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Biotechnology industry
Published in Ronald P. Evens, Biotechnology, 2020
The Development Division takes on the product candidate from the research division to perform the clinical trials with patients with the target disease and establish its efficacy and safety (Figure 10.5). Clinical trials in humans progress from Phase 1 (with normal subjects for product activity and safety), to Phase 2 (in patients with target disease to document disease improvement, reasonable dosing schemes, safety), and metabolism (absorption-distribution-metabolism-elimination studies in normal subjects and patients), to Phase 3 (pivotal studies in target patients to establish safety and efficacy sufficient for product approval for marketing). The biostatistics group summarizes and analyses the data from the clinical trials for statistical reports. Project management coordinates and tracks all the studies and helps keep projects on time and on target in support of everyone else. Quality assurance is an internal audit function to ensure all the projects and reports are of the highest quality to ensure product approval by regulatory authorities. Resources may be limited as a candidate moves through the phases of research, creating the need to outsource a function to a vendor with the requisite expertise, usually called a contract research organization (CRO). Clinical data from the patient trials with the accompanying clinical trial reports are the outcomes from the Development Division.
Background and Motivation
Published in Arkadiy Pitman, Oleksandr Sverdlov, L. Bruce Pearce, Mathematical and Statistical Skills in the Biopharmaceutical Industry, 2019
Arkadiy Pitman, Oleksandr Sverdlov, L. Bruce Pearce
One may argue that high specialization and vertical separation of duties may potentially create a lot of problems. Modern business models (especially in the CRO settings) require that any task should be performed as cheaply as possible by those qualified to perform it. As a result, lack of understanding of what will be done at subsequent steps may lead to small oversights that necessarily pile up in big multi-step projects.
The role of monitoring of research for compliance and detecting misconduct
Published in Frank Wells, Michael Farthing, Fraud and Misconduct in Biomedical Research, 2019
In clinical practice, it is common today to use computers for a number of aspects of a clinical trial that used to be performed manually or using paper forms. We use computers to transmit clinical laboratory results directly from the laboratory to the investigator, and to the sponsor during clinical trials.6,7 Sponsors also use computers for remote electronic CRF data entry systems or contract with contract research organizations (CROs) for clinical data entry, analysis, and reporting. When the electronic records/electronic signature rule was finalized, the FDA reiterated that the same documentation expectations and requirements for records and access as defined in the IND regulations still applied, regardless of whether or not the records were created and/or maintained on paper or electronically.19 Although it was not explicitly stated until recently, the FDA has for many years considered computer systems used in drug development, regardless of where and how they are used, also to be subject to regulatory requirements, audit, and inspection.20
Trend of drug clinical trials in mainland China from 2009 to 2020
Published in Current Medical Research and Opinion, 2022
Yu Cao, Lianming Liao, Xin Liu, Qingshan Zheng, Zhongyuan Xu, Haitao Niu
Chinese authorities have made great efforts to improve research quality. For example, CFDA launched a self-inspection and verification program for clinical data, requiring applicants, contract research organizations (CROs) and clinical sites to self-inspect data to ensure authenticity of clinical data in July 2015. After 12 months (as of July 2016), CFDA reported that around 90 percent of the 1,622 applications have been withdrawn by applicants or rejected by CFDA. This program significantly enhances the quality of clinical trials in China since then. Participate protection is also emphasized. Presently 8 hospitals and medical centers were accredited by AAHRPP (Association for the Accreditation of Human Research Protection Program, USA), 76 hospitals or medical centers were accredited FERCAP (Forum for Ethical Review Committees in Asian and Western Pacific Region). China Forums of Clinical Research Capacity Building and Human Research Participants Protection (CCHRPP) was launched in 2017, and became a national-wide annual conference since then The working committee of CCHRPP who issued the first consensus on collaboration of institutional review boards in 2017, which was updated in 2019.
One small step in time, one giant leap for DMPK kind – a CRO perspective of the evolving core discipline of drug development
Published in Xenobiotica, 2022
John S. Kendrick, Colin Webber
With the growth of outsourcing, the relationships between members of the DMPK community have shifted. Where once a transactional procurement focussed encounter existed, over time, first a strategic collaboration and then preferred partnership agreements have formed, where dedicated capacity and schedules are offered for a guarantee of regular study volumes. The increasingly robust teamwork between Pharma and CROs has been ably demonstrated during the coronavirus pandemic, the dedication and resolve of both parties enabling rapid response and solutions to the global threat to health and life we have all experienced first-hand. This outsourcing paradigm has continued to be self-perpetuating not only with structural re-organisations in large pharma companies being commonplace every few years, but also by the flow of venture capital funding into smaller biotech companies with a smaller number of assets, but with broader rather than specialised DMPK knowledge. However, consolidation of the CRO industry has also gathered pace, particularly in the last 5 years, so that niche providers are often acquired and assimilated by larger multi-national CROs. While these drivers have the ultimate benefit in delivering end-to-end drug development services, it has also led to CROs becoming greater early adaptors for new technology, innovators for new approaches and thought providers for the evolving DMPK landscape.
Meeting report of the first European biotransformation workshop
Published in Xenobiotica, 2021
M. Walles, A. Pähler, L. Weidolf, E. M. Isin
In the next breakout session, all participants joined in a discussion on challenges in the interactions between CROs and Pharma companies. It was pointed out that the knowledge transfer linked to analytical methods between pharma companies and CROs is often not ideal and that CROs often have to spend additional amount of time on method development. Strong relationships and integration of CRO staff into the internal team was proposed to assure smooth operation, decision making and common data interpretation. In addition, it was emphasized that analytical metabolite alignment between studies at different sites and CROs is challenging and therefore it would be advantageous to source an entire project to a CRO. There is a trend that radiolabeled ADME studies (rat and human) are outsourced to CROs as a package to ensure alignment of metabolites. The training of next generation of biotransformation scientists at CROs and Pharma companies was also a point of discussion and joined efforts need to be made to ensure a proper training and secure provision of competent biotransformation scientists. For new modalities, it was highlighted that certain CROs possess a deep expertise and that it would be advantageous for pharma companies to tap into the CRO knowledge instead of building it up internally for each new modality. In general, a continuous conversation between CROs and pharma companies was encouraged.