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Xzencis AB is an expert consultancy providing Translational Safety Solutions.
We operate along the entire pharmaceutical value chain from target identification to marketed products.
Our services encompass integrated expertise in medicine, medicinal regulations, pre-clinical toxicology, clinical Patient Safety (PS) and Pharmacovigilance (PV), business administration, business development, and licensing.
We find solutions where others struggle to break out of traditional functional boundaries.
We cover a wide area of expertise
Nonclinical Drug Safety
Traditional Non-clinical Drug Safety (Toxicology) services, study planning, evaluation, monitoring and, particularly, strategy development and problem solving.
Patient Safety/ Pharmacovigilance
Pharmacovigilance system development, review and supervision, audit support, Patient Safety Physician services. We specialize in startups, small and medium size companies.
Translational Safety
We offer unique, integrated services: long-term safety strategy development and execution, strategic pre-clinical to clinical transitions, clinical trial problem solving and crisis management.
Business Development
In- and outbound licensing and M&A support at all R&D stages, pre-clinical and clinical safety Due Diligence, data room planning, etc.
Investor Services
Unique to our company, we offer project review and risk assessment services including translation of project risks into quantitative financial terms and forecasts for investors.
Interim roles
We can assume temporary leadership roles in small to mid-sized companies: Chief Medical Officer (CMO), Head of Non-Clinical Drug Safety or Patient Safety/ Pharmacovigilance, PV/PS Therapy Area Lead, EU-QPPV and drug project project lead for our customers.
Safety Governance
Safety Governance is often overlooked, especially in small companies. We can set up independent, bespoke, and interdisciplinary bodies tailored to meet the specific needs of our clients, both ad hoc or long-term.
Organizational Design
We take pride in our ability to develop custom-tailored, value-adding, and impactful cross-functional safety value chains, setups and organizational designs spanning the entire R&D lifecycle
They trust our expertise
We cater to a diverse clientele, including small pharmaceutical startups, prominent brand companies, expert networks, consulting agencies, venture capitalists, angels, banks, grant institutions, and startup incubators.
Steffen W Ernst MD PhD MBA DABT ERT(BTS)
Engaged in science, strategic management, and leadership tasks. I have experience as a line and matrix leader, both locally and remotely, practicing an entrepreneurial, visionary, and transformational leadership style. I possess strong managerial and leadership capabilities. I wholeheartedly subscribe to the principles of ‘Humanocracy’.
(G. Hamel & M. Zanini, Harvard Business Review Press, 2020)
Xzencis is represented by Dr. Steffen Ernst. However, many assignment require additional hands, brains and expertise. Xzencis is well connected and can draw on an extensive network of senior, experienced Toxicologists, NCDS sub-discipline experts, Safety Physicians, Safety Scientists and Pharmacovigilance Systems experts – all with tested and proven, impeccable track records.
- Medical background in Anesthesiology (MD 1995, Germany)
- Separate education and PhD in Toxicology (1996, US)
- US Board certified in General Toxicology (since 2001)
- European Registered Toxicologist (since 2002, BTS UK)
- MBA from the Edinburgh Business School (2015)
- Trained in Lean Sigma (Black Belt level).
- Experienced Clinical Safety Physician
- Experienced line leader up to Vice President level in large international Pharma companies.
- Active licence to practice medicine (Sweden)
- Considerable Business Development experience, in- outbound licensing
- Founder of pharmaceutical start-up companies in the UK and Sweden
- Multilingual, internationally connected and well-networked.
- Freelancing consultant since 2019
Our Vision
Safety is an abstract construct – often only felt by the consequences of inadequate safety. We thrive to maximize pharmaceutical Drug Safety as a value-adding entity in its own right – for the benefit of patients and public health.
Xzencis’ business model is based on a visionary, advanced, and integrated approach to pre-clinical and clinical Drug Safety. This approach is grounded on the integration of cross-functional scientific data and information with knowledge of local and international guidelines and regulations for the pharmaceutical industry.
Decades of hands-on experience, a unique set of academic and professional qualifications and an extensive expert network shaped our vision – and consistent delivery of high quality translational safety solutions to our customers.
