Waste to protein: A systematic review of a century of advancement in microbial fermentation of agro-industrial byproducts.

Increasing global consumption of protein over the last five decades, coupled with concerns about the impact on emissions of animal-based protein production, has created interest in alternative protein sources. Microbial proteins (MPs), derived through the fermentation of agro-industrial byproducts, present a promising option. This review assesses a century of advancements in this domain. We conducted a comprehensive review and meta-analysis, examining 347 relevant research papers to identify trends, technological advancements, and key influencing factors in the production of MP. The analysis covered the types of feedstocks and microbes, fermentation methods, and the implications of nucleic acid content on the food-grade quality of proteins. A conditional inference tree model and Bayesian factor were used to ascertain the impact of various parameters on protein content. Out of all the studied parameters, such as type of feedstock (lignocellulose, free sugars, gases, and others), type of fermentation (solid, liquid, gas), type of microbe (bacteria, fungi, yeast, and mix), and operating parameters (temperature, time, and pH), the type of fermentation and microbe were identified as the largest influences on protein content. Gas and liquid fermentation demonstrated higher protein content, averaging 52% and 42%, respectively. Among microbes, bacterial species produced a higher protein content of 51%. The suitable operating parameters, such as pH, time, and temperature, were also identified for different microbes. The results point to opportunities for continued innovation in feedstock, microbes, and regulatory alignment to fully realize the potential of MP in contributing to global food security and sustainability goals.

Anticipatory regulation for pandemic responses: are we there yet?

Can drug and vaccine regulatory agencies leverage their experience during the coronavirus disease 2019 (COVID-19) pandemic to advance from reactive regulation to adaptive regulation and beyond to anticipatory regulation to prevent or curb future pandemics?

Delivering impactful solutions for the bioeconomy.

We are increasingly challenged to operate within our planetary boundaries, while delivering on United Nations (UN) Sustainable Development Goal (SDG) 2030 targets, and net-zero emissions by 2050. Failure to solve these challenges risks economic, social, political, climate, food, water, and fuel security. Therefore, new, scalable, and adoptable circular economy solutions are urgently required. The ability of plants to use light, capture CO2, and drive complex biochemistry is pivotal to delivering these solutions. However, harnessing this capability efficiently also requires robust accompanying economic, financial, market, and strategic analytics. A framework for this is presented here in the Commercialization Tourbillon. It supports the delivery of emerging plant biotechnologies and bio-inspired light-driven industry solutions within the critical 2030-2050 timeframe, to achieve validated economic, social, and environmental benefits.

Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed.

The US Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with US Food and Drug Administration (FDA) reviewers. Yet, of the 116 pivotal trials supporting Breakthrough-designated drugs approved 2013-2018, 96 (83%) were already underway or completed when the designation was granted, limiting the potential of the designation to influence trial design. We found no difference between these trials and the 20 (17%) that had not yet begun when the designation was granted (which had greater potential to be impacted by the designation) with respect to phase, size, intervention model (single-arm vs. multi-arm), or use of surrogate end points under the Accelerated Approval (AA) pathway. This finding suggests that, in contrast to previous studies, observed trial characteristics were not likely attributable to the designation, and instead other factors such as disease category (e.g., oncology) may be driving both trial design and Breakthrough designation. The 20 trials in our sample that began after designation was granted were, however, over 8 months shorter than trials of nondesignated drugs. This suggests that designations granted early in clinical development may reduce trial time by influencing aspects of clinical programs other than design characteristics, such as timelines for FDA responses. Alternately, certain drugs may be more likely to both receive an early designation and have a shorter trial duration, for example, because of therapeutic category or large effect size.

Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine.

Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.

Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.

Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient populations. The potential for more immediate signals of efficacy during clinical trials suggests such medicines will reach the market more rapidly than traditional drugs will. Using data from the Food and Drug Administration (FDA), we examined the regulatory review and pivotal trial characteristics of precision medicines. We found that in the period January 2013-June 2017, precision medicines were developed and reviewed almost two years faster than nonprecision medicines. In addition, approximately 48 percent of the precision medicines in our study qualified for the FDA's breakthrough therapy designation. Precision medicines were also approved based on fewer pivotal trials with fewer patients, and the trials were less likely to be randomized, blinded, or controlled with either an active or placebo comparator.

The Tortoise and the Hare: Evolving Regulatory Landscapes for Biosimilars.

Challenges in demonstrating interchangeability and safety, as well as the ongoing evolution of regulations governing biosimilars, have meant that the development of the biosimilars industry has not been, and will not be, a carbon copy of the generics industry. Complexity in the development process reduces the cost advantages for biosimilars that generics offer over originators. There has been a marked difference in the number of biosimilars approved by the European Medicines Agency (EMA) and US FDA due to a lack of consensus and the different rates of progress in establishing both law and stable evidence-based regulatory guidelines for biosimilars. In this review, we provide a précis of the history and status of the regulatory regimes in the USA and Europe. Included is an assessment of market and nonmarket factors that may continue to influence the development of the biosimilars industry.