spacer
home > ict > summer 2019 > the landscape of clinical approval
PUBLICATIONS
International Clinical Trials

The Landscape of Clinical Approval





Cell and gene therapies, and other advanced medicinal products, have generated substantial public health interest, and deservedly so. These living drugs have shown remarkable effectiveness against cancer and other life-threatening illnesses, including rare diseases with previously no treatment available. Recent approvals of cell- and gene-based therapies underscore the industry’s conviction that these drugs will have a strong, positive impact on patient health (1-2). At the same time, accelerated approval pathways are placing a heavy onus on drug developers to assure a consistently pure and efficacious product. Sourcing donor material and assuring efficacy are a lot more complicated when a drug comprises living cells and tissues rather than synthetic products. Accelerated approval also puts significant strain on starting material suppliers, especially in the cell therapy space.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
About the authors


Dominic Clarke PhD has 15-plus years of experience developing enabling solutions for cell therapy and bioprocessing applications. Dominic is the Global Head of Cell Therapy at HemaCare, the leading provider of donor starting material for development and commercial cell and gene therapies, where he is actively engaged with industry experts to ensure the highest quality materials are delivered. Previously, he has held roles as the Global Product Manager for Charter Medical's cell therapy and bioprocessing disposables portfolio, focused on creating flexible closedsystem solutions for early- and late-stage production, and as the Director of Research and Development at BioLife Solutions, developing novel biopreservation media and methods to support extended stability of cells and tissues.



Brad N Taylor PhD is the Global Marketing Director at HemaCare. Brad has 13- plus years of experience in the biotech industry, addressing multiple aspects of drug discovery and preclinical development. Previously, he has held roles as Application Scientist and Product Manager in the In Vivo Imaging division of PerkinElmer, where he worked to bring innovative solutions to market to assist the research community in expediting and streamlining the process of preclinical drug discovery for cancer and other clinical applications in animal models of disease.


Print this page
Send to a friend
Privacy statement
News and Press Releases

Pharmapack Europe 2020 Award Winners Announced

Exhibitor Innovations 1. Best Innovation in Drug Delivery Device (injectable): The Connect™ Auto-Sensing Injection System by Credence MedSystems 2. Best Innovation in Drug Delivery Device (respiratory): Safe'n'Spray™ by NEMERA 3. Best Innovation in Primary Packaging (solid dosage): Push Tab® loop by Huhtamaki Flexible Packaging 4. Best Innovation in Primary Packaging (liquid dosage): Pourer “Lotus” by PACKSYS GmbH 5. Best Innovation in Secondary Packaging: Patient Support App by Rondo 6. Best Innovation in Machinery: Quantifeel Quality Assurance Platform by Smart Skin Technologies
More info >>

White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.

Medpace

Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
More info >>

 
Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement