Kristina Bieker, Ph.D.

Kristina Bieker, Ph.D., has focused her legal career on strategic patent portfolio development for early‑stage and emerging growth companies in the life sciences sector. Her practice centered on advising biotechnology, pharmaceutical, and medical device companies—as well as leading venture capital firms—on the creation, protection, and monetization of highly complex intellectual property assets.

Her experience includes molecular biology, small‑molecule and peptide therapeutics, medical devices, drug delivery platforms, immunotherapeutics, nanotechnologies, nucleic acid systems, and viral vector technologies supporting, for example, oncology, gene therapy, vaccine development, neuroprotection, cardiovascular health, and preventive medicine. Her areas of specialty include designing integrated patent and regulatory exclusivity strategies, evaluating competitive landscapes, and supporting scientific differentiation.

She works closely with company management, scientists, and venture investors to develop strategies that drive scientific differentiation and commercial value by building intellectual property portfolios, negotiating complex transactions and financings, and supporting high‑value corporate outcomes.

Kristina also works with nonprofit research institutions such as universities and hospitals to identify, protect, and move groundbreaking scientific discoveries into early‑stage commercial development.

The following matters illustrate Kristina’s work with early‑ and mid‑stage life sciences companies and leading life sciences venture capital firms.

EXEMPLARY EARLY‑ AND MID‑STAGE COMPANY REPRESENTATION

• Enobia Pharma — Developed the international patent and regulatory exclusivity strategy for asfotase alfa, the first treatment for otherwise fatal neonatal hypophosphatasia; advised the company through multiple rounds of financing, culminating in Alexion’s $1.08B acquisition. The drug, Strensiq, is now available worldwide.
• Cynapsus Therapeutics — Developed the company’s patent portfolio, advised on key strategic agreements, and supported growth through multiple financings, culminating in Sunovion’s $624M acquisition.
• Fusion Pharmaceuticals — Developed a diverse international patent portfolio covering multiple facets of targeted radiotherapeutics; advised on strategic partnerships, venture financings, and the company’s 2020 public offering. Fusion was acquired by AstraZeneca for $2.4B.
• Zealand Pharmaceuticals — Prosecuted the GLP‑1 peptide portfolio, supporting the commercialization of therapies that transformed the treatment of diabetes, obesity, and related metabolic diseases.
• Corbus Pharmaceuticals — Obtained key patents across the company’s immunology and oncology programs; advised on the company’s 2017 public offerings totaling approximately $78.4M.

EARLY‑STAGE VENTURE CAPITAL REPRESENTATION

Kristina represented many of the top life sciences venture capital firms in North America and Europe. She provided investment due diligence and strategic planning and frequently continued to advise investee companies in executing strategies for robust competitive positioning and high‑value exits.

• TVM Capital — Advised on the formation of more than 20 companies, including strategic diligence and planning for CoLucid Pharmaceuticals, culminating in its $960M acquisition by Eli Lilly.
• Arix Bioscience — Led diligence and licensing analysis for VelosBio’s $58M Series A financing; VelosBio was acquired by Merck for $2.75B.
• OrbiMed — Supported early‑stage diligence for Tricida’s formation and Series A financing; advised on IP strategy for Perfuse Therapeutics from pre‑formation through portfolio and venture financing strategy.
• Sofinnova Partners — Conducted IP diligence for Noema Pharma; subsequently advised on patent and regulatory exclusivity strategies and Series B financing.

Kristina began her scientific career conducting research at the Whitehead Institute, Princeton University, and MIT in developmental biology, genetics and biochemistry, and neurobiology, respectively. Select first‑author research and review articles have been published in Cell, EMBO Journal, Proceedings of the National Academy of Sciences, Genomics, and Trends in Genetics.

What began as a three‑month sabbatical from the Harvard Society of Fellows to explore the biotechnology industry unexpectedly redirected her career. That sabbatical evolved into a full‑time role as a Technology Specialist at Fish & Richardson, where she first combined her scientific background with intellectual property strategy.

She later co‑founded Clark & Elbing, where she practiced for more than two decades and served as Managing Partner for eight years. Kristina subsequently joined Goodwin to leverage the firm’s broad capabilities across multiple practice areas, both within the Life Sciences group and also outside it. This enabled her to fulfill her goal of supporting clients with a fully integrated and coordinated approach to life science innovation.

• Frequent speaker and symposium leader on intellectual property, venture capital due diligence, translational medicine, early‑stage biotech lifecycle management, and cross‑disciplinary therapeutic development.
• Member, Women Business Leaders of the U.S. Health Care Industry Foundation
• Supporter and participant, 826 Boston

• IAM Patent 1000 (2016–present) – Patent Prosecution & Strategy
• Legal 500 (multiple years) – Intellectual Property
• Managing IP / IP Stars (multiple years)
• Super Lawyers (multiple years)
• Euromoney / Expert Guides – Patents; Women in Business Law
• Best Lawyers in America (multiple years) – Patent Law / Biotechnology