Outsourcing Clinical Trials Israel 2020

Biography: Isaac Israel has served as Kitov’s Chief Executive Officer and a member of the board since 2012. Prior to joining Kitov, Mr. Israel founded BeeContact (formerly TASE: BCNT) and served as CEO from 2001 to 2007. Mr. Israel has served as owner and founding CEO of Uneri Capital, a capital market consulting firm specializing in healthcare, since 2008. He serves on the board of various public and private healthcare corporations, including chairman of the board of NextGen Biomed, which is traded on the TASE.

Session Details: Keynote: Journey To FDA Approval 17-03-2020, 3:00 pm View In Agenda

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 18-03-2020, 10:00 am 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

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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.

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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 17-03-2020, 4:30 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 17-03-2020, 12:00 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 18-03-2020, 11:00 am Speaker Hosted Roundtables 18-03-2020, 1:30 pm 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 18-03-2020, 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.

Session Details: PANEL DISCUSSION – Taking Steps To Develop That Successful And Long Lasting Partnership 17-03-2020, 4:30 pm View In Agenda

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.

Session Details: Top Three Tips In Managing Your Finances More Efficiently 18-03-2020, 9:00 am View In Agenda

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.

Session Details: Duo Session: Partnering With The Perfect CRO: What To Look For When Making The Big Decision 17-03-2020, 9:00 am PANEL DISCUSSION: Learning from Start-Up Medical Device’s Success Stories 18-03-2020, 11:00 am View In Agenda

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

Session Details: Regional Differences In Patient Recruitment: Working With Sites In The US And Europe 18-03-2020, 10:00 am View In Agenda

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Session Details: Logistics Processes Based On Combined Supply Chain And Logistics Data 17-03-2020, 3:00 pm View In Agenda

Biography: Experienced Global Category Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in U.S. Food and Drug Administration (FDA) regulations in the Clinical Trials area, Oncology, CNS and Pain , CRO Management and supply chain for Clinical Trials. Strong operations professional with a Master in Health Administration focused in Health/Health Care Administration/Management from Tel Aviv University.

Session Details: Sourcing Everything But The CRO: Identifying The Services Needed That Your CRO Hasn’t 17-03-2020, 11:00 am 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.

Session Details: Managing Your Global Sites More Efficiently 17-03-2020, 11:00 am View In Agenda

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.

Session Details: 5 Considerations Needed For A Successful Clinical Trial In Rare Diseases 17-03-2020, 10:00 am 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 17-03-2020, 12:00 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

Session Details: Deep Dive Into The Medical Device Regulation: What You Need To Know 18-03-2020, 9:00 am PANEL DISCUSSION: Learning from Start-Up Medical Device’s Success Stories 18-03-2020, 11:00 am View In Agenda

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: Speaker Hosted Roundtables 18-03-2020, 1:30 pm View In Agenda

Biography: CURICULUM VITAE  Tina Conkic DOB: 17.11.1968, Belgrade, Serbia Phone +972525282873; e-mail: tinaconkic@gmail.com Address: HaHalutz 46/8 Nahariya Israel Professional skills:

• 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...)

 Personal skills:          High ability of learning, approaching and adapting to new environment, communicative with excellent personal skills. Languages: Hebrew (written & spoken) English (written & spoken) Serbian (written & spoken, mother tongue) French  (written – basic knowledge) Spanish (written – basic knowledge) Professional experience: March 2010. – Present: Protalix Biotherapeutics Drug accountability coordinator / Manager

• Establishing GCP based documentation system for CTM / IP use within Clinical Trials

(Including writing Clinical Trial documents relating to CTM / IP)

• Monitoring Clinical Trial Materials use for compliance with GCP

(by either performing monitoring visit reports at sites or reviewing and approving monitoring visit reports from subcontractor CRA/monitors)

• Training clinical trial personal and/or CRA/monitors
• Shipping validation planning according to GMP / GDP / GCP

May 2007. – March 2010: Protalix Biotherapeutics QC laboratory Team Leader

• Team management
• HPLC methods development and validation
• TOC method development and validation
• Establishing system for raw material quality control

(development of methods for raw material identification by Raman Spectrophotometer) January 2006. – May 2007: Protalix Biotherapeutics QC manager

• Establishing Quality Control laboratory within bio-technology start-up company
• Pre-validation analytical/biochemical R&D method change to QC laboratory and GMP standards
• Team management

October 2004. – December 2005: Shemen Industries Laboratory  manager

• Laboratory team management
• Management of central laboratory providing services for five factories from “Shemen” industry group, performing analysis of vegetable oil (soy, corn, sunflower, canola, palm, olive), soy meal, soy protein, margarine and soy lacityn.

May 2001. – October 2004: Shemen Industries Analyst in chemical laboratory

• Performing analysis of final product (vegetable oil, soy meal, soy protein) and in-process product
• Establishing new laboratory facilities (purchasing, verification and use of new analytical equipment, including SOP preparation and team training)
• Development and verification/validation of analytical methods (GC, HPLC, NIR IR, Keidahl, Fibertec…) for analysis of food products and water.
• Writing and implementing SOP according to ISO.

July 2000. – May 2001: Tambour Colour Industry Analyst in in-process laboratory

• Performing analysis of in-process and final powder color product
• Performing analysis for product development
• Working according to the ISO 9002

September 1996. – July 2000: Dexxon pharmaceutical Industries Analyst/team leader in clinical laboratory

• Developing and validation of analytical methods for blood/plasma analysis within bioequivalence clinical studies
• Preparing Protocols and Reports for bioequivalence analytical results
• Performing analysis on GC (ECD), HPLC (UV, FLUO)
• Working according to GLP

Education: June 2010:       CRA qualification course, Bioforum, Israel 1997 – 2005:   Numerous professional courses in field of HPLC and GC 1984 - 1987.      Chemical technician Dr Dusica Stefanovic high school, Belgrade, Serbia Recommendations will be provided as required.

Session Details: Examining Drug Accountability In Clinical Trials 17-03-2020, 1:45 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.

Session Details: PANEL DISCUSSION – Taking Steps To Develop That Successful And Long Lasting Partnership 17-03-2020, 4:30 pm View In Agenda

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Session Details: Digital Tools And Social Media Optimization To Enhance Patient Recruitment 17-03-2020, 4:00 pm View In Agenda

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Session Details: Conducting Clinical Trials Abroad: What Are The Challenges, Advantages And Specifics To Make Sure It’s Successful 18-03-2020, 11:30 am View In Agenda

Biography: Chava is an experienced professional in the life science industry. She have fulfilled various positions in different types of companies, and has contributed my unique and multidisciplinary point of view. Chava have started as an engineer, and due to her interest in business development and strategy, she have obtained a degree in Business Analytics and Strategic Management from the University of Manchester (UK). Using her recent education, she is a Product Manager in the drug delivery arena. As part of her experience in leading a development project for a cardiovascular medical devices company, Chava has gained a proven track record for launching a combination drug-device product, and a profound know-how of manufacturing and regulation.

Session Details: Synnect™ Smart plunger rod technology for monitoring injections taken at home in clinical trials 18-03-2020, 11:30 am 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.

Session Details: Duo Session: Partnering With The Perfect CRO: What To Look For When Making The Big Decision 17-03-2020, 9:00 am Privacy Regulations: What You Need To Know When Dealing With Companies Outside Of Israel 17-03-2020, 4:30 pm View In Agenda