PHARMA & BIOTECH CONSULTANT - MELODY JANSSEN
Have you ever wondered how such a tiny thing as a virus can wipe out millions of human lives? I have, since my teenage years. I was always fascinated by the versatile nature of viruses and how some of them manage to escape the immune system so effectively.
Naturally, when it was time to choose a study, it had to be infectious diseases.
I chose to study “human biology” at the Philipps University of Marburg majoring in infectious diseases. My master thesis was based on work I had done with the Rift Valley Fever Virus in Canada under the supervision of Dr. Heinz Feldmann.
During my PhD I wanted to continue my work in virology in a Biosafety level 4 lab, but life can take unpredicted turns and my path instead led me to the University of Utrecht and the Drug Delivery group, where. under the supervision of the renowned Prof. Huub Schellekens and Prof. Wim Jiskoot, I finished my PhD investigating the effects of protein aggregates on immunogenicity. During that time, I was already heavily involved in the immunogenicity community and also worked with MSD, Roche and Merck Serono.
Fueled by my entrepreneurial family, my first move after defending my PhD was starting a service-based company (ADA InVivo) dealing with the prediction of immunogenicity. I received a startup loan from the Rabobank and had my office in a technology incubator at the University of Utrecht. During my year at Utrecht Inc I had the opportunity to brainstorm and learn from fellow start up and also established entrepreneurs.
The concept of my service proved itself to be a ‘nice to have tool’ but not commercially viable. When a headhunter asked me to join the bioanalytical group for immuno- and bioassays at Triskelion, a Dutch CRO, I said yes.
ADA InVivo was not closed down but its scope was adjusted to fit into my family business of adult education, where it is still successfully active
My time spent at Triskelion, were very useful years and I learned a lot about people and project management, strategy, assay set up, validation, routine analysis and troubleshooting for a range of products and clients, from small biotech to large pharma.
After a few years, my scientific curiosity exceeded what a CRO could offer, so I decided that I wanted to work for an innovative biotech company. I started as head of R&D for a vaccine company, Mymetics. During my years at Mymetics I expanded my bioanalytical expertise into the world of manufacturing. I learned very valuable lessons in manufacturing and subsequently, potency assays and other analytical tools. I had the pleasure to work side by side with Dr. Toon Stegmann, now a good friend of mine. While working at Mymetics, I was already freelancing in my spare time. When the workload became too high I had to make a decision what was closer to my heart: full time job or freelancing, freelancing won the day
I started SciPot Consultancy in May 2017 and it has been the time of my life. I love my clients, the projects, the diversity of the work and the people I collaborate with. Every project is a new challenge which I face with passion and commitment.
My business concept ranges from clients that hire me for a fixed number of hours per week, but also ad-hoc clients, including some long-lasting working relationships.
The class of products I worked with range from small molecules, peptides, recombinant human proteins, antibodies, vaccines (human and veterinary), ADCs, ATMPs to drug delivery systems and biosimilars.
Each product has unique needs and projects may cover aspects such as (bio)analytical assay set up / validation / troubleshooting, immunogenicity strategy, gap analysis, tech transfers, bioprocess development, manufacturing and program management. You can’t do these types of projects without extensive regulatory knowledge in GLP / GCP / GMP and all guidelines dealing with assay method validation from a variety of regulatory sources such as the FDA, EMA, USP, EuP, ICH and other more local guidelines (such as the Australian Therapeutic Goods Administration). I have been interpreting, utilizing and teaching these guidelines for more than a decade now.
Despite the regulatory influence on my work and my knowledge of the guidelines and how to use them where needed, I would not call myself a regulatory expert. Nevertheless, I normally attended scientific meetings with EMA, FDA, UFDA and facility audits as a subject matter expert, supported by very experienced regulatory experts from Biopharma Excellence especially with Dr. Gabriele Dallmann.
In addition, PTI, has employed me as a trainer for many years, bringing and sharing my experience especially in the field of bioanalytics and immunogenicity to companies all around Europe and beyond. I am not only the trainer during these courses, I also learn so much from the companies. I try to make my courses as interactive as I can so a vigorous exchange of knowledge can take place. My clients teach me how they interpret the guidelines and which difficulties they face every day with their assays and regulatory bodies.
I recently became a member of the European Immunogenicity Platform, EIP, where I am part of a European network and beyond of immunogenicity experts. I am honored to be part of that community and discuss urgent topics in the field of immunogenicity.
I am part of the assay subgroup and we are currently working on opinion papers addressing several hot topics in the field.