20150924 smb cristal therapeutics jeroen tonnaer
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This document summarizes a presentation given by Dr. Jeroen Tonnaer of Cristal Therapeutics about their nanomedicine platform called CriPec. CriPec nanomedicines are designed to improve the efficacy and tolerability of drugs by extending their circulation time, improving their distribution in the body, and enabling active or passive targeting to tissues. The first CriPec product is a nanomedicine version of docetaxel currently in Phase I clinical trials. The presentation outlines the unique features of the CriPec platform, its therapeutic potential in areas of high unmet medical need, its intellectual property protection, value drivers including clinical development and partnering opportunities, and considerations for licensing the CriP
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RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control. RTRT recognises that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end-product testing and the context as such be an integral part of the control strategy. The RTRT principle is already authorised for use as an optional alternative to routine sterility testing of products terminally sterilised in their final container i.e. parametric release. Enhanced product knowledge and process understanding, the use of quality risk management principles and the application of an appropriate pharmaceutical quality system, as defined within ICH Q8,Q9 and Q10 provide the platform for establishing RTRT mechanisms for other applications, for new products as well as established marketed products. Release of a product can be a combination of a RTR approach for certain critical quality attributes (CQAs) and a more conventional evaluation for other CQAs (partial RTR).
This presentation deals with the concepts of Real Time Release Testing. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
Quality by design (qbd)
1) The document presents an overview of Quality by Design (QbD) in pharmaceutical development. It defines QbD, compares the current and QbD approaches, and outlines the benefits, objectives, and elements of QbD.
2) The key elements of QbD discussed are defining objectives, determining critical quality attributes, risk assessment, experimental design, control strategy, and continuous improvement. Ishikawa and risk assessment methods are also summarized.
3) Implementing QbD provides quality medicines to patients, production improvements for manufacturers, and greater confidence for drug regulators by ensuring predefined product quality objectives.
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PCT Presentation Shared October 2016
This document summarizes PCT's vision and history as a leader in cell therapy manufacturing. PCT aims to make transformative cell-based therapies accessible to all through providing high-quality and scalable manufacturing services. Over 30 years, PCT has gained unprecedented expertise manufacturing over 20 cell therapy products and treating over 6,000 patients. PCT partners with companies from start-ups to large pharmaceutical companies, and aims to guide clients through the entire development and manufacturing process.
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To learn more visit:
https://insidescientific.com/webinar/cutting-edge-conversations-discovering-new-innovations-in-oncology/
Starting off the conversation, Dr. David Bunka will present specific case studies for prostate cancer, multiple myeloma and chronic myelomonocytic leukaemia, highlighting the ability of Optimer technology to deliver novel targeted therapeutics for cancer treatment. Optimer binders are small, highly target specific oligonucleotide-based affinity binders. The Optimer platform offers the ability to develop specific binders targeted to a specific biomarker or to an oncological cell phenotype without the need for known biomarkers. Optimer therapeutics are enabling new strategies in cancer treatment, including the targeted delivery of diverse payloads to cancer cells for precision chemotherapy, or gene therapy approaches.
Dr. Cathie Miller will discuss how archived tissues contain valuable information for clinical research. For over thirty years, BioIVT has worked to expand the characterization of their archived tissues. BioIVT offers complete NGS project management that ensures success. In this presentation, Dr. Miller will review BioIVT’s comprehensive process, their strengths in sample collection through library prep, their in-house and validated partnership capabilities and how BioIVT elevates science.
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- 1. From Molecule to Business Health Valley/SMB September 24, 2015 Nijmegen CriPec® Nanomedicines for Superior Therapeutic Performance Dr. Jeroen Tonnaer, CBO
- 2. 2 Introduction • Pharmaceutical company developing nanomedicines • Founded in April 2011 • Located in Maastricht, The Netherlands • Headcount: 10 fte • Private - VC funded: 2
- 3. 3 CriPec® Nanomedicines Improved efficacy and tolerability CriPec® improves the therapeutic profile of drugs as a result of: • Extended systemic circulation • Improved disposition over the body • Active or passive targeting to tissue, cellular and molecular targets • Tuneable and timely release 3
- 4. CriPec® polymer drug linker entrapment of drug, so inactive release native drug & degradation NP coupling of drug drug linker CriPec® polymer incl. linker drug lactic acid Unique CriPec® Platform Transiently stable nanomedicines 4 PATENT PROTECTED BY 5 PATENT FAMILIES
- 5. range of therapeutic agents (small molecules - peptides) biodegradable and safe fragments multiple administration routes controllable size from 30 nm up to 100 nm X surface functionalisation for cellular and molecular targeting ease of manufacturing customised drug release Unique Features of CriPec® Highly flexible nanomedicinal platform 5
- 6. Therapeutic effect CriPec® Docetaxel Breast xenograft model 6 s.c. MDA-MB-231 xenografts in nude mice (n=8±SD) 0 14 28 42 56 0 250 500 750 1000 1250 1500 single dose vehicle Taxotere 60 mg/kg CriPec docetaxel 60 mg/kg time (days) tumourvolume(mm3 ) s.c. MDA-MB-231 xenografts in nude mice (n=10±SD) 0 14 28 42 56 0 250 500 750 1000 1250 1500 1750 2000 vehicle Taxotere 30 mg/kg CriPec docetaxel 125 mg/kg single dose time (days) tumourvolume(mm3 )
- 7. Unique Opportunity • CriPec® is unique and competitive nanotechnology platform that enables development of multiple (targeted) products • CriPec® boosts efficacy and improves tolerability • Applicable in disease areas with high unmet medical need • First product started clinical development July 2015 • Attractive co-development potential • CriPec® platform & products are protected by 5 patent families 7
- 8. Value Drivers • Clinical - Clinical phase I: safety of CriPec® docetaxel and PK profile - Clinical phase IIa/IIb: efficacy of CriPec® docetaxel • Platform - In house PoC for CriPec® peptide, CriVac® antigen, and CriPec® active targeting (ATN) - A commercial viable, robust and generic cGMP-manufacturing process • Business - Successful feasibility studies for partners - Successful (license) partnerships (full (co-)development programs) 8
- 9. Pipeline 9 indication discovery PoC preclinical phase I phase IIa Proprietary programs CriPec® docetaxel solid tumours CriPec® dexamethasone inflammatory CriPec® active targeting solid tumours CriPec® oligonucleotides various Collaborative programs CriPec® peptides solid tumours CriVac® antigens solid tumours achieved ongoing
- 10. General BD&L Considerations DO: • Understand the candidate licensee’s strategy and needs - Unlikely our opportunity will move the company’s strategy - Look for gaps we can fill - Ask for specific guidance on what the company is looking for • Appeal to licensee’s core values, for example: - Cutting-edge science - Novel medicines that make a difference • Demonstrate how our offering fits into their pipeline or research framework 10
- 11. General BD&L Considerations DON’T: • Forget that there is a fundamental difference between research (which advances technology without being constrained by business requirements) and product development (which must satisfy customer needs with safe, proven therapies that are competitive and cost-effective) • Expect to successfully license technology with no proven customer or market fit 11
- 12. CriPec® Docetaxel BD&L Considerations • Concept of disruptive vs. incremental innovation • Understanding stakeholders’ innovation preference • Multinationals • Regional players (e.g. Asian Pharma) • Adopters (e.g. innovative generics manufacturers) • Drafting CriPec® docetaxel licensing strategy • Analysis of market gaps in oncology • New application areas for CriPec® docetaxel • Competitive landscape (USPs vs. taxotere & NM competition) • Stakeholders landscape • Valuation of CriPec® docetaxel • Outline licensing deal 12