Morrison Foerster is an international law firm with lawyers practicing throughout the United States, Asia, and Europe. Click to discover more.

mofo_share_image.jpg

Morrison Foerster

common-default.jpeg

Terms / Notices

Cookies

Privacy Policy

Reporting Hotline

Attorney Advertising

Alumni

  Linkedin

MoFo LinkedIN

  Facebook

MoFo Facebook

YouTube

MoFo Youtube

Morrison Foerster - Footer

MoForum 2025 | Life Sciences - Women of Impact

You have not solved the recaptcha challenge yet or session expired, try again.

Email Disclaimer

Disclaimer

Unsolicited e-mails and information sent to Morrison Foerster will not be considered confidential, may be disclosed to others pursuant to our <a href="https://www.mofo.com/about/privacy-policy.html">Privacy Policy</a>, may not receive a response, and do not create an attorney-client relationship with Morrison Foerster. If you are not already a client of Morrison Foerster, do not include any confidential information in this message. Also, please note that our attorneys do not seek to practice law in any jurisdiction in which they are not properly authorized to do so.

Feedback

mofo-logo-2022.svg

People

Capabilities

Resources

About

Culture

Offices

Careers

Stay Connected

Morrison Foerster is proud to present MoForum 2025 | Life Sciences – Women of Impact, a premier event celebrating the...

Morrison Foerster is proud to present MoForum 2025 | Life Sciences – Women of Impact, a premier event celebrating the contributions and achievements of women in life sciences. This unique program will spotlight female entrepreneurs, leaders, scientists, and investors who are shaping the future of the industry.Gain inspiration and insights as our distinguished speakers share their stories of success, career journeys, and perspectives on navigating and thriving in the ever-evolving life sciences market.We are delighted to feature influential voices from across the life sciences ecosystem, including:<ul><li>Yvonne Hao, Secretary of Economic Development for the Commonwealth of Massachusetts</li><li>Padmini Pillai, White House Fellow </li><li>Florence Bourgeois, Co-Director of the Harvard-MIT Center for Regulatory Science</li></ul>MoForum 2025 | Life Sciences – Women of Impact is tailored for professionals in the life sciences industry—including executives, policy makers, researchers, investors, and innovators—who are eager to connect, learn, and empower one another to drive meaningful change.A detailed agenda will be available soon. Please use the RSVP button above to register.<hr>

Sign Up

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As a member of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Partner

Bindu Donovan has been litigating high-stakes intellectual property disputes in the life sciences field for over 25 years.Bindu, a seasoned partner in Morrison Foerster’s Intellectual Property Litigation group specializes in patent litigation in U.S. federal district courts. She has a broad range of experience in life sciences, representing clients in matters related to biologic and small-molecule drugs, medical devices, recombinant proteins, and vaccines. Her extensive portfolio extends to representing innovator companies in Hatch-Waxman cases covering treatments for ADHD, diabetes, influenza, hypertension, and metastatic prostate cancer, including blockbuster drugs.Bindu excels in leading large litigation teams in all aspects of complex patent infringement disputes, including pre-suit investigations, pre-trial and expert discovery, trial preparation, and trial. She is adept at coordinating global strategies for her clients’ most important products. Additionally, her experience includes breach of contract and trade secret disputes, mediation, and arbitration.Bindu has been consistently recognized as a leading practitioner in her field. LMG Life Sciences acknowledged her contributions to life sciences-related patent work, and IAM Patent 1000 ranked her as a Leading IP Litigation Lawyer. Additional notable accolades include being named one of the Top 250 Women in Litigation and a Local Litigation Star by Benchmark Litigation. Managing Intellectual Property also named her an “IP Star” and one of the Top 250 Women in IP.Bindu serves on the board of managers of the New Jersey Intellectual Property Law Association (NJIPLA) and participates in various other legal organizations.<h4>Representative Experience</h4><ul><li>Represented international biopharmaceutical company in confidential matter involving offensive and defensive patent assertion strategy concerning vaccines.</li><li>Represented international biopharmaceutical company in confidential pre-suit investigation relating to fusion protein.</li><li>Represented VMI Holland BV in breach of contract action.</li><li>Represented patent holder Johnson & Johnson subsidiary, Actelion Pharmaceuticals Ltd., in patent infringement suits filed under the Hatch-Waxman Act involving pulmonary arterial hypertension drug Tracleer®.</li><li>Represented patent holder Avanos in patent infringement suit involving cooled radiofrequency ablation products.</li><li>Represented patent holder Johnson & Johnson subsidiary, Janssen, in patent infringement suits filed under the Hatch-Waxman Act and inter partes review proceedings involving prostate cancer drug, Zytiga®.</li><li>Represented patent holders Gilead and Roche/Genentech in patent infringement suit filed under the Hatch-Waxman Act involving influenza drug, Tamiflu®.</li><li>Represented patent holders Cordis Corporation and Wyeth in patent infringement suits involving drug eluting stents.</li><li>Represented defendant Johnson & Johnson in patent infringement suit involving sunscreen compositions.</li><li>Represented a pharmaceutical company in a patent infringement lawsuit filed under the Hatch-Waxman Act involving a medication for ADHD.</li><li>Represented patent holder SmithKline Beecham in patent infringement suit filed under the Hatch-Waxman Act involving Type 2 diabetes drug, Avandia®.</li></ul>

Bindu Donovan

Alyssa Monsen is a seasoned lawyer specializing in life sciences patent litigation.Her legal practice is concentrated in U.S. federal district and appellate courts, as well as inter partes review proceedings before the Patent Trial and Appeal Board. Alyssa has a robust track record of representing innovator pharmaceutical companies in high-stakes litigation, with a focus on therapies related to oncology, ophthalmology, and infectious diseases.Her experience spans all phases of patent litigation, encompassing pre-litigation strategic planning, trial, and appeals to the Federal Circuit. Additionally, Alyssa is skilled in advising clients on patent portfolio assessment, due diligence, and strategies for international patent enforcement.Alyssa has been recognized by Super Lawyers as a Rising Star since 2017, and Best Lawyers added her to its 2023 Ones to Watch list in the areas of Intellectual Property and Patent Litigation.Before her legal career, Alyssa served as a strategy consultant for pharmaceutical companies at Computer Sciences Corporation. She also gained valuable experience in market research, working with a firm that serves hedge funds and institutional investors, focusing on the pharmaceutical, biotechnology, medical device, and dental sectors.<h4>Representative Experience</h4><ul><li>Trial and appeal counsel for Johnson & Johnson subsidiary Janssen Pharmaceuticals in patent infringement suits filed under the Hatch-Waxman Act and inter partes review proceedings involving blockbuster prostate cancer drug, Zytiga®.</li><li>Litigation counsel for Genetech, Gilead, and Hoffman-La Roche in a patent infringement suit filed under the Hatch-Waxman Act involving blockbuster influenza drug, Tamiflu®.</li><li>Trial and appeal counsel for plaintiffs in patent infringement suits filed under the Hatch-Waxman Act involving topical ophthalmic antibiotic, AzaSite®.</li></ul>

Alyssa Monsen

Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector. She regularly helps clients develop and implement privacy compliance programs and advises companies on managing risk in connection with cutting-edge technologies and data initiatives.Melissa has particular experience in advising clients on compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other laws governing the collection and use of medical and health information.Melissa regularly counsels clients responding to data breaches and security incidents. She has successfully defended clients in numerous regulatory inquiries regarding data security practices, including investigations by the Federal Trade Commission, the U.S. Department of Health and Human Services, state attorneys general, and foreign regulators following data security incidents.Melissa also advises multinational companies on the privacy and data security aspects of their M&A transactions and has experience drafting and negotiating tailored privacy and data security contract provisions.In 2019, 2020, and 2021, The Legal 500 US recognized Melissa as a “Rising Star” in the area of cyber law, data privacy, and data protection. In 2016, she was shortlisted for the “Future Leader – Gender Diversity” award at the inaugural Chambers USA Diversity Awards. Melissa was a 2015 recipient of the Burton Award for Legal Achievement, which honors excellence in legal writing.Melissa earned her J.D., cum laude, from Howard University School of Law.

Melissa Crespo

Amy advises on corporate and transactional matters with a special focus on domestic and cross-border mergers and acquisitions, joint ventures and other corporate transactions.Her clients have included U.S. and global public and private companies in a wide range of industries including technology, financial services, consumer products, healthcare, life sciences, insurance and private equity. She has worked on a number of complex cross-border transactions in the UK, Europe, Asia and Australia.Prior to joining Morrison Foerster, Amy was Senior Legal Counsel at MILVIK BIMA, a fintech provider of micro-insurance and telehealth solutions, where she helped them navigate the complex regulatory landscapes of emerging markets across Asia, Africa and Latin America. She also served as Senior Legal Counsel at Aviva plc in London, where she advised on a range of corporate and M&A matters, and supported their corporate venture fund focused on technology investments.Amy was also previously a corporate associate at another international law firm in London, where she advised on corporate and cross-border M&A matters.She earned her law degree at the University of Sydney in Australia, and is qualified as an attorney in New York and a solicitor in England & Wales.

Amy Chen

Associate

Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.As co-chair of the Patent Group, Mike manages a team that includes 80+ Ph.D.s and 100+ attorneys and others with advanced scientific degrees in life sciences and related engineering disciplines. From small molecules and antibodies to gene editing, artificial intelligence, and machine learning, MoFo has deep experience protecting some of the most important innovations in the life sciences and food and agriculture sectors.Life SciencesFor his work across the life sciences sector, Mike was named San Francisco Biotechnology Lawyer of the Year by Best Lawyers in America in 2020 and is recommended for his patent strategy and prosecution practice in LMG Life Sciences. He also led the team that was named 2022 Patent Management and Strategy Firm of the Year at the 2022 LMG Life Sciences Americas Awards.Food + AgricultureRecognized as “one of the world’s foremost plant and agriculture IP lawyers,” Mike manages a wide range of intellectual property issues related to plants and plant products. He and his team advise clients on plant and plant utility patents; licensing agreements for plant IP; litigation in U.S. state and federal court and before the International Trade Commission; and regulatory approvals from the USDA, FDA, and EPA for gene edited and genetically engineered plants.Patent Strategy + ProsecutionMike is a Legal 500 US Hall of Fame lawyer for patent prosecution and is consistently named one of the leading IP lawyers by Managing Intellectual Property, Chambers USA and Chambers Global, and IAM Patent 1000.Mike works closely with many clients to develop and manage their patent portfolios. He helps clients identify, monitor, and assess the infringement risks of third-party patents. He also assists clients in preparing both offensive and defensive patent portfolios, with a particular emphasis on drafting patent applications that will be utilized in licensing and in litigation efforts.IP Due DiligenceFor venture capitalists seeking to invest in early- and mid-stage companies, underwriters involved in IPOs, and companies seeking to acquire or merge with other companies, Mike has managed extensive IP diligence. His work includes assessment of the strengths and weaknesses of patent portfolios, evaluation of freedom to operate issues, and strategic recommendations for maximizing the value of patent portfolios going forward.Mike also works closely with the IP Litigation Group on various litigation matters including patent interferences to determine the first-to-invent and patent re-examination work and actively participates in both mediation and arbitration proceedings on behalf of clients in the life sciences and food and agriculture areas.He is a frequent lecturer and speaker. Among numerous speaking engagements, Mike is the IP instructor at the UC Davis Licensing Academy and founded Morrison Foerster’s annual Harvard Biotechnology Club Fall Patent Law Course.Mike holds a Ph.D. in plant physiology (biochemistry) and an M.S. in agronomy from the University of California, Davis; a B.S. in biology from the University of California, Berkeley; and a J.D. from Golden Gate University School of Law. He was a post-doctoral fellow in plant molecular biology at the Harvard Medical School and the Department of Molecular Biology at Massachusetts General Hospital, where he worked on the Arabidopsis genome project.

Michael Ward

Matt Karlyn has 25 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensing, and technology transactions. His clients range from Fortune 100 companies to start-ups, and he regularly advises companies on matters involving IP commercialization, complex collaboration transactions, licensing initiatives, subscription-based economics, and business transactions related to the procurement, development, commercialization, and use of technology and life sciences products. He has also worked with a number of clients on corporate transactions including mergers and acquisitions, as well as private equity and venture capital financing.Matt is ranked Band 1 by Chambers USA for Intellectual Property: Licensing in Massachusetts. Clients in Chambers describe Matt as: “accessible and engaged, and he is really focused on getting the right answer for us."<h4>Life Sciences</h4>Life sciences clients, including pharmaceutical, medical device, and healthcare companies, rely on Matt for his breadth of knowledge in licensing, collaboration, and commercialization strategies across a wide range of transactions designed to strengthen operations and maximize value. Matt’s clients come from sectors across the global economy and include emerging companies, privately held companies, and many of the world’s biggest brands.Matt has broad experience with commercial transactions and agreements in the life sciences space, including:<ul><li>Intellectual property and technology licenses</li><li>Collaboration and development transactions</li><li>Commercialization agreements</li><li>Supply and manufacturing transactions</li></ul><h4>Technology</h4>Matt regularly advises on the use of technology in business, pricing strategies, and market terms across a wide variety of technology transactions that benefit clients both large and small. He has extensive experience negotiating a wide range of transactions, including:<ul><li>Enterprise resource planning and customer relationship management licensing and implementation transactions</li><li>Cloud-based transactions including software-as-a-services, platform-as-a-service, and infrastructure-as-a-service.</li><li>Software licensing</li><li>Supply chain and procurement deals</li></ul>Additionally, Matt has worked on many of the largest outsourcing transactions in the United States, representing numerous Fortune 100 companies on information technology, business process, finance and accounting, facilities services, and other outsourcing transactions.Matt is a frequent author and speaker on topics pertaining to drafting and negotiating commercial technology, outsourcing, and licensing transactions. He has published over 25 articles (including chapters in two books), given over 175 presentations on licensing, technology, outsourcing, and data security, and is the co-author of A Guide to IT Contracting: Checklists, Tools, and Techniques.Matt is currently co-chair of the Legal and Regulatory policy group at the Massachusetts Biotechnology Council. He served as chair of the New England Chapter of the International Association of Outsourcing Professionals, and served for five years on the board of directors of Julie’s Family Learning Program, a wellness program for mothers and children in South Boston.

MoForum 2025 | Life Sciences - Women of Impact

30 Jan 2025 2:30 PM - 6:30 PM EST