Ken Linsk · Life Sciences Attorney

Counsel for life sciences companies, from preclinical through commercial launch.

A solo practice built on 25+ years advising early-stage life sciences companies across the full clinical-to-commercial lifecycle — clinical trial contracting, IP licensing and technology transfer, and complex cross-border collaborations.

Therapeutic focus — Oncology Dermatology Gastroenterology Rare disease Ophthalmology US / EU / Japan
01

Areas of practice

01

Clinical Trial Contracting

CTAs, ICFs, CRO master services agreements, KOL and consultant agreements, patient recruitment and clinical site agreements.

02

Licensing, IP & Tech Transfer

License review, MTAs, and technology transfer agreements; coordination with patent and trademark counsel across academia and industry.

03

Business Development & Collaboration

Complex royalty and payment structures, cross-border deals across the US, EU and Japan, term sheets and due diligence.

04

Promotional & Regulatory Review

MLR/PRC legal review of scripts, videos, posters, advertising and media for approved and investigational products.

05

Clinical Operations & Data Privacy

HIPAA, GDPR, FMV analysis, HCP contracts, PRO device procurement, participant stipends, Quality Agreements and drug supply.

06

Corporate & Finance

Angel and Series A financing support, SEC reporting and registration statements, and a structured finance background.

02

How I work

I work with life sciences companies either as their outside general counsel or alongside their in-house counsel and legal teams — an attorney who understands both the science and the deal.

From clinical trial contracting through commercial launch, I draft and negotiate the agreements that move a program forward: CTAs, CRO master services agreements, KOL and consultant contracts, and collaboration agreements with complex royalty and milestone structures. I've sat on MLR/promotional review committees, cleared advertising for approved and investigational products, and guided startups from angel funding through Series A.

I work fluidly across
CROs IRBs Academic institutions Sponsors Vendors Matrixed, cross-border teams
03

Selected experience

2003 — Present

Solo Attorney

Denver, CO
  • —Serve as outside counsel to early-stage life sciences companies across clinical development and commercialization.
  • —Draft and negotiate CTAs, CRO MSAs, KOL and consultant agreements, and collaboration agreements with complex royalty and milestone structures.
  • —Serve on MLR/promotional review committees, clearing advertising, scripts, videos, posters and media for approved and investigational products.
  • —Advise on cross-border transactions spanning the US, EU and Japan; negotiate Quality Agreements and clinical/commercial drug supply agreements.
  • —Counsel startups on early-stage financing — including a NYC company advised from angel funding through its ~$15M Series A raise.
2006

Outside Consultant

Bristol-Myers Squibb, NJ
  • —Provided outside contract and transactional support for clinical and commercial operations as part of the MLR team.
  • —Handled medical and legal review of advertising and HCP/DTC correspondence for an approved drug.
2000 — 2002

Associate General Counsel

Eyetech Pharmaceuticals, NYC
  • —In-house counsel for an ophthalmology-focused biotech, managing clinical trial contracting and corporate transactional matters.
Early career

Corporate & Finance, New York

Law firm associate · investment banking · federal clerkship
  • —Law firm associate at Orrick, Herrington & Sutcliffe (New York): CDOs, derivatives, structured finance, M&A, distressed debt purchase and sale, and IPOs.
  • —Law firm associate at Sullivan & Worcester (Washington, D.C.): general corporate, M&A, and Investment Company Act of 1940 matters.
  • —Counsel to internet/technology startups (advertising, email security, film finance).
  • —Investment banking roles at Credit Suisse First Boston and Duff & Phelps Credit Ratings Co., including structured finance, "Bowie Bonds" securitizations, and transaction management for commercial paper programs.
  • —Law clerk to a Judge of the U.S. District Court for the District of Delaware, Wilmington, DE.
04

Writing on clinical trials law

Selected articles
05

Credentials

Education
J.D., George Washington University Law School
Law Review · Top 10% of class · 1994
B.S., Accounting
University of Florida · 1991
Bar admissions
  • Colorado
  • New York
  • Texas (inactive)
Get in touch

Let's talk about your next agreement.

Attorney
Ken Linsk · Ken Linsk, LLC
Location
Denver, Colorado
Admitted
Colorado · New York · Texas (inactive)

Contacting me does not create an attorney–client relationship. Please don't include confidential details in your first message.