Linda Marbán, Ph.D.
Chief Executive Officer and Director
Dr. Marbán is currently serving as our Chief Executive Officer, and has served in that capacity and on the Board since November 2013. As co-founder of Capricor, Inc., our wholly-owned subsidiary, Dr. Marbán has been with Capricor, Inc. since 2005 and became its Chief Executive Officer in 2010. Dr. Marbán has been in the biotechnology field for more than 20 years and brings extensive experience across research, product development and business development to the Company.
From 2003-2009, Dr. Marbán held various senior roles at Excigen, Inc., a gene therapy biotechnology company, where she was responsible for operations and business development and where she oversaw the development of a biologic pacemaker for the heart. Prior to Excigen, Dr. Marbán worked in academic science, first at the Cleveland Clinic Foundation working on the development of contractile dysfunction in heart failure due to myocarditis, followed by a postdoctoral fellowship at Johns Hopkins University. While at Johns Hopkins, she advanced to the rank of Research Assistant Professor in the Department of Pediatrics, specializing in the mechanism of the biophysical properties of cardiac muscle. Her tenure at Johns Hopkins ran from 2000 through 2003.
Dr. Marbán earned a Ph.D. from Case Western Reserve University in cardiac physiology and her Bachelor of Science from the University of Maryland.
Kristi A. H. Elliott, Ph.D.
Chief Science Officer
Dr. Elliott joined Capricor in 2021 and serves as our Chief Science Officer where she oversees Capricor’s exosome platform and pipeline development. She has over 15 years of experience in biotechnology combining her extensive stem cell knowledge and expertise in exosome platform development. As an innovator in the exosome field, Dr. Elliott has been involved in the conception and implementation of exosome purification, scale-up, loading and targeting processes for multiple exosome-based product candidates.
Prior to her role as Vice President of Research and Development, Dr. Elliott served as a Technical Advisor in Business Development and Strategy for Exotech Bio and AD Skincare; both joint ventures between Harvest Capital Strategies and Intrexon Corp., focused on exosome therapeutics. Prior to this role, Dr. Elliott held various roles at Intrexon Corp., including Senior Director of Stem Cell and Exosome Development and Director of the Human Therapeutics Division. During her tenure at Intrexon, she managed a cross-functional team including operations, bioinformatics, engineering, and research and development. She was responsible for multiple primary and stem cell therapeutics and exosome-based research programs from concept through the development of IND-enabling studies. Dr. Elliott held several other roles in small biotechs focused on stem cell technologies and began her career as a stem cell specialist at the University of California, Irvine.
Dr. Elliott received her B.A. in biology and M.S. in molecular biology from Rutgers University. She earned her Ph.D. in human genetics and molecular biology from The Johns Hopkins School of Medicine.
AJ Bergmann, M.B.A.
Chief Financial Officer
Mr. Bergmann has served as our Chief Financial Officer since 2018 and has been involved in the biotechnology industry for over a decade. He also serves as the Company’s corporate treasurer. Mr. Bergmann joined Capricor, Inc. in 2011 and held various roles of increasing responsibility throughout his tenure. Prior to joining Capricor, Inc., Mr. Bergmann had experience in accounting, finance and operations management of companies ranging in size from start-ups to mid-size companies.
Prior to Capricor, Inc., he was with the business management firm, Gettleson, Witzer, and O’Connor, in Beverly Hills, California, where he focused on accounting and finance for several production studios generating motion picture releases and worldwide revenue that exceeded $1 billion. The firm’s clients included international foundations, actors, writers, producers and directors across the entertainment industry. While at the firm, he focused on asset management, budgeting and tax forecasting. Earlier in his career, Mr. Bergmann served in financial positions in various industries. During his time at Capricor, Mr. Bergmann coordinated the Company’s reverse merger and subsequent uplisting to the Nasdaq Capital Market and has completed equity financings yielding over $100 million, to date. Mr. Bergmann oversees the Company’s finance, accounting and human resource functions.
Mr. Bergmann graduated from Providence College with a Bachelor of Science degree in Management and a minor in Finance. He has an M.B.A. from the University of Southern California’s Marshall School of Business. He is actively involved in various venture capital and entrepreneurial associations throughout the Southern California area.
Karen G. Krasney, J.D.
Executive Vice President and General Counsel
Ms. Krasney has served as our Executive Vice President, Secretary and General Counsel since 2012. Ms. Krasny’s career spans over 40 years serving as general counsel for numerous corporations and private companies engaged in a wide variety of industries. Her extensive background and vast experience has been focused on domestic and international corporate and business law, as well as litigation. Ms. Krasney has been involved in the medical technology arena since the mid 1990s, representing several medical technology companies developing products for the treatment of cardiovascular disease. Commencing in 2002,
Ms. Krasney served as legal counsel for Biosensors International Group Ltd., a multinational medical device company that developed, manufactured and sold medical devices for cardiology applications. In 2006, she accepted the position of General Counsel and Executive Vice President of Biosensors and served in that capacity until 2010. During her tenure at Biosensors Ms. Krasney, among other things, headed the legal team that facilitated the company’s successful initial public offering in Singapore and was responsible for negotiating and documenting all agreements for the company worldwide, including licensing agreements with major medical device companies and agreements required for the company’s international clinical trials. During her tenure at Capricor, Ms. Krasney has been responsible for overseeing all legal matters involving the Company including, business transactions, corporate governance, and intellectual property and has played an integral role in all transactional matters involving the Company. Ms. Krasney also serves as a director on the board of Cardiovascular Research Foundation, a non- profit research and education entity, and as a director for a private non-profit charitable foundation.
Ms. Krasney received her Bachelor of Arts degree from the University of California, Los Angeles and her Juris Doctorate from the University of Southern California.
Vice President of Quality
Ms. Shad joined Capricor in 2022 serving as our Vice President of Quality where she oversees all facets of Quality Assurance and Quality Control for Capricor’s product pipeline. She has approximately 20 years of experience in managing quality functions with a demonstrated history of working through all phases of clinical development for multiple cell and gene therapy products focused on quality systems implementation and development, GMP facility operations, and regulatory submissions.
Prior to her role as Vice President of Quality, Ms. Shad served as Executive Director, Clinical Quality, Site Head for Kite Pharma, a Gilead Company, where she focused on leading the sites for autologous and vector manufacturing. She led clinical trial stage quality functions including but not limited to quality systems, quality operations, quality engineering, LIMS, QC analytical, QC microbiology, and sample management. Additionally, prior to this role, Ms. Shad held various roles at the City of Hope National Medical Center concluding her time there as Senior Director, Office of Quality Systems. During her tenure at City of Hope, she was responsible for the quality management of GMP facilities and oversaw all GXP activities for multiple biologics. Her early career was built off a foundation of science where she served as a Research and Development Chemist and Research Scientist.
Ms. Shad received her B.S. and M.S. in Biochemistry from Laurentian University and the University of Guelph in Ontario, Canada, and later went on to obtain an additional M.S. in Regulatory Affairs from San Diego State University. She is an active member of the Regulatory Affairs Professional Society (RAPS), Parenteral Drug Association (PDA), and American Society for Quality (ASQ).
Vice President of Clinical Operations
Mr. Awadalla joined Capricor in 2023 serving as our Vice President of Clinical Operations overseeing all aspects of clinical trial execution for Capricor’s clinical-stage programs. Mr. Awadalla comes to Capricor with over 20 years of experience in clinical development, clinical operations and data management. Mr. Awadalla specializes in cell therapy clinical trials across multiple therapeutic areas including oncology, inflammation, degenerative and rare diseases.
Prior to joining Capricor, Mr. Awadalla served as Vice President of Research and Development and Head of Clinical Operations for Celularity Inc. where he oversaw the company’s clinical portfolio by designing and executing multiple clinical trials. During his tenure at Celularity, the company cleared multiple INDs and received Fast Track and Orphan Drug Designations for their allogeneic cellular therapy products in hematology, oncology and degenerative diseases. Prior to Celularity, Mr. Awadalla was the Executive Director of Clinical Operations at Mustang Bio where led the clinical operations team in successfully clearing INDs and initiating their first clinical trial with their autologous cell therapy product. Mr. Awadalla also held positions of increasing responsibility in global clinical operations at Celgene. At Celgene, Mr. Awadalla played an integral role in the execution, management and submission of global clinical trials which led the NDA approval of Otezla®, a drug for the treatment of psoriasis and psoriatic arthritis. The worldwide rights to Otezla® were eventually acquired by Amgen for approximately $11.2 billion.
Mr. Awadalla received his Bachelor of Science in Biochemistry/Molecular Biology from the Richard Stockton University of New Jersey.
Minghao Sun, Ph.D.
Vice President of Research and Product Development
Dr. Sun joined Capricor in 2021 and is currently serving as our Vice President of Research and Product Development where he oversees Capricor’s exosome platform and pipeline development as well as process development for CAP-1002. He has approximately 15 years of experience in biotechnology combining his extensive molecular and virology knowledge with multiple years of expertise in exosome research. As an innovator in the exosome field, Dr. Sun has focused on the design of exosome engineering constructs, loading, targeting and manufacturing for multiple exosome-based product candidates.
Prior to joining Capricor, Dr. Sun served as the Head of In Vitro Pharmacology (IVP) at Wuxi AppTec, a global pharmaceutical company, where he oversaw the IVP activities, strategy as well as initiated new business opportunities to drive the revenue growth. Prior to joining Wuxi AppTec, Dr. Sun was Director of Stem Cell Research at TransOva Genetics, a global leader in reproductive technology. Prior to that, he worked at Intrexon Corp., where he held positions of increasing responsibility, including, antibody discovery, stem cell research, and managing multiple exosome-related programs leading to multiple product candidates where he was head and general manager of their San Diego site.
Dr. Sun received his B.A. in Virology and M.S. in Medical Virology from Wuhan University, China. He then earned his Ph.D. in Pathobiology from Penn State University and completed his postdoctoral training in oncology in Dr. Peter Vogt’s lab at Scripps Research Institute in San Diego, California.
Yushi Feng, Ph.D.
Vice President of Regulatory Affairs
Dr. Feng joined Capricor in 2023 serving as our Vice President of Regulatory Affairs overseeing all global regulatory strategy for our DMD program as well as our exosome platform. Dr. Feng brings over 17 years of regulatory experience from both industry and the FDA, with an expansive career focusing on oncology, neurology, rare and infectious diseases as well as CMC (Chemistry Manufacturing and Controls) experience spanning multiple disciplines with extensive experience in manufacturing and quality systems.
Prior to Capricor, Dr. Feng was Vice President of Regulatory Affairs at Codiak BioSciences, where he shepherded multiple successful industry-first regulatory filings on exosome-based therapeutics in the U.S. and United Kingdom. Earlier in his career, Dr. Feng was with Wave Life Sciences advancing the use of oligonucleotides for rare neurodegenerative diseases including Duchenne muscular dystrophy and Huntington’s disease. Prior to Wave, Dr. Feng served as a chemistry reviewer at the FDA covering infectious diseases, ophthalmology and transplant. Prior to that, Dr. Feng explored the functions of formulation and analytical development at Eli Lilly Company and Vertex Pharmaceuticals.
Dr. Feng received his Ph.D. in Pharmaceutics from the University of Minnesota and received his undergraduate degree at Ocean University of China.