Precision For Medicine

How confident are you that your ADA data truly reflects immunogenicity? When circulating drug interferes with detection, sponsors risk underestimating immunogenicity and drawing incomplete conclusions about a therapeutic’s safety, pharmacokinetic, and efficacy profile. One of the most significant technical challenges in immunogenicity testing is detecting anti-drug antibodies in the presence of circulating therapeutic drug. Residual drug can mask ADA through immune complex formation, reducing assay sensitivity and producing potential false-negative results. To improve assessment of drug tolerance, Precision for Medicine employs approaches such as acid dissociation (our most widely applied technique), Affinity Capture Elution (ACE), Solid-Phase Extraction with Acid Dissociation (SPEAD), and High Ionic Strength Dissociation Assays (HISDA) using magnesium chloride when acidic conditions are too harsh. We run these on a sensitive electrochemiluminescent (MSD) platform and can perform all required protein conjugations in-house. At Precision, we develop ADA assays around the molecule and context of use—screening, confirmatory, and titer tiers; bridging or antigen-capture formats; MRD; selectivity; cut point strategy; and drug tolerance. We believe ADA data should connect exposure, immunogenicity, safety, and response interpretation across development. https://lnkd.in/e3YKes7R

Receptor occupancy data tells us that a therapeutic engages its target. The next question is often more important: what happens next? Deb Phippard and Jenny Zilberberg discuss several practical considerations: • Why sample management can be as important as assay performance • When peripheral blood serves as a useful surrogate and when it may not • How receptor internalization, recycling, and shedding affect interpretation • The challenges of developing RO assays for novel targets and complex modalities • Why sponsors increasingly connect receptor occupancy with downstream biological activity As therapeutic modalities continue to evolve, receptor occupancy remains an important tool for understanding target engagement. The strongest insights often emerge when receptor occupancy data are evaluated alongside pharmacodynamic, biomarker, and mechanistic endpoints to build a more complete picture of biological response. Explore the full article: https://lnkd.in/ep_xWyNf

Scientific expertise only creates value within a coordinated governance structure. Precision for Medicine's FSP model runs on three governance levels, operational, program, and executive, built on shared metrics and real-time insight. See the framework in our FSP eBook. https://lnkd.in/ekJMyMhP

Getting on the list is hard. Turning access into utilization is harder. To succeed in China, The Institute@Precision Asia-Pacific Series reveals why NRDL isn’t the destination. It’s the beginning. Our experts. Your advantage. https://lnkd.in/eGA_rMQX

Early data can shape the future of a development program, but only when it is tied to the right biological questions. In Clinical Trials Arena, our Chief Scientific Officer, Deb Phippard, PhD, shares her perspective on how biotech funding pressures are changing early clinical development and why focused translational strategy is critical for making better decisions, faster. Read the full interview here: https://lnkd.in/eMxryrHh

We're proud to celebrate Anoop Santhosh on his appointment as Director, Expansion and Innovation on the newly formed HBA APAC Operating Board. Congratulations to Anoop and the entire board as they lead the HBA mission to build a global health and life science workforce that reflects the patients it serves. As VP & Head of India for Precision for Medicine, Anoop’s experience in the APAC region will help ensure that this board will drive HBA’s APAC strategy. #India

Clinical trial speed balances regulatory innovation and operational agility. FDA and U.S. Department of Health and Human Services (HHS) are addressing that question through Operation TrialBlazer, a new initiative focused on streamlining IND processes and accelerating early-phase clinical trials in the U.S. In a recent BioSpace interview with Jennifer "Jef" Akst and Heather McKenzie, our Chief Medical Officer and former FDA Division Director, Harpreet Singh, MD, discusses why regulatory efficiency is only part of the equation. Many development delays occur at the operational level, making execution, flexibility, and speed just as critical to success. Operation TrialBlazer is an important step forward, and its long-term impact will depend on continued advances in trial operations and clinical development infrastructure. Read more in the BioSpace article here: https://lnkd.in/g_MamnDe

Join Anoop Santhosh, Vice President and Head of India, Precision for Medicine, along with a panel of life science industry leaders, at the PHUSE Academia Meet session at 2pm on Monday August 10 at the Department of Statistics, CUSAT in Kochi, Kerala, India. Precision is proud to support PHUSE in their work in industry-academia collaboration, to provide new opportunities to the next generation of clinical researchers while developing the talent necessary to accelerate the development of novel therapies. To learn more about PHUSE Academia Meet, visit https://lnkd.in/dduZHkgS #Oncology #ClinicalDevelopment #Biostatistics #APAC #India #DrugDevelopment #PrecisionForMedicine

Impact outcomes with a better beginning for patients, sponsors, and yourself. Senior Feasibility Associate/Feasibility Manager (UK) -https://lnkd.in/ewN7sZ5q Senior CRA (Serbia) - https://lnkd.in/ej9BgX6f

Not all evidence travels. In this new blog, Harpreet Singh, MD, Chief Medical Officer at Precision for Medicine and former Director of FDA Oncology Division 2, explains why even successful global oncology trials can face regulatory scrutiny when evidence does not clearly translate across patient populations and treatment settings. The piece highlights the importance of building regulatory strategy into trial design from the start, especially for sponsors advancing programs in China and across APAC. With deep regulatory expertise and a growing presence throughout the region, Precision for Medicine helps sponsors generate evidence that can support global regulatory success. Generate evidence that travels: https://lnkd.in/e48ebcFe