Ya-El Mandel

Company Overview: A boutique consultancy for clinical development and clinical operations functions.

• Providing support and services to small- to medium-sized biopharma companies.
• Working directly with the CEO or CMO to fill in existing gaps and add value.
• Supporting fundraising activities.
• Presentations of clinical plans to regulatory agencies, potential investors, or board members, as needed.
• Vendor selection and management.
• Assisting in talent acquisition and mentorship for in-house, growing clinical teams.
• Boutique consultancy for clinical development and clinical operations functions.

Company Overview:

• A privately held company raised $58M.
• Developing a drug for treatment-resistant epilepsy (focal/adults).
• 505(b)(2) pathway.

Clinical Operations responsibilities:

• Support the portfolio of opened and planned clinical studies, and manage all activities for all studies: from protocol development, study design, regulatory and ethics submissions, study start-up, study conduct, and study closeout activities.
• Phase 1 SAD/MAD with the new formulation was conducted from July to August 2021.
• Phase 1b/2a dose escalation study concluded in Q4 2022 (n=40, 4 cohorts, USA/ISR).
• Phase 2b (will be used as a pivotal study). n = 300, 15 countries, 85 sites globally. FPFV: December 2022.

Clinical Development responsabilities:

• Vendor selection and management
• Overseeing data analysis and interpretation.
• Providing scientific and clinical input to study-related documents and analysis plans: design, author, and review clinical study synopses, protocols, amendments, study reports, and other study-related documents, including a strategic review of plans.
• Writing abstracts and manuscripts, and presenting at scientific conferences.
• Direct supervision of Clinical Operations, Medical Monitoring, Biostatistics, Data Management, Medical Writing, Safety, and Pharmacovigilance.
• Presenting clinical data to the Board of Directors, investors, and management.

• Supervising all industry-sponsored clinical studies in the department.
• Mentored students through individual sessions or group discussions on how best to apply their knowledge from class into real-world scenarios.
• Grant writing.
• Guest lecturer: Clinical Research course for medical students and EM residents.

• Managing clinical operations among all the companies in our portfolio.
• Fundraising activities.
• Negotiations regarding asset development with strategic partners.

Mount Sinai spin-off.

• Company Overview: Developing novel, non-invasive platform technology to risk-stratify atrial fibrillation patients based on hemodynamic effect.
• NIH K-12 funded

• Apex-Radial Pulse Deficit as an Indicator for Worsening Symptoms for Patients with Atrial Fibrillation.
• Heart Rate Volatility Measured in the ER as a Predictor of Escalation of Care and In-Hospital Mortality.

Overseeing all industry and government-funded clinical trials in the CT Surgery Department.

• Prospective, non-randomized, multicenter clinical evaluation of Edwards pericardial bioprostheses with a new tissue treatment platform (COMMENCE) by Edwards Lifesciences.
• Rate Control Versus Rhythm Control for Postoperative Atrial Fibrillation by CTSN.
• Surgical Ablation Versus No Surgical Ablation for Patients with Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery by CTSN.
• CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) by Medtronic.

• Started volunteering as a paramedic upon graduation from the paramedic course in the IDF.
• Working as a paramedic in a mobile intensive care unit, managing a crew of 3 medics.
• Participating in extensive community service programs carried out by MDA (blood donations actions, food banks, public EMS trainings).

• Was in charge of grading exams and papers, and providing ongoing academic guidance and mentorship to students.

• Coordinated medical response to various incoming events, liaising with national service providers, making initial medical assessment of the severity.
• Owned the entire follow-up cycle, starting with dispatching of ambulances and mobile intensive care units and completing the handling of the cases with the hospitals.
• Headed a department of four Team Leaders managing two dozen Emergency Medical Technicians.

• Undergone a 14 months-long paramedic course conducted by the Israeli Emergency Medical Services.
• Responsible for all medical activities in the unit, commanding a staff of 15 medics.
• Driving professional development of the medical staff from the recruitment stages, through training and service.
• Serving as a commander of the military clinic and participating in all operational combat activities as part of the Special Forces unit.