Clinical Data Management Innovation 2023

We are pleased to announce the launch of a brand new event: Clinical Data Management Innovation will take place on 13th-14th September 2023 in Princeton!

13 - 14

September

2023
  • Princeton, New Jersey
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  • Why attend?
  • Agenda
  • Speakers
  • Plan Your Visit
  • Sponsors
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Featured Speakers

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Terry Katz​

Sr. Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo, Inc.

Terry Katz is Senior Director of Biostatistics and Data Management Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA International, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician and Certifications as a Quality Engineer and a Six Sigma Green Belt. He is Chair of DIA's GCP-QA Community; formerly he was a Core Committee member for NJ CDISC User Group and Chair of the Statistical Taskforce for the Animal Health Institute. Terry also completed a 3-month Fellowship in Kenya to improve capacity and capability for the local hospitals to run oncology clinical trials.

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Eric Nicolai​

Associate Director, Clinical Data Management, Bristol-Myers Squibb

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Joshua Cox​

Vice President, Clinical Data Management, Loxo at Lilly, Eli Lilly and Company

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Rosanne Petros​

Associate Director, Clinical Research, Merck Research Laboratories

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Chris Natale​

Director, Clinical Data Management, Oncology, Moderna

Chris has ~25 years industry experience, ranging from working in the CRO space, as well as for big Pharma to small Biotechs. He is currently at Moderna, as the Director, Clinical Data Management, where he manages multiple direct reports and oversees the Oncology portfolio.  Chris has worked across a variety of therapeutic areas, including Oncology, Virology, Immunology, Cardiovascular, Women’s Health, Neurology, and Metabolic Disorders.  He has  worked on studies ranging from both Phase 1 Healthy Volunteer and Phase 1 Oncology through Phase 3 registrational trials.  Chris is honored to have worked on multiple treatments that made it to market and significantly improved both the quantity and quality of life of the individuals needing treatment.

Chris attended Montclair State University (NJ), where he received both his Bachelor’s and Master of Science degrees in Biology.  He also spent more than 20 years there as a part-time Adjunct Biology Professor.

Away from work, Chris enjoys traveling, hiking, fishing, birdwatching, nature photography, movies, Broadway shows, concerts, and spending time with his family.

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Satish Dachepally​

Executive Director, Clinical Database Programming, Incyte Corporation

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    2023 Sponsors Included:

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    Company Information

    Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. Saama’s unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. For more information, visit http://www.saama.com.

    Company Website

    To learn more , please visit our website - www.saama.com

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    Company Information

    Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

    Company Website

    To learn more , please visit our website - http://www.premier-research.com/

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    Company Information

    SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies.  With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You.

    Company Website

    To learn more , please visit our website - https://www.sdcclinical.com/

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    Company Information

    Novotech is internationally recognized as the leading Asia Pacific centred Biotech Contract Research Organization (CRO) with global execution capabilities.

    Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 3000 staff globally and 34 office locations.”

    About Novotech- The Asia Pacific Centred Global Biotech CRO | Novotech CRO (novotech-cro.com)

    Company Website

    To learn more , please visit our website - https://novotech-cro.com/

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    Company Information

    eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

    Company Website

    To learn more , please visit our website - www.eclinicalsol.com

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    Company Information

    Clinvigilant Research provides Global Clinical Trial Solutions to Pharmaceuticals, Nutraceuticals, Medical Device and CRO companies with effective eClinical Solutions, Clinical Trials Services, Consulting and Outsourcing services, which start with product development and end with marketing. We are providing tailored creative strategy to meet your objectives; time constrains and budget. We ensure that all your clinical program goals are achieved.

    Company Website

    To learn more , please visit our website - https://www.clinvigilant.com/

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    Company Information

    Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Founded in 2005, the company’s cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations.

    Company Website

    To learn more , please visit our website - https://medrio.com/

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    Company Information

    Pinnacle 21 is the center of Certara’s Data Sciences platform for life sciences companies. We are the global leader in leveraging clean data for informed decision-making, including preparing study data for regulatory submission. We enable our clients to validate data quality and compliance with CDISC standards, creating a smooth data pipeline from Data Management and Biostatistics teams to health authorities such as the FDA, PMDA and NMPA. Streamlined approvals bring life-saving medicines to patients faster.

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      Why attend?

      We are pleased to announce the launch of a brand new event: Clinical Data Management Innovation will take place on 13th-14th September 2023 in Princeton!

      This event has been exclusively designed for the cutting-edge clinical data & analytics leaders, and will focus on designing your clinical data strategy, leveraging data analytics to maximize the use of your data, and using data effectively when preparing for regulatory submission. Topics will include working with sites to make data entry and collection as easy as possible, the uses of real world evidence, and understanding the regulatory environment surrounding clinical data.

      Co-located with our brand new Clinical Trials in Rare Diseases conference, we will also include sessions on using limited data sets in rare disease and orphan drug trials, and how to make your data work for you in trials with reduced numbers of participants.

      We look forward to seeing you there!

      A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

      The programme will feature a range of speakers from the likes of Bristol Myers Squib, Otsuka, Cerevel Therapeutics, Merck, Daiichi Sankyo and many more, who through a variety of interactive session formats will offer insight on promoting successful clinical data management.

      Testimonials

      See What It's All About

      Agenda

      • 13 Sep 2023
      • 14 Sep 2023
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      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      9 AM

      PANEL DISCUSSION: Innovating your clinical data management processes: what’s new in 2023?

      • How is data management and data capture evolving, and how can you make your processes most efficient?
      • Overcoming obstacles in order to ensure data is captured and processed in a timely manner
      • Choosing vendors for clinical data management: what new players are in the market?
      • Modernizing approaches to traditional data management: what new data engineering tools are available?
      • Using data management technology to reduce burden on short-staffed sites

      Speakers

      9:30 AM

      Session reserved for featured sponsor

      10 AM

      Opportunities created by incorporating real world evidence into clinical trials

      • Tapping into the full potential of real world evidence and incorporating this into your trial
      • Barriers to adopting RWE: how to address and overcome these
      • Navigating regulations in the USA in relation to the use of real world evidence in clinical trials

      Speakers

      10:30 AM

      Morning refreshments and networking

      11:15 AM

      Best practice in acquiring and reviewing external and biomarker data to reduce turnaround and improve quality

      • How to ensure biomarker data is processed and reviewed in a timely manner and the benefits of this
      • Assessing different platforms and available technologies for handling biomarker data
      • Centralizing and aligning biomarker data in order to increase efficiency

      Speakers

      11:45 AM

      Session reserved for sponsor

      12:15 PM

      The impact of high turnover of site staff on data collection and what sponsor companies can do to help

      • How to deal with high turnover of staff as a sponsor company: what issues are caused by this?
      • Assessing available technology and processes to alleviate pressure and workload on site staff
      • The importance of maintaining a strong relationship with sites when it comes to data entry and collection

      Speakers

      12:45 PM

      TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

      Learn how elluminate and eClinical’s biometrics services deliver:

      • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
      • Improved study oversight with a holistic view of risk across all data sources
      • 50 out-of-the-box visualizations to support cross-study analysis for deeper insights with self-service access to clinical and operational analytics
      • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

      Speakers

      1 PM

      Lunch and networking

      2 PM

      PANEL DISCUSSION: Optimizing data capture: new trends in data acquisition to ensure data benefits indication and treatment

      • Ensuring no data that is collected goes to waste: where are biotech and pharma companies collecting unnecessary data?
      • Bringing down overall costs by eliminating collection of data which is not used as part of your trial
      • Regulatory guidance around data acquisition and choosing which data to collect
      • How minimizing the number of data points captured can ease burden on patients during site visits, increase retention, and speed up overall study timelines

      Speakers

      2:30 PM

      Hybrid trials using DCT technology and processes: focus on patients and the sites

      • Highlighting the complexity that Hybrid/DCT brings whilst moving away from the common brick-and-mortar sites.
      • Discussing the rise in regulator concerns in areas such as investigator oversight, and participant’s safety when face to face contact is limited.
      • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more.
      • Major points to consider in designing hybrid/DCT trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind.

      Speakers

      3 PM

      High impact CDISC Open-Source Alliance (COSA) projects

      • Highlights of some of the most important COSA projects and related standards development
      • Using the CDISC Open Rule Engine (CORE) for conformance checking
      • Piloting Dataset-JSON as a SAS v5 XPORT replacement
      • The OAK project: automated CDASH to SDTM transformations
      • Digital protocol and study design projects
      • Other COSA projects generating interest from industry

      Speakers

      3:30 PM

      Afternoon refreshments and networking

      4:15 PM

      Data Management in oncology: the importance of using suitable technology in your clinical trial in order to create a manageable data structure

      • Challenges in how we collect data: number of data forms and adverse effects in oncology
      • Using the right technology to maximize efficiency of data systems in oncology trials
      • Understanding how to use and analyze data effectively
      • Looking at how to manage your data structure

      Speakers

      4:45 PM

      Session reserved for sponsor

      5:15 PM

      Choosing the right technology vendors for clinical data management

      • Weighing up the cost and benefits of different providers for data collection and analysis
      • Striking the balance of outsourcing vs keeping data management in house: what can vendors offer?
      • What new innovations and technology are available in 2023: keeping ahead of the curve when selecting data vendors

      Speakers

      5:45 PM

      Chairperson’s closing remarks

      Speakers

      End Of Day 1 and Networking Drinks

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      9 AM

      Problem-Solving Roundtable Discussions

      During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical data management. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      ROUNDTABLE 1: Building a strong relationship with sites to ensure data is collected and processed efficiently and in a timely manner

      Devdatt (Dev) Patel, Director, Clinical Data Management, Seagen

      ROUNDTABLE 2: Getting the most out of limited data sets in rare disease clinical trials

      Noopur Singh, Director, Medical Affairs, Xentria

      ROUNDTABLE 3: Choosing technology and vendors to fit your needs for clinical data management

      Keith Chiasson, Vice President, Drug Development, Feldan Therapeutics

      Speakers

      10:30 AM

      Morning refreshments and networking

      11:15 AM

      PANEL DISCUSSION: Fostering a strong relationship with sites in order to ensure data management is as streamlined and efficient as possible

      • What more should sponsors be doing in order to relieve burden on understaffed sites?
      • An overview of new technology and innovative processes available in order to increase efficiency around data collection and entry
      • How can having a good relationship with your site improve processes and reduce overall trial timelines?
      • Regulatory considerations around data collection and site processes
      • Managing expectations of site staff when it comes to data entry without damaging relationships
      • Training site staff on your technology and systems in order to avoid errors and ease burden on sites

      Speakers

      11:45 AM

      Session reserved for sponsor

      12:15 PM

      Strategies for data standardization and real-time data analytics

      • Challenges and benefits of real-time data: what can this add to your trial, and what additional challenges are created?
      • Analyzing, sorting and handling large amounts of real-time data: understanding best practice
      • Choosing vendors and technologies to support real-time data collection and analytics: what should you consider?

      Speakers

      12:45 PM

      Lunch, networking and prize draw!

      1:45 PM

      Leveraging data and information from electronic medical records in order to shorten patient recruitment timelines

      • What are the benefits of electronic medical records and how can they enhance patient recruitment processes?
      • Navigating challenges and overcoming hurdles when using electronic medical records
      • Using electronic medical records in conjunction with other methods of identifying and screening patients in order to shorten timelines and reduce overall costs

      Speakers

      2:15 PM

      Session reserved for sponsor

      2:45 PM

      Weighing up statistical significance vs clinical meaningfulness when submitting a new drug for approval

      • Ensuring data and results from your trial are meaningful to patients: is putting out your drug worthwhile to patients?
      • Meeting expectations from the FDA and regulatory bodies when it comes to clinical meaningfulness of your data
      • Considerations when preparing documents for submissions and proving clinical meaningfulness

      Speakers

      3:15 PM

      Chairperson’s closing remarks

      Speakers

      End Of Conference

      Speakers

      Select a speaker to learn more

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      Audrey Hill
      Senior Director, Data Management, Advaxis

      Session Details:

      PANEL DISCUSSION: Optimizing data capture: new trends in data acquisition to ensure data benefits indication and treatment

      2023-09-13, 2:00 PM

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      Will Newton
      Senior Healthcare Reporter, Clinical Trials Arena, GlobalData Healthcare

      Will Newton is a Senior Reporter for Clinical Trials Arena and GlobalData Healthcare, focusing on clinical trial design, healthcare business and regulation, and new technologies. Now based in New York City, he previously covered diabetes drug development at Close Concerns’ industry-facing publication in San Francisco. William holds a BA in Economics from Williams College.

      Session Details:

      Chairperson’s closing remarks

      2023-09-14, 3:15 PM

      Session Details:

      Chairperson’s opening remarks

      2023-09-13, 8:50 AM

      Session Details:

      PANEL DISCUSSION: Optimizing data capture: new trends in data acquisition to ensure data benefits indication and treatment

      2023-09-13, 2:00 PM

      Session Details:

      Chairperson’s closing remarks

      2023-09-13, 5:45 PM

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      Madhu Kumar Komuravelli
      Head of Data Management, BlueRock Therapeutics

      Worked in the Pharmaceutical/Biotech/CRO industry since last 23 years with more than 20 years of experience in the Clinical Data Management area on both Sponsor & CRO Side. Successfully led multi-faceted data management project teams to globalize clinical data management processes, systems & organizations and currently working at Regeneron Pharmaceuticals as the Data Management Site Head (Basking Ridge, NJ)/ Associate Director, CDM. Handled and supported several Clinical Studies (Phase 1 to Phase 4) across various therapeutic areas like Immunology, Oncology, CV, CNS, & Rare diseases. Completely familiar with technology and its role in the Clinical Data Management space and performed/supported several technology related initiatives.

      Session Details:

      Leveraging data and information from electronic medical records in order to shorten patient recruitment timelines

      2023-09-14, 1:45 PM

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      Eric Nicolai
      Associate Director, Clinical Data Management, Bristol-Myers Squibb

      Session Details:

      PANEL DISCUSSION: Fostering a strong relationship with sites in order to ensure data management is as streamlined and efficient as possible

      2023-09-14, 11:15 AM

      Session Details:

      Best practice in acquiring and reviewing external and biomarker data to reduce turnaround and improve quality

      2023-09-13, 11:15 AM

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      Sam Hume
      Vice President, Data Science, CDISC

      Session Details:

      PANEL DISCUSSION: Innovating your clinical data management processes: what’s new in 2023?

      2023-09-13, 9:00 AM

      Session Details:

      High impact CDISC Open-Source Alliance (COSA) projects

      2023-09-13, 3:00 PM

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      Guang-Liang Wang
      Ph.D., Head of Data Management, Cerevel Therapeutics

      Session Details:

      Strategies for data standardization and real-time data analytics

      2023-09-14, 12:15 PM

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      Terry Katz
      Sr. Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo, Inc.

      Terry Katz is Senior Director of Biostatistics and Data Management Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA International, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician and Certifications as a Quality Engineer and a Six Sigma Green Belt. He is Chair of DIA's GCP-QA Community; formerly he was a Core Committee member for NJ CDISC User Group and Chair of the Statistical Taskforce for the Animal Health Institute. Terry also completed a 3-month Fellowship in Kenya to improve capacity and capability for the local hospitals to run oncology clinical trials.

      Session Details:

      Opportunities created by incorporating real world evidence into clinical trials

      2023-09-13, 10:00 AM

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      Mohammad Alajarmeh
      Director, Clinical Operations, Eunoia Health

      Session Details:

      Weighing up statistical significance vs clinical meaningfulness when submitting a new drug for approval

      2023-09-14, 2:45 PM

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      Keith Chiasson
      Vice President, Drug Development, Feldan Therapeutics

      Session Details:

      Problem-Solving Roundtable Discussions

      2023-09-14, 9:00 AM

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      Satish Dachepally
      Executive Director, Clinical Database Programming, Incyte Corporation

      Session Details:

      PANEL DISCUSSION: Optimizing data capture: new trends in data acquisition to ensure data benefits indication and treatment

      2023-09-13, 2:00 PM

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      Narayan Lebaka
      Senior Director, Clinical Data Management, Inspirna

      Narayan has and ten (10)+ years of award-winning and progressive experience delivering the highest standards of clinical data management at Bayer and Bristol Myers Squibb (BMS). Bayer Gold Award 2017, Bronze Award 2016, and Pinnacle Award 2015; BMS Performance Award. In-depth knowledge of all aspects of clinical data management, reporting, reconciliation, study reviews, and standards development that drive pharmaceutical businesses forward. 

      Session Details:

      PANEL DISCUSSION: Fostering a strong relationship with sites in order to ensure data management is as streamlined and efficient as possible

      2023-09-14, 11:15 AM

      Session Details:

      Data Management in oncology: the importance of using suitable technology in your clinical trial in order to create a manageable data structure

      2023-09-13, 4:15 PM

      View In Agenda
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      Joshua Cox
      Vice President, Clinical Data Management, Loxo at Lilly, Eli Lilly and Company

      Session Details:

      PANEL DISCUSSION: Fostering a strong relationship with sites in order to ensure data management is as streamlined and efficient as possible

      2023-09-14, 11:15 AM

      Session Details:

      Choosing the right technology vendors for clinical data management

      2023-09-13, 5:15 PM

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      Joe Shan
      MPH, Executive Director, Clinical Development Operations, MEI Pharma

      Session Details:

      PANEL DISCUSSION: Optimizing data capture: new trends in data acquisition to ensure data benefits indication and treatment

      2023-09-13, 2:00 PM

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      Rosanne Petros
      Associate Director, Clinical Research, Merck Research Laboratories

      Session Details:

      PANEL DISCUSSION: Fostering a strong relationship with sites in order to ensure data management is as streamlined and efficient as possible

      2023-09-14, 11:15 AM

      Session Details:

      The impact of high turnover of site staff on data collection and what sponsor companies can do to help

      2023-09-13, 12:15 PM

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      Chris Natale
      Director, Clinical Data Management, Oncology, Moderna

      Chris has ~25 years industry experience, ranging from working in the CRO space, as well as for big Pharma to small Biotechs. He is currently at Moderna, as the Director, Clinical Data Management, where he manages multiple direct reports and oversees the Oncology portfolio.  Chris has worked across a variety of therapeutic areas, including Oncology, Virology, Immunology, Cardiovascular, Women’s Health, Neurology, and Metabolic Disorders.  He has  worked on studies ranging from both Phase 1 Healthy Volunteer and Phase 1 Oncology through Phase 3 registrational trials.  Chris is honored to have worked on multiple treatments that made it to market and significantly improved both the quantity and quality of life of the individuals needing treatment.

      Chris attended Montclair State University (NJ), where he received both his Bachelor’s and Master of Science degrees in Biology.  He also spent more than 20 years there as a part-time Adjunct Biology Professor.

      Away from work, Chris enjoys traveling, hiking, fishing, birdwatching, nature photography, movies, Broadway shows, concerts, and spending time with his family.

      Session Details:

      PANEL DISCUSSION: Innovating your clinical data management processes: what’s new in 2023?

      2023-09-13, 9:00 AM

      Session Details:

      PANEL DISCUSSION: Optimizing data capture: new trends in data acquisition to ensure data benefits indication and treatment

      2023-09-13, 2:00 PM

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      Devdatt (Dev) Patel
      Director, Clinical Data Management, Seagen

      Session Details:

      Problem-Solving Roundtable Discussions

      2023-09-14, 9:00 AM

      Session Details:

      PANEL DISCUSSION: Innovating your clinical data management processes: what’s new in 2023?

      2023-09-13, 9:00 AM

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      Noopur Singh
      Director, Medical Affairs, Xentria

      Noopur’s motivation stems from her desire to help mitigate treatment access challenges seen across indications. She is focused on strategic patient-centered drug development that bridges scientific gaps and cuts through red tape across the drug supply chain. She is determined to increase access to treatments to help fulfill current unmet needs. Her approach stems from the patient journey, ensuring it is integrated throughout the drug development life cycle. In her role as Director of Medical Affairs, Noopur nurtures Xentria’s key relationships with patient experts, key opinion leaders and clinical investigators.

      Prior to her role at Xentria, Noopur was the Research Director at the Foundation for Sarcoidosis Research where she played a key role in the development and execution of the organization’s scientific research agenda. Noopur has also worked as Clinical Site Manager for Synexus Clinical Research in Chicago, where she was responsible for operationalizing clinical trials. Noopur held several roles at Lurie’s Children’s Hospital Chicago where she managed over 25 industry-sponsored trials. She has also been an active participant in the Therapeutics Development Network with the Cystic Fibrosis Foundation. Noopur earned a B.S.in Kinesiology from the University of Michigan.

      Session Details:

      Problem-Solving Roundtable Discussions

      2023-09-14, 9:00 AM

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      Harit Nandani
      Director, Clinical Data Management, GRAIL, Inc.

      Harit Nandani has 12+ years of experience in clinical trials data and technology leadership for both diagnostics and therapeutic trials. He specializes in clinical trial data management and analysis, configuring systems for population-scale studies, and using analytics tools to monitor projects. Currently, he is the Director of Clinical Data Management at GRAIL, overseeing data and systems for trials in the UK and US supporting early cancer detection diagnostics development. He has worked on projects enrolling over 300,000 participants, leading to the development of the Galleri test, which has detected over 50 types of cancer and has been named one of TIME Magazine's best inventions and The Atlantic's 10 most promising breakthroughs of 2022. Prior to GRAIL, Harit led late-stage pivotal trials in Oncology at Gilead Sciences and worked in various clinical research roles at a CRO and a small biopharmaceutical development company.

      Session Details:

      PANEL DISCUSSION: Innovating your clinical data management processes: what’s new in 2023?

      2023-09-13, 9:00 AM

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      Kim Chau
      Vice President, Clinical Operations, Exai Bio

      Session Details:

      PANEL DISCUSSION: Fostering a strong relationship with sites in order to ensure data management is as streamlined and efficient as possible

      2023-09-14, 11:15 AM

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      Dawn Kaminski
      Vice President, BD Operations, eClinical Solutions

      Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials.

      During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project.

      Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.

      Session Details:

      TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

      2023-09-13, 12:45 PM

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      Plan Your Visit

      Venue

      Princeton Marriott at Forrestal, 100 College Road East Princeton, New Jersey 08540

      Accommodation

      Please be aware that should you be contacted by any 3rd party housing companies that they are not affiliated with us or the hotel.

      Sponsors

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      Session Sponsors

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      Exhibitors

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      A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

      The programme will feature a range of speakers from the likes of Bristol Myers Squib, Otsuka, Cerevel Therapeutics, Merck, Daiichi Sankyo and many more, who through a variety of interactive session formats will offer insight on promoting successful clinical data management.

      See What It's All About

      Enquiry

      Contact Us

      SPONSORSHIP ENQUIRIES

      Ben Lloyd-Davies

      Head of Healthcare Sales

      +44 (0)20 7936 6948

      SPEAKER ENQUIRIES

      Louisa Manning

      Programme Director

      +44 (0)20 766 10552

      MARKETING ENQUIRIES

      Moona Popal

      Marketing Manager

      SPONSORSHIP ENQUIRIES

      To enquire about sponsorship opportunities for the conference, please contact

      Ben Lloyd-Davies

      Head of Healthcare Sales


      +44 (0)20 7936 6948

      SPEAKER ENQUIRES

      To enquire about speaking opportunities for the conference, please contact:

      Louisa Manning

      Programme Director


      +44 (0)20 766 10552