Topic
Biotech and innovation
How new therapeutic technologies move from idea to evidence, and how to weigh the claims made for them.
This page collects every article by Dr. Damon Tojjar in this topic. For all topics see browse by topic, and for the source-anchored record see damontojjar.com/record.
Articles in this topic (14)
- CAR-T's New Boxed Warning: Reading the Evidence on Secondary T-Cell Cancers
In January 2024 the FDA required a boxed warning for secondary T-cell cancers on all six approved CAR-T cell products, spanning Kymriah, Yescarta, Tecartus,...
- Manufacturing Is the Medicine: Why CMC and GMP Decide Whether a Cell or Gene Therapy Reaches Patients
For cell and gene therapies, manufacturing is not a preliminary step toward the medicine. It substantially is the medicine. Chemistry, manufacturing, and controls...
- Wearables in Clinical Trials: What Fit for Purpose Really Requires
A wearable result deserves your trust only when the sensor and the endpoint built on it have been shown to be fit for purpose for the specific question a trial is...
- Beyond Animal Testing: What the FDA's New-Approach-Methodologies Roadmap Changes
In April 2025 the U.S. Food and Drug Administration published its Roadmap to Reducing Animal Testing in Preclinical Safety Studies, and by April 2026 it reported...
- Build Once, Reuse Often: How FDA's Platform Technology Designation Works
FDA's Platform Technology Designation is a formal way to recognize that one well-understood, reusable technology sits underneath many different drugs, so the data...
- The First AI-Designed Drug Reached Phase 2a: What the Trial Actually Showed
The headline and the fine printRentosertib, a TNIK inhibitor whose biological target and chemical structure both emerged from generative AI, is the first such drug...
- Antibody-Drug Conjugates: What the Antibody, Linker, and Payload Each Do
An antibody-drug conjugate joins three engineered parts: an antibody that finds a tumor marker, a chemical linker that holds a potent toxin during transit, and a...
- The Two-Fold Bet: How Human Genetic Evidence Reshapes the Odds a Drug Target Succeeds
A drug target backed by human genetic evidence linking that target to the disease is roughly twice as likely to survive clinical development and reach approval as a...
- The 100 Days Mission and What Makes a Vaccine Platform Truly Ready
The short answerPlatform readiness is several distinct properties that have to align at the same time. A vaccine platform is ready for rapid pandemic response when...
- How Drug Stability Is Proven: ICH Q1 and the Science of Shelf Life
What an expiry date actually certifiesAn expiry date is not a guess about when a medicine goes bad. It is a certified claim: the last day on which the manufacturer...
- Immunogenicity and Anti-Drug Antibodies: Why the Body Sometimes Fights a Biologic
A biologic is a protein, and the immune system is built to notice proteins that are not the body's own. When it does, it can make anti-drug antibodies, antibodies...
- Can a Chip Replace a Mouse? The Evidence Standards Behind Organ-on-Chip Systems
A chip does not replace a mouse the way a newer phone replaces an older one. A microphysiological system, the technical term for an organ-on-chip, earns a...
- Why Most Preclinical Breakthroughs Never Reach Patients: Rigor and Reproducibility
Most preclinical breakthroughs never reach patients because the experiments behind them were not rigorous or reproducible enough to have been reliably true in the...
- How siRNA Drugs Silence a Gene: The GalNAc-Liver Delivery Story
Small interfering RNA (siRNA) drugs feed a cell a short RNA that guides the cell's own machinery to chop up one specific messenger RNA, silencing a single gene...