Jayne Woolf, BCMAS

BMS is poised to enter the Eosinophilic Esophagitis (EoE) market. Buried in the BMS Q2 2024 earnings call was news that company's eosinophilic esophagitis (EoE) treatment, cendakimab, successfully met Phase 3 clinical endpoints. Similar to already-approved, Dupixent, cendakimab is a biologic with subcutaneous injections every other week. Specifics on the data have yet to be released, this new agent could pose some competitive pressure for Dupixent in EoE. #gastroenterology #clinicaldata https://lnkd.in/g_2a2MWv

9

A recent analysis from Biomedtracker of clinical trial phase transitions between 2014 and 2023 suggests biopharma development success rates are falling. This poses several questions: what are the underlying reasons dragging success rates down and what does this mean for R&D productivity and the return on investment on pipeline spend? https://lnkd.in/ezX4Dsmb Citeline Commercial #biopharma #clinicaltrials #RnD

9

Access to physicians can be challenging, so it's crucial to focus efforts on reaching those who can truly impact revenue. Quality data is key to driving effectiveness. Commercial alerts provide a solution to connect with the right physicians at the right time with the right messaging. #salesforceeffectiveness #pharmamarketing #raredisease #omnichannel

10

Ac-225 is making waves in targeted alpha therapy for cancer treatment. This rare radioactive isotope shows promise in delivering potent alpha particles directly to cancer cells, offering a new approach for treating resistant cancers. Despite production and safety challenges, ongoing research hints at a bright future for Ac-225 in oncology. Bayer's Ac-225 PSMA-Trillium aims to reduce doses to non-target organs, potentially transforming the treatment journey for men with mCRPC by addressing salivary gland issues commonly associated with PSMA treatments. Positive outcomes could revolutionize disease management.

3

How can generative AI revolutionize the life sciences industry and transform patient care? The rise of generative AI presents immense opportunities for healthcare and life sciences companies. According to Deloitte's 2024 survey, 75% of leading healthcare firms are already experimenting with or scaling generative AI use cases. This powerful technology can unlock game-changing applications: Supply Chain Optimization Generative AI can analyze data on disease prevalence, socioeconomic factors, and logistics to create micromarket demand forecasts and optimized supply chain strategies. This could dramatically improve cost efficiency and care delivery for patients, healthcare organizations, insurers, and governments. Accelerated Drug Discovery By rapidly processing vast datasets, generative AI can accelerate drug discovery pipelines, identify novel drug candidates, and optimize clinical trial designs. This could lead to faster development of life-saving therapies. Personalized Treatment Plans Generative AI models can synthesize patient data, medical literature, and clinical guidelines to generate personalized treatment recommendations tailored to each individual's unique health profile. As life sciences leaders, we must prioritize the ethical development and deployment of generative AI while mitigating risks to ensure trustworthiness and health equity. Embracing this transformative technology responsibly can drive innovation, enhance patient outcomes, and create a more sustainable healthcare ecosystem. https://lnkd.in/ePt-RnTm #AI #healthcare #patientcare

6

Issa K. recently joined The Global Marketing Show podcast by Rapport International to discuss key strategies for medtech companies navigating regulatory challenges. As Ambrosia Ventures’ principal consultant, I emphasized: • Early Engagement: Connect with regulatory bodies early. • Global Perspective: Understand international requirements. • Continuous Learning: Stay updated on regulatory changes. A big thank you to Wendy Pease 🌍 for having us as a guest! At Ambrosia Ventures, we specialize in helping medtech companies navigate complex regulations and accelerate innovation. Let’s connect to align your strategy with the latest trends! https://lnkd.in/g5bC7uP4 #MedTech #RegulatoryAffairs #Innovation #GlobalStrategy #AmbrosiaVentures

2

🎉 Prepare for an exciting month filled with events!🎉 This month is packed with incredible events you won’t want to miss! From inspiring industry conferences and networking opportunities, there’s something for everyone. Here’s a glimpse of what’s coming up: ✨ Gene Therapy Analytical Development & CMC Summit, 30 October - November 1 | Boston, MA, USA ✨ Bio-Europe Fall 2024, 4 - 6 November | Stockholm, Sweden ✨ PEGS Europe 2024, 5 - 7 November | Barcelona, Spain ✨ Extractables & Leachables Europe 2024, 4 - 6 November | Vienna, Austria Don’t miss out—mark your calendar, register, and join us to connect, learn, and make the most of these fantastic industry events! 📅 #healthscience

12

Biosecure Act: Implications for the Biotech Industry   The U.S. House Committee for Oversight and Accountability voted 40-1 to approve the BIOSECURE Act on May 15, 2024. This legislation is designed to leverage the purchasing power of the U.S. federal government to encourage life sciences companies to dissociate from certain Chinese "biotechnology companies of concern" and to rigorously monitor their supply chains for any biotechnology products or services from these entities.   Although the Act includes provisions to mitigate some of the disruption, its primary goal is to incentivize U.S. companies to diversify away from Chinese-based biotechnology goods and services, seeking alternative suppliers and service providers instead.   This shift could lead to considerable changes in commercial contracting and supply chain oversight within the pharmaceutical and biotechnology sectors. U.S. companies in these industries frequently engage Chinese contract development and manufacturing organizations (CDMOs) for a range of services, including manufacturing, development, formulation, packaging, and distribution. Under the BIOSECURE Act, these companies may face a critical choice between maintaining relationships with these "biotechnology companies of concern" or continuing to do business with the U.S. federal government.   Given the extensive involvement of the identified biotechnology companies of concern with a significant portion of U.S. pharmaceutical and biotechnology companies, the BIOSECURE Act could further strain already challenged supply chains, exacerbating ongoing drug shortages.   This legislation represents a pivotal development for the biotech industry, signalling a potential shift in how companies manage their supply chains and partnerships on a global scale. Biotechnology activity Pharmanews

3

1 Comment

Are you looking for the next big thing in drug development? Look no further than cell and gene therapy (CGT) programs 📌 According to a recent research brief by NEWDIGS at Tufts Medical Center FoCUS Project, CGT has a higher probability of clinical and regulatory success, and a greater likelihood of approval from Phase I compared to other therapeutic modalities. In fact, they are 2-3.5X more likely to succeed than the entire drug pipeline 📌 The research also found that CAR-T/TCR therapies for blood cancers are 3X as likely to be approved when entering Phase I as the average oncology drug and over 2X as likely as the average hematological oncology drug 📌 Orphan gene therapies are 2-3.5X as likely to be approved when entering Phase I as the average drug in clinical trials, outperforming in every clinical development phase. Orphan gene therapies are 2X as likely to be approved when entering Phase I as the average drug in similar therapeutic areas #DrugDevelopment #CellTherapy #GeneTherapy #ClinicalTrials #ResearchBrief #perspectives #cellandgenetherapy #perspectives EOS Intelligence

11

Pulse Edge specializes in guiding life science companies through the complex path to market access. From early strategic planning and market analysis to value proposition development and launch readiness, we support strategic decision-making to ensure that value-adding therapies reach patients. Our expertise spans commercial strategy, pipeline planning, market valuation, and launch excellence. Our commitment is to support your growth by delivering successful outcomes. Interested in how we could help you navigate the road to revenues? Let's connect. #MarketAccess #PharmaStrategy #HealthInnovation 

1