Phil Garner’s Post

🌟 Excited to share our latest publication in Advanced Drug Delivery Reviews! 🚀 This paper dives into the evolving landscape of integrated models in clinical oncology drug development. Key highlights include: 📌 Introduction to NLME modeling and survival analysis. 📌 Common sub-models: PK, biomarkers, safety, survival, dropout, and covariates. 📌 Methodology for integrated model development. 📌 Review of integrated models in oncology (2013–2023). 📌 Value of these models in dose optimization, patient-focused strategies, and emerging biomarkers. Read it here: https://lnkd.in/dpuNGDgx Honored to contribute to this work as shared first author with Eman Ibrahim. A heartfelt thank you to our coauthors — Maddalena Centanni, Celine Sarr (Dartois), Karthik Venkatakrishnan, and Lena Friberg — for valuable insights and collabration. This journey has been an incredible learning experience, and I’m deeply grateful for the opportunity to work with such a talented team! #Pharmacometrics #Oncology #ModelInformedDrugDevelopment #ProjectOptimus

Another significant paper in our MIDD-themed issue of Advanced Drug Delivery Reviews (Impact Factor: 15+), authored by Prof Lena Friberg and her team from the Uppsala PK/PD Group. Han Liu et al. highlight and underscore the critical role of MIDD in advancing oncology drug development. #MIDD #Oncology #Pharmacometrics #Project Optimus

Finding the right dose for an oncology compound could be the utmost single important and challenge task in the drug development. Thoughtful study designs, exposure information, translational data, and statistical modeling play an increasingly important role. The proposed "three steps toward dose optimization" procedure (https://lnkd.in/gvd76D9Q) provides some efficient fit for purpose designs and analyses that can increase the likelihood and reduce the uncertainty of selecting an optimal dose for a registration trial that demonstrates a balanced safety and efficacy profile.

FDA's Oncology Center of Excellence #ProjectOptimus is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. You can check it out here: https://lnkd.in/gZyk425i However, it does not appear to consider pharmacogenomics as a goal or key area for this initiative. Pharmacogenomics is certainly a factor in finding the right dose. Am I missing something here? Love to hear your thoughts! #pgx #pharmacogenomics #genomics #precisionmedicine

"Is RxNorm Enough for Precision Oncology?" Precision oncology is all about matching therapies to patients based on clinical and genomic profiles. While RxNorm is great for drug standardization, it has limitations in oncology. Here are some key gaps—and solutions: 1️⃣ Biomarker Associations: RxNorm doesn’t link drugs to biomarkers (e.g., EGFR mutations). Integrate tools like OncoKB to fill this gap. 2️⃣ Combination Therapies: Multi-drug regimens are common in oncology. Use frameworks like HemOnc to represent these effectively. 3️⃣ Static Relationships: Oncology evolves rapidly, but RxNorm data is static. Dynamic pipelines can pull updates from trials and guidelines. 4️⃣ Insufficient Granularity: RxNorm lacks detail for targeted pathways like HER2 or VEGF. Incorporate ontologies like NCIt for greater specificity. 5️⃣ Experimental Drugs: Investigational therapies aren’t covered. Link to data from ClinicalTrials and similar repositories. 6️⃣ Biosimilars: RxNorm doesn’t track biologics vs. biosimilars or interchangeability. Adding metadata from the FDA’s Purple Book resolves this. How are you addressing these challenges in your workflows? A big thank-you to Melinda Wong, RPh for her incredible insights, which have inspired many of these recommendations! #PrecisionOncology #RxNorm #ClinicalInformatics #OncologySolutions

Since its initial public offering at $14.75 in 2020, Lantern Pharma Inc. (Nasdaq: LTRN)'s stock remained around $5 for the past two years. However, since March 1, it has nearly doubled in value as additional drugs progressed into trial phases. “It validates the model that goes after a patient population that is in need of affordable, available medicines,” Sharma says. “Our hope is that we can bring this model of velocity and efficiency across multiple cancer categories.” Learn more about how Lantern Pharma's cutting-edge AI is changing the game in healthcare in this DCEO Healthcare feature! https://lnkd.in/grVgJyks

Through Project Optimus, the FDA is pushing drug developers to establish dose optimisation strategies early in the drug development process, moving away from the “more is better” mentality.💡 https://lnkd.in/eVhWrDKZ At Physiomics plc, we're dedicated to guiding our partners through this evolving landscape. By using quantitative and mechanistic approaches to translational modelling, we help our clients in determining and justifying the optimal dose, dose escalation, and scheduling for First in Human trials. This boosts your chances of clinical success by aligning with the latest FDA guidelines. Curious to learn more about how we can assist you in navigating these changes? Reach out to us today! Clinical Trials Arena #oncology #fda #projectoptimus #dosing #drugdevelopment #biotech #pharma #biopharma #cancer #optimaldosing

Join Certara's upcoming webinar on Targeted Radiation Therapies!

From planning and logistics to regulatory approvals and patient recruitment, immuno-oncology (IO) therapies pose unique challenges in clinical research. Discover how IQVIA Biotech’s cutting-edge approach helps biotech and emerging biopharma companies to successfully navigate IO trials and advance cancer treatments. https://bit.ly/3JtCac3 #ImmunoOncology #clinicalresearch

Excited to announce GATC Health partnership with A28 Therapeutics to optimize clinical trial strategy and accelerate development using GATC's AI. Together, we demonstrated de-risked decision-making for A28's cancer drug candidate. This collaboration showcases how GATC's AI speeds up quality decision-making in drug discovery, potentially saving years of research and fostering the creation of safer and more effective therapeutics. WVU Innovation Corporation, #HealthcareInnovation #AI #DrugDiscovery