Strategic advising to optimize your patient-centric evidence generation

Strategic advising to generate empirical evidence to demonstrate the value of your product/company for key stakeholders (e.g. patients, providers, regulators, and reimbursement authorities).

  • Regulatory Policy (landscape assessment and policy advising for venture-backed healthcare firms)

  • COA Strategy Development

  • Endpoint Development

  • Navigating Regulatory Authorities (from briefing packages to in-person meetings)

  • Internal and External Facing Communications 

  • Prospective, Real-World Study Design

Alicyn Campbell started her career in Outcomes Research specializing in the characterization and assessment of symptom distress lung cancer patients, as this was an area of high unmet need. She was the Co-chair of the Critical Path/FDA Non Small Cell Lung Cancer (NSCLC) working group from 2011-2015.  Additionally, she developed the Symptoms in Lung Cancer (SILC) tool while at Roche which was included in multiple front-line Phase 3 registration trials.

Her passion is in the assessment of treatment burden and comparative tolerability of anti-cancer therapies. Standardized assessment of the patient experience of side-effects, included in standard labeling empowers patients and their families to make informed decisions during what is arguably one of the most difficult diagnoses one faces in their lifetime. She believes reliable empirical evidence is the backbone of empowered decision making. Her work in this area was recognized by Former Vice President Biden’s Cancer Moonshot Initiative.

Alicyn’s work includes endpoint development (performance tests, digital health, clinical outcome assessments), qualitative and quantitative research, treatment preference and satisfaction, and burden of illness, in oncology and rare disease (e.g. Hemophilia).

Additionally, Alicyn has extensive experience in regulatory policy, across multiple disease areas.  She has been a close partner, contributor, and advisor to numerous policy initiatives such as the landmark 21st Century Cures Legislation. She participated in Hill briefings to educate Senators and Representatives on both sides of the aisle on the importance of the patient experience in drug development and decision making (found here). Her influencing work resulted in a key label claim for a study she helped design, the landmark Hycela PREFMAB study with the first ever patient experience data in the label. Her prior employer was part of the PDUFA VI re-authorization and Alicyn was a key advisor influencing the generation of 4 new guidances on the patient voice to increase the availability of patient relevant evidence in approved labeling. She excels at thinking years ahead of what a product needs, then working to ensure the regulatory landscape can understand and keep pace with these innovations in drug development. Alicyn has been asked to evaluate these markets beyond her work in Clinical Outcomes Assessments including Adverse Event Attribution, Machine Intelligence (including in silico modeling of biological systems), diagnostics, and real-world evidence. From policy landscape assessments, to guidance on formal and informal mechanisms for binding and non-binding agency feedback: if you’re a venture backed health-care firm in need of direction to navigate the regulatory landscape for your new product, we’re here to help.