In our latest Team Highlight we’re featuring Kako Lee and chatting with her about her journey into the QA field, advice to newcomers in the industry, her thoughts on AI, and why she joined RegDev. 

 

RegDev: Did you always like and have an interest in science or the medical realm growing up?  

Kako: I always have had a deep curiosity and affinity for the holistic approaches to both Western and Eastern medicine throughout my secondary and post-graduate education. 

 

“I gain satisfaction and gratification knowing that my work contributes to patient advocacy.” 

  

RegDev: What led you into the industry and into your particular specialties?  

Kako: My pharmaceutical career started right after completing my graduate studies when I was hired by a virtual pharmaceutical company in San Diego that specialized on the drug discovery and development of HIV and cancer drugs. The company was the first to develop and commercialize HIV protease inhibitors. I was responsible for coordinating and supporting the company’s Japanese business partner’s regulatory activities. This is how I first started learning and moving into the process of the drug development cycle.  

Throughout the multiple transitions of the company that led to the merger of Warner-Lambert and Pfizer, my role and responsibilities expanded into Regulatory Affairs, QA/Auditor, Project Management, and Business Development.  I was intrigued with the QA activities and specifically resonated with the roles and responsibilities to ensure the safety and quality of drugs. My tenure at Pfizer granted me further insight and career development skills within the QA field.
 

Through my work consulting and contracting for various clients, I gain satisfaction and gratification knowing that my work contributes to patient advocacy. My career in QA has distilled in me the deep sense of responsibility knowing that my role in QA stands as a safeguard for those that rely upon us.  

 

My collaboration with global partners has given me greater insights and experience and has deepened and solidified my resolve for global regulatory compliance.  I have always remained vigilant in my personal quest to ensure that “If I cannot give the drug product to those I love, it should not be given to any patients.” 

 

“Be willing to challenge yourself.” 

  

RegDev: What would you recommend to a young person just starting out in the industry?  

Kako: Be willing to challenge yourself. Undertake every role and responsibility that leads to complete understanding of each team member’s contribution to the safety of the final product. 

  

RegDev: What do you wish you had known at the beginning?  

Kako: I wish I had access to the information now available via internet/electronic communications that would have increased my early understanding of drug development. 

  

RegDev: What do you see happening in terms of industry trends?  

Kako: Due to the increased competition in pharmaceutical/biotechnology companies, a rush to investment return appears to supersede the holistic oversight necessary prior to product release.  RegDev satisfies the industry’s need for consistency and diversity that is beyond the internal capabilities of a broad spectrum of companies within the industry. 

  

RegDev: Any thoughts about how AI might shape and affect your work? 
 

Kako: AI will certainly have an effect and its place within the pharmaceutical industry.  However, the human factors involved in production and manufacture of pharmaceutical products will always require human oversight into standardized practices, policies, and ethical development in our industry. 

 

“The collective experience and expertise of the RegDev team encapsulates a vast knowledge and skill set.” 

 

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

Kako: My desire was to contribute to a team that is passionate and diverse in industry experiences. The collective experience and expertise of the RegDev team encapsulates a vast knowledge and skill set that brings value to the broad array of clients throughout the industry.
 

Having worked with current RegDev principal consultants in previous years of my career, I was drawn to their professionalism, standards, and work ethic that they have incorporated into RegDev company culture.