15
June

08:00 AM BST

CLINICAL OPERATIONS

Strategy Meeting Online 2021

Establishing tomorrow’s new normal for clinical operations professionals

Online Strategy Meetings

Real Insights Real Networking

Need a unique online conference experience? Looking for a chance for real discussions and genuine networking? Proventa International’s online Clinical strategy meetings help you make those important connections through interactive roundtable discussions and keynote panel debates – all in a totally online format.

Join clinical operations professionals from all over the world. Engage with your senior peers, discover new insights and help take your company to the next level.

See the complete agenda and facilitator line-up

Download the strategy meeting brochure for full details

Download Brochure

Facilitator Faculty

Each of our unique roundtable discussions will be lead by one of our expert facilitators

Ana Sharma

Vice President, Head of Research & Development Clinical Quality Assurance Takeda

Arijit Chakravarty

CEO and Founder Fractal Therapeutics

Cynthia Verst

President, Design and Delivery Innovation for Research & Development Solutions IQVIA

Christopher Varner

Project Manager IQVIA Virtual Trial Solutions

Dina Berdieva

VP of Clinical Operations Arcturus Therapeutics

Domenico Merante

VP Clinical Development Nephrology & Orphan Diseases CSL Vifor

Domenico Merante graduated in Medicine at University of Pisa/Italy in 1988. He specialized at the same University in 1993 and practiced at the main Pisa city hospital of St. Chiara whilst specializing in endocrinology and diabetes. His practice experience is 20+ years, including working as emergency doctor for 12 years in the NHS in Italy.  During the compulsory military service, he also worked for three years as Medical Officer and subsequently as Chief Medical Officer of a ship unit named “Ammiraglio Magnaghi” in the Italian Navy. Domenico focus is on diabetic neuropathy, neuropathic pain and diabetic wound treatments.
In addition to his medical practice experience, so far Domenico has developed 26 years’ experience in global clinical development, half of which spent with Japanese organizations (Daiichi Sankyo, Shionogi and Sosei Heptares) within the pharmaceutical and biotechnology environment. The other half of his career was with Lab. Guidotti, Novo Nordisk, Eli Lilly and GSK in Italy and in the UK. In this context, Domenico has worked in global clinical development programs (phase 1,2 and 3) in pain area, infectious diseases, type 1 & 2 diabetes and diabetic complications (including painful diabetic neuropathy), severe hypertension, metabolic and endocrine area. To date Domenico has produced 103 publications as main or co-author among full papers, abstracts and oral presentations.

Eyal Ron

Chief Technical Officer Polyrizon Biotech

Farah Ahmad

Chief Commercial Officer Strategikon Pharma

Frank Leu

CEO Novapeutics

Frank Menius

Data Scientist Yprime

Gurdyal Kalsi

Chief Medical Officer Asklepion Pharma

Jim Beck

Director of Data Flow and Standards, Biostatistics Business Operations Group IQVIA

21-year tenure with Quintiles / IQVIA Data Management, Biostatistics and IT organizations
Currently Director of Data Flow & Standards team within the Biostatistics Innovation Group
Implementation and governance of processes related to the flow of metadata and data as it 
moves from initial consumption through the Biostatistics workflow.
Implementation of standards and standardization for IQVIA and Sponsor Biostatistical 
libraries and processes including specifications, programming code & macros, submission 
packages, define.xml, etc.
Strategy team represents CDISC (SDTM, ADaM) Subject Matter Experts and Biostatistics 
(TLF, Define.XML, aCRF, SDRG, etc.) Subject Matter Experts partnering with sponsors and 
industry to establish new ways of working.
Experience spanning multiple TAs, including Psychiatry, Neurology, Respiratory
About Me:
I am based in the Durham, NC Office (QRTP), US Eastern Time zone.
I am a father of 3 girls
In my spare time I enjoy: Running, Playing Basketball, Playing Guitar, and Spending time with Family

Jim Marshall

Associate Director, Materials Management Alnylam Pharmaceuticals

Jim Marshall is a performance-driven Supply Chain leader with over 20 years of experience in the BioPharmaceutical industry. Materials Management expert who has led the implementation of an SAP ERP system in a commercial environment utilizing both in-house and external manufacturing. Experienced in supplier auditing and qualification processes, sourcing and management of CMOs, and the use of QRM and OpEx to manage the end to end supply chain. Well-developed leadership skills that include formulation and deployment of strategy, succession planning and talent development, operational budget responsibility and ensuring compliance with Corporate Standards and cGMP/ICH regulations. A compliance-minded individual with strong knowledge of cGMPs, global regulatory requirements, and an understating of how they impact the supply chain. Demonstrated capability in a primary engagement role representing supply chain and functional operations to external regulatory agencies.

Jonas Renstroem

Director, Global Site Management and Centralized Monitoring IQVIA

Lance Hill

Chief Executive Officer Within3

Lars Rosendal

Vice President, Global Clinical Operations LEO Pharma

Magali Taiel

Chief Medical Officer Gensight Biological

Dr. Taiel completed her doctorate in Medicine with board certification in Ophthalmology from Lariboisiere Saint Louis University, Paris, France, in 1993, and her Associate Professor degree in 1998. Dr Taiel completed her internship at academic Paris hospitals, was an Associate Professor of Ophthalmology, served as an Ophthalmology Department Head, and ran Surgical and Medical Ophthalmology private practice. After 13 years of Ophthalmology public and private practice, Dr Taiel has been engaged in the Pharma Industry for 20 years; she brings extensive experience and expertise in drug clinical development, gene therapy, and medical affairs. She started her career at Servier company headquarter, and then worked in Ophthalmology area at Pfizer for several years; she then held international and management positions in various therapeutic areas, including both technical and supervision duties, at Eli Lilly Company for many years. Then, as VP Clinical Development, she led Clinical Development and Operations, to develop antisense oligonucleotides in Inherited Retinal diseases at ProQR Therapeutics. She then moved to GenSight-Biologics in 2018, to supervise the Medical Department and lead Gene Therapy programs in Inherited Retinal and Neuro-Ophthalmology diseases, as the CMO of the company. Dr. Taiel has authored numerous protocols and articles published in peer reviewed journals, and made critical contributions to successful clinical development and launch of many products. She brings extensive years of experience from both academic medicine and the pharma industry.

Monali Khanna

Associate Director – Data Science, and Consulting Yprime

Prasun Mishra

CEO, Founder / CEO, Founding President r, Agility Pharmaceuticals / American Association for Precision Medicine (AAPM)

Ran Frenkel

EVP, Chief Development Officer Karyopharm Therapeutics

Ray Liu

Global Head of Oncology Data Science and Analytics AstraZeneca

Russell Reeve

Vice President Biostatistcs and Decision Sciences IQVIA

Dr. Reeve is the global head of Biostatistics and Decision Sciences within IQVIA Research & Development Services. This 
organization has more than 300 professionals providing biostatistical and pharmacological services, including trial design, 
analysis, and reporting. Biostatistics has offices in all major markets, with offices in North America, Europe, Africa, and Asia.
Dr. Reeve has been in the pharmaceutical industry since 1992, and has been at IQVIA since 2007, with increasing levels of 
responsibility.
Dr. Reeve earned a BS in Mathematics and Statistics from Utah State University, an MS in Operations Research from 
Rensselaer Polytechnic Institute, and a PhD in Statistics from Virginia Polytechnic Institute and State University. Dr. Reeve 
has published numerous peer-reviewed papers and book chapters, is a reviewer for major statistical journals, has been on 
the Advisory Board of George Mason University Statistics Department, and on the Board of Directors of North Carolina 
State University’s Colleges of Sciences Foundation.

Sashka Dimitrievska

Global Therapeutic Area Head Oncology Clinical Insights AstraZeneca

Tania Chander

Vice President, Clinical Operations Novocure

<span data-sheets-value="{"1":2,"2":"Tania Chander \nVP, Clinical Operations\nNovocure"}" data-sheets-userformat="{"2":15145,"3":{"1":0},"6":{"1":[{"1":2,"2":0,"5":[null,2,0]},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"8":{"1":[{"1":2,"2":0,"5":[null,2,0]},{"1":0,"2":0,"3":3},{"1":1,"2":0,"4":1}]},"11":4,"12":0,"14":[null,2,0],"15":"Arial","16":9}">As Vice President of Global Clinical Operations at Novocure, Tania is responsible for operational excellence and execution of all Novocure sponsored clinical trials. She has over 17 years of biopharmaceutical experience in early and late stage clinical development across multiple therapeutic areas, primarily in Oncology. Tania has extensive knowledge and expertise in clinical planning, including protocol design, site selection, recruitment and data analysis. Prior to Novocure, she held positions at Curis, AstraZeneca (formerly, MedImmune) and Bristol-Myers Squibb in Medical Affairs, Strategic Portfolio Planning and Program Management. She received her Bachelor and Doctor of Pharmacy degrees from Rutgers University.

Terek Peterson

Vice President, Customer Experience and Data Science Yprime

Tracy Vanderslice

Vice President & Head, Global Clinical Sciences & Delivery GSK

William Blumentals

Head of Pharmacoepidemiology Sanofi Genzyme

William Blumentals is the Head of Pharmacoepidemiology at Sanofi Genzyme in the Epidemiology and Benefit-Risk Team and based in Cambridge, MA. While leading Sanofi Genzyme, Willy was also the Interim Head of Pharmacoepidemiology for General Medicines and Consumer Healthcare. Willy has over 18 years of experience working in pharma companies on Pharmacoepidemiology to support Drug Safety, Regulatory, Medical Affairs, and Commercial. Previously, he served as an epidemiology director and safety epidemiology lead at Shire. Other recent positions included Shionogi, where Willy established a new global epidemiology department; introducing and developing epidemiology recognition during an 18-month appointment in Osaka, Japan. He also served as Global Head of Epidemiology for Virology and Transplant and Administrative Site Head at Hoffmann-La Roche in Nutley, New Jersey. 
Willy received his doctoral degree in epidemiology from the University of South Florida, and holds an M.S. in statistics from Temple University, and an M.P.H. in epidemiology from the University of Alabama at Birmingham.

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Reasons to Attend the Virtual Strategy Meeting

Fully Interactive Virtual Conference

We’re all bored of the same webinar format by now. Instead, join intimate groups of like-minded professionals and discuss the topics that really matter to you

Personalised and Easy to Join Agenda

Pick the roundtable discussions that you want to be part of. Simply choose your sessions and we will send you the direct links and calendar reminder to join

Senior Decision Makers

All our roundtable discussions are aimed at director level and above. Discover how your peers are tackling the industries biggest challenges and have your thoughts heard

Private and Intimate Discussions

Each sessions is read by an industry expert and the roundtables are limited to ensure you have fruitful and genuine conversations with your colleagues

Agenda

See Which Topics Are Discussed at the Online Strategy Meeting

07:45 EST

Roundtable Tracks

Risk Based Monitoring: Employing Risk-Based Monitoring to Ensure Continuous Product Supply During a Global Crisis – BMS Patient Recruitment / Patient Centricity & Virtual Trials: The future of patient recruitment and site engagement – Novocure Emerging Biopharma: 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? – GenSight Biologics Clinical Outsourcing: Relationship management in the era of COVID-19 – Fractal Therapeutics AI & Disruptive Technology: Don’t panic even disruptive technologies don’t have to disrupt – Bar Ilan University

09:00 EST

A Transformation Of Pandemic Proportions: Adopting The Best Of Virtual Work For Clinical Teams In 2021 And Beyond Before the pandemic, clinical teams were considering alternatives to in-person meetings, but many needed proof before building virtual into their strategy. When COVID-19 cancelled or postponed in-person ad boards, investigator meetings, and other critical activities, teams found themselves without the ability to connect globally. A shift occurred when clinical teams took up a combination of asynchronous and real-time virtual engagement and developed a new way of operating that will endure through 2021 and beyond. An expert panel will discuss why clinical teams are moving forward with hybrid virtual engagement at the core of their strategy. Chaired by Within3 Magali Taiel — Chief Medical Officer, GenSight Biologics Lars Rosendal — VP & Head of Global Clinical Operations, LEO Pharma

09:45 EST

Roundtable Tracks

Risk Based Monitoring: Mitigating risks around data quality issues through various forms of centralized monitoring – IQVIA Patient Recruitment / Patient Centricity & Virtual Trials: How to make decentralized trials work for patients and sites – IQVIA Virtual Trial Solutions Emerging Biopharma: Current & emerging therapeutic areas with high clinical focus & investment – Couch Clinical Outsourcing: Internal delivery VS. external: What studies should now be kept inhouse VS what should be outsourced using realistic parameters – IQVIA Clinical Data / RWE: 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 – yprime AI & Disruptive Technology: The Role Technology Can Play in Driving Efficiency, Insights And Speed in Clinical Outsourcing – Clinical Maestro

11:00 EST

KEYNOTE SESSION by ARENSIA Dr. Claudia Hesselmann, PhD — Co-founder & CEO, ARENSIA and Tatiana Eidus — Director Corporate Development North America, ARENSIA

11:45 EST

Roundtable Tracks

Risk Based Monitoring: The immediate and future impact of RBM on the industry – Karyopharm Therapeutics Patient Recruitment / Patient Centricity & Virtual Trials: What is Patient Centricity in Clinical Trials and How Can We Achieve It – Takeda Emerging Biopharma: ANCA-associated vasculitis and a patient-centric clinical study vision in this life-threatening condition – Vifor Pharma Clinical Outsourcing: What is the current state and future vision of vendor qualification and oversight? – AcuityBio Clinical Data / RWE: Emerging trends in the expanded use of RWE across the life sciences – Sanofi Genzyme AI & Disruptive Technology: What are the examples of costs and time savings using AI/machine intelligence? -BERG Health

13:00 EST

Roundtable Tracks

Risk Based Monitoring: Remote RBM for data integrity – Asklepion Pharma Patient Recruitment / Patient Centricity & Virtual Trials: Strategies to Design and Deliver Patient Centric Trials – GSK Emerging Biopharma: Predict, identify and respond to sporadic disruptions in the COVID era – CG Oncology Clinical Outsourcing: Successfully managing various outsourced models – Arcturus Therapeutics Clinical Data / RWE:New ways of using clinical data to support drug development across the lifecycle from early stage through FDA approval – AstraZeneca AI & Disruptive Technology: Explore how AI can lead to enhanced decision making process in clinical trials – Agility Pharmaceuticals

Who Should Attend the Event?