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Novel Screening Systems for Tailored Medicine and Pharmacogenomics
Celltech and Genomics GmbH
Company Profile: Celltech and Genomics GmbH
Specialised in cell-based screening systems and diagnostics
Founded in 2020: Former members of ITN Chromosome4D
Executives
CEO: Dr. Franz Gruner
CSO: Dr. Daniel Hayley
Head of Diagnostics: Dr. Ivana Podolski
Head of Epigenetic Assay Development: Dr. Timotheus Savvidopolous
CSO of Subsidiary Company in India: Dr. Mahatma Singh
©Celltech and Genomics GmbH
Overview of Presentation
• Product Idea
• Research and Development
• Supply Chain Management
• Manufacturing
• Marketing & Sales
• Quality Management
• Finance
©Celltech and Genomics GmbH
Product Idea
©Celltech and Genomics GmbH
Drug Development: from bench to bedside
Discovery
•Drug Synthesis
•Drug Targeting
•Receptor Binding
Preclinical
Development
•Drug Delivery
•Pharmacology: ADME
•Dose Ranging
Clinical
Development
•Phase I – III trials
•Efficacy
•Safety
•Dose Selection
Approval
• Phase IV: FDA
•Safety
•Efficacy
•Diagnosis
•Monitoring
Market
•Prognosis
•Postmarketing Surveillance
•Competetive Advantae
• Failure rate: 95% of all anti-cancer drugs tested in Phase I trials [1]
• Reason: no sufficient model for drug testing in preclinical development
[1]: MORENO AND PEARSON, 2013
©Celltech and Genomics GmbH
Models for Drug Discovery - comparison
Model
2D cell culture
x
.
Cons
Not physiological
Reduced cell-cell and matrix interactions
Cellular signalling altered
Are the current models sufficient?
 No. 95 % failure rate in clinical trials
Mouse Models
x
Pros
Conducted on plastic substrata
Reproducibility
Cost efficient
High throughput
3D cell culture using
human primary cells
Physiologically relevant (in vivo)
High variability
Translational model (pre-clinical trials) Expensive
Species differences
Telomerase activity and cytokine
response different between mice and
humans
More physiologically relevant
Difficult to set up
Provides microenvironmental cues
Time consuming
Enhances screening processes for drug Can be expensive
development
Cellular communication, cell-cell and
cell-matrix interactions in vivo-like
Plug and play cryopreserved 3D assay
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Tailored Medicine to different ethnic groups
Project objective
• Epigenetic variations on DNA and Chromatin base were found for different ethnic groups
• Response to drugs differs due to variations in signal transduction
Goal
Development of fast (high-throughput) and cost-efficient screening systems, that can be
adapted to various questionings (anti-cancer drugs, chromatin variations)
DAWSON AND KOUZARIDES 2012
©Celltech and Genomics GmbH
Research and Development
©Celltech and Genomics GmbH
Tailored Medicine for different ethnic groups
• Cell-based screening systems for various strategies: drug screenings, epigenetic investigations
• Focused biocompatible bio-ink printing in 96-well plates: why?
 applicable for a high throughput approach
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Project Outline:
• Innovative 3D technologies: additive printing
• Establish cell based assays in 3D: drug discovery, chromatin-based assays, immuno assays, etc.
• Establish cryopreservation in a 96 well pate format
©Celltech and Genomics GmbH
Donor Samples
Caucasian versus Asian Donor Samples
Develop novel in vitro models based on human cells with tissue- and disease-specific
phenotypes to build a relevant model for different ethnic groups.
To build analytical tools that enable study of partner-generated materials in our
subsidiary company, which are suitable for a commercial exploitation.
©Celltech and Genomics GmbH
Supply Chain Management
• Where do we get our material from?
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Methodology:
Primary cell isolation from mammary tumours
©Celltech and Genomics GmbH
Donor Sample Supply
Caucasian Samples (Celltech and Genomics GmbH)
Develop novel in vitro models based on human cells with tissue- and disease-specific
phenotypes based on Caucasian donor samples. Provide Caucasian Donor Samples.
Asian Samples (Subsidiary Company in India)
Provide Asian Donor Samples
Production under modern GMP conditions
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Manufacturing
• Best Location?
• What are the Requirements?
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Location
Outsourcing to subsidiary company in India
• Fiscal retrenchment of personnel
Headquarter and Administration
• Gilund
R&D and Production
• Pune
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Requirements of Production
GLP and GMP Conditions
• Donor samples from local hospitals: Patients who filled in consent form
• The cell banks derived from donor samples will be set up under GLP conditions
• The production will be conducted under GMP and LPS free conditions
 immunological assays
©Celltech and Genomics GmbH
Marketing & Sales
• How do I advertise my product?
• Where can I sell it?
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Market Analysis and Market Access
American and European Market
• German Headquarter in Munich (Bavaria)  Supply for western countries
• Demographic change in western countries: Main focus should be on Asia
Asian Market
• Subsidiary in India supplies Asians market  Great growth potential
©Celltech and Genomics GmbH
Market Access
Subsidiary Company in India
• China is largest growing market  good potential for growth rates
©Celltech and Genomics GmbH
Sales and Distribution
Delivery in cryopreserved ready to use “Plug and Play” Format
How do we get our product to the customer in a cryopreserved state?
5 Year Contract with Cryoport. Innovative delivery in mobile liquid nitrogen tanks. The
company could undertake national and international deliveries for us.  How?
©Celltech and Genomics GmbH
Quality Mangement
©Celltech and Genomics GmbH
Quality Management
High productions standards
• Consistent monitoring of production
• Investment in R&D
• Risk management
Customer convenience
• Evaluation if customers are satisfied with services
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Finance Plan
• Expected Costs for R&D
• Production Costs
• Costs for Logistics
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Finance Plan
Funding Source I: First Years
• Grants
• Crowd Funding
Funding Source II: Becoming a commercial company
• Transition from GmbH to AG (incorporated company)
• Money from stakeholders
©Celltech and Genomc GmbH
Celltech and Genomics GmbH
Great working and family friendly environment
Innovative and Promising Products
 Do you want to work for Celltech and Genomics GmbH?
Do you trust Gruner, Hayley, Podolski, Savvidopolous and
Singh with your funding? 
©Celltech and Genomc GmbH
Acknowledgements
Thank you for your attention!!