Eric Hardter, Ph.D., RAC (US, CAN, EU)
Regulatory Manager, Regulatory Strategy
I joined Emmes seeking to continue my growth as a regulatory affairs professional, with the promise of management of a diverse portfolio of clients spanning multiple therapeutic indications, drug classes, phases of study, and international localities.How do you describe Emmes to other people
Emmes is a full-service CRO that strives to provide tailored support for both public and private sector clients in every step of the investigational product lifecycle, including pre-submission activities through post-licensure studies.A bit about me
Outside of work you’ll catch me pursuing my decidedly non-regulatory related habits which include but are not limited to pugs, disc golf, and visiting Montgomery County’s lovely offering of microbreweries. I also occasionally provide content for a prominent fantasy football website!How I chose my career
I fell into the bucket of STEM doctoral graduates who wanted to pursue neither continued laboratory work nor teaching following obtaining my degree. While I didn’t have any familiarity with clinical trials research, it appeared as a way to apply my graduate school experiences tangentially. I initially started with data analysis and visualization, but quickly transitioned to regulatory affairs and never looked back.Best part about working at Emmes
The best part about working at Emmes, specifically in a service group, is the ability to work across contracts with varying subject matter. While this demands an ability to be dynamic and agile, it more importantly enables us to perform a wide scope of activities and work side by side with a large proportion of “Emmesaries.”Background
Even dating back to high school, my passion has been rooted in the sciences. However, as the definition of insanity is doing the same thing over and over and expecting different results, I realized in graduate school that I needed to find something outside of the laboratory when I finally entered the working world. As an East Coast guy my entire life (I remain a proud, if relocated Pennsylvanian), pursuing work with clinical trials in a company based largely in the mid-Atlantic was a perfect next step following graduation. After spending a few years working as a regulatory affairs specialist, I was tasked both with leading the Regulatory Affairs Strategy team, which I’ve been doing since 2019, and also providing support for Emmes’ Business Development activities.Education
B.S. Biochemistry, University of Delaware
Ph.D. Chemical Biology, Boston College
Regulatory Affairs Certification (US, CAN, EU)
Hardter E., Collins J., Shmueli-Blumberg D., Armstrong G. (2020) Procurement and Distribution of Study Medicines. In: Piantadosi S., Meinert C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_34-1.
Lofwall, M; Rosa, C; Hardter, E; Schwartz, J; and Kropp, F. Regulatory considerations for a multi-site clinical trial treating opioid use disorder (OUD) with vulnerable populations: pregnant women, infants, and potential prisoners. Invited Session, Society for Clinical Trials Virtual Annual Meeting, September 2020 – April 2021.
Hardter, E; Lewis, M; Perlman, A; Jelstrom, E; Shmueli-Blumberg, D; and Lindblad, R. Regulatory considerations for HHS-sponsored, non-drug human subjects research studies. Oral Presentation, Society for Clinical Trials Annual Meeting, May 2019.
Hardter, E; Armstrong, G; Wright, M; Shmueli-Blumberg, D; Jelstrom, E; and Lindblad, R. A “compound” problem: general strategies and key resources for the utilization of approved, commercially available drugs in a blinded, controlled clinical trial. Oral Presentation, Society for Clinical Trials Annual Meeting, May 2018.
Working in a service group entails a wide and diverse portfolio, which spans nearly all of the Emmes Therapeutic Research Units. While there are too many projects to name specifically, the contracts I’ve been working on the longest include the National Eye Institute, and the National Institute on Drug Abuse.