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Our Team

ONL’s team is comprised of experienced and successful life science industry executives and world-renowned thought-leaders in relevant fields of ocular disease research.

David Esposito

PRESIDENT AND
CHIEF EXECUTIVE OFFICER

David Esposito is an experienced healthcare executive who has built and scaled multiple companies that resulted in successful exits to strategic buyers.

David is the former CEO of Armune BioScience where he led the development and commercialization of blood-based diagnostics to improve the early detection of cancer. The Company successfully launched the only non-PSA blood test to improve the detection of prostate cancer. Armune BioScience was sold to Exact Sciences (EXAS) in 2017.

He was President of Phadia US Inc. (allergy and autoimmune diagnostics) and played a pivotal role in the sale of the business to Thermo Fisher Scientific (TMO) in 2011. David began his career as a sales representative with Merck & Co. Inc. and rose through the ranks of sales, marketing and commercial strategy for the US Division.

David is a combat veteran, led an infantry platoon with the 101st Airborne Division through several combat operations, and was recognized with a Bronze Star for combat action in Iraq in 1991. David earned his B.S. degree in Civil Engineering from the United States Military Academy at West Point and his MBA from Syracuse University.

David Zacks, MD, PhD

CO-FOUNDER AND
CHIEF SCIENTIFIC OFFICER

Dr. Zacks is a professor of ophthalmology and a clinician-scientist at the University of Michigan, Kellogg Eye Center. For over the past 15 years his research has focused on the molecular regulatory mechanisms controlling photoreceptor death or survival in retinal disease. Dr. Zacks is a pioneer and recognized thought leader in the field of retinal neuroprotection and photoreceptor cells physiology. He has demonstrated that the Fas pathway is largely responsible for cell death and has discovered unique molecules that block the Fas receptor and preserve photoreceptors.

A recognized expert in the study of retinal detachment, Dr. Zacks has received numerous honors for his work, including the Macula Society’s W. Richard Green Lecture and Award in 2011. He earned his M.D. and Ph.D. degrees at Albert Einstein College of Medicine and completed his residency in ophthalmology and fellowship in vitreoretinal surgery at Massachusetts Eye and Ear Infirmary of Harvard Medical School.

Connie Chang

CHIEF OPERATING
OFFICER

Connie brings a diverse 25-year career in life science and business to ONL, having worked in large and small pharma, early-stage biomedical technology commercialization and management consulting. Previously, she served as Vice President of Corporate Affairs at Millendo Therapeutics where she was responsible for building critical infrastructure as the company became publicly traded, including investor and public relations, corporate communications, and facilities/operations. Connie was managing director of Fast Forward Medical Innovation (FFMI), the commercialization and entrepreneurship arm of the University of Michigan Medical School, supporting early-stage technology development. At Sepracor (now Sunovion) Connie was Senior Director and brand team leader for the sedative hypnotic and respiratory franchises, developing integrated marketing plans and sales force strategies, including the launch of product line extensions. Earlier in her career, Connie worked at Pfizer on commercial teams in allergy/respiratory, cardiovascular and CNS.

Connie received her Bachelor of Arts degree in psychobiology from Harvard University, graduating magna cum laude and Phi Beta Kappa, and an MBA from Harvard Business School.

Andrew Kocab, PhD

SENIOR DIRECTOR, RESEARCH AND STRATEGIC PARTNERSHIPS

Dr. Kocab earned his Ph.D. in immunology at the University of Michigan where he studied cell signaling pathways related to cell death and inflammation. Specifically, his work focused on understanding the signaling from receptors closely related to Fas, as well as the effector proteins involved in regulating these processes.

During his time at ONL, Dr. Kocab has worked closely with senior management on a variety of key functions across the company. He currently leads the company’s research, preclinical, and data management activities. In his role, Dr. Kocab also serves as the company’s primary liaison with critical strategic partners and collaborators.

Lindsay Puscas, MS, COA, CCRP

DIRECTOR OF
CLINICAL OPERATIONS

Lindsay Puscas is an experienced clinical research professional with a specialized background in ophthalmologic clinical trials.

Lindsay formerly served as Clinical Research Project Manager for the Kellogg Eye Center at the University of Michigan, the nation’s largest public research university. Over her ten years there she oversaw a portfolio of over 200 clinical studies ranging from phase 0 to post-market approval, with a focus in inherited retinal dystrophy pediatric gene therapy trials. Lindsay managed a nine-person team to execute every aspect of the clinical trial process, including protocol and study development, regulatory compliance and risk mitigation, subject recruitment and retention, as well as safety and data management.

Previously, Lindsay worked as an emergency medical technician and a rehabilitation specialist for adults with brain and spinal cord injuries. A Certified Clinical Research Professional and Ophthalmic Assistant, Lindsay earned her B.S. in Nutritional Sciences from Michigan State university and M.S. in Nutrition and Food Science from Wayne State University.

Lori Huang, PharmD, MBA

DIRECTOR OF
CLINICAL AFFAIRS

Lori is a highly accomplished bio-pharmaceutical professional with 13+ years of cross-functional experience in biotech, pharmaceutical and hospital industries. Her expertise in clinical development and precision in operations have allowed her to develop innovative solutions and forge strategic partnerships. With a strong commitment to excellence, she is dedicated to utilizing her data analysis skills to make a significant impact in the field of healthcare and drive the successful commercialization of groundbreaking therapies.

Lori received her Bachelors in Science degree in biology and music from South Dakota State University, PharmD from Wingate University, PGY1 General and PGY2 Critical Care Residency from The Nebraska Medical Center, and MBA from The University of Michigan Ross School of Business.

Amanda Maciel

Manager of Accounting and Financial Reporting

Since joining ONL in 2021, Amanda has been responsible for developing an in-house capability for accounting and financial reporting, a key area for the company’s future growth and success. Amanda most recently was senior accountant with Millendo Therapeutics, a publicly-traded, early-stage biopharma company where she managed internal accounting and finance processes, in addition to leading special projects for the implementation of enterprise-wide financial administration systems. Amanda has a background in corporate accounting from the technology manufacturing sector in addition to her degree in Management Science from University of California, San Diego.

Linda Kemnitz

Manager, Administrative
Operations

Linda has nearly 25 years of experience providing operations and administrative support across a broad range of companies, from large CROs to small biotech. Linda joined ONL in 2018 where, in her role as Manager, Administrative Operations, she helps behind the scenes with multiple functions related to company operations including financial management, information technology/cybersecurity and HR.

Stephanie Wietholter, MS, COA, OSC

Project Manager,
Clinical Operations

Stephanie Wietholter is an experienced clinical research coordinator with nearly ten years of combined experience in ophthalmic clinical trials and working as a certified ophthalmic assistant in a retina clinic.

Stephanie began working at the University of Michigan Kellogg Eye Center in 2013. For five years, she worked as a certified ophthalmic assistant where she performed many specialized clinical tests for retinal and inherited retinal dystrophy patients, including a year working as an Electrophysiologist Assistant and performing diagnostic ERGs on clinic patients. Her experience in the Retinal Dystrophy Department led to a position as a Clinical Research Coordinator in the Kellogg Clinical Research Center. Her time as a research coordinator included managing numerous phase 1, 2, and 3 clinical trials and research studies ranging in a variety of ophthalmic conditions.

Stephanie’s background includes a B.S. in Brain Behavior and Cognitive Science from the University of Michigan and an M.S. in Pharmacology and Toxicology from the Michigan State University College of Osteopathic Medicine.

Sushanta Mallick, PhD, MBA

GLAUCOMA STRATEGY AND DEVELOPMENT ADVISOR

Dr. Mallick brings 30 years of experience in ophthalmology research and development, with over a decade in senior leadership roles in companies spanning the US, Canada, and Europe. Prior to joining ONL, Dr. Mallick was the Vice President and Head of Clinical Development at Nicox Ophthalmics, an international ophthalmology company headquartered in Nice, France, where he led the development program for two ongoing Phase 3 clinical trials in the US and China for its lead compound in glaucoma. Dr. Mallick gained his therapeutic area expertise in ophthalmology at Alcon Research Ltd. in Ft. Worth, Texas, where he held positions of increasing responsibilities that resulted in four product approvals in glaucoma and culminated in an appointment with Alcon’s ESBATech, a biomedical research company based in Zurich, Switzerland. As the clinical unit head there, he directed two IND submissions and proof of concept trials resulting in the market approval for a new wet AMD product. As Vice President of R&D at QLT Inc. in Vancouver, he led the development of an oral synthetic retinoid as an orphan drug in inherited retinal diseases. Previously, as Vice President and Global Development Lead at Shire/Takeda, he managed all aspects of multiple ophthalmic development programs, from late preclinical stages through commercialization. Dr. Mallick has a MPharm in Pharmaceutics, PhD in Biochemistry and MBA in Marketing and International Management.

Kristin Williams

Lead Regulatory and
Compliance Consultant

Kristin is an experienced regulatory and compliance professional with over 15 years of experience in ophthalmology spanning clinical, quality, and regulatory affairs.  Prior to starting her consulting company, Kristin formerly served as the Vice President of Quality and Regulatory Affairs at Lexitas Pharma Services, Inc., and as one of Lexitas’s first employees built the quality and regulatory departments from the ground up.  Kristin specialized in helping ophthalmic clients understand and navigate the complex regulatory processes necessary for drug approval.  Prior to her ten years at Lexitas, Kristin worked at Inspire Pharmaceuticals with several marketed and investigational ophthalmic products. 

Kristin is a NC-licensed attorney and a patent attorney, holding a Juris Doctor and Master of Jurisprudence in Health Law from Loyola University Chicago.  She is also RAC certified and holds multiple data protection certifications.

Barbara Berglund

Lead CMC
Consultant

Barb has been working in the pharmaceutical industry for over twenty years. She has worked extensively across multiple types of therapeutic formulations for approvals in the US, Canada, Europe, Australia, Britain, Brazil and Japan. Her experience spans quality and operations, including strategic leadership roles in quality control, quality assurance, project management, and clinical trial manufacturing. In her operations, laboratory, and quality roles, Barb has worked directly with drugs from innovation, through clinical trials, through registration, and to commercialization, and has directly supported the CMC process; this includes pre-IND documentation, FDA interactions, and creation and editing of the submission documents for CTD e-filing. She has worked with innovator drugs, generics, and commercial products with orphan indications ranging from diluents to small molecules, peptides, proteins, encapsulated DNA and adjuvated vaccines.

She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and in Pharmacological & Physiological Science. She received her Project Management Professional certification in 2007, her Six Sigma Green Belt in 2008, and her Certified Manager of Quality/Operational Excellence and Certified Quality Auditor from the American Society for Quality in 2015.

Melanie Fortin

Project Manager Consultant, Clinical Operations

Melanie Fortin is a passionate life sciences professional with more than 14 years in the Eye Care industry with a focus on Ophthalmology Research (Preclinical as well as Clinical Phases I-IV) for both anterior and posterior segment ophthalmic indications. Throughout her career, Melanie has served in various roles of increasing responsibility for military, private practice, academia, CRO, and biotech sponsors in positions including ophthalmic technician and clinical research coordinator, research department supervisor, Clinical Trial Assistant (CTA), Clinical Trial Manager (CTM), Clinical Project Manager (CPM), and Clinical Operations Consultant. Melanie is dedicated to advancing the field of ophthalmology clinical research while aiding in the fight to develop new treatments and pharmacotherapies that will transform and improve the lives and vision of people all over the world.

Melanie has multiple scientific publications and was awarded the Chris J. Barry Award for Best Article in the Journal of Ophthalmic Photography in 2015. Melanie is a United States Air Force veteran who served with the Aerospace Vision department of the 4th Medical Group and was awarded the Air Force Achievement Medal. Melanie earned her B.S. degree in Human Biology from the University of Colorado and a M.S. in Biomedical Sciences.

David Kleinman, MD, MBA, FACS

Clinical
Consultant

David M. Kleinman, MD, MBA, FACS is a board-certified ophthalmologist with fellowship training in vitreoretinal surgery. He practices clinically at the Flaum Eye Institute at the University of Rochester Medical Center where he serves as a Professor of Clinical Ophthalmology (part time). Dr. Kleinman received his medical degree with honors from University of Colorado School of Medicine where he also completed his ophthalmology residency. His fellowship in vitreoretinal surgery was completed at the University of Toronto School of Medicine.

Dr. Kleinman is the former Chief of Ophthalmology at Denver Health Medical Center in Denver, Colorado. He has been a clinical investigator for multiple studies evaluating the pharmaceutical treatment of retinal disease and has made numerous contributions to clinical and research publications in national and international journals of ophthalmology. In addition, he participated as a surgeon for the Himalayan Cataract Project and served as a staff ophthalmologist for Project ORBIS International, Inc. Dr. Kleinman is an experienced ophthalmic consultant to the pharmaceutical industry and has special expertise in clinical trial design, clinical operations, and strategic planning. He has been a longstanding retinal consultant to ONL and served as Consulting Chief Medical Officer from 2014 to 2018.