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Team

Management

David Clements, M.S.

Managing Officer - Vaccines

Alan Johnson, Ph.D.

Managing Officer - Chemistry

Marcia McKinnon

Managing Officer - Finance

Sean O’Malley, Ph.D.

Principal Scientist

David has over 35 years of experience in molecular biology and the development of recombinant protein expression systems at Hawaii Biotech. He has worked on a variety of projects involving molecular genetics and has extensive experience in the expression of recombinant proteins in heterologous host cell systems. He has been actively involved in the development of Hawaii Biotech’s recombinant subunit vaccine platform, utilizing a stable insect cell expression system. For over 15 years, he has been responsible for the development of the necessary cell lines and large-scale cell culture processes needed for cGMP production of the dengue and West Nile virus vaccines. This includes production of pilot lots suitable for toxicology studies, tech-transfer to GMP manufactures and oversite of upstream and downstream operations. In addition to his role in cGMP manufacture, he has also have been involved in the preparation of pre-IND and IND packages for the dengue, West Nile and Zika vaccines. He has been Principal Investigator on several SBIR grants directed towards the development of recombinant subunit vaccines for malaria, Tick-borne flaviviruses, Crimean-Congo hemorrhagic fever, Chikungunya, and SARS 1 and 2. He received his degree in Biochemistry from the University of Hawaii at Manoa, where his studies focused on the molecular genetics of toxin production in plant pathogenic bacteria.
Alan has been the Director of Chemistry at Hawaii Biotech Inc since 2013. Previously, he was the Director of Chemistry at PanThera Biopharma, a Hawaii Biotech spin-off. He has been the Principal Investigator for several NIH grants and contracts involved with the discovery and development of small molecule therapeutics to treat infectious diseases. He was a Group Leader at X-Ceptor Therapeutics, where he focused on the discovery of small molecule modulators of the nuclear receptor LXR to treat metabolic disease. He began his professional career at Allergan Inc. working in the area of the nuclear receptors. At Allergan, his work led to the identification of RAR subtype specific agonists and antagonists. He has coauthored numerous articles in the area of organic and medicinal chemistry and is a coauthor on multiple issued patents. He obtained his B.A. in chemistry at UC San Diego and his Ph.D. in synthetic organic chemistry from Oregon State University, before completing an NIH post-doctoral fellowship at the University of Rochester.
With four decades of experience in finance and accounting, Marcia McKinnon now serves as Hawaii Biotech’s Managing Officer - Finance. Since joining the company in 2006 as a Senior Accountant, she has advanced through key leadership roles, including Accounting Manager and Controller, demonstrating expertise in financial reporting, compliance, internal controls, and strategic financial planning. In her new role, Marcia oversees financial operations, treasury management, budgeting, and regulatory compliance, ensuring adherence to GAAP and federal contractor cost accounting standards (CAS). She also leads the finance team, driving efficiency and transparency in financial processes. Marcia holds a Bachelor of Science in Accounting from the Rochester Institute of Technology and has a diverse background in accounting, tax, and financial management. Known for her leadership, integrity, and dedication, she continues to play a pivotal role in Hawaii Biotech’s financial success.
Sean has nearly 30 years of experience in synthetic organic and medicinal chemistry, rational drug design, and molecular modeling. He has supervised high-throughput docking, screening, analytical, biochemical, and hit-to-lead and lead optimization medicinal chemistry activities with a team of scientists at Hawaii Biotech, as a program supervisor in a matrix management context. In addition, he has overseen external CRO activities including: ADME assays, PK and tox studies; animal efficacy studies, model development, and optimization and implementation of scale-up process chemistry methods for bulk syntheses of key investigational compounds.  He has served as Principal Investigator on multiple NIAID grants and DoD contracts. Current and past projects include work in biodefense antitoxin therapeutics, antibody-directed enzyme-activated anticancer and antifungal prodrug design, and immunoassays. He holds a BA in Chemistry from the University of Virginia and a Ph.D. in Organic Chemistry from the University of Texas at Austin.

David Clements, M.S.

Managing Officer - Vaccines

Alan Johnson, Ph.D.

Managing Officer - Chemistry

David has over 35 years of experience in molecular biology and the development of recombinant protein expression systems at Hawaii Biotech. He has worked on a variety of projects involving molecular genetics and has extensive experience in the expression of recombinant proteins in heterologous host cell systems. He has been actively involved in the development of Hawaii Biotech’s recombinant subunit vaccine platform, utilizing a stable insect cell expression system. For over 15 years, he has been responsible for the development of the necessary cell lines and large-scale cell culture processes needed for cGMP production of the dengue and West Nile virus vaccines. This includes production of pilot lots suitable for toxicology studies, tech-transfer to GMP manufactures and oversite of upstream and downstream operations. In addition to his role in cGMP manufacture, he has also have been involved in the preparation of pre-IND and IND packages for the dengue, West Nile and Zika vaccines. He has been Principal Investigator on several SBIR grants directed towards the development of recombinant subunit vaccines for malaria, Tick-borne flaviviruses, Crimean-Congo hemorrhagic fever, Chikungunya, and SARS 1 and 2. He received his degree in Biochemistry from the University of Hawaii at Manoa, where his studies focused on the molecular genetics of toxin production in plant pathogenic bacteria.
Alan has been the Director of Chemistry at Hawaii Biotech Inc since 2013. Previously, he was the Director of Chemistry at PanThera Biopharma, a Hawaii Biotech spin-off. He has been the Principal Investigator for several NIH grants and contracts involved with the discovery and development of small molecule therapeutics to treat infectious diseases. He was a Group Leader at X-Ceptor Therapeutics, where he focused on the discovery of small molecule modulators of the nuclear receptor LXR to treat metabolic disease. He began his professional career at Allergan Inc. working in the area of the nuclear receptors. At Allergan, his work led to the identification of RAR subtype specific agonists and antagonists. He has coauthored numerous articles in the area of organic and medicinal chemistry and is a coauthor on multiple issued patents. He obtained his B.A. in chemistry at UC San Diego and his Ph.D. in synthetic organic chemistry from Oregon State University, before completing an NIH post-doctoral fellowship at the University of Rochester.

Marcia McKinnon

Managing Officer - Finance

Sean O’Malley, Ph.D.

Principal Scientist

With four decades of experience in finance and accounting, Marcia McKinnon now serves as Hawaii Biotech’s Managing Officer - Finance. Since joining the company in 2006 as a Senior Accountant, she has advanced through key leadership roles, including Accounting Manager and Controller, demonstrating expertise in financial reporting, compliance, internal controls, and strategic financial planning. In her new role, Marcia oversees financial operations, treasury management, budgeting, and regulatory compliance, ensuring adherence to GAAP and federal contractor cost accounting standards (CAS). She also leads the finance team, driving efficiency and transparency in financial processes. Marcia holds a Bachelor of Science in Accounting from the Rochester Institute of Technology and has a diverse background in accounting, tax, and financial management. Known for her leadership, integrity, and dedication, she continues to play a pivotal role in Hawaii Biotech’s financial success.
Sean has nearly 30 years of experience in synthetic organic and medicinal chemistry, rational drug design, and molecular modeling. He has supervised high-throughput docking, screening, analytical, biochemical, and hit-to-lead and lead optimization medicinal chemistry activities with a team of scientists at Hawaii Biotech, as a program supervisor in a matrix management context. In addition, he has overseen external CRO activities including: ADME assays, PK and tox studies; animal efficacy studies, model development, and optimization and implementation of scale-up process chemistry methods for bulk syntheses of key investigational compounds.  He has served as Principal Investigator on multiple NIAID grants and DoD contracts. Current and past projects include work in biodefense antitoxin therapeutics, antibody-directed enzyme-activated anticancer and antifungal prodrug design, and immunoassays. He holds a BA in Chemistry from the University of Virginia and a Ph.D. in Organic Chemistry from the University of Texas at Austin.

Board of Directors

Debra Beresini
Director

Debra is an experienced leader, manager, investor, and entrepreneur. In 1997, she co-founded invencor, inc. based in the San Francisco Bay Area, and has since served as its CEO. Over the years, invencor has managed debt and equity funds and consulted with lending institutions on credit facilities for startup companies. While invencor continues to serve in that role, its primary focus is to support women entrepreneurs and those rising through the ranks of their companies. In 2013, Debra was named one of the “100 Most Influential Women in Silicon Valley” by the Silicon Valley Business Journal. She was on the Board of Trustees for VentureCapital.org (VCO) for 17 years with 5 of those years as Chair. During her time at VCO, she and the team founded WeROC (Women Entrepreneurs Realizing Opportunities for Capital). Through VCO, women are coached on their presentation skills in order to raise money from investors at the WeROC conferences. She was previously Senior Vice President and Manager of the National Division at Silicon Valley Bank. She graduated Summa Cum Laude from Dominican College (now Dominican University) and has an MBA from the Jack Welch Management Institute, Strayer University.

Debra also runs a family-owned vineyard, Beresini Winery, with her husband, Steve, in Carneros, Napa producing Pinot Noir, Chardonnay, and Pinot Noir Rose. Recently, they opened a Winery and Tasting Room for their award-winning wines in Glen Ellen, California.

Mark Bogart. Ph.D.
Director

Mark is a highly successful biotech entrepreneur. He discovered and commercialized a key part of the maternal serum triple test for Down’s Syndrome carried out on pregnant women. The test became part of the standard of care for pregnant women in the first world. Dr. Bogart is an investor in over a dozen biomedical and technology companies and has served on the Boards of Genetic Information Management Systems, Kuehnle Agrosystems, Kona Blue Water Farms, and Hawaii Biotech, Inc. He did his post-doctoral training in Genetics at UCSD and is Board Certified in Clinical Cytogenetics by the American Board of Medical Genetics and was a founding member of the American College of Medical Genetics. During his academic career in clinical and research genetics Dr. Bogart published over 50 scientific articles and received three patents. Transitioning from academics to business he started a patent management and licensing company (Biomedical Patent Management Corp.) and a diagnostic genetics laboratory (Mid-Pacific Genetics) which was subsequently sold to the Queen’s Medical Center in Honolulu. He has served on a number of State committees and non-profit Boards in both California and Hawaii. He received a BA from the University of California, San Diego (UCSD) and a PhD in a joint program between UCSD and San Diego State University.

Michele Yelmene
Director

Michele has over 35 years of hands-on biotech and pharmaceutical industry experience in all aspects of drug development from bench research and clinical trial design through product registration and post marketing activities. Her breadth of experience includes the submission of over 100 INDs with 18 drugs/biologics achieving domestic and international regulatory marketing approval.

She has designed, conducted, and reported global clinical studies in a wide variety of therapeutic areas, including infectious diseases, metabolic and endocrine disorders, and oncology. She has also implemented and overseen Quality Systems and manufacturing for Phase 1 through commercial launch of new drugs and biologics in addition to preparing for and hosting inspections by FDA and other regulatory authorities.

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