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GET IN TOUCH WITH US: UK: +44 (0)207 096 1222US: +44 (0)20 3314 0100 [email protected] www.proventainternational.com Connect with us
FACILITATOR FACULTY
SPONSORS
AGENDA
KEYNOTE PRESENTATION
TRACK 1: Risk Based Monitoring
TRACK 2: Patient Recruitment / Patient Centricity & Virtual Trials
TRACK 3: Emerging Biopharma
TRACK 4: Clinical Outsourcing
TRACK 5: Clinical Data/RWE
TRACK 6: A.I & Disruptive Technology
LEADING INSIGHTS FROM
Ana SharmaVice President, Head of Research & Development Clinical Quality AssuranceTakeda
William BlumentalsHead of Pharmacoepidemiology
Sanofi Genzyme
Jim MarshallHead of Supply Chain Global Product Development & SupplyBristol Myers Squibb
Gurdyal KalsiChief Medical OfficerAsklepion Pharma
Paola GrandiChief Scientific OfficerCG Oncology
Frank LeuChief Executive OfficerNovapeutics
Arijit ChakravartyCEO and FounderFractal Therapeutics
Tracy VandersliceVice President & Head, Global Clinical Sciences & Delivery, GSK
OUR UNIQUE ONLINE MEETING FORMATRoundtable DiscussionsThese interactive and informal discussion groups are the hallmark of the meeting. The brightest minds in the industry are brought together in 60-minute sessions that enable participants from all over the world to share ideas, challenges and lessons learned.
Personalised AgendaEach delegate receives a personalised agenda with the roundtable discussions that you choose. You only attend sessions and meetings that fit your challenges and interests, ensuring your time spent on the online platform is focused and well-utilised.
Innovative SolutionsThe most effective and time efficient way to assess potential partners at a strategiclevel. Identify key solution providers that can take your business to the next level and we will help arrange private meetings so you can connect.
Strategic NetworkingStrategic networking opportunities form a key benefit of the meeting. Our new online format for building and strengthening alliances to make lasting connections that benefit you.
OUR VISION
OUR MISSION
To be a platform for creating life-saving therapies and to facilitate the creation of a completely patient centric pharmaceutical industry.
By encouraging key leaders and their companies to put the patient at the very heart beat of every innovation. Sharing valuable insights and strategies to assist in the discovery, development and commercialisation of life saving therapies.
CLINICAL OPERATIONSSTRATEGY MEETING 2021
15th June 2021, Tuesday 12:00 GMT | 07:00 EST
UK: +44 (0)207 096 1222US: +44 (0)20 3314 0100 [email protected] www.proventainternational.com
Paola GrandiChief Scientific OfficerCG Oncology
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CLINICAL OPERATIONSSTRATEGY MEETING 2021
Ana SharmaVice President, Head of Research & Development Clinical Quality Assurance, Takeda
Domenico MeranteVP Clinical Development Nephrology & Orphan DiseasesVifor Pharma
Ashish DugarVice President, Global Medical Affairs, Sarepta Therapeutics
Frank LeuCEONovapeutics
Arijit ChakravartyCEO and FounderFractal Therapeutics
Eyal RonCTOAcuityBio
Farah AhmedChief Commercial OfficerStrategikon Pharma (Clinical Maestro)
Dina BerdievaVP of Clinical OperationsArcturus Therapeutics
Gurdyal KalsiChief Medical OfficerAsklepion Pharma
Magali TaielChief Medical OfficerGenSight Biologics
Jim MarshallHead of Supply Chain Global Product Development & Supply Bristol Myers Squibb
Ran FrenkelEVP, Chief Development OfficerKaryopharm Therapeutics
Hemchand SookdeoVP, Head of Project Management & Portfolio OperationsQlaris Bio
Lars RosendalVP & Head of Global Clinical OperationsLEO Pharma
Rangaprasad SarangarajanChief Scientific Officer & SVP Clinical and Translational Sciences, BERG Health
William BlumentalsHead of PharmacoepidemiologySanofi Genzyme
Tania ChanderVP, Clinical OperationsNovocure
Sashka DimitrievskaGlobal Oncology Head for IPAstraZeneca
Tracy VandersliceVice President & Head, Global Clinical Sciences & DeliveryGSK
FACILITATORFACULTY
UK: +44 (0)207 096 1222US: +44 (0)20 3314 0100 [email protected] www.proventainternational.com
SPONSORSOUR
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CLINICAL OPERATIONSSTRATEGY MEETING 2021
LEAD SPONSORIQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 67,000 employees worldwide. Learn more at www.iqvia.com.
KEY OPINION LEADER
Within3 invented a better way for life sciences companies to have conversations with the people who matter most—from doctors to patients to payers, and more. Our virtual engagement platform gives stakeholders the freedom to communicate anytime, anywhere, on any device. With practical tools to foster meaningful discussions and a dedicated client success team on every project, most Within3 projects achieve 100% stakeholder participation. To learn more and request a needs assessment and demo, visit www.within3.com.
YPrime’s cloud-based technology streamlines clinical trial data collection and management. eCOA and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. Like you, we know that breakthroughs aren’t magic. They’re the result of steady work and consistent enhancements over time. So we’re always adapting and improving. Testing and pushing. All to improve the data quality, efficiency and user experience of your clinical studies.In other words, we’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.
CO-HOST SPONSORSStrategikon Pharma’s mission is to apply best-in-class processes and technologies to improve planning and execution of the biopharmaceutical industry’s most critical function – developing new medical treatments. Our Clinical Maestro™ solution is the industry’s leading cloud-based platform that modernizes outsourcing for clinical programs. It enables all parties engaged in clinical trials, Sponsor Companies, Vendors and Service Providers, to plan studies, model and manage clinical contracts in an entirely systematic way. Faster, more accurately and with less effort it provides an end-to-end solution for pre-RFP planning, budgeting, scenario creation through to reforecasting and change orders to performance metrics and vendor management. www.clinicalmaestro.com.
AGENDAPART 1
UK: +44 (0)207 096 1222US: +44 (0)20 3314 0100 [email protected] www.proventainternational.com 04
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TRACK & TIME (GMT) (EST) 1 RISK BASED MONITORING 2 PATIENT RECRUITMENT / PATIENT
CENTRICITY & VIRTUAL TRIALS 3 EMERGING BIOPHARMA 4 CLINICAL OUTSOURCING 5 CLINICAL DATA/RWE 6 A.I & DISRUPTIVE TECHNOLOGY
12:00-12:30 07:00-07:30 KEYNOTE OPENING SESSION KEYNOTE OPENING SESSION
12:30-12:45 07:30-07:45 BREAK
12:45-13:45 07:45-08:45
What are the threats, impacts and implications of risk-based monitoring during a global crisis? Jim Marshall — Head of Supply Chain Global Product Development & Supply, Bristol Myers Squibb
NEW! The future of patient recruitment and site engagement Tania Chander — VP, Clinical Operations, Novocure
How can patients be informed on clinical trials recruiting for their disease? What are the practical means? and how to increase patients’ awareness and information? Magali Taiel — Chief Medical Officer, GenSight Biologics
Relationship management in the era of COVID-19: establishing best practices, new metrics, and effective communication during a crisis Arijit Chakravarty — CEO and Founder, Fractal Therapeutics
Tools to enable data capture through electronic means and increased virtualization such as electronic consent, eCOA, telehealth and medical wearables Ashish Dugar — Vice President, Global Medical Affairs, Sarepta Therapeutics
NEW! Blockchain, Data mining, AI, and Disruptive Technologies Frank Leu — CEO, Novapeutics
13:45-14:00 08:45-09:00 BREAK
14:00-14:30 09:00-09:30
NEW! — INDUSTRY PANEL SESSION Thriving through a rapid changing environment to support the continuity of
clinical trials, to stay beyond COVID-19 through data and analytics Chaired by Within3
Panellist: Magali Taiel — Chief Medical Officer, GenSight Biologics
NEW! — INDUSTRY PANEL SESSION Thriving through a rapid changing environment to support the continuity of
clinical trials, to stay beyond COVID-19 through data and analytics Chaired by Within3
Panellist: Magali Taiel — Chief Medical Officer, GenSight Biologics
14:30-14:45 09:30-09:45 BREAK
14:45-15:45 09:45-10:45
Mitigating risks around data quality issues through various forms of centralized monitoring
Virtual Trials: What are the latest successes and failures?
Current & emerging therapeutic areas with high clinical focus & investment
Internal delivery VS. external: What studies should now be kept inhouse VS what should be outsourced using realistic parameters
Utilising protocols for the eCOA, ePRO & eSource platforms by moving towards a patient-centric approach to minimise errors and improve clinical trial efficiency, clinical trial data collection, and developments for approval processes - Title TBC
The Role Technology Can Play in Driving Efficiency, Insights And Speed in Clinical Outsourcing Farah Ahmed — Chief Commercial Officer, Strategikon Pharma (Clinical Maestro)
15:45-16:00 10:45-11:00 BREAK
16:00-16:30 11:00-11:30 KEYNOTE SESSION
16:30-16:45 11:30-11:45 BREAK
16:45-17:45 11:45-12:45
NEW! Exploring the future of remote monitoring and telemedicine through COVID-19 and beyond Ran Frenkel — EVP, Chief Development Officer, Karyopharm Therapeutics
NEW! Getting back on track: How can approved trials on hold resume whilst adapting to global changes Ana Sharma — Vice President, Head of Research & Development Clinical Quality Assurance, Takeda
Overcoming challenges in clinical operations and site management: Innovative approaches to ensure compliance and improve quality Domenico Merante — VP Clinical Development Nephrology & Orphan Diseases, Vifor Pharma
What is the current state and future vision of vendor qualification and oversight? Eyal Ron — CTO, AcuityBio
Emerging trends in the expanded use of RWE across the life sciences industry. Where is the industry going? William Blumentals — Head of Pharmacoepidemiology, Sanofi Genzyme
What are the examples of costs and time savings using AI/machine intelligence? Rangaprasad Sarangarajan — Chief Scientific Officer & SVP Clinical and Translational Sciences, BERG Health
17:45-18:00 12:45-13:00 BREAK
18:00-19:00 13:00-14:00
Indentify challenges when defining appropiate metrics to measure the impact of risk-based monitoring Gurdyal Kalsi — Chief Medical Officer, Asklepion Pharma
Improving clinical study planning and modeling through patient-centric initiatives: Virtual trials, online patient recruitment, ePRO, social media, mHealth Tracy Vanderslice — Vice President & Head, Global Clinical Sciences & Delivery, GSK
Predict, identify and respond to sporadic disruptions in the COVID era Paola Grandi — Chief Scientific Officer, CG Oncology
Successfully managing various outsourced models Dina Berdieva — VP of Clinical Operations, Arcturus Therapeutics
How are mobile technologies, AI, and machine learning being used to generate RWE? Sashka Dimitrievska — Global Oncology Head for IP, AstraZeneca
How can we bring disruptive technology innovations across all steps of clinical fields? Hemchand Sookdeo — VP, Head of Project Management & Portfolio Operations, Qlaris Bio
19:00 14:00 END OF DAY
CLINICAL OPERATIONSSTRATEGY MEETING 2021
