There has been a dramatic change in the non-clinical development landscape in the last two decades which has affected the senior expertise in the pharma industry. This decline in senior expertise has also affected major pharmaceutical companies as many of these companies would rely on outsourcing operational activities. There is a rising demand for senior expertise in the field of non-clinical drug development. PreClinical Safety (PCS) Consultants Ltd is among the key player in the industry who have the in-house expertise essential for non-clinical drug development.

PreClinical Safety (PCS) is an integrated drug development company that offers independent expert advisory services, pharmacological and non-clinical safety evaluations to the pharmaceutical, agrochemical, chemical, and food industries, to academic institutions engaged in science and research, to business investors and CROs.

PCS combines the longstanding experience and expertise essential for developing adequate non-clinical testing strategies that support the specific needs of clinical development for a drug in a given indication and implement these operationally through testing programs ultimately building a comprehensive basis for a robust risk-benefit assessment for human patients. The outcomes of such non-clinical development programs and their integrated interpretation are the foundation of suitable risk management and mitigation strategies to support clinical development.

Founded in 1989, PCS has attained experience in a wide range of test items that are utilized in drug development, it includes small molecules, herbals, biotechnology-derived products, and other materials such as food supplements, chemicals, and impurities.

In our recent encounter with Dr. Sephanie Plassmann, we discussed the distinguishing services and solutions of the company and how it aims to stay a market leader.

 

Could you briefly tell us about PreClinical Safety (PCS) and what it offers?

 

PCS is a front-runner in providing integrated drug development services using digitalized formats since the beginning. Because we strongly believe in involving the most senior experts, our team members work from different areas in the world (including Europe and USA). We never believed in the concept that people can only work successfully as a team when physically sitting in one building. Not only does that allow us to expand our services on a need basis, but on top, we can interact with international clients and partners and benefit from time differences, which regularly allows us to react proactively and in due course, as and when required.

 

How do you ensure that the quality of the offerings is not compromised due to short delivery time?

 

Our team is highly committed to helping patients suffering from diseases and conditions with high unmet medical needs including rare conditions (orphan diseases), which need to be addressed case-by-case. Long-standing experience is the basis for our sound understanding of how resources are most efficiently used for bringing drugs on the market in the shortest possible time while maintaining the highest quality standards.

 

How has senior expertise helped PreClinical Safety (PCS) stand out amongst the competitors?

 

Our team offers a solution to companies that require unique expertise, which is lost or much less 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 JAS (juvenile animal) studies. In this field, only a handful of scientists worldwide have senior experience, which the PCS team offers based on our expertise through hands-on experience for well over 25 years. This is a good example of the shortage of available resources, because specifically in the field of pediatric drug development, there is an increasing demand for expertise, although this is only one of many examples.  

 

How will you describe the company culture at PreClinical Safety (PCS) Consultants?

 

Diversity rocks! We are multi-national and implement ICH-conform concepts, including regulatory interactions around the globe. Our approaches are driven by strategic considerations which are implemented in a hands-on pragmatic process on a day-to-day basis. We are helping clients to robustly implement the process from the start including the selection of the right places, designing the studies, and working with the CROs to run the studies.

 

What can we expect from PreClinical Safety (PCS) Consultants in the coming years?

 

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 a good quality experience, we also engage in the development of the field by passing on our expertise through the education and training of fellow scientists.

 

Quote:

 

“PCS strongly believes in the concept of close and mutual interaction with all disciplines along the way and from a scientific perspective, preclinical development builds the bridge from bench to bedside.”

About Dr. Stephanie Plassman: Dr. Stephanie is a board-certified specialist in veterinary pharmacology and toxicology and acts as an independent consultant for international companies & institutions since 2004. Her experience has granted her expertise in pharmacology, non-clinical safety, and drug development—both strategic and hands-on operational perspectives. Dr. Stephanie has been part of the industry for over three decades and joined PCS in 2011. Since then her efforts have been dedicated to expanding the expertise of PCS.

 

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