Lacerta Therapeutics

ABOUT LACERTA

Founded in 2017, Lacerta has just opened a brand-new R&D laboratory facility custom built to our specifications in the heart of Alachua, Florida. We invite you to take a look at our team and our work to see our continued growth–and what the future promises.

EDGAR Rodriguez, PhD

CEO & CSO

Edgar Rodriguez, PhD
CEO and CSO

Dr. Edgardo Rodriguez-Lebron is one of Lacerta’s co-founders and has actively guided Lacerta as scientific advisor, Chief Scientific Officer, Chairman of the Board and now Chief Executive Officer.

Dr. Rodriguez-Lebron brings over two decades of research experience and entrepreneurial leadership to Lacerta. His research on Huntington’s disease, spinocerebellar ataxias and other neurodegenerative diseases has been funded by the NIH and multiple foundations. He has also secured tens of millions of dollars in non-dilutive funds to fuel Lacerta’s growth and commitment to finding a cure for rare CNS diseases. His ongoing affiliation with the University of Florida keeps him on the cutting edge of scientific discoveries.

Dr. Rodriguez-Lebron holds multiple patents in AAV technology and degrees in Molecular Biology from the University of Central Florida and a Ph.D. in Neuroscience from the University of Florida. An active contributor to the gene therapy community, he is an ASGCT member and serves as the CSO of NF2Biosolutions, a nonprofit focused on the development of a gene therapy approach to neurofibromatosis type 2 (NF2). He has co-founded and helped launch multiple startups in the Gainesville, Florida area. A Florida Gator at heart and by degree, Dr. Rodriguez-Lebron can be found cheering on the home team most fall weekends.

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Darin Falk, PhD

VP, Head of Gene Therapy Programs

Darin Falk, PhD
VP, Head of Gene Therapy Programs

Dr. Falk received his PhD and post-degree training at the University of Florida (UF). During his time as faculty in the UF Department of Pediatrics, he worked closely within the Powell Gene Therapy Center to develop AAV-based gene therapies for neuromuscular diseases. These activities were supported by funding from the National Institutes of Health, Department of Defense, Muscular Dystrophy Association and Children’s Miracle Network. His research has focused on the development of AAV therapies for over 13 years. In his current role as the Head of Gene Therapy Programs at Lacerta, Darin leads development and preclinical activities focused on AAV gene therapies for Lacerta’s therapeutic pipeline.

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Shyam Gajavelli, PhD

Director, Pre-Clinical Technology

Shyam Gajavelli, PhD
Director, Pre-Clinical Technology

Dr. Shyam Gajavelli brings over two decades of pre-clinical research experience in neurotrauma with viral vectors for gene therapy, cell transplantation, biomarkers, and histological assessments in identifying immunological factors that promote or inhibit neurological repair. He has previously managed state, federal and industry-funded projects—including those from the Department of Defense at the Miami Project to Cure Paralysis at the University of Miami. He brings broad research interests with expertise in animal virology and a particular focus on developing effective gene therapy-based strategies to both mitigate trauma induced cognitive and motor deficits and enhance neural regeneration.

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Shannon Wilson, MBA

Controller

Shannon Wilson
Controller

Shannon Wilson has over 13 years of experience in Accounting & Finance. She started her career in public accounting as an auditor, where she conducted financial audits of various industries. She has extensive experience in financial reporting and in federal and state compliance. Prior to joining Lacerta, Shannon was the Director of Finance for a local school district. She helped manage a budget of more than $100 million, including federal and state grants, allocated across eighteen schools and twenty departments. She was also in charge of the preparation and submission of annual financial reporting to the Department of Education, School Board, and State Auditor General’s Office. She received her MBA with a concentration in Accounting from Saint Leo University.

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Board of directors

Jackson Streeter

Director and Chairman

Dr. Streeter was the CEO and Executive Director of the Florida Technology Seed Capital Fund, a seed stage venture fund investing in companies commercializing technologies developed from State of Florida Universities, Colleges or Research Institutes. Since inception, the fund has created over 50 companies with private investment matching Florida state funding at a 9:1 ratio and having over $1.2 billion in economic impact for the State of Florida.
Dr. Streeter served as the CEO of Banyan Biomarkers San Diego, CA. During his time, the company received over $110M in contracts and grants with the NIH and Department of Defense and raised $20M in private capital for the development of a first ever blood test for traumatic brain injury from technology developed at the McKnight Brain Institute at UF. The Banyan brain injury test received FDA clearance on 14 February 2018.
Prior to serving as CEO of Banyan Biomarkers, Dr. Streeter founded and served as CEO and CSO for PhotoThera, Inc. where he raised over $120 million in private capital and was responsible for the design and management of five U.S. and international clinical trials for the treatment of strokes. He was also the co-founder of American Veterinary Laser which was acquired in a private transaction.
Dr. Streeter is the inventor of over twenty patents and author on multiple scientific publications. Dr. Streeter has served on the following boards and executive committees: Florida Research Consortium, Governor’s Life Science Task Force for the State of Florida, FBI counter terrorism south east working group, Walter H. Coulter Center Committee at the University of Miami, Department of Defense Grey Team in Afghanistan, Sid Martin Biotechnology Incubator Advisory Board, Cade Museum Board and the Gainesville Chamber of Commerce Board of Directors.
Dr. Streeter served as an Officer in the U.S. Navy, completing a general surgery internship at Naval Regional Medical Center Portsmouth, Virginia and then primary Flight School at Naval Air Station Pensacola, Florida. During his military service, he was the first Naval Flight Surgeon selected as a TOPGUN staff instructor, served on several overseas deployments and was awarded the Navy Achievement Medal and the Navy Commendation Medal. He earned his B.S. degree in Biology from the University of Nevada Reno and his M.D. from the University of Nevada School of Medicine and has a wife Maria and two daughters.

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Edgar Rodriguez, PhD

CEO and CSO

Edgar Rodriguez, PhD
CEO and CSO

Dr. Edgardo Rodriguez-Lebron is one of Lacerta’s co-founders and has actively guided Lacerta as scientific advisor, Chief Scientific Officer, Chairman of the Board and now Chief Executive Officer.

Dr. Rodriguez-Lebron brings over two decades of research experience and entrepreneurial leadership to Lacerta. His research on Huntington’s disease, spinocerebellar ataxias and other neurodegenerative diseases has been funded by the NIH and multiple foundations. He has also secured tens of millions of dollars in non-dilutive funds to fuel Lacerta’s growth and commitment to finding a cure for rare CNS diseases. His ongoing affiliation with the University of Florida keeps him on the cutting edge of scientific discoveries.

Dr. Rodriguez-Lebron holds multiple patents in AAV technology and degrees in Molecular Biology from the University of Central Florida and a Ph.D. in Neuroscience from the University of Florida. An active contributor to the gene therapy community, he is an ASGCT member and serves as the CSO of NF2Biosolutions, a nonprofit focused on the development of a gene therapy approach to neurofibromatosis type 2 (NF2). He has co-founded and helped launch multiple startups in the Gainesville, Florida area. A Florida Gator at heart and by degree, Dr. Rodriguez-Lebron can be found cheering on the home team most fall weekends.

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Coy Heldermon, MD, PhD

Director
Dr. Heldermon is an Associate Professor of Medicine at the University of Florida. His research expertise is in the use of gene replacement and stem cell therapies for the treatment of inherited disorders such as lysosomal storage diseases. He has extensive preclinical data for the use of AAV to treat Sanfilippo syndrome B.
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Kenneth Warrington, Jr., PhD

Director
Dr. Warrington is a Lacerta co-founder with decades of broad expertise across the viral vector product development continuum from discovery through GMP-compliant manufacturing in support of IND-enabling preclinical and early stage clinical programs. He has deep expertise in advanced therapy manufacturing, including live attenuated and virus-like particle vaccines, live challenge viruses, viral vectors, and cell therapies. He served on the faculty board at the University of Florida Pediatrics Division of Cellular & Molecular Therapy with a research program focused on AAV vector development and production. During his industrial career, Dr. Warrington has lead technical operation and business development roles for global contract testing and manufacturing organizations including Meridian Life Science, SGS Life Science, WuXi Apptec, and Biostem Life Sciences. He is currently Head of Strategy & Innovation and a Sr. Director of Business Development at GenScript ProBio, leading their gene & cell therapy CMC services. He chairs the scientific advisory board at Biostem Life Sciences. He holds a B.S in Biology & Chemistry from St. Lawrence University and a PhD in Pharmacology & Experimental Therapeutics from the University of Florida.
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Joseph Zenkus

Director
Joe Zenkus, MS PT, MBA, is the Head of Business Development and Strategic Alliances at Sarepta Therapeutics. Joe has more than 15 years of experience in the life sciences industry, primarily in business development, corporate strategy and commercial roles. He has effectively and consistently built high performing organizations and executed on a wide range of deal types globally, from early discovery to commercial stage programs. Prior to joining Sarepta, Joe served as the Business Development Lead for Pfizer’s Rare Disease Business Unit. He previously held various leadership roles at Mylan in Corporate Development, Corporate Reorganization and Sales Operations. Earlier in his career, he held sales roles at Schering-Plough/Merck. Joe earned an MBA in Finance from London Business School and an MS in Physical Therapy from the University of Massachusetts.
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Scientific Advisors

Nicholas Muzyczka, PhD | Co-founder
Dr. Muzyczka received his PhD in Biochemistry from Johns Hopkins in 1973 and joined Dan Nathans’ laboratory as a postdoctoral fellow where he began his work on gene therapy. In 1980, his lab initiated the development of AAV vectors for gene therapy. His lab invented a way of doing genetics on AAV, and then invented the first AAV vectors, as well as the AAV vectors that are in use today. In 1994, he founded the Powell Gene Therapy Center at the University of Florida where he served as Director for six years. In 1995, he was awarded the American Cancer Society Edward R. Koger chair. His laboratory went on to develop many of the techniques currently used in AAV technology, including standard methods for vector production, purification and quality control. His laboratory also participated in experiments that demonstrated the first long term AAV mediated expression in the eye and CNS. To enable these animal studies, his lab helped humanize the small marker gene GFP and his lab participated in the first demonstration of using rAAV to create an animal disease model. His basic research in AAV biology includes mapping of the TR sequences that are recognized by the Rep protein for replication, the identification of the cellular proteins required for replication and the complete reconstitution of AAV DNA replication in vitro, the identification of the transcription control elements in all three AAV promoters, and the characterization of more than 100 AAV capsid mutants that control capsid assembly, cell entry and trafficking. His laboratory has also developed novel vectors for targeting AAV to specific tissues. In 1999, he founded Applied Genetic Technologies Corp (AGTC) with the help of four fellow scientists at UF and UNC. He served as the company’s first CEO and COB and served as a Director on the Board until 2012, shortly before the company went public. In 2015, he founded Lacerta Therapeutics, whose mission is to develop therapies for central nervous system and lysosomal storage diseases, and he currently serves as its COB. In 2017, he was inducted into the National Academy of Inventors.
Barry Byrne, MD, PhD | Co-founder
Dr. Byrne is a Professor of Pediatrics and the Director of the Powell Gene Therapy Center at the University of Florida, and his research is aimed at understanding types of inherited muscle disease, which leads to heart and skeletal muscle dysfunction. His current research focus is aimed to help those affected by Pompe Disease, an autosomal recessive lysosomal storage disease, and Barth Syndrome, a chromosomal X-linked defect. Dr. Byrne has participated in multiple gene therapy clinical trials and has made many contributions to AAV technology.
Todd E. Golde, MD, PhD | Co-founder
Dr. Golde is a Professor of Neuroscience and the Director of the Center for Translational Research in Neurodegenerative Disease at the University of Florida, where he directs a robust program of scientific discovery aimed at translating basic discoveries in neurodegenerative disease into diagnostics and treatments for patients with Alzheimer’s and Parkinson’s disease.
Coy Heldermon, MD, PhD | Co-founder

Dr. Heldermon is an Associate Professor of Medicine at the University of Florida. His research expertise is in the use of gene replacement and stem cell therapies for the treatment of inherited disorders such as lysosomal storage diseases. He has extensive preclinical data for the use of AAV to treat Sanfilippo syndrome B.

Ronald Mandel, PhD | Co-founder
Dr. Mandel is a Professor of Neurosciences at the University of Florida with over 25 years’ experience in the study of neurodegenerative diseases, with a particular focus on Parkinson’s disease. His laboratory is a leader in preclinical studies in the use of AAV for gene therapy. Prior to accepting the academic appointment in the Powell Gene Therapy Center, he developed gene therapy applications for the brain at Somatix Inc. and CellGenesys Inc.
Edgar Rodriguez, PhD | Co-founder

Dr. Rodríguez-Lebrón has expertise in AAV-based gene therapies that make use of microRNA molecules and gene editing tools to suppress the expression of these proteins in CNS resident cells. He uses model systems to test novel gene-based therapies that prevent, halt or reverse neurodegenerative processes caused by the abnormal accumulation of misfolded proteins.

Arun Srivastava, PhD | Co-founder

Dr. Srivastava is a Professor of Pediatrics and Chief of the Division of Cellular and Molecular Therapy at the University of Florida with over 30 years of experience with AAV vectors and was the first to completely sequence AAV DNA. He has made many basic contributions to AAV biology. Most recently, he has developed over 250 different AAV capsid mutants using rational design approaches that increase transduction by up to two orders of magnitude in animal models.

Kenneth Warrington, Jr., PhD | Co-founder

Dr. Warrington has a broad expertise across the AAV gene therapy product development continuum including discovery, process development/scale up for clinical grade manufacturing, CMC and product characterization using a broad range of platforms, and GMP-compliant testing to support IND-enabling preclinical and early stage clinical programs.

Sergei Zolothukin, PhD | Co-founder

Dr. Zolotukhin is an Associate Professor of Pediatrics at the University of Florida with 30 years of experience in the gene therapy field. He has developed many of the methods for purification and quality control of AAV vectors and has pioneered the development of improved capsid engineering methods and baculovirus vector production platforms.

Arun Srivastava, PhD | Co-founder
Dr. Srivastava is a Professor of Pediatrics and Chief of the Division of Cellular and Molecular Therapy at the University of Florida, with over 30 years of experience with AAV vectors and was the first to completely sequence AAV DNA. He has made many basic contributions to AAV biology. Most recently, he has developed over 250 different AAV capsid mutants using rational design approaches that increase transduction by up to two orders of magnitude in animal models.