I drive superior results through negotiation and alliance management of IP-based Life Science Transactions
Upon leaving GSK, I founded a solo law practice dedicated to excellence in life science transactions - creating and nurturing collaborative interactions between biopharma companies, universities, and research institutions to advance development of innovative solutions to health challenges in the US and around the globe.
As Immediate-past President, I chaired the Society's committee on leadership and nominations and mentored other Board members. The Society honored my service by awarding me the Frank Barnes Award for mentorship.
As President, I streamlined the Board Committee structure and debuted a new strategy to develop a virtual content ecosystem, emphasizing ROI and fiscal prudence while investing in a new online community networking platform.
As President-Elect, I developed and rolled out a program of virtual events for LES members experiencing career transitions due to the COVID-19 pandemic. I was also a member of the Board's COVID-19 task force, which resolved a long-term financial obligation and mitigated financial risk during the pivot from in-person events to virtual platformed events.
Role change that arose from a functional reorganization associated with GSK's spinout of its consumer healthcare business in 2021 and consolidation of the vaccines and pharmaceutical business segments. Practice concentrated on interactions between GSK and U.S. Government entities. Handled license agreements, CRADAs, clinical trial agreements, and settlement agreements related to licenses and other financial matters. Also lead counsel for nondilutive funding proposals and contracts (FAR and OTA) supporting the vaccines R&D pipeline. Represented GSK in Government accounting audits, contract closeouts and a significant Termination Settlement Proposal.
At GSK, I was the sole North American attorney for significant (over $1M) IP-driven business transactions to align the Vaccines pipeline with GSK's business strategy. I handled complex asset acquisitions, in-licenses, and collaboration agreements, as well as asset divestments (including site divestment) and termination/settlement agreements. I also negotiated multi-party collaborative clinical trial agreements and CRADAs. I provided the business with U.S. risk mitigation advice on royalty obligations and strategic alliances. In addition, I was the sole North American attorney for the Vaccines portfolio of R&D contracts with U.S. government entities, including NIH/NIAID, BARDA and DARPA.
LES is the leading multidisciplinary professional society for the business applications of IP rights and their management; for more than 50 years, LES has promoted best practices in IP transactions, IP protection, and IP strategy. As a Board member, I led a review and modernization of the Society's communications strategy, newsletters and website.
I began my legal career at HBS&R, where I joined the firm's life sciences patent prosecution practice group. I represented the Massachusetts Institute of Technology (MIT) and selected spin-out companies.
While at THT, I developed a life sciences patent practice. I represented small and mid-cap biopharmaceutical companies and venture capital investors. Projects included patent portfolio development, patent invalidity and non-infringement opinions, and IP due diligence. In particular, I had strategic management responsibility for a large portfolio of regenerative medicine patents.
Biogen-IDEC (NASDAQ: BIIB), originally Biogen, Inc., was founded in 1978, and is the oldest independent, global, fully integrated biopharmaceutical firm, and has a diversified biologics product portfolio for neurology, autoimmunity, and oncology disease indications. I joined Biogen as Assistant General Counsel, IP and was promoted to Associate General Counsel, IP in September 2000. While at Biogen, I was responsible for all IP matters relating to selected clinical- and late research-stage product development programs. Key accomplishments included:
I led all IP activities in support of new product launch of AMEVIVE® (alefacept) for treatment of psoriasis in United States and Europe, including:
I was also the in-house team leader for Noelle v. Lederman, U.S. Patent Interference No. 104,415; together, the team secured a favorable decision of noninterference-in-fact, which cleared FTO obstacles from commercialization of a humanized monoclonal antibody therapeutic for autoimmunity and transplant indications.
I managed licensee-licensor relationships with six different land-grant and private universities having conflicting and overlapping IP rights in a humanized monoclonal antibody product candidate.
I was a lead negotiator in the in-licensing of neublastin, a recombinant biologic candidate for neuropathic pain.
While at Foley Hoag (FH), I maintained a life sciences patent practice, in which I represented biopharmaceutical companies of all sizes and at all stages of corporate lifecycle. My projects included patent portfolio development, patent invalidity and non-infringement opinions, and IP due diligence. In 2005, I led an investigation, analyzed and mediated resolution of an inventorship dispute between two tenured professors at Johns Hopkins University, which enabled both to commercialize neuroprotective therapeutic candidates with their respective startup companies.
Emergent BioSolutions Inc. (NYSE: EBS) is a global specialty biopharmaceutical firm and a leading biodefense contractor, supplying its flagship vaccine, BioThrax (anthrax vaccine adsorbed) to the U.S. Strategic National Stockpile. I served as the company's first Chief IP Counsel, founded its IP Department, supported its Initial Public Offering (IPO), and guided all IP aspects of its subsequent 9+ year growth through sequential M&A activities.
I became a member of Emergent's Legal Affairs Division leadership team upon being promoted to Vice President in April 2009. I managed an IP department consisting of 8 patent professionals at 4 corporate sites across 8 time zones. Together, we were responsible for management and oversight of the company's $5.2M annual IP budget. As V.P., I led all aspects of corporate IP strategy, governance and compliance, including the following specific activities and accomplishments:
In my early years at Emergent, prior to becoming V.P., my key accomplishments included the following:
I created FIPS as a legal consulting firm to help small business and entrepreneurial innovators access the value of their current and future IP assets to achieve their strategic objectives. FIPS had a proactive and collaborative approach to assisting clients throughout the life cycle of IP-based business transactions (technology transfers, R&D collaborations, licensing, funding & investments, joint ventures, M&A, and asset sales). FIPS achieved break-even status within its first six months of operations.