2019 Speakers Confirmed:

Transcription

1 2019 Speakers Confirmed: Sharon Goldfarb, VP Regulatory & Clinical, GI View Avraham Biran, Director Clinical, Regulatory & Quality, BlueWind Medical Tsvia Erlich, VP Regulatory & Clinical Affairs, ConTIPI Ilana Lorber, Medical Director, NeoTX Noa Kirshenboim, VP Clinical Operations, PolyPid Tali Amir-Azulay, Head of Biometrics & Clinical Operations, Sol-Gel Izrael Citron, VP RA & Clinical, Aspect Imaging Linda Marshall, Regional Clinical Site Lead, Pfizer Yair Manor, Clinical Director, Lumenis Irit Gliko-Kabir, Senior Director of Clinical Operations, BioLineRx Shirley Giorini-Sifenm Chief Regulatory & Clinical Officer, Rainbow Medical Investment Fund Michal Izrael, VP R&D, Kadimastem Yonni Shem-Tov, Director of Business Operations Global Clinical Operations, TEVA Tina Conkic, Drug Accountability Manager, Protalix Biotheraputics Aurelie Schwarzbach, Clinical Project Manager, Gamida Cell Marina Weisflender, Head of Clinical & Regulatory Affairs, Amorphical Pnina Strauss-Levy, VP Clinical & Regulatory Affairs, Intec Pharmaceuticals Orly Weinreb, R&D Neuroscientist, Independent Edith Dekel, Director of Clinical Operations, Ayala Pharmaceuticals Dudu Rigler, VP Clinical Research & Regulation, Nano Retina Guy Ben-Bashat, Director of Clinical Affairs, OPKO Biologics TBC, Ministry of Health Israel Yoram Cohen, Senior Director Supply Chain, Protalix Biotheraputics Sagit Pinto-Finkel, Director of Clinical Finance, OPKO Biologics

2 Outsourcing in Clinical Trials Israel Day 1 12 th March :20 Registration and refreshments 8:50 Chair s opening remarks 9:00 Divulging The Tools Used To Drive Vendor Engagement Demonstrating budget management strategies to ensure trials remain on budget Promoting the use of realistic KPIs when measuring the success of your CRO to ensure trials remain on time Exploring recent trials to understand how strong communication has driven multiple vendors working harmoniously Pinpointing the tools to use to manage international trials to ensure vendors remain engaged Using various vendors to meet requirements to detail the need to use specialist tools when managing multiple vendors Yonni Shem-Tov, Director of Business Operations Global Clinical Operations, TEVA 9:30 for PRA Health Sciences 10:00 Emphasizing Tactics & Best Practice Employed To Drive Inspection Readiness An overview of Good Clinical Practice standards, to ensure readiness for site inspections Evaluating how to ensure vendors conform to best practise and keep within standard guidelines Implementing a culture of inspection readiness across your team and partners, to drive clinical quality Discussing methods and solutions to ensure better documentation management, enabling inspection readiness Linda Marshall, Regional Clinical Site Lead, Pfizer 10:45 Morning refreshments and networking

3 11:15 Case Study: Designing Patient-Centric Trials To Reduce Early Termination Rates Highlighting the importance of implementing a patient retention strategy to reduce early termination rates Exploring the main causes of patients exiting the trial early, to address and tackle this in future trials Determining how to reduce patient recruitment & retention costs whilst still ensuring successful completion Investigating what large, medium & small organisations are doing to reduce early termination rates what s best for you? Izrael Citron, VP RA & Clinical, Aspect Imaging 11:45 12:15 Defining Regulatory Pathways For Orphan Drugs The Full Picture Reviewing the FDA & EMA s current guidelines for Orphan Drugs, how do these differ? Concluding the differences in guidelines between FDA & EMA frameworks to ensure compliance in multiple territories Presenting the challenges faced when conducting clinical trials for orphan drugs to determine how to meet current regulatory standards Assessing the best vendors to engage with for orphan drug clinical activities to ensure clinical success Michal Izrael, VP R&D, Kadimastem 12:45 Delving Into Israel s Clinical Landscape How To Ensure Smooth Study Start-Up & Avoid The Common Pitfalls Exploring pros and cons of hosting phase 1 clinical trials in Israel to discuss what could be done to improve data collected Comparing the use of local vs international vendors to ensure clinical success in Israel Assessing your internal expertise to identify which aspects to outsource to make the most of your in-house abilities Generating an awareness of the costs involved when starting your clinical trial in Israel how to manage these from the beginning Noa Kirshenboim, VP Clinical Operations, PolyPid

4 1:15 Lunch and networking 2:15 Managing Multiple Vendors How To Increase Collaboration For Optimal Results Identifying differing outsourcing models to balance which works best for each trial sponsor Lessons learnt from previous trials to counter what went wrong and how to improve this Unlocking communication between different vendors to conclude what tactics can be adopted to improve this Reviewing common mistakes made when dealing with multiple vendors to ascertain different management tools to improve this Ilana Lorber, Medical Director, NeoTX 2:45 3:15 Case Study: Working With Multiple CROs Defining the common challenges faced when working with multiple vendors to plan ahead Evaluating budget management strategies when working with multiple CROs Highlighting best practice adopted during clinical trials to help multiple CROs work coherently Insight from Gamida Cell analysing recent clinical trial operations when working with multiple CROs & Vendors Aurelie Schwarzbach, Clinical Project Manager, Gamida Cell 3:45 Bringing Quality Assurance Front-Of-Mind To Improve Trial Results Developing water-tight quality assurance strategy to ensure FDA audits are successful Understanding GDP audits, their purpose and importance to improve clinical quality Engaging with audit consultants to perform essential regulatory compliance work the pros & cons Adopting auditing as a tool to manage and improve the quality of CROs Tsvia Erlich, VP Regulatory & Clinical Affairs, ConTIPI

5 4:15 Afternoon refreshments and networking 4:45 Developing Patient Recruitment Strategies To Enable On Time Trial Launch Evaluating relying on your CRO to enrol patients, to ascertain how to ensure this is done on time and on budget Investigating the use of dedicated patient recruitment vendors, cost vs. control can this enable an on-time launch Contractually manging your CRO to include milestones & targets which can contribute to an on time & on budget trial Highlighting digital media trends, to review whether using social media can help you meet your patient quota Tina Conkic, Drug Accountability Manager, Protalix Biotheraputics 5:15 5:45 Evaluating Clinical Trial Models Highlighting the key challenges associated with standardized trials and how collaboration with other sponsors can be beneficial Outlining your CRO selection process including how to evaluate their level of experience Pinpointing best practices for specialist patient recruitment and engagement in order to prevent study start-up delays Edith Dekel, Director of Clinical Operations, Ayala Pharmaceuticals 6:15 Chair s summation and close of conference 6:20 Drinks Reception Sponsored by Clinical Trials Arena Outsourcing in Clinical Trials Israel Day 2 13 th March :45 Registration and refreshments

6 09:20 Chair s opening remarks DATA PROTECTION WORKSHOP Join this morning session to address data protection concerns within Israel and the wider international trial landscape. Split into 2 distinct sessions, you will learn and discuss data protection compliance for both GDPR and Israeli Privacy Law to ensure compliance at vendor contracting and patient enrollment stages Overcoming Key Differences Between GDPR & Israeli Privacy Law Developing an understand of both GDPR & Israeli Privacy Law, to reflect on which aspects effect your clinical trials Defining the key differences and conflicts between both laws to ascertain how this may cause invalid contracts Assessing the impact of GDPR & Israeli Privacy Law on international trials conducted by Israeli companies, how can this be addressed Highlighting the danger of sharing patient data, internally and externally for regulatory approvals 10:15 Vendor Israeli Data Law (Lawyer/ Consultant) Evaluating The Impact Of EU GDPR On Global Clinical Trial Operations Identifying the key changes to adopt in the wake of GDPR when designing contracts Discussing best practices for collecting patient data, to identify what level of consent is required Running internal systems and databases, identifying if your data security measures meet GDPR requirements Submitting data for regulatory approval, what consent do you need Understanding the effect GDPR has on European citizens residing internationally, do these rules still apply? 10:45 Morning refreshments and networking

7 Stream A: Outsourcing & Clinical Operations Stream B: Clinical Technology & Data Management 11:15 Combination Products: Handling Hard-To- Manage Studies The challenge of implementing clinical requirements in the development process Addressing key challenges faced when operating clinical trials for combination products to learn from past mistakes Understanding the regulatory issues faced when submitting a combination product for approval Establishing methods to obtain regulatory approval to enable swift movement between phases Exploring the increased use of incorporating complex technology to understand the growing market trend Emphasizing Israel s position as a technology leader to develop state-of-the-art medical devices Spotlighting the regulatory challenges of incorporating AI into Medical Devices, what s the FDA s view on this? Yair Manor, Clinical Director, Lumenis Dudu Rigler, VP Clinical Research & Regulation, Nano Retina 11:45 12:15 Jetting-Off: Unlocking The Advantages & Disadvantages Of International Trials Utilizing Integrated etmf Management For Effective Clinical Trial Management Exploring the benefits of conducting phase 1 trials in Israel against international locations to keep initial costs at a minimum Identifying international trial location trends to assess the best markets for different therapeutic areas Highlighting case studies from the far east and Africa to review key challenges faced when conducting trials in these markets Identifying the regulatory challenges of working in different regulatory environments Pinpointing the regulatory data demands of FDA and EMA when working in non- EU/US locations Exploring current etmf solutions available on the market to ascertain which are best for your trial Identifying trends across big pharma to develop own custom systems the pros and cons Highlighting the specific challenges faced by smaller companies when implementing an etmf to devise strategies to manage this Identifying the challenges of etmf integration with other data management systems Pinpointing the need to allocate a TMF Owner to ensure you are inspection ready Identifying how etmf can ensure on time study start-up to improve overall trial efficiency

8 Izrael Citron, VP RA & Clinical, Aspect Imaging Orly Weinreb, R&D Neuroscientist, Independent Sagit Pinto-Finkel, Director of Clinical Finance, OPKO Biologics 12:45 Lunch and networking 1:45 Phase 1: What To Consider When Enlisting A CRO Discussing how to choose the right CRO, what to ask and what to watch out for New to clinical trials beginners tips for managing CROs & multiple vendors Lessons learnt from experience, and how to avoid them in future trials Tali Amir-Azulay, Head of Biometrics & Clinical Operations, Sol-Gel Tackling Payment Issues Across Multiple Study Sites Pinpointing the advantages of implementing ECRS into your trial operations strategy to streamline payments Promoting the operational challenges faced when working with multiple sites to understand what tech solutions can be used Collaborating with suitable solution providers to streamline finance processes and contribute to the success of the trial Guy Ben-Bashat, Director of Clinical Affairs, OPKO Biologics Sagit Pinto-Finkel, Director of Clinical Finance, OPKO Biologics 2:15 2:45 Why Do Patients Take Part In Clinical Trials? Evaluating key drivers to persuade patients to take part in trials Working with a CRO to identify a suitable strategy for recruiting patients Assessing the advantages of using a specialist patient recruitment firm to ensure your trial is a top priority Sharon Goldfarb, VP Regulatory & Clinical, GI View Unlocking The Power Of Big Data: Accelerating Clinical Trial Timelines Exploring the impact big data will have on study design and execution Discussing the varied uses of big data applications to provide more accurate data Assessing the cost benefits of using big data analysis when presenting to regulators Shirley Giorini-Sifenm Chief Regulatory & Clinical Officer, Rainbow Medical Investment Fund 3:15 Afternoon refreshments and networking

9 3:45 Speaker Hosted Roundtables Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables RT 1 RT 2 RT 3 Vendor management: How do you build trust with your partners? - Yoram Cohen, Senior Director Supply Chain, Protalix Biotheraputics Which country should you run your clinical trial next? Choosing the right CRO sharing experiences 4:45 Chair s summation and close of conference