Services
Strategic counsel for the questions that decide a program.
AlaBioPharma is engaged when a biotech or pharmaceutical sponsor needs senior scientific judgment — not a deliverable, not a deck, but a decision they can defend. Each engagement is custom-scoped around a single clinical or regulatory question.
Regulatory Strategy
Pre-IND, IND, and end-of-phase strategy in a regulatory theater that does not stand still. We help sponsors anticipate agency response and structure their narrative accordingly.
- Pre-IND and IND package review
- Briefing book authorship and rehearsal
- Abuse liability and scheduling strategy
Translational Medicine
Bridging the molecule and the patient. We help sponsors build, audit, or execute the translational platform that justifies the move from bench to first-in-human.
- Biomarker strategy and validation
- Preclinical-to-clinical dose projection
- Mechanism-of-action interrogation
Pre-Clinical and Clinical Trial Design
Protocols designed to answer the question, not pad the dossier. Endpoint selection, population definition, and statistical framing built around the molecule.
- Phase 1 and 2 protocol design
- Endpoint and biomarker selection
- Operational scope and CRO oversight
CNS and Neuropsychiatry
Deep, specialist counsel in the therapeutic area where our team has spent most of its career. Pharmacology, toxicology, and abuse liability across the CNS.
- Receptor and channel pharmacology
- Neurotoxicology and safety pharmacology
- Abuse liability and scheduling
Scientific Diligence
Independent technical diligence for investors, boards, and licensing teams. We read the data, not the deck, and tell you what we found.
- Technical and scientific diligence
- Asset-level program review
- Second-opinion regulatory memos
Advisory and Grant Review
Standing advisory roles, scientific advisory board service, and grant review support for academic and foundation programs. Honest, prepared, on the record.
- Scientific advisory board service
- NIH-style grant review
- Standing advisor engagements
Let's begin the conversation
We work with a small number of clients each year so that every engagement gets the focus it deserves. Tell us about the molecule, the program, or the question on the table.