Kristina Bieker, Ph.D., is a partner in Goodwin’s Life Sciences and Technology groups, where she focuses on strategic patent portfolio development for early-stage life sciences companies and handling intellectual property matters during financings, public offerings, mergers and strategic partnerships. With a Ph.D. in molecular biology, Dr. Bieker represents both private and public biotech, pharmaceutical and medical device companies on matters relating to patent prosecution, including patentability, non-infringement and invalidity opinions, licensing, joint development agreements, and patent enforcement. In addition, she performs IP due diligence on potential investments for some of the top venture capital firms and serial entrepreneurs in the world.
Dr. Bieker’s experience encompasses cellular immunotherapies; gene therapy; nano and viral systems for oncolytic, gene therapy and vaccine indications; preventative medicine; treatments for devastating neurological and other tissue injuries; and treatments — and more critically, cures — for developmental and progressive neurological diseases such as autism, ALS and Alzheimer’s.
Prior to joining Goodwin, Dr. Bieker was a partner at McDermott Will & Emery. She also spent 22 years as a co-founder of an IP boutique dedicated to life sciences patent prosecution, serving as a managing partner for eight years.
- Advised TVM Capital Life Science Management Inc. on a number of IP due diligence matters related to new company formations
- Led the IP due diligence for Noema Pharma, a developer of medical therapies intended to address the most disabling symptoms in orphan conditions of the brain and nervous system, in its $59.3 million Series A financing
- Led the IP due diligence for Galecto, a clinical-stage biotechnology company developing therapeutics that are designed to target the biological processes that lie at the heart of fibrosis and impact a broad range of fibrotic and related diseases, in its $85 million IPO
- Led the IP due diligence for Fusion Pharmaceuticals, an oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, in its $212.5 million IPO, acquisition of assets owned by a biotechnology company developing protein therapeutics for genetic disorders, and the Company’s Series B financing
- Led the IP due diligence for Perfuse Therapeutics, a biotechnology company focused on a novel mechanism to improve retinal perfusion, in its $9 million Series A financing.
- Led IP due diligence for OrbiMed, a healthcare investment firm that seeks to invest in the pharmaceutical, life science, healthcare service, medical device, biopharmaceutical and diagnostic sectors, in a €90 million Series C financing round co-led by OrbiMed for Galecto Biotech, the leading developer of galectin modulators for the treatment of severe diseases, including fibrosis and cancer*
- Led IP due diligence for Arix Bioscience, a global health care and life science company supporting medical innovation, in a $58 million Series A financing led by VelosBio, a biotechnology company intended to provide cancer research*
- Represented Turnstone Biologics, a developer of oncolytic viral immunotherapies designed to improve survival for patients with cancer, handling prosecution of their patent portfolio and IP matters up to and including the Takeda investment of $120 million of up-front payments and milestone payments potentially exceeding $900 million*
- Represented Cynapsus Therapeutics, a specialty pharmaceutical company developing a drug to treat the motor symptoms of Parkinson’s disease, in a portfolio development covering a therapeutic that prevents “frozen” states in Parkinson’s patients. Representation began at the seed stage and included licensing, an IPO and, ultimately, the sale of the company to Sunovion Pharmaceuticals for more than $600 million*
- Represented Enobia Pharma Corp., a company that develops therapies for the treatment of serious genetic bone disorders, in a portfolio development covering a therapeutic to treat an otherwise deadly pediatric bone disease and assisted with the company’s sale to Alexion Pharmaceuticals, Inc. for $1.4 billion*
- Represented Audentes Therapeutics, a clinical-stage biotechnology company focused on developing and commercializing gene therapy for rare diseases, regarding their $231 million in financing. Handled the portfolio development for multiple product lines (XLMTM, Crigler-Najjar, Pompi Disease and CASQ-CPUT) and also handled IP issues in the IPO and follow-on offering*
- Represented investors in Tricida at the company formation stage and for follow-on financings. Tricida is a biopharmaceutical company focused on the discovery and development of non-absorbed oral drug therapies. In November 2017, Tricida announced the closing of an oversubscribed $57.5 million Series D financing, bringing the company’s total raised capital to $153.3 million. Ms. Bieker conducted IP due diligence and strategic analysis at the company formation stage, resulting in the initial two-tranche financing by lead investor Orbimed*
- Represented ObsEva SA, a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise women’s reproductive health and pregnancies. Led the development of the company’s patent portfolio strategies for multiple lead programs, resulting in the issuance of key patents, and handled transactional matters including a $60 million private placement in October 2017 with well-known investors and venture capital firms, including New Enterprise Associates (NEA), New Leaf Venture Partners, Sofinnova Ventures, DAFNA Capital Management, Sphera Global Healthcare Fund, and Venrock Healthcare Capital Partners, as well as Aisling Capital, First Manhattan Co., Ghost Tree Capital and Omega Funds. This $96.8 million financing followed the company’s IPO in June 2017*
- Represented Corbus Pharmaceuticals, a clinical-stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases. Obtained the first patent protection for Corbus on commercial products with multiple patents covering the use of pharmaceutical compositions for anabasum, used in the treatment of multiple fibrotic diseases including ostio-fibrosis. According to the company’s press release, it is a “first-in-class therapy targeting multiple rare inflammatory and fibrotic diseases with clear unmet needs and significant morbidity and mortality.” With the increased company valuation resulting from these significant patent protections, Corbus announced that the underwriters of its previously announced public offering of common stock exercised in full their option to purchase nearly 700,000 additional shares, resulting in additional gross proceeds of approximately $5 million, for a total of $37.5 million*
- Led IP due diligence for Arix Bioscience, a global healthcare and life science company supporting medical innovation, in a $30 million Series C financing round co-led by Arix for Aura Biosciences, a company developing a new class of therapies to selectively destroy cancer cells, namely ocular melanoma, a rare and aggressive eye cancer*
- Represented Cidara Therapeutics, a clinical-stage biotechnology company focused on the development of novel anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives, in a $32 million Series A financing, a $42 million Series B financing, a $76.8 million IPO in 2015 and two follow-on offerings of $120 million and $150 million in 2018*
- Led IP due diligence for Kala Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFY Mucus Penetrating Particles technology, with an initial focus on the treatment of eye diseases, in a $68 million Series C financing*
- Led IP due diligence for Olema Pharmaceuticals, a biotechnology company intended to develop new drugs for the treatment and prevention of estrogen receptor (ER) positive breast cancer, in a $6 million Series A financing and due diligence review of a license agreement with Pfizer*
- Led IP due diligence for Emovi, a developer of a knee assessment device designed to transform the complete knee episode of care, making it more efficient with better outcomes, in $15 million Series C financing led by TVM Capital Life Science*
- Led IP due diligence for Panthera Dental, a developer of CAD/CAM prosthetic implant technology and dental sleep appliances created to offer next-generation products to the dental industry worldwide, in an undisclosed Series B financing led by TVM Capital Life Science*
- Led IP due diligence for PreciThera, a developer of precision medicines intended to treat orphan diseases which are made through the development of innovative biological agents, enabling patients who, up until now, had very limited options to have required treatments, in a $36 million Series A financing led by OrbiMed*
- Led IP due diligence for Synlogic, a biopharmaceutical company focused on advancing the drug discovery and development platform for Synthetic Biotic medicines, which are designed using synthetic biology to genetically reprogram beneficial microbes to treat metabolic and inflammatory diseases and cancer, in a $40 million Series B financing led by OrbiMed*
- Led IP due diligence for Zealand Pharmaceuticals, a biotechnology company focused on the discovery, design, and development of peptide-based medicines, in a $78 million IPO*
*Denotes experience prior to joining Goodwin.
Areas of Practice
Dr. Bieker is a member of the Silverstein Foundation for Parkinson’s with GBA, 826 Boston, and Women Business Leaders of the U.S. Health Care Industry Foundation.
During her academic career, Dr. Bieker conducted cell biology, genetics, and neurobiology research using molecular biology and biochemistry techniques. 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.
Boston College Law School
- U.S. Patent and Trademark Office (USPTO)
Recognition & Awards
- The Best Lawyers in America Best Lawyers, 2023
- Super Lawyers (M&A, IP & Technology Transactions), 2019
- IAM1000, 2016 to present
- The Legal 500 US 2021, 2019
- Expert Guides, Women in Business Law and Patents, 2019
- Junior Fellow, Society of Fellows, Harvard University, 1991-1992
- Scientist at Massachusetts Institute of Technology in the laboratory of Dr. H. Robert Horvitz (Nobel Laureate), 1991-1992
- Leo Leva Research Award Recipient, 1986
- Research Fellow, The Whitehead Institute in the laboratory of David Page, 1985-1986
- Genetics Society of America Research Award Recipient, 1985