With the growing demand for new medicines to meet critical healthcare needs with speed and efficiency, it has become essential to explore novel approaches and data sources. Thanks to the prevailing digital revolution, and advances in predictive analytics and computing platforms, a new frontier has emerged to enhance the drug development process. We elucidate pertinent aspects of the use of real world evidence in regulatory settings, with emphasis on study design, analytical strategies, data quality and regulatory requirements

This presentation will discuss the economics of commercially available sources of real world data in the United States from the perspective of a biopharmaceutical company, including: costs of accessing common sources of real world data; economic considerations when licensing by therapeutic area, for internal use vs. use by a third party, single project vs. unlimited use during a period, and related concerns; potential value of information gleaned from analyses of real world data

Launching an innovative patient-centric Medtech program comes with challenges. To prepare for a spencer program initiative, Otsuka Pharmaceuticals co-developed an employee pilot program with Spencer Health Solutions. Tom Rhoads, CEO is joined by Kelly Roland, MS, Assoc Director, Applied Innovation, and Process Improvement at Otsuka to discuss this innovative program.

Because of the COVID-19 pandemic, there is an urgent global need for timely, high-quality clinical evidence. An influx of real-world evidence (RWE) research has included the recent publication and subsequent retraction of high-profile studies with methodological shortcomings. This reinforces the need to conduct, review and report RWE research using standards agreed upon by professional societies dedicated to RWE.

With regulatory authorities around the world starting to accept External Control Arms (ECAs) for some indications, coupled with the abundance and prolific growth of Real-World Data (RWD), devising a strategy to approach ECA is imperative. The strategy should consider macro and micro aspects; starting with a regulatory portfolio discussion, through protocol design and ending with a decision around data choice and integration. A misstep or a missed step can be costly, both financially and timeline wise. We will discuss how, with 4 “easy” questions, a successful ECA data strategy can be accomplished.

The real world data hype caused high expectations, including RCTs might only play a minor role in future drug development. But they are rather complementary to RCT data and cannot replace them. Artificial intelligence may change drug development and time to market significantly, but will not replace past knowledge and experience. Real World Evidence generation can be enhanced by AI and is key for public health.

Radiomics, the cutting-edge field of extracting high dimensional data from medical images, is emerging as critical component of personalized medicine. By adding an individual patients’ tumor phenotypic (structural) information through imaging biomarkers coupled with genetic data, drug developers can create more precise therapies and achieve the last mile in personalized medicine. Learn how HealthMyne Radiomic solutions can help stratify trial arms, inform cohort selection, trial design and clinical end points.

COVID-19 has disrupted drug development, evidence generation, and care-delivery. This presentation will provide an overview of how COVID-19 has accelerated the generation and adoption of real-world data (RWD)/real-world evidence (RWE) for drug development, its potential for the future, and the importance of collaboration for RWE to achieve it's full potential.

Hugo Health is accelerating efforts to leverage the digital transformation for research, employ remote methods, and engage participants as true partners in the process. This re-engineering can add efficiency, speed and new sources of information to the research ecosystem. It is also moving research from transactional to relational. This presentation presents on-going progress and lessons learned.

Learn how real-world data is used effectively today, why it is critically important for protocol design and feasibility, and where you can find resources to help apply it across your research teams.

The use of historical trial data (HTD) in clinical trials offers the opportunity to accelerate the development of life saving treatments and delivery to patients in need. In this talk, an overview of regulatory guidance related to historical trial data related to HTD use will be provided, as will suggestions to expand the applicability of such methods. We will also present potential uses of historical trial data sharing in COVID-19 trials.

The pharmaceutical industry is facing significant challenges in today's environment. Pressure continues to mount around R&D productivity, drug pricing, and evidence generation. Organizations are investing in capabilities to harness the power of Real World Data to inform decisions across the product lifecycle and transform how drugs are discovered, developed, and commercialized. Join us to learn about emerging trends in the use of digital health data and the evolution of technology.

Overview of the Clinical Trial Solutions at Tempus which support precision patient identification and recruitment for oncology clinical trials through the TIME Trial program, a rapid activation Just-in-Time network of research-experienced clinical trial sites

Watch a live demonstration of protocol design utilizing real-world data on the TriNetX platform for a phase III cardiovascular randomized controlled trial, and a subsequent label expansion.

To advance a patient-centered health ecosystem, patient perspectives must be considered as researchers, policy makers, and regulators establish standards for collecting and applying real-world evidence (RWE) in decision-making. The patient community’s role in RWE is not widely understood. This presentation will describe findings from a convening on patient-community views on RWE, related concerns, and the communications, information, and tools needed by patients to understand, trust, contribute to and use RWE.

The ability to leverage clinical-genomic real world data and evidence (RWD&E) sources in clinical trial design and execution provides exciting opportunities for the trialist and has the potential to significantly improve the likelihood of successful execution. It is imperative that sponsors understand the benefits and limitations of RWD&E to trial design and execution to ensure that the promise of this powerful tool is realized.

Challenges associated with curating large volumes of siloed data, creating research-specific workflows and incorporating related non-imaging data have been limiting factors in AI development across Life Sciences R&D. At Flywheel we have developed an enterprise-scale research data management solution for medical imaging and associated data types. Drawing upon our experience in the Life Sciences, we discuss streamlining the ingestion and organization of petabytes of diverse data from internal and external sources, including real world data. Additionally, we illustrate our ability to scale processing and support machine learning workflows

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.