PharmApprove - an SSI Strategy Company

At SSI Strategy, our mission is clear: to Build Better Biotech companies by offering an alternative path to success. Maxwell Craig, SVP Business Consulting at SSI shares his thoughts. Building Better Biotechs means thinking with the end in mind. To me, this starts with building the value story of your therapy into the development life cycle as early as possible. Many times, companies get to their Phase 2 or Phase 3 trials and just start thinking about regulatory needs or the value they're going to present to payers. Then, they scramble to add things like real-world evidence studies or patient-reported outcomes at the last minute. However, they should really be thinking about precedents in the disease space that have come before. They should shape their development program in the most effective way to have as much clinical data as possible. This data should satisfy the needs of key stakeholders, including regulators, healthcare providers, patients, payers, and investors. Defining the value of your program early in development builds a platform for harmonization of strategy across the company and sets a north star that your program is striving toward. An early, aligned value story leads to effective and efficient drug development.

??Only 2 days left! Have you registered for our webinar: "EU HTA Regulation: What’s changing & why it matters"? Our experts Dr Chantal W.M. van Gils & Dr Sigrid Klaar will be sharing insights into the New EU Health Technology Assessment (HTA) Regulation and the significant implications for the biotech and drug development sectors. ?? Date: Thursday, 27th June ?? Time: 14:00 BST / 15:00 CEST / 09:00 EDT This session is designed to introduce you to the new regulation, its key components, and how it works. ?? Register Now: https://lnkd.in/eTwY_TTC hashtag #Webinar #HealthTech #EURegulation #Biotech #DrugDevelopment #HTA #RealWorldEvidence #Oncology #Pharma #Healthcare #MedicalResearch #IndustryExperts

At SSI Strategy, our mission is clear: to Build Better Biotech companies by offering an alternative path to success. Gabe Miller, Recruiting consultant at SSI shares his thoughts. To me, Building Better Biotechs means making biotech milestones feel less like moonshots. No one goes into biotech believing it's going to be easy; if anything, it's everything but. We make the jump into biotech because we're eternal optimists: we believe that new advancements in science & technology can pave pathways to new diagnostics, treatments & cures. We believe these advancements can improve the lives of patients with high unmet needs. At SSI, we're not just optimists, but pragmatic optimists. While we're guided by our ambitions to accelerate patient access to innovative care, we're grounded by our experiences & expertise to make that happen. For recruiting, that means bringing together the best & brightest biotech operators and business consultants to assemble agile teams that drive value in our clients' dynamic situations. We seek experienced operators who are not just experts in a given disease state, modality, or function, but who have demonstrated track records of building value in ambiguous environments. We look for experienced business consultants who are not just PowerPoint artists or Excel wizards, but who have proven abilities in building cogent strategies & operationalizing them with relentless execution. We learn from our failures, celebrate our wins, and share in the risk of building with our biotech clients because – ultimately – we believe in the work that we do. There's something special when the work becomes bigger than just oneself, and for recruiting, it's our goal to find others who share in that belief. It takes courage to build a biotech, and we all show up a little bit braver when we recognize that we don't have to do it alone.

??Only one week left! Join us for this informative webinar: "EU HTA Regulation: What’s changing & why it matters!". Our experts Dr Chantal W.M. van Gils & Dr Sigrid Klaar will be sharing insights into the New EU Health Technology Assessment (HTA) Regulation and the significant implications for the biotech and drug development sectors. ?? Date: Thursday, 27th June ?? Time: 14:00 BST / 15:00 CEST / 09:00 EDT This session is designed to introduce you to the new regulation, its key components, and how it works. ?? Register Now: https://lnkd.in/eTwY_TTC #Webinar #HealthTech #EURegulation #Biotech #DrugDevelopment #HTA #RealWorldEvidence #Oncology #Pharma #Healthcare #MedicalResearch #IndustryExperts

? Building Better Biotechs: Insights from Our Medical Team? At SSI Strategy, our mission is clear: to Build Better Biotech companies by offering an alternative path to success. But what does "Building Better Biotechs" mean to our Medical team? Our SVP Medical, Delphine Moreau, shares her thoughts. When I think about what it means to Build Better Biotechs, I always come back to the idea of developing fit-for-purpose medical capabilities as a solid foundation for success. As a SVP of the Medical team at SSI Strategy, I’ve seen firsthand the challenges companies face when they build their medical teams too late, too small, or conversely, too big, often with misguided head office/field ratios. That’s why our medical team works closely with our clients to develop tailored, scalable workforce plans and medical strategies that align with their company’s stage and evolving priorities. We bring our expertise to help them establish the right medical team at the right time, develop robust medical strategies, and create effective communication materials that resonate with stakeholders and clearly convey the value of their therapies. But building strong medical capabilities isn’t just about having the right people and plans in place. It’s also about ensuring seamless collaboration with other functions across the company. From clinical development to pharmacovigilance, quality, regulatory, and commercial, we help our clients break down silos and foster a culture of collaboration and information sharing. When everyone works together towards a common goal, the scientific narrative of the company and its assets becomes truly cohesive and compelling. At the end of the day, what drives me and my team is knowing that we’re helping our clients bring life-changing therapies to patients faster and more efficiently. By helping them build strong medical capabilities, we’re not just supporting their success – we’re accelerating it, helping them meet their commitments to patients and investors more quickly.

??EU HTA Regulation: What’s changing & why it matters! Join us for this informative webinar led by our experts, Dr?Chantal W.M. van Gils?& Dr?Sigrid Klaar. They will be sharing insights into the New EU Health Technology Assessment (HTA) Regulation and the significant implications for the biotech and drug development sectors. ?? Date: Thursday, 27th June ?? Time: 14:00 BST / 15:00 CEST / 09:00 EDT This session is designed to introduce you to the new regulation, its key components, and how it works. ?? Register Now:?https://lnkd.in/eTwY_TTC #Webinar?#HealthTech?#EURegulation?#Biotech?#DrugDevelopment?#HTA?#RealWorldEvidence?#Oncology?#Pharma?#Healthcare?#MedicalResearch?#IndustryExperts

? Building Better Biotechs: Insights from Our IT Team? At SSI Strategy, our mission is clear: to build better biotech companies by offering an alternative path to success. But what does "Building Better Biotechs" mean to our IT team? Our VP Information Technology, Niklas Bendelius, shares his thoughts. Building Better Biotechs means building better technological solutions. I believe that technology is a crucial foundation for our company's success. Our IT team is dedicated to developing and implementing secure, scalable, and user-friendly systems that empower our colleagues to collaborate effectively, work efficiently, and provide exceptional service to our clients in the life sciences industry. By creating a seamless digital environment, we enable our teams to focus on delivering strategic guidance, expert insights, and innovative solutions to support our clients' goals. From robust communication platforms to data management tools, we provide the technological backbone that keeps our company running smoothly. However, Building Better Biotechs goes beyond just adopting the latest software and hardware. It's about fostering a culture of continuous improvement, where every team member is empowered to leverage technology to streamline processes, enhance productivity, and drive better outcomes. Our IT team is committed to being a proactive partner in this pursuit. We constantly explore new ways to optimize our technological infrastructure, support our colleagues' evolving needs, and maintain the highest standards of data security and compliance. By building better technological solutions, we enable our company to deliver the exceptional service and expertise that our clients rely on to bring life-changing therapies to patients worldwide.

??Webinar Series: Navigating the New EU HTA Regulation with Confidence Join our insight-packed webinar series where our experts will share strategies on how to navigate the new European Health Technology Assessment (HTA) regulation. Our series of five webinars will cover every aspect of the new regulation, focusing on the critical Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs), which will first apply to oncology drugs and advanced therapy medicinal products (ATMPs) from January 12, 2025. The first webinar: "EU HTA Regulation: What’s Changing & Why It Matters!" will kick off on Thursday, 27th June, hosted by Dr Chantal W.M. van Gils, VP Evidence & Value at SSI Strategy, and Dr Sigrid Klaar, Medical Advisor & NDA Advisory Board Member. This session will explore these key topics: ?? Introduction to Health Technology Assessment (HTA) and the differing needs of payers and regulators. ?? Detailed explanation of the EU HTA Regulation. ?? Understanding the implications for companies in the biotech and drug development sectors. Register now to secure your spot! https://lnkd.in/eTwY_TTC

Facing an Oral Explanation with the EMA's CHMP? This critical meeting is your last chance to address lingering concerns before a decision on marketing authorization. This article provides proven strategies for nailing this high-stake presentation. Learn how to: 1?? craft a compelling narrative, 2?? deliver a polished presentation, and 3?? prepare for tough Q&A. With the right approach, you can maximize your chances of a positive outcome. Don't let your Oral Explanation be a gamble. With an approval on the line, you can trust our experts with 20+ years of experience in securing positive CHMP opinions. Contact us today!

? Building Better Biotechs: Insights from Our People & Culture Team? ? At SSI Strategy, our mission is clear: to build better biotech companies by offering an alternative path to success. But what does "Building Better Biotechs" mean to our People & Culture team? Our VP People & Culture, Erica Lindewald, shares her thoughts. ? "When I think about 'Building Better Biotechs,' I immediately think about building a better culture. At SSI Strategy we strive to cultivate an environment where each person feels respected, supported, and able to do their most impactful work. By leveraging diversity of thought and fostering an entrepreneurial spirit across our teams, we bring the highest level of expertise to solve our clients' complex challenges. ? Our culture is the foundation upon which we build our success. It's not just about what we do, but how we do it. We believe that by creating a positive, inclusive, and collaborative workplace, we empower our team members to reach their full potential. This, in turn, allows us to deliver exceptional results for our clients. ? Our commitment to our people and our culture is unwavering, and it's what sets us apart as we help our clients bring life-changing therapies to patients around the world."