Towards progressive regulatory approaches for agricultural applications of animal biotechnology

Traditional breeding techniques, applied incrementally over thousands of years, have yielded huge benefits in the characteristics of agricultural animals. This is a result of significant, measurable changes to the genomes of those animal species and breeds. Genome editing techniques may now be applied to achieve targeted DNA sequence alterations, with the potential to affect traits of interest to production of agricultural animals in just one generation. New opportunities arise to improve characteristics difficult to achieve or not amenable to traditional breeding, including disease resistance, and traits that can improve animal welfare, reduce environmental impact, or mitigate impacts of climate change. Countries and supranational institutions are in the process of defining regulatory approaches for genome edited animals and can benefit from sharing approaches and experiences to institute progressive policies in which regulatory oversight is scaled to the particular level of risk involved. To facilitate information sharing and discussion on animal biotechnology, an international community of researchers, developers, breeders, regulators, and communicators recently held a series of seven virtual workshop sessions on applications of biotechnology for animal agriculture, food and environmental safety assessment, regulatory approaches, and market and consumer acceptance. In this report, we summarize the topics presented in the workshop sessions, as well as discussions coming out of the breakout sessions. This is framed within the context of past and recent scientific and regulatory developments. This is a pivotal moment for determination of regulatory approaches and establishment of trust across the innovation through-chain, from researchers, developers, regulators, breeders, farmers through to consumers.

Differences between sperm sharing and egg sharing are morally relevant

Sperm sharing arrangements involve a man (‘the sharer’) allowing his sperm to be used by people seeking donor sperm (‘the recipients’) in exchange for reduced price in vitro fertilisation. Clinics in the UK have offered egg sharing since the 1990s and the arrangement has been subjected to regulatory oversight and significant ethical analysis. By contrast, until now no published ethical or empirical research has analysed sperm sharing. Moreover the Human Fertilisation and Embryology Authority (HFEA) does not record the number of sperm sharing arrangements taking place.This paper describes the sperm sharing process providing an analysis of all the UK clinics advertising sperm sharing services. The ethical rationale for egg sharing is described: reducing the number of women exposed to the risks of stimulation and retrieval. This advantage is absent in sperm sharing where donation has no physical drawbacks. The key adverse social and emotional outcome of gamete sharing arises when the sharer’s own treatment is unsuccessful and the recipient’s is successful. This outcome is more likely in sperm sharing than in egg sharing given sperm from sharers can be used by up to 10 families whereas shared eggs only go to one other family.Given its morally relevant differences from egg sharing, sperm sharing requires its own ethical analysis. The HFEA should begin recording sperm sharing arrangements in order to enable meaningful ethical and policy scrutiny.

Risk Governance and Bank Performance

Global discourse is geared towards greater accountability and regulatory oversight of banks to promote sound financial systems and charter value. The authors applied dynamic pool panel analysis to investigate the relationship between risk governance and financial performance among African global banks spanning the years 2015 to 2020. They find significant positive association between financial experts on risk committee and bank profitability. The results further reveal that risk committee activism as a proxy for risk committee effectiveness significantly increase bank profitability. Therefore, stakeholders must prioritize regular risk committee meetings and attach importance to risk committee compositions with finance experts on the majority. Additionally, this study offers policy implications for regulators and bank mangers to clearly define risk committee financial experts and minimum financial experts required to serve on the risk committee.

Current State of Regulatory Oversight of Biosimilars in India and Its Implications on the Quality of Drugs: A Comparative Assessment with EU and FDA Regulations

Biosimilars are biologic products that are highly similar to a licensed reference biologic, with no clinically meaningful differences in quality characteristics, biological activity, safety, or efficacy. Biosimilars can help to fulfill unmet medical needs due to their cost effectiveness while at the same time being as efficacious as the innovator drug. They can also improve patient access to otherwise costly innovator biologics. India has the largest number of approved biosimilars as compared to the US and Europe. However, the numbers of clinical studies that are conducted to prove the biosimilarity are lesser than the number of biosimilars approved, which is evident by the number of CTRI registrations done. Some studies have shown the quality of biosimilars approved and marketed in India to be inferior to the innovator drug. This raises concerns regarding the quality of the biosimilars. In this review, the similarities and differences in the guidelines, the approval process, and quality enforcement measures prevailing in the three regulatory regions of USA, Europe and India are discussed. Changes in the approval process and post approval monitoring of drugs and manufacturing facilities are recommended in order to ensure sustained quality standards of drugs entering the market.

Preventing Prescription Drug Misuse: A Regulatory Perspective in the United States, Europe, and India

Prescription medicines, such as analgesics, stimulants, steroids, anti-depressants, psychotropics, and certain antibiotics are commonly mishandled in a variety of ways, including overdosing, abuse, diversion, and drug trafficking. Because of the considerable risk to public health, they are subject to strict regulatory oversight. The drugs possess abuse potential at specific dose and hence prone to abuse therefore they are categorized as Controlled substances. Therefore, they are subject to constant vigilance over the pharmaceutical supply chain. The complete clinical data as well as post marketing surveillance study of such drugs are critical to be in place as per the regulatory requirements. The countries have kept up with the times by constantly updating the system with regulatory laws and strategies to prevent cases of misuse. The current review will give a quick summary of how prescription medications and prohibited substances are regulated in the United States, Europe, and India. It will also emphasize current trends in drug usage, as well as the issues that these countries face and the preventive policies implemented to manage and prevent drug misuse. It will also make recommendations for new regulatory initiatives to address the current drug- misuse-related concerns. As a result, a review of the regulatory system in various countries will present current challenges and new lessons for countries around the globe.

Online seminars as an information source for direct-to-consumer stem cell therapy

Aim: To attend stem-cell (SC) seminars hosted by US-based direct-to-consumer SC businesses either in person or via online ‘webinars’ to determine accuracy and regulatory oversight of the advertised SC therapies. Methods: The therapeutic claims, costs, risks, scientific evidence in support of a therapy and any regulatory oversight were collated using pre-established checklists. Participation consisted of one live attendance of a seminar, and following COVID-19 restrictions, review of seven recorded presentations available on the internet from SC businesses. Results & conclusion: None of the SC therapies advertised by direct-to-consumer clinics reviewed were supported by proper clinical evidence nor substantiated by peer reviewed literature.

Automated Bolus Calculators and Connected Insulin Pens: A Smart Combination for Multiple Daily Injection Insulin Therapy

Although automated bolus calculators (ABCs) have become a mainstay in insulin pump therapy, they have not achieved similar levels of adoption by persons with diabetes (PWD) using multiple daily injections of insulin (MDI). Only a small number of blood glucose meters (BGMs) have incorporated ABC functionality and the proliferation of unregulated ABC smartphone apps raised safety concerns and eventually led to Food and Drug Administration (FDA)–mandated regulatory oversight for these types of apps. With the recent introduction of smartphone-connected insulin pens, manufacturer-supported companion ABC apps may offer an ideal solution for PWD and health care professionals that reduces errors of mental math when calculating bolus insulin dosing, increases the quality of diabetes data reporting, and improves glycemic outcomes.

Perspectives on Challenges to Cell Therapy Development in Taiwan: Strengthening Evidential Standards and Ways Forward

Over the past years, the field of regenerative medicine and cell therapy has garnered much interest, extending beyond the bench to broader use, and commercialization. These therapies undergo stringent regulatory oversight as a result of their complexities and potential risk across different jurisdictions. Taiwan’s government, with the aim of developing the country as a hub for regenerative medicine in Asia, enacted a dual track act to promote the development of regenerative and cell therapy products. This qualitative study used purposive sampling to recruit sixteen experts (Twelve respondents from medical institutions and four respondents from the industry) to understand their perspectives on one of the regulatory tracks which governs the medical use of cell technologies and challenges regarding its implementation. Semi-structured interviews were conducted, transcribed, coded and thematically analyzed. Three major themes emerged from the analysis: 1) Perceptions of the “Special Regulation for Cell Therapy” 2) Emerging issues and controversies on the medical use of cell technologies in private clinics, and 3) Challenges impeding the clinical innovation of cell technologies. As reported by the experts, it was clear that the special regulation for cell therapy was aimed at legalizing the clinical use of cell therapy in a similar fashion to an evidence-based pathway, to promote clinical innovation, ensure manufacturing consistency, and improve oversight on cell-based therapies. Thus, the regulation addresses the issues of safety concerns, patient’s access and stem cell tourism. However, the limited approved cell techniques, quality control during cell processing, time, and criteria used in evaluating applications in addition to the need to develop evidential standards for clinical evidence are some of the difficulties faced. Thus, policy interventions on funding, educational resources, training, and regulatory clarity addressing these challenges may positively impact clinical innovation of cell therapy in Taiwan.