Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development

Petrova, E. N.

doi:10.1007/978-1-4614-7801-0_2

Cited by 55 publications

(46 citation statements)

References 59 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The firm's business model involves discovering new candidate drugs and developing them until clinical proof of concept, with the aim to license them to pharmaceutical companies. DrugCorp's innovation development could be considered to be highly technology driven, following the technology-push model common in the pharmaceutical industry (Petrova, 2014). Innovation activities of DrugCorp belong to the category of radical innovations, which usually involve the development of new technologies for relatively unknown markets (Dewar and Dutton, 1986;Ettlie et al, 1984;McDermott and O'Connor, 2002;O'Connor, 1998).…”

Section: Case Studies 41 Drugcorpmentioning

confidence: 99%

Meeting up for management control: bracketing interaction in innovation development

Bürkland

Zachariassen

Oliveira

2019

QRAM

View full text Add to dashboard Cite

Purpose The purpose of this paper is to examine meetings as a form of meta-practice and investigate their role related to management control of innovation development. Design/methodology/approach This research draws on case studies of two biotechnology firms operating in pharmaceuticals and medicine, which represent different contexts regarding the uncertainty and complexity of innovation development. Findings The study suggests two distinct roles of meetings in the context of innovation development: meetings as regulating and ordering; and meetings as a resource. In the first role, meetings serve as a regulative mechanism that brings together multiple elements of control into a system. Meetings as a meta-practice regulate and order by bracketing elements of innovation in time and space, rendering the innovation process more manageable and allowing actors to handle the complexity of knowledge. In the second role, meetings are used as a resource, sporadically intervening in the ongoing activities of innovation projects. The study explains how these two roles relate to the uncertainty and complexity of innovation development and have different implications for management control. Originality/value The study challenges the instrumental view of meetings by taking a closer look at their structuring potential in the organization. Understanding the roles of meetings provides another perspective on the functioning of management control and opens new avenues for studying the practices of control and decision-making.

show abstract

Section: Case Studies 41 Drugcorpmentioning

confidence: 99%

Meeting up for management control: bracketing interaction in innovation development

Bürkland

Zachariassen

Oliveira

2019

QRAM

View full text Add to dashboard Cite

show abstract

“…However, due to inadequate funding to carry out clinical trials, four of the OMPOs plan to out-license their products after pre-clinical or phase 1 studies. This is unfortunate, since globally, when such products are acquired by multinational companies, their subsequent pricing makes them inaccessible to most Indian patients [42]. The lack of suitable incentives for the development of OMPs in the country has also led six of the OMPOs to eye international markets, and they are planning to apply to foreign regulatory agencies such as the EMA and the USFDA.…”

Section: Discussionmentioning

confidence: 99%

The work, goals, challenges, achievements, and recommendations of orphan medicinal product organizations in India: an interview-based study

Choudhury

Saberwal

2019

Orphanet J Rare Dis

View full text Add to dashboard Cite

BackgroundOrphan medicinal products (OMPs) are intended for the diagnosis, prevention, management or treatment of rare diseases (RDs). Each RD affects only a small fraction of the population, and therefore, historically, industry hesitated to undertake relevant research and development (R&D). In response, the governments of many countries came up with orphan drug policies and RD policies which were hugely successful in incentivizing companies to do so. In India, in the absence of any such policy until recently, there are very few organizations involved in RD R&D.ObjectivesWe wished to understand (i) the OMP Organizations’ (OMPOs’) areas of work and the nature of their work, (ii) their goals, (iii) the challenges they faced and how they were overcoming them, (iv) their achievements, and (v) their recommendations to the government to help their R&D, their success as commercial entities (where applicable), and patients’ access to their products or services.ResultsTen of the 14 OMPOs are companies, whereas four are not-for-profit organizations. Almost all of the OMPOs are heavily into R&D. Six have already made their products or services available to patients. Four plan to out-license their products after the pre-clinical phase or phase 1 trials, eight plan to cater to patients directly and two of the OMPOs have been established only recently and thus do not yet have any product or service to offer patients. Nine OMPOs import about 90% of the components in the production process, which comprises either capital or recurrent expenditure. For most, locally manufactured alternatives are not available or are of inadequate quality. Most of the OMPOs have had productive collaborations with local or foreign academics or hospitals for R&D, animal efficacy studies, clinical trials or providing services to patients. The main challenges for the OMPOs are the lack of adequate funding, supportive government policies, and a conducive ecosystem.ConclusionsThese OMPOs are pioneers in their respective fields in India, and despite the challenges, have achieved new levels of innovation. With suitable government policies, they could scale up and provide relevant products and services to the large number of RD patients in the country whose medical needs are largely unmet.

show abstract

“…The need for follow-on RCTs can only be determined on the case-by-case basis. While, in some situations, follow-on drugs might feature higher efficacy, reduced side effects, or a more convenient regimen ([ 85 ], p. 34–35), in other cases they represent insignificant modifications of the existing medicines that can be so minor and the clinical need for such modifications can be so small that the clinical benefit would not outweigh the costs of conducting trials.…”

Section: Main Textmentioning

confidence: 99%

Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

Kim

Hasford

2020

BMC Med Ethics

View full text Add to dashboard Cite

The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

show abstract

Innovation in the Pharmaceutical Industry: The Process of Drug Discovery and Development

Cited by 55 publications

References 59 publications

Meeting up for management control: bracketing interaction in innovation development

Meeting up for management control: bracketing interaction in innovation development

The work, goals, challenges, achievements, and recommendations of orphan medicinal product organizations in India: an interview-based study

Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

Contact Info

Product

Resources

About