8:30 am
- Profile how an RWE ecosystem can benefit medical affairs and R&D; in driving trial design optimizations, portfolio prioritizations, and integrated clinico-medical operations
- Discuss challenges in data acquisition, dissemination, and differentiating clinically-relevant data from “big data”
- Examine the infrastructure, platform, budget, and staff needed to overhaul an organization’s RWE practices
- Pinpoint specific use cases and sub-functions where RWE can enhance insights-gathering, patient centered drug development and value based clinical lifecycle
- Collaborate with colleagues on common challenges facing the implementation and improvement of RWE in clinical and R&D; and how it can link both to medical affairs for launch excellence
1:00 pm
1:15 pm
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. In addition, where the FDA views these policies taking RWD-acceptance can foster further innovations.
- Analyze both policies and their impacts on clinical, commercial, and medical use of real world data, as well as opportunities for new drug development
- Examine advances in safety monitoring and efficacy demonstration to regulatory bodies through advanced analytics
- Learn how the FDA is implementing 21st Century Cures Act RWE requirements into the regulatory framework
- Assess long-term goals for the use of real world data and its relationship with RCTs
2:00 pm
As the use of patient data continues to be a sensitive topic, combined with the constant scrutiny of drug pricing and the healthcare landscape in flux, government entities, specifically those interacting with health services and drug developers, receive increased pressure to maintain transparent data practices.
- Gain insight into the data governance overhaul within CMS, including the role of external stakeholders, internal challenges, and key outputs
- Define and discuss “transparency” with regards to data and the responsibility of government entities to continue making its information accessibility by patients, researchers, and prescribers
- Explore the correlation between transparent, accessible, real world data and the shift towards value based care by analyzing its effect on health care costs
- Survey the current political and policy landscape in order to assess the state of data transparency and forecast future trends
2:45 pm
3:30 pm
- Share use cases of applying IBM Watson Health cognitive technologies in life science industry
- Define blockchain technology and its implications for secure, trusted and transparent owner-mediated exchange of health records, and access for R&D; for the life science industry
- Share use cases where blockchain technology can be applied in support of clinical trials management and outcome-based contracts
- Pinpoint the methodology used to enhance real world evidence analysis, as well as population health projects through efficient, real-time data exchange
Shahram Ebadollahi, PhD, MBA
Vice President, Innovations & Chief Science Officer
IBM Watson Health Group
Vice President, Innovations & Chief Science Officer
IBM Watson Health Group



