Master of Industrial Drug Development

Department of Pharmacy - University of Copenhagen

Lene Jørgensen is heading the study programmes of Master of Industrial Drug Development (MIND) and Master of Medicines Regulatory Affairs (MRA). She has a keen interest in pharmaceutical, development, design and production as well as regulatory aspects.

Lene has been teaching pharmacists for over 20 years. Since 2012, she has been heading the MRA programme, and since 2019, she has also been leading the MIND programme. Her aim is to integrate the best from research with practical applications in the development and registration of medicinal products. Additionally, she strives to ensure that courses and educational activities are valuable for both participants, lecturers, and course responsibles.

Susanne Hohn holds a Master of Science degree in molecular biology and is employed as a high school teacher at Rosborg Gymnasium and HF in Vejle, the third-largest high school in the country, where she has been employed since 2009. Here, she teaches chemistry, biology, and biotechnology. As a student on the MIND program, she is only lacking her final assignment - and we had the opportunity to speak with her when she was here in connection with her latest course, "QA, QC and GXP in Pharmaceutical Production" https://mind.ku.dk/courses/qa-qc-gxp/

In addition to her MIND courses, Susanne has completed a couple of optional courses at Master in Personal Medicine (https://personligmedicin.ku.dk/): Bioinformatics and DataScience. These courses were more relevant to her daily work as a high school teacher. The courses have been approved for credit.

Tell us about your education and work experience

"I haven't always been a high school teacher. In the year 2000, I completed my education, including maternity leave, and after an Aarhus University and Ferrosan project, I moved to Switzerland where my husband had found work, and we lived there with our children for 7 years. During this time, I was employed at the University of Bern, then for 4 years at a spin-off biotech company near Zurich, and for 2 years at a company, also in Zurich, that developed cosmetic active ingredients.

When we returned to Denmark in 2008, I could almost only find work in the Copenhagen area with my skills. But I wanted to go to Jutland because that's where I'm from. Then biotechnology emerged as a high school subject, opening more job opportunities. As a molecular biologist, one has both the specialized knowledge and the link between chemistry and biology, enabling teaching in pure biotechnology. Some schools have both a biology and a chemistry teacher for a biotech class, but I teach biotechnology as a whole."

What would you like to specialize in?

"MIND is a very broad education, from disease to target and drug until the product can be marketed - it's the entire life cycle. In my current job, I can best utilize drug discovery, as well as pharmacodynamics (PD) and pharmacokinetics (PK), which I use in connection with the written assignments in chemistry A and biotechnology A. The assignments involve how the drug is synthesized, how it acts on the body, how it is absorbed by the body, and how it is broken down by the body. Usually, it only takes a couple of years before a newly marketed drug is included in a chemistry A or biotech assignment, so it happens very fast. That was also one of the things that inspired me to seek out this education."

What made you choose a Master's degree, and how did you become aware of MIND in the first place?

"I became aware of MIND around 2014 when I saw an advertisement in Ingeniøren. My husband is a member of IDA, the engineers' union, so I also read Ingeniøren. Therefore, I thought it could be exciting to pursue further education to stay updated and learn more about the process behind drug development. I have only worked in drug discovery and a bit in drug development while working in Switzerland. And I'm simply curious."

How do you combine the two things, work, and education?

"My boss, rector Hanne Hautop, had to approve my taking the education, and then I applied to the Statens Kompetencefond (DSK) for support. Your employer must contribute when you apply for support from DSK, so they give me 50 hours per course, regardless of whether the MIND course lasts one or two weeks. They also pay for my books and travel card. The few times when I haven't had course expenses and accommodation paid by DSK, my employer has covered all expenses.

The fact that I spend my free time away for weeks at a time because I live too far away to go home every evening, is fine. My children have more or less left home, and my husband usually prepares good food and wine for me when I come home on Fridays after a course. Fortunately, I have both personal and professional interest in gaining more knowledge, so I feel very privileged that I have had the opportunity to take the MIND education."

How does it work in practice regarding your other tasks?

"I receive compensation for my working hours. In practice, this means that, for example, I am teaching at four courses in this school year, so here I receive a50 hours’ compensation per course. That amounts to 200 hours deducted from my total tally of hours in a year. The schedule is so flexible that the students don't notice my absence. Personally, I have older children: my son is 25 years old, and my daughter is 20 years old."

How do you experience the teaching skills and expertise of the instructors?

"Everyone is academically strong, and many of those from the industry are excellent communicators. Some courses are conducted by employees of UCPH, who are also academically strong, but I could have wished for a more industrial perspective. Some participants have industrial experience, while others do not. Furthermore, it is unlikely that we have taken the courses in the same order. There are nine mandatory courses, and my first course was 'Non-clinical Safety and Toxicology.' Its focus was animal studies, guidelines, and graphs, where maybe I understood half of it. It was a significant course to start with, but it gave me a very good foundation for understanding everything else, so it was fortunate that I took it first.

I like it when there is teacher from the industry on the course – on almost all courses, there has been an UCPH employee and a co-chair from the industry, except for the course Clinical Pharmacology and Biostatistics. I think it's a pedagogical challenge, where some teachers may assume that we have knowledge on specific subjects, but we don't, necessarily. Many participants alsoonly take a single course."

What would you highlight about the courses you have attended?

"This week's course, 'QA QC and GXM for Pharmaceutical Production,' has given a hands-on feeling for the paperwork and documentation involved. You learn a lot about identifying problems and their causes. So, you're prepared for what it's all about: Quality, safety, and efficacy. Now, tomorrow is the last day, but so far, the course has delivered as expected and with many excellent cases. They were good at that, even though the documents we were supposed to read for the course were a bit difficult to navigate.

The first course I attended, 'Non-clinical Safety and Toxicology,' I think was one of the best I have experienced. Perhaps because I can use it in my work. The course was about how to conduct all the experiments leading to the stage where you must find the 'first in human dose.' That's what's so exciting: should you use cell cultures or study animals? And how do you then scale up or convert to move from a rat to a human? Even though it was my first MIND course, and I was completely blown away, it was really good.

I would also highlight the course 'Drug Discovery' by Professor Stephan Pless. Because it is a topic, I know something about, it's much more enjoyable: you can participate in the dialogue. Stephan Pless had organized a whole symposium where external speakers came, and others could also come and listen. It was really well organized and showed both local and global breadth and depth."

Do you have any advice for others considering taking the education?

"You need to have the time for it, as it also takes up some of your private life. I'm here all week and can't just go home. I also think you need to have a background in research and business experience, like I do, otherwise, it will quickly become too heavy. I feel like I'm a better educator because I am now better informed about drug development, where I have the whole story, and I use it both in theory and in practice.

I also use MIND to make contacts. I have just been in Copenhagen with 9 chemistry A-level students, and here we visited several of the contacts I have made through MIND. They know that I am the pipeline to their future employees; my students might even study at UCPH and possibly work in the companies we visit. So, I hope they are willing to showcase what they do and talk about it. Before I started MIND, there were many aspects I had considered but not learned about; for example, when can a drug go into production and when is animal testing used in the process. I also know more about how documentation is handled. But I still prefer being in the laboratory, and I will probably never be someone who sits at a desk. Now I know how much work is involved before, during, and after getting a new drug to market."

Interview from 2024

Career changes led to new academic needs

For many years, Lene Sønderbye Kjærulff worked in research, but over the past years, she has changed her career path towards information management and project coordination in the life science industry. Working as a project coordinator on projects focusing on pharmaceutical development, she realized that she needed a broader basis and more general drug development competencies than what she had obtained from her educational background in biochemistry.

Lene Sønderbye Kjærulff’s manager supported her interest in educating herself further in other aspects than research. It felt natural for Lene Sønderbye Kjærulff to choose Master of Industrial Drug Development, as she had already heard about the master’s programme and it fitted well with her academic and work-related needs. The structure of the master’s programme was well suited for her:

“I liked that it was flexible with closed courses, where you finalized one part before starting on the next. It fits very well with my temperament.”

Master of Industrial Drug Development as a pharmacist ‘light’ education

Lene Sønderbye Kjærulff finds the master’s programme very useful for her work at Lundbeck:

“It was most definitely relevant. I gained a better and broader knowledge relevant for working in the life science industry, especially in connection to the chain of drug development. I think of it as a pharmacist ‘light’ education, as you go through a range of topics, which I believe are covered in the pharmacist education. For example CMC, regulatory affairs, and quality assurance.”

Lene Sønderbye Kjærulff finds the education recommendable for people who work in the life science industry, but who lack the broad knowledge in the pharmaceutical field. She highlights the different possibilities:

“If you do not need the whole package, you could just enrol in one of the great courses, for example the regulatory courses. I very much like that you have the ability to hand pick according to your needs.”

Networking and sparring opportunities

Even though the course participants differ from course to course, Lene Sønderbye Kjærulff finds it giving for the education that you meet many people from the life science industry at the courses:

“When participating in for example the regulatory course, you can hear about how they work in other life science companies like Novo Nordisk and Leo Pharma. You can bring your own challenges to the table, be sparring partners, and learn how other companies would approach the same issues.”

Newly gained competencies led to new career opportunities

When asked if Lene Sønderbye Kjærulff found her new competencies applicable to her work in Lundbeck, she is not hesitant to mention the changes in her career life.

“I was offered the position as project manager at Lundbeck while I wrote the master’s thesis. Before then, I was a project coordinator, and I believe the education has played a part in my increased involvement and responsibility in the specific projects. Bottom line, I believe the education and the competencies gained from the Master of Industrial Drug Development, contributed to my promotion as project manager in Lundbeck. It certainly did not hurt.”

In Lene Sønderbye Kjærulff’s new position as project manager, the knowledge gained from the education helps her in different ways:

“I feel better prepared to talk to people from different areas of drug development. As part of the project management, we have a project team represented by many different areas for example CMC and toxicology. The education has helped me to ask better questions and improve my understanding of the different representatives and their contributions, needs, and challenges in drug development projects. Basically, I have gained a broader understanding of the value chain that helps us to lead a project forward and what is of importance in different areas of drug development.”

Interview from May 2021.

New work tasks created the need for continuing education

Ea Pettersson became acquainted with the Master of Industrial Drug Development, as she needed new knowledge for a new work task. She found the Master of Industrial Drug Development to be ‘spot on’. While her primary intention was to enrol in a single course, Ea Petterson quickly found an interest in the full master’s programme:

“The master gives you the full perspective and understanding of the drug development phases. There are not many master’s programmes offering a full package like this.”

Understanding the connection between drug development phases

When asked who would benefit from a Master in Industrial Drug Development, Ea Pettersson points out that:

“The master’s programme is applicable to everyone working in the life science industry. However, it is of special interest to people who want to understand the connection between the drug development phases. In my position as director, it is important to know the crucial elements and requirements in the development of a drug. This programme can most definitely give you this overview, which is a great academic and professional ballast to obtain.”

Meeting other people with great expertise

Ea Pettersson highlights that the encounter with her fellow master’s students was of great value:

“In group work you spar with people working with other drug development phases, and people from different backgrounds and companies. You get an insight into other companies and organizational cultures.”

The external outlook was part of her argument to her management in Novo Nordisk when she applied for the master’s programme:

“The Master in Industrial Drug Development gives you an external input which you would not achieve through an internal educational programme within your own life science company. The course directors and external teachers are highly skilled scientists from both university and the life science industry. As they are the best in the field, you are presented with topics that are new and of current interest. They bring real life cases to the table which you can easily relate to.”

On a personal level, Ea Pettersson is pleased that the master’s programme also gave her professional direction:

“When you learn about all phases of drug development, you also have the chance to explore what phases you find the most intriguing and fun to work with.”

New career opportunities

The contribution of the master programme is clear to Ea Pettersson:

“My role has changed at Novo Nordisk. The master’s programme has most likely supported me in my transfer from an academic position as a chemist to a position as director. I have gained a better business understanding and a greater perspective. If you would like to be a manager in the life science industry with a strong professional academic foundation, the Master of Industrial Drug Development is worthwhile considering.”

Interview from June 2021.

In this interview we meet Gitte, who works in QA with drug substance and drug product for the clinical phases of drug development. Gitte shares how the master has provided her with a solid foundation and understanding of what the various drug development processes entail, and how she uses these insights in her daily work.

Understanding the development work prior to my own

I have a background in pharmacy and currently work at Ferring Pharmaceuticals with development and quality assurance. In my department, we handle drugs that are ready to be given to humans in clinical trials. Although I am involved in the later stages of the drug development process, I believe it is important to get a better understanding of the work that has been made prior to ours in the preclinical phases.

Continuing professional development and deep knowledge

I was looking for some further education when I discovered MIND. MIND has provided me with the opportunity to understand the practical aspects of drug development processes, including who does what, why, and how. For instance, we had lecturers from different pharma companies, and that gave me interesting insight into how other companies approach drug development, and that has been very useful in my daily work.

Investigating and learning through own projects

During the master's programme, I had the opportunity to delve into the phase that comes just before the clinical phases which I work with daily. I based my master thesis work on a Ferring project I am involved in, just focusing on the preclinical phases. This was very rewarding and also enabled me to better understand and engage with my project afterwards.

Solid foundation and comprehensive understanding

MIND has provided me with a solid foundation and understanding of what the various drug development processes entail. I have gained insights into what different departments are focusing on, what their terms mean, and why they operate as they do. This has given me knowledge of their professional "language" and procedures. It is beneficial to better understand others’ decisions and choices before they reach my desk. It actually makes my work easier.

Market Access as an integrated factor in all drug development phases

One course that particularly captivated me was Market Access, which deals with how to get medicines to the market and sold after approval by the regulatory authorities. Considerations about Market Access need to be integrated from the early stages all the way until the product reaches the market. If a medicine cannot be sold once it hits the market, an enormous amount of money has been wasted on its development. Therefore, Market Access must be considered from the very first idea. This perspective was interesting, given that I work with the clinical phase before the medicine is actually being marketed.

Making an important connection to the real world

We had several instructors from the industry, and I think that is an important priority. It makes a connection to the real world which university lecturers do not have in the same way. Of course, they keep up with research and what is happening in the industry. There are also many collaborations between the industry and the university, and I think that combination is very beneficial and also interesting to get an insight of.

A significant advantage

MIND has strengthened my skills in the development and marketing phases of a pharmaceutical product. I will highlight this master as a significant advantage if I were to find another job. I also connected with other students on LinkedIn from the different courses. Who knows, someday we might need each other in finding the next job opportunity.

Crash course in all stages of a drug development process

MIND is an interesting programme and very well-structured. We started off with a 14-day course covering all the different processes in drug development - from Drug Discovery to Market Access. It was rewarding and provided a great overview of the entire process from end to end.

Interview from June 2024.

Meet Ekaterine, a Senior Medical Director working for Ferring Pharmaceuticals A/S in Denmark, sharing her journey as medical doctor with a PhD in diabetes genetics to working with early and late phase clinical trials. Ekaterine tells how MIND helped her navigate through the transitions between different job roles when new job opportunities opened up.

Transitioning from one job role to another

My first employment at pharma industry after I graduated Lund University with PhD in diabetes genetics was at Novo Nordisk. I spent the first eight years working as a Principal Scientist at epidemiology department mainly working on non-interventional studies, followed by five years at medical and science department working on phase 2 and phase 3 clinical trials. . It was like joining a totally new field as I transitioned my job role from real world evidence generation studies to clinical trials. That was when my manager suggested that I joined the Master of Industrial Drug Development to accelerate my ability to excel in a new job role. The specific skills effectively acquired at MIND had benefit me the most when I have joined Ferring Pharmaceuticals and got medical responsibility of Phase 1 studies, since I had good understanding of pre-clinical work and a strong grasp of translatability to first-in-human clinical studies.

A niche-oriented and narrow-focused field

Even though I have spent 15 years at Pharma Industry jobs, you still lack understanding of the big picture of the drug development process and every time I have changed the job role, the procedures, tasks, and stakeholders were relatively new and it takes time to catch up. . Working with drug development at very large companies like Novo Nordisk, you often work on niche-oriented tasks, however the good overview of the entire process of drug development is crucial and demands close collaboration between interdisciplinary teams. Thus, it is very important for specialists working on the same projects to have a fundamental understanding of each other's skill areas for streamlining the work process. While people often learn on the job, providing targeted education like MIND to employees new to the pharma industry or those in new roles is essential—not only for the benefit of the project but also to facilitate their professional growth.

Underestimating other people’s work

When you lack understanding of the big picture of the drug development process, you may underestimate the work of others and be surprised when a study you are focused on cannot proceed due to a lack of drugs. Each team tends to be centred around their own tasks, leaving little time to explore different departments in depth. MIND provided me with the opportunity to delve into various areas of drug development at different phases, significantly enhancing my understanding of the field as a whole.

Shifting stakeholders require new tools and glossary

Two years ago, I had the opportunity to join Ferring Pharmaceuticals and work on early clinical trials, specifically phase 1 studies. Without the knowledge gained from my master's programme, especially the module in toxicology, I would have struggled to comprehend the discussions in these early studies. When attending meetings in the early stages of drug development, stakeholders such as toxicologists, pharmacokineticists , scientists from research and discovery, formulation scientists, and medicinal chemists are present. These conversations often revolve around drug substance, formulation, drug properties (absorption, distribution, metabolism and excretion), preclinical safety and efficacy testing. . During my 13 years at Novo Nordisk, I never encountered a chemist as their role is typically accomplished in the later phases of development. However, thanks to MIND, I was able to understand and actively participate, the discussions during these meetings.

Holistic approach to the drug development process

As a specialist, I got to expand and refine my knowledge. Drug development is a highly regulated environment, and each MIND modules always provided us with literature and guideline references. The most beneficial outcome from the program, was the very holistic approach to drug development process.

A valuable investment for professionals in the industry and new inspiration

I highly recommend MIND to everyone working with drug development. One can try to start with a single module, before joining a full master’s program The program is well-organized with highly skilled lecturers. It has been a very positive experience in terms of education and networking. However, it is also quite demanding, as it lasts 5-6 years and adds to your everyday job responsibilities. Additionally, after each module, you must pass exams and ultimately write a master’s thesis. As an adult student, this requires significant dedication and effort.

Interview from June 2024.