The Impact of the COVID-19 Pandemic on the Future of Science Careers.

As COVID-19 swept across the world, it created a global pandemic and an unpredictable and challenging job market. This article discusses the future of the 2020-2021 job market in both academia and industry in the midst and aftermath of this pandemic.

[Introducing the Academy of Pharmaceutical Science and Technology, Japan].

The Academy of Pharmaceutical Science and Technology, Japan (APSTJ) has contributed to advances in pharmaceutical sciences and progress in formulation technologies. The APSTJ has some 2000 individual members including pharmacists, researchers, technologists, and representatives of regulatory authorities. Remarkably, more than 800 individual members are from the industry. The APSTJ holds an annual meeting and several conferences or seminars on pharmaceutical technologies and skills. It has also set up 13 focus groups (FGs), including some working energetically on medical pharmacy research. For example, the FG on "personalized formulations" aims to develop a suitable dosage form for each individual patient to confirm the concept of personalized medication. To provide opportunities to hear the voices of patients and understand their medical needs, another FG has started a hospital-based internship program for industrial researchers. Furthermore, as an activity of the Japan Agency for Medical Research and Development, an industry-university joint consortium for "pediatric drug formulations" was organized within an FG to develop suitable formulations for pediatric use. The mission of the APSTJ is to provide safe, effective, user-friendly drug products based on pharmaceutical science and technology and cooperation with clinical researchers and medical staff.

What Does It Really Look Like to Properly Address a "Human Error Problem" in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance.

A clear picture of what Human Performance success looks like is now available from BioPhorum, where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool, which includes warning flags that help to identify significant obstacles in the way of effective human performance integration with operations that must be addressed. The effort to improve reliable operations within biopharma using elements of human performance borrowed from other industries have experienced uneven results and slow progress across the last seven years and has been bogged down for multiple significant reasons. These include a mental model that persists within the industry where workers are assumed to be the problem that needs fixing, the mistaken belief that Lean/Operational Excellence is a cure-all and nearly equivalent to human performance, neglecting the need to fundamentally rethink why and how investigations are performed, and truly underestimating the time, effort, strength of sponsor support, and strategy needed to change how work is designed, executed, and then later learned from.LAY ABSTRACT: Human Performance is an integrated risk management approach to improving systems, that includes human factors and systems safety, that leads to higher reliability and enhanced operational resilience. A clear picture of what Human Performance looks like in biopharma is available from the BioPhorum, where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool that will help to identify the steps to effective human performance integration with operations. The effort to improve reliable operations within biopharma using elements of human performance borrowed from other industries has experienced uneven results and slow progress across the last seven years and has been bogged down for multiple significant reasons. These include a mental model that persists within the industry where workers are assumed to be the problem that needs fixing, the mistaken belief that Lean practices (intended to improve productivity & efficiency) is a cure-all and nearly equivalent to human performance, neglecting the need to fundamentally rethink why and how investigations are performed, and truly underestimating the time, effort, strength of sponsor support needed to change how work is designed, executed, and then later learned from.

Una nueva visión en la gestión de la logística de aprovisionamientos en la industria biotecnológica cubana / A new vision in the management of supply logistics in the cuban biotechnological industry

El objetivo de esta investigación es proponer una nueva metodología en la gestión logística de los aprovisionamientos para las industrias biotecnológicas cubanas que funcionan esencialmente con un ciclo completo de desempeño empresarial, desde la investigación básica de nuevos biofármacos, hasta llegar a la fabricación y comercialización de sus productos, donde la amplia y compleja gama de surtidos a suministrar en un contexto adverso para el país, conlleva a utilizar diferentes métodos de gestión de los aprovisionamientos en correspondencia con su destino y frecuencia de uso. De esta manera, se propone dividir las materias primas y materiales a proveer en: 1) insumos de proyectos, que emplean de forma esporádica pequeñas, pero múltiples variedades de mercancías 2) insumos de procesos, que se caracterizan por consumir altos volúmenes de productos, pero poco diversos, como sucede en las actividades de producción. Finalmente, se evalúa la implementación de este procedimiento en una de las entidades biotecnológicas de mayor prestigio en Cuba, el Centro de Inmunología Molecular, demostrando las ventajas y alcance de esta propuesta que permitió elevar la efectividad en la gestión de los aprovisionamientos, y de esta manera la eficiencia empresarial(AU)

The objective of this work is to propose a new methodology for the logistics management of supplies in Cuban biotechnological industries. They work essentially on a full cycle of enterprise performance, from basic research to the manufacture and marketing of new biopharmaceuticals products. The wide and complex range of supply requirements, in an adverse country-wide context, leads to the use of different methods for managing supplies, in accordance with their destination and frequency of use. We propose to divide the supplies and materials into two categories: 1) supplies for projects, for those that are highly varied, used sporadically and in small quantities, 2) process supplies, for those that are regularly used in large volumes -such as manufacture process-, and a relatively small variety of supply types. The implementation of this methodology is assessed in one of the most prestigious biotechnological entities in Cuba, the Molecular Immunology Center. The effectiveness in the management of supplies was increased, and therefore, business efficiency(AU)

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5 day, week-long event - A Full Immersion Bioanalytical Week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS and LBA approaches, including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 3 discusses the recommendations for large molecule bioanalysis using LBA, biomarkers and immunogenicity. Part 1 (small molecule bioanalysis using LCMS) and Part 2 (hybrid LBA/LCMS and regulatory inputs from major global health authorities) have been published in volume 7, issues 22 and 23 of Bioanalysis, respectively.

The US approach to biosimilars: the long-awaited FDA approval pathway.

In the US, the Biologics Price Competition and Innovation Act (BPCI Act, 2009) provided the pathway to create an abbreviated licensure procedure for biologic products that are demonstrated to be biosimilar to or interchangeable with a Food and Drug Administration (FDA) licensed biologic product. In February 2012, the FDA issued three guidelines that list the requirements for biosimilar registration. The topics covered include scientific and quality considerations to demonstrate biosimilarity to a reference product and a guidance that clarifies the BPCI Act implementation. The sponsor application for the biosimilar approval must contain biosimilarity information based on data derived from analytical, animal, and clinical studies. Clinical studies should include an assessment of immunogenicity, pharmacokinetics, pharmacodynamics, and address one or more indications licensed for the reference product. To demonstrate biosimilarity the applicant is allowed to use comparative animal or clinical data with a non-US-licensed product. According to these guidelines, the FDA will consider different aspects when evaluating biosimilarity, such as product formulation, complexity, and stability which will have a risk-based approach and will depend on the degree of knowledge of the product characteristics, as well as clinical experience with the reference one. The FDA intends to use a risk-based and facts-focused approach for review of applications of biosimilars, although it faces several challenges. Once a biologic medicine has been demonstrated to be biosimilar to the reference product, an abridged development program for the biosimilar medicine can be carried out in a similar way to that established by the European Medicines Agency (EMA). In addition, FDA legislation goes a step further than the EMA, offering the possibility to adopt full interchangeability for biosimilars.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a) shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b) identifies common challenges that indigenous entrepreneurs face, c) highlights the key role played by the state, and d) reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.

Model-based drug development survey finds pharmacometrics impacting decision making in the pharmaceutical industry.

During the past decade, the pharmaceutical industry has seen the increasing application of pharmacometrics approaches in drug development. However, the full potential of incorporating model-based approaches in drug development and its impact on decision making has not been fully realized to date. In 2009, a survey on model-based drug development (MBDD) was conducted (1) to further understand the current state of MBDD in the pharmaceutical industry and (2) to identify opportunities to realize the full potential of MBDD. Ten large and mid-sized pharmaceutical companies provided responses to this survey. The results indicate that MBDD is achieving broad application in early and late development and is positively affecting both internal and regulatory decisions. Senior leadership (vice president and higher) within the companies indicated widely accepted utility for dose selection and gaining acceptance for study design and regulatory interactions but limited acceptance in discovery and commercial/pipeline decisions. Mounting appreciation for the impact of MBDD on internal and regulatory decision-making bodes well for the future of the pharmacometric discipline and the growth of opportunities to realize the full potential of MBDD.

How many patents does a biopharmaceutical company need?

Young biotech companies may not need extensive patent portfolios to survive or grow.

Multiobjective long-term planning of biopharmaceutical manufacturing facilities.

Biopharmaceutical companies with large portfolios of clinical and commercial products typically need to allocate production across several multiproduct facilities, including third party contract manufacturers. This poses several capacity planning challenges which are further complicated by the need to satisfy different stakeholders often with conflicting objectives. This work addresses the question of how a biopharmaceutical manufacturer can make better long-term capacity planning decisions given multiple strategic criteria such as cost, risk, customer service level, and capacity utilization targets. A long-term planning model that allows for multiple facilities and accounts for multiple objectives via goal programming is developed. An industrial case study based on a large scale biopharmaceutical manufacturer is used to illustrate the functionality of the model. A single objective model is used to identify how best to use existing capacity so as to maximize profits for different demand scenarios. Mitigating risk due to unforeseen circumstances by including a dual facility constraint is shown to be a reasonable strategy at base case demand levels but unacceptable if demands are 150% higher than expected. The capacity analysis identifies where existing capacity fails to meet demands given the constraints. A multiobjective model is used to demonstrate how key performance measures change given different decision making policies where different weights are assigned to cost, customer service level, and utilization targets. The analysis demonstrates that a high profit can still be achieved while meeting key targets more closely. The sensitivity of the optimal solution to different limits on the targets is illustrated.

Medium term planning of biopharmaceutical manufacture using mathematical programming.

Regulatory pressures and capacity constraints are forcing the biopharmaceutical industry to consider employing multiproduct manufacturing facilities running on a campaign basis. The need for such flexible and cost-effective manufacture poses a significant challenge for planning and scheduling. This paper reviews the problem of planning and scheduling of biopharmaceutical manufacture and presents a methodology for the planning of multiproduct biopharmaceutical manufacturing facilities. The problem is formulated as a mixed integer linear program (MILP) to represent the relevant decisions required within the planning process and is tested on two typical biopharmaceutical industry planning problems. The proposed formulation is compared with an industrial rule based approach, which it outperforms in terms of profitability. The results indicate that the developed formulation offers an effective representation of the planning problem and would be a useful decision tool for manufacturers in the biopharmaceutical industry particularly at times of limited manufacturing capacity.