Outsourcing in Clinical Trials & Clinical Trial Supply Israel 2023

Biography:

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Biography: Yael Genosar, Associate Director of Clinical Supply Chain at OPKO Biologics Israel. Experienced Clinical Supply chain manager with four years of experience in managing supply chain in a global clinical trial. Previously Project Manager at Hot Mobile a wireless telecommunications company, leading technologies projects.

Session Details: KEYNOTE: Clinical Supply Challenges During a Worldwide Pandemic 06-06-2022, 9:45 am KEYNOTE: Clinical Supply Challenges During a Worldwide Pandemic 06-06-2022, 9:45 am View In Agenda

Biography: Julio discovered he had Hepatitis C by chance in 1994. He went through three year-long courses on interferon treatment. These years were not easy and Julio struggled with many challenges and questions and he looked for support. When he realized there are no support groups or patient associations for liver patients in Israel, Julio decided in 1998 to establish Hetz- the Israeli Organization for Liver Health. Today Julio is cured from HCV. Nevertheless, he dedicates his life to supporting liver patients and their families, strengthening Hetz's capacity to advocate for the PATIENTS' RIGHT TO KNOW they have a liver disease, and the government's obligation to screen and to treat them. Actually Julio is directing HETZ and is representative of the patients in the National Council of Liver of the Ministry of Health in Israel.

Session Details: Exploring Patient Collaboration and the Benefits it can Bring to the Sponsor and the Patient 07-06-2022, 10:00 am View In Agenda

Biography:

• Clinical trials:
• Coordination of Clinical Trial Material / Investigational Product supply to clinical sites according to Local legislation, Sponsor’s SOP and GCP / GDP / GMP
• Coordination of Clinical Trial Material / Investigational Product use on clinical trial sites according to Local legislation, site’s SOP and GCP
• Training of clinical / pharmacy personal on all aspects of drug accountability (including preparation of treatment)
• Training of clinical personal on use of medical devices (when applicable)
• Quality control:
• QC laboratory team leadership
• Organization of QC laboratory according to GMP
• Planning and execution of Development and Validation of Analytical and Biochemical methods according to GMP, USP and PhEur
• Auditing of QC laboratory methods and results
• Preparation of regulatory required documents according to GMP (SOP, methods, reports...)

Session Details: Examining Drug Accountability In Clinical Trials 06-06-2022, 12:00 pm View In Agenda

Biography:

Dr. Shahar is an accomplished director level manager with scientific and operational management experience in diverse settings.

Dr.  Shahar has an extensive background in clinical R&D, leading medical device, medical technology and drug studies.

Session Details: Launching Your First Clinical Trial: From Design, to the Clinic, to the Market 06-06-2022, 8:45 am Launching Your First Clinical Trial: From Design, to the Clinic, to the Market 06-06-2022, 8:45 am LEADERS PANEL DISCUSSION How Have the Lessons Learnt from COVID-19 Changed the Way We Are Going to Run Trials in the Future? 06-06-2022, 11:15 am View In Agenda

Biography: Aurélie Schwarzbach has over 15 years of experience in the clinical research field. She is currently a senior project manager at Gamida Cell, a Jerusalem-based company, that she joined 7 years ago. She has been managing several clinical activities in studies of different phases, mainly Phase I-II and Phase III studies. More recently, she has orchestrated the clinical activities and documents preparation for the submission of a Biologics License Application (BLA) for omidubicel, an advanced cell therapy of Gamida Cell advanced cell therapies (www.gamida-cell.com).

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Biography:

Session Details: LEADERS PANEL DISCUSSION How Have the Lessons Learnt from COVID-19 Changed the Way We Are Going to Run Trials in the Future? 06-06-2022, 11:15 am View In Agenda

Biography: Accomplished Director level manager with over 10 years of management experience in diverse setting. Innovative, data-driven and multi-disciplinary leader, expertise in CMC, Formulation, Drug Delivery and Development Platforms. Extensive knowledge in Immune system, cardiovascular, and cancer. In top industry and academic labs

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Biography: Hadar has a B.Sc. in Chemical engineering From BGU (Ben-Gurion University of the Negev) & B.Sc. in Polymer engineering from Shankar College of Engineering. Experienced in leading R&D projects in Biopharmaceutical companies. Worked in Perrigo API performing commercial procurement for the API division, then joined Teva in 2011 as Senior procurement manager in R&D performing global procurement. Since joining Clinical Supply Chain group, within TEVA's R&D global clinical operations in 2018, Hadar been leading clinical supply chain projects within a variety of programs and TAs, each one includes multiple clinical trials in different clinical phases, identifying unique challenges and tailoring the project planning accordingly with ongoing risk management in accordance with international guidelines and regulations. She holds various responsibilities including plan efficient drug product demands, coordinating the manufacturing with CMC in all TEVA's manufacturing plants, sourcing of comparators, plan and design the clinical drug packaging and labeling, Design IRT/RTSM system, set-up and oversee maintenance and overall ensure timely delivery within specifications, quality and standards. Hadar initiated and led new approach for P&L at Teva, following by process change.  

Session Details: DtP - a Patient Centric Approach 06-06-2022, 11:15 am View In Agenda

Biography: Professor of Clinical Biochemistry the Lily and Avraham Gildor Chair for the Investigation of Growth Factors, Head of the Elton Laboratory for Molecular Neuroendocrinology, Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine, Sagol School of Neuroscience and Adams Super Center for Brain Studies, Tel Aviv University. Former Director, the Adams Super Center for Brain Studies & the Edersheim Levie-Gitter Institute for Functional Brain Imaging. Serves as Editor-in-Chief of the Journal of Molecular Neuroscience. The inventor of CP201 and CP102. Holds a B.Sc. from Tel Aviv University and a Ph.D. from the Weizmann Institute of Science.

Session Details: Brain Protection: Case Study 06-06-2022, 3:15 pm Brain Protection: Case Study 06-06-2022, 3:15 pm View In Agenda

Biography: I am a M.Sc. graduate in life sciences and Bbiotechnology (the Hebrew University of Jerusalem, Israel). After graduating' I have acquired vast experience in the biomed industry and research and development of innovative botanical products. For the past six years, I have served as R&D, Quality and Vocational Training Director in the Israeli Ministry of Health's Medical Cannabis Agency (IMCA).  There, I took a major part in designing the policy and regulation for the emerging medical cannabis industry, including writing the clinical methodology and quality procedures for medical cannabis products. Currently, I am the Head of the Medical Cannabis Clinical Research Center at the Chaim Sheba Hospital, Tel Hashomer, Israel; and an academic coordinator of the "cannabis for medical and research" course in the School of Graduate Studies, Sackler Faculty of Medicine, Tel Aviv University.

Session Details: Bringing a Cannabis Product to Market: Navigating the Logistical and Regulatory Hurdles 06-06-2022, 12:00 pm View In Agenda

Biography: Mrs. Erlich is a senior regulatory, clinical trials, and compliance expert for the health-care and medical device industry. She has served as a senior management member and held VP positions in national startups and international health-care companies since 2003. As part of her job, she managed large company teams, delineated the regulatory and compliance strategy and led its implementation, leading to multinational market clearance, including the EU, USA, South America and the Japanese market. She also designed and managed multinational multisets clinical trials and submissions. In addition, since 2001, she also served as a senior consultant in the PushMed group and N.G.I.T, for more than 70 medical device companies in miscellanies clinical fields. As a consultant she established quality systems, lead the design control process to support successful regulatory submissions, supported the company during CE audits and FDA inspections, and tailored regulatory and clinical strategy. She also held meetings with regulatory bodies, including notified bodies and FDA, and managed clearance file submissions, such as a Technical File, 510(k) notices and post market activities. Tsvia Erlich joined ConTIPI Medical, as Regulatory and Clinical Affairs officer in 2007. She holds a BSc. degree (cum laude) in Biochemistry and Food Engineering from the Hebrew University in Jerusalem. Later, she graduated the Technion Institute of Technology, Haifa and received her M.Sc. degree (cum laude) in Biotechnology and Food Engineering, in 1993.  During that time she completed her research in the field of protein engineering at the laboratory of Professor Yuval Shoham, at Technion Institute. She holds CQE and CQM certificates since 1999 and is an active member of RAPS and she lectures at national and international conferences.

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Session Details: Mimicking Insect Immunity to Control Hospital Acquired Infections 06-06-2022, 1:45 pm View In Agenda

Biography: Mr. Bennett has worked in clinical development for approximately 20 years and has worked for WCT since September 2021. He began his career in clinical research in a phase 1 clinic and soon after held roles as a Clinical Research Associate on both early and late phase clinical trials with responsibilities for data validation and site management. This solid base experience in ICH-GCP was further supplemented with broad operational knowledge regarding the conduct of clinical trials when he was appointed as a Clinical Trial Manager of Phase I, II and II trials within global programs. Building on this operational grounding, he has latterly (seven years) held positions where he has led crossfunctional project teams within clinical research and has been responsible for project strategies, clinical development plans, clinical trial methodologies (concept/design), protocol authorship and the transformation of the scientific endeavor into an operationalized activity. Through being part of R&D leadership teams, he has contributed to business management and the development of operating models and outsourcing strategies. He has been responsible for representing pipeline projects in R&D governance boards and holds experiences throughout the drug development life cycle.

Session Details: Proactive Choices for an Adaptive Strategy 06-06-2022, 9:15 am Proactive Choices for an Adaptive Strategy 06-06-2022, 9:15 am View In Agenda

Biography:

Session Details: How We Did It: Getting Device Approval Through the FDA’s Breakthrough Devices Program 07-06-2022, 9:30 am View In Agenda

Biography: Daniela Duffett is the European Solutions Consultant at Suvoda, based out of our Barcelona office. She consults with clients and prospects, delivering presentations and demonstrations, while acting as a Subject Matter Expert on Suvoda’s solutions. She started at Suvoda three years ago on the Project Management side of our Services Delivery organisation, so can impart her hands-on delivery experience & knowledge.  

Session Details: Leveraging the Power of Supply Chain Technology 06-06-2022, 10:15 am View In Agenda