Enriching Oncology Studies with RWD Before, During and After the Trial

Register free: http://www.appliedclinicaltrialsonline.com/act/RWD

Event Overview:

The fragmentation of health data is one of the greatest challenges facing healthcare today. Patients have dozens of interactions with healthcare systems throughout their lives, and that information is retained in siloed databases across disparate institutions. With clinical trials being one of the most critical sources of evidence on drug effectiveness and safety, especially in oncology trials, it is imperative that we bridge the gap between clinical trial data and real-world data (RWD) to expand and extend trial value.

In this webinar, experts from Medable, Datavant and Parexel discuss how enriching oncology clinical trials with RWD generates deeper insights and improves operational efficiency to achieve better patient outcomes. By combining the power of a SaaS DCT platform with real-world data connectivity, therapies and new interventions can be approved faster and brought to market with higher fidelity evidence of their effectiveness and safety in a well-defined group of patients. This unlocks better outcomes, faster research, and healthcare at a lower cost.

By linking RWD with clinical trial data, sponsors can:

• Optimize protocol and study design by adding richer clinical details about the patient's health
• Ensure appropriate trial continuation by explaining and understanding patient response
• Differentiate with a safe and effective intervention by observing long-term effectiveness

Key Learning Objectives:

• Simplify research by combining a decentralized clinical trial platform with the linkage of real-world data
• Make the research experience frictionless for patients and sites by relieving them of the burden of clinic visits and manual data collection
• Improve the quality and duration of evidence at a fraction of traditional trial costs

Who Should Attend:

• Clinical Operations/Development, Oncology Leads, R&D, Study Management, Chief Medical Officers, Chief Scientific Officers, Medical Affairs at Large Pharma and Mid-Market Biotech

Speakers

Archana Sah
SVP, DCT Solutions, Oncology
Medable

Archana Sah is a clinical development thought leader with 26 years’ of experience and a passion for developing lifesaving medicines and products for patients. Having led and contributed to 15 FDA/EMEA drug approvals (12 in Oncology and Immuno-Oncology), Archana is widely recognized as a strategic expert on emerging topics ranging from therapeutic landscape and treatment trends expertise to innovation in clinical excellence. Archana has held leadership roles at Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two oncology startups, CTI Biopharma and Tizona Therapeutics.

A leader in driving industry-wide strategic collaborations, Archana is passionate about bringing innovation and efficiencies across the entire clinical trials ecosystem with a patient-centric approach.

● Founding Chair, Oncology Board, Society for Clinical Research Sites

● Founding Chair, 2019, 2020, 2021 Annual Global Oncology Site Solutions Summit focused on delivering oncology clinical research best practices and solutions for operational excellence between Sites, Sponsors/CROs, Patients and Oncology Vendors

● Advisor, American Cancer Society Cancer Action Network focused on multiple topics including: Barriers to Clinical Trial Enrollment-policy implementation, Integrated Trial Matching for cancer patients and providers, Clinicaltrial.gov Modernization, COVID-19 Adaptation and Cancer Treatment Act

● Past Advisor, Forum on Drug Discovery & Development, National Academy of Sciences: Clinical Trial Site Standards and Harmonization

Vera Mucaj
Chief Scientific Officer
Datavant

Vera Macoj is the Chief Scientific Officer at Datavant. Datavant is the leader in healthcare data connectivity, with the mission of "Connecting the World's Health Data to Improve Patient Outcomes". She leads a team focused on developing and defining key use cases for connected health data in research, including driving the connection between clinical trial data and real-world data. Vera is a scientist by training, and holds a BA in Biochemistry from Harvard College, and a PhD in Cell and Molecular Biology from the University of Pennsylvania Perelman School of Medicine. She has authored multiple peer-reviewed scientific papers in cancer research. Prior to joining Datavant, Vera worked at McKinsey & Company, where she supported pharmaceutical clients on growth strategy, business development, and M&A.

Michelle Hoiseth
Chief Data Officer
Parexel

Michelle Hoiseth has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Ms Hoiseth presently leads PAREXEL’s Scientific Data Organization and Real World Data Services team, working closely with her colleagues to solve the challenges to the use of real world data in clinical research.

MaryAnne Rizk, Ph.D
Chief Strategy Officer
Medable

Rizk joined Medable as the Chief Strategy Officer after leading the digital R&D cloud strategy at IQVIA for two years. Prior to that, Rizk was global vice president of CRO partnerships for Oracle for five years and previously was a director at Medidata Solutions and a project manager at Merck. In August, Rizk was named a PharmaVoice 100 leader. She is also a member of the Healthcare Businesswomen’s Association, Prix Galien Foundation Digital Advisory Board and Society for Clinical Research Sites (SCRS) Innovation Council.

Register free: http://www.appliedclinicaltrialsonline.com/act/RWD