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The Xzencis approach to Translational Safety
The particular strength and expertise of Xzencis lies in its integrated, translational approach to safety, with particular focus on planning and executing the various transitions from the pre-clinical space (laboratory bench) into humans and the clinic (bedside).
This work requires integration of data, feedback, requirements and objectives from all relevant sources and functions, to meet NCDS, DMPK, Pharmacology/Bioscience, Clinical, Patient Safety and competitor product assessment requirements. The overall goal is the construction of a value-carrying and competitive product safety profile based on an incremental and genuinely evidence-based process.
The role of translational safety
Translational safety encompasses the entire safety value chain of pharmaceuticals from early discovery at the start of a drug project to the drug’s eventual withdrawal in any form, branded or generic, from its final markets. This safety value chain involves many different functions, disciplines, and areas of expertise, working in different but related aspects of safe development and marketing of pharmaceuticals. This whole end-to-end process can be described as translational safety.
Translational safety stresses practical and applied processes that are not so much dependent on cutting-edge science and predictive analysis, so much as rooted in pragmatic organizational and strategic aspects, with particular emphasis on the clinical and postlaunch safety development stages.
Innovative pharmaceutical product development is a highly risky and expensive business and the most costly failures and losses relate to breaches of safety discipline. Since the business stakes are so high, safety strategy must be much more than a regulatory ‘box-ticking’ exercise. It requires a genuinely integrated and incremental approach that defines objectives along the whole pre-clinical and clinical safety value chain, based on proactive risk management and practical experience. This is the essence of the Xzencis approach to translational safety.
Effective Transational Safety
The harrowing case of the drug thalidomide, originally developed in the 1950s as a sedative and tranquilizer but extended to treatment of other conditions, including morning sickness in pregnancy, was the one that fundamentally changed the pharmaceutical industry’s relationship with safety. Typical for the time, Thalidomide marketing showed a complete lack of translational safety in that it was never properly assessed for its new intended application, only tested to a limited extent in animals and never trialed among pregnant women.
By contrast, the huge success of the thalidomide derivative lenalidomide (Revlimidâ) showed not only that product development by concise safety objectives is possible, but also demonstrates the enormous commercial potential of developing and communicating defined product safety profiles as an independent asset. Drug Safety beyond basic regulatory reqirements is a developable and optimisable entity that every drug company owes to all its stakeholders.
Xzencis translational safety expertise
Based on its expertise and competence in Discovery Safety Science from Target Identification, regulatory Non-Clinical Drug Safety and clinical Pharmacovigilance/ Patient Safety, Xzencis sets out to build seamless, objective-driven, translational safety strategies across the entire product life-cycle value chain. A key part in this is the concise collection and integration of all relevant information and data irrespective of nature, source and format. Xzencis expertise in translational safety also takes in safety strategy development, pre-clinical, clinical, and marketed-product safety problem solving, inbound and outbound licensing, and Due Diligence as well as organisational design and implementation of upgraded safety systems in small and mid-sized pharmaceutical companies.
The Xzencis approach to pharmaceutical drug safety is described in a comprehensive textbook on the subject: Principles of Translational Science in Medicine: From Bench to Bedside (see Resources), with two chapters on Toxicology in Translation (Pharmaceutical toxicology and Translational safety medicine) contributed by Xzencis founder Dr. Steffan Ernst and others. While Dr. Ernst represents Xzencis’s primary overall expertise in translational safety, the company can additionally draw on its extensive network of senior, experienced safety physicians and scientists, all with tested and proven track records in relevant disciplines such as toxicology, NCDS sub-disciplines, and Pharmacovigilance (PV) systems.
Xzencis translational safety services can be applied across a wide range of therapeutic areas and concepts, types of pharmacological modulators, and life-cycle stages and at all different project scales and scopes.
Click on Xzencis translational safety services for further information.
Click on Principles of Translational Science in Medicine: From Bench to Bedside for book details.