Sigla Sciences

?? Fascinating analysis from my colleague Jennifer Hinkel MSc CHW FRSA on what's ahead for US biopharma in 2025. After spending two decades at the intersection of AI, healthcare, and behavior change, I'm particularly intrigued by the predictions around digital health, AI regulation, and data privacy. The potential rollback of Biden's AI executive order could accelerate healthcare AI deployment - but as someone who's built patient engagement systems, I know firsthand that proper oversight and data quality are crucial for building trust and driving adoption. Great read on what healthcare tech leaders should watch in 2025. #HealthTech #AI #DigitalHealth #Healthcare

?? Breaking down the 2025 Biopharma Crystal Ball: Post-Election Analysis Big changes are coming to US healthcare & biopharma in 2025. Our latest analysis dives into 6 key areas that industry leaders need to watch: ???China relations & BIOSECURE Act impacts ???Vaccine policy shifts ???IRA implementation challenges ???Medicare privatization trends ???Digital health & AI regulation ???Immigration, IP & more Read our founder's full analysis on what's ahead and how companies can prepare for potential policy shifts under the new administration. #Healthcare #Pharma #Policy #BusinessStrategy #HealthTech

?? Accelerating Market Access with AI-Driven Systematic Literature Reviews ???? At Sigla Sciences, we are empowering pharma and biotech companies to accelerate HTA submissions with AI-powered tools. When facing tight timelines and vast amounts of data, traditional approaches to systematic literature reviews (SLR) can fall short. ?? We helped a client streamline their SLR process, screening over 10,000+ papers in record time while maintaining the rigor required for international HTA submissions. The result? A rapid and efficient review process that met regulatory and compliance standards. By combining AI tools and expert oversight, we’re setting a new standard in evidence synthesis and accelerating access. ?? Curious how AI can accelerate your market access strategy? Let’s connect and explore solutions! ?? #AIinPharma #MarketAccess #HealthTech #HTA #SystematicReview #Innovation

Critically important dynamic to consider — IRA MFP compliance and the possible different methods for calculating and paying refunds on Maximum Fair Price!

How’s this for an “October Surprise” of the health policy variety… CMS finally dropped its final IRA MFP guidance yesterday! Some huge updates align with the asks Sigla Sciences and 40.4 Solutions made of CMS, including the separation of the MTF Data and Payments functions and the inclusion of Prescriber ID for 340B deduplication - both crucial for manufacturers. Manufacturer effectuation plans are still due next summer, so time is of the essence to align your teams. We’re here to support your plans. We’ve analyzed all 313 pages and are ready to provide context. Kudos to Matt Smith and Jason Hardaway for their teamwork in deciphering it all. FYI Adam Fein Jennifer Benton Pete Zaudtke MacKay Jimeson Lee Blansett J. Lance Grady James Nicholls Alka Bhatt Niesha Griffith, MS, RPh, FASHP Brian Reid Amy Demske James Nicholls David T. Grace Satish Valluri Lexa Molinari, PharmD, MS #healthpolicy #InflationReductionAct #Medicare

?? So, you're thinking about launching a Personalized Biotherapeutic? Hold on, there's a lot you need to know! ?? Personalized Biotherapeutics (PBs) are revolutionizing medicine, but launching one between now and 2026? You're stepping into uncharted territory. With the stakes so high, even the most seasoned teams face serious challenges—from navigating complex regulatory landscapes to ensuring market access across the US and Europe. ?? Miss one critical step, and your groundbreaking therapy could stumble before it even reaches patients. ?? Don't let that happen! Learn the insider strategies that make or break a PB launch, and position yourself for success in this fast-evolving field. Your PB launch needs to be flawless. Are you ready? Read on to discover the keys to mastering this high-stakes game. ???? #PersonalizedMedicine #Biotherapeutics #Pharma #MarketAccess #Biotech

?? New Post Alert! ?? Planning a successful market access launch is like orchestrating a symphony, and it starts about 2 years before expected launch date. Dive into our latest article where we break down the 5 key pillars to focus on for a seamless and impactful product launch: Trade and Distribution/Channel ????, Coverage & Reimbursement Operations ????, Value Proposition and Access Marketing ????, Pricing & Contracting ????, and Patient Support Programs ??????. Discover why each pillar is crucial and the early tasks you need to prioritize for success. Whether you're gearing up for a new product launch or looking to refine your market access strategy, this guide is a must-read. Partner with Sigla Sciences to streamline your market access planning and execution. Let’s make your launch a hit! ??? #MarketAccess #Biotech #Pharma

This week’s updates on AI and biopharma!

Despite significant advancements over the past decade, bringing innovative Precision Oncology treatments from research to clinical practice remains challenging, especially in terms of market access. Our latest article delves into the strategic approaches necessary to overcome these hurdles and ensure that cutting-edge therapies reach the patients who need them most. Click to read more and explore how robust data, economic evidence, payer engagement, and patient access programs can pave the way for successful market access in precision oncology. #Oncology #PrecisionMedicine #MarketAccess

Trying to keep up with the latest news around SCOTUS decisions and how health policy might be impacted? Read a brief analysis below and stay up to date on how these cases could shape HHS, FDA, and other agency actions. #healthpolicy #healthlaw #biopharma