BioDev Services’ Post

Join us at the North Carolina Regulatory Affairs Forum for a lively discussion on the importance of development plans and gap analyses for achieving success in the pre-IND/IND phase of drug development presented by Allucent experts Sheila Plant, PhD, MHS, RAC and Joshua Taylor, PhD, RAC. For more information about the event and to register, click here: https://lnkd.in/dDxY4FnJ. #Allucent #BringNewTherapiesToLight #RegulatorySubmissions #RegulatoryStrategy #FDAApproval #ClinicalTrials

In her latest Forbes article, Eileen Faucher explains the business case for expanding diversity in clinical trials. At BTH, we have developed methodologies to gain insights into best practices in this regard. Reach out to learn how better patient representation in clinical trials can be a lever of sustained competitive advantage. Eileen@brasstackshealth.com #competitiveintelligence #forbes #healthequity #clinicaltrialdiversity

Now this is interesting: Starting Dec. 2, the FDA is expanding its Split Real-Time Application Review (STAR) pilot, now allowing expedited review of original marketing applications—not just supplements—for groundbreaking therapies addressing serious unmet needs. This expansion could shorten review times by over a month. Even though a month isn't that long, it still offers a minor bump in cost efficiency and getting treatments into the hands of patients sooner. Ultimately, technologies that offer substantial clinical improvements now have a clearer, faster pathway to market. This will be important especially as we begin introducing new technologies that enable more complex therapeutics that may provide far better results for patients that have diseases with existing therapies. As new technologies enable better therapeutics, removing barriers (however small) to approval is a plus. This is definitely a step in the right direction.... #ThinkMultigenic #FDA #Biotech #Innovation #GeneTherapy #CellTherapy #Healthcare

Hurry up and take advantage of the early bird pricing for 𝐑𝐄𝐂𝐎𝐍 2025! Join us at the University of Maryland, Baltimore, on January 27 & 28, 2025. 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲!🎉 ➡ https://lnkd.in/g84STPHx Get ready to navigate the fast-changing regulatory landscape and explore key industry topics. Our goal is to prepare, motivate, and advance you and your organization for growth. Join us for four tracks and engaging panel discussions with industry experts. Over the course of the two-day conference, we will delve into: 1. 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐭𝐨 𝐄𝐧𝐝𝐩𝐨𝐢𝐧𝐭 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧 - Establishing reasonable surrogate endpoints. 2. 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 - Towards a streamlined global regulatory assessment. 3. 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐎𝐩𝐭𝐢𝐦𝐮𝐬 - R&D strategies, practicality, and collaboration between FDA and sponsors. 4. 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 - Strategies and implications for enhancing clinical trial diversity. Spread the word among your colleagues- we can't wait to welcome you all there! #RECON #UniversityOfMarylandBaltimore #DrugDevelopment #Pharma #BioTech #FDA #ProjectOptimus #ClinicalTrials #RegulatoryStrategy #Biomarkers #Endpoints #RegulatoryHarmonization #VivproCorp #MorePowerToYou

Registration is now open for 📅 𝐑𝐄𝐂𝐎𝐍 2025 at the University of Maryland, Baltimore, on January 27 & 28, 2025. 𝐓𝐚𝐤𝐞 𝐚𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞 𝐨𝐟 𝐄𝐚𝐫𝐥𝐲 𝐛𝐢𝐫𝐝 𝐩𝐫𝐢𝐜𝐢𝐧𝐠🎉 ➡ https://lnkd.in/g84STPHx Join us at 𝐑𝐄𝐂𝐎𝐍 as we explore the rapidly changing regulatory landscape and the most relevant topics in the industry. Our goal is to prepare, motivate, and advance you and your organization for growth. We will cover four tracks and host engaging panel discussions, providing you with the opportunity to engage with experts in an intimate setting. Over the course of the two-day conference, we will delve into: 1. 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐭𝐨 𝐄𝐧𝐝𝐩𝐨𝐢𝐧𝐭 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧 - Establishing reasonable surrogate endpoints. 2. 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 - Towards a streamlined global regulatory assessment. 3. 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐎𝐩𝐭𝐢𝐦𝐮𝐬 - R&D strategies, practicality, and collaboration between FDA and sponsors. 4. 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 - Strategies and implications for enhancing clinical trial diversity. We can't wait to see you there! #RECON2025 #UniversityofMaryland #DrugDevelopment #Pharma #ProjectOptimus #ClinicalTrials #RegulatoryStrategy #FDA #Biomarkers #Endpoints #RegulatoryHarmonization #VivproCorp #MorePowerToYou

A staggering 80% of clinical drug trials face delays, posing significant challenges to budgets and delivery timelines. With daily costs running between $600,000 to $8 million, even a short delay can have substantial financial repercussions. Find out how strategic planning and the right partnerships can help mitigate these delays in our comprehensive guide. 👉 Learn more in our latest blog: https://lnkd.in/gHNDbdsX #ClinicalTrialDelays #DrugTrialCosts #PharmaIndustry #ClinicalResearch #TrialManagement

Explore the Financial Impact of Delays in Drug Development at the 23rd Annual #ContractPharmaConference! On Day 1, join Zachary Smith from Tufts Center for the Study of Drug Development for Session 4 as he discusses the "Cost of a Day of Delay in Drug Development." Gain valuable insights into how even a single day can affect timelines and budgets in this critical area. Don't miss this important session that could help your business save time and money. Register today: https://hubs.li/Q02NCHvX0

Your individual drug development needs are important, and your drug’s journey requires a customized approach.   Watch this video to see how our investment in your success translates to a collaborative experience. https://okt.to/EUVgtf #drugdevelopment

Drug pooling has long been a topic of conversation among clinical supply managers. While use of drug pooling is far less common today than it was over a decade ago, our co-founder and Senior Director of Customer Solutions, Marc Lisi, shares how it can still be helpful in making today's trials more efficient. With clinical trial design getting more and more complex, time pressures to deliver on these trials continually increasing, and sponsors looking to save costs wherever possible, drug pooling can prove to be extremely beneficial in specific situations. Learn more at https://lnkd.in/eGiRswmS #Suvoda #clinicaltrials #clinicalresearch #drugpooling #healthtech

Some of the clever and friendly Certara gang is in Brussels for DIA Europe. We will be here for a few more days to talk about accelerated healthcare, regulatory strategy, Artificial Intelligence, Biosimulation and much more (and there is decent coffee) Visit us at Booth #C4 to learn more about drug development and regulatory strategy #diaeurope2024 #certara #drugdevelopment #brussels #regulatoryaffairs