Pre-Conference Workshop - June 19, 2018
Workshop Registration and Morning Coffee
WORKSHOP: Driving Clinical Strategy & Optimized Design with RWD and Clinical Patient-Level Data
For pharmaceutical companies, in theory, the ability to now access data pulled directly from the real world translates to a major upgrade in analytical muscle. In practice, RWD projects are extremely challenging. Gathering the data is expensive, time-consuming and requires a great deal of analytical and therapeutic expertise to turn it into reliable insights. But done right, RWD has the potential to boost brand performance and fine tune commercial strategy. Throughout the industry, clinical research and development teams are slowly learning how to incorporate RWD into their strategies. In this hands on workshop, discuss how real world data is being utilized throughout clinical research and the future potential RWD has to transform drug development.
- Discuss the use of RWD through electronic health records to expedite the generation of research hypotheses for clinical research or the recruitment of patients for clinical trials
- Discover best strategies to utilize RWD to inform clinical trial design and execution
- Pinpoint specific examples where RWD/RWE can enhance insights-gahtering, patient centered drug development and value-based clinical lifecycle
Lunch for Workshop Attendees
Day One - June 19, 2018
Summit Registration and Morning Coffee
Chairperson’s Welcome and Opening Remarks
SHARED PLENARY SESSIONS
FDA Guidance on Real World Data Regulatory Decision Making
A major area of focus for the FDA the past few years has been to expand the use of real world data. With the regulatory landscape evolving to allow for increased use of real world data, the life science industry must be informed on specific guidelines, benchmarks and intent of new policies in order to appropriately develop new products.
- Learn how the FDA is implementing the 21st Century Cures Act requirements into the regulatory framework
- Analyze both policies and their impacts on clinical, commercial and medical use of real world data as well as opportunities for new drug development
- Discuss the regulatory hurdles to increase the use of real world data sources
KEYNOTE PANEL DISCUSSION: Optimize Business Insights and Enhance R&D Through Real World Data and Advanced Analytics
As actionable insights and opportunities for both clinical and commercial uses are gathered from the expanded access to, and acceptance of real world data, so is the presence of challenges in data quality and threats of patient privacy hacks. The life science industry must find a balance in capitalizing on the utilization of real world data.
- Gain insight from a leadership perspective on how expanded real world data capabilities have altered biopharmaceutical development and commercialization
- Understand how RWE is being used to meet the Post Marketing Study (PMS) commitment for FDA
- Learn how RWE is used throughout the life cycle of a molecule starting from first human dose
- Learn how to perform data oversight and quality control when acquiring and accessing data from third-party vendors
PANEL DISCUSSION: Artificial Intelligence: Pharma’s Path to Adopting AI and Other Emerging Technologies
Emerging technologies are dominating the conversation across the pharmaceutical industry. Artificial intelligence and machine learning have pushed many industries toward a highly powerful state. Many pharmaceutical companies are beginning projects involving some elements of AI and ML. AI has the potential to increase research productivity exponentially. Through this panel discussion learn how the industry is moving from aspiration to adoption of using these technologies.
- Explore where machine learning and artificial intelligence will help in the product development process
- Utilize the digital transformation to drive performance and connect data
Afternoon Refreshments Break
Real World Data for Clinical Innovation and R&D Summit Track
Utilize RWD Through Aquisition to Inform Clinical Trial Design
While clinical trials remain the gold standard for drug approval, more information is needed on how specific drugs perform within different groups of participants. Patients have varying experiences, characteristics and treatment protocols that differ from the controlled environment of randomized clinical trials and the information collected often does not generalize to a broader group of patients. RWD can provide important health information about patients to fill in the knowledge gap between clinical trials and actual clinical practice. In this session hear how the industry is developing framework to guide the use of RWD to inform clinical trial design.
- Discuss the use of RWD (through pragmatic clinical trials, large sample trials etc.) to support clinical trial design
- Expedite drug development through protocol harmonization
Integrate RWD to Predict Patient Enrollment, Increase Retention Rates and Improve the Number of Patients Per Site in Clinical Trials
Patient recruitment is critical to keep your clinical trial on track. Clinical trials often take longer than expected and cost companies more than predicted. Through the use of real world data and analytics, precise study plans can be developed and sites can be selected based on the target population, in result speeding up the clinical trial process. These new innovative data driven tools can maximize site recruitment and bring about new recruitment channels.
- Innovative data and analytics tools to increase patient recruitment patient retention rates through protocol specific strategies for patient engagement
- Leverage data and analytics for enrollment planning and trial execution
Leverage Digital Technology to Collect RWD to Enhance Clinical Research
Over the past few years, digital technologies and mobile solutions have become game changing features of modern clinical trials. However, the pharmaceutical industry has been behind in adopting these innovative technologies. Weareable devices and other digital technologies seamlessly collect data from the real world. This presentation will discuss the opportunities for technology to be a main player in clinical research.
- Discover the benefits of remote data monitoring and the ideal model vs. current practices being used throughout the industry
- Strategies to use technology to design a better trial and in turn accelerate time to market
Cocktail and Networking Reception
Day Two - June 20, 2018
Chairperson’s Welcome and Review of Day One
Discover Novel Biomarkers through the Harnessing of Patient Reported Outcomes and RWD
Hear about initiatives in PDUFA VI that have elevated the role of patient reported outcomes in the drug development lifecycle and their effect on biomarker research.
- Learn how to qualify a biomarker and determine its clinical significance
- Synergize new biomarkers with clinical trial protocol design
Analyze Electronic Health Record Data to Support Potential New Indicators for Medicines
The ability to gather real world data from electronic health records can assist in drug development. Analyzing EHR data allows researchers to discover patterns that may not be visible in smaller sample sizes, which can support new indicators for medicine. EHRs allow the assessment of the benefits and risks of different medical treatments as well as the relative effectiveness of medicines in the real world.
- Provide accurate, up-to-date and complete information about patients at the point of care
- Pinpoint the methodology used to enhance real world evidence analysis, as well as population health projects through efficient, real-time data exchange
Networking and Refreshment Break
Glance Into the Future: New Technologies for Risk Based Monitoring in Clinical Trials
Poor quality and risk management of clinical trials significantly impacts the success, timeliness and cost-effectiveness of clinical trials. Proactively building quality standards and risk management into the design and planning of clinical trials leads to higher quality clinical trials overall. Risk based monitoring (RBM) moves away from the traditional approach of frequent on site visits towards a combination of activities including centralized data collection and monitoring. As we move into 2018 the search for new and innovative technologies, tools and techniques to facilitate RBM continues.
- Discover existing technologies used to consolidate data into a single automated platform to enable faster and more informed decisions
- Gain insight into the future
CASE STUDY: CancerLinQ and FDA Collaboration on Real World Impacts of Precision Medicine Therapies
This year, ASCO and the FDA entered into a partnership to examine the real-world use of newly-approved cancer treatments. CancerLinQ, ASCO’s big data initiative, will harness analytics to help inform regulatory decision-making.
- Learn about the methodology used to collect data and well as understanding the information flow from patient to platform to regulatory bodies
- Explore the goals of the collaboration, as well as breakthroughs in data leveraging, patient reported outcomes, real world evidence, and development of checkpoint inhibitors
- Discuss how insights gained through data leveraging will further impact both drug development and regulatory decision-making
Close of Summit