Somerville Development Partners Limited

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🔬 Download our approval deep dive on Winrevair Winrevair (sotatercept) is the first activin signalling inhibitor therapy approved to treat pulmonary arterial hypertension (PAH) and the first new medicine approved for the treatment of PAH in nearly a decade. ⬇ Access our deep dive into this approval here ⬇ https://lnkd.in/eCcWq3xu

🔬 How the EMA Supports Small and Medium-Sized Enterprises (SMEs) in Medicine Development 🔬 SMEs are critical to innovation in the pharmaceutical industry, driving the development of new treatments. SME's can benefit from the EMA's support, which includes: 1️⃣ Regulatory fee incentives to ease financial pressures. 2️⃣ Dedicated guidance from the EMA's SME Office on navigating complex regulatory pathways. Want to learn more? Our blog covers: 1️⃣ Why SMEs are essential to medicine development 2️⃣ How many medicines SMEs develop in Europe 3️⃣ Detailed EMA support initiatives Read the full blog to discover how the EMA empowers SMEs to bring innovative medicines to market ⬇ https://lnkd.in/e8FqhdCM #Pharma #SMEs #MedicinalProducts #EMA #Innovation

🔬 How the EMA Supports Small and Medium-Sized Enterprises (SMEs) in Medicine Development 🔬 SMEs are critical to innovation in the pharmaceutical industry, driving the development of new treatments. SME's can benefit from the EMA's support, which includes: 1️⃣ Regulatory fee incentives to ease financial pressures. 2️⃣ Dedicated guidance from the EMA's SME Office on navigating complex regulatory pathways. Want to learn more? Our blog covers: 1️⃣ Why SMEs are essential to medicine development 2️⃣ How many medicines SMEs develop in Europe 3️⃣ Detailed EMA support initiatives Read the full blog to discover how the EMA empowers SMEs to bring innovative medicines to market ⬇ https://lnkd.in/e8FqhdCM #Pharma #SMEs #MedicinalProducts #EMA #Innovation

Very interesting commentary on accelerated approvals granted by the FDA! Most (60%) of accelerated approvals are for oncology indications (based on early or surrogate endpoints reasonably likely to predict clinical benefit) – patient access through this route is a median of 3.1 years earlier (versus the traditional pathway). 15% (30 of 198) of oncology accelerated approvals have been withdrawn due to failed or incomplete confirmatory trials. More recent examples include Aliqopa (copanlisib); Blenrep (belantamab mafodotin-blmf); Gavreto (pralsetinib); Pepaxto (melphalan flufenamide); Truseltiq (infigratinib); and Exkivity (mobocertinib). Failed confirmatory trials are not always a result of absence of meaningful clinical benefit but can be a result of methodological issues in study design. FDA may now require that confirmatory trials be underway before granting accelerated approval. The FDA’s Oncology Center of Excellence has initiated Project Optimus to promote better characterization of dose and schedule before initiation of registrational trials.

🔬 The Critical Role of Scientific Advice in Medicine Development 🔬 Scientific advice is essential for ensuring that medicinal products meet regulatory expectations and are developed efficiently. Three key pilot procedures are helping streamline this process: 1️⃣ Simultaneous National Scientific Advice (SNSA) – Allows companies to receive advice from multiple national authorities simultaneously, aligning strategies early. 2️⃣ SAWP-CTCG Scientific Advice – Combines expertise from the EMA's Scientific Advice Working Party (SAWP) and Clinical Trials Coordination Group (CTCG) to optimize clinical trial planning and regulatory compliance. 3️⃣ Pre-CTA Advice – Provides critical feedback before submitting a Clinical Trial Application (CTA), ensuring trial design and protocols meet required standards. These pilot procedures aim to provide medicine developers with faster, clearer guidance and more efficient development paths for innovative medicines. ⬇ Download our latest paper for more detailed information ⬇ https://lnkd.in/ec_Kmdk7 #ScientificAdvice #MedicinalProducts #Pharma #Biotech #ClinicalTrials

🔬 The Importance of #ScientificAdvice in Medicinal Product Development 🔬 Scientific advice and protocol assistance are essential tools for navigating the complex regulatory environment in the pharmaceutical industry. By seeking guidance from authorities like the European Medicines Agency (EMA), companies can align their development process with regulatory expectations, improving the chances of success. Key Benefits: 1️⃣ Supports MAA filing by addressing regulatory requirements early. 2️⃣ Streamlines MAA evaluation, reducing delays. 3️⃣ Clarifies expectations for developing a safe and effective product. 4️⃣ Reduces the risk of MAA rejection. Questions can cover areas like: 1️⃣ Quality and CMC 2️⃣ Non-clinical/clinical data 3️⃣ Development strategy The right advice at the right time can make all the difference. To learn more, take a look at our blog detailing the benefits of taking scientific advice ⬇ https://lnkd.in/eck9HS5W #Pharma #ScientificAdvice #EMA #Biotech

Are you navigating the complexities of EU regulatory requirements in the #Pharmaceutical or #Biotech sectors? Engaging with regulatory bodies for #ScientificAdvice can greatly influence the success of your clinical and commercial strategies. Our newly released whitepaper provides a thorough examination of this critical process. Topics covered include: 1️⃣ The differences between national and central scientific advice 2️⃣ Scientific advice procedural timelines 3️⃣ New scientific advice pilot procedures ⬇ Download your copy here ⬇ https://lnkd.in/ec_Kmdk7

For pharmaceutical and biotech companies, obtaining scientific advice from European regulatory bodies is an important step toward regulatory success. Our latest whitepaper provides in-depth guidance on how the critical role of scientific advice in the EU. Key insights include: 1️⃣ National scientific advice 2️⃣ Centralised scientific advice 3️⃣ Pilot scientific advice procedures ⬇ Download your copy here ⬇ https://lnkd.in/ec_Kmdk7 #Pharmaceuticals #Biotechnology #ScientificAdvice #RegulatoryAffairs #DrugDevelopment

Sponsors should always seek scientific advice in the EU. Prospectively engaging with the regulators will help sponsors from two important perspectives… 1.        You don’t know, what you don’t know! 2.        Forewarned is forearmed! We give you detailed insights in our latest webinar, 'Crafting Effective Scientific Advice Strategies in the EU’. ⬇ View the webinar recording and presentation slides here ⬇ https://lnkd.in/e2Uhc2ep