Name: Luigi Artuso
How long have you been with Metrics Contract Services?
What is your role?
I am a Development Scientist responsible for formulating new solid oral products by quality design, strength and stability that deliver the new novel active pharmaceutical ingredients (API) to a target bioavailable region in the body for the desired therapeutic indication.
The novel drug (API) targets a specific therapeutic need predominately by deficiency or inhibition as indicated by the client’s drug discovery program in pharmaceutical research. Our clients’ projects represent everything from virtual to small and large drug discovery platforms.
The API is typically mixed together with other FDA-approved raw materials into new solid oral dosage products (immediate, modified and extended release tablets, oral disintegrating tablets and capsules). The typical target bioavailability for a novel drug may or may not be known during the first stages or may change along the way during early phases of drug approval. The key is to design a quality efficient process that manages and supports the drug’s stability (shelf life) that is scalable to commercial. The obligation is to provide each new drug with the quality target profile to deliver the drug as intended for today and tomorrow. After this, it is up to the client to provide the FDA with drug efficacy data demonstrating that the benefit of administering the drug outweighs the risk.
What accomplishment/project/area of work is your specialty or makes you proud?
I have been fortunate to experience multiple venues of work, from family farm to the pharmaceutical industry. The accomplishments began early and always centered around providing innovative and creative ways to provide a quality product. From supplying agricultural products to pharmaceutical products. Currently, I have been fortunate to lead and participate on teams of highly intelligent staff that have delivered more than 150 first time in man studies (FTIM) for new drugs.
Are there any special organizational strategies you use to be efficient at work?
I typically use a risk-based QBD approach combined with the four-quadrant hierarchy grouping. Thoughtful patience, good science and jumping right in is required. Too much organization of an unknown material will limit the time to provide sound quality products. Too little time spent on organization will collapse into an overwhelming hurdle. However, there is not a “one size fits all” for work that spans the new drug development market. You have to design a matrix development approach that provides four experiments with results that mitigate the risk of the 12 experiments that fall within the border. Too much of a systematic approach would require 16 experiments and then you generate so much data that none of it makes sense. I guess what I am trying to say is a balanced approach.
What are your team’s latest achievements?
Latest achievements involve determination of physical attributes that limited the scale up processability of a pro-drug API. The API was manufactured at two different sites; however, all physical properties matched along with the synthetic scheme. Both APIs produced similar moisture levels 0.1%, similar residual solvent levels, equivalent salt content, equivalent impurities, mean size distribution in equivalent spheres, and conforming shape and XRPD patterns. The scant properties of cohesion were discovered as an abundance of micron-submicron particles that congregate on large needle shaped particles. The solvent system for recrystallization with a ketone provided adequate process characteristics, when recrystallization was performed with a ketone/alcohol system an abundance of fine material was present that provoked primary-particle cohesion along with surface adhesion properties. This supports standard crystalline habits where the concentration and solvent selection exhibit as a critical process specific parameter of quality and not as a critical quality attribute.
How do you think those accomplishments might impact the contract pharmaceutical industry and the industry at large?
The fast-track model allows for potential life saving drugs to continue an efficient path to commercialization for our clients. Our team produces quality products for new drugs on the path to approval and now we have the capacity to support the lifecycle of the product with an expansion that specifically supports commercial production. The contract industry should expect to see growth around the $10 billion mark by 2026. Drug patents diminish in value and expire within a limited time. The clock begins early, typically in discovery; thus discovery time to commercial launch takes years to complete and transferring technology from company to company takes years off the patent. Our company can now shorten the length of time to market for the clients’ ROI and most importantly shorten the length of time for patient therapeutic benefit.
What is the most rewarding part of your job?
Developing new drugs into delivery systems and actually seeing at home the half time commercial of a drug that you developed.
What is the best piece of advice you ever received from one of your mentors/colleagues?
Rooted in chemistry as a synthetic crown chemist, I was gradually challenged with synthesizing elaborate macrocyclic structures to Bis-macrocycle structures to redox-active Bis-macrocycle structures that would selectively bind alkali and alkali earth metals. I ended up developing a process that could be continued on to heterocyclic donor atoms of the redox-active bis-macrocyclic structures that would end up with increased binding ability for the non-specific metals. Thus, it was not anything that was said but was implied to always keep in mind the process and utilize science. A scheme that is only good for a one-time product is isolated and difficult. The one thing that was said in the discovery environment was “Don’t be afraid to fail.”