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2025 CABS Investor Forum

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Please join Morrison Foerster at the 2024 Chinese American Bio/Pharmaceutical Society (CABS) Investor Forum on January 15, 2025...

Please join Morrison Foerster at the 2024 Chinese American Bio/Pharmaceutical Society (CABS) Investor Forum on January 15, 2025 from 8:00 AM – 3:00 PM (Pacific) in conjunction with the J.P. Morgan Healthcare Conference. This event will be hybrid, with in-person programing hosted at Morrison Foerster’s San Francisco office.The forum will explore the opportunities and challenges facing the life sciences industry, including drug development, pharmaceutical innovation, and biotechnology.Program Highlights:<ul><li>Spotlight Presentation: “Life Sciences in Transition: What the New Administration Means for the Industry”, presented by MoFo Partner Brigid Bondoc</li><li>Panel Discussions:</li><li>“Thriving in Uncertainty: Carving Out a Niche in the Life Sciences Jungle”, moderated by MoFo Partner Janet Xiao</li><li>“Alchemy of Success: Leveraging Commercial Deals to Drive Drug Development”, moderated by Alex Zhang, Founder and CEO of OneTwenty Therapeutics</li></ul>This year, the forum will feature an afternoon Roadshow session, offering innovators and entrepreneurs in the healthcare and biotech spaces the opportunity to pitch in front of over 150 venture capitalists, business development professionals, and biotech executives.Register and learn more about the <a href="https://www.cabsweb.org/events/5956700/Welcome+to+the+2025+CABS+Investor+Forum/" target="_blank">event</a>. <hr>

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Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceutical companies, such as Celgene and Genentech, to emerging startup companies around the world. She advises her clients on patent matters relating to various technologies, including antibody therapeutics, cell therapeutics, nanomedicine, gene therapy, drug delivery systems, diagnostics, and nutraceuticals.Recognized by Chambers as being highly sought after for patent prosecution and strategy mandates by innovators from around the world, Janet develops and strengthens her clients’ complex patent portfolios to maximize their commercial value. She is instrumental in developing strategies for multibillion-dollar patent portfolios for pharmaceutical clients. As impressed clients noted to Chambers, “Janet’s work is thorough, polished and always of the highest caliber. She is well equipped to advise international clients on patent prosecution and strategy in the biotech industry, drawing on substantial technical knowledge.”Janet works extensively in performing IP due diligence reviews in the contexts of VC investments, technology transactions, mergers and acquisitions, and marketing and manufacturing clearance for biopharmaceutical products. She helps some of the world’s most-sophisticated biopharmaceutical companies and investors assess potential risks and devise preemptive risk-management strategies for their product development and investments. She has led hundreds of IP due diligence projects, and is noted for her in-depth knowledge of patent landscapes in the fields of cancer immunotherapy, gene editing, next-generation sequencing, liquid biopsy, antibody manufacturing, and medical devices. Janet works regularly with patent litigators in the event of legal challenges by third-party competitors or vice versa, and she is frequently called upon to represent clients in litigation and post-grant proceedings.Janet is the Head of firm’s China Life Sciences Group and served as co-chair of the global Life Sciences Group from 2016 to 2019. She is among the very few IP attorneys in the world who are both equipped with solid skills in global strategic IP management and knowledgeable about IP issues unique to China and Chinese clients, and she has been the go-to counsel for IP issues in U.S./China cross-border transactions and operations in China. Chambers Global praises her as an outstanding IP lawyer “who is renowned for her work on IP issues concerning complex cross-border transactions, where she regularly advises Chinese clients.” In a recent edition of Chambers Global, a client says, “Janet . . . is very experienced in advising life sciences clients doing business in China and the US . . . She is highly responsive and always gives practical advice. Her IP expertise adds tremendous value to our business.”Since 2005, Janet has been actively involved in the leadership team of the Chinese-American Biopharmaceutical Society (CABS), a nonprofit organization dedicated to bridging the life sciences communities in the U.S. and China, including serving as president for the 2011–2012 term. She is also a member of BayHelix, a nonprofit organization of Chinese heritage leaders in the global life sciences and healthcare fields.

肖荐（Janet Xiao）博士的业务侧重于为生命科学公司处理在全球范围内的专利采购、专利组合管理和战略策划事宜。肖博士服务的客户范围广泛，包括大型跨国生物制药公司，例如赛尔基因公司（Celgene）和基因泰克公司（Genentech），也包括全球范围的新兴创业公司。她经常就与各种技术有关的专利事宜向客户提供法律意见，其中涉及的技术包括抗体疗法、细胞疗法、纳米医学、基因疗法、给药系统、诊断和和营养学等。来自全球的创新者纷纷向肖博士寻求专利申请和专利战略的法律咨询，这一点也得到了《钱伯斯指南》的认可。她帮助客户开发和加强其复杂的专利组合，从而为客户实现最大的商业价值。在为制药行业的客户制定数十亿美元专利组合的战略方面，肖博士发挥着重要的作用。《钱伯斯指南》曾引用客户评价称，“肖博士是我曾合作过的律师当中知识最渊博、效率最高的一位律师。她能很好地将专利组合的历史信息用于全球专利申请问题上。”肖博士针对风险投资、技术交易、并购和生物医药产品的市场推广与生产许可事宜开展广泛的知识产权尽职调查审查工作。她协助世界上一些最成功的生物制药公司和投资者，为其产品开发和投资评估潜在风险，并制定先发制人的风险管理策略。她曾牵头处理过数百个知识产权尽职调查项目，并凭借自己对癌症免疫治疗、基因编辑、新一代测序、液体活检、抗体制造和医疗设备领域的专利方面的深厚知识而闻名。肖博士时常与专利诉讼律师合作，处理由第三方竞争者提出的法律质疑，或对第三方竞争者提出的法律质疑，她还经常受聘代表客户处理专利诉讼和授予后程序。肖博士是美富中国生命科学业务组主管，她曾在2016至2019期间担任美富全球生命科学业务组的联席主管。肖博士是全球为数不多的既拥有很强的全球战略性知识产权管理技能，同时又对中国和中国客户独特的知识产权问题具有深刻理解的知识产权律师之一，她一直是处理中美跨境交易和在中国境内经营中所涉知识产权问题的首选律师。《钱伯斯全球指南》称赞她是一位优秀的知识产权律师，“她因处理与复杂跨境交易有关的知识产权问题工作而知名，经常代表中国客户处理这方面的事宜” 。在近期一版《钱伯斯全球指南》中，某客户评价称，“肖博士在为于中国和美国开展业务的生命科学客户提供法律意见方面，有非常丰富的经验。她非常负责而且总是提供切实可行的法律意见。她在知识产权方面的专业意见为我们的业务增添了巨大价值。”自2005年以来，肖博士一直积极参与北美华人生物医药协会（CABS）的领导工作。该协会是一家非营利组织，致力于成为连接中美两国生命科学领域的纽带。肖博士在2011至2012年间担任该协会主席。她还是百华协会（BayHelix）的成员。百华协会是一家非营利组织，由全球生命科技和医疗保健产业领域的华人精英组成。

Janet Xiao

Partner

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

Life Sciences + Healthcare

2025 CABS Investor Forum

15 Jan 2025 8:00 AM - 3:00 PM PST