Ketty Shkolnik, Phd Email & Phone Number

I specialize in delivering high-quality, tailor-made clinical and regulatory solutions to drive and support product success.Key Skills:1. Clinical Development • Developing clinical strategies and clinical plans for POC, pivotal, RCT, usability and post-market studies• Creating Clinical Investigation Packages (clinical protocol design, CRFs, IB, ICF, trial agreements)• Preparing regulatory submission packages to Ethical Committees & Regulatory Authorities across various territories• Designing and executing clinical operations, including the development of trial-specific documents and plans • Leading usability study design and management2. Clinical Project Management• Full-cycle execution of clinical plans (budget, feasibility, site selection, startup, regulatory submission, and study conduct) in the USA, EU, and Israel• Handling site management 3. Regulatory• Overseeing the trial’s regulatory process and managing all communications with regulatory bodies• Building a strong Post-Market Surveillance foundation• Preparing regulatory documentation for FDA and CE (MDR) submissions4. Medical Writing• Designing clinical protocols for POC, pivotal, RCT, and post-market studies• Analyzing clinical study data and writing Clinical Study Reports• Developing and authoring key regulatory documents like IB, CEP, CER, PSUR, PMS plans, PMCF, risk/benefit analyses, and academic publications5. Clinical Department Management• Building and managing successful clinical research teams across the US, EU, and local teams• Managing departmental budgets and clinical resources• Developing Clinical Standard Operating Procedures (SOPs) and ensuring quality and compliance with MDR, FDA, and GCP guidelines

Tel Aviv, Israel

NUVO GROUP- Developing the Future of Pregnancy. Focused on developing wearable, sensor-based technologies that utilize big data analytics to drastically improve pregnancy healthcare on a global scale.As the leader of clinical development, I oversee activities across multiple territories, including:• Clinical research: Full cycle from protocol preparation and study setup to execution, data analysis, and final reports writing• Regulation: preparation of regulatory submissions documents (EC/IRB/CA), FDA (achieved an FDA clearance in 2021), and CE submission (as per MDR). • Quality: Establishment of clinical SOPs

Israel

OCON Medical develops, manufactures, and commercializes innovative women’s health products.In my role, I was responsible for the company’s overall clinical strategy, including the design, and management of the entire repertoire of clinical activities, including:• Leading the clinical team (CPM, CTM, global CRO team) • Planning and executing clinical studies, from proof-of-concept to post-market • Overseeing scientific manuscripts and medical writing for the company • Managing communication with KOLs, the Scientific Advisory Board, and clinical investigators

Yokneam, Israel

Syneron Candela - a global medical device company; Acquired by Apax Partners in July 2017.In my role, I was responsible for:• Designing and executing clinical studies• Leading innovative projects from concept through clinical studies within the R&D "Research Group"• Managing multidisciplinary teams for both pre-clinical and clinical development • Collaborating closely with physicians and Key Opinion Leaders • Designing and conducting animal studies

Amot Mishpat Bldg, 8 Shaul Hamelech Blvd. Tel Aviv, Israel

Galmed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel drug for treating liver diseases and cholesterol gallstones.My responsibilities included:• Managing a multi-center, multinational Phase IIb study• Designing and reviewing study documents and key study tools• Coordinating regulatory submissions• Leading the operational aspects of the study, including study-specific training• Developing procedures in collaboration with study vendors• Ensuring overall study compliance• Overseeing a global CRO • Managing the study budget

4 Pekeris St, Park Hamada, Rehovot

Minovia Therapeutics - Pioneering Cell Therapy for Mitochondrial DiseasesFounded in 2011, Minovia is the first company to use cell therapy to treat mitochondrial diseases through its unique Mitochondrial Augmentation Therapy (MAT) platform. Currently a clinical-stage company, Minovia operates in Israel, the EU, and the US.In my role, I was responsible for:• Strategic planning• Operations and budget management• Fundraising (equity, Office of Chief Scientist)• Pre-clinical development (CRO, vendors, consultants)• IP portfolio, including execution of licensing deals

Ph.D., Reproductive Endocrinology/Molecular Biology

M.Sc., Immunology, Molecular Cell Biology

B.Sc., Life Sciences, Magna Cum Laude