Using GastroPlus to teach complex biopharmaceutical concepts

Context: In response to the COVID-19 pandemic, many educational adjustments had to be made to move in-person teaching to online classrooms. This report showcases the use of the software GastroPlus at an undergraduate level pharmacy course. Programme description: This course aimed for the students to learn how to perform mechanistically based simulation to predict the oral absorption pattern, pharmacokinetics and biopharmaceutics properties of compounds in humans. The computer simulation offered the opportunity to teach concepts about bioavailability providing all kinds of experience with major biopharmaceutic determinants that affect systemic drug exposure. Evaluation: The advantage of this approach was seen by the enhanced performance on the biopharmaceutics questions on the final exam compared with the previous year where the laboratory was not implemented: An increase from 2019 (where no laboratory was implemented) through 2021 in correct scores from 52, 76 to 75%, respectively. Conclusion: There is great benefit in using computer programs and simulations as a technique to enhance active learning and to educate pharmacy students in salient aspects of biopharmaceutics.

Online Teaching Practice and Effect Evaluation of Biopharmaceutical Experiment Course during Epidemic Prevention

Biopharmaceutical experiment is a professional compulsory course for undergraduates majoring in pharmacy. It is a key link in the training of undergraduates majoring in pharmacy and is extremely important for the training of students' professional quality. At the beginning of 2020, the outbreak of novel coronavirus pneumonia caused various colleges and universities across the country to postpone the opening of classes and began to teach online. As a compulsory course for undergraduates, the experimental course of biopharmaceuticals also began to teach online, which is different from other theoretical courses and experimental courses. Online teaching has its particularity and limitation. Method:After discussion, the teaching group adopts PPT recording and dubbing to make a video showing the experimental principles and method content, and then the teacher personally demonstrates the demonstration, records the experimental demonstration video, and then synthesizes the video clip into a network video course and uploads it to the learning software. Watch the video online, and the teacher will speak and answer questions online to complete the experiment teaching. Results:Although online teaching cannot be operated by students personally, there are also many advantages in online teaching. 1. Fully mobilize students to cultivate independent learning, 2. Give full play to the advantages of the network, improve communication and interaction, 3. Use software platforms to strengthen teaching management. Therefore, Online teaching improves students' learning efficiency to a certain extent, and strengthens students' understanding of experimental principles and methods. At the same time, in view of the opportunity of recording video courses, this teaching group has expanded and improved the video materials of biopharmaceutical experiments, improved the multimedia teaching technology of the teaching group, and also provided supplements for offline teaching of experimental courses. Conclusion:During the epidemic prevention and control period, online video teaching is used to ensure that the teaching plan is completed on time and as planned, and the smooth progress of the teaching work is ensured. With the popularization of smart devices, online teaching methods will become more and more mature and common in the future experimental and theoretical teaching work, making school teaching methods more diversified, and ensuring that when public emergencies occur, the teaching work can also be carried out normally. © 2021, Editorial Board of Pharmaceutical Biotechnology. All right reserved.

Biopharmaceutics 4.0, Advanced Pre-Clinical Development of mRNA-Encoded Monoclonal Antibodies to Immunosuppressed Murine Models.

Administration of mRNA against SARS-CoV-2 has demonstrated sufficient efficacy, tolerability and clinical potential to disrupt the vaccination field. A multiple-arm, cohort randomized, mixed blind, placebo-controlled study was designed to investigate the in vivo expression of mRNA antibodies to immunosuppressed murine models to conduct efficacy, safety and bioavailability evaluation. Enabling 4.0 tools we reduced animal sacrifice, while interventions were designed compliant to HARRP and SPIRIT engagement: (a) Randomization, blinding; (b) pharmaceutical grade formulation, monitoring; (c) biochemical and histological analysis; and (d) theoretic, statistical analysis. Risk assessment molded the study orientations, according to the ARRIVE guidelines. The primary target of this protocol is the validation of the research hypothesis that autologous translation of Trastuzumab by in vitro transcribed mRNA-encoded antibodies to immunosuppressed animal models, is non-inferior to classical treatments. The secondary target is the comparative pharmacokinetic assessment of the novel scheme, between immunodeficient and healthy subjects. Herein, the debut clinical protocol, investigating the pharmacokinetic/pharmacodynamic impact of mRNA vaccination to immunodeficient organisms. Our design, contributes novel methodology to guide the preclinical development of RNA antibody modalities by resolving efficacy, tolerability and dose regime adjustment for special populations that are incapable of humoral defense.

Warp-Speed Covid-19 Vaccine Development: Beneficiaries of Maturation in Biopharmaceutical Technologies and Public-Private Partnerships.

It is anticipated that effective vaccines will enable the resumption of social and economic normalcy. Current calls for masking, social distancing and other restrictive measures for the public-good are difficult to enforce and are unstainable. As ~2-4% of the 50 million SARS-CoV2-infected have succumbed to Covid-19, the US department of Health and Human Services has organized a public-private partnership called Operation Warp Speed (OWS) to develop, produce and deliver 300 million doses of safe and effective vaccines with a January 2021 target. While a majority of the 300+ Covid-19 vaccine candidates are in various stages of preclinical and early-stage clinical testing, 6 clinical candidates are supported with over 10 billion USD plus integrated resources under the OWS agenda. This unprecedented approach is investing in the manufacture of product candidates ahead of product approval. It is enabled by new gene and recombinant pharmaceutical platform technologies that are accelerating the clinical study timeline from ~10 to less than 1 year. It is anticipated that one or more of the 6 candidates under the OWS initiative will be safe, effective and provide a sustained immune response to prevent infection and disease progression. This way, social and economic activities could return to normalcy.

Prodrugs for Improved Drug Delivery: Lessons Learned from Recently Developed and Marketed Products.

Prodrugs are bioreversible, inactive drug derivatives, which have the ability to convert into a parent drug in the body. In the past, prodrugs were used as a last option; however, nowadays, prodrugs are considered already in the early stages of drug development. Optimal prodrug needs to have effective absorption, distribution, metabolism, and elimination (ADME) features to be chemically stable, to be selective towards the particular site in the body, and to have appropriate safety. Traditional prodrug approach aims to improve physicochemical/biopharmaceutical drug properties; modern prodrugs also include cellular and molecular parameters to accomplish desired drug effect and site-specificity. Here, we present recently investigated prodrugs, their pharmaceutical and clinical advantages, and challenges facing the overall prodrug development. Given examples illustrate that prodrugs can accomplish appropriate solubility, increase permeability, provide site-specific targeting (i.e., to organs, tissues, enzymes, or transporters), overcome rapid drug metabolism, decrease toxicity, or provide better patient compliance, all with the aim to provide optimal drug therapy and outcome. Overall, the prodrug approach is a powerful tool to decrease the time/costs of developing new drug entities and improve overall drug therapy.