Recent Progress in Advanced Therapy Medicinal Products: Scaffold Design, Cell Priming and Genetic Engineering
A special issue of Bioengineering (ISSN 2306-5354).
Deadline for manuscript submissions: closed (15 September 2022) | Viewed by 481
Special Issue Editors
Interests: regenerative medicine; medical devices; data analytics
Special Issue Information
Dear Colleagues,
Regenerative Medicine is a rapidly evolving field, accompanied by an ever-increasing number of approved Advanced Therapy Medicinal Products (ATMPs) in Europe from EMA and Cellular and Gene Therapy Products by the Center for Biologics Evaluation and Research (CBER) office of the FDA. Beyond gene therapy products regulated by the FDA CBER, genetic drugs such as siRNA and antisense oligonucleotides have been authorized at a faster pace by FDA for the treatment of rare monogenic diseases.
This Special Issue of Bioengineering on Recent Progress in Advanced Therapy Medicinal Products welcomes submissions that address key challenges leading to the clinical use authorization of these products (i.e., gene therapy medicines, somatic cell therapy medicines, tissue-engineered medicine, genetic drugs) and their adoption by all stakeholders, patients, healthcare providers, and reimbursement/health technology assessment bodies. Challenges include product (bio)engineering, cost-effective manufacturing, safety improvement, product delivery to right targets, preclinical evaluation to support the first human studies, clinical evaluation to support safety and efficacy demonstration and health economics analysis, regulatory filing for authorization, and innovative models to facilitate market access and adoption of the products.
Original articles should present unprecedented solutions to the above-mentioned challenges to improve existing products or generate new ones. Review articles illustrating the most recent progress in Advanced Therapy Medicinal Products (i.e., within the last 3 years) are also encouraged.
Dr. Yves Bayon
Dr. Vincent Ronfard
Guest Editors
Manuscript Submission Information
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Keywords
- cell therapy
- gene therapy
- tissue-engineering
- genetic drugs
- formulation
- manufacturing
- clinical evaluation
- reimbursement
- market access
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