Law / Rajaii Consulting
At Rajaii Consulting I wrote eight biotech R&D dossiers, including a 160-plus-page feasibility assessment of IV co-administration.
Explore the source recordRajaii Consulting · Biotechnology
I wrote a feasibility assessment for a biotech client considering an investigational therapy alongside an approved antibody.
“each component makes a contribution to the claimed effects”
Public context for the assessment; the client-specific label is not reproduced.
Read the provision ↗Fixed-combination dosage forms. An IV co-administration proposal requires a separate applicability analysis.“The U.S. government does not review or approve the safety and science of all studies listed in the ClinicalTrials.gov database.”
Registration supplies a study record, not a finding of safety.
Read the registry’s scope ↗Inspect the protocol, results and relevance to the proposed regimen.“only the right to exclude others from doing so”
A patent does not confer a right to practice the invention.
Read the scope of the right ↗Patent rights and clinical feasibility are separate questions.
A biotech client wanted to pair an investigational therapy with an approved antibody. I checked the antibody’s label to see what was already approved.
What it establishesThe fixed-combination policy requires a contribution from each component and a safe and effective combination for the labeled population.
What remains openThis provision addresses fixed-combination dosage forms. Whether it applies to a proposed IV co-administration strategy requires analysis of that proposal; the passage is not a client-specific conclusion.
My contributionI traced the approved uses and regulatory precedent, then separated them from the unanswered co-administration question.
I traced the proposed use through trial records and publications to distinguish what investigators planned from what they observed.
What it establishesA registry identifies the study design, population, interventions and reported status. Linked results or publications can supply observed outcomes.
What remains openRegistration alone is not a positive result. A different regimen, dose or population may leave the proposed pairing untested.
My contributionI traced scientific claims to the relevant protocol and results, distinguishing the evidence available from the application being proposed.
I checked which parts of the proposed approach the patent claims described. The clinical question still depended on evidence about the therapies.
What it establishesPublished patent documents expose claims, specifications and prosecution records for examination.
What remains openA patent is not clinical validation. Scope, status and enforceability require analysis of the specific record; a search alone is not a clearance opinion.
My contributionI organized the IP evidence alongside the scientific and regulatory record, keeping patent scope separate from clinical feasibility.
Practice
The assessment brought regulatory, scientific and IP questions into a single feasibility record. The client, investigational candidate and conclusions remain confidential; these public source categories show the structure of the work.
I trace scientific statements to their sources and distinguish the observed result from the proposed application.
Legal experience
As a Summer Law Associate at McCormick, Barstow, Sheppard, Wayte & Carruth LLP, I reviewed medical records and causation for malpractice defense and contributed legal memoranda and litigation drafting.
Historical role in the CV ↗At Wisconsin’s Law and Entrepreneurship Clinic, I worked on startup transactions under attorney supervision, including operating agreements, terms, privacy policies and governance documents.
At New Era ADR, I researched consumer arbitration rules and biometric privacy statutes and analyzed dispute-resolution workflows.
At AI Data Training Hub, I authored reviewer standards covering citation accuracy, reasoning-chain validity, jurisdiction, evidence quality and calibrated uncertainty.
Explore the review standards ↗