SSI Strategy

Bringing Your Drug to the EU Market?   Our recent webinar hosted by Chantal W.M. van Gils and Maxwell Craig, explores how the new EU HTA regulation will transform drug development.   Key takeaways: 📌Early integration of HTA considerations in target product profiles 📌Emphasis on patient value and real-world evidence 📌Cross-functional collaboration crucial: regulatory, clinical, and market access 📌Innovative approaches needed for rare diseases and advanced therapies   This regulation could reshape how we approach evidence generation and value demonstration. Are you ready for 2025? Click below to access the webinar summary and full recording. https://lnkd.in/dD8XhR8F #DrugDevelopment #ClinicalResearch #HealthTechnologyAssessment

🎉 Celebrating 30 years of Bio Europe! Join us in shaping the future of drug development partnerships.   Our expert team is ready to help build your winning strategy: Kimberly F. Kushner, Adriana Valenciano, Arne Saupstad, and Lena Demetre.   Connect via the partnering platform or email [email protected]   Can't make the conference? Join our Happy Hour on Nov 4th at Best Western Royal Star Hotel. Network, mingle, and meet our team! RSVP here: https://lnkd.in/dSad_4_b   #BioEurope30 #DrugDevelopment #Partnerships #Networking

Safety Governance During Clinical Trials As your asset moves through clinical trials, a robust safety governance framework is essential to managing risks and ensuring the safety of your patients. But is your safety governance structure ready to handle the complexities ahead? At SSI Strategy, we help you: 🔹Build a robust safety governance framework from the ground up, to ensure proper safety oversight and sound, responsible and timely decision making.  🔹Implement signal management processes to proactively identify and manage potential safety risks. 🔹Guide the governance process, ensuring key stakeholders such your Chief Medical Officer and legal team are aligned on critical safety decisions. 🔹Communicate safety risks effectively to regulatory authorities, IRB’s and physicians when necessary. 🔹Bring an objective, unbiased perspective to help you identify issues that might be missed internally.   Join us at the World Drug Safety Congress in Boston, October 29th–30th, and let's explore how we can enhance your safety governance to keep your trials on track. We look forward to connecting with you! #DrugSafety #Pharmacovigilance #ClinicalTrials #SafetyGovernance #WorldDrugSafetyCongress

Countdown to The MedTech Conference!   We're less than a week away from the MedTech Conference. Bob Honigberg is looking forward to connecting and exploring the latest in medical technology. If you're attending, we'd love to connect. Can't wait to see you in Toronto! 

Risk is part of the biotech landscape, but how you manage it can define your success. On the latest episode of The Emerging Biotech Leader podcast, host Ramin Frahood chats with Helen Kargaryani, VP Global Head of Quality/Quality Services at SSI Strategy, to explore the pivotal role of risk management in safeguarding biotech ventures. Helen’s advice is clear: “Quality is the ultimate goal.” By integrating risk management and Quality Management Systems (QMS) early on, companies—especially startups—can set the foundation for long-term success. Here are some insights from the episode: ✔️ Avoid common pitfalls: Failing to incorporate risk management into strategic planning can have severe consequences, from compliance issues to product shortages. ✔️ Scale strategically: Start small but plan big. Early implementation allows you to scale your risk management strategies as your company grows. ✔️ Don’t isolate risk management: Embed it within the company culture to ensure a comprehensive and effective approach. Listen and learn how smart risk management can drive your venture forward. https://lnkd.in/dJm5UfvK Are you involved in biotech and have insights to share? We’d like to hear from you! Send a message to [email protected].

Join Our Upcoming Webinar: EU HTA Regulation Insights - Expert Strategies for Success! Building on the success of our previous webinar, we’re excited to invite you to our next session. Our experts Chantal W.M. van Gils and Maxwell Craig will address real concerns and questions based on feedback from clients and other industry leaders. If you have questions, send them to [email protected] Missed the first webinar? Watch the recording here. https://lnkd.in/dz_jywfP Don't miss this session! Click the link below to register https://lnkd.in/dX2MUtwp

Heading to The World Drug Safety Congress Americas? Join our team Olga Minkov, Amit Patel, Alexandra Kinnally and over 2,500 senior leaders in biopharma as we discuss the latest challenges in pharmacovigilance and device safety. You can reach our team at [email protected] See you there! #WorldDrugSafety #Pharmacovigilance #DrugSafety #Biopharma

We are proud to be named one of Consulting Magazine's Best Small Firms to Work For - for the 4th year running! This recognition is a testament to our incredible team and the supportive, innovative culture we've built together. A huge thank you to our leadership team for their vision and guidance, and to all our stakeholders for their unwavering support. We are committed to fostering an environment where our employees can thrive, which in turn allows us to deliver exceptional results for our clients. To our team: thank you for making SSI Strategy a great place to work. Here's to many more years of success and growth together! #BestFirmsToWorkFor #ConsultingExcellence #TeamSSIStrategy

Is Your PV System Ready? We Know the Challenges You Are Facing For innovative biotech companies, a robust Pharmacovigilance (PV) system is crucial for safeguarding patient well-being and maintaining compliance. Did you know that approximately 30% of FDA PV inspections result in serious findings requiring immediate action? At SSI Strategy, we understand your challenges. We partner with biotech leaders like you to build PV systems that not only prioritize patient safety but also withstand regulatory scrutiny. Our tailored approach includes: 🔹Strategic risk management aligned with your product pipeline 🔹Comprehensive system assessments to identify any specific vulnerabilities 🔹Inspection readiness support, including mock PADE & BIMO inspections By leveraging our multidisciplinary expertise, and inspection readiness toolkit we help you establish a PV system that supports your innovation while ensuring quality, compliance, and patient-centricity. Let's connect at the World Drug Safety Congress in Boston, October 29-30. We'd love to hear about your PV challenges and explore how we can support your mission of bringing innovative therapies to patients. [email protected] #PatientSafety #Pharmacovigilance #RegulatoryCompliance #BiotechInnovation

Our team is gearing up for the The Cell & Gene Meeting on the Mesa in Phoenix!   Join us, along with senior leaders and key decision-makers, to explore the latest advancements in cell and gene therapy, gene editing, and tissue engineering.   Reach out to Madhav Gurijala, Nino Devidze, or Debra Webster to discuss how we can support your development programs. You can also contact us at [email protected]   Looking forward to connecting with you!