KLIFO’s Post

Catch me and the Diaceutics Team at ASCO, ready to tell you more about our complimentary Precision Medicine 101 educational program. A high-level educational program with a broad overview of precision medicine including who it benefits, when and where it should be weaved into drug development and commercialization planning. #ASCO2024 #ASCO24 #PrecisionMedicine #BetterTestingBetterTreatment

This white paper is a good reminder of the clinical and regulatory incentives associated with Orphan drug/biologic development. As Mike Eging states, companies can be caught off guard at the speed to approval and launch if the data are compelling. Commercial strategies including distribution, market, and patient access leads to a greater likelihood of success if considered early.

Here it is, folks: The healthcare industry's equivalent of the script for The Empire Strikes Back has officially launched. And I wrote it! (And I designed it!) Go grab yourself a copy through the link in the post below from Ambrose Healthcare. And if you missed the previous release (ostensibly the healthcare industry's equivalent of the script for A New Hope—I also wrote and designed it), you can catch it here: https://lnkd.in/eBmnumK4 Both white papers examine the current landscape for companies developing drugs for the treatment of rare diseases throughout the world, such as: - Nations leading the drive to invest in rare disease drug development - Government incentives for pharma companies - Recent case studies demonstrating the benefits of leveraging incentives - Technological resources to streamline clinical trials - Strategies for fostering integrated communities of researchers, practitioners, and patients

I’ve been drafting, negotiating and teaching about CTAs for a long time now, and they always seem to be perceived by Clin Ops as the rate limiting step to getting a site activated. However, I think it’s because CROs have been tasked with negotiating these agreements rather than having in-house counsel manage the negotiations (like every other contact a Sponsor needs to support its business). Looking forward to learning how other industry leaders approach these agreements to support speedy site activation, as well as those from academic institutions that are generally sitting on the other side of the table from me. #clinicaltrials #CTAs

Good Morning from New Jersey! It's Day One at the Nexus Conference - 21st BioPharma Clinical Trials! What a fantastic opportunity to connect with leaders and innovators in the world of clinical trials. Today, we are excited to participate in the Panel Discussion on Running Clinical Trials in Different Geographic Regions: Assessing Opportunities and Challenges, featuring Rui Rui Zhang Xiang Business Director. Stay tuned for insights and key takeaways on overcoming the complexities of global trials! #ClinicalTrials #Biopharma #PharmaInnovation

𝗚𝗲𝗻𝗲𝗻𝘁𝗲𝗰𝗵 𝗽𝗮𝘃𝗲𝘀 𝗽𝗮𝘁𝗵 𝘁𝗼 𝗶𝗻𝗰𝗿𝗲𝗮𝘀𝗲𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗱𝗶𝘃𝗲𝗿𝘀𝗶𝘁𝘆 𝗮𝘀 𝗮 ‘𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗶𝗺𝗽𝗲𝗿𝗮𝘁𝗶𝘃𝗲’ Genentech is aiming to lead the charge for clinical trial diversity in the pharma industry and it’s using a mix of regulatory commitments, trial site partnerships and community activism to get there. Quita Beeler Highsmith, MBA Genentech has already filed 20 diversity action plans for Phase 3 studies with the FDA ahead of the agency’s final ruling, which it believes is the most in the industry. The FDA guidance is tied to the Food and Drug Omnibus Reform Act of 2022 (FDORA), which requires pharma companies to submit diversity action plans to the agency ahead of pivotal trials. https://lnkd.in/ew9mvdsF

Complex challenges call for a nimble approach. And, because every clinical trial looks different, every LabConnect solution looks different. How can you accelerate your drug development milestones with our nimble approach? Download our latest case study today to get started! => https://lnkd.in/g9fr2D7K #LabConnect #CaseStudy #ClinicalTrial #Nimble

If you are in Philly next week, tune into our cross-industry panel focusing on clinical trial agreement negotiation pitfalls and best practices. Or just drop me a note to say hi! #CTAs #acceleratingnegotiations

#LabConnect #CaseStudy #ClinicalTrial #Nimble Complex challenges call for a nimble approach. And, because every clinical trial looks different, every LabConnect solution looks different. How can you accelerate your drug development milestones with our nimble approach? Download our latest case study today to get started! 👉https://lnkd.in/g9fr2D7K

It's simple... Speed + Expertise = LabConnect's Nimble Approach. See how we're helping clients achieve their clinical trial objectives faster.