Peter L. Holmberg

In this month's Drug Delivery Leader "Frankly Fran" opinion column, Fran DeGrazio shares insights on pharma and biopharma's need for regulatory harmonization due to the substantial diversity in regulations when viewed from a global perspective. For more more on this click: https://lnkd.in/emxrHaya #drugdelivery #regulatory #harmonization

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In Drug Channels, MMIT and The Dedham Group share five steps pharma companies can take to improve patient access to genetic testing and next-generation sequencing, from educating providers on lab networks to sharing appropriate test requirements and patient eligibility criteria. Read it here: https://ow.ly/TN1N50RFGZ8 #Pharma #PharmaManufacturers #MarketAccess

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ASCO 2024 has concluded, unveiling numerous top stories in the field of oncology. However, amidst the noise and clutter, one particular abstract seems to have slipped under the radar. Read on below for more details! #ASCO #Oncology #mRNA #vaccine #Moderna #Merck

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“This is how it has always been done” or “This is how everyone does it” are no longer sufficient. We have to be creative and take risks to disrupt the status quo and forge new paths. #healthcare #clinicaltrials #raredisease

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A deep understanding of the patient journey is core to designing better #raredisease patient support programs — and it all starts with the right data. I share some thoughts in PM360 Magazine: https://bit.ly/4cyNqQW

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The news that the FDA has approved Lilly's #Alzheimer's treatment #donanemab, to be branded #Kisunla, means that in the marathon stop/start process of transforming the Alzheimer's market we are now in a state of forward motion. Given the truly formidable obstacles to bringing an effective Alzheimer's disease modifying treatment to market on a path littered with others' failures, Lilly is to be congratulated. However, the forward path to effective commercialisation will be tough. For more insights into what the next challenges might be and insights into the renaissance of the wider CNS market, check out our white paper, here: https://lnkd.in/gamddXiF

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Join me on April 23 to hear perspectives from top clinical research experts and disease area specialists on Alzheimer’s Disease (AD) and Multiple Sclerosis (MS) treatments. 🧠 Learn about development challenges in each, how they were overcome, and the shared lessons that can propel novel approaches to more effective clinical trials.   Register now to secure your spot and join in this innovative conversation! #Alzheimers #MultipleSclerosis #ClinicalTrials #Biotech

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💥 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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💥 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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Policy changes, such as the U.S. Inflation Reduction Act (IRA) and the EU HTA Regulation, are reshaping the regulatory landscape and imposing new requirements on how companies utilize RWE. In the following interview, #ArielBerger, executive director, integrated solutions, real-world evidence discusses the expanding role of RWE in drug development and the importance of early planning. #AlmudenaOlidGonzalez, director, value and access consulting opens up about the impact of policy changes on RWE requirements and the role of post-launch RWE in market access.

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"IQVIA estimates that the dearth of a Humira (adalimumab) biosimilars last year cost patients and employers cumulatively $6 billion." #Biosimilars #Adalimumab like #Hulio from #BioconBiologics can provide #affordable #access to #patients and save billions for the Government. #Biosimilars are the way forward for affordable biologics therapy. Read the article: US Specific "The biosimilar Hulio was offered last year at a WAC of $498 for a month's supply, versus $3,461 for Humira, according to a Samsung Bioepis biosimilar report. Still, the vast majority of prescriptions filled in 2023 were for the Humira originator product, prompting market research group IQVIA to conclude that “maintaining patients on Humira comes at a cost of up to about $6 billion per year for patients and employers, compared to a full transition to adalimumab biosimilars.” Biocon Biologics Matt Erick Joshua Salsi https://lnkd.in/gN74FShF

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Post Covid19 clinical supply chains are facing a combination of known but heightened challenges and technological opportunities. The impact of technology enhancements such as #artificialintelligence today remains still uncertain as the industry is discovering the full potential. Meanwhile, rising complexity of supply chains, especially in the face of advanced medicinal products is enhanced by data-driven decision-making. Great observations from Anne Stolle PhD, MSc and Berlinger & Co. AG! #clinicalsupplychainsreimagined

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Join us as we unravel the evolution of data-quality assessments in respiratory drug development. Historically, adherence to ATS/ERS guidelines has been the gold standard, but with persistent challenges in data accuracy, it's time for a change. In this webinar, industry leaders from Clario and ArtiQ will delve into: - Limitations of traditional quality standards - The pivotal role of data plausibility assessment - Embedding AI to capture the highest quality data - Managing cost while expediting faster drug development Don't miss out on this opportunity to revolutionize your approach to respiratory clinical trials. Secure your spot today! https://lnkd.in/enaKJKF9 #RespiratoryResearch #DrugDevelopment #DataQuality

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AT #DIA2024, Jackie Vanderpuye-Orgle, Ph.D., VP of Advanced Analytics at Parexel, presented her poster on Artificial Intelligence/Machine Learning advances in Real World Data Analytics. Jackie's presentation reviewed the immense potential for unlocking unique insights from patient data and contends the need for advances in data storage, analysis, and acquisition facilitate ML algorithms and frameworks to continuously learn from additional data sources and drive optimal drug development. Though exciting developments, she noted the lack of specific guidance on credible and acceptable use of ML techniques for predictive RWD analytics that lends to the necessity for thorough regulatory oversight. #DIA #MachineLearning #RWD #AI

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Exciting insights from Kyle Felmet and Jennifer Lospinoso in Two Labs' latest blog, discussing the dynamic commercialization strategies for cell and gene therapies. Their expertise sheds light on the necessary strategic planning and innovative distribution models crucial for these treatments to reach patients effectively. This is a great read for anyone interested in the future of healthcare!

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❔ How do we position regional and community sites for success and mitigate risks for sponsors? ❔ In our new Oncology report, Parexel’s Karen McIntyre and Angela Hirst weigh in on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. 🚧 That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/g7Tzd3t2 #ResearchSites #Oncology #NovelInsights

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How do we position regional and community sites for success and mitigate risks for sponsors? In our new Oncology report, Parexel’s Karen McIntyre and Angela Hirst weigh in on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/gfibr9S4 #ParexelBiotech #ResearchSites #Oncology #NovelInsights

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In 2023 alone, practices in The Network participated in over 200 trials, enrolling more than 1,000 patients in treatment studies across various disease states. Read more in our 2023 Annual Report 📊 https://lnkd.in/g2khrtTR #ClinicalResearch #ClinicalTrials #CommunityOncology

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