SSI Strategy

Fragmented health technology assessments across Europe have long complicated market access for drug developers. The new EU HTA regulation aims to change that by introducing a unified process for evaluating clinical and relative effectiveness and safety. But this shift presents a new challenge: aligning with tighter timelines and earlier evaluations. If your organization is targeting Europe, adapting to these changes isn’t optional—it’s essential to secure market access and stay competitive. For key insights, listen to the full webinar hosted by Chantal W.M. van Gils and Maxwell Craig. https://lnkd.in/d9B74_Zq Need help aligning your regulatory and HTA processes? SSI Strategy can guide your team to build the right framework. Let’s talk! letstalk@ssistrategy.com

Is your medical leadership evolving as fast as your company? In our recent podcast episode, Steven Zelenkofske highlights that the best CMOs in biotech are those who don't just adapt—they redefine their approach as the company evolves. It's not about simply checking boxes in a role, but having the right skills at the right time to meet new challenges. At SSI Strategy, we partner with biotech leaders to build adaptable, forward-thinking medical leadership teams. Are you ready for a leadership team that’s truly built for change? Let’s talk! letstalk@ssistrategy.com Listen to the full episode for deep insights on how to align leadership with the changing needs of your business. https://lnkd.in/d6gBT_hf

Quality isn’t a checkbox—it’s your competitive edge! Two approaches to trial quality: 🔹Strategic: Quality by design from the start. 🔹Traditional: Reactive inspection preparation. The difference? Up to $40K per day. At SSI, we partner with you to achieve excellence in clinical research by building quality into every decision, every process, every day. Ready to elevate your quality strategy? Let's talk! letstalk@ssistrategy.com 📄 Learn more from our detailed insights: https://lnkd.in/dkvU8zGH

We piloted Microsoft Copilot to see how generative AI could transform biotech, and here’s what we learned. 📌Set Realistic Expectations: Overpromising undermines trust. Being clear about what AI can do—and what it can’t—keeps teams engaged and focused. 📌Support Teams Through the Process: Adoption follows a curve, from excitement to frustration to growth. Steady guidance ensures successful integration. 📌Identify High-Impact Applications: Focus on areas where AI delivers the most value, like automating routine tasks or improving document creation and communication.   Our pilot program showed us that adopting AI isn’t just about technology but about preparing people for change. For biotechs, this means rethinking processes to focus on what truly matters.   Looking to build a better biotech? Let’s talk! letstalk@ssistrategy.com Click the link to learn more about how AI can fit into your organization. https://lnkd.in/dV5CXaY8

Biotech leaders often delay involving clinical expertise until after crucial development decisions are made. This timing gap can lead to costly pivots and missed opportunities in drug development. As shared by Dr. Steven Zelenkofske in our latest episode of the Emerging Biotech Leader podcast, the modern CMO role is "like an octopus with eight arms" - requiring a delicate balance of clinical expertise, operational oversight, and strategic leadership. At SSI Strategy, we partner with biotech leaders like you to structure your medical team for success. Ready to optimize your medical leadership strategy? Let's talk! letstalk@ssistrategy.com 🎧Listen to the full episode with Dr Steven Zelenkofske here: https://lnkd.in/d6gBT_hf #BiotechLeadership #DrugDevelopment #MedicalAffairs

Hola from Barcelona! Chantal is at ISPOR and would love to connect! If you’re attending or in the area, don’t hesitate to reach out.   Join her poster presentation on: “Early Cost-Effectiveness of SPECTRIS Therapy (evoking gamma band oscillations) in Alzheimer’s Disease,” in collaboration with Cognito Therapeutics, Inc. 📍 Poster ID: EE632 🗓 Tuesday, 19th November 🕓 16:00 - 19:00 Looking forward to meeting you!

The new EU HTA regulation is set to reshape market access in Europe. For global drug developers, this means navigating new, mandatory processes that directly impact your timeline and strategy. Implementation begins in January 2025, starting with oncology and ATMPs, and expanding to orphan drugs in 2028. The time to adapt is now—delays in understanding these requirements could cost valuable market access opportunities. Chantal W.M. van Gils and Maxwell Craig outline the essentials of these changes in our latest webinar. Watch the full webinar to prepare your pipeline for success: https://lnkd.in/d9B74_Zq Need guidance? Contact us today to discuss how we can support your readiness. letstalk@ssistrategy.com #EUMarketLaunch #EUProductLaunch #EUMarketStrategy #HTA #HealthTechnologyAssessment #EUHTA #HTARegulation #MarketAccess #ClinicalEffectiveness

Routine Updates Are Costing You Growth! As a biotech leader, you can’t afford board meetings that simply recycle reports—you need high-impact conversations that drive innovation and growth.   Stop wasting boardroom time. SSI Strategy partners with CEOs to transform meetings into strategic sessions, shifting from routine reporting to meaningful decision-making. Let’s talk! letstalk@ssistrategy.com   🎧 Listen to the full episode where Nick Amigone shares insights on building a more effective board strategy. https://lnkd.in/d6RmWNvR   #BiotechLeadership #BoardroomExcellence #SSIStrategy

Countdown to ISPOR Europe! Chantal W.M. van Gils will be attending and available to discuss evidence generation, value-based care, and all things HTA. You’re invited to join her poster presentation: “Early Cost-Effectiveness of SPECTRIS Therapy (evoking gamma band oscillations) in Alzheimer’s Disease,” created in collaboration with Cognito Therapeutics, Inc.. 📍 Poster ID: EE632 🗓 Tuesday, 19th November 🕓 16:00 - 19:00 Looking forward to meeting you in Barcelona! #ISPOREurope

Rounding out my recent travels with a stop in beautiful Stockholm 🌍, original home to our regulatory team: NDA Group - an SSI Strategy Company, and this year’s #BIOEurope2024! One topic that has been consistent across recent conferences: the impact of the current funding environment on innovation 📉💡. The industry is on the edge of one of the most significant patent cliffs in history, beginning in 2025. Layering in the Inflation Reduction Act (IRA) and its push to lower drug prices—a vital measure, yet one that raises questions about its influence on innovation and investment in drug discovery. I’d love to hear thoughts from this community on a few specific areas: 1 ) How do you see the IRA affecting funding for innovative therapies? 2) What creative strategies are companies considering to address both the IRA and the upcoming patent cliff? Let’s keep the conversation going in the comments! 💬 Thomas Lönngren Björn Carlsson Arne Saupstad Adriana Valenciano Lena Demetre