Outsourcing in Clinical Trials Israel – Virtual Conference 2021

Biography: Moshe has been the President and CEO of 3QBD since 2006. Moshe’s team are bringing a new Technology to the Bio-Diagnostic market, with some of their 1st applications include OBS and Gyn. Diagnosing the Vaginal Flora in less than 90 seconds. 3QBD detect: BV, Trichomoniasis, Candida Albican, Infections caused by pathogens. simultaneously by one test We are looking for Distributors in Europe specially East Europe.

Session Details: From Device Design To The Clinic: An Entrepreneurship Guide For Start-Ups 14-04-2021, 12:45 pm View In Agenda

Biography: David has been the CEO of Dali Medical since 2003. Dali Medical develop Innovative Injectable Drug Delivery Devices - from product concept to regulatory approval and commercialization. Their R&D activities include Developing novel concepts for auto-injectors and Safe Auto-Needles for self-administration of injectable drugs and biologics, bringing these concepts from a general idea to a commercially available device through and Technology transfer to external contract manufacturers and subcontractors both in Israel and internationally

Session Details: Synnect™ Smart plunger rod technology for monitoring injections taken at home in clinical trials 14-04-2021, 1:30 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: Medicalization of cannabis in Israel 14-04-2021, 3:00 pm View In Agenda

Biography: Dr. Stela Gengrinovitch founded BioSight on year 2000. Dr. Gengrinovitch has accumulative experience of over 20 years in cell biology, enzymology and biochemistry. Prior to founding BioSight, Dr. Gengrinovitch served as a fellow academic researcher and published several articles in well known scientific journals. Dr. Gengrinovitch also served as a Research and Development Manager at Enzymotec.  Dr. Gengrinovitch holds a BSc degree in chemistry and a PhD degree in biochemistry from the Technion Institute of Technology.

Session Details: A Regulatory Sponsor Guide In Getting Your Product Approved 14-04-2021, 12:45 pm 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: Think Tank: How To Make Your Trial More Efficient By Spending Less 14-04-2021, 11:00 am View In Agenda

Biography: VP Clinical & Regulatory Affairs A Doctor of Veterinary Medicine from the Hebrew University of Jerusalem, Dr. Shalev Stein has nine years of experience as a clinical trials and regulatory affairs leader at innovative medical device companies. Dr. Shalev has led clinical trials at several medical device companies, including Nuvo Group, CarboFix Orthopedics, and Oridion Medical, managing trials from concept to execution, with clinically significant results for FDA and CE approvals (510K and de novo).

Session Details: Fireside Chat: Measuring Device Success In Clinical Trials 14-04-2021, 11:45 am 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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Biography: Aida Bibliowicz has wide-ranging experience in drug development and clinical development international programs. Prior to joining RedHill Ms. Bibliowicz worked as Director, Project Management and Regulatory Affairs at Cato Research Israel, overseeing large multinational clinical studies in various indications. Ms. Bibliowicz holds a M.Sc. in Quality Assurance and Reliability from the Israel Institute of Technology, Technion, and an MBA from the Tel Aviv University.

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Biography: Dina Kofler has been with Medinol since 2013. As VP Clinical Affairs, she leads the clinical department and manages all clinical trial activities including the pivotal trials that constituted the clinical basis for the EluNIR DES’ approval in the United States, Europe and Israel. Before joining Medinol, Dina worked at MediWound Ltd. and prior to that she worked for 14 years at Teva Pharmaceutical Industries Ltd and held various clinical-trial management positions. She holds B.Sc. in Biology from the Tel Aviv University and an MBA from the Herriot-Watt University’s Edinburgh Business School.

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Biography: Irit is the current VP of clinical operations for Gamida Cell. Her tasks include Management of Clinical Department (clinical trial managers) and clinical activities with Clinical Investigators, CRO's and other vendors. Irit and her team design and update the clinical operational strategy Plan. Prior to Gamida, irit was the head of clinical development and Cartiheal

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Session Details: Teva Presentation: How Data Driven Analytics Enables Logistics To Become An Added Value Partner To Supply Chain 14-04-2021, 2:30 pm View In Agenda

Biography: Experienced Clinical Operations Manager with a demonstrated history of working in the pharmaceuticals industry. Broad experience in pharma products development, drug-device combinations, Oncology, Cardiology and Neurology, Good Clinical Practice (GCP), and Biotechnology. Strong operations professional with a MBA focused in Bio medical from College of Management.

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Biography: Shelly is an Experienced Clinical Operations Team Lead at OPKO Biologics, where she currently holds the position as Associate Director. Her Clinical research experience (including pivotal phase 3 studies ) in all phases of study life cycle, including start up, interim and close out. She has wide experience to motivate and integrate teams and teach/mentor team members. Shelly has Expert knowledge of relevant regulations, EDC, IXRS and central labs, including set up and management.

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Biography: Clinical Supply Chain Team Manager & Head of Global Procurement for worldwide clinical studies in accordance with international guidelines and regulations and global procurement for continual improvement, minimizing the time from requisition to delivery/service and cost reduction to ensure sourced material and services meet the needs of the company global projects. Previously - Global clinical supply chain Team Manager for worldwide clinical studies in accordance to international guidelines and regulations. Leading a team who responsible for all aspects related to the drug supplies and RTSM system design. Accountable for drug forecast, manufacturing demands, Packaging&Distribution, RTSM customization to support protocol design and follow local and global regulations

Session Details: 4 Ways How IRT Can Simplify Your Overall Management And Costs 14-04-2021, 12:45 pm View In Agenda

Biography: Extensive expertise in EMC and Safety Design for Medical Devices, Risk Management and Process Development, Regulatory strategy planning and execution for US, EU and global markets. Experience in CT, MR, Ultrasound, EP imaging, Interventional Catheters, Mammo, Molecular imaging. Outstanding success in developing and implementing globally compliant Quality Management Systems for independent and corporate environment activity. Business partner

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Biography: Mgr Clinical Supply Chain Project Management, Global Clinical Operations, Global R&D, TEVA 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.  

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Biography: Michal Klein,  B Pharm , MHA ,   Quality Unit Manager and QP at Roche Israel , Experienced Quality Assurance Manager with a demonstrated history of working in the Pharmaceutical industry and as a GMP/GDP inspector of the  Israeli Ministry of Health Institute for Standardization and Control of Pharmaceuticals

Session Details: Logistic and Quality challenges for IMP release in Israel 14-04-2021, 11:45 am View In Agenda

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• 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 14-04-2021, 1:30 pm View In Agenda

Biography: Aurélie Schwarzbach started her carrier in clinical research about 15 years ago as a CRA in France and then in Israel. She joined Gamida Cell 5 years ago, where she is currently a clinical project manager. Gamida Cell is  a Jerusalem based company that develops an advanced cell therapy treatment based on hematopoietic stem cells expansion  from umbilical cord. This treatment is intended for patients with severe blood disease in need of a bone marrow transplant but who lack a matched donor.

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Session Details: Conducting Clinical Trials Abroad: What Are The Challenges, Advantages And Specifics To Make Sure It’s Successful 14-04-2021, 11:45 am View In Agenda

Biography: Dr‭. ‬Izrael Joined Kadimastem in 2009‭. ‬Prior to joining Kadimastem‭, ‬as part of her doctoral work at the Weizmann Institute of Science in the laboratory of Prof‭. ‬Revel‭, ‬Dr‭. ‬Izrael was a central part of the team that invented and developed the technology which became the basis for Kadimastem’s cell therapy product for Amyotrophic Lateral Sclerosis‭ (‬ALS‭) ‬and other neurodegenerative diseases‭. ‬At Kadimastem she served as‭ ‬the head of the drug screening team‭, ‬based on human oligodendrocytes‭ (‬Myeling forming cells‭), ‬and in 2012‭ ‬was appointed to run‭ ‬the neurodegenerative department at Kadimastem‭, ‬responsible for Kadimastem’s cell product for ALS‭. ‬In 2017‭ ‬she was appointed as VP for Research and Development for ALS and Neurodegenerative Diseases‭. ‬Dr‭.‬‭ ‬Izrael holds a PhD in molecular genetics from the Weizmann Institute of Science and M.Sc‭. ‬in Neurobiology from the Hebrew University of Jerusalem‭. ‬Dr‭. ‬Izrael has published 16‭ ‬scientific papers and patents in the field of neurobiology and development of technologies based on stem cell derivatives for the treatment of central nervous system disease and drug screening‭.

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Session Details: Keynote: Journey To FDA Approval 14-04-2021, 3:00 pm View In Agenda

Biography: Marina Weisfelner is an Attorney at Law specialized in Commercial & Regulatory Law in Biopharmaceutical and Medical Device R&D field. Marina holds an LL.B and Master's degree in Law Studies. Professionally, Marina grew up at Innovative R&D Division in TEVA Pharmaceutical Industries LTD., there she served in operations of multi-national, multi-center clinical trials. Marina also served as an Chief Operating Officer of Clinical & Regulatory Affairs in bio-pharmaceutical start-up. She brought her vast experience in the clinical and regulatory into her legal practice while working as an attorney for the one of the leading Law Firms in the field. As an Attorney she is specialized in commercial and contracts law, focusing compliance with major regulatory authority's guidelines and regulations. Marina also has expertise in the full range of product development stages challenges, such as interactions and contracting with contract manufacturing organizations (CMOs), nonclinical and clinical lab services and other service providers. Marina has a vast experience in identifying and assessing compatibility of contract research organizations (CROs) to Sponsor’s needs and identifying and contracting Key Opinion Leaders (KoLs) in various clinical indications. In addition, in a framework of commercial aspects of bio-pharmaceutical development Marina has an expertise in performing clinical and legal-regulatory due diligence (including Trial Master File reviews) in connection with licensing transactions related to biotechnology, medical devices and pharmaceuticals at all stages of development, and in advising on regulatory aspects and challenges to be expected for potential targets for clients investment, by reviewing and assessing the overall development strategy, both in terms of funding, development status and timelines.

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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

Session Details: CMC 101 For Phase III Clinical Studies 14-04-2021, 10:30 am View In Agenda

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Session Details: Synnect™ Smart plunger rod technology for monitoring injections taken at home in clinical trials 14-04-2021, 1:30 pm View In Agenda

Biography: A courageous Quality Leader with lots of broad experience and the ability to motivate people at the team and individual level. An Innovative, "out of the box" thinker with excellent communication skills.

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Biography: Have over 27 years’ experience in clinical trials management. Prior to joining V-Wave medical as Director of Clinical Affairs i worked at PolyPid as Senior Clinical Development for 1.5 years and worked for 12 years at Medinol Ltd., where i was responsible for leading the operations of the company’s coronary/peripheral/drug-eluting stenting clinical trials. I have also managed various clinical trials at Bristol Myers Squibb (BMS) and Bayer pharmaceutical companies. I hold RN and medical administration degrees from Tel-Aviv University, and an MBA from Herriot-Watt University, Edinburgh Business School.

Session Details: Regional Differences In Patient Recruitment: Working With Sites In The US And Europe 14-04-2021, 2:30 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: Medicalization of cannabis in Israel 14-04-2021, 3:00 pm View In Agenda