Nick Lewis’ Post

In a recent draft guidance @US_FDA recommends that sponsors developing investigational medical products enroll an adequate number of trial participants from under-represented populations and prepare a diversity plan - learn more at this #ASCPT2024 Pre-con! https://bit.ly/2rTP1zy

🖐️ Five early-stage regulatory strategies that work 🎯 Identifying patients most likely to benefit from a drug raises the probability of success for a clinical trial and leads to a higher return on investment. However, developing a companion diagnostic test (CDx) to stratify patients can unnecessarily consume time and resources if a sponsor isn’t well prepared. In this edition of the New Medicines, Novel Insights newsletter, former regulators Mwango Kashoki, M.D., M.P.H., and Sinan Sarac, M.D., Ph.D., M.Sc., leverage decades of experience advising CDx developers to provide you five refined strategies to maximize the benefits of IND meetings and streamline development. Read the full article below and subscribe to stay up to date on the latest #NovelInsights from our bi-weekly clinical trial newsletter! #PrecisionOncology #Biomarkers #PatientSafety #Regulatory

Almac Diagnostic Services can guide and support your biomarker programmes in relation to IVDR. Learn more from our expert speakers in a recent webinar, hosted by Xtalks, as they discuss their experience with IVDR and describe strategies for solving the specific challenges faced during the IVDR submission process for clinical trial assays being utilised as CDx, allowing global trials to commence and complete in a timely manner. View webinar here: https://hubs.li/Q02D8B1w0 #IVDR #ClinicalTrials #Regulatory #CompanionDiagnostics #IVD #CDx #RegulatoryAffairs

Dr. Alberto Gutierrez will be co-chairing the “Regulatory Strategies for Point-of-Care Diagnostics Special Forum” at the 16th Annual Next Generation Dx Summit in Washington, DC on August 20th. The forum begins with a keynote presentation entitled “Updates on US FDA POC Test Regulations” presented by Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health (FDA). A panel discussion entitled “Regulatory Strategies for Point-of-Care Diagnostics: Learning from Success Stories and Avoiding Pitfalls” and plenary fireside chat entitled “Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward” feature FDA regulators including Courtney H. Lias, PhD, Acting Director, OHT7: Office of in vitro Diagnostic Devices (FDA), and industry experts. Join the discussion to learn more about the essential components and nuances that are pivotal for regulatory approval for point-of-care diagnostics. #ndapartners #diagnostics #FDA #IVD #LDTs #laboratorydevelopedtests #NGDx #IVDR #regulatorysciences https://lnkd.in/d_z6tMBP.

good news .. steps by steps

Citeline partnered with Pharma Ignite for a roundtable to discuss the pros and cons of basing clinical trials in today’s European landscape. The free report covers: - The factors making the US a key clinical trial location, despite recent changes to European systems. - A critical element that gives clinical trials in Europe an edge over the United States. - The particular advantages offered by Eastern Europe as a clinical trial destination. - The impacts of new regulatory and process changes in Europe. Varying financial incentives for conducting clinical trials across European countries. https://lnkd.in/eS7a3yMp #clinicaltrials #europe #pharma

Allucent helps sponsors navigate the complex NDA & BLA submissions with the FDA! From mastering Pre-NDA/BLA meetings to crafting impactful #FDA meeting packages, we provide the insights needed for a seamless drug approval process. 🚀💼 Want to explore how we can support your next steps? Send me a message, and I'll connect you with our expert Regulatory Strategy team.

Across my time at the FDA and Industry, I have learned the importance of being an effective story teller and how this helps position a development program to receive useful insights from regulatory agencies. My collegues Matthew Hight, PhD, RAC , Joshua Taylor, PhD, RAC, and I have shared insights from our experiences engaging the FDA in formal meetings and approaches to leverage these insights while preparing for and attending Pre-NDA and Pre-BLA meetings. Please enjoy these insights as you read and share the blog post below here! #Allucent #BringNewTherapiesToLight #ClinicalTrials #DrugDiscovery #FDAApproval #RegulatorySubmissions

Rescue Mission in Biopharma: When you need to be rescued, call them. Don’t bother for the run of the mill services. Let all other service providers— internally & externally alike— fail and give up. Then, Global Allied pharmaceuticals(GAP via www.TakeChargeMedical.com)manages to fix it. From Article 21 to the CIA violations; from the known cases of study holds, to regulatory recall’s with 483, etc. have been managed. GAP is a supreme solution provider with precision, accuracy & the structured proven track record in biopharma and devices. GAP offers a known and commanded authority, as well as a sustained value net in this space.

🚀 Exciting Changes Ahead in the Diagnostics Industry! 🚀 The FDA is set to revolutionize the regulatory landscape for Laboratory Developed Tests (LDTs) with new rules coming into effect in April 2024. These changes aim to enhance patient safety and ensure diagnostic excellence by subjecting LDTs to the same stringent oversight as in vitro diagnostics (IVDs). At Compliance Insight, we've detailed everything your lab or life science company needs to know to navigate this pivotal shift successfully. From strategic adjustments to phased implementation plans, our latest blog post covers the essential steps to prepare and thrive in the evolving diagnostic landscape. 👉 Stay ahead of the curve by reading the full article on our blog. Click to learn how to adapt and excel under the new FDA regulations: https://lnkd.in/gwE2mGbM #FDA #LaboratoryDevelopedTests #QualityAssurance