Articles

Newsletter Summer 2018 - Lana Pauls, MPH, My Career Trajectory – Themes & Contrasts

 

I joined Kinexum earlier this year, filling two roles:

 

Director, Client Engagement, and

Consultant, focusing on regulatory affairs, regulatory strategy, CTD submission development, and project management

The purpose of this article is to compare and contrast my regulatory perspective and experiences over the three VERY DIFFERENT roles I have played over the past three decades.

The Beginning:

I started my career at the FDA in 1990 as a Project Manager, interestingly enough, working from time to time directly with Kinexum founder, Dr. Zan Fleming, for approximately 6 years (I stayed in touch with Zan until he left the Agency in mid-1998).  One of my most memorable experiences as a project manager was when a Medical Officer in the review division told the sponsor that they had to re-do a $1.7 million trial because she “didn’t like the design.”  This happened in my first week on the job, and I was simply awestruck.  At this point, from a sponsor’s perspective (and mine), working with the Agency seemed like navigating a black hole, as there was no ‘true’ project management, and absolutely NO transparency or consistency across the review divisions.   The sponsor heeded the advice and repeated the trial.  This made me think the Agency had omnipotent powers.

With the implementation of the original Prescription Drug User Fee Act (PDUFA) in 1992, project management was institutionalized, and processes, procedures and communications slowly began to improve.  PDUFA also increased funding, and established timelines for reviews.  In approximately 1999, the Center for Drug Evaluation and Research (CDER) implemented a Quality Assurance (QA) unit to help increase consistency and transparency. 

PDUFA II to PDUFA VI continued to implement increasing consistency and transparency, by mandating new timelines, development of guidances, pilot programs, and public meetings.

Over the years, I held a variety of leadership roles in project management, quality assurance, strategic planning and training, and observed the Agency evolve from an omnipotent regulator to a supportive regulator giving tractable guidance to the pharmaceutical industry.  I cannot deny that there is still a sense of mystery from the sponsor’s perspective, especially for start-up pharmaceutical companies.  However, my perspective certainly changed over the years, and I now truly believe that the FDA and Pharma are “on the same side” in terms of delivering safe and effective life science products to patients.

The Next Step:

After 26 years at the FDA, culminating in a leadership position in Post Marketing, I joined IQVIA (formerly known as QuintilesIMS) as a Director of Global Regulatory Affairs (GRA), in which role I provided regulatory affairs strategies and supported regulatory CTD submissions to the FDA and other regulatory authorities.

IQVIA, with over 59,000 employees is the largest Contract Research Organization (CRO) in the world.

When I moved to IQVIA, I thought that the mystery would diminish because of the volume of “working knowledge” and established SOPs.  Although hundreds of SOPs were in place for the vast number of employees on payroll (I was required to sign off on over 70 SOPs in my first week), the actual day-to-day work was not necessarily well-defined, and often inconsistent across individuals on the same team, as well as across project teams.  This “industrialized approach” and multiple silos (each having its own “piece of the pie” sometimes interfered with morale, and could lead to differing interpretations of regulations, causing inconsistencies in final work product and delays.  In addition, GRA was not centralized, and existed as a sub-group among multiple Operating Divisions, which again contributed to inconsistencies and sometimes confusion.  This experience impacted my perspective of how a large CRO views FDA’s opinions and comments and its relationships with current and potential clients.

Current State:

After two years with the large CRO, I decided to work either within a smaller company, or as an independent consultant.  I have found a productive and enjoyable application of my expertise and experience in consulting for Kinexum clients, helping Kinexum implement systems and processes and engage with its clients, and conducting assignments through my Regexel, LLC.  I have great respect for my Kinexum colleagues, who are dedicated and collegial professionals, and see the value for clients of the Kinexum approach, which can assemble a team of experienced functional experts to advise regarding the complex, interdisciplinary work of life science product development.

Conclusion:

The common bottom line throughout my career has been the motivation to more effectively and speedily bring safe and effective products that save lives and improve the quality of life for the American public, and this has brought, and continues to bring me, deep satisfaction.