We sat down with Brian Farnan, our Director of GMP QA to learn more about his passion for pharmaceutical Quality and Compliance, what he enjoys about his role in the drug development process, what drew him to RegDev, and what he loves most about working with his clients.
 

RegDev: Hi Brian! Please tell us a little about your background. How did you get into the field?  

Brian: Looking back, initially, and still to this day, my professional career pathway has continuously and seamlessly matured in the global pharmaceutical industry, with Quality and Compliance being my two primary functional areas of interest and responsibility. I grew up in Ireland and attended University College Dublin, graduating with a Bachelor of Science degree (Chemistry, Pharmacology and Mathematical Sciences). Shortly after graduating from university, I immigrated to the United States.   

For the first nine years in the U.S., and before pivoting to a focused and protracted career in pharmaceutical Quality and Compliance, I held positions working as an analytical chemist in a pharmaceutical company, a packaging supervisor with a large cosmetic company, and an aseptic sterile manufacturing/production supervisor with a large global pharmaceutical company.  

This valuable cross-functional experience led me to want to grow further professionally by pursuing a focused career in the areas of pharmaceutical Quality and Compliance, because I realized that all functional areas which support a drug/medicinal product lifecycle ‘cradle-to-grave’, and not just Quality and Compliance, are equally as important from an ultimate clinical benefit and patient safety perspective.  

My professional pharmaceutical Quality and Compliance career has now spanned thirty-plus years, and my level of interest, enthusiasm and dedication remains strong. To find and pursue a professional career for which I have an immense overall passion, has been a highly rewarding experience in life. 

 

RegDev: What’s your favorite part of your role in the drug development lifecycle? 

Brian: Drug development is a critically important discipline within the pharmaceutical industry which allows for drug/medicinal products to go forward and be approved by regulatory authorities and marketed globally. As a discipline, drug development continues to grow with the introduction of new drug product categories and modalities in recent years, and we see also that a concerted effort has been made and continues to be made by leading global regulatory authorities to harmonize associated global standards (e.g., ICH and PIC/S) covering the development and manufacture of drug/medicinal products.  

My favorite part of my role in supporting clients with drug development lifecycle projects is comprised of three main sub-parts.  First, I immerse myself to gain a complete understanding of the client’s landscape, focusing on its drug/medicinal product candidate/s in development (i.e., product category and associated supporting science). Second, I work together closely with my clients to gain a complete understanding of the development work that they have conducted to date (i.e., where, and how that work was conducted), and an understanding of the level of compliance of the client’s Quality Management System to support the development work conducted.  Finally, I ensure that I am abreast of current regulations and standards which apply to the client’s development project. 

By acting equally upon each of these parts as given above, I am well-positioned to bring clients ultimate success as they navigate their respective drug development pathways through the different clinical phases and receive regulatory authority approval to manufacture and distribute their drug/medicinal product/s on a commercial scale. Strongly positioning my clients for success overall is a favorite part of the role I have in supporting clients with drug development projects. 

 

RegDev: Why did you decide to join the RegDev team? 

Brian: Before joining RegDev, Inc., I held the position of Senior Director GMP Quality & Compliance with a company which was focused on developing small molecule oncology drug products. During this time, the company retained RegDev, Inc. to conduct a GMP Gap Assessment against the company’s Quality Management System, and to evaluate drug product development work that was conducted up to that time for a leading drug product candidate in development. 

The Gap Assessment approach and methodology exercised by the RegDev consultants was extremely thorough and resulted in the generation of a detailed ‘roadmap to success’ which included recommended improvements and risk mitigation strategies. The manner in which the Gap Assessment project was managed by RegDev impressed me to the point that my mindset changed, thinking to myself how much more rewarding it would be from a professional career perspective to be able to work for such a company like RegDev helping multiple clients within the industry to achieve success with their development/commercial drug programs. Upon learning that there was an open position at RegDev for a Director GMP Quality Assurance, I immediately submitted my application.  

Another major factor in wishing to join a company like RegDev from a professional career perspective, was that I would have the opportunity to work for a professional services organization as distinct from working within just one company. I have found this to be extremely rewarding and satisfying. 

 

RegDev: What are some notable projects you’ve worked on that you feel most proud of? 

Brian: For this point, I immediately associate the word ‘notable’ with such words as rewarding, satisfying, and successful. As with all projects I undertake for RegDev, I approach them with a very objective mindset, ensuring that from the onset of each project I strive to gain a complete understanding of what needs to be accomplished to achieve a successful outcome for the client. All assigned projects are different of course, with their unique set of circumstances. 

As project categories go, I most enjoy applying myself to client projects that are related to the conduct of Mock Inspections and qualification audits and conducting in-depth gap assessments /remediating internal systems and processes. Most notable projects over the last twelve months or so have involved the conduct of three in-depth gap assessments for clients in early phase drug development. All three clients exhibited a moderately acceptable to acceptable level with respect to the associated product development work that was conducted but each were lacking in their respective quality management systems for the phase of drug development they were engaged in. Being able to identify required QMS improvements with proposed and effective CAPA actions, each with associated target timelines, was something I felt quite proud of as each of the three projects came to completion. 

Another notable client project I supported am proud of, was the conduct of a critically important CDMO qualification audit overseas in China for a biological drug product in early phase development. The potential sponsor for the biological drug product (in the U.S.) wanted to ensure that the product had been developed acceptably from a U.S. FDA perspective through Phase 1 before it entered Phase 2. A notable aspect and takeaway from this CDMO qualification audit was how education and learning influenced the qualification audit proceedings, as I interacted closely and openly with the CDMO management team. Being able to clearly increase the CDMO management team’s awareness and level of understanding of associated global regulations and standards was extremely rewarding and satisfying for me, achieving ultimate success for both the CDMO and the potential sponsor of the biological drug product. 

 

RegDev: What are common pain points you see in the industry? 

Brian: Whether companies are involved in developing drug products or commercializing approved drug products, related activities inevitably bring forth several challenges (scientific and technical challenges, regulatory challenges, and quality management system challenges, to name a few). Within the last decade, though, the industry has seen a significant increase in the number of companies, especially new start-up bio-pharma companies, pursuing the development and commercialization of biotechnological drug products, commonly referred to in the industry as ‘biologics’ or large molecule drug products.  These drug products are developed and produced using living organisms, materials derived from living organisms, or cellular, subcellular, or molecular components of living organisms. 

The most common pain point I have observed to date centers around the level (or lack) of understanding new start-up bio-pharma companies have regarding the extent to which its supporting Quality Management System (QMS) should be established to support its drug development activities, particularly in the pre-clinical and early clinical phase following the drug discovery phase.  In parallel, new start-up bio-pharma companies oftentimes encounter additional but related pain points due to their lack of understanding of applicable global regulations and standards which need to be adhered to on a phase-appropriate basis. 

Supporting such new start-up bio-pharma companies to address these types of unanticipated yet common pain points, helping them to establish an acceptable phase appropriate QMS and ensuring that all drug development related activities are conducted in adherence to applicable regulations and standards, ensures successful outcomes are achieved for such companies. 

 

RegDev: How can RegDev make a difference in the industry or in the GMP space specifically? 

Brian: I believe RegDev has made and will continue to make a significant difference in the industry with any client it directly supports, whether that is in strategic drug development, quality management systems, independent verification (mock inspections/audits), or risk management.  Additionally, I believe RegDev’s unique footprint for making a difference in the industry is found in how RegDev dedicates itself to supporting its clients. With a core focus on collaboration and partnership, RegDev provides a tailored approach and innovative solutions that address the quality and compliance issues that each of our clients faces. RegDev conducts business with the highest standards of integrity and ethics, striving at all times for drug and patient safety while securing sensitive client information. Finally, RegDev specializes in process optimization to improve effectiveness, reduce risk, and increase efficiency for its clients during the drug development and approvals process. 

I believe RegDev does make and will continue to make a significant and noticeable difference in the industry by solidly positioning itself to earn the respect of our clients. We continually prove our value through our high-quality and detailed support services, ensuring successful outcomes are achieved for our clients. 

 

RegDev: What do you like most about working with RegDev clients? 

Brian: Besides focusing earnestly on creating value-added outcomes and helping each client to achieve success with their respective programs, I very much enjoy working directly with RegDev clients as a professional consultant. In all aspects of my work, I consider myself to be an integral member of a client’s management team, striving to fully understand a client’s landscape (product and systems related), and exhibiting the highest level of professional integrity, ethics and objectiveness that I can, in order to achieve a successful outcome for the client. 

Sometimes the scope of a client’s project may expand to a follow-up, second, or third phase and this too is especially satisfying and rewarding for me. It is gratifying to know that the client’s management team has gained confidence in the initial project work I conducted and is now looking to achieve further success by having me address additional areas where the client needs direct help and support. 

In summary, developing and fostering strong professional working relationships with clients and helping clients to achieve success is what I like most about working with my RegDev clients. I believe that my professional behavior, working closely with clients to help them achieve success, does make all the difference — both to the client themselves and to RegDev.