Steven Tjoe > Goodwin > Washington DC, United States > Lawyer Profile

Goodwin
1900 N Street NW
Washington, District of Columbia 20036
United States
Steven Tjoe photo

Position

Partner

Career

Steven Tjoe is a partner in the firm’s Technology and Life Sciences groups and a member of the firm’s Life Sciences Regulatory & Compliance practice. He focuses his practice on product development strategies and regulatory compliance counseling, in particular as related to medical devices, digital health products, in vitro diagnostics, laboratory developed tests, compounded drugs, cell and gene therapies, and other drugs and biologics. Steven advises clients in analyzing premarket pathways, product adverse event risk profiles, product communications and marketing, and GMP compliance. Steven also advises on Hatch-Waxman patent listing and exclusivity issues, is a contributor to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., and regularly conducts risk analyses for offerings and transactions involving FDA-regulated entities across the medical device, drug, and biologic industries.

Recently, Steven has brought his experience as former regulatory counsel at FDA to help in vitro diagnostic, laboratory developed test, digital health developer, and non-traditional medical device manufacturer clients launch critical diagnostic and therapeutic products in response to the COVID-19 public health emergency.

Education

JD, 2013, Antonin Scalia Law School, George Mason University / MS, 2012, Case Western Reserve University / BA, 2006, Duke University

Lawyer Rankings

United States > Healthcare > Life sciences

(Next Generation Partners)

Steven Tjoe – Goodwin

Goodwin’s global practice advises biotech, pharma, and healthcare companies, along with life science venture capital and investment firms. The growing practice supports clients in matters as wide-ranging as regulatory compliance, IP and M&A. The team’s representation of Prime Medicine in its $3.5bn deal with Bristol Myers Squibb evidences its excellence in research collaboration and license agreement matters. The practice is headed by Kingsley Taft, vastly experienced in commercial, financing and capital market transactions, and Mitchell Bloom, who specializes in emerging companies and life sciences investors. Both in Boston, transactional lawyer Robert Puopolo and Marishka DeToy, who focuses on capital markets and corporate matters, are key figures in the practice. In DC, Steven Tjoe focuses on product development strategies and FDA regulatory counseling. Arriving on the Boston-based team from Cooley LLP are Joshua Rottner, venture capital and growth equity funds specialist, and Michael McGrail, focused on medical devices and life sciences. Other key hires include litigation expert Michael Siekman, arriving in Boston from McDermott Will & Emery LLP, M&A specialist Amanda Gill, from Paul, Weiss, Rifkind, Wharton & Garrison LLP, and IP lawyer Carl Morales, from Fenwick & West LLP; the latter two are based in New York.