Difference between revisions of "Team:Oxford/Human Practices"
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<li>Relevant subset: Committee for Advanced Therapies (CAT) | <li>Relevant subset: Committee for Advanced Therapies (CAT) | ||
<li>Roles: | <li>Roles: | ||
| − | < | + | </div></div><li>Regulation of Advanced Therapy Medicinal Products (ATMPs) |
| − | < | + | </div></div><li>ATMPs include gene therapy/somatic cell therapy/tissue engineered medicinal products (criteria for classification listed on Article 17 of Regulation (EC) No 1394/2007) |
| − | < | + | </div></div><li>Assessment of quality, safety, and efficacy of ATMPs |
</ul> | </ul> | ||
<p><B>Medicines and Healthcare Products Regulatory Agency (MHRA)</B></p> | <p><B>Medicines and Healthcare Products Regulatory Agency (MHRA)</B></p> | ||
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<li>National level regulation (UK) | <li>National level regulation (UK) | ||
<li>Roles: | <li>Roles: | ||
| − | < | + | </div></div><li>Assessment and authorisation of medicinal products supplied in the UK |
| − | < | + | </div></div><li>Regulation of clinical trials |
| − | < | + | </div></div><li>Post-marketing surveillance for therapeutic side-effects |
| − | < | + | </div></div><li>Quality surveillance system to test medicinal products |
| − | < | + | </div></div><li>Monitoring of compliance to statutory obligations relating to medicinal products |
</ul> | </ul> | ||
<p><B>United States Food and Drug Administration (FDA)</B></p> | <p><B>United States Food and Drug Administration (FDA)</B></p> | ||
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<li>Relevant subset: Centre for Biologics Evaluation and Research (CBER) | <li>Relevant subset: Centre for Biologics Evaluation and Research (CBER) | ||
<li>Roles: | <li>Roles: | ||
| − | < | + | </div></div><li>Regulation of biological therapeutic agents |
| − | < | + | </div></div><li>Biological medicinal products include blood/tissue/gene therapy/vaccine/probiotic/cell-based products |
| − | < | + | </div></div><li>Assessment of quality, safety, and efficacy of biological therapeutics |
</ul> | </ul> | ||
<p><B>Pharmaceuticals and Medical Devices Agency (PMDA)</B></p> | <p><B>Pharmaceuticals and Medical Devices Agency (PMDA)</B></p> | ||
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<li>National level regulation (Japan) | <li>National level regulation (Japan) | ||
<li>Roles: | <li>Roles: | ||
| − | < | + | </div></div><li>Review of medicinal product clinical trials |
| − | < | + | </div></div><li>Monitoring of compliance to statutory obligations relating to medicinal products |
| − | < | + | </div></div><li>Post-marketing surveillance for therapeutic side-effects |
| − | < | + | </div></div><li>Compensation for adverse reactions |
</ul> | </ul> | ||
<p><B>Central Drugs Standard Control Organisation (CDSCO)</B></p> | <p><B>Central Drugs Standard Control Organisation (CDSCO)</B></p> | ||
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<li>National level regulation (India) | <li>National level regulation (India) | ||
<li>Roles: | <li>Roles: | ||
| − | < | + | </div></div><li>Assessment and authorisation of medicinal products supplied in India |
| − | < | + | </div></div><li>Regulation of clinical trials |
| − | < | + | </div></div><li>Quality control of imported medicinal products |
</ul> | </ul> | ||
Revision as of 14:12, 17 October 2018
Human Practices
Overview
An important aspect of synthetic biology is the consideration of how the technology has applications in the context of the wider society. We believed that collaborating with scientists, clinicians, social scientists, patients and the general public was essential to ensuring that our product benefits society. Our approach to human practices involved working with professionals, patients and the public to understand their opinions about various aspects of our project, and using this feedback to alter the design of our project and tailor our educational outreach activities.
The focus of our work on human practices was to integrate four major themes:
- Applied Design
Our approach to applied design involved creating surveys and interviewing patients to analyse the unmet patient needs and the most important issues that require addressing to improve patients’ quality of life. Regular conversations with patients, as well as professionals with knowledge in the law, manufacture and clinical delivery of therapeutics, enabled our design to continually evolve in light of this feedback.
- Public Engagement and Outreach
As a field still in its infancy, public knowledge of synthetic biology is limited and is often viewed with scepticism. As a result, public acceptance of genetically engineered therapeutics will be restricted by public knowledge unless educational resources are provided. The provision of summer school classes, public outreach events, online resources and a long-term public education plan were parts of our public outreach efforts. Our public engagement was integrated with our work covering applied design, since we remained open to feedback and used guidance from the public to shape our product design.
- Entrepreneurship
Our focus on entrepreneurship was a way of understanding how our therapeutic could be transitioned from the lab into the real world. We interviewed IBD patients and other key decision makers to determine the best value proposition. We surveyed the public about their preferences for potential products, and considered patents and regulatory procedures governing how our therapeutic can be taken into market.
- Safety
Safety is an essential consideration for the design of any genetically modified organism, particularly those used as medications. Discussions with clinicians and researchers, as well as some of the questions raised by patients and public we spoke to, encouraged us to make safety a key focus of our integrated human practices. Taking on the advice of professionals, we developed different designs of a kill switch and modeled the safety risks associated with our design.
Detailed information about our work centred around each of the four themes can be found on the respective pages of our wiki.
Overview of Integrated Human Practices
Our philosophy regarding human practices was to ensure a reciprocal relationship between our team and society, ensuring that we remain open to feedback from the public, patients and professionals. Our human practices work involved the education of the wider public about our project ideas and the broader applications of synthetic biology, as well as discussions and interviews to understand society’s opinions of our project. We acted upon the feedback we received, meaning that our project continually evolved in light of the public’s input. An important focus of our work was to ensure that ‘society’ encompassed the broadest range of individuals, so we engaged with clinicians, researchers, professionals involved in the legal and business side of drug development, patients, students and the lay public.
In this manner, our vision and plans for human practices were altered throughout the course of the project. The timeline below summarises our work for human practices and demonstrates how engaging with different individuals prompted us to take alternative pathways in the project, both in terms of human practices and the design of our therapeutic.
Timeline of Integrated Human Practices Work
Patient Involvement
Engaging with patients - the end-users of our product - was important for understanding the unmet patient needs that we are aiming to rectify. Our initial engagement with patients was in the form of surveys that were distributed to patient groups for a variety of autoimmune diseases. The results of the survey were useful at providing an overview of the common issues faced by patients and the common side effects of existing medication. This gave us an insight into what features will be important in the design of the product, although it became apparent that it would be beneficial to conduct one-to-one patient interviews to gain a greater understanding of the specific impact of the disease on patients’ quality of life. Taking on advice from clinicians, as well as the apparent range of symptoms associated with different autoimmune diseases, we chose to focus our product on the treatment of IBD. As a widely accepted method of “gaining insight into people’s feelings, understanding and perceptions”, one-to-one interviews played an important role in understanding the issues that our product must rectify to have the most significant benefit to patients’ quality of life. A complete analysis of the patient interviews and its impact on our project design can be found in our Applied Design page.
Safety
Regulation
European Medicines Agency (EMA)
- International level regulation (EU)
- Relevant subset: Committee for Advanced Therapies (CAT)
- Roles: