7 th Annual Clinical Data Integration & Management March 20 th 21 st Princeton, NJ

Transcription

1 7 th Annual Clinical Data Integration & Management March 20 th 21 st Princeton, NJ 2018 Speaking faculty Audrey Hill, Senior Director, Data Management, Advaxis Abhijit Parab, Director, Clinical Data Management and Programming, Allergan Barbara Skinn, PhD, RN, Operations Portfolio Lead, Immuno-Oncology, BMS Sam Hume, DSc, Head of Data Exchange Technologies, CDISC Eric Hillaert, Senior Director of Product Development, Analytics, EDETEK Jude Burger, Advisor, Clinical Information and Process Automation Monitoring, Eli Lilly J. Leigh Kerr, Former Director and Head of Clinical & Business Operations, Endo Pharmaceuticals Dr. Susanne Kolbmann, Senior Manager BD, Inamed Swapna Bapat, IT Manager BTL, Clinical R&D IT, The Janssen Pharmaceutical Companies of Johnson & Johnson Robert Spicer, Senior IT Manager, Clinical R&D IT, The Janssen Pharmaceutical Companies of Johnson & Johnson Terrence O. Tormey, CEO, Kibow Biotech Kimberly Dorsch, CCRP, CRCP, Program Director, LifeNet Health Kumar Komuravelli, Director, Clinical Data Management, Mallinckrodt Pharmaceuticals Wenle Zhao, PhD, Professor in Biostatistics, Medical University of South Carolina Caroline Manning, Associate Director, Headquarters Clinical Quality Management, Merck Rosanne Petros, Associate Director, Clinical Research Manager, Merck Research Lab Patrick Zbyszewski, VP, Data Management, Onconova Pharmaceuticals Chris Grady, Associate Director, Clinical Data Management. Progenics Pharmaceuticals Shari DeVore, Senior Manager, Sanofi Data Expert Services Dr. Georgia Mitsi, Sr. Director Search & Evaluation, Digital Healthcare Initiatives, Sunovion Pharmaceuticals Lindsey Mathew, Director, Clinical Operations, Valeant Pharmaceuticals

2 Clinical Data Integration & Management March 20 th Program Day One 08:30 Registration and refreshments 09:15 Chair s opening remarks Analyzing the impact of new technology on a clinical trial - A site and CRA perspective 09:30 Clarifying advantages and challenges associated with introducing new data collection technology at the trial site Studying the impact to the Site Monitoring Plan and the Data Management Plan Revealing Institutional Review Board and Ethics Committee considerations when incorporating technology into a clinical trial Presenting case studies outlining the development of a training program to ensure successful incorporation of the technology Kimberly Dorsch, CCRP, CRCP, Program Director, LifeNet Health Making decisions on the basis of key safety result listings during dose-escalation studies: technical procedures, involvement of external DSMBs, and strategies to speed up the process 10:00 Reviewing study types where serial dose-escalation meetings are required Integrating safety review processes alongside the persons involved Studying technical procedures: extraction of key safety data from data base versus manual transcription from source data Looking at quality aspects: data monitoring, data cleaning; clean data versus unclean (but doublechecked) data Stressing the importance of drug exposure data Dr. Susanne Kolbmann, Senior Manager BD, Inamed

3 Discussing Robotic Process Automation (RPA): An emerging technology that will enable virtual workforces within organizations to improve productivity and efficiency responding 10:30 Exploring what RPA is and how it can help my business Assessing what the strengths and limitations of RPA are and what complementary technologies are available Reviewing what I should consider before starting with RPA Robert Spicer, Senior IT Manager, Clinical R&D IT, The Janssen Pharmaceutical Companies of Johnson & Johnson Case Study: Activating a clinical data strategy using a clinical data intelligence hub 11:00 What is a successful data strategy for a mid-size pharmaceutical organization? Why is a solid data strategy important? What does a data strategy look like and what are the key components that it contains? Who is responsible for defining, implementing and adjusting an organizational data strategy? Key considerations for assessing foundational systems for your data strategy such as a Clinical Data Hub and what to consider when assessing possible solutions Key takeaways from implementing a Clinical Data Intelligence Hub J. Leigh Kerr, Former Director and Head of Clinical & Business Operations, Endo Pharmaceuticals 11:30 Morning refreshments and networking Examining ICH s recent e6 (R2) guide to maintain required standards and run compliant trials 12:00 Appreciating crucial points of this guideline in the data management field to make trials easier for companies Creating sub teams to discover and implement what is needed to find solutions in house to save time and money Highlighting the process of documentation needed by companies to comply with regulations Exploring the consequences of non-compliance to be ready to react Defining ways to carefully and efficiently check manuals and different committees guidelines Barbara Skinn, PhD, RN, Operations Portfolio Lead, Immuno-Oncology, BMS 12:30 Interactive session with Kumar Komuravelli, Director, Clinical Data Management, Mallinckrodt Pharmaceuticals and

4 Handling the newest European regulations around data protection laws 2016/679 to be absolutely prepared when they come into force 13:00 Presenting how new regulation enforcements are going to replace past agreements to face new guidelines appropriately Exploring new ways to comply with global data protection (regulations 2016/679) to deal with the current lack of guidance Investigating potential data omissions because of the impossibility to use EU data to diminish negative effects on studies based in the USA Underlining European patients different rights to obtain reliable results and not to have people leaving your trials Analyzing EU revival of many GCPs to compliantly implement your available data which must be present on companies portals 13:30 Lunch and networking 14:30 Interactive On-Stage Interview Abhijit Parab, Director, Clinical Data Management and Programming, Allergan Presenting end to end continuous data integration in digital clinical trials 15:00 Assessing Information Exchange to ensure a quick and precise analysis of relevant data Analyzing event-driven information to discover what might have caused the most common occurrences Studying real-time data integrations for crucial time saving Covering traceability and validation to boost compliance Focusing on IOT and adapters Eric Hillaert, Senior Director of Product Development, Analytics, EDETEK 15:30 Afternoon refreshments and networking 16:00 Speaker Hosted s Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best

5 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 45 minutes, and delegates may attend up to 2 roundtables 1 Analyzing any potential new EDC systems for a quicker integration and better study flow Shari DeVore, Senior Manager, Sanofi Data Expert Services 2 Choosing the right vendor to make sure investments on devices pay off in the shortest time possible Terrence O. Tormey, CEO, Kibow Biotech 3 Sharing best practices for optimal utilization of data in real time to be able to get to your conclusions quicker Abhijit Parab, Director, Clinical Data Management and Programming, Allergan 4 Studying company implementations of a cross-functional Risk-Based Monitoring (RBM) approach: Hits and misses Patrick Zbyszewski, VP, Data Management, Onconova Reviewing data management for platform trials 5 Swapna Bapat, IT Manager BTL, Clinical R&D IT, The Janssen Pharmaceutical Companies of Johnson & Johnson 17:30 Chair s summary and close of conference

6 Clinical Data Integration & Management March 21 st Program Day Two 08:15 Registration and refreshments 09:00 Chair s opening remarks APIs are the future of clinical research data exchange Addressing how the availability of standard application programming interfaces, (APIs) will change how data and metadata are exchanged Analyzing how APIs foster increased efficiency in clinical research processes Assessing how APIs can improve data quality Studying examples highlighting API usage for esource Reviewing examples highlighting API use in common data exchange scenarios Sam Hume, DSc, Head of Data Exchange Technologies, CDISC Brainstorming group session: Employing training strategies to ensure a successful trial 10:00 Audience will work collectively to establish Best practices for the Sponsor/ CRO training sessions for CRA staff Techniques to ensure the site is ready to perform Kimberly Dorsch, CCRP, CRCP, Program Director, LifeNet Health Applying innovations to your trial site to make staff work smarter rather than harder to accomplish your company s goals 10:30 Developing the ability to make work fully understandable for all professionals involved in trials to ensure your study runs optimally Uploading your data onto your website as quickly as possible to comply perfectly with requirements Ensuring that all necessary tools are at service for your trial to avoid acquiring new devices and needing to start from the beginning

7 Having electronic diaries which must be user-friendly to have a patients demographics as broad as possible Utilizing appropriate tools to present your data whilst meeting population requirements to give reliable results Lindsey Mathew, Director, Clinical Operations, Valeant Pharmaceuticals 11:00 Morning refreshments and networking Panel: Establishing perfect communication within different departments to improve each step in your clinical operations and ensure data management cooperation 11:30 Establishing pragmatic communication from the beginning to avoid repeating data already monitored Encouraging regular cross function meetings across trials to ensure central study monitoring Working directly with your PV, clinical operations and biostatistics teams to have the right information to analyze Building relationships and good teamwork through defined team structures to create achievable action plans Ensuring drug approval through open communication and precise questioning to colleagues in different sites Jude Burger, Advisor, Clinical Information and Process Automation Monitoring, Eli Lilly Dr. Georgia Mitsi, Sr. Director Search & Evaluation, Digital Healthcare Initiatives, Sunovion Pharmaceuticals Chris Grady, Associate Director, Clinical Data Management. Progenics Pharmaceuticals Audrey Hill, Senior Director, Data Management, Advaxis Evaluating risk identification methods to assess potential gaps to ensure RBM success 12:30 Identifying site risk assessment best practices across more than one risk identification tool/system Investigating whether identified risk or perceived risk is driving monitoring frequency or if other factors are involved? Recognizing and identifying data trends not easily visible during on-site monitoring using centralized data monitoring Discovering whether real-time trial data access provides earlier risk identification and mitigation Caroline Manning, Associate Director, Headquarters Clinical Quality Management, Merck Rosanne Petros, Associate Director, Clinical Research Manager, Merck Research Lab 13:00 Lunch and networking

8 Adopting architecture design strategies for an integrated system for clinical trials 14:00 Analyzing real world data to support solutions in the regulations field to increase chances of drug approval Evaluating ideal data management in the right framework to ensure quick data validation Building a careful review of databases to accurately transfer data to different warehouses Extracting and transcribing data carefully from the central database to use them to obtain FDA validation Comparing and doing cross reference data with clear explanations from all of your clinical trials whilst keeping a good balance to avoid FDA guaranty Wenle Zhao, PhD, Professor in Biostatistics, Medical University of South Carolina Assessing innovative data cut plans 14:30 Unveiling what a data cut plan is Analyzing prerequisites to support the data cut process Learning how it helps to clean & review the data Discovering how often you need to do it Kumar Komuravelli, Director, Clinical Data Management, Mallinckrodt Pharmaceuticals 15:00 Open Session with Dr. Georgia Mitsi, Sr. Director Search & Evaluation, Digital Healthcare Initiatives, Sunovion Pharmaceuticals 15:30 Chair s summary and close of conference