As one of the key contributors to current abuse-deterrent studies being performed in the Alcami laboratory and having over 11 years of experience performing analytical testing in the pharmaceutical industry, Angela Moore was the perfect scientist to meet up with for a conversation on abuse-deterrent studies.
Moore was drawn to the pharmaceutical industry by having the ability to be a behind the scenes collaborator working on getting new drugs developed and brought to the market. She thrives on learning new technologies and being part of a team that can help save people’s lives through medicines.
Thanks for stepping out of the lab to share your experiences with abuse-deterrent studies. First of all, how would you explain your work with abuse-deterrence to a family member, for instance?
Thanks for having me. Being able to share what my team does is a great way of showing how patients come first in our line of work. I would say to my family that I research how people misuse or abuse long-acting opioid drug products in real life. After researching how people abuse them, I develop methodical scientific ways to mimic the abuse in a laboratory setting to see if new drug products can resist the abuse. This testing is meant to ensure that any new opioid products that are available by prescription cannot be easily used to get high in the future.
What led you to pursue this career and where has it taken you?
To go back to the beginning, my start in abuse-deterrent testing began when I was tasked with evaluating abuse-deterrent properties of a new drug prototype. With this assignment, I began extensively researching abuse-deterrent techniques and worked as a part of a collaborative team to develop testing plans. I’ve met face-to-face with the FDA to discuss abuse-deterrent testing plans. I’ve led teams to perform the extensive amounts of in vitro testing and authored reports and FDA submissions that are required to bring these new products to the market.
Are there particular cases that you’re especially encouraged by that you’re working on now or have done in the past?
I’ve evaluated several products that have shown resistance to common abuse techniques and this gives me hope for the future as the world faces the opioid addiction crisis. Due to client confidentiality, I’m not able to discuss the specific products that I’ve performed tests on, but I can say that these products have a strong possibility of making an impact in the addiction emergency that we face.
What is Alcami’s approach when preparing for an abuse deterrence study?
Alcami has full GMP traceability; some other places that are also performing these experiments haven’t even been inspected by the FDA. Alcami also has vast experience in this area with a very good understanding of different types of manipulation techniques that can be used. This is critical since manipulation is one of the most important parts of in vitro abuse-deterrent testing.
Alcami also has a good idea of how much time it takes to abuse a product and what the FDA is looking for in these cases. For example, if a tablet can be ground down into really tiny pieces, but it takes an hour to complete this, that’s probably not going to be a common route of abuse in a real-world experience.
Alcami also uses a team-based approach when applying appropriate resources to effectively utilize and meet client deadlines. This is especially important as Category 1 strategies and results drive the in-vivo Category 2 and 3 studies required for abuse-deterrent labeling of drug products.
How does Alcami’s abuse-deterrent studies help combat the national opioid crisis and how has working on abuse-deterrents affected your views on the epidemic?
I think everybody is affected in some way, shape or form. I have former classmates who have either overdosed or have been affected by opioids first-hand. Working on abuse-deterrent testing gives me hope because it gives a view of the behind the scenes innovations and the effort that pharmaceutical companies are putting forth to help combat this horrible epidemic that is facing our world. Alcami has patients in mind when working to help solve this problem through formulations.
Thanks for all of your insight, Angela. To conclude, let’s do a lightning Q & A round, if that is okay with you?
- What’s a typical timeline for testing?
That’s totally dependent on the scope of the project and the client needs, however, Alcami has been able to meet aggressive timelines in the past through team-based approaches to testing.
- Has Alcami worked on products that have been approved by the FDA before?
Yes, we’ve worked on multiple cases that have been approved by the FDA.
- What things does the FDA look for in a successful filing for this type of study?
One of the most important aspects of Category 1 testing is study design and repeatability. Multiple replicates give confidence in results. Also, a well-thought-out design of experiments and testing to failure is key for these studies. Exact study requirements are not clearly defined through current guidance and the FDA uses a “totality of evidence” approach when evaluating these formulations.
- Do you recommend moving forward with studies prior to FDA reviewing protocols?
This is entirely dependent on timelines. However, Alcami recommends to at least engage in conversations with the FDA about testing protocols, as requirements change and every formulations is different.
- What types of studies are performed within abuse deterrence?
The typical studies mimic real-world abuse of the opioid in question. Some main examples are: physical manipulation evaluations, large volume extractions, syringeability testing, smoking studies, liquid-liquid and free-base extractions, and if needed, isolation of opioid/antagonist studies. Alcami can also build a customizable project that suits the clients’ needs.
Angela Moore, M.Sc. has over 12 years of experience performing analytical testing in the pharmaceutical industry for both branded and generic products and their active pharmaceutical ingredients. She has considerable experience successfully executing several FDA Category 1 in vitro abuse-deterrent studies on drug products that are designed to help combat opioid abuse. She also performs development and validation studies for API and Drug Products, generates technical test protocols and reports, and is the subject matter expert for the company in abuse-deterrent products and testing. Angela holds both Master of Science and Bachelor of Science degrees in Chemistry from East Carolina University.
Antibiotic Potency Testing: Diffusion (Cylinder-Plate) Method
Both the European Pharmacopoeia and the US Pharmacopeial Convention (USP) require testing of...
Antibiotic Potency Testing: The Turbidimetric Method
Part One: Biologics and the Problem with Residual DNA
Part One: Biologics and the Problem with Residual DNA