Frank S. David, MD, PhD
Managing Director, Pharmagellan
Professor of the Practice, Department of Biology, Tufts University
Student research opportunities (updated 9/21/24)
My academic interest is in how biopharma companies’ drug development strategies are influenced by policies and programs related to regulation, pricing, and other factors.[1]
As part of that effort, I have several opportunities available for students to contribute to ongoing or pending research projects. Some representative examples are below.
This work would be unpaid, but Tufts students may be eligible to receive independent study credit (e.g., via BIO 95 or BIO 195) after a trial period.
If you are interested in working on a project with me, please send the following materials to frank.david@tufts.edu:
Your CV or resume
A one-page cover letter describing your interest in the biopharma industry
A 250-word (or less) answer to one of the prompts below
1. Drug approvals after failed clinical trials
Background: The U.S. Food and Drug Administration (FDA) requires new drugs to demonstrate “substantial evidence” of efficacy to obtain authorization for marketing.[2] However, there are several historical examples of drugs for which the efficacy data from clinical trials were mixed, as well as a handful of approvals without any bona fide clinical trial successes. The goal of this work is to update a prior published analysis[3] by refining and expanding the set of included drugs and categorizing the scenarios in which the FDA grants approvals despite trial failures. Besides adding to the knowledge base in drug regulation, this project aims to help drug developers and investors determine the odds a program with negative clinical study data will reach the market.
Prompt question: What is one reason why it might be appropriate for the FDA to approve a new drug that has failed one or more pivotal clinical trials?
2. Probability of success for clinical trials in various phases of development
Background: A key component of decision-making in drug development is estimating a project’s risk-adjusted net present value (rNPV).[4] The rNPV calculation uses an estimated probability of success (POS) for each phase of development. Several prior studies[5] have derived benchmark POS values for clinical phase transitions in biopharma, but there is no consolidated analysis of how to harmonize and reconcile these disparate estimates. This project aims to conduct a narrative review of past research in this area to help biopharma professionals and investors determine the most appropriate POS values to incorporate into their financial models.
Prompt question: What is one reason why two studies to estimate the POS of clinical phase transitions for drug candidates might not agree with one another?
3. Impact of drug price legislation on biopharma innovation
Background: The Inflation Reduction Act (IRA) imposes mandatory price cuts on certain drugs made available under Medicare.[6] Opponents of the IRA argue the legislation will stifle biomedical innovation, in part by reducing investment in so-called “follow-on indications” pursued after the drug’s initial approval.[7] However, there are currently no data to establish a current benchmark of how approvals evolve over a drug’s lifetime that could serve as a baseline with which to compare pre- and post-IRA levels. This project aims to establish such a baseline to enable future analyses.
Prompt question: Why might the IRA dissuade a company with an approved lung cancer drug from pursuing a follow-on approval for the drug in osteosarcoma, a rare bone tumor, even if there were a good scientific rationale to suggest the drug would also work in the latter indication?
[1] List of published articles: https://orcid.org/0000-0002-8025-4427
[2] https://www.fda.gov/media/133660/download
[3] https://pubmed.ncbi.nlm.nih.gov/36780148/
[4] For background, see https://www.pauljanssenfuturelab.eu/toolbox/rnpv-explained/
[5] See e.g., https://academic.oup.com/biostatistics/article/20/2/273/4817524 and citations therein
[6] https://www.cms.gov/inflation-reduction-act-and-medicare