Precision Medicine Group

New website https://lnkd.in/eaZdfisZ. Same unusual name. Too busy to visit the website or watch the video? Connect with Teresa Pokladowski, and find out how your complex development project can go the distance with Precision.

What does the FDA's accelerated approval of adagrasib mean for colorectal cancer patients and drug developers? Dr. Harpreet Singh, MD, our Chief Medical Officer and former FDA oncology division director, breaks down this significant development and its implications. Key points: - FDA granted accelerated approval for adagrasib + cetuximab on June 21st - First KRAS G12C targeting drug approved for colorectal cancer - 34% overall response rate in the single-arm KRYSTAL-1 trial - Targets ~4% of colorectal cancer patients with KRAS G12C mutations Dr. Singh's insights: - KRAS was previously considered "undruggable" in colorectal cancer - This approval addresses a high unmet need in a specific patient subgroup - KRYSTAL-10 confirmatory trial is ongoing to potentially convert to full approval This breakthrough could reshape targeted therapies in colorectal cancer. What are your thoughts on this accelerated approval? How might it impact oncology drug development or patient care? #OncologyTrials #DrugDevelopment #ColorectalCancer #PrecisionMedicine Follow Dr. Harpreet Singh, MD Singh for more expert analysis on breakthrough treatments and FDA insights.

In this issue of our Precision Manufacturing newsletter, we highlight the complexities and potential impacts of the BIOSECURE Act amid evolving diplomatic and legal landscapes. Click below to read more and subscribe today! #BIOSECURE #WuXi #biopharma #supplychain #complexbiologics

A well-defined, adaptable tech ops strategy is crucial for driving innovation and securing investment in the rapidly evolving biopharmaceutical industry. In this issue of our Precision Manufacturing Newsletter, our experts offer early-stage and emerging biopharma companies key insights and considerations for developing a robust tech ops strategy. Click below to read more and subscribe today! #NextGenMedicine #PatientFocused #PrecisionManufacturing #TechOps #Innovation #SupplyChain #RegulatoryCompliance

Now available on-demand! In the webinar, Precision experts Drs. Dawn Lain Butler and Amanda Woodrooffe guide you through the essential aspects of IHC, including antibody selection, IHC’s advantages for target validation, and its significance in disease screening and treatment choices. View it now! https://lnkd.in/easy9_Dz

Precision was proud to sponsor Maryland MEP's 5th Annual Biotech Boot Camp! This year, we had the pleasure of hosting students at our Frederick, MD facility, where they experienced our cutting-edge work firsthand and explored diverse career paths within biotech. A big thank you to Kurt Langenbach and our Talent Acquisition Team for making this day unforgettable! Click here to learn more: https://lnkd.in/eKb4HjMi #BiotechBootCamp #STEM #womeninscience

FDA ODAC Vote: Reshaping Perioperative Trial Designs in Oncology Watch our Chief Medical Officer and former FDA oncology division director, Dr. Harpreet Singh, MD, as she breaks down the recent FDA Oncologic Drugs Advisory Committee (ODAC) vote and its significant implications for drug development. Key points covered: -Unanimous ODAC vote on future perioperative trial designs -FDA's concerns about potential overtreatment in resectable lung cancer -Implications for drug developers across multiple cancer types Dr. Singh's insights: -The need for higher standards in approving long-term post-surgery treatments -How this vote could influence trial designs beyond lung cancer -Potential requirement for additional trial arms to justify treatment phases What does this mean for patients, providers, and the future of cancer drug development? Watch to find out. 💬 How do you think these potential changes in trial design will affect the pace of drug development in oncology? #OncologyTrials #DrugDevelopment #ClinicalTrialDesign Follow Dr. Singh for more #FDAinsights and expert analysis.

Project Farma’s Anshul Mangal sat down with Pharmaceutical Technology to discuss the impact of the BIOSECURE Act on pharmaceutical companies and outline steps both large pharma and small-to-mid-sized biotechs can take to mitigate its impact. Click here to read more: https://hubs.ly/Q02JdR550 #BIOSECUREACT#CDMO#WuXi#patientfocused

Seamless clinical trials combine two phases into one dynamic study design. It’s something we’ve done 46 times in the past 3 years—here’s what we’ve learned… https://hubs.ly/Q02HMNb70 #oncology #clinicaltrials #drugdevelopment

In this issue of our Precision Manufacturing newsletter, we outline the key considerations for acquiring a cell and gene therapy biotech. From evaluating R&D pipelines to mitigating risks, ensuring leadership synergy, and fortifying IP foundations, our experts provide a blueprint for navigating this complex and competitive terrain. Click below to read more and subscribe today! #GeneTherapy #CellTherapy #CGT #Growth #IntellectualProperty