Q&A with Rachel Beck, Ph.D.: What Do Analytical Chemistry and Forensic Toxicology Contribute to Drug Development and Formulation Evaluation?

Categories: Abuse Deterrent

Dr. Rachel Beck is an expert in analytical chemistry and forensic toxicology.  In 2018, Dr. Beck joined PinneyAssociates where she is a key contributor to our abuse-deterrent formulation strategy and evaluation team.  She has been qualified as an expert witness in both criminal and civil courts of law and is a fellow of the American Board of Forensic Toxicology.  While on the faculty at the University of Alabama, in the Department of Pathology, she developed a liquid chromatography tandem mass spectrometry (LC-MS/MS) confirmation laboratory for both prescription and pain management drug analytes for the hospital.

 

How does your expertise in analytical chemistry and forensic toxicology support PinneyAssociates’ clients?

My background is especially relevant to testing of abuse deterrent properties and drug development.

Drug development in general depends on good analytical chemistry.  I can help sponsors evaluate metabolic processes and determine the PK profile of a drug.  If the drug is metabolized, companies need to understand the effect of any metabolites.  Further, assessing chemistry laboratory data and discerning potential anomalies depends on understanding the testing protocols.  My experience in developing laboratory workflows and protocols puts me in a position to “read” the data and assess any irregularities. Missing or additional data and tracking data trends are key to discerning and interpreting Sponsor’s data. It may be as simple as a missing data point, or trend data may be accurate and point to a potential problem.

Rigorous abuse deterrent testing depends on accurately simulating drug abuse behaviors.  In my 11+ years in forensic toxicology, I focused on how people prepared drugs for abuse: what methods they applied; what the time course of their efforts was; how much effort drug abusers are willing to put in to maximize the effect of a substance and minimize the time to obtain that effect.  Development of abuse deterrent products depends on a deep understanding of drug abuse behaviors.

 

Your work was key to identifying a new fentanyl analogue (fentalogue) within Jefferson County, Alabama. What does that expertise mean for pharmaceutical developers and manufacturers of controlled substances and other drugs that act on the central nervous system? 

The process of identifying a novel psychoactive substance (NPS) requires an understanding of how to apply laboratory methods and resources.  Also key to the process is perspective into what drugs people are abusing and how they are abusing them.  For developers and manufacturers of compounds and formulations potentially resistant to manipulation and abuse, effective assessment of a drug pipeline requires efficient merging of innovative laboratory methods with insights into real-world abuse of drugs.

 

How has the increase in novel psychoactive substances impacted medical examiners offices? How does your experience in this setting benefit industry?

Statements and reporting that attribute morbidity and mortality to specific substances depend on accurate data.  Good data on drug abuse behaviors and solid drug abuse assessments provide the basis for accurate interpretations.

During the years I worked in forensic toxicology, first at the Alabama Department of Forensic Sciences and then later at the Jefferson County Coroner and Medical Examiner’s (JCCME) Office, we saw both the number and volume of novel psychoactive substances increase, together with recurrent shifts in these substances.  We needed to be able to identify these substances to protect the health of anyone potentially touched by them, including drug abusers, first responders, health care providers treating patients in the emergency department, and even laboratory personnel responsible for managing and testing evidence.

In the face of this public health challenge, I designed and validated a multi-pronged methodological approach in order to identify and report new novel psychoactive substances, which combined known information (i.e., suspect/decedent history and investigator notes), with analytical data (i.e., positive immunoassay screens, spectrum, molecular ion, retention time, etc.), and insights from discussions of illicit drug use on social media. This process not only helped accurately report the drug analytes to the Medical Examiner but ultimately allowed for proper transmission of the data to the Department of Public Health, CDC, and beyond.

Forensic sciences, especially the toxicology and chemistry fields, are charged with determining if a prescription or illicit drug analyte were involved in a particular incident (traffic crash, overdose, etc.). Part of this responsibility is to report findings on drug behaviors to local and state regulatory and public health entities. These data affect new regulation requirements which in turn affect pharmaceutical companies’ processes. Ultimately, to successfully design and receive FDA approval for new drug analytes and formulations, we have to understand current and past use, misuse, abuse, overdose and diversion behaviors.

 

References

Atherton D, Dye D, Robison CA, Beck R. (2019) n-Ethyl Pentylone-Related Deaths in Alabama. J Forensic Sci. 64 (1), pp 304-308.

Beck RC, Kloda S, Whiddon J, Davis GG, Robinson CA. Methodical approach for the identification of novel psychoactive substances. Presented at Society of Forensic Toxicology 2017 Annual Meeting. Boca Raton, FL. (January 2018).

Beck RC, Kloda S, Whiddon J, Dye WD, Robinson CA. Jefferson County fentalogues: A 6 month review. Presented at Society of Forensic Toxicology 2017 Annual Meeting. Boca Raton, FL. (January 2018).