BUSINESS DEVELOPMENT / LEGAL / TECHNOLOGY TRANSFER
Bioscience - Pharma - Healthcare
Highly collaborative Senior Technology Commercialization Leader with 15+ years' experience leading strategic growth in the Life Sciences, Bioscience and Diagnostics industries, guiding product conceptualization, R&D, product development, regulatory compliance, technology transfer/intellectual property initiatives, product launch and commercialization.
* Transformational Leadership: Recognized as a Change Agent with the strategic vision to transform organizations and define strategic partnerships.
* Intellectual Property (IP): Extensive knowledge and experience managing the entire IP process - from triage of invention disclosures, drafting of claim sets and specifications to discussions with the PTO pertaining to Office Action responses.
* Legal: Responsible for negotiation, drafting and execution of sponsored research / MTA / collaboration and licensing agreements.
* Business Development / Marketing: Skilled at researching and presenting strategic new business opportunities to key stakeholders, developing business plans and marketing materials that increase client base and build new sales opportunities in both domestic and international arenas.
* Creating Collaborative Opportunities: Recognized cross-functional collaborator possessing the ability to forge strategic partnerships and define business alliances that accelerate innovation and strengthen the connections between research and funding.
* Fully immersed in the ecosystem of commercialization and economic development with deep experience across all facets of the Life Sciences industry (government, private sector, and medical).
* Formed University of Maryland's UMVentures: Driving Innovation Program; designed to increase collaborative engagement between researchers on multiple campuses and funders; successfully obtained regional and international funding for start-up entities.
* Pivotal role in leading the transformation of company from a start-up to international, SEC reporting entity with product and royalty revenues.
* Developed Medical Device incubator program and recruited seasoned management; entity was recently awarded High Impact Economic Development Activity (HIEDA) status by University of Maryland System.
* For University of Maryland, created campus-wide corporate partnership program; created and managed alliances which including Pfizer, Lilly, MedImmune and created a novel online collaboration tool and video program for targeted webinars to potential partners; showcasing research strengths of the University.
AREAS OF EXPERTISE
* Business & Strategic Development
* Intellectual Property Portfolio Development
* Technology Transfer
* Program & Project Management
* Biotechnology Product Development
* Corporate Compliance
* Legal Contract Negotiation and Drafting
* Market Research
* Financial Forecasting & Budget Development
UNIVERSITY OF MARYLAND, OFFICE OF RESEARCH AND DEVELOPMENT - Baltimore, MD Sept. 2011 to Present
Senior Business Development and Alliance Officer (2015 - Present)
Senior Licensing Officer (2011 to 2015)
METAMORPHIX, INC. - Beltsville, MD Sept. 1997 to March 2011
VP of Strategic Planning & Chief Compliance Officer - Beltsville, MD (Oct. 2004 to March 2011)
VP of Business Development - Savage, MD (May 2001 to Sept. 2004)
Director of Product Development - Baltimore, MD (Nov. 1998 to Apr. 2001)
R&D Transgenics Group Leader - Baltimore, MD (Sept. 1997 to Nov. 1998)
NATIONAL INSTITUTES OF HEALTH - Bethesda, MD May 1993 to Sept. 1997
NIH Staff Fellow - National Institute of Mental Health, Transgenic Core Facility (May 1995 to Sept. 1997)
NIH Postdoctoral Fellow - National Institute of Neurologic Disorders and Stroke (May 1993 to Apr. 1995)
UNIVERSITY OF MARYLAND, OFFICE OF RESEARCH AND DEVELOPMENT
Senior Business Development and Alliances Officer
2015 to Present
Championed reorganization of roles within the Office of Research and Development (ORD), including the introduction of the Senior Business Development and Alliances Officer role, to enhance partnership opportunities and increase awareness of the ORD with researchers and funders. Early focus aligned business development activities, identified and developed a more successful pipeline of translational research, and cultivated relationships and strategic partnerships with academic researchers, funding agencies, and corporate entities including AstraZeneca/MedImmune, Pfizer, Boston Scientific, Takeda, Sanofi and GlaxoSmithKline.
* Created and launched University of Maryland UMVentures: Driving Innovation program to increase collaboration and forge alliances between campuses, medical schools and engineering disciplines. Since April 2015, the program has helped file 7 different patent provisionals and successfully obtained state and investor funding.
* Developed incubator/accelerator concept for University. Identified and recruited a seasoned leader for the Maryland Development Center (MDC) group; provides shared resources and mentorship to start-up teams. To date, MDC has successfully assisted 6 UMB start-ups in executing option/license agreements for medical device technologies. Entity was Awarded High Impact Economic Development Activity status by University of Maryland System.
UNIVERSITY OF MARYLAND, OFFICE OF RESEARCH AND DEVELOPMENT
Senior Licensing Officer
2011 to 2015
Guided the identification, evaluation, and execution of technology commercialization activities (i.e. disclosure, protection, development of IP, patent applications, and licensing agreements) for the University of Maryland. Served as change agent for the organization to bolster ORD capabilities and create synergistic opportunities between campuses, faculty, and researchers to position University at the forefront of innovation. Led team of 3; reported to Chief Commercialization Officer
* Secured key license agreements with Bristol-Myers Squibb, MedImmune, Life Technologies, Cook Medical, and Becton Dickenson, Takeda, Covance, Bristol Myers Squibb among others.
Oct. 2004 to March 2011
Vice President of Strategic Planning & Chief Compliance Officer
Joined MetaMorphix in 1997 as an R&D Group Leader and promoted through various leadership positions in Product Development, Business Development, Strategic Planning, and Compliance. As an Officer for the company, contributed greatly to the companys transformation from a start-up R&D through product development and commercialization.
Led corporate compliance activities during the company's transition from a private corporation to an SEC publicly reporting entity. Forged strategic opportunities for the corporation, aimed at the development of genomic products and services. Led business development efforts for the company and invited by CEO to serve as technical representative to assist the company in fundraising efforts and presenting the technology to prospective investors; $150 million+ raised.
Strategic Planning / Business Development:
* Led strategic growth of the company from a 3-employee start-up to an international, revenue generating commercial entity with a peak staff of 75.
* Conducted marketing research and prepared financial forecasts for products in development and authored corporate marketing plans that resulted in technology advancement through the establishment of investment and collaboration opportunities.
* Drafted reports for the executive management team on strategic opportunities, and made presentations to the Board of Directors, potential collaborators, and licensees of corporate technologies.
* Drafted and executed agreements for all genomic technologies, with DNA testing market becoming one of the company's largest revenue streams. Executed agreements for additional SNP-based disease diagnostic testing services, which enabled us to offer new products and secure a new revenue stream representing over 30% of total product revenues in 2009.
Corporate Legal Compliance:
* Designed and implemented the company's Corporate Compliance program upon the company's transition from a private to publicly reporting entity.
* Executed strategic plan for top priorities in the area of compliance and risk management; including the creation of an employee manual (HIPAA compliance requirement), business continuity and document retention plan, anonymous hotline, board committee charters and corporate code of conduct.
* Obtained and coordinated information from internal departments and SEC attorneys for disclosures within the company's public filings. Also served as liaison with external auditors for disclosures pertaining to contracts and intellectual property necessary to complete audits.
* Established a corporate-wide, secure electronic library of all material contract documents, utilized in all due diligence, corporate confidential disclosures, and related legal activities.
* Reduced non-IP-related legal fees by 45% (compared to the previous year) by drafting and reviewing corporate contracts prior to submission to external counsel.
* Coordinated the drafting and release of corporate communications such as press releases, product brochures and marketing material. Managed corporate website; established anonymous employee hotline for reporting.
* Oversaw the filing and management of patent applications. As of 2011, the company had >35 U.S. patents.
* Generated Intellectual Property valuation analyses, which included modeling of potential royalty revenues derived from issuance of patent claims. This enabled the company to attract a prominent law firm to assist in licensing and perform infringement prosecution in return for a percentage of future revenues.
* Issued patent claims resulting in claim sets that ensured competitors obtained commercialization licenses in the Myostatin Growth Factor field. Patents also ensured the "Freedom to Operate" in commerce.
* Met with scientists on regular basis to determine if new patentable discoveries existed and to strategize on obtaining future patentable subject matter.
Vice President of Business Development
May 2001 to Sept. 2004
Executed licensing, collaborative research and development agreements, asset purchase agreements, joint ventures, and relevant sponsored research and consulting arrangements. Identified product opportunities in the development of the company's technology platforms. Managed team of 3 and all external counsel relationships.
* Prepared and presented financial forecasts and managed capital budget expenditures. Tracked individual project budgets and monitored cost effectiveness of overall product development.
* Negotiated and executed a number of agreements to secure company's position as an industry leader in Growth Factor technology development, which included: a Cross License Agreement with Wyeth Pharmaceuticals (now part of Pfizer) for Growth Factors; an Option Agreement with Merck for licensing of Growth Factors inhibitor technology; Cargill, Monsanto and Merial Collaboration Agreements pertaining to the use of genomic sequence information to identify informative SNPs for use in development of diagnostics; a Joint Venture Agreement with Willmar; and a Sponsored Research Agreement with Johns Hopkins University for research pertaining to the company's lead Growth Factor.
* Licensed enabling delivery system technology from Embrex, the world's largest supplier of vaccination equipment to the food industry.
* Served as technical expert during investment road shows in the U.S. (Wall Street) and internationally (Geneva, Zurich, Amsterdam, London, Paris), securing angel and convertible debt offerings which funded the company until profitability. Represented corporate business and technology at local and international conferences, trade shows, and meetings.
Director of Product Development
Nov. 1998 to Apr. 2001
Responsible for supervision of company research activities in addition to management of the Company intellectual property portfolio (35 issued U.S. patents) and licensing activities. Generated corporate business and marketing plans for all products in development.
* Established CRADA with the USDA to generate transgenic animals for the determination of production efficiency from use of proprietary company peptides.
* Licensed technology from Avigenics, Inc. and from the University of Texas for internal research program to introduce gene knockout technology in stem cells and primordial germ cells.
* Presented technical data to FDA on lead product. Enabled the company to obtain IND to begin clinical testing.
* Managed patent prosecution leading to issuance of patents pertaining to the use of Myostatin inhibitors to treat muscular degenerative disorders and increase muscle mass. Ultimately, these patents enabled the company to successfully negotiate a license with Pfizer/Wyeth due to the strength of the patent claim set.
R&D Transgenic Group Leader
Sept. 1997 to Nov. 1998
Managed external sponsored research collaborations and supervised internal research and development efforts, with a staff of 3 Ph.Ds. and one M.S.
* Managed the company review process of technology from local and international organizations that perform cloning and transgenic research. Coordinated "freedom to operate" analyses in these areas.
* Member of R&D Team that demonstrated the role of lead Growth Factor in novel therapeutic approach to treatment of diabetes and obesity. This discovery resulted in licensing of IP to Pfizer/Wyeth for human field, allowing the company to buy back majority of its stock.
NATIONAL INSTITUTES OF HEALTH
May 1995 to Sept. 1997
NIH Staff Fellow
National Institute of Mental Health (NIMH) Transgenic Core Facility
Generated transgenic mouse models to investigate the role of neurotransmitters, such as pro-opiomelanocortin (POMC) and dynorphin, in neurological development. Supervised a staff of 2 researchers.
NATIONAL INSTITUTES OF HEALTH
NIH Postdoctoral Fellow
May 1993 to Apr. 1995
National Institute of Neurological Disorders and Stroke (NINDS)
Postdoctoral studies involved the identification of Transforming Growth Factor-Beta family members involved in hematopoietic and immune cell regulation during the development of autoimmune disorders.
EARLY CAREER: Includes Biological Scientist and Laboratory Manager for the University of Michigan Medical Center; Medical Technologist Supervisor for the Department of Clinical Chemistry and Histology Lab; Medical Technologist at State University Hospital of New York at Stony Brook and founding member of Versaponents, Inc., a custom manufacturer specializing in metal fabrication for the lighting industry.
EDUCATION AND BOARD INVOLVEMENT
Ph.D. in Immunology and Molecular Pathology, University of Florida, Department of Medicine, Gainesville, FL, 1993
Completed graduate research work in the area of viral fusion proteins and epitopes critical for entry into host cells. Established cellular mechanisms required for activation and infectivity of EBV. Thesis: "Molecular analysis of the Epstein-Barr virus gp85 gene"
B.S., Biology; Medical Technology Certification State University of New York at Stony Brook - Stony Brook, NY
Board Participation: SFT, Board of Directors; Advanced Metrics, Advisory Board; Maryland Development Center Advisory Board
Full patent and publication list is available upon request.