Spinnaker Life Sciences Strategy Consulting

Welcome to the September edition of the Spinnaker Insights newsletter. This month, we explore how biopharma companies and investors can deepen their understanding of stakeholder dynamics, addressing common pitfalls that contribute to new-product revenue underperformance and enhancing the accuracy of forecasts. #LifeSciences #CommercialStrategy #InvestmentStrategy

"Buy on data; sell on the launch" is a common biopharma investment strategy, reflecting the excitement generated by promising clinical trial data, which often boosts stock prices. However, the launch phase is often slower and more challenging than expected, leading to tempered expectations and lower stock prices. Companies tend to overestimate their product’s differentiation and underestimate the difficulty of changing physician and patient behavior. With payers controlling access and most physicians now employees of hospitals or private equity, incentives to adopt new products are often misaligned. The Diffusion of Innovation framework provides a pragmatic approach to evaluating new products by comparing their relative advantage, compatibility, and financial implications against current standards of care. Partner Harris Kaplan explores how these factors impact innovation, product adoption, and more realistic assessments of commercial potential. Click the link below to learn more. https://lnkd.in/eE3PWs-f #biopharma #investmentstrategy #biopharmainvestment #productdifferentiation #commercialpotential Subscribe here to receive our latest insights and newsletters: https://lnkd.in/eGAaapyA

The recent U.S. Supreme Court decision in Loper Bright Enterprises v. Raimondo, which overruled the Chevron doctrine, marks a significant shift in administrative law that will profoundly impact federal regulatory agencies. As a result, industries like healthcare and life sciences, which rely heavily on regulatory guidance, must brace for legal uncertainty and increased scrutiny. The ruling could slow regulatory processes and lead to more litigation, particularly in areas such as hospital reimbursements, drug pricing, and the FDA’s approval processes. To navigate this new landscape, companies will need to enhance their legal readiness, monitor regulatory changes closely, and advocate for clearer legislative directives. Click the link below to learn more. https://lnkd.in/dBGsMkse #Chevron #ChevronDoctrine #SupremeCourt #Healthcare #LifeSciences #FDA Subscribe here to receive our latest insights and newsletters: https://lnkd.in/eGAaapyA

Artificial Intelligence (AI) is making waves in the life sciences sector, driving significant advancements in areas like drug discovery, patient care, and supply chain management. But with these innovations come challenges that companies must navigate to fully realize AI's potential. This deep dive explores how AI is transforming the industry—from its historical roots in computational biology to the cutting-edge technologies shaping drug development today. It also addresses the hurdles, such as data quality and regulatory challenges, that need to be overcome for AI to deliver on its promise. For anyone in biotech or pharma, understanding these dynamics is key to staying competitive and unlocking new opportunities. Click the link below to learn more. https://lnkd.in/euBuH4fV #AI #LifeSciences #Innovation #DrugDiscovery #ClinicalTrials #Healthcare Subscribe here to receive our latest insights and newsletters: https://lnkd.in/eGAaapyA

Welcome to the August edition of the Spinnaker Insights newsletter. This month, we dive into the past and future role of artificial intelligence in the life sciences industry. #LifeSciences #ArtificialIntelligence #DrugDiscovery #ClinicalTrials

Congratulations to Spinnaker Partner Harris Kaplan on being recognized as a “venerable industry expert” in Noah Pines’s recent piece “The Value of Deep Customer Listening.” Harris has been a leading figure in marketing research, having founded three successful research companies, introduced many advanced methodologies into the life sciences, and conducted research on over 100 products. As Noah reflects on how market research has evolved over the last decade, he’s right to note how pivotal a few profound customer insights, obtained through firsthand discussions with key stakeholders, can be on the success of a brand – despite an increasing movement away from these primary sources in recent years. At Spinnaker, we recognize how these high-fidelity learning experiences are indispensable for developing effective commercial and marketing strategies, and are committed to synthesizing these approaches with robust data analytics to deliver comprehensive solutions for our clients. Read the full article below. https://lnkd.in/espyffPc #LifeSciences #Biopharma #PrimaryMarketResearch #MarketingResearch #CustomerInsights #StrategicConsulting #InPersonResearch #HealthcareMarketing

With the FDA’s recent draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” greater emphasis is being placed on increasing clinical study enrollment of historically underrepresented populations. Conducting diverse clinical trials is both a regulatory and ethical imperative that offers strategic advantages to pharma and biotech companies. By including a more representative patient population in studies, companies can ensure the development of assets that improve health outcomes for a larger cross-section of the population and, in turn, strengthen their position in the market with a drug tailored to ensure a more universally safe uptake. Click the link below to learn more. https://lnkd.in/efwn-Wya #clinicaltrials #FDA #diversityinclinicaltrials #diversityactionsplans Subscribe here to receive our latest insights and newsletters: https://lnkd.in/eGAaapyA

Happy National Intern Day to our two amazing interns, Caitlin Gu and George Song. We're so lucky to have you both on our team this summer! #NationalInternDay

Biosimilars have had a transformative impact in the biopharmaceutical industry over the past decade. While they have improved cost savings and patient access, biosimilars have faced nuanced challenges in market adoption--an obstacle not typically encountered by generics. With 12 blockbuster biologics facing pressure from companies with biosimilars in their pipeline, questions of market adoption are timely. We anticipate increased US adoption in the coming years—changes proposed from the Inflation Reduction Act place greater liability on plan sponsors that could encourage them to increase the utilization of biosimilars. Explore how these developments are influencing the healthcare sector and what the implications are for patients, providers, and industry stakeholders. Click the link below to learn more. https://lnkd.in/edskaknX #biosimilars #humira #biologics #biologictherapies Subscribe here to receive our latest insights and newsletters: https://lnkd.in/eGAaapyA

This year, our Boston team had the opportunity to participate in Bike MS with the National MS Society, a charity ride dedicated to raising funds and awareness for Multiple Sclerosis (MS) research and support. Multiple sclerosis is an autoimmune disease where the immune system mistakenly attacks the protective myelin sheath covering nerve fibers, leading to communication problems between the brain and the rest of the body. Disease-modifying therapies are available and can slow disease progression and delay disability, but there is no cure. Ongoing funding is necessary to support continued research, advance our understanding of the disease, and develop innovative therapies that could offer hope to the millions living with MS worldwide.   We were so glad to be able to participate and donate to such an amazing cause!   #BikeMS #BikeMSInsideOut #MultipleSclerosis