ALLISON B. PEARSON
Indianapolis,IN
Summary
Policy expert and leader with 14 + years of experience in Medicaid, pharmaceutical and health tech policy. Well versed in working cross-functionally, building relationships with key stakeholders and communicating complex information in a clear and concise manner. Dynamic communicator and strategic thinker experienced in advocacy strategies to influence policy.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Director, Global Regulatory Policy
Flatiron Health
New York, NY
01.2022 - Current
- Develop and implement policy initiatives to advance organizational objectives related to real-world evidence, digital health, decentralized clinical trials, health equity, artificial intelligence, machine learning, medical device regulation, and software as a medical device in the US and Europe.
- Collaborate with senior leadership to set long-term objectives for the company.
- Prepare written materials such as policy analysis, policy position papers, and talking points related to company priorities.
- Represent Flatiron on several external US and EU trade association working groups to further Flatiron's external regulatory policy strategy.
- Work collaboratively with internal and external stakeholders to influence the regulatory policy environment and advance FDA, EMA and PMDA guidelines for the use of real-world evidence.
- Draft and submit public comments in response to regulations and guidance issued by regulators and health authorities.
- Gather regulatory policy intelligence, analyze changes in the regulatory environment, and work closely with internal subject matter experts to assess the impact of regulatory policies on the Flatiron Health’s business goals.
- Build influence through engagement in relevant trade associations, coalitions and alliances.
Consultant, US Regulatory Policy & Strategy
Eli Lilly and Company
Indianapolis, IN
07.2018 - 01.2022
- Responsible for development of Lilly policy positions, engagement of key external stakeholders, and creation and execution of major policy plans
- Led regulatory policy work related to patient-focused drug development, benefit-risk, patient reported outcomes, digital health, decentralized clinical trials, pregnancy registries, and post-market reform
- Led regulatory commenting efforts and facilitate input from Lilly subject matter experts
- Implemented PDUFA VI
- Developed Lilly PDUFA VII policy positions and proposals – two of which were included in the commitment letter approved by Congress.
- Represented Lilly on several external trade association working groups to further Lilly’s external regulatory policy strategy.
- Engaged with FDA on priority issues.
- Drafted public comment letters to be submitted to the Food and Drug Administration (FDA)
- Advised regulatory scientists on current regulatory guideless that affect Lilly products or businesses
- Served as a mentor and primary project coach for the regulatory policy Visiting Scientist Fellows and interns.
Associate Consultant, Clinical Contracts
Eli Lilly and Company
Indianapolis, IN
07.2016 - 07.2018
- Understood the clinical contracting needs of the Global Product Development Teams and the US Affiliate and educated and guided team personnel regarding the clinical contracting process and key contract requirements
- Reviewed previous contracting history with investigative sites to develop customized clinical trial agreements between Lilly and external parties in order to decrease the time it takes to negotiate
- Negotiated clinical trial agreements and master clinical trial agreements with site personnel
- Drafted clinical trial agreement amendments and assignments
- Negotiated confidentiality agreements with potential investigative sites
- Developed relationships with both internal and external parties, including internal medical associates, Lilly field personnel, Lilly attorneys, management, investigative site personnel, business office personnel, and site attorneys in order to successfully negotiate the clinical trial agreement
- Explained compliance concepts and how they impact contracts and payments to customers
- Identified and implemented improvements to the contracting and grant management processes
- Served as the CMS Coordinator back up to assist with the reporting of payments made to subjects who are Medicare beneficiaries for injuries or complications arising out of clinical trials pursuant to Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007.
Compliance Officer/Chief Privacy Officer
MDwise, Inc.
Indianapolis, IN
10.2013 - 07.2016
- Ensured compliance with contractual State and Federal rules, regulations and laws for the Hoosier Healthwise (HHW) and Healthy Indiana Plan (HIP), including HIP 2.0
- Served as primary liaison with the Office of Medicaid and Policy Planning (OMPP), Family and Social Services Administration (FSSA) and MDwise executive leadership team
- Monitored operational performance and progress towards quality improvement goals for the Hoosier Healthwise and Healthy Indiana Plan programs
- Coordinated reporting to the OMPP/FSSA and monitor reporting accuracy and timeliness
- Reviewed and approved any redline changes to the provider Medicaid and Marketplace physician contracts
- Lead monthly MDwise Hoosier Healthwise and Healthy Indiana Plan policy meetings
- Conducted routine internal audits to ensure compliance with all privacy laws and standards, Federal, State, and MDwise policies and procedures
- Managed the delegation oversight process and oversaw periodic annual audits of all MDwise delivery system subcontractors, including utilization management, quality department, case management disease management and provider relations
- Reviewed all internal and external MDwise HWW and HIP marketing documents for publication before final approval was requested from OMPP to ensure all marketing materials and processes complied with Federal regulations and guidelines
- Lead staff education on HIPAA, HITECH, HITRUST, False Claims Act (FCA) and other relevant regulations
- Managed, prepared and responded to external audits such as Readiness Reviews, External Quality Review Audits, as well as periodic monthly, and quarterly or annual audits by State or Federal stakeholders
- Met with State personnel including contract compliance analysts, program analysts, and other regulatory agencies on a monthly and quarterly basis
- Scheduled, researched, developed, managed and prepared MDwise responses to requests for proposals from State and Federal agencies
- Tracked and analyzed State and Federal policy developments including the 2015 CMS proposed Medicaid rule
- Ensured timely follow up for all statewide member inquires, including member eligibility, questions and physician complaints
- Assisted with RFP writing.
Academic Contractor – Global Public Policy
Eli Lilly and Company
Indianapolis, IN
06.2012 - 04.2013
- Led the creation of a database tool to track key aspects of state implementation of the Affordable Care Act
- Oversaw the development of State leave behind documents for the designate state government affairs associates to summarize key policy positions on the Affordable Care Act
- Drafted a white paper on the implications of the Affordable Care Act’s Medicaid expansion provisions
- Tracked and reported on state biosimilar legislation and coordinated analysis among team leaders
- Drafted an internal leave behind outlining the policy implications of biosimilars on the company
- Assisted the Pharmaceuticals in the Environment committee research and track key issues related to drug take back programs.
Disease Management Educator
Advantage Health Solutions, Inc.
Indianapolis, IN
10.2009 - 06.2012
- Provided education and coaching to commercial and Medicare members
- Worked to promote awareness and compliance by members with chronic health concerns
- Acted as a resource and liaison with providers and members regarding the programs offered
- Conducted diabetes education classes with enrolled members.
Health Educator
LifeMasters Supported SelfCare, Inc.
Indianapolis, IN
07.2007 - 10.2009
- Provided disease management education to enrolled participants
- Formulated education plans based on participant needs and desired health outcomes.
Department of Community & Preventive Medicine Intern
Mount Sinai School of Medicine
New York, NY
01.2007 - 04.2007
- Conducted literature reviews and collected research data regarding environmental health disparities
- Completed data analysis and engaged in technical writing and reporting of research findings.
Administrative Secretary
Agency for Health Care Administration, Medicaid Pharmacy
Tallahassee, FL
09.2004 - 01.2007
- Assisted with implementing the Medicaid Lock-In Program
- Administered changes to the Florida Medicaid Preferred Drug List.
Administrative Internship
Florida Department of Health
Tallahassee, FL
05.2006 - 07.2006
- Researched Florida pesticide laws and procedures within the Bureau of Environmental Health
- Assisted the Bureau of Epidemiology develop emergency response packets.
Medicaid Pharmacy Services Intern
Agency for Health Care Administration
Tallahassee, FL
05.2004 - 08.2004
- Communicated the results of the Meadows vs
- Hernandez lawsuit to all Florida Medicaid recipients
- Collected rebates from prescription drug manufacturers.
Education
Juris Doctor (J.D.) -
Indiana University Robert H. McKinney School of Law
04-2013
Master of Public Health, Environmental Health -
Florida A&M University
04.2007
Bachelor of Science, Health Care Management -
Florida A&M University
04.2005
Skills
- Policy Analysis
- Excellent Written & Oral Communication
- Policy Development
- Policy Implementation
- Teamwork and Collaboration
- Analytical Thinking
- Regulatory Intelligence
Certification
Certified in Healthcare Compliance (CHC)
Community Service
- Community Partners Committee Member, URBAN Act Academy – 2018 to 2020
- Board Member, Horizons Indy – 2020 to 2023
- Board Member, Improving Kids Environment – 2012 to 2016
- Secretary, Improving Kids Environment – 2011 to 2012
- Board Member, Improving Kids Environment – 2009 to 2011
- Habit for Humanity of Greater Indianapolis – 2007 to 2010
Publications
Adamson, Blythe, Pearson, Allison, & Pittell, Harlan, (2024). Navigating Medicare Drug Price Negotiation in Oncology: The Need for Real-World Evidence. Health Affairs.
Timeline
Director, Global Regulatory Policy
Flatiron Health
01.2022 - Current
Consultant, US Regulatory Policy & Strategy
Eli Lilly and Company
07.2018 - 01.2022
Associate Consultant, Clinical Contracts
Eli Lilly and Company
07.2016 - 07.2018
Compliance Officer/Chief Privacy Officer
MDwise, Inc.
10.2013 - 07.2016
Academic Contractor – Global Public Policy
Eli Lilly and Company
06.2012 - 04.2013
Disease Management Educator
Advantage Health Solutions, Inc.
10.2009 - 06.2012
Health Educator
LifeMasters Supported SelfCare, Inc.
07.2007 - 10.2009
Department of Community & Preventive Medicine Intern
Mount Sinai School of Medicine
01.2007 - 04.2007
Administrative Internship
Florida Department of Health
05.2006 - 07.2006
Administrative Secretary
Agency for Health Care Administration, Medicaid Pharmacy
09.2004 - 01.2007
Medicaid Pharmacy Services Intern
Agency for Health Care Administration
05.2004 - 08.2004
Juris Doctor (J.D.) -
Indiana University Robert H. McKinney School of Law
Master of Public Health, Environmental Health -
Florida A&M University
Bachelor of Science, Health Care Management -
Florida A&M University