CIO Bulletin

Providing independent expert advisory services, pharmacological and non-clinical safety evaluations PreClinical Safety (PCS) Consultants Ltd

The pharmaceutical industry has several unusual characteristics, both in its structure and business operations, which are little known outside the industry but materially affect the process of bringing new pharmaceuticals to the patient.

However, we live in a time of enormous scientific innovation and promise for improved human health. Our understanding of biology is expanding enormously alongside the increased identification of novel targets and their associated modalities.

Still, drug-development costs and timelines continue to rise, and the likelihood of success continues to fall. According to a McKinsey report, the top 20 pharmaceutical firms collectively spent approximately $60 billion on drug development each year. The estimated average cost of bringing a drug to market, including drug failures, was 42.6 billion in 2019 — a 140 percent increase in the past decade.

Approving a new drug is a massive undertaking, and selecting the right partners, who prioritize in sync with you and focus on high quality and fast turnaround, goes a long way in avoiding missteps and moving your drug program closer to success.

PreClinical Safety (PCS) Consultants is the right partner who is offering exactly what drug companies need. They provide independent expert advisory services, pharmacological and non-clinical safety evaluations to the pharmaceutical, agro-chemical, chemical, and food industries, academic institutions engaged in science and research, and to business investors and CROs.

Following are excerpts from the conversation with Dr. med. vet. Stephanie Plassmann, Senior Expert in non-clinical drug development at PreClinical Safety (PCS) Consultants Ltd.

Q. What inspired you to establish PreClinical Safety (PCS) Consultants Ltd?

My idea for implementing translational medicine is to integrate all disciplines involved in drug development, which is extremely complex. There are many small companies with promising research projects, but they need expertise and experience in non-clinical drug development to succeed. From a scientific perspective, preclinical development builds the bridge from bench to bedside. Success means bringing effective drugs on the market in the shortest possible time while maintaining the highest quality standards to make helpful medicines available to patients as soon as possible.

PCS was founded in 1989, and at the outset, the company focused on delivering consulting services in the core safety disciplines, histopathology, and toxicology. However, non-clinical drug development is more than safety aspects only. I developed the company further in drug metabolism and pharmacokinetics, non-clinical pharmacology, and quality assurance according to GLP (Good Laboratory Practice). I later included even clinical pharmacology on a case-by-case basis. Therefore, PCS is recognized today as The Integrated Drug Development Company, integrating all disciplines involved in non-clinical drug development, including the transition to clinical development.

I took over PCS in 2011 but had been working with the company for many years at that time, first as a client myself, and later I became an independent consultant and joined the team. I could see strong potential to expand the services of the company further. Therefore, today, our team offers expertise in all areas needed for integrated non-clinical drug development, with established hands-on expertise and experience for over 30 years, to support our clients’ projects.

Q. What makes PreClinical Safety (PCS) Consultants Ltd relevant today? Could you give us some context?

In the last 20 years, the landscape of non-clinical drug development has changed dramatically, resulting in a loss of senior expertise in the pharmaceutical industry. On top of that, the biotechnology sector has developed very dynamically. Many innovative products were invented, often by small and midsize companies focusing on research rather than development. However, the drain on non-clinical expertise also affects major pharmaceutical companies since many of these players outsource operational activities rather than keeping in-house resources and expertise. Taken collectively, the demand for senior expertise in non-clinical drug development continues to increase. Sound non-clinical drug development links the operational aspects, which these days are covered mainly by Contract Research Organizations (CROs), with the underlying developmental strategy for a given pharmaceutical drug, both of which must be based on a sound scientific concept to be successful.

Our team offers a solution to companies that require this unique expertise, which is lost or scarcely available in many places today, in a broad range of indications and all relevant areas of preclinical drug development, including DART (developmental and reproductive toxicity) and juvenile animal studies (JAS). Only a handful of scientists worldwide have senior experience in this field, which the PCS team offers based on our expertise through hands-on experience for well over 30 years.

Q. How do your services stand out from your competitors?

PCS comprises a dedicated team of senior experts, each with over 25 years of continuous hands-on experience and expertise in preclinical drug development, including preclinical pharmacology, toxicology, toxicopathology, DMPK, and GLP. We are — on purpose — a small and dedicated team because we want to provide high quality rather than “high-throughput” advice. PCS is recognized for providing high-quality service since our team members all make very significant contributions to the success of PCS, and that is appreciated by our partners, clients, and colleagues in the scientific community. We work hands-on with our clients, taking responsibility for the process—and pride in the success of their projects! All of our collaborations have been long-term over many years.

Furthermore, we continuously contribute to the field by presenting at scientific conferences and publishing scientific papers. One of our publications demonstrating our experience and expertise is a book chapter authored by my colleague Dr. Elisabeth O’Connor and me: “Critical Aspects of Integrated Non-Clinical Drug Development: Concepts, Strategies, and Potential Pitfalls”: A Comprehensive Guide to Toxicology in Preclinical Drug Development. Editor Ali S. Faqi. 2nd edition. We have just submitted the updated manuscript for the next edition.

Q. How was your experience working through the pandemic?

We are closely involved in contributing to the management of the pandemic. Amongst other activities, we have contributed through regular workshops on vaccine development offered by the AGAH (Association for Applied Human Pharmacology, (www.agah.eu) to promote the understanding of vaccine development from a non-clinical perspective.

Q. How did your services help out during the pandemic?

The pandemic has further increased the demand for resources and expertise in medicine development. Particularly on a daily level, in practical medicine, there was and still is a great need for support from experts in drug development to address concerns with innovative technologies such as those used in the development of vaccines against COVID-19. A significant proportion of our engagement in this field is voluntary.

Q. Can you tell us about the work culture at PreClinical Safety (PCS) Consultants Ltd?

Diversity rocks! We are multi-national and implement ICH-conform concepts, including global regulatory interactions. Our approaches are driven by daily strategic considerations implemented in a hands-on, pragmatic process. We are helping clients to robustly enforce the process from the start, including selecting the right places, designing the studies, and working with the CROs to run the studies. We also offer to monitor these studies from a scientific and GLP perspective. Additionally, our group of experts truly helps clients write the regulatory documents, defend the programs in terms of development, and accompany them to regulatory meetings, whether in the US, Europe, or other places in the world.

We strongly believe in involving the most senior experts. Our team members work from different areas in the world (including Europe and USA). Not only does that allow us to expand our services on a need basis, but also we can interact with international clients and partners and benefit from time differences, which allows us to react proactively and in due course, as and when required.

Tell us about your expertise in drug development.

I am a veterinary surgeon and a board-certified veterinary specialist in pharmacology and toxicology. I have acted as an independent consultant for international companies and institutions since 2004. My expertise focuses on pharmacology, non-clinical drug safety, and drug development, both from a strategic and hands-on operational perspective comprising a broad spectrum of indications from early to late-stage development.

I have nearly 30-years of experience in the pharmaceutical industry and held positions, including in senior management at F.Hoffmann-La Roche AG (Basel, Switzerland), Switch Biotech AG (Munich, Germany), and Morphochem AG (Munich, Germany). Starting in big pharma, I learned non-clinical drug development from scratch, from early to late-stage, and how it is embedded in the overall process. I took this forward to my next position as project leader in a small biotechnology company developing gene therapy in wound healing.

My last job in the industry, before I became independent, was as Vice President Drug Development at Morphochem, a biotech company, where I was responsible for both the operational aspects of non-clinical drug development as well as for the overall development strategy, comprising all disciplines involved, including clinical, regulatory and portfolio management. When I joined the company in 1999, there were no internal resources available in drug development, as the company was at a research stage. I built up the internal structures and a network of external collaborations. These structures are all available in a big pharmaceutical company, and it was a huge challenge to take responsibility for the whole process in a biotech company. I implemented the drug development process by thinking about it from the end, i.e., defining a drug target profile first. Your non-clinical drug development cannot start without knowing the condition the clinicians intend to treat. The indication will define clinical and, therefore, non-clinical drug development.

At Morphochem, my team’s job was to define the drug target profile for the molecules the chemist would develop and then implement the non-clinical testing strategies operationally to support clinical development.

“The integrated drug development company”

Q. What’s your vision for the near future?

We are further expanding as a team because of the increasing demand for our services. In addition, as there is only a handful of people with good experience quality, we also engage in the development of the field by passing on our expertise through the education and training of fellow scientists. We are actively involved in the scientific advancement of non-clinical drug development, which continues to face emerging challenges, through workshops, trainings, publications, and interactive communication with other scientists in the field.

Guiding PreClinical Safety (PCS) Consultants Ltd to industry dominance

Dr. med. vet. Stephanie Plassmann is senior expert in non-clinical drug development at PreClinical Safety (PCS) Consultants Ltd. She is a veterinary surgeon and a board-certified veterinary specialist in pharmacology and toxicology and has nearly 30 years of experience in the pharmaceutical industry.

She has held positions including in senior management at F.Hoffmann-La Roche, Switch Biotech, and Morphochem. Dr. Plassmann took over PCS in 2011, and since she joined the company in 2004, her efforts have been dedicated to expanding the expertise of PCS. Today, the company comprises a committed team of senior experts in preclinical drug development, including preclinical pharmacology, toxicology, toxicopathology, DMPK, and GLP.

Dr. med. vet. Elisabeth (Lisa) O’Connor is senior expert in non-clinical drug development at PreClinical Safety (PCS) Consultants Ltd. She is a postgraduate agricultural engineer and a veterinary surgeon; she is also a Diplomate of the American Board of Toxicology (DABT). She has three decades of experience in the pharmaceutical industry and has held positions including in senior management at Sandoz, Novartis, and OSI Pharmaceuticals. Dr. O’Connor joined the team of PCS in 2010.