanding role of real‑world evidence in regulatory decision‑making If you’ll be attending #RAPSEuroConvergence2026, reach out to coordinate a conversation or grab a coffee in Lisbon. ☕️ #RAPSEuroConvergence #RAPS #RegulatoryAffairs #DrugDevelopment

𝗙𝗔𝗦𝗧‑𝗘𝗨 launched in January 2026 to speed up the authorization of multinational clinical trials in Europe. Recent communications from the Heads of Medicines Agencies highlight just how strong Sponsor interest has become. During the latest FAST‑EU submission window, the initiative received 23 applications, and participating Member States agreed to accept four applications for this cycle. For these evaluations, the Reporting Member State role will be assumed by Belgium, Norway, Spain, and the Czech Republic. 📅 The next FAST‑EU submission window is scheduled for 22-23 April 2026, and applicants are invited to indicate their preferred weeks for CTIS submission. 👉 Swipe to learn what FAST-EU means in practice, including eligibility considerations, what to expect from the accelerated process, and how Sponsors can prepare for an end‑to‑end 70‑day timeline from CTIS submission to final conclusion. #FASTEU #ClinicalTrials #RegulatoryAffairs #EURegulation

🛫 Heading to #AACR2026 in San Diego? Don’t miss this opportunity to meet with Salamandra’s Melissa Pegues and Kristin Vasmanis, RAC-US. The American Association for Cancer Research Annual Meeting is a cornerstone event for cancer research and innovation, and our team is looking forward to learning about the latest advances, reconnecting with colleagues, and building new collaborations. If you’re developing an innovative oncology program and need 𝘀𝗰𝗶𝗲𝗻𝗰𝗲-𝗱𝗿𝗶𝘃𝗲𝗻 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘂𝗽𝗽𝗼𝗿𝘁, we’d welcome the conversation. 💬 Message us or connect at #AACR2026 to discuss your pipeline and where strategic regulatory insight can make an impact #AACR2026 #Oncology #CancerResearch #Biotech #DrugDevelopment #OncologyStartups #RegulatoryStrategy

𝗥𝗲𝗳𝘂𝘀𝗮𝗹‐𝘁𝗼‐𝗙𝗶𝗹𝗲 (𝗥𝗧𝗙) actions have featured prominently in recent news coverage. What is often less well understood is that the 𝗡𝗗𝗔/𝗕𝗟𝗔 𝗿𝗲𝘃𝗶𝗲𝘄 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 𝗽𝗿𝗼𝗰𝗲𝗲𝗱𝘀 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗱𝗶𝘀𝘁𝗶𝗻𝗰𝘁 𝗽𝗵𝗮𝘀𝗲𝘀. FDA review begins with a 𝗙𝗶𝗹𝗶𝗻𝗴 𝗥𝗲𝘃𝗶𝗲𝘄, during which the Agency assesses whether an application is sufficiently complete to permit scientific evaluation. If filed, the application proceeds to a 𝗦𝘂𝗯𝘀𝘁𝗮𝗻𝘁𝗶𝘃𝗲 𝗥𝗲𝘃𝗶𝗲𝘄, where FDA conducts an in‑depth assessment of the scientific data supporting approval. Recent remarks from 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝗲𝗿 𝗠𝗮𝗿𝘁𝗶𝗻 𝗠𝗮𝗸𝗮𝗿𝘆 suggest changes to the FDA’s Filing Review may be coming soon. Makary has indicated that implementation of 𝗮𝗿𝘁𝗶𝗳𝗶𝗰𝗶𝗮𝗹 𝗶𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 (𝗔𝗜) could significantly reduce administrative time associated with the traditional 60‑day reviews conducted at NDA and BLA filing. We will continue to monitor this development and share updates as they emerge. 👉 Until then, 𝘀𝘄𝗶𝗽𝗲 𝘁𝗼 𝗲𝘅𝗽𝗹𝗼𝗿𝗲 the NDA/BLA review process, including key differences between Filing Review and Substantive Review phases and how to prepare for each.

Early Phase 1 studies remain a significant inflection point in small molecule drug development - getting them right pays dividends across the program. In her latest Insight, Kristin Vasmanis, RAC-US, a Senior Clinical Pharmacology Consultant at Salamandra, highlights how thoughtful planning, validated bioanalytical methods, and modern model‑informed approaches can streamline development, while aligning with today’s regulatory expectations. 🔗 https://lnkd.in/ef8Xcvm2 By translating nonclinical and in vitro ADME data into an understanding of fundamental PK properties in humans, Sponsors can build a strong foundation for key operational and safety decisions. At Salamandra, we help clients navigate these critical early decisions with confidence and scientific rigor. Reach out to learn more about how we can support your program. #TranslationalScience, #DrugDevelopment, #ClinicalPharmacology, #Biopharmaceutics, #Pharmacokinetics, #ADME, #Phase1Studies

✈️ 𝗦𝗮𝗹𝗮𝗺𝗮𝗻𝗱𝗿𝗮 𝗶𝘀 𝗵𝗲𝗮𝗱𝗶𝗻𝗴 𝘁𝗼 𝗦𝗮𝗻 𝗗𝗶𝗲𝗴𝗼 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗦𝗼𝗰𝗶𝗲𝘁𝘆 𝗼𝗳 𝗧𝗼𝘅𝗶𝗰𝗼𝗹𝗼𝗴𝘆 𝗔𝗻𝗻𝘂𝗮𝗹 𝗠𝗲𝗲𝘁𝗶𝗻𝗴 𝟮𝟬𝟮𝟲! Melissa Pegues, Salamandra’s Senior Nonclinical Consultant, will be attending Society of Toxicology (SOT) 2026 to engage in conversations on the latest developments in toxicology, regulatory science, and nonclinical strategy. SOT is always a great opportunity to exchange perspectives, connect with colleagues, and explore how evolving science is shaping drug development. If you’ll be at #SOT2026 and are interested in connecting or discussing a potential collaboration, reach out! We'd love to talk. #SOT2026 #Toxicology #RegulatoryScience

🔍 The FDA is taking a fresh look at SUPAC. With a new request for comments, long‑standing guidances may soon be modernized to better reflect current manufacturing technologies and risk‑based approaches. Check out the highlights below for what to watch and how industry can engage. #FDA #SUPAC #CMC #PostApprovalChanges #LifecycleManagement #PharmaManufacturing #QualitySystems #ICHQ9R1 #ICHQ12

𝗛𝗼𝘄 𝗪𝗲𝗴𝗼𝘃𝘆® 𝗕𝗲𝗰𝗮𝗺𝗲 𝘁𝗵𝗲 𝗙𝗶𝗿𝘀𝘁 𝗙𝗗𝗔‐𝗔𝗽𝗽𝗿𝗼𝘃𝗲𝗱 𝗢𝗿𝗮𝗹 𝗚𝗟𝗣‐𝟭 𝗳𝗼𝗿 𝗪𝗲𝗶𝗴𝗵𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 The long‑anticipated arrival of an oral GLP‑1 therapy for weight loss represents an important milestone. However, the Wegovy® pill’s first‑to‑market success was enabled primarily by prior platform knowledge and regulatory experience rather than the introduction of a new oral delivery technology capable of overcoming the well‑known challenges of oral peptide formulation. With growing demand for GLP-1 receptor agonists in weight management, an oral dosage form has been highly anticipated as an alternative to weekly injections for new and existing patients alike. In December 2025, the FDA approved the first oral GLP-1 product for weight loss: the Wegovy® pill. While the Wegovy® pill was first to market, that milestone was driven less by a new oral delivery breakthrough and more by Novo Nordisk’s ability to leverage prior formulation and regulatory experience with oral semaglutide - an important distinction for other developers navigating the inherent bioavailability, stability, and absorption challenges of oral peptides. In our latest article, Salamandra team members Emily Weil and Rebecca Creer, RAC-US:   • Examine the formulation strategy behind the Wegovy® pill  • Discuss the regulatory advantages that enabled its approval  • Explore why this success may be difficult to replicate  • Highlight alternative formulation approaches emerging in a highly competitive space. 🔗https://lnkd.in/e3xbdx26 If you have questions on this topic or are facing formulation challenges requiring regulatory support, our team would be happy to help. #GLP1, #Wegovy, #SNAC, #peptides, #DrugDevelopment

𝗔𝘀 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗺𝘂𝗹𝘁𝗶𝗽𝗹𝗲 𝗺𝘆𝗲𝗹𝗼𝗺𝗮 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝘁𝗼 𝗮𝗱𝘃𝗮𝗻𝗰𝗲, 𝗺𝗼𝗿𝗲 𝘀𝗲𝗻𝘀𝗶𝘁𝗶𝘃𝗲 𝗲𝗻𝗱𝗽𝗼𝗶𝗻𝘁𝘀 𝗮𝗿𝗲 𝗻𝗲𝗲𝗱𝗲𝗱 𝘁𝗼 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝗲𝗮𝗿𝗹𝗶𝗲𝗿 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗼𝗳 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹𝗹𝘆 𝗯𝗲𝗻𝗲𝗳𝗶𝗰𝗶𝗮𝗹 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀.   The FDA’s recent draft guidance marks a pivotal shift: 𝗠𝗶𝗻𝗶𝗺𝗮𝗹 𝗥𝗲𝘀𝗶𝗱𝘂𝗮𝗹 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 (𝗠𝗥𝗗) is moving from an exploratory endpoint toward a valuable, accepted standard in multiple myeloma development. For Sponsors, this has important implications for:  • Trial design and endpoint selection   • Statistical planning  • Regulatory strategy and interactions with FDA Understanding how and when MRD can support accelerated approval is now critical to efficient development programs. 🔍 𝗘𝘅𝗽𝗹𝗼𝗿𝗲 𝘁𝗵𝗲 𝗸𝗲𝘆 𝗵𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗯𝗲𝗹𝗼𝘄 and learn how this guidance may impact your clinical and regulatory strategy. If you’re navigating MRD endpoints, or preparing for upcoming regulatory discussions, we’re happy to connect. #ClinicalDevelopment #ClinicalTrials #Oncology #MultipleMyeloma #MRD #FDA #Biotech #DrugDevelopment #RegulatoryStrategy