— Insights
Field notes from the development path.
Practical, source-checked articles on drug development, regulatory strategy, non-dilutive funding, and asset positioning — written by Dr. Ross A. Hamilton, PhD, from programs he has led or reviewed. Every statistic is cited to a primary source.
Market Positioning Solutions
What is label expansion in biotech? A founder's guide to multiplying an asset's market
Label expansion is the practice of adding indications, patient populations, lines of therapy, or combinations to a drug's approved or planned labeling.
No. 02How a label expansion strategy turned a $200M/year biologic into a multi-billion-dollar opportunity (anonymized case study)
A first-in-class biologic I managed for a rare pediatric leukemia had a U.S.
No. 03What is a target product profile (TPP), and why investors ask for it
A target product profile (TPP) is a planning document that describes a drug in the format of its future label: indication, population, dosing, efficacy, safety, and presentation.
No. 04How to credibly size a drug's addressable market (TAM) for investors
A credible drug market size is built bottom-up from epidemiology, not quoted from a market report.
No. 05Bayesian basket trials: a faster path for rare and orphan indications
A Bayesian basket trial tests one drug across several biomarker-defined or mechanistically related diseases under a single master protocol, and uses a hierarchical model so each…
No. 06Alternative paths to FDA approval: 505(b)(2), accelerated approval, and creative regulatory strategy
There is no single road to FDA approval. A 505(b)(2) application lets you rely on published literature or FDA's prior findings for an approved drug.
Life Sciences Consulting
What is an IND application? The modules that matter and where programs stall
An Investigational New Drug application (IND) is the submission under 21 CFR Part 312 that allows a sponsor to ship an unapproved drug across state lines and dose it in people.
No. 08FDA Fast Track Designation: who qualifies and how to write a request that gets accepted
Fast Track is an FDA designation for a drug intended to treat a serious condition when nonclinical or clinical data show its potential to address an unmet medical need.
No. 09Non-dilutive funding for biotech startups: the complete landscape (CPRIT, NIH/SBIR, NCI programs, in-kind support)
Non-dilutive funding for a biotech startup comes from four main sources: federal SBIR and STTR grants led by NIH, institute-specific mechanisms such as NCI's late-stage awards…
No. 10How to win a CPRIT award: lessons from $25M+ in competitive funding
Winning a CPRIT product development award means convincing out-of-state peer reviewers, outside due-diligence contractors, and a state oversight committee that your cancer program…
No. 11Orphan Drug vs. Fast Track vs. Breakthrough vs. Rare Pediatric Disease designation: which to pursue, in what order
Pursue Orphan Drug designation first, as soon as you can document US prevalence under 200,000 and a medically plausible mechanism, and file Rare Pediatric Disease designation with…
No. 12PK/PD, ADA, and biomarker assays explained for biotech founders
Pharmacokinetic (PK) assays measure how much drug is in the blood over time.
Product Development Services
How to manage a CRO: an insider's playbook for biotech founders
Managing a contract research organization (CRO) well means keeping the decisions the regulations will not let you outsource: selecting a qualified vendor, defining the work in…
No. 14The virtual biotech model: advancing a drug with no labs and a team of five
A virtual biotech advances a drug candidate with no laboratories of its own.
No. 15Biologics, small molecules, DNA therapeutics, radiopharmaceuticals: how modality shapes your development plan
Modality decides which nonclinical guideline governs your program, which animal species you test in, how you set a starting dose, whether immunogenicity is a central risk, and how fragile your supply chain is.
No. 16What does a fractional R&D leader actually do?
A fractional R&D leader is a part-time chief scientific or development officer embedded in a company for a fixed share of each week.
Cross-Cutting
How custom-engineered AI accelerates drug development without loosening scientific rigor
Custom-engineered AI speeds drug development when it is confined to tasks whose output can be checked against a primary source, and when every claim carries provenance, an audit trail, and a human sign-off.
No. 18From bench to first-in-human: an honest timeline of what happens between discovery and Phase 1
Getting from a validated target to a first human dose usually takes four to seven years.