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 12-04-2021, 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 12-04-2021, 1:15 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: Medicalization of cannabis in Israel 12-04-2021, 2:15 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 12-04-2021, 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 12-04-2021, 9:30 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).

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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: Teva Presentation: How Data Driven Analytics Enables Logistics To Become An Added Value Partner To Supply Chain 12-04-2021, 2:15 pm View In Agenda

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 12-04-2021, 12:45 pm View In Agenda

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: Adapting Your Labeling Creation Process In a Changing Environment , View In Agenda

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

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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 12-04-2021, 1:15 pm 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

Session Details: CMC 101 For Phase III Clinical Studies 12-04-2021, 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 12-04-2021, 1:15 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: Medicalization of cannabis in Israel 12-04-2021, 2:15 pm View In Agenda

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Biography: Josh Hexter joined Oramed (NASDAQ: ORMP) as Chief Operating & Business Officer in the fall of 2019. He brings to Oramed more than 20 years of prominent leadership, business development, operations know-how and management in biotechnology and medical devices. Prior to joining Oramed, Josh was the Chief Business Officer at BrainsWay (NASDAQ: BWAY). Prior to BrainsWay Josh was the Chief Operating Officer at Oramed (NASDAQ: ORMP) and prior to that he was the Executive Director of Corporate Licensing at BioLineRx (NASDAQ: BLRX). Before joining BioLineRx, Josh worked in private equity and venture capital and served as CEO of a VC-backed startup.

Session Details: PANEL DISCUSSION – Taking Steps To Develop That Successful And Long Lasting Partnership 12-04-2021, 1:15 pm View In Agenda

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Session Details: Q&A: Considerations Needed For A Successful Clinical Trial 12-04-2021, 2:45 pm View In Agenda

Biography: Peter MacLennan, TCRS CEO, is an experienced professional with a track record of success in academia, pharma, biotech and CROs. He has in-depth knowledge of clinical development with an emphasis on risk management, project governance, metrics, and budgeting. With his TCRS colleagues, his task is to ensure that our clients’ objectives are delivered on time, on budget and to the highest standards of quality.

Session Details: Clinical Trials in the UK: Positive Benefits from COVID and Brexit? 12-04-2021, 12:15 pm View In Agenda

Biography: Beenu Kapoor is a creator of platform technology products leveraging her Business Operations, IT, Product Development and Consulting skills to augment digital transformation in R&D Clinical Development. Beenu has more than 25 years of experience focused on driving business outcomes by defining and implementing strategies, roadmaps, solutions involving innovative business operating models, process redesign and technology digitization agenda. She is currently serving as a leader on the IQVIA Technology team responsible for IQVIA’s Trial Management Product Suite

Session Details: Clinical Trial Management Systems and The Next Era of Unparalleled Data Integration, Seamless Connectivity and Intuitive Design. 12-04-2021, 11:00 am View In Agenda

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Session Details: Patient Journey In Cell and Gene Therapy 12-04-2021, 1:45 pm View In Agenda

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Session Details: Reducing Risk with Temperature Excursion Management in IRT 12-04-2021, 12:15 pm View In Agenda

Biography: As Clinical Supply Chain Solutions Consultant, Henk currently assists Suvoda with his deep knowledge in various areas of clinical trial supply management. Prior to Suvoda, he co-founded the clinical trial supplies department at Grünenthal GmbH and served as its Associate Director for 10 years. While at Grünenthal, he developed operational processes and championed risk management procedures to establish the company as a clear market leader in the area of clinical supply chain. More recently, Henk served as Senior Investigational Medicinal Product Manager at BioNTech SE, where he streamlined data processing operations in the clinical supply chain for personalized oncology therapies. Henk is well-regarded in the field for his expertise in IRT, temperature excursion management, and direct-to-patient logistics. In addition, he is very experienced in conducting supplier audits, having participated in more than 30 audit visits as a technical expert. He holds a Bachelor of Science degree from Zuyd University of Applied Sciences in Physiotherapy.

Session Details: Reducing Risk with Temperature Excursion Management in IRT 12-04-2021, 12:15 pm View In Agenda

Biography: I am the Founder and CEO of MedicSense Ltd., a Clinical and Regulatory Affairs consultancy firm that specializes in assisting companies to navigate through the international clinical and regulatory maze. With more than twenty years of experience, I specialize in developing company-tailored clinical and regulatory strategies, meet technical and regulatory demands for your products, guiding you through specific technological requirements and best practices for the collection of clinical data. My previous experience includes managing clinical and regulatory affairs departments in both well-established and start-up companies.

Session Details: Usability Evaluation of Medical Devices 12-04-2021, 12:15 pm View In Agenda

Biography: With over 15 years healthcare industry sales experience, I am strongly passionate about biotechnology, and clinical trials. I currently work for Novotech, the Asia Pacific CRO. Contact me to learn more about my experiences serving clients, and conducting clinical trials in the Asia Pacific region.

Session Details: Asia Pacific: The Solution for Accelerating your Clinical Trial Program 12-04-2021, 10:00 am View In Agenda

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Maliha Haider is the Director of Data Management at Axiom Real-Time Metrics, where she oversees Data Management of clinical trials from study start up to close out. She has over 10 years of experience in creating and maintaining Data Management Plans, Case Report Forms and Data Integrity Plans along with a

comprehensive understanding of clinical studies in multiple therapeutic areas, EDC Configuration, eCRF Design and Project Management.

Session Details: Unified Platforms: Key Modules and Data Considerations For Study Success 12-04-2021, 2:00 pm View In Agenda

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Kaitlyn Townsley is the Associate Director of Product Innovation at Axiom Real-Time Metrics Inc., where she continually innovates Fusion eClinical Suite and related technologies to support the evolving technological needs of Clinical Trials as Studies increase in complexity, maintaining the balance between an easy and intuitive platform, and providing Sponsors with the complex tools they require to run their Clinical Programs.

Session Details: Unified Platforms: Key Modules and Data Considerations For Study Success 12-04-2021, 2:00 pm View In Agenda

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Session Details: Clinical Trial Management Systems and The Next Era of Unparalleled Data Integration, Seamless Connectivity and Intuitive Design. 12-04-2021, 11:00 am View In Agenda