We offer integrated pre-clinical & clinical safety services for the pharmaceutical industry
Toxicology/Safety Pharmacology, Pharmacovigilance/Patient Safety, Business Development/licensing, Organisational Design and Management
WHO WE ARE
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 pharmaceutical regulation, pre-clinical Toxicology, clinical Patient Safety (PS) and Pharmacovigilance (PV), Business Administration and Development, and licensing/ M&A support.
WHAT WE DO
Xzencis provides an extensive suite of integrated pre-clinical and clinical services for the pharmaceutical industry and pharma investors:
Nonclinical Drug Safety
Non-clinical Drug Safety (NCDS) problem solving, and standard non-clinical safety services.
- 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 relative to clinical objectives
- Pivotal Toxicology and Safety Pharmacology studies
- Study placement and monitoring at major CROs
- Data interpretation
- High-level document compilation
- Dynamic safety product development
All NCDS work is handled through ApconiX.
ApconiX's large team of senior experts and huge turn-around of studies at major CROs offer clients dedicated support across any imaginable NCDS sub-discipline and benefits normally only found in large corporate NCDS functions.
- 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 relative to clinical objectives
- Pivotal Toxicology and Safety Pharmacology studies
- Study placement and monitoring at major CROs
- Data interpretation
- High-level document compilation
- Dynamic safety product development
All NCDS work is handled through ApconiX.
ApconiX's large team of senior experts and huge turn-around of studies at major CROs offer clients dedicated support across any imaginable NCDS sub-discipline and benefits normally only found in large corporate NCDS functions.
Patient Safety/ Pharmacovigilance
-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
-Safety problem solving/ clinical trial crisis management
-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
-Safety problem solving/ clinical trial crisis management
Translational Safety
The particular strength and expertise of Xzencis lie in the integrated, translational approach to safety.
Planning and executing the transition from the pre-clinical space into man and the clinic is our specific focus. In this endeavor, we integrate data, information and objectives from all relevant sources and functions, per minimum: NCDS, DMPK, Pharmacology/BioScience, Clinical, Patient Safety and competitor product assessment.
The declared goal is the incremental, evidence-based build of a competitive, value-carrying product safety profile.
Planning and executing the transition from the pre-clinical space into man and the clinic is our specific focus. In this endeavor, we integrate data, information and objectives from all relevant sources and functions, per minimum: NCDS, DMPK, Pharmacology/BioScience, Clinical, Patient Safety and competitor product assessment.
The declared goal is the incremental, evidence-based build of a competitive, value-carrying product safety profile.
Business Development/licensing/ M&A
-In/outbound licensing NCDS and/or PS/PV review
-Holistic, Translational Safety Risk Assessment (project and program level)
-Inbound Due Diligence
-Outbound Due Diligence preparation
-Holistic, Translational Safety Risk Assessment (project and program level)
-Inbound Due Diligence
-Outbound Due Diligence preparation
Investor Support
-Review and quantitative Translational Safety Risk Assessment of drug project/product/program opportunities from pre-clinical to completed Phase II trials.
-Translation and implementation of identified safety risks into quantitative and qualitative financial terms in the valuation process
-Translation and implementation of identified safety risks into quantitative and qualitative financial terms in the valuation process
Management/ Change Management
We provide temporary leadership roles in small to mid-sized companies:
- CMO
- Head of PV/PS function role
- PV/PS Therapy Area Lead
- QPPV
- PS/PV function crisis management.
If needed, we can step in with a dedicated and proven team of Senior Safety Physicians and Senior Safety Scientists on relatively short notice.
Counsel and advice for PS/PV functions regarding regulatory compliance, strategy, organizational design and corporate integration:
- Established functions wishing to improve on current structures and practices.
- Emerging functions setting up PV/PS principles for the first time
- CMO
- Head of PV/PS function role
- PV/PS Therapy Area Lead
- QPPV
- PS/PV function crisis management.
If needed, we can step in with a dedicated and proven team of Senior Safety Physicians and Senior Safety Scientists on relatively short notice.
Counsel and advice for PS/PV functions regarding regulatory compliance, strategy, organizational design and corporate integration:
- Established functions wishing to improve on current structures and practices.
- Emerging functions setting up PV/PS principles for the first time
Safety Governance
1. Setup and management of independent, bespoke, interdisciplinary Safety Governance bodies for smaller companies or special programs, including but not limited to Non-clinical Drug Safety, DMPK, Clinical Safety (Safety Physician/ Safety Scientist).
Optional: e.g., Biostatistics, Clinical Pharmacology, Clinical Operations, Pharmacovigilance Operations, CMC/Formulations, target organ experts, disease experts etc.
2. FTIM Safety/ human exposure limit committees
• Prior to FTIM
• Prior to first exposure of new patient segment (WOCBPs, children, elderly etc.)
• Safety assessment of dose/exposure limits in planned and ongoing trials
3. Clinical Trial Data Safety Monitoring Boards/ Data Monitoring Boards
Optional: e.g., Biostatistics, Clinical Pharmacology, Clinical Operations, Pharmacovigilance Operations, CMC/Formulations, target organ experts, disease experts etc.
2. FTIM Safety/ human exposure limit committees
• Prior to FTIM
• Prior to first exposure of new patient segment (WOCBPs, children, elderly etc.)
• Safety assessment of dose/exposure limits in planned and ongoing trials
3. Clinical Trial Data Safety Monitoring Boards/ Data Monitoring Boards
European Innovation Council (EIC) Accelerator (2023 only)
Based on our own (fading) experience, we are happy to offer up to 1 hour of free counsel and advice to pre-Round 1, and up to 2 hours to pre-Round 2 pharmaceutical startups at our own discretion and availability. Unfortunately, we cannot provide continued counsel and support in any form beyond that.
OUR CLIENTS
The quality of our services is recognized by our extensive expert network.
We serve a wide range of customers, from small pharma startups to the largest brand companies, expert networks, consulting agencies, investors (venture capital, angel investors, banks , grant institutions), startup incubators....
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OUR STORY
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.
Our unique expertise lays in safety strategy development, pre-clinical, clinical, and marketed-product safety problem solving, in- and outbound licensing/ Due Diligence as well as organisational design and implementation of upgraded safety systems in small and mid-sized pharmaceutical companies.
We are not confined or committed to any specific Therapy Area, type of pharmacological modulators, therapeutic concepts or life-cycle stage. We review each opportunity carefully. Should we not feel 100% comfortable, we will say so and do our best to identify the most appropriate party for the task -free of charge.
We are not confined or committed to any specific Therapy Area, type of pharmacological modulators, therapeutic concepts or life-cycle stage. We review each opportunity carefully. Should we not feel 100% comfortable, we will say so and do our best to identify the most appropriate party for the task -free of charge.
OUR FOUNDER
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
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)
Engaged in science, strategic management and leadership tasks alike. Experienced line and matrix leader (local and remote) practicing an entrepreneurial, visionary and transformational leadership style. Strong managerial and leadership capabilities.
Wholeheartedly subscribing to the principles of Humanocracy (G. Hamel & M. Zanini, Harvard Business Review Press, 2020)
Xzencis AB is an expert consultancy focused on Translational Safety Solutions along the entire pharmaceutical value chain from Target Identification to marketed products.