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    Xzencis AB

    Xzencis AB is an expert consultancy focused on Translational Safety Solutions along the entire pharmaceutical value chain from Target Identification to marketed products. Its services are based on expertise in medicinal regulation, pre-clinical toxicology, clinical Patient Safety (PS) and Pharmacovigilance (PV), business administration, business development and licensing.

    The strength of Xzencis is founded in its distinctive combination of subject matter expertise and practical business experience that allows it to assist a range of clients including small to mid-sized pharmaceutical companies, private and institutional investors, and service agencies with complex and highly specialized issues. These include safety strategy development and execution, pre-clinical and clinical challenges, inbound or outbound licensing, building organizational design and Safety Value chains, Safety Governance, and Due Diligence and assessment of quantitative risk for investors.

    Products & Services

    Xzencis provides an extensive suite of integrated pre-clinical and clinical services for the pharmaceutical industry, under seven overall headings:

    Pre-clinical: including Non-clinical Drug Safety problem solving as well as standard chores like Target Safety Assessment, Discovery Toxicology services, Explorative Toxicology studies, Dose range finding studies, Safety Pharmacology studies, Test species selection and justification, CTA/IND/NDA-enabling NCDS program design and strategy, Pivotal Toxicology and Safety Pharmacology studies, Study placement and monitoring at major CROs, data interpretation, high-level document compilation, and dynamic safety product development. All NCDS work is handled through ApconiX, whose large team of experts offer clients dedicated support across all NCDS sub-disciplines.

    Patient Safety/ Pharmacovigilance: including safety problem solving in clinical trials and for marketed products, Patient Safety Physician services, Safety source selection & monitoring, AE case review, Signal Identification, Risk Assessment and Management, Clinical safety strategy development, CSS and CSP development and compilation, Clinical trial safety monitoring incl. DMC/SMC, Safety Management Plan development, PSMF review and development, High-level document compilation, and safety problem solving in clinical trials.

    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 transition from the pre-clinical space into humans and the clinic. In this endeavour, we select and integrate data, information and objectives from all relevant sources and functions (e.g., NCDS, DMPK, Pharmacology/Bioscience, Clinical, Patient Safety and competitor product profiling). Our overall goal is an incremental, evidence-based build of a competitive, value-carrying product safety profile.

    Business Development: including In-outbound licensing NCDS and/or PS/PV, inbound Due Diligence, outbound Due Diligence preparation.

    Investor Assessments:  Review and Quantitative risk assessments from pre-clinical to completed Phase II trials, and translation of identified safety risks into quantitative and qualitative financial terms.

    Change Management: Xzencis is able to assume temporary leadership roles in small to mid-sized companies at CMO, Head of PV/PS function, PV/PS Therapy Area Lead or QPPV levels. These services also include PS/PV function crisis management, insertion of dedicated and proven teams of Senior Safety Physicians and Senior Safety Scientists at relatively short notice, providing counsel and advice for PS/PV functions regarding regulatory compliance, strategy, organisational design and corporate integration of established functions needing to upgrade according to translational safety principles or emerging functions setting up PV/PS principles for the first time.

    Safety Governance: Setup and management of independent, bespoke, interdisciplinary Safety Governance bodies for smaller companies or special programs, to include mandatory non-clinical Drug Safety, DMPK, Clinical Safety (Safety Physician/ Safety Scientist) and optional, e.g., Biostatistics, Clinical Pharmacology, Clinical Operations, Pharmacovigilance Operations, CMC/Formulations, target organ experts, disease experts, etc.

    Company History and Structure

    Based at Mölnlycke, near Gothenburg in Sweden, Xzencis was founded in November 2018 with the vision of developing operational and product safety as a developable, value-adding and competitive asset in the pharmaceutical industry.

    Xzencis is represented by its founder, Dr. Steffen Ernst, who brings experience and qualifications from a 25-year career in the life sciences, including clinical and cross-functional experience in five different large and medium sized pharmaceutical companies and activities across the entire value chain, from initial Target Identification to product externalization at end of patent life.

    Dr. Ernst’s qualifications include an active medical license (Sweden) PhD in Toxicology (1996, US) and US Board certification in General Toxicology (since 2001), European Registered Toxicologist since 2002, MBA from the Edinburgh Business School (2015) and Black Belt-level training in Lean Sigma.

    He has considerable business development experience with inbound and outbound licensing, and has founded pharmaceutical start-up companies in the UK and Sweden, adding to his considerable managerial and line leadership expertise and experience.

    Where extra personnel are required, Xzencis can call on an extensive network of senior, experienced Toxicologists, NCDS sub-discipline experts, Safety Physicians, Safety Scientists and PV Systems experts – all with tested and proven, impeccable track records.

    Xzencis is currently transitioning from a personal consultancy into a larger service provider.

    Quality, Regulatory and Standards

    The Xzencis business model is based on a visionary and advanced approach to pre-clinical and clinical drug safety and in-depth knowledge of local and international guidelines and regulations for the pharmaceutical industry that need to be applied depending on assignment and nature of task.

    The quality of Xzencis services is also supported by long established professional experience, an extensive expert network, along with impressive academic and professional qualifications.

    TRANSLATION SAFETY SOLUTIONS

    Integrated Pre-Clinical & Clinical Studies for the Pharmaceutical Industry

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    Xzencis AB

    Contact Information
    Address: Alvägen 3, 435 37 Mölnlycke, SWEDEN
    Telephone No: +46 733 603 593
    Email Address: hello@xzencis.com
    Web Address: https://xzencis.com/

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