Traditional Drug Development Process: An Overview for Actuaries by Actuaries

Overview

Summary of research from the Initiative 18/11 

  • Pharmacy team about the drug development process for traditional pharmaceuticals: Who does the research and discovery?
  • What does the research and discovery process entail?
  • How are targets identified and validated for research and discovery?
  • What are clinical trials and how are they conducted? 
  • How is the drug development process regulated? 
  • How is the drug development process funded? 

At the conclusion of this session, attendees will be able to answer:

  • Who does the research and discovery for new pharmaceuticals? 
  • What does the research and discovery process entail? 
  • How are targets identified and validated for research and discovery? 
  • What are clinical trials and how are they conducted? 
  • How is the drug development process regulated? 
  • How is the drug development process funded?
Agenda and Speakers

Moderator(s): Gregory Warren, FSA, MAAA, FCA

Presenter(s): Kerri Miller, PharmD; Ian Smith, FSA, MAAA

Gregory Warren, FSA, MAAA, FCA (Moderator)

SVP and Chief Actuary, Optum Advisory Services

Greg currently serves as Senior Vice President of Risk Management & Growth Advisory and Chief Actuary at Optum Advisory Services. Greg has worked as a health care actuary for 25 years, providing strategic and financial risk guidance to payers, providers and employers in the public and private healthcare markets. His expertise includes actuarial projections as well as analytical and financial reporting for Medicare, Medicaid and Commercial Health Plans, Government entities, Accountable Care Organizations, Self-Funded Employers, Pharmacy Benefit Managers, Pharmacies and Life Sciences Companies. Much of Greg's career has focused in serving various stakeholders in the pharmacy ecosystem. He has led the client reporting, business analytics and sales finance areas of a Fortune 50 company operating some of the largest retail, mail and specialty pharmacy operations in North America and has had executive responsibilities in a large pharmacy benefit manager overseeing the finance, underwriting, actuarial, client reporting, business analytics and pharmacy network relations functions. He also served in benefits consulting roles and more recently risk management & growth consulting for pharmacy ecosystem stakeholders such as manufacturers, health plans, employers, pharmacies, PBMs and provider systems, before becoming Chief Actuary for Optum Advisory Services.

Kerri Miller, PharmD

Kerri Miller has spent the past 20+ years in a variety of settings within Managed Care Pharmacy. She has held senior roles with top-tier PBM and insurance carrier companies and in these roles, she was extensively involved in formulary management, prior authorization administration, rebate negotiation and network contracting. Kerri brings a strong understanding of the pharmaceutical industry having spent 10 years in the Market Access Account Management for both large and small biotech pharmaceutical companies. Additionally, Kerri spent time as a Pharmacy Benefit Consultant working with employers, health plans, unions and hospital systems to develop overall pharmacy benefit management strategies, along with negotiating and managing PBM contracts. Kerri is actively involved in several Managed Care Pharmacy organizations and spends time mentoring pharmacy students and educating them about opportunities in Managed Care. Kerri received her Bachelor of Science and Doctorate of Pharmacy degrees from the University of Utah. She also completed a Clinical Pharmacy Residency at the University of Utah and a Clinical Research Fellowship in Kidney Transplantation at the University of Minnesota.

Ian Smith, FSA, MAAA

Ian Smith has worked in the health industry for thirteen years. He is a Fellow of the Society of Actuaries and a Member of the American Academy of Actuaries. He has seven years of experience forecasting medical and pharmacy health care costs for Commercial, Medicare, and Medicaid insurance carriers. He also has a background in determining consumer prices for health related expenses for members of Commercial insurance, Medicare, and the population at large. Currently he leads the model development and creation for an actuarial focused pharmacy consulting division serving Life Science companies as well as Providers and Payers.

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