TD2 Blog

How the FDA’s Plausible Mechanism Framework Signals the Future of Precision Oncology

admin@td2inc.com (TD2 Admin) — Fri, 13 Mar 2026 16:28:04 GMT

The FDA’s newly announced Plausible Mechanism Framework marks an important step toward aligning regulatory pathways with the realities of modern precision medicine. While the initiative is focused on individualized therapies for ultra rare diseases, the underlying principles closely reflect the direction oncology research has already been moving for years. As cancer treatment becomes increasingly molecularly defined, this framework offers insight into how regulatory thinking is evolving to support highly targeted therapies, including cell and gene therapies.

What Makes Radioligand Therapy IND Strategy Fundamentally Different?

admin@td2inc.com (TD2 Admin) — Wed, 04 Mar 2026 15:08:40 GMT

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Receptor Mediated Therapies in the Clinic: From Targeting to Impact

admin@td2inc.com (TD2 Admin) — Wed, 07 Jan 2026 17:05:46 GMT

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Receptor mediated therapies have fundamentally changed how cancer is treated in the clinic. What began with early monoclonal antibodies has expanded into a diverse landscape of modalities designed to engage cell surface receptors with increasing precision. Today, these therapies are not only improving outcomes but also reshaping expectations for how mechanism translates into clinical benefit.

A Translational Lens on Synergistic Cancer Therapy: Insights from Our Recent Case Study

admin@td2inc.com (TD2 Admin) — Mon, 13 Oct 2025 11:41:57 GMT

In cancer drug development, monotherapies often lose ground when tumors adapt. This is especially true for KRASmutant non–small cell lung cancers with concurrent LKB1 loss, where resistance and metabolic plasticity are common. We believe the path forward lies in strategically designed combination therapies and deep mechanistic insight.

Redesigning Preclinical Oncology: A Framework for Improving Clinical Translatability with AI, RECIST-Inspired Metrics, and Systems-Level Thinking

ETrachet@td2.com (Erin Trachet) — Thu, 25 Sep 2025 12:57:25 GMT

Despite decades of investment in oncology drug development, the translational pipeline from preclinical models to clinical success remains inefficient and error prone. A staggering number of therapies showing preclinical promise fail during early-phase clinical trials, typically due to unexpected toxicity or insufficient efficacy. These failures are frequently rooted in foundational shortcomings of the preclinical paradigm including inappropriate models, non-clinical endpoints, a disconnect between preclinical results and clinical expectations and single target focus of a complex disease.

Radiopharmaceutical Dosing Under FDA’s New Spotlight: What You Should Know

admin@td2inc.com (TD2 Admin) — Wed, 27 Aug 2025 10:53:10 GMT

The FDA has issued a new draft guidance titled “Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development.” This document provides a framework for identifying optimal administered activity and dosing schedules for radiopharmaceutical therapies (RPTs) in oncology, with the goal of balancing efficacy and long-term safety.

Expanding Access to CART Therapies: TD2 Oncology Featured in SCRS inFocus

admin@td2inc.com (TD2 Admin) — Tue, 26 Aug 2025 14:12:22 GMT

In June 2025, the FDA announced a major shift in regulatory guidance: the elimination of Risk Evaluation and Mitigation Strategy (REMS) requirements for all approved autologous CART therapies targeting CD19 and BCMA. This change reflects the growing clinical experience and confidence in managing CART associated risks such as cytokine release syndrome and neurotoxicity through standard protocols.

The Rise of Humanized Mouse Models in Oncology: What Drug Developers Need to Know

admin@td2inc.com (TD2 Admin) — Wed, 06 Aug 2025 13:00:00 GMT

Traditional mouse models remain a cornerstone of preclinical oncology research. Syngeneic and xenografts mouse models continue to play a critical role in evaluating tumor growth, therapeutic efficacy, pharmacokinetics & pharmacodynamics, and toxicology. Their reliability, scalability, and extensive historical data make them indispensable tools in drug development.

Flow Cytometry User Groups And The Relaunch Of The NWFCS

jennifer-stewart@td2inc.com (Jennifer J. Stewart) — Thu, 31 Jul 2025 11:36:38 GMT

By Jennifer J. Stewart, PhD

Live Dead Measurement and Cell Viability

marrisssa-bailey@td2inc.com (Marrisssa Bailey BS) — Thu, 24 Jul 2025 12:58:44 GMT

By Marrisssa Bailey, BS