An expert delivering exquisite consulting services to pharmaceuticals and biologics industry: Jeff Yuen & Associates

To optimize development timelines and costs, guarantee regulatory compliance, and accelerate the commercialization of a product, biologics, which are complex molecular entities, there is a fundamental need for strategic planning and insight to successfully maneuver from pre-clinical to clinical through to commercialization. Retaining the right outside expert consultants with experience in the chemistry, manufacturing, and controls (CMC) regulatory process from the IND or clinical trials phase to the BLA or commercial phase often can facilitate new product approvals. Globally, there are various consultants delivering outstanding services to biologics and pharmaceutical companies, but Jeff Yuen & Associates, Inc. (JYA) stands out head and shoulders above its many competitors.

Established in 1998, JYA works closely with clients and their CMOs, CROs, and CTLs to ensure sites and subject matter experts are well-prepared for mission-critical regulatory inspections. JYA strives to ensure that client engagements are properly executed and that customers always remain satisfied. JYA is not afraid to “course correct” whenever needed and most importantly does not promote or accept assignments where we the team does not have proper subject matter experts necessary to complete the engagement.

In conversation with Jeff Yuen, Founder of JYA

How would you describe your professional journey so far? Tell us about a few roadblocks and learning lessons that helped you grow through the years.

My journey is a “journey of convergence.” I have always had a passion and desire to help others. Learning from mistakes and failures in life has taught me perseverance, patience, and compassion for others, no matter what the circumstances. Having failed to get into medical school, God opened doors for me to pursue a career in public health. Having failed to land a job as an epidemiologist for a county health department, I found myself working for the State of California, DHS, Chronic Diseases Branch as a Graduate Student Assistant; it was not even a permanent position. Keeping my eyes open for a permanent job, I was hired by the State of CA, DHS, Food and Drug Branch a department just down the hall from my office in the same building. As a peace officer and FDB investigator, I built a promising career until I met Terri Dodds, a commissioned officer with the US Public Health Service (USPHS) stationed with the US Food and Drug Administration (FDA), Los Angeles District. After several years, I finally took a chance, applied and was accepted a commission with the USPHS commissioned officer and started my career with the federal government. I came to the FDA at a time just after the infamous generic drug scandal giving me the unique opportunity to support the start of FDA’s important pre-approval site inspection program which exists to this day.

To this day, all pharmaceutical, medical device and biotech products, whether innovative, biosimilar, bio better or simply generic, are required to be approved by the pre-approval inspection compliance program. Having been involved in early biotech FDA field inspections and blockbuster product approvals (e.g., Herceptin/Rituxan (Genentech/IDEC) and Neuogen (Amgen)), I developed a reputation as a tough investigator with a strong technical background and education. My wife, a breast cancer survivor was Her2+ and was administered Herceptin as part of her chemo and immunotherapy. Her cancer changed my life. I left government work in June 1998 to start my consulting firm, having been told by industry colleagues that I could have an even greater impact on public health by helping companies get through their regulatory and compliance hurdles vs. inspecting them.

Q. Trust is one of the most important currencies of leadership that requires authenticity and consistency to maintain. What’s your take on this?   

Trust is critical to one’s personal and professional success. Key business leaders must trust that outside feedback and recommendations are unbiased, apolitical, and balanced. Often, trust is pivotal and necessary when it comes to making unpopular or difficult decisions. Trusting in a vision for how to deliver services is also something that is instrumental and mandatory to establishing the foundation for company growth.

“Our team at Jeff Yuen & Associates, Inc provides the highest quality service for all pharmaceutical phases including pre-clinical, clinical and commercial operations, testing and regulatory support.”

Q. As the founder of the company, what are your major roles and responsibilities?   

As founder, I am responsible for ensuring that my team’s “non-binding” advice and guidance are foundationally sound, practical, pragmatic, and balanced as far as science and compliance. We believe that compliance and business cannot be viewed as separate but rather both must remain tightly intertwined. The multitude of clients we serve in the pharmaceutical and biotech space such as cell, and gene therapy, targeted patient therapies, vaccines, combination products, etc. demand that we remain practical and pragmatic while delivering the highest-quality products that not only meet specifications, but also more importantly meet or exceed regulatory agency (e.g., FDA, EMA, PMDA, etc.) expectations.

I am also a trend setter when it comes to compliance often anticipating and preparing clients not only for the present, but also for the future compliance expectations (e.g., data integrity, QA review of electronic raw data, proper pre-viral and post-viral segregation concepts, proper release of products only with closed deviation investigations, proper deviation investigations, determination of root cause(s) and appropriate CAPAs, etc. The JYA quality model or “solar system” is well known and has been proven repeatedly with our most successful clients.

Q. What can you tell us about JYA? What are its focus areas? Can you introduce us to your services? What are their key features? 

JYA is recognized for its team of experts in CGMP regulatory compliance; we are well known within industry and by FDA’s Office of Compliance for providing objective, unbiased practical and pragmatic advice that meets or exceeds industry and FDA expectations. JYA has an over 24-year record of helping clients prepare for FDA approval of new products with nearly a 100% “first time” success rate. We are also instrumental in new facility construction and design projects.  While at FDA, I reviewed plans for new facility design and have remained active in new facilities being built worldwide as we speak.  JYA is devoted to the advancement and commercialization of innovative, medically necessary pharmaceutical and biotech products. 

Q. What level of growth do you hope to see in the next five years?   

As we continue to expand our team, I have established two new partners: Gary Brennan and Monique Mendoza, two pharmaceutical veterans, to support this major expansion of the team, which therefore allows for the JYA mission and vision to be spread to more clients across the globe. JYA has grown from 2 associates in 1998 to 30 in 2020 and 75 or more in 2023. I have learned as a leader that it’s time to move out of the way for the most part and allow new leaders to drive the day to day business.  I will remain a key visionary and customer point of contact having established a remarkable network of government and industry colleagues throughout my career. Relationships and people remain the key to our success.  Having never really marketed our services in earnest, we source most, if not all existing and new business through “word of mouth” marketing. In my humble opinion, the best marketing in the world.

Q. Is there anything you would like to add before we wrap up?

This is the story of the convergence of education, career, family, and a deep faith that led Jeff to establish one of the world’s most well-respected consulting firms for the pharmaceutical and biotech industries, driven by their unwavering values to serve the greater good. “We look at both our clients and the patients whose lives we touch,” Jeff is known to “bend time” and can often be heard saying, “You can have all the technical knowledge and expertise you need, but more than anything, you must care about the lives you touch daily. That’s why we do what we do. … Every minute of your life is critical make it count!”

This last chapter of my career will be devoted to giving back to charitable causes to fulfill my passion, desire, and duty as a person, a community leader, and a fellow believer. We can all do something with our talents and time to give back those that are less fortunate inside and outside of our comfort zone.

Meet the leader behind the success of Jeff Yuen & Associates, Inc.

CDR Jeff Yuen, Founder is a well-respected domestic and international speaker with over 32 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service. CDR Yuen’s leadership and insights along with his endless energy and special charisma have influenced, shaped, and prepared many companies and their leaders for success during this challenging era of technological advancements and stricter compliance expectations. Considered to be more than a consultant, he is a mentor and player coach to many leaders worldwide.

CDR Yuen possesses a BS in Biological Sciences from UCI, a Master’s in Public Health from UCLA, and an MBA from National University.

“We understand the importance of being collaborative, progressive and pragmatic as a partner.”