Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
As senior director of product lifecycle management I am managing a highly motivated, educated, and scientific group of project managers and subject matter experts that help clients to solve operational issues in production and analytical environments to make compliant pharmaceutical products. Sometimes people refer to this as CMC work. This needs to be done in a highly regulated environment with a wide array of different pharmaceutical products with different experts. I connect the experts, help my team members in trouble shooting, support in solutions for our clients in these areas.
Development with the end in mind is my creed. It is based on the 7 Habits of Highly Effective People by Stephen Covey. He says, "Begin with the end in mind." I recognize this as an important pillar in personal growth I have adapted this to something to use to align and sharpen a development team in the pharmaceutical industry. In my early years in the industry I assumed like mindedness, similar scientific background, similar experiences would create similar goals. In this instance making, testing, and bringing to the market a certain medicine to help a group of people (patients) in need. And yes, everybody that I have worked with had this goal, but we fail to see what we do not know. Similar scientific backgrounds can hugely differ knowledge on a topic, knowledge gaps differ greatly and therefore everybody assumes too much. Development with the end in mind is a tool. The tool is not the end goal, or for that matter a goal in itself, but a way to bridge the assumption-gap and create common ground to move to a more defined, laser focused goal to get where we all want to be; help patients!
The diversity of products: In the past we had small molecules, then we got biologicals and now cell and gene therapy. The challenge is that we find clients not being able to deal with a different product in all kinds of areas. The challenge is that either the clients are small and startups or big but did not develop the technology from the ground-up. The solutions we have for clients are getting them diverse expertise in and the knowledge that we can also offer adjacent expertise. This way we can help them grow and develop quicker and more flexible. Furthermore, we see that these new technologies generate familiar issues like compartmentalization and then our experience in inter-service line communication is important because of the earlier discussed assumption gaps. Tools like development with the end in mind help greatly to solve our clients' issues with this.
The value is in the fact that we are not one service line. We do not just offer deep SME consulting, or are a CRO, or are experts on medical devices. We are all interlinked. The best consultants, the best CRO's, the best SME's see the bigger picture and how the move further (ergo: getting your product to the patient in a safe, compliant way). This often lies beyond just the specific one department or one expert. Nobody makes medicine on their own or in one department. They need a team a various expertise. We, as RCO, are that value gain for the clients. This is different per client, but the value is that we can complement each client in their needs. In this manner we help the client with an expert or expertise and then together to become more than one plus one.
I'm a proud father of three children. For myself I am most proud of myself if I can combine completely being there in the moment with them and my busy work life.
The diversity of people in background and knowledge. It gets us the extra mile in life and for our clients.
November 13, 2013
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...
January 26, 2016
The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...
May 20, 2020
The coming pharmaceutical industrial revolution, Pharma 4.0, is an implementation of new systems into the various manufacturing processes leading to an automated production. Introduction of these...