Pre-Conference Summit - Wednesday, June 20, 2018
Workshop Registration and Morning Coffee
Pre-Conference Summit- Building a COE 101
Chairperson’s Welcome and Opening Remarks
Does Your Organization Have Data Driven DNA to Successfully Integrate a CoE Team?
Centers of excellence (COE) are created for two main reasons: to help manage workload and to support problem solving leading to improved commercial quality. A real world data center of excellence serves both project management and innovation interests among various therapeutic areas within an organization. To bridge these functions and effectively meet the needs of all stakeholders a model where interests are connected to the CoE can acheieve the organizations goals.
- Build a culture to sustain a CoE function
- Discuss the necessary building blocks that must be in place to successfully build a center of excellence
- Construct a new business unit from the ground up in an exciting environment of engagement and innovation
Recruit, Train & Develop a High Performing Sustainable CoE Team to Achieve your Business Goals
Building a CoE team is challenging as it is a significant investment that is difficult to quantify. The business struggles to understand how the team is providing value while data scientists also struggle to show their value to the business, however, thekey to a CoE’s success is its personnel. Once a center is established it is critical for management to 1) Set clear goals 2) Build a robust collaborative team 3) Build an organization culture around the CoE team 4) Build an infrastructure to support the team to set the team up for success and ensure optimal results are obtained. As part of this session we will walk you through the building blocks to set up a robust CoE team
- Recruit and develop talent to serve as data experts to better serve internal teams
- Develop comprehensive training programs for new hires and existing employees to utilize advanced analytics and innovative technologies Examine existing personnel in data & analytics services as well as other data-related internal departments to help build a team of new and existing talent
The Value of Partnering with the Right Third Party to Provide your CoE Function with the Infrastructure & Tools to Thrive
Data and analytics is both an art and a science and experience individuals are able to leverage tools in a creative and effective ways than novices. It is critical to establish the right infrastructure for both novices and experienced data scientists. With an infrastructure comes the usage of tools and technologies. It is critical for an organization to find the right third party partner to fit their organization goals and priorities. As real world evidence becomes more applicable for both clinical and commercial projects, respective teams have the opportunity to efficiently partner on joint-data projects in order to share information and resources.
- How to build a formal organizational structure, enabling your organization to strike the right balance between agility and sound management in deploying analytics technologies
- How to assses and scope out the right partner to achieve your business goals
- Building a roadmap to work collaboratively and effectively with your third party partners
Morning Networking and Refreshment Break
Ruthless Prioratization: How to Build a Long Term CoE Model to Solve Short Term Problems
Once an organization decides to develop a center of excellence for a given discipline, their internal experts must design, scope and build the unit. Those that take on the task of leading the platform creation have a large variety of responsibilities to source, including Management, IT and Data Ccience. The objectives and priorities of the center of excellence must be explicitly laid out in order to ensure success. In this discussion, attendees will discuss how to:
- Set achieveable goals for your CoE and prioritize how each team members time is spent
- Implement a set of policies, procedures and tools that are accessible to users
- Consider both clinical and commercial interests prior to developing a platform and carefully design the CoE scope
- Learn how to avoid overlap when liaising with internal data teams as well as how to communicate both data sharing and project leadership procedures
Building a CoE with a Limited Budget: Navigating Internal Hurdles
Communicating the value and importance of data scientists & data & analytics CoEs is challenging as the short term as their merit is unmeasurable – therefore, securing funding is one of the most critical aspects when launching a CoE. While CoEs can help reduce the short-term operational cost of a business, and have an even more substantial impact on the long-term profitability of the organization during the initial phases it does require significant resources and financial support, running a successful CoE does not happen for free. It is crucial to communicate the value CoEs will add to the organization and provide a clear plan on recouperating ROI .
- How to best demonstrate and communicate the value of a CoE function to senior management
- Quantifying operational and strategic benefits of a CoE to validate the investment
- Construct a clear plan to allocate resources and minimize the opportunity cost to the business
Lunch for Pre-Conference Attendees
End of Pre-Conference Summit
Day One - Wednesday, June 20, 2018
Summit Registration and Morning Coffee
Chairperson’s Welcome and Opening Remarks
Shared Plenary Sessions
FDA Guidance on Real World Data Regulatory Decision Making Post Passage of 21st Century Cures Act
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
Centers of Excellence Track Case Study Segment
CASE STUDY: Building a Centralized Big Data CoE to be the Bedrock for Establishing a Data Driven Company
While adoption of analytics is still at a nascent stage in the pharmaceutical industry, leading organizations are anticipating (if they have not already) taking a step ahead of their competitors with the implementation of data analytics into their management systems. Hear first-hand from an organization that has built and sustained a successful CoE. This session will shed light on the lessons learnt, best practices and common pitfalls, when building & managing a CoE. A few of the common misconceptions on longevity of the CoE function will be addressed.
Case Study TBD
CASE STUDY: Innovations Throughout Digital Care Path: From RWD/RWE to AI to IoT and Beyond
Due to the recent advancements in the health technology space, along with the proliferation of digital technology for patients and consumers, companies have an array of challenges as well as unique opportunities to capitalize on the vast amounts of real world data that can drive real world evidence decision making. Adding to this variety are new advances in AI, and IoT which harbor even greater opportunities for ROI for those companies.
- Harness RWD/RWE for emerging trends among weareables, AI and IoT to better optimize innovation strategies
- Optimize RWD data driven wereables, AI and IoT strategies to improve the customer experience
- Understand the concept of the digital consumer from the RWD/RWE healthcare perspective
Out of Industry Perspective: Expedite Access to Data Sets to Grow Your Competitive Advantage
Data is growing at an astounding rate. New tools and solutions are helping companies connect and analyze internal and external data to streamline decision making across teams. Due to these innovative solutions, life science organizations are now able to scale their internal real world evidence capabilities.
- Inform on provider and patient behaviors to target the most effective intervention points
- Increase patient recruitment rates and trial management by understanding real world treatment patterns versus the gold standard, randomized clinical trial experience
- Adopt a knowledge and data driven aproach
Cocktail and Networking Reception
Day Two - Thursday, June 21, 2018
Chairperson’s Welcome and Review of Day One
Case Study: Precision Medicine Center of Excellence
In 2015, Pfizer launched its Center of Excellence in Precision Medicine (CEPM) in Chile. Efforts at this center focus mainly on validating new, more precise and less invasive technologies for diagnosing cancer. The CEPM’s work validates new technology platforms for next-generation sequencing-based molecular diagnostics. In this session, hear first hand from Pfizer on challenges they face while building upon their centers of excellence.
Metrics and Measurements to Quantify Value- Convey a Clear Value Proposition by Setting Clear-Cut Benchmarks
The time has come to put metrics and measurements in place that allow pharma companies to align their strategies around the push for greater profitability putting them on the right track for growth. Senior management across the industry have looked to the traditional metrics, which are no longer sufficient to ensure a profitable brand. It is important to set in place the right benchmarks, metrics and measurements to set your center of excellence up for success.
- Discuss the most effective parameters to judge the success and value a CoE brings to an organization
- Define common set of best practices and work standards to be followed, and provide direct guidance and support to assist plans in implementing these standards
Networking and Refreshment Break
Data Standards in the Drug Lifecycle: Establishing a Basis for Clear Set Guidelines
There have been many efforts to identify best practices and standards for collecting and analyzing real world data. Despite the increased availability of standards, there has been little agreement among researchers and other stakeholders on the best methods and standards for conducting analysis using real world data. The greatest benefits of data standardization will only be achieved with the adoption and use of a single standards across an entire RWE ecosystem, and those benefits are substantial. In this session, discuss best practices and standards for collecting and analyzing real world data.
- Develop qualitative and quantitative metrics to effectively collect RWD
- Cite successful case examples of working with third parties and best practices for ensuring data quality
- Discuss the limitations of RWD such as invalid inaccurate or incomplete data and the quality of data
Future of COE/RWE Panel: Where is the industry going?
Over the past several years new real world evidence analytic platforms have emerged. Real world evidence is essential at every stage of a product lifecycle from understanding a products value to gaining market access. As the need for real world evidence increases, RWE organizations with strong capabilities will have significant competitive advantage over their peers. This session will shed light on:
- Uses of electronic health records and databases containing other health-related data (claims, pharmacy) can support observational studies and pragmatic clinical trials, both of which can be important sources of real-world evidence now and in the future
- Creating richer, more robust datasets in the future than any one source alone can yield. Combining data from different sources is currently a labor-intensive process due to challenges with data standardization and interoperability.
- Patients and consumers have a significant role to play in the collection of real-world data and generation of real-world evidence, but to be effective, patient and consumer engagement approaches would include considering them partners and capturing outcomes that are important to them.
CLOSING KEYNOTE: A Blueprint for Breakthrough: Exploring Utility of Real World Evidence
With many technological advances in healthcare data capture, storage and access, including data on patient demographics and pathology reports- new opportunities for information collection have been created. These new sources of evidence and potentially generate new hypotheses in research, validate previous findings and support regulatory decisions for labeling treatments. This panel discussion will shed light on three areas: indentifying relevant disease and drug candidates as potential uses cases, developing regulatory strategies for optimal use of RWE in oncology and outling potential opportunities to pilot studies in oncology to be used for clinical evidence generation and support regulatory decisions.
Close of Summit