Day 2 Stream. Addressing key operational and outsourcing issues for Israeli biopharma and medical device companies engaged in clinical trials

Transcription

1 Day 2 Stream Addressing key operational and outsourcing issues for Israeli biopharma and medical device companies engaged in clinical trials 2016 SPEAKERS INCLUDE; Event Chair Day 1; Dr. Sharon Hashmueli, VP and Clinical Affairs, ccam Biotherapeutics Ltd. Event Chair Day 2 Biopharmaceutical Stream; Tali Amir-Azulay, VP Clinical Research Operations, Immunovative Therapies Event Chair Day 2 Medical Device Stream; Moshe Golan, President and CEO, 3QBD Chen Sagy Bross PhD, Clinical Affairs, EPD-Medical Tali Amir-Azulay, Director of Clinical Operations, Immunovative Therapies Dana Niv, Associate Clinical Operations Manager, Site Management & Monitoring, AbbVie Moshe Golan, President and CEO, 3QBD Ofer Spiegelstein, PhD, Senior Director, Head of Phase-1 & Clinical Pharmacology, Teva Helena Grinberg-Rashi, Chief Clinical and Product Officer, Beta O2 Eran Harary, MD, Senior Vice President of Clinical Strategy, Alcobra Pharma Ltd. Julio Burman, CEO, Hetz Liver Association (European Liver Patient s Association) David Nakar, Clinical and Regulatory Affairs Project Manager, Valtech Cardio Israel Citron, Vice President of Quality Assurance & Regulatory Affairs, Aspect Imaging Dr. Ravit Geva, Medical Oncology Specialist, Head, Research Unit, Tel-Aviv Sourasky Medical Center Yael Gothelf, Vice President of Scientific and Regulatory Affairs, BrainStorm Cell Therapeutics Shirley Giorini Silfen, VP Clinical and Regulatory Affairs, Rainbow Medical Investment Company Nahum Rosenberg, CEO, Sheltagen Medical Yossi Mazel, CEO, Orbix Medical Iddo Peleg, Director of Clinical Operations, Gamida Cell Elizabeth Tarshish, Senior Regional Clinical Trial Manager, Teva Bernard S. Green, PhD, CSO, Semorex Inc. Nadav Kidron, CEO, Oramed Pharmaceuticals Dov Shimon, CEO, Qray Medical Solomon Babani, Vice President, BioPharma Solutions, Covance

2 Outsourcing in Clinical Trials Israel 14 th 15 th March 2016 Tel Aviv Day Two 08:30 Registration and refreshments The day will be split into 2 streams, and include sessions focussed on both medical device trials and biopharma trials. Please attend the presentations more appropriate for you. 9:00 Biopharma Stream Delving into monitoring methods for your trials to determine which partner is in-line with your operational objectives Pinpointing best practice in collaboration with your CRO partner Establishing a strong sponsor-vendor relationship for the future to ensure familiarized processes and strong best practices for conducting clinical trials Highlighting how set procedures with your preferred CRO vendors can help to reduce trial timelines and ensure clinical trial efficiency Recognizing CRO partnerships can offer you the chance to work alongside preferred vendor personnel at a site level to optimize the communication process Taking into account the time saved during a new trial start-up with a preferred vendor due to familiar processes and personnel Delving into how you can overcome the limitations of preferred vendors by Medical Device Stream Analysing medical device trial start-ups to identify key factors to consider for small device companies Delegates to attend biopharma stream

3 selectively outsourcing to other vendors within certain areas Eran Harary, MD, Senior VP, Clinical Strategy, Alcobra Ltd. 09:30 Reviewing the quality of existing clinical trial sites within Israel, and their capabilities for hosting early phase trials A site s perspective Delegates to attend biopharma stream Establishing how recent reforms by the Ministry of Health has led to a more streamlined application process for trial start-ups Integrating on-site investigators into your processes to help gain expert assistance from sites for your clinical trials Reviewing the wealth of sites available to start-up companies in Israel to identify local eligible sites for early phase studies Highlighting the importance of reaching out to site investigators to safeguard the day-to-day processes of the trial Emphasizing the highly trained medical professionals available at hospitals and academic institutions who are well positioned to assist and manage trials Dr. Ravit Geva, Medical Oncology Specialist, Head, Research Unit, Tel-Aviv Sourasky Medical Center 10:00 Paperless Clinical Trial: Integrating EDC and EHR systems Identifying the importance of detailed Experiences outsourcing medical devices within Europe and the US; key challenges and differences

4 and in-depth planning of data collection to ensure the reduction of paper records generations thus dramatically reducing the follow-on need for SDV Examining the potential cost and time saving which could be achieved by utilizing data integration systems Preparing the required in-house and outsourced infrastructures to ensure the reliability, quality, integrity, and traceability of a well-organized and easily accessible clinical data Ensuring effective exchange of data between clinical trial sponsors and CROs during all trial phases Tali Amir-Azulay, VP Clinical Research Operations, Immunovative Therapies Considering non-vendor partnerships prior to CRO selection to help save costs on feasibility studies Identifying CROs that match with your company culture to ensure a good sponsor-vendor relationship Addressing the regulatory differences in the US and EU and Ensuring speed by allowing CROs to focus on core competencies, while using in/outsourcing as a flexible resource solution Highlighting the benefits of continued vendor partnerships for trial timelines if your trials are well run Chen Sagy Bross PhD, Clinical Affairs, EPD-Medical 10:30 Morning refreshments and networking 11:00 Focussing on emerging markets to identify where patient enrolment and foreign vendor selection can take advantage of growing pharmaceutical industries Selective Outsourcing Case Study; A new approach to diagnosis of invasive fungal infection Diagnosis of invasive fungal infection (IFI) is a widely recognized need Semorex demonstrated an IFI diagnosis approach based on the fungal biomarker ergosterol Development of a commercial kit requires ousourcing, including: Synthesis of reagents, including internal standard for mass spectral analysis Company to prepare prototype and Delving into strategies which will ensure you source the right partner for your medical device trials Indentifying how to prioritize resources appropriately to help establish infrastructure and stability for the growth of a medical device company Making the most of limited resources during your medical device studies Spotlighting methods to work economically with limited resources to help your studies progress Moshe Golan, President and CEO, 3QBD

5 subsequent commercial kits Coordinator for hospital-supplied clinical samples Company to provide advice/assistance in obtaining regulatory (CE mark) approval Bernard S. Green, PhD, CSO, Semorex Inc. 11:30 Keynote Presentation; Building a comprehensive consortium of partners to apply for an EU grant or to complement clinical trials Spotlighting the grants available to Israeli sponsor companies seeking to run their trials in Europe Highlighting the added benefits of involving multiple supporting bodies in your consortium for the benefit of your clinical trials Incorporating associations and advocacy groups within your consortium to help build your knowledge base for your clinical operations Identifying how a strong consortium of partners to help build and strengthen your application for an EU grant Examining the breakdown of a an EU grant and what this could mean for your clinical operations Judi Felber, Associate, Agora Partners Reviewing the hybrid model of outsourcing to determine when it can be used to optimize your clinical operations Thoroughly reviewing existing in-house structures to explore whether hybrid outsourcing is an option for your trials Reviewing hybrid outsourcing as a new strategic way that companies can do business and potentially reduce costs Highlighting that correctly used outsourcing hybrid models have the potential to optimize performance of your clinical trial operations Sourcing the appropriate vendors for your outsourced procedures within due time to ensure trials remain on time Implementing a strong communication network between sponsors working inhouse and vendors to ensure trial operations are run efficiently Helena Grinberg-Rashi, Chief Clinical and Product Officer, Beta O2 12:00 Lunch and networking

6 13:00 Spotlighting patient recruitment within Israel; Case Study from the Hetz Liver Association The Hetz Association is a non-profit organization set up to help support the rights of liver disease patients. The main goals of the group include; Diagnosis of as many people with viral Hepatitis in Israel as possible Ensuring optimal treatment of patients Promotion of public awareness and advocacy activities for the prevention, diagnosis and treatment of disease and for tackling the stigma associated with it Raising awareness of hepatitis related issues among the public and decision makers, as well as other activities to improve patients' health and quality of life Julio Burman, CEO, Hetz Liver Association (European Liver Patient s Association) Panel Discussion; Focusing on the best ways to design a medical device study based on stats Analysing the most appropriate Points of Entry (Points of Assessment) to use in advance of the study to ensure you will be able to produce valid results Evaluating which hybrid end point testing you will use, and identifying how this will be measures Defining how you will measure and establish your Primary endpoint during pre-trial planning Reviewing the importance of your Secondary endpoint to trial success to evaluate the need for trial re-runs Yossi Mazel, CEO, Orbix Medical Tal Lavi, Clinical Trial Manager, Check-Cap Ramot Yair MSC, Biovo Technologies, COO & VP R&D 13:30 Delving into the best ways of carrying out site management at different locations to improve the performance of your trials Reviewing the need to develop a broad and inclusive project management structure which places clinical sites at the core of your operations Preparing thorough and consistent QA checks on current vendor activity at your sites to ensure they are working to the required standards Focusing on ways that vendors are collecting and analyzing data at sites to ensure the information can be matched Live Interview with a Medical Device Expert: Interactive interview from an innovative medical device company hosted by conference Chair. Highlighting common pitfalls in the medical device start-up process, and advice on how to steer away from funding problems Evaluating steps taken to secure a good early phase site which can offer a start-up the academic assistance it needs Sourcing patients for your medical device trial from the best locations; Case study example from Israel and beyond Shirley Giorini Silfen, VP Clinical and Regulatory

7 with your trial objectives Affairs, Rainbow Medical Investment Company Planning the timing and duration of follow up meetings to ensure there is a thorough review of CRO activity at your sites, and meetings between key trial partners Elizabeth Tarshish, Senior Manager, RCTM, Teva 14:00 Afternoon break and refreshments 14: Speaker Hosted s 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 3 roundtables Weighing up the benefits of using partial of full remote based monitoring on a case by case basis David Nakar, Clinical and Regulatory Affairs Project Manager, Valtech Cardio Discussing the range of EU grants available to pharma and biotech companies in Israel to help small start-ups source the funds they need for hosting clinical trials Nahum Rosenberg, CEO, Sheltagen Medical Establishing QA models which allow sponsor companies to spot struggling CROs before timelines are affected - Dana Niv, Associate Clinical Operations Manager, Site Management & Monitoring, AbbVie Assessing the cost effectiveness and capabilities of Virtual CROs to smaller biotechs in an increasingly online world Nadav Kidron, CEO, Oramed Pharmaceuticals 16:00 Close of conference