Dr. Stephanie Plassmann’s successful three-decade career in the pharmaceutical industry is defined by her innovative spirit, bold risk-taking, unwavering determination, and impactful contributions. As a Senior Expert at Preclinical Safety (PCS) Consultants Ltd, an integrated drug development company, she is dedicated to advancing non-clinical drug development to improve the lives of people suffering from severe illnesses.
When PCS was founded in 1989, its initial focus was on toxicopathology, and later on toxicology. Stephanie joined PCS in 2004, and since she took over PCS in 2011, Stephanie has developed the company further in the areas of drug metabolism and pharmacokinetics, non-clinical pharmacology, and quality assurance as per Good Laboratory Practice (GLP). She later also included clinical pharmacology on a case-by-case basis, and successfully established PCS in the field as integrated drug development company, involving all disciplines in non-clinical drug development.
Stephanie is a veterinary surgeon, a board-certified specialist in veterinary pharmacology and toxicology, and a Eurotox-registered toxicologist. She is also a visionary role model for the next generation, inspiring young scientists to follow their passion, persevere, fight for their vision, and prove wrong the naysayers who say, “You can’t do it.” Stephanie hopes to leave a lasting impression in her field and always make a change for patients.
A Fascinating Beginning
Stephanie’s professional journey is truly fascinating. Like many veterinary students, she started studying veterinary medicine with the intention of becoming a practitioner, driven by her love for medicine and animals.
“I had always been drawn to medicine, whether human or veterinary, but the latter intrigued me more,” she says. The challenge of working with multiple species, rather than just one, seemed far more interesting to her. And, before she even began her formal studies in medicine, she worked with a practicing veterinarian. For several years, she spent her weekends, holidays, and spare time learning from him. But, then, something shifted.
In her fourth year of veterinary school, Stephanie realized she no longer looked forward to working with the practitioner. “I began to wonder why,” she says. Around the same time, during an exam in pharmaceutical development, she had a conversation with a professor. When he asked what she wanted to do in the future, Stephanie half-heartedly said, “I want to become a general practitioner.” His response, she recalls, was simple: “That’s not the best option for you. You need to do something else.”
Although Stephanie was puzzled when she heard it, she soon realized that he had “hit the nail on the head.” Later, she understood that while she found it very satisfying to work with patients, doing routine work plays a big part in veterinary practice, whereas she was curious to discover and explore new territories. She realized not only that until this point in her life, she always had remained on a steep continuous learning curve, but also how much she enjoyed and needed this part of her life. This realization led her to change her career path. Instead of pursuing clinical practice, she decided to do a PhD in pharmacology and toxicology. Once she started working in the laboratory, she discovered a new love: scientific research. Stephanie points out that in veterinary school, no one told them that veterinarians could play a crucial role in pharmaceutical drug development. In this field, the expertise of veterinarians is very much needed, as characterization is conducted across different species, she explains.
Stephanie began applying for roles in pharmacology and toxicology, and ended up starting in toxicology. Her first job in the pharmaceutical industry was at Hoffmann-La Roche in Basel, Switzerland, in 1994. Later, she also worked at smaller start-up companies, Switch Biotech AG (Munich, Germany) and Morphochem AG (Munich, Germany). In 2004, she became an independent consultant for international companies and institutions.
A Presentation that Changed the Outlook
Soon after Stephanie started working at Hoffmann-La Roche, she attended a presentation by a physician – a principal investigator running a clinical trial for Saquinavir, a protease inhibitor developed to treat HIV. No efficacious treatment had been available for this devastating infection at the time. This presentation completely changed her outlook on the potential impact of pharmaceutical development. Stephanie recalls that during the presentation, the principal investigator explained that Saquinavir had been tested on a group of bedridden patients who had no hope of recovery, and they made a full recovery after receiving the treatment. And then the physician said something that has stayed with her ever since: “This is the kind of jackpot you’re looking for in pharmaceutical development. Never stop doing this work.” This statement deeply moved Stephanie. “I still get goosebumps thinking about it,” she says.
Stephanie shares that she had also contributed to the project – albeit in a small way – and it still fills her with pride. As she recognizes that every contribution leads to improving people’s health and quality of life, she wants her efforts to help many more patients.
“It’s extremely rewarding to know you’ve made a contribution and created positive change,” she says.
A Female in the Pharmaceutical Industry
Stephanie stepped into the pharmaceutical space at a time when it was uncommon for women to join it, particularly in academic and leading positions. It was very much a male-dominated industry. As a woman in the field, she often heard people say, “You can’t do it. This is impossible.” She also surprised people when she quit her good job in a big pharma company to move to a small biotech company. According to her, she made this decision for the sake of scientific interest. “It was not financially rewarding, but it was scientifically interesting,” she says. “It was a gene therapy project, which was totally innovative at the time and had very little chance to succeed.”
The project itself didn’t succeed, but the gene therapy field did. “This is how you make progress in the field of drug development,” Stephanie says. “You have to take risks.” And, then the next unusual step she took was becoming independent – that too at a young age; at the time, consultants would usually be male in their late 50s or early 60s, Stephanie says.
Balancing Work and Life
Stephanie is often asked by people whether it is not a challenge to maintain a good work-life balance in her position. However, as she truly enjoys what she is doing her work forms a big part of her life. She considers them to be at one. “My work doesn’t conflict with my life,” she says. “In fact, my life and work mutually fuel each other because I enjoy what I do.”
Outside of work, Stephanie has broad interests. She loves arts and music and actively engages in these activities. She paints, sings, dances, participates in multiple sports, and enjoys spending time in nature. Stephanie likes going hiking when time allows, taking a break from work for a day or half a day. Her personal time, however, does not interfere with her work schedule. She and her team are always available for their clients.
“I’m not a one-woman show,” Stephanie says. “I’ve a very good team.” This makes the whole process very efficient. It is also possible because they keep administrative tasks to an absolute minimum. “We really focus on the task and the work,” Stephanie says.
And, according to her, they have efficient communication processes, which allow her to take time off when needed. “When I want to take time off, I can rely on my team to step in, and they will reach out if I’m needed,” she says.
Changing Landscape of the Industry
Over the last 30 years, the industry has changed significantly. When Stephanie joined the pharmaceutical industry, pharma companies mostly handled everything in-house. All studies were required to meet a certain quality standard – to be used for the approval of new medicines in markets worldwide. And, pharma companies adhered to an established standard known as Good Laboratory Practice (GLP) for regulatory studies. Stephanie explains that GLP requires documentation of every step in the process, ensuring that anyone reviewing the study results years later can verify and confirm them independently using the original data.
Stephanie was trained in GLP as a hands-on study director. At the same time, as part of a pharmaceutical company, she was directly involved in drug development and in the process of advancing drugs through from before entering clinical development to marketing approval, in parallel to clinical development. According to Stephanie, today these phases often overlap but, earlier, the process was distinctly segmented into a preclinical phase followed by separate clinical phases – phase one, phase two, and phase three, although preclinical development keeps going to support the next clinical step. Working in this position allowed her to learn from a practical perspective, an operational perspective, a strategic perspective, and a regulatory perspective.
Stephanie points out that when she worked for a small biotech company, she was responsible for building up the necessary resources for them. “I could only do this because I knew the requirements of the developmental process, which I learned from where I started,” she says. She adds that the field has changed since then, as many biotech companies have emerged that focus mainly on the research side of drug development. Additionally, big pharmaceutical companies have shut down in-house facilities and outsourced their operations to contract research organizations (CROs) working under GLP. “Nowadays, nearly none of the big pharma companies run these GLP studies in-house anymore,” Stephanie says.
She points out that the CRO landscape in the non-clinical field has also changed a lot. There were a large number of different small CROs when she started, but they have now consolidated. Today, the industry is dominated by two major players in Europe, the US, and globally, both of which have been well-established for a long time. At the same time, new CROs are emerging in new regions, which may or may not fully operate under GLP principles following OECD standards (OECD principles of GLP No. 1, first issued in 1981, revised 1997), which are based on the FDA GLPs (first issued in 1976), meaning their studies may not be accepted by other countries. Moreover, major regions including the founding members U.S., Japan and Europe are operating according to the standards of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH – www.ich.org), which is the most important standard for mutual acceptance of study programmes from a regulatory perspective to meet state of the art requirements for robust drug development, including non-clinical safety assessments, Stephanie says. Currently, ICH includes 23 Members and 41 Observers (www.ich.org/page/members-observers) and continues to grow.
She also explains that the CROs handle the operational aspects of the studies, while the pharmaceutical experts have the knowledge about the compound and own the developmental process. According to Stephanie, the link to understanding and therefore successfully managing operational, strategic, and regulatory aspects of the field is increasingly getting lost because professionals trained in this intertwined process – like she and her team – are gradually leaving the field – many are retiring. She is concerned about this drain of expertise, mainly because the new people joining the industry today have not much opportunity to be trained in the same integrated way.
Over time, this complex field has developed in so many ways, Stephanie says. When she started, areas like safety pharmacology, juvenile animal toxicity, and pediatric drug development didn’t even exist. As the need for them emerged, these disciplines were established and developed. At the time, no guidelines were available for these areas. “Over the years, we have been actively involved in developing guidelines for new areas, based on practical experience” Stephanie says.
Vision for the Future
PCS has always adopted innovative approaches, even from the beginning. In 1989, it was already an innovative move to offer services as a consultancy, especially since the expertise typically resided within the pharmaceutical companies. “It was a totally new approach,” Stephanie says.
Looking to the future, PCS is training a small number of young people – providing them the best training possible. This approach also allows them to gain fresh perspectives from the next generation and leverage their expertise and familiarity with certain emerging tools.
Stephanie also says that they are certainly assessing the development of AI on a continuous basis as it develops although there are many concerns for the time being, such as confidentiality, for which adequate processes remain to be established. However, AI may currently be helpful in some ways, such as for the preparation of learning materials or to evaluate literature although the use of AI for such purposes requires expertise and critical appraisal as it often generates false information. Stephanie hopes that AI may help increase efficiency in pharmaceutical drug development on the long run but expects that it will take time and is unlikely ready to replace current routines for a number of years to come. The greatest challenge lies in the prediction of efficacy in humans and she hopes that there will be significant progress with AI in the future.
Additionally, under Stephanie’s leadership, PCS is actively and proactively involved in the development of the pharmaceutical field in different areas such as through engagement in scientific societies and contribution to the development of guidelines, including in discussions with regulators.
“We are always trying to stay one step ahead because we see the needs and developments with our clients,” Stephanie says. “We try to determine: Which direction is research heading? What advancements are required in medical development? What diseases are we working to fight and overcome?”
She adds that the field is very dynamic and changing at an extremely rapid pace – one has to stay on top of it. “We can do this because what we do is hands-on work, just as we always have.”
Little Steps to Conquer Big Gaps!
Stephanie believes that in the pharmaceutical field, it is crucial to base science on thorough and robust facts. People involved in this industry need to remain on a learning curve, as the human body and diseases are extremely complex to understand. “So many factors come into play, and it’s impossible to know them all,” she says. Throughout history, much of medical development and disease treatment has relied on empirical approaches because of not knowing all the factors involved in a given disease and heterogenous patient populations.
According to Stephanie, one must always challenge one’s beliefs, convictions, and ideas; one must reflect on what one does. She also points out it is important to believe in what one is doing and give it the best effort possible at any given moment. “Later, when reviewing the results, we may find that they were not as expected, perhaps because our concepts were limited or even incorrect, and therefore our strategy, testing, and operations were faulty,” Stephanie says. The question is how to take such learning outcomes forward. The only adequate way in such a situation is to revise the concept forming the basis of a given strategy and re-consider the resulting approaches. Stephanie says that this is one way how medicine makes progress. “I believe it is super important to hammer home this message because it is so easy to say, ‘Oh, you were wrong here’. Absolutely, it is important to acknowledge when you were wrong – that is the first step to learn. But then, the question is: how can I do better next time? There are no easy answers in medicine’.”
“We take small little steps to conquer huge gaps, and after a while, we have hopefully taken enough steps to jump over a deep abyss and win,” she adds.
