Research Strategy Development
- SITUATION: A health tech company needed a plan for how to generate evidence to validate its claims.
- TASK: Design an evidence-generation strategy and research roadmap for the company's product.
- ACTION: Defined an end-to-end therapeutic model for the intervention in partnership with internal and external experts. The model defined parameters for dose, potency, temporality, and frequency; described the theoretical therapeutic pathway and mechanism of action, which could be validated and then used in hypothesis testing; defined biomarkers for leading and lagging clinical and health economic outcomes. I developed protocol synopses for several retrospective and prospective studies.
- RESULT: The client has a robust framework to design and conduct research studies to generate needed evidence.
Clinical Innovation Org Establishment
- SITUATION: Industry-wide, clinical development was recognized as being notoriously slow to adapt to changes in healthcare and technology.
- TASK: On behalf of Johnson & Johnson senior leadership, design and deploy an operational model and dedicated team to accelerate change and technology adoption that reduces cost and timelines.
- ACTION: My European counterpart and I translated the leadership's vision—dedicated innovation accelerator—into a comprehensive approach and an internal/external collaboration model. We developed a framework for innovation portfolio management, established partnerships with promising entrepreneurs creating life science services and software solutions, and secured commitment from internal clinician-scientists to conduct demonstration projects within their clinical trials. We developed a transition model to enable the core clinical development organization to adopt and scale these solutions to standard practices.
- RESULT: The company's approach to clinical trials and technologies utilized have kept pace with a rapidly changing healthcare world; trials are user-friendly for investigators, staff, and participants despite inherent drivers of protocol complexity.
Research Outreach & Participant Communications
- SITUATION: Johnson & Johnson and Apple partnered on a large population health study evaluating a digital health app and Watch as a tool for early detection of heart rhythm abnormalities in adults 65+.
- TASK: Design and implement a recruitment strategy drawing from my unique expertise in recruitment for direct-to-participant population health studies.
- ACTION: I conducted a market-sizing analysis that revealed we needed to reach every individual in the U.S. within this age cohort to recruit the required number of participants. To achieve this goal, I successfully advocated for budgetary support and flexibility in the study timeline. I selected an omnichannel marketing agency to formulate a strategy leveraging paid, owned, and earned media across print, digital, social, and programmatic channels and to develop branding, photos, and video assets. Additionally, I explored partnerships with influencers, health systems, and other organizations to help promote the study.
- RESULT: Launched the campaign on time, with 5,000 participants joining the study in the first-week post-launch, exceeding expectations. Even amid the pandemic, the study recruited sufficient numbers to generate meaningful conclusions.