Meet the Experts: Marc Stegeman and Jan Zorgdrager

October 14, 2019

ProPharma Group has launched a “Meet the Expert” series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support clients’ complex challenges throughout the complete product lifecycle.

Meet the Experts: Marc Stegeman, Principal Consultant and Jan Zorgdrager, Principal Consultant

Marc Stegeman

Introduction: Jan Zorgdrager and Marc Stegeman work as Principal Consultants in the Leiden office. Jan has a longstanding background in clinical development and Marc in QA/GMP. This is an excellent complementary experience to support the challenges of customers in the medical cannabis field.

Tell us about a day in the life of a Principal Consultant. 

Marc: Jan and I are quite active in the medical cannabis industry. On a typical day, we are engaged in managing a variety of projects. Jan focuses on clinical development of cannabinoids and especially on isolation of cannabinoids and its formulation. One challenging project we are currently involved in is a novel dosage containing THC. We are close to the phase I study now. My focus is on QA and compliance. On an a typical day, I am checking the GMP compliance status of production facilities in Canada, Israel, or up north in The Netherlands. I support these companies with improving processes and compliance. On another typical day, we are busy talking with clients and seeing how we may support them. Our ProPharma Group support may range from one day and one person to full project teams for years.

What do you like best about working with clients?

Jan Zorgdrager

Jan: It is a pleasure to serve customers in their endeavor to develop products and bring those to the market. The diversity of their ideas and their different approaches to the development of their products makes me enthusiastic too and that helps to overcome the difficult times each project has to go through. It is particularly interesting to go together on uncharted territory like new treatments, ways of administration such as with new medical devices, and finding out how to best approach (Regulatory) Authorities with cannabis-related questions.

What is one lesson you have learned in this industry that has stuck with you?

Marc: My one lesson is that the medical cannabis industry may be a profitable one, but it is never easy money. During my conversations with customers, I often come across three types: 1) customers with background in pharma, who thoroughly understand the importance of compliance; 2) customers who have no experience with compliance, but who are listening and learning; and 3) cowboys. Usually, it all becomes clear within a couple of minutes and it is, hopefully, to start off all the challenges that Jan just described.

What are the biggest challenges on the horizon for this industry?

Jan: The biggest challenge for the cannabis industry is to find out which conditions can actually be relieved with cannabis products. There is a lot of hope in this industry but to date only a few clinical studies have shown to be statistically better than placebo. Yet, many people report a benefit from using medical cannabis. How to close that gap? Is it terpenes, the combination of cannabinoids, the purified forms? Or will it be a means to improve overall well-being? It is exciting to be part of that adventurous journey.

What’s one thing you wish clients knew about ProPharma Group?

Marc: I wish clients to know that ProPharma is a single-source service provider in medical cannabis: worldwide and with proven expertise. We have much of the expertise in-house and where needed we supplement this with our extensive worldwide network. We are also able to scale-up and scale-down the ProPharma Group team as the project progresses and based upon what the customer needs. Every project has its own unique challenges, but we are always able to overcome, with the customer in mind, and a happy customer in the end.

 

 

 




Compliance Life Science Consulting

October 25, 2012

Five Most Common Mistakes When Writing an Investigation

The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...

Read the Full Article
Compliance Life Science Consulting

March 12, 2013

Three Key Steps to Conducting a Strong Investigation

Unexpected events often happen in the everyday world. However, in the regulated world great efforts are made to minimize the severity and frequency of unexpected events. Yet, despite best efforts,...

Read the Full Article
Program & Project Management Life Science Consulting

November 21, 2012

Project Management - 100% Responsibility and 0% Authority

Project Managers face a unique set of challenges every day. One of those that comes to mind often is how we, as Project Managers, succeed when we have 100% of the responsibility for the project...

Read the Full Article