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Tom Caravela
💥 The Value of In-House Medical Affairs to the MSL 💥 Check out this weeks MSL Talk Podcast with Erlene Seymour, MD, Medical Director, US Medical Affairs Hematology at BeiGene who discusses the value of In House or HQ Medical Affairs to the MSL Learn more about…. 👉 Why is it important for MSLs to know about their inhouse counterparts and what comes from their support 👉 What makes in house medical affairs so valuable to MSLs and to the organization 👉 Advice for MSLs in how they should view and interact with their inhouse counterparts 👉 Advice for MSLs that may want to pursue a role in house or HQ medical affairs position 👉 What is it that helps MSLs stand out and separate themselves from the others The MSL Talk Podcast will be available Tuesday May 14th, 2024 on all podcast platforms and the MSL Talk YouTube Channel. MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLTalk #careers
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Tom Caravela
💥 The Value of In-House Medical Affairs to the MSL 💥 Check out this weeks MSL Talk Podcast with Erlene Seymour, MD, Medical Director, US Medical Affairs Hematology at BeiGene who discusses the value of In House or HQ Medical Affairs to the MSL Learn more about…. 👉 Why is it important for MSLs to know about their inhouse counterparts and what comes from their support 👉 What makes in house medical affairs so valuable to MSLs and to the organization 👉 Advice for MSLs in how they should view and interact with their inhouse counterparts 👉 Advice for MSLs that may want to pursue a role in house or HQ medical affairs position 👉 What is it that helps MSLs stand out and separate themselves from the others The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel. MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLTalk #careers
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Tom Caravela
💥 The Value of In-House Medical Affairs to the MSL 💥 Check out this weeks MSL Talk Podcast with Erlene Seymour, MD, Medical Director, US Medical Affairs Hematology at BeiGene who discusses the value of In House or HQ Medical Affairs to the MSL Learn more about…. 👉 Why is it important for MSLs to know about their inhouse counterparts and what comes from their support 👉 What makes in house medical affairs so valuable to MSLs and to the organization 👉 Advice for MSLs in how they should view and interact with their inhouse counterparts 👉 Advice for MSLs that may want to pursue a role in house or HQ medical affairs position 👉 What is it that helps MSLs stand out and separate themselves from the others The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel. MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLTalk #careers
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Tom Caravela
💥 SUPER MSL: The Quest to Become the TOP MSL on Your Team💥 Don't miss this weeks MSL Talk podcast with Daniel Snyder, Ph.D., Senior Medical Affairs & HEOR Leader who discusses the differentiators for MSLs that will make you stand out and become the top MSL on your team. Learn more about…. 👉 The qualities and differentiators of a “Super MSL” 👉 The skills and attributes that make MSLs stand out relative to their peers 👉 What common mistakes do MSLs need to avoid to 👉 What MSL Team leader should do to encourage and entice ideal MSL skills The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel. MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLtalk #careers
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Tom Caravela
💥 SUPER MSL: The Quest to Become the TOP MSL on Your Team💥 Don't miss this weeks MSL Talk podcast with Daniel Snyder, Ph.D., Senior Medical Affairs & HEOR Leader who discusses the differentiators for MSLs that will make you stand out and become the top MSL on your team. Learn more about…. 👉 The qualities and differentiators of a “Super MSL” 👉 The skills and attributes that make MSLs stand out relative to their peers 👉 What common mistakes do MSLs need to avoid to 👉 What MSL Team leader should do to encourage and entice ideal MSL skills The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel. MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLtalk #careers
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Karin Hoelzer
Great article summarizing a fascinating and very timely #MedPAC conversation last week. If nothing else, the article puts some of FDA's proposals around #biosimilars and #interchangable #biosimilars into context and reinforces how complex #drugpricing policy really is. One grim reality for many #raredisease patients: list prices have little correlation with actual #out-of-pocket costs for our patients, many of whom rely on #medicalproducts on #specialtytiers of the formularies. For background, MedPac is the #Medicare Payment Advisory Commission, an independent legislative branch set up to advise #Congress on the Centers for Medicare & Medicaid Services #Medicare program, and a key voice in the #drugpricing and #pbm #pharmacybenefitmanager reform debates.
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Bryan Blair
🔬 Biopharma Layoffs: Navigating Challenges in a Shifting Landscape Recent trends in biopharma layoffs have left many scientists reeling. Here are key takeaways from a recent STAT article: 67% of life science layoffs in H1 2024 were at large biopharma companies (>$1B annual sales), up from 47% in 2021-2023. Job postings in biotech dropped from 21,366 to 12,300 between early 2021 and 2024. Scientists face unique challenges in job searches, including maintaining confidentiality about previous work. Visa constraints add pressure for international workers, limiting job search time. Networking remains crucial: Some successful companies are hiring primarily through personal connections. The industry sees this as part of a cyclical pattern, influenced by patent expirations and acquisitions. Despite these challenges, opportunities still exist. Adaptability, networking, and a broader job search approach are key for scientists navigating this evolving landscape. What strategies have you found effective in weathering industry changes? Share your thoughts below! #BiopharmaJobs #CareerTransition #LifeSciences #Networking
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Karin Hoelzer
FDA and the pharmaceutical industry have come a VERY LONG way in routinely incorporating patient preferences and perspectives as an integral part of #drugdevelopment; yet, we still have a long way to go. Patient perspectives are at the center of patient-focused drug-development #PFDD and key to success in #raredisease #drugdevelopment. From informing #endpoint selection and #clinicaltrial design to #riskbenefit considerations, labeling, and so much more, #patientexperiencedata makes #clinical #developmentprograms truly #patientcentric and ensures that the trials - and the final product - meet the needs of (all!) patient populations. Yet, patient experience data is still too often collected too late in the drug-development process, after critical decisions have been made and it is very hard if not impossible to course-correct. What are best practices and lessons learned in the US and globally to incorporate patient perspectives early, and most effectively, in the drug development process? And how do patient organizations, regulators, industry, and academia effectively collaborate to capture what truly matters to patients? I am so delighted to speak about this topic on this esteemed panel at #DIA2024. Thank you Steffen Thirstrup for moderating this enlightening conversation, and to Robyn Bent, Juan Garcia Burgos, Rosa Gonzalez-Quevedo, Maria Apostolaros and Dr Solange Corriol-Rohou, MD-Rohou for making this conversation possible.
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Tina W.
📨 Potential implications exist in regard to #LCM and #strategies regarding market exclusivity, see below, the latest from the FTC, sending warning letters to ten major pharma companies in an attempt to continue challenging and cracking down on #JunkPatents. 📂 The claims are around 'inaccurate or improper' patents in place which essentially block competition and keep drug prices high. Many big-name prescription brands are included in this round of probes. 2️⃣ 0️⃣ : "The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate." 🤔 Are your brands affected? ❓ How might actions against you or your competitors affect your LCM strategy? https://lnkd.in/eVuapvWJ #LifeCycleManagement #RegulatoryAffairs #Policy #FTC #FederalTradeCommission #OrangeBook #PharmaPatents #AntiTrust #Pharma
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Bryan Blair
🚨 10 Key Takeaways from "Behind Big Pharma's layoffs — is there an end in sight?" 🚨 1️⃣ Massive Job Losses: In 2023, the biopharma industry saw around 14,000 job losses due to layoffs. 2️⃣ Bristol Myers Squibb Cuts: The company plans to eliminate 2,200 jobs by 2025, including 860 in New Jersey. 3️⃣ Bayer Restructuring: Bayer has already reduced its workforce by 1,500, with more layoffs possible. 4️⃣ Expense Trends: Pharma companies' selling, general, and administrative expenses have stayed at 29% for decades, while R&D spending has risen from 12% to nearly 18% of revenue since 2000. 5️⃣ Funding Worries: An EY Biotech report reveals that 31% of biotechs may run out of funds within a year. 6️⃣ High-Demand Skills: Digital technology, AI, and market access skills are currently in high demand. 7️⃣ AI's Impact: An EY-Parthenon report suggests AI could drive future hiring in biopharma as it becomes crucial in drug development. 8️⃣ Economic Shifts: The European Central Bank has cut interest rates from a high of 4% as inflation decreases, while the Federal Reserve has yet to follow suit. 9️⃣ Political Uncertainty: The November 2024 election is unpredictable and could impact the industry, though effects will only be known post-election. 🔟 Future Outlook: Arda Ural of EY predicts a potential return to normalcy by 2025, with the worst of the layoffs possibly over by then. Stay tuned for more insights and trends from the biopharma industry! 💡✨ #Pharma #Biotech #Layoffs #JobMarket #AI #Innovation #Healthcare #Economy #FutureTrends
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Dr. Timos Papagatsias
Gene&Cell Therapy >> Bristol Myers to shutter Bay Area cell therapy facility as it eliminates jobs and costs: Bristol Myers Squibb is closing a cell therapy manufacturing site in California as the company implements a $1.5 billion cost-cutting program that was announced this week, according to a company spokesperson. The Redwood City, CA facility will be closed and employees who aren’t being let go will be relocated to another site in Brisbane, also in the Bay Area. The changes come amid layoffs of roughly 2,200 employees company-wide, representing about 6% of its global workforce, and a pipeline reorganization as new CEO Chris Boerner steers Bristol Myers through a “transition period” following several big acquisitions. “Unfortunately, there were impacts to some of our employees as a result of these changes,” the spokesperson said in an email. “We remain committed to the San Francisco Bay Area as an important innovation hub.” The San Francisco Business Times first reported the news Friday morning. According to BMS’ website, the Redwood City site made up the company’s Cancer Immunology & Cell Therapy Thematic Research Center. Most of the research centered around the tumor microenvironment in order to “inform the science required to enable early drug development.” The Brisbane site, meanwhile, has teams spanning the development spectrum — from drug discovery to late-stage clinical trials — and several therapeutic areas. BMS recently expanded the site by 27,000 square feet, hosting a ribbon-cutting last September. Bristol Myers sells two of the six FDA-approved CAR-T treatments for aggressive blood cancers: Abecma and Breyanzi. Both therapies came to BMS as part of the 2019 Celgene buyout, with Breyanzi originating at the Celgene-acquired Juno Therapeutics. It’s also developing a handful of CAR-T programs, one for relapsed or refractory multiple myeloma targeting GPRC5D and another going after CD19 for systemic lupus erythematosus, or SLE. There is also a dual-targeting BCMA and GPRC5D-directed CAR-T for late-line multiple myeloma. #lucidquest #genetherapy #celltherapy
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Tina W.
📣 More news releases in advance of the forthcoming #ASCO meeting in Chicago!! Results from Merck's TROP2-targeting ADC sacituzumab tirumotecan PIII OptiTROP-Breast01 trial were released ahead of #2024ASCO: ⤵ Showing "reduced the risk of disease progression or death by 69% versus chemotherapy in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) who have failed at least two prior therapies." Merck has also moved this asset into NSCLC. 🌎 Other global manufacturers with treatments in this TROP2 ADC space (BC and/or LC) include Gilead Sciences and AstraZeneca/Daiichi Sankyo US #Merck #Oncology #ADC #BreastCancer #TNBC #ASCO #AstraZeneca #AZ #Gilead #DaiichiSankyo #MedicalAffairs #Pharma #Healthcare
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Tina W.
👑Royalty Pharma's expanding portfolio...buys in, to the tune of $525M, to the biotech ImmuNext for a cut of Sanofi's acquired MS Drug, frexalimab. 💰 This will yield the right to earn royalties and milestone payments from the autoimmune disease drug, on global sales up to $2B, on a 'tiered royalty structure' Frexalimab’s Potential and Sanofi’s #Strategy 📒 Mid-stage P3 results on this were published in NEJM "Sanofi plans to seek approval for the medicine in 2027, anticipating annual sales of over 5 billion euros (approximately $5.4 billion) and royalties through 2041" 📈 This investment highlights the potential benefits of frexalimab in the treatment of multiple sclerosis (MS) and Royalty Pharma's strategic approach to portfolio diversification. #RMS #MultipleSclerosis #Biotech #Innovation #Sanofi #RoyaltyPharma #Pharma #Healthcare
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Oliver Morkel
Navigating change is part of any industry and in life sciences the pace can be especially swift. Recent industry news highlights significant shifts within Medical Affairs and Clinical Development, which have implications for talent acquisition and retention. Medical Affairs has evolved rapidly, transitioning from a support role to a strategic powerhouse within pharmaceutical companies. With increased emphasis on patient-centricity and value-based outcomes, professionals in this field are now pivotal in bridging the gap between R&D and the market. Specialists who can leverage real-world evidence and communicate complex data transparently are in high demand. Meanwhile, Clinical Development is also undergoing transformation. Heightened by the pandemic, there's been a surge in virtual trials and decentralized approaches. This digital pivot requires an infusion of tech-savvy professionals to oversee the design and implementation of these novel trial frameworks. Turnover in these sectors often reflects the dynamic nature of life sciences. Professionals gravitate towards opportunities that allow them to impact patient outcomes directly and innovate at the frontiers of science. Companies that fail to provide progressive pathways for career development may see higher defection rates. On a related note, the industry has unfortunately not been immune to redundancies, albeit selectively. This is often a strategic move to realign resources with the changing landscape. It's also creating a fertile ground for recruitment, offering a chance to bring in fresh perspectives or experienced hands who can steer the ship through these transformations. Growth, remains a strong theme. Investment in biotech start-ups continues to rise, and this influx of capital is driving demand for experienced personnel who can hit the ground running in a high-stakes environment. As recruiters, our role is to help companies stay ahead of the curve by identifying talent that not only fits the technical needs of these roles but can also thrive amidst industry flux. For businesses looking to strengthen their teams or for professionals seeking to pivot their skills towards these burgeoning areas, reach out. Let's collaborate to harness the potential of these changes for your advantage. #MedicalAffairs #ClinicalDevelopment #LifeSciencesRecruitment
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Diane Giaquinta
Looking forward to presenting the results of our research "Exploring Payer Attitudes and Reactions to the Inflation Reduction Act" followed by a panel discussion with Medicare pharmacy experts @Sharon Jhawar and @Cindy Pigg. The presentation will be 11:00 am on May 1st at Asembia's AXS24 Summit in Las Vegas. Please reach out at the meeting if you would like to connect to discuss this and other important Market Access issues. #AXS24 #Inizio #IRA #MarketAccess
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Mohit Manrao
This content is for US audiences only. The relentless pace of oncology innovation never slows down – even after AstraZeneca’s thrilling ASCO appearance just a few weeks ago. Today, we announced positive high-level results from the NIAGARA Phase 3 study with our IO medicine demonstrating clinically meaningful and statistically significant benefits in muscle-invasive bladder cancer (MIBC). Administering our IO therapy plus chemo as neoadjuvant treatment, then as adjuvant monotherapy after surgery led to improved event-free survival in patients with MIBC. This cancer is hard to treat and likely to spread, so we see the promise for a more effective options in this patient population. Pushing the boundaries of science has allowed us to begin realizing the potential of IO treatments in new tumor areas like bladder cancer. And today’s positive readout means that we’re starting to see the impact on the patients we serve. We look forward to sharing the full results of the NIAGARA trial at a future medical conference. Read more about the announcement: https://bit.ly/4eFKaW2 #USOnly #AstraZenecaUS
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William Sarraille
A Terrific Summary of the #LDT Rule From Sidley Austin LLP Below: The Impact on #RareDiseases Cannot Be Overstated As a rare disease patient, this #laboratory developed test rule is very disturbing. It has a substantial likelihood of both increasing the cost of and delaying the development of rare disease patient diagnostics. But the impact doesn’t end there—It’s a huge threat to rare disease research and drug development. What Does the Rule Do?: It subjects many #LDTs to new regulation where those tests have previously not been subject to costly and time consuming #clinicaltrial and other burdensome #FDA regulatory requirements. Why the Rule Is So Important in the Rare Disease Space: The development of these diagnostics will be significantly impeded by this regulation. LDTs are critical to: 1) rare disease treatment development, including the design of trials and #CTR participant identification, 2) the successful (and timely) navigation of the #FDA drug approval process, by helping to show efficacy in the target population, 3) identifying coverage criteria that meet #insurancepayer concerns adequately to pave the way for reasonable coverage, and 4) providing #patientaccess to patients post-approval by permitting the identification of the full population needing treatment. Folks, this is a really big deal and a really big problem. #drugdevelopment #orphandiseases #orphandrugs #patientsfirst #clinicallabs #clinicallaboratories #clia
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Bryan Blair
10 Key Takeaways from Neil Versel's Article for BioSpace on the Impact of the IRA on Pharma R&D and VC Investments 1. Federal Court Decisions: Johnson & Johnson and Bristol Myers Squibb's legal challenges to the IRA's drug price negotiations were dismissed by a judge in New Jersey, joining previous unsuccessful legal efforts by AstraZeneca and PhRMA. 2. Medicare Drug Price Negotiations: The Centers for Medicare and Medicaid Services are proceeding with negotiations for the first 10 drugs, with negotiated rates set to be implemented in 2026. 3. Shift in R&D Strategies: Big Pharma, including names like Pfizer, is adjusting its research and development focus towards biologics over small molecules due to the IRA's patent protection cap of 9 years for small molecules vs. 13 years for biologics. 4. Venture Capital Funding Trends: Venture capital funding has shown a significant preference for biologics, with a 50% higher investment in 2023 compared to small molecules, partly due to the IRA's influence as highlighted by John Stanford of Incubate. 5. Pharmaceutical Company Adjustments: Specific companies are revising their pipelines, with Pfizer shifting to antibody-drug conjugates and bispecific antibodies, while Vir Biotechnology, Inc. and Protagonist Therapeutics are stepping away from certain small molecule projects. 6. Eli Lilly and Company and Daiichi Sankyo US's Cautious Watch: Despite the changing landscape, companies like Eli Lilly and Daiichi Sankyo are observing Medicare negotiations outcomes before making significant strategic shifts, indicating varied industry responses to the IRA. 7. The IRA's Impact on Drug Launch Strategies: Christiana Bardon M.D. from MPM BioImpact notes that the IRA may alter how and when companies launch drugs, with a likely shift towards larger patient population indications at launch, potentially disadvantaging rarer diseases. 8. Medicare Part D Changes: The IRA introduces a cap on individual out-of-pocket drug expenses, projected by the Congressional Budget Office to reduce drug spending by $100 billion over a decade, impacting biopharma R&D budgets. 9. Investment Shifts to "Safer Science": The industry might lean towards lower-risk, "me-too" drugs due to the IRA's economic pressures, as indicated by John Stanford, affecting the variety and innovation in drug development. 10. Legislative Efforts and Future Uncertainties: While bipartisan legislation aims to equalize the patent protection period for all drugs, the industry remains in a state of flux with major pharmaceutical companies and investors adjusting strategies amidst legal appeals and potential policy changes. https://lnkd.in/eUMFvwVv
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