ABOUT DIACARTA

President and CEO, Founder

Aiguo Zhang, Ph.D.

Dr. Zhang is an active entrepreneur and executive in the biotech and pharmaceutical industries with extensive experience ranging from startups to major corporations, including Panomics, Affymetrix and Bio-Rad. Dr. Zhang brings knowledge and an extensive network in Asia and Emerging Markets to his role at DiaCarta. His substantial experience in R&D management and capability building in Asia and Emerging Markets has a project scope ranging from discovery research to sales and marketing in both US and international markets. He received his Ph.D. from Simon Fraser University in molecular toxicology and pharmacology, was a postdoctoral scholar at the University of Massachusetts, and served as an assistant professor of research at the University of California, Berkeley. Dr. Zhang has published many research papers in leading scientific journals. His inventions are the subject of many patents and patent-pending applications.

Founder and Consultant

Paul Okunieff, M.D.

Dr. Paul Okunieff is board-certified in therapeutic radiology and is among the pioneers of in-vivo nuclear magnetic resonance imaging of tumors. Dr. Okunieff moved to the University of Florida in 2009 from the University of Rochester School of Medicine and Dentistry, where he served as Philip Rubin Professor in radiation oncology and chair of the department of radiation oncology. Prior to his appointment in Rochester in 1998, Dr. Okunieff served as the branch chief of radiation oncology at the National Cancer Institute and as an assistant professor in radiation oncology at Harvard Medical School between 1988 and 1993. Dr. Okunieff earned his medical degree from Harvard Medical School, where he also completed his postdoctoral fellowship in medicine and a fellowship in radiation medicine at Massachusetts General Hospital. He earned bachelor’s degrees in electrical engineering & computer science, and biological science from Massachusetts Institute of Technology. Dr. Okunieff serves as the radiation oncology chair for the Southwest Oncology Group, and a diplomat of the National Board of Medical Examiners where he serves on national committees overseeing the safety and quality of therapeutic radiation delivery.

CTO & Sr. VP of R&D

Michael Sha, Ph.D.

Dr. Sha is a highly recognized R&D leader with more than 20 years’ experience in molecular diagnostics. His R&D at previous companies has provided extensive opportunities to work with NGS and its application in liquid biopsy for cancer diagnostic, fetal cell diagnostics for NIPT, metagenomics, in vitro diagnostics/ companion diagnostic and bio-nanotechnology. Dr. Sha worked as the R&D director to lead and develop functional screening of uncultivable bacteria through microfluidic chip PCR and NGS at GALT Inc. His focus, work ethic, and drive have led multiple teams to receive numerous awards, over $3 million for CTC/ctDNA NGS and cardiac biomarkers POC projects for the Intensity Innovation Program through three years continually during working at Thermo Fisher Inc. He also worked as a senior staff scientist to lead molecular biology team for developing Chip PCR for NGS and CMOS-based Sequencing System at Illumina Inc. At Roche Diagnostics, Dr. Sha focused to discover biomarkers for the rare fetal cell from the maternal blood circulation for noninvasive prenatal diagnosis. Dr. Sha was a postdoctoral in HPV E6-mediated p53 protein degradation research at the school of medicine, UCSF. He holds ten patents and has published over fifty papers.

Senior VP, Business Development

Ramanathan Vairavan, Ph.D

Ram has more than 40 years experience in the clinical diagnostics industry. He worked for Hoechst Ag/Behring Diagnostics of Germany in the US, Germany & Singapore where held various positions in research, development, operation, international sales, marketing and executive management. He co-founded Autogenomics, a biotechnology company based in Carlsbad, CA, which developed and marketed an automated multiplexing microarray platform for molecular testing using novel biofilm chip technology to perform disease signatures through genomic and proteomic profiling with tests in the area of women’s health, genetic disorders, pharmacogenomics, cancer and infectious disease. He has extensive contacts with opinion leaders in the US and Europe and has set up distribution in about 30 countries in EU, Middle East, FE and SE Asia.

Senior VP of Companion Diagnostics

Hongjun (Harry) Yang, Ph.D.

Dr. Hongjun Yang currently serves as an SVP of Companion Diagnostics at DiaCarta, Inc. Dr. Yang is a well-established, passionate and dynamic executive in biomedical and pharmaceutical industry and academia with diversified multidisciplinary background and extensive experience in Research and Development management, technology innovation, corporate development, global business development and collaboration, long-term strategic planning, quality management system (QMS), clinical trial operation (IND, CTP, HGR), and compliance with the regulations (CLIA, CAP, GXP), chemical manufacturing control (CMC), commercialization and product launching in diagnostics, therapeutics, biopharmaceutical industries and specialized in precision medicine, biomarkers & diagnostics, public health, etc.

Dr. Yang has been served as an executive at multiple startup companies and institutes in both US and China. He was the original developer of electrochemiluminescence (ECL) technology and its instrumentation which is exclusively owned by Roche diagnostics. He is a pioneer for flow-thru DNA chip technology, an initiator of global human genome HapMap program, gene expression database, NGS platform design, biomarkers and companion diagnostics for precision medicine. Dr. Yang also initiated the growth and development of Zhangjiang Biopharma Park, Shanghai, China as well as the promotion for the international collaborations between China and West Countries. Prior to the current post, Dr. Yang served as a director of personalized Healthcare and biomarkers at AstraZeneca-China, then was promoted as an executive personalized healthcare strategy leader at AstraZeneca-Global due to his outstanding performance and delivery. Recently he joined DiaCarta as SVP of companion diagnostics and he is focused on the next generation of companion diagnostics to facilitate anti-cancer drug discovery and development, and the implementation of precision medicine.

Dr. Yang has been active in various professional organizations. He is a member of American Society of Clinical Oncology (ASCO), The European Society for Medical Oncology (ESMO); He also served on the board of director of China Society of Biotechnology (CSBT) and Chinese Biopharmaceutical Association (CBA). He is the founder and founding chairman of Precision Medicine Committee in CSBT.

QA/QR Executive

Michael Acosta

A Quality Assurance and Regulatory Affairs professional with over 40 years of experience in the biotech industries, including pharmaceutical, medical devices, biologics and in vitro diagnostics.  Effective in communicating and interacting with several domestic and international regulatory agencies in an ever changing regulatory environment.  Hands on executive level individual with extensive experience in start-up, small and large companies, advancing products from concept to commercialization.  Known to be extremely resourceful and able to facilitate and complete multiple projects in any situation.  Successful track record with U.S. & International regulatory inspections of implemented Quality Management Systems.

Vice President of External Affairs

Anne K. Vallerga, Ph.D., MBA

Anne Kathyrn Vallerga, M.A., Ph.D., M.B.A. has over 22 years of experience in bioproduct development, corporate strategy, mergers, acquisitions, and strategic business development, including identifying and out-licensing or in-licensing. This includes immunobiologics, small molecule pharmaceutical drugs, device and companion diagnostic technologies. Dr Anne Vallerga has successfully developed and subsequently sold or strategically partnered several late pre-clinical and clinical Phase I/II/III pharmaceutical and companion diagnostic assets to private and public companies. Dr. Vallerga has also successfully managed, both scientifically, financially, and operationally, a 100-million-dollar contract, 10 million-dollar-grant and several single- and double-digit multi-million-dollar collaborative therapeutic drug and device product development projects in diagnostics, medical devices, cancer, immunity, infection, allergy and regenerative medicine. Product successes have been achieved by Anne Vallerga in diagnostics/prognostics, early detection, and biomarker validation. This includes development and commercialization of an advanced instrumented diagnostic devices and reagent kit products that received US approvals and are in uses today. Dr. Vallerga also has led or been an important part of teams that developed lymphatic drug-delivery/diagnostic device systems for intratumoral or intralymphatic diagnostic and companion therapeutic products, for example used in combination with immunotherapy, radiotherapy and/or chemotherapy for cancer or other patients.  Dr. Vallerga previously led drug, diagnostic and device product development as President of Colby Pharmaceutical Company, Executive Vice President Pangene Corporation and was the Diagnostics Program Group Leader within SRI International (formerly Stanford Research Institute) Pharmaceutical Drug Development Division. She also was employed as an important member of the Stanford University Medical School Institutional Review Board (IRB). Dr. Vallerga trained in Molecular and Cell Biology and Physiology at the University of California-Berkeley and UC-San Francisco in the Departments of Molecular Cell Biology and Pharmaceutical Chemistry, respectively. Anne Vallerga also received an MBA (high academic distinction) with a focus on Healthcare Leadership from the Dominican University of California and completed Advanced Business training at the University of California-Berkeley in the BioExecutive Institute, Haas School of Business.

VP of Finance and Principle Financial Officer

Dennis Gao

Vice President, Sales

Jack Smith

Jack has more than 25 years of experience in the clinical diagnostics and pharmaceutical industry. He worked most recently at Guardant Health in the Colorectal Cancer Screening Division. Prior to Guardant Health he was the National Sales Director for Northwest Laboratories (Avero Diagnostics) which provided full-service laboratory testing.

He has served in many roles, including Vice President, Revenue Strategy at Bio-Reference Laboratories and Regional Vice President of Sales at Coronis Health.

He has built a strong foundation in laboratory management and sales through his varied experiences, including in-depth medical and molecular knowledge and expertise including oncology, infectious diseases, and non-invasive prenatal testing.

Vice President of Regulatory

King Lee, Ph.D.

Dr. King Lee is serving as the Executive Director of Regulatory Affairs at Brightech International and Vice President of Regulatory Affairs of Axella Research. Both companies have been jointly working on numerous projects since 2015. Prior to that, Dr. Lee was the Vice President of Regulatory and Clinical Affairs for Cornerstone Pharmaceuticals, Inc., a company that develops novel anti-cancer agents such as Altered Energy Metabolism-Directed (AEMD) compounds that affect tumor-specific pyruvate dehydrogenase complex (PDC), since 2004. Dr. Lee was also an independent consultant to a number of companies, including ExSAR Corporation and ZYWIE LCC, providing regulatory affairs services in the development of new products for the treatment of metabolic diseases such as Tay-Sachs disease and Gaucher’s Disease. Dr. Lee is also a consultant to Pars Pharmaceuticals, which a CRO providing various services to pharmaceutical companies. Previously, he was the Vice President of Regulatory Affairs for Acorda Therapeutics, Inc. Prior to Acorda during the years 2001-2003, Dr. Lee was Executive Director of Regulatory Affairs/Quality Assurance for ATON Pharma, Inc. (acquired by Merck), and worked with drugs such as ZOLINZA™ (vorinostat) which was approved by the FDA in 2006 for the treatment of cutaneous T-cell lymphoma. Prior to ATON, Dr. Lee was the Director of Regulatory Affairs/Quality Assurance for VION Pharmaceuticals, Inc. from 1996 to 2001, responsible for Regulatory Affairs, preclincal and clinical assessments of several types of oncology products including ribonucleotide inductase inhibitors, novel alkylating agents, and biologics. He was the Manager of Regulatory Affairs/Clinical Affairs for IBEX Technologies, Inc. from 1993 to 1996, responsible for an IND and clinical development of hematological products. Prior to IBEX, Dr. Lee was with Sterling-Winthrop from 1987 to1993, where he was involved with several INDs that led to NDAs and FDA approval of drugs such as congestive heart failure products including Primacor (milirinone) and MRI contrast agents including Omniscan™ (gadodiamide). Dr. Lee began his career in the pharmaceutical industry at Wyeth in 1985. He has been an adjunct professor at Quinnipiac University since 2006, and from 1982 to 1983 was a part-time faculty member of Eastern Kentucky University. Dr. Lee has authored and co-authored over 40 publications (scientific and professional papers, books and review articles) and numerous scientific abstracts. Dr. Lee received his Ph.D. in Pharmacology from the College of Medicine of the University of Kentucky in 1983 and was certified by the Regulatory Affairs Professionals Board in 1994.

Vice President of Product Management and Marketing

Wei Liu, Ph.D., MBA

Wei has worked in research, product management, and marketing roles over his career in both big (Bio-Rad and Thermo Fisher Scientific) and small companies. He has marketed products in bio-research, environmental analysis, and molecular diagnostics fields, holding global and Asia-pacific marketing roles. Wei has earned his Ph.D. from the University of Illinois at Chicago and his MBA from the Hass School of Business, University of Berkeley. He has 14 publications and 4 patents.

Vice President, Clinical Affairs

Zheng Li, MBBS, MS

Experienced leader and Clinical Laboratory (CAP-accredited) Director with over 20 years of molecular diagnostics industry, with in-depth medical and molecular knowledge and expertise, including companion diagnostics, oncology, infectious diseases, non-invasive prenatal testing, and biomarker strategy. Strong hands-on knowledge in product development processes and quality management systems, from basic research to manufacture, FDA, and CLIA regulations. His previous positions consist of executive roles at various leading liquid biopsy/precision medicine companies such as Guardant Health and Predicine, as well as senior management positions in fortune 500 companies, Thermo Fisher, Siemens, and Novartis, etc. He had more than 10 patents and over 20 publications.

CLIA Lab Director

C. Mark Lu, M.D.

Dr. Lu is a board-certified Clinical Pathologist and Hematopathologist. He studied at Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China. He was trained at Beijing University Health Science Center, UC San Diego and Harvard University before joining UC San Francisco faculty in 2003. Currently he is the Vice Chairman of Department of Laboratory Medicine, UC San Francisco. Dr. Lu has published more than 70 peer-reviewed articles, and authored the popular «Guide to Diagnostic Tests» (2007, 2012, 2017), which has been translated into seven non-English languages. He contributes to the «Current Medical Diagnosis & Treatment» (2010-2020 eds), and five other medical textbooks. Dr. Lu represents the American Society of Hematology on the Editorial Board of the Lab Tests Online (http://labtestonline.org) , a worldwide and free online resource for the general public on medical diagnostic tests

General Manager, Asia Pacific

Effie Ho, Ph.D., MBA

Effie brought in more than 15 years industrial experience to the company including many years at J&J and Pfizer. Specialized in drug and medical device’s business development strategies and RA/Clinical Development execution in emerging healthcare markets horizontally (strategy planning, RA and Clinical planning, local partner, raising capital, execution clinical planning , regulatory approval and vertically (execution of clinical development in China, Taiwan, Korea, HK) with proven records from IP to products. Obtained M.B.A. from Penn state University, PA, USA; Postdoc at Harvard Medical School, Boston, MA, Obtained PhD from Rutgers University, NJ, USA.

Sr. Director, BD & Clinical (EU)

Dr Mauro Scimia

Mauro has a master’s degree in Medicine, from the University of Rome, School of Medicine. Mauro also learned Biostatistics, Regression Analysis, Clinical trials design and implementation at John Hopkins University through Coursera. Other education background includes several management courses like finance, marketing, leadership, and conflict resolution at various career stages. Past experiences include the following: International Marketing Manager for Menarini Diagnostics in Europe; Marketing Manager for Glaxo Pharmaceuticals in the Middle East; Country Manager Italy for NeuroMedical Systems and for Hologic; European Manager for Third Wave Technologies; HPV PapilloCheck Consultant Italy for Greiner BioOne; European Manager and Board Director for Cytocore; Reginal Business Director for Exact Sciences, Europe; Currently Strategic and Business Development for DiaCarta.

Chairman of the Audit Committee

Jack Kaye

Jack Kaye joined the DiaCarta board on April 1, 2022, and will serve as Chairman of the Company’s audit committee. He currently serves on the boards of  Dyadic International, Inc. (since February 2015) and UniQure B. V. where he has served since May 2016. At both companies, he serves as chair of the audit committees and as a member of their compensation committees. Mr. Kaye’s prior board service includes Keryx Biopharmaceuticals Inc., a position he has held from 2006  to May 2016 and he was also a member of their nominating and governance committee.  He also served on the boards of  Tongli Pharmaceuticals (USA) Inc. and Balboa Biosciences, Inc., where he served as Chairman of both audit committees.  Mr. Kaye was selected to participate on several dissident board slates which included the Astellas, Inc./OSI, Roche Pharmaceuticals, Inc./Illumina, and the Horizon, Inc./Depomed hostile M&A transactions. Mr. Kaye was a partner at Deloitte & Touché LLP from 1978 until May 2006, when he retired. At Deloitte, Mr. Kaye was responsible for serving a diverse client base of public and private, global, and domestic companies in a variety of industries. Mr. Kaye has extensive experience consulting with clients on accounting and reporting matters, private and public debt financings, SEC rules and regulations, and corporate governance/ Sarbanes-Oxley issues. In addition, he has served as Deloitte’s Tristate liaison with the banking and finance community and assisted clients with numerous merger and acquisition transactions. Mr. Kaye served as Partner-in-Charge of Deloitte’s Tri-State Core Client practice, a position he held for more than twenty years. He earned a B.B.A. from Baruch College of the City University and is a Certified Public Accountant.