Two weeks ago, over 60 of us came together in NYC for a fantastic day of discussion at the Bioethics International Roundtable as leaders from across the biopharmaceutical industry. As always, the event was inspiring as we explored key topics such as clinical trial diversity, patient centricity, access to medicines globally, and the rapidly evolving focus on ESG in our industry. I was particularly inspired by the discussion focused on sharing individual results to clinical trial participants, a topic that has been a passion for me since my GSK days where I was deeply involved in the development of plain language summaries, internally and externally, as it was a new component of clinical trial transparency spurred on by the EU Clinical Trial Regulation requirement. From that point, it simply made sense to move from sharing aggregate results to sharing individual results. So proud to represent Legacy Health Strategies in this forum and to have developed the capability to operationalize sharing of individual and aggregate results via a digital communication platform connecting sponsors and participants, before, during and after clinical trials. Looking forward to collaborating further to ensure the industry lives up to its full potential for good! - CEO Jessica Scott, MD, JD #BioethicsInternational #BEI #HealthEquity #ClinicalTrials #PatientEngagement #ESG #Transparency #LegacyHealthStrategies #DrugDevelopment #RoundTable #Pharma #NYC
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On the cross-country flight home from a wonderful and busy BIO International Convention, I spent some time reflecting on three years here at the National Pharmaceutical Council. I still remember flying to DC as the brand-new President and CEO of the organization in June 2021 – a trip that simultaneously feels like yesterday and a lifetime ago, given the changes in the industry, health policy, and research environment. The work of NPC has never been more relevant — or more important. We have a great team, and this team appreciates the challenges we face. Here are three reflections I’d offer for anyone interested in the future of innovation. • To meet the challenges of today and tomorrow, NPC has built new capabilities that allow us to build on our 70-year legacy as we conduct rigorous, policy-relevant research and communicate it with impact. I invite you to learn more about the value we provide to NPC members and the benefits member companies experience. https://lnkd.in/etCWVqTE • NPC’s research informs many of the important policy conversations going on right now. To stay up to date on our latest, I hope you subscribe to the NPC This Week Newsletter to get a weekly look-ahead at the policy, research, and industry conversations that matter to the future of biopharmaceutical innovation. https://lnkd.in/eBAj7B_B • I’m proud of the team at NPC and what we’ve accomplished — while recognizing the challenges in front of us. If you’d like to see more of our recent research, analysis, and work, check out our 2023 Annual Report. https://lnkd.in/eB6u2nWd I’ve loved every minute of the past three years and look forward to many more. These aren’t challenges we can solve alone, and it has never been more important for drugmakers, payers, and policymakers to understand the ecosystem and work together for the benefit of patients. If we haven’t spoken in a while, I’d love to hear from you, whether in the DMs, email, or phone. #pharma #innovation #healthpolicy
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This is a very important topic with industry leaders and influencers. Send me a message if you want more information. See you there! #DIA2024 #ICH #Data #RegulatoryOperations
Exciting News! 🚀 We are thrilled to announce that Brooke C., Vice President, Head of Delivery and Advisory US at Epista, will be joining the 60th Annual DIA Meeting from June 16 - 20 in San Diego! This year, the DIA 2024 Global Annual Meeting will bring together industry stakeholders, regulators, academics, and patients to tackle the most pressing challenges in Life Science.💡 Brooke will further hold two presentation at the global meeting! One will be taken place on Monday, June 17th at 3:30pm about: Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization. Here Co-presenters will be: 💡Dr. Andrew Chang, Novo Nordisk 💡Ciby J. Abraham, Ph.D., AstraZeneca 💡Alexander Gaffney, MS, RAC, AgencyIQ 💡Lawrence Yu, Ph.D., FDA We are looking forward listening to Brooke and all the other industry experts! Next week we will announce the other session Brooke will be talking at the Meeting - stay tuned! #DIA2024 #LifeSciences #HealthcareInnovation #EpistaLifeScience #Pharmaceutical #Healthcare
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Last week, we shared insights on transformative strategies in pharmaceutical development. Join us on our next 4x4 Innovation Meet that is happening TODAY, 27 June 2024 at 22:00 (Singapore time). Attend here: https://lnkd.in/gd4apAEg #PharmaInnovation #DrugDevelopment #4x4InnovationMeet #Pharmaceuticals #HealthcareInnovation #BusinessStrategy #MarketStrategy
💡 𝐒𝐡𝐚𝐩𝐢𝐧𝐠 𝐓𝐨𝐦𝐨𝐫𝐫𝐨𝐰'𝐬 𝐏𝐡𝐚𝐫𝐦𝐚 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞: 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐫𝐨𝐦 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐋𝐞𝐚𝐝𝐞𝐫𝐬 At our 4x4 Innovation Meet on June 20, 2024, industry leaders, including Mike Rea, CEO of IDEA Pharma, shared insights on transformative strategies in pharmaceutical development. 🔹𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐄𝐚𝐫𝐥𝐲-𝐏𝐡𝐚𝐬𝐞 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: A key discussion was the importance of implementing an appropriate market strategy from the start of drug development. Traditionally, early clinical trials focus on safety and efficacy. However, as Mike Rea showed with the Cymbalta case study, aligning these phases with market needs can increase commercial success and relevance. This makes market adoption smoother and more effective. 🔹𝐑𝐞𝐝𝐞𝐟𝐢𝐧𝐢𝐧𝐠 𝐑&𝐃 𝐒𝐮𝐜𝐜𝐞𝐬𝐬 𝐌𝐞𝐭𝐫𝐢𝐜𝐬: We also examined the need to change how we measure R&D success. Instead of only aiming for regulatory approval, the industry should use metrics that predict long-term market success and impact on patients. This ensures that new medicines are not only approved, but also successful and beneficial to consumers. These discussions provide important guidance for the strategic positioning of new products in a competitive market. Join us 𝐭𝐨𝐦𝐨𝐫𝐫𝐨𝐰 for the next 4x4 Innovation Meet to explore the latest developments across various industries: https://lnkd.in/gse8rcyA #PharmaInnovation #DrugDevelopment #4x4InnovationMeet #Pharmaceuticals #HealthcareInnovation #BusinessStrategy #MarketStrategy Magnus Hakvåg, 🔑Maria Boicova-Wynants Donal O'Connell; Sanaz Javadi Farahzadi; Dr. Dominique Christ; Dr. Claas Gerding-Reimers; Erdem KAYA; Archana Pandit; Udo Gennari; Priggya Arora; Shalini Sitaraman Menezes; Magda Voltolini; Ivan Gauci; Mustafa Cakir, RTTP, QPIP, Bastian Best; Dr. Jörn Plettig; Martin Schlosser; Henry K.H. Wang; Philipp Hammans; David Perkins — Software Patent Expert; Mário Castro Marques; David Durand; David Kalow; Dr. Benjamin DELSOL (PhD, LL.M); Stefan Brehm; Bastian July; Ines Duhanic, LL.M. (Stockholm); Amr Eldakak; Matthew Wahlrab; Rich McDonnell; Bruce Vojak; Christian Behr; Sam Bergstrom
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Reignite Your Passion for Innovation | Building Empowering Innovation Systems | Custom Software Tools to Enhance Relationships & Identify Opportunities | Award-Winning Strategist
Finding multiple use cases for your R&D investment plays a large role in de-risking your investment AND delivering a Return on Investment (ROI). Pharma, it turns out, has publicly available datasets that justify this conclusion. The data shows that thinking broadly about use case for a new compound is a critical component of an overall strategy for managing risk early in the investment phase. In pharma, early testing to find potential treatment indications for the compound gives you a number of 'shots on goal' as you look to spend over $1B to move your compound through clinical trials. When we investigated Roche, we saw that each New Molecule Entity (NME), as Roche defines them, had, on average, 7.5 indications and treatment modalities for each NME over our ten-year period. First, NME submissions for clinical trials were heavily biased towards oncology (see comment for our graph). When the first indication was not oncology, the majority of the time oncology was the second indication. This strategy outperforms others over the long run. Based on these observations, we can accurately predict Roche's next investments by knowing which phases of clinical trials it prefers. If you like insights like this, join us weekly at the 4x4 Innovation Group each Thursday @ 7AM Pacific where Martin Schweiger holds lively discussions with leading experts like Mike Rea on innovation strategies that ACTUALLY move the needle. Join us 𝐭𝐨𝐦𝐨𝐫𝐫𝐨𝐰 for the next 4x4 Innovation Meet to explore the latest developments across various industries: https://lnkd.in/gse8rcyA #innovationmanagement
💡 𝐒𝐡𝐚𝐩𝐢𝐧𝐠 𝐓𝐨𝐦𝐨𝐫𝐫𝐨𝐰'𝐬 𝐏𝐡𝐚𝐫𝐦𝐚 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞: 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐫𝐨𝐦 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐋𝐞𝐚𝐝𝐞𝐫𝐬 At our 4x4 Innovation Meet on June 20, 2024, industry leaders, including Mike Rea, CEO of IDEA Pharma, shared insights on transformative strategies in pharmaceutical development. 🔹𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐄𝐚𝐫𝐥𝐲-𝐏𝐡𝐚𝐬𝐞 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: A key discussion was the importance of implementing an appropriate market strategy from the start of drug development. Traditionally, early clinical trials focus on safety and efficacy. However, as Mike Rea showed with the Cymbalta case study, aligning these phases with market needs can increase commercial success and relevance. This makes market adoption smoother and more effective. 🔹𝐑𝐞𝐝𝐞𝐟𝐢𝐧𝐢𝐧𝐠 𝐑&𝐃 𝐒𝐮𝐜𝐜𝐞𝐬𝐬 𝐌𝐞𝐭𝐫𝐢𝐜𝐬: We also examined the need to change how we measure R&D success. Instead of only aiming for regulatory approval, the industry should use metrics that predict long-term market success and impact on patients. This ensures that new medicines are not only approved, but also successful and beneficial to consumers. These discussions provide important guidance for the strategic positioning of new products in a competitive market. Join us 𝐭𝐨𝐦𝐨𝐫𝐫𝐨𝐰 for the next 4x4 Innovation Meet to explore the latest developments across various industries: https://lnkd.in/gse8rcyA #PharmaInnovation #DrugDevelopment #4x4InnovationMeet #Pharmaceuticals #HealthcareInnovation #BusinessStrategy #MarketStrategy Magnus Hakvåg, 🔑Maria Boicova-Wynants Donal O'Connell; Sanaz Javadi Farahzadi; Dr. Dominique Christ; Dr. Claas Gerding-Reimers; Erdem KAYA; Archana Pandit; Udo Gennari; Priggya Arora; Shalini Sitaraman Menezes; Magda Voltolini; Ivan Gauci; Mustafa Cakir, RTTP, QPIP, Bastian Best; Dr. Jörn Plettig; Martin Schlosser; Henry K.H. Wang; Philipp Hammans; David Perkins — Software Patent Expert; Mário Castro Marques; David Durand; David Kalow; Dr. Benjamin DELSOL (PhD, LL.M); Stefan Brehm; Bastian July; Ines Duhanic, LL.M. (Stockholm); Amr Eldakak; Matthew Wahlrab; Rich McDonnell; Bruce Vojak; Christian Behr; Sam Bergstrom
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💡 𝐒𝐡𝐚𝐩𝐢𝐧𝐠 𝐓𝐨𝐦𝐨𝐫𝐫𝐨𝐰'𝐬 𝐏𝐡𝐚𝐫𝐦𝐚 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞: 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐫𝐨𝐦 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐋𝐞𝐚𝐝𝐞𝐫𝐬 At our 4x4 Innovation Meet on June 20, 2024, industry leaders, including Mike Rea, CEO of IDEA Pharma, shared insights on transformative strategies in pharmaceutical development. 🔹𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐄𝐚𝐫𝐥𝐲-𝐏𝐡𝐚𝐬𝐞 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: A key discussion was the importance of implementing an appropriate market strategy from the start of drug development. Traditionally, early clinical trials focus on safety and efficacy. However, as Mike Rea showed with the Cymbalta case study, aligning these phases with market needs can increase commercial success and relevance. This makes market adoption smoother and more effective. 🔹𝐑𝐞𝐝𝐞𝐟𝐢𝐧𝐢𝐧𝐠 𝐑&𝐃 𝐒𝐮𝐜𝐜𝐞𝐬𝐬 𝐌𝐞𝐭𝐫𝐢𝐜𝐬: We also examined the need to change how we measure R&D success. Instead of only aiming for regulatory approval, the industry should use metrics that predict long-term market success and impact on patients. This ensures that new medicines are not only approved, but also successful and beneficial to consumers. These discussions provide important guidance for the strategic positioning of new products in a competitive market. Join us 𝐭𝐨𝐦𝐨𝐫𝐫𝐨𝐰 for the next 4x4 Innovation Meet to explore the latest developments across various industries: https://lnkd.in/gse8rcyA #PharmaInnovation #DrugDevelopment #4x4InnovationMeet #Pharmaceuticals #HealthcareInnovation #BusinessStrategy #MarketStrategy Magnus Hakvåg, 🔑Maria Boicova-Wynants Donal O'Connell; Sanaz Javadi Farahzadi; Dr. Dominique Christ; Dr. Claas Gerding-Reimers; Erdem KAYA; Archana Pandit; Udo Gennari; Priggya Arora; Shalini Sitaraman Menezes; Magda Voltolini; Ivan Gauci; Mustafa Cakir, RTTP, QPIP, Bastian Best; Dr. Jörn Plettig; Martin Schlosser; Henry K.H. Wang; Philipp Hammans; David Perkins — Software Patent Expert; Mário Castro Marques; David Durand; David Kalow; Dr. Benjamin DELSOL (PhD, LL.M); Stefan Brehm; Bastian July; Ines Duhanic, LL.M. (Stockholm); Amr Eldakak; Matthew Wahlrab; Rich McDonnell; Bruce Vojak; Christian Behr; Sam Bergstrom
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Diving Into Competitive Intelligence: The Key to Innovation in Pharma 🚀 Discover how Competitive Intelligence (CI) is revolutionizing pharmaceutical healthcare. Our latest blog explores CI's vital role in identifying market opportunities, enhancing R&D, and navigating complex regulatory landscapes. Learn about the challenges and successes of CI in driving groundbreaking innovations. As the pharma sector evolves, understanding the competitive landscape through CI is becoming indispensable for leading companies towards novel solutions and improved patient outcomes. Embrace insights and fuel innovation. Dive into the blog for a glimpse into the future of healthcare innovation. https://lnkd.in/d_XMTV94 #PharmaceuticalInnovation #CompetitiveIntelligence #HealthcareRevolution #InnovationThroughInsight
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Traditional value measures, such as efficacy and safety, are no longer sufficient to convince payers to reimburse new medicines at a price that optimises access and supports commercial success. It is crucial to be prepared to respond to payers' evolving requirements. Adapting your evidence generation strategies to incorporate Real World Evidence, Patient Reported Outcomes, and other new data requirements will be vital to ensure the success of new innovative therapies. 💡 Download your copy of our latest white paper below to discover the key imperatives to achieve operational excellence in Value and Access and obtain a price that rewards innovation. https://lnkd.in/eSXQzC8e #Pharma #Pharmaceuticals #PharmaceuticalStrategy #Biopharma #Strategy #Consulting #OperationalExcellence #ValueandAccess #MarketAccess #Innovation #Pricing #ValueMeasures
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CEO | Board Director | Cell and Gene Therapy |Rare Disease Patient Advocate |Global Network | Women's Leadership
Here are my Top 10 events of 2023 at Phacilitate Advanced Therapies Week. I am WILDLY optimistic about 2024! No cautious optimism here! 17 approvals pending for 2024, M&A off to a great start, expanded approvals... and it's only January! 1.Time to Talk Global Patient Access 2.First CRISPR Therapy Approvals 3.Pharma Dominates M&A and Partnerships 4.Pharma Fuels Enabling Technology Market 5.CGT Development Enters Emerging Markets 6.CDMO Industry Sees High Profile Acquisitions 7.Cell Therapy Space Faces Growing Pains 8.Rare Disease Benefits in 2023 9.FDA Collaboration Accelerates 10.CGT Shows Promise in Auto-Immune Disease Audrey GreenbergAnshul Mangal Phacilitate #ATW #top10 #cellandgenetherapy #celltherapy #genetherapy #advancedtherapies #lifesciences #healthcare #biotech #biotechnology #pharma #pharmaceuticals #patientaccess #patientadvocacy FDA #raredisease #autoimmunedisease #beyondoncology #crispr #globalaccess
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Following the launch of the Harnessing the Full Potential of Real-World Data Enhance Clinical Trials Roundtable Discussion (12 June 2024, 11am-12pm EST/4pm-5pm BST, 60 minutes), we had the opportunity to sit down with the content director Prishu Kagra to discuss the key themes of the session. Specialists from leading #Pharma organizations Sanofi, Novartis, GSK, AstraZeneca and Parexel will be sharing their best practice use cases for implementing real-world data and evidence to drive innovation, improve patient outcomes, and advance healthcare delivery in clinical trials. Swipe below to see the key themes of the upcoming virtual roundtable >>> Register FREE: https://lnkd.in/eSPseiVg #AMGWorld #Technology #ClinicalOperations #ClinicalInnovation #Digitalization #RealWorldData
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🌍 On #RareDiseaseDay, we stand in solidarity with the millions of people worldwide living with rare diseases. Erika Spens, Director of #RegulatoryAffairs, dives into how the EU and the US protect #OrphanDrugs, ensuring patients can access the vital treatments they need. Market exclusivity is a key incentive for #pharmaceutical companies to develop therapies for rare diseases, which might otherwise be overlooked due to the smaller patient populations. Learn more about what Cytel can do for #RareDiseases: https://bit.ly/49xoAQt #biotech #pharma #pharmaceuticalindustry #clinicaldevelopment #drug #drugdevelopment #FDA #EMA
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