Sharon Bakalash MD, PhD, CBA
Business development, Clinical development
Dr. Bakalash is a seasoned Ophthalmic surgeon with more than two decades of demonstrated clinical and scientific leadership in ophthalmic sciences and medicine. She heads the SB Strategic Development Consultants Group, providing clinical development, strategic planning, search and evaluation, and business development guidance.
Dr. Bakalash had served in various roles of exceeding responsibilities within the pharmaceutical and device industry. In her last role within Novartis, she was responsible for the US early development portfolio in both Ophthalmology and ENT—forming development strategies, enabling pipeline enrichment stemming from both external and internal innovation. Prior to that, she headed the Search and Evaluation organization within business development at Alcon, where she was tasked with evaluating, negotiating and overseeing numerous licensing transactions- spanning acquisitions, joint ventures and a wide variety of co- development frameworks.
Prior to Novartis, Dr. Bakalash was a part of the Office of Technology Development (http://otd.harvard.edu/) at the Harvard Medical School, where she was charged with identifying, commercializing and out-licensing innovations. Through the years, as an active scientist and a physician, Sharon had consulted to biotech device and Pharma companies, and conducted pre-clinical and clinical research.
Dr. Bakalash holds an MD from Ben Gurion University, a PhD in Neuroimmunology from the Weizmann Institute of Science and a Business degree from Northeastern University. Dr. Bakalash has also completed a post-doctoral fellowship at the Harvard Eye research institute at Harvard University, where the focus of her research was on stem cell involvement in neuronal degeneration.
Nancy Cariker-Moon, RAC CQE
Regulaotry affairs affiliate
Nancy Cariker-Moon has over twenty years of experience in regulatory affairs and quality assurance working with pharmaceuticals, medical devices, and biologics in the areas of ophthalmology, dermatology, surgical, anesthesia, and veterinary medicine. She has participated in multiple stages of product development from preparing companies for pre-Investigational New Drug (IND) meetings, following up with clinical trial protocol submissions, through submitting and receiving approval for the New Drug Application (NDA), to post-approval marketing activities and lifecycle maintenance.
Working with agencies in more than 30 countries world-wide including US, EU, and Canada, Nancy has prepared, submitted, and received approval for clinical trial protocols, electronic Common Technical Documents (eCTD), amendments to drug applications, prescription drug labeling including Structure Product Labeling (SPL), and post-approval supplements.
On behalf of application holders and manufacturing facilities, Nancy has devised and executed systems for Current Good Manufacturing Practices (CGMP), Quality Management System (QMS), pharmacovigilance and medical device reporting and complaints systems. In addition, she has overseen establishment registrations and represents facilities during interactions with regulatory agency inspectors.
Clinical development affiliate
Catherine Tone has more than 25 years of experience in the pharmaceutical industry. She began her career managing a laboratory before moving into clinical research and documentation control. Her years in clinical research were invaluable as medical writing was added to her resumé. Knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and documentation control ultimately coalesced into quality assurance roles and responsibilities.
Regarding clinical research, she has been directly responsible for protocol and case report form development, investigator recruitment, study implementation, auditing and monitoring trials, and preparation of final reports for a variety of clinical applications in the US and internationally.
She has designed and implemented quality systems in compliance with FDA regulations to include writing SOPs for manufacturing, laboratory, clinical, and document control use. She has also worked in pharmacovigilance and medical device reporting and complaints.
Catherine is a co-author on multiple peer-reviewed publications and presentations. In addition, she has written, reviewed, and edited multiple white papers, manuscripts for publications, posters and presentations.
CMC, manufacturing affiliate
Gaurav Mehta brings 20+ years of industry development and operations experience across startup and Fortune 500 companies primarily in pharmaceuticals, medical devices, and combination life science products. He has led cross-functional teams made up of regulatory, manufacturing and supply chain operations, finance, quality, commercial, data/digital, and legal disciplines to drive scale-up, market expansion, commercialization, top/bottom-line growth, transformations, quality assurance remediation, regulatory compliance, and FDA/MoH alignments.
Gaurav is driven to introduce new, impactful solutions in the healthcare space and make them available to a wider audience. His past automation and technical transformation experience also enables him to be comfortable in the digital space. He currently heads up the development of an entire manufacturing technical operations and global supply chain for a bio-pharmaceutical startup taking it from clinical supply to product approval and commercialization. Past experience highlights include:
Implementation of a greenfield pharmaceutical manufacturing facility in Singapore
Medical Device technical operations transfer from USA to Indonesia
Turning around operations, significant quality hurdles and programs to positive
Global business and digital transformation to enable EBIT and stock availability improvements
Leading the creation and execution of 5-year strategic plans