Enablers and Barriers of a Drug Development Industry

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Results

Participant Response Rate

It was anticipated that 60 people would be identified for this research and that approximately 50% would consent to participate. However, more people were identified than expected and the response rate was higher than anticipated. For the evaluation of industry expertise, 60 of the 63 identified people approached consented to participate, giving a response rate of 95.2%. The assessment of industry enablers and barriers included a stakeholder category and 106 of the 116 identified eligible people contacted agreed to participate, giving a response rate of 91.4% (Table 18). A single participant from each identified drug development company, drug discovery group and support services organisation meeting the inclusion criteria was approached, therefore the sample size could not simply be increased if the response rate was lower than expected (257). If the person approached was not available, another senior person form their organisation could be nominated to participate. The stakeholder category included those representing NZ government ministries and their agencies, universities (including their commercial entities), NZ affiliates of multinational pharmaceutical companies, those with extensive industry experience who did not fit into the other categories, investors, intellectual property and legal advisors and others. Further details of these participants are supplied in Section 4.3.4.

Participant Characteristics

This research involved representatives from 12 drug discovery groups, 12 drug development companies, 36 support services organisations and 46 industry stakeholders, giving a total of 106 participants. The gender and role of all participants are given in Table 19. The data confirm that participants were senior personnel from the organisation they represented. There was a predominance of male participants, especially representing drug discovery groups.Table 20 provides the characteristics of the participants who contributed to the assessment of NZ’s expertise (i.e., participants from the drug discovery groups, drug development companies and the support services organisations). It shows that the majority of all participants (77.7%) were aged 45 years or older, and all participants from the drug discovery groups were over 45 years. The participants were highly qualified and all had a tertiary qualification. The majority of participants (53.3%) had only degrees from NZ, 28.3% of participants had only overseas degrees, and 15% of participants had both NZ and overseas qualifications. The majority of all participants were born in NZ (56.7%), but many were born and educated overseas, especially those representing drug development companies. Twenty-five percent of all participants were born in the UK and the remaining participants were mainly from Australia, Asia and North America.

Organisation Characteristics

Drug Discovery Groups

The majority of the drug discovery groups are located in the universities, with funding from a variety of sources, but predominantly government and grant funding. My research found 12 drug discovery groups meeting the research election criteria. These 12 groups had a total of 20 drug discovery programmes underway, all of which originated from the group’s own research (Table 21). Of the 20 programmes, seven had identified a lead compound and the remaining 13 were in the lead selection stage. Phase I clinical trials of all 20 programmes were predicted to start in the next 5 years from the date of the interview: two compounds in 2010, two in 2011, four in 2012, five in 2013, six in 2014 and the remaining one in 2015. 4.3.2 Drug Development Companies Most of the compounds under development originated from university or private research in NZ and the drug development companies were funded by a range of sources including overseas investors and private funding from NZ (Table 22). The expected year of product launch was 2011 (one compound); 2012 (two compounds); 2013 (one compound); 2014 (four compounds); 2015 (one compound) and 2016 (one compound). This information was not available for two compounds—one had been discontinued due to lack of efficacy and the timing of the product launch for the second compound was unknown.

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Support Services Organisations

The characteristics of the support services organisations are provided in Table 23. The majority of organisations surveyed were private companies or consultants and so were self-funding. They had been in operation for an average of 11.6 years.

Stakeholders

The stakeholder category included those representing NZ government ministries and their agencies, universities (including their commercial entities), NZ affiliates of multinational pharmaceutical companies, those with extensive industry experience who did not fit into the other categories, investors, intellectual property and legal advisors and others (Table 24).

Expertise

Participants’ Expertise

The participants had a mean of 19.1 years experience in drug development. The main source of participants’ expertise in their drug development role was from job experience rather than their qualifications, although participants in drug discovery utilised their qualifications more than the other participants (Table 25). More than 80% of participants did not intend a career in drug development when they were undertaking their qualifications. Approximately half of the participants had acquired a specific drug development skill; the most common was training for clinical research (i.e., Good Clinical Practice, Clinical Research Associate or other pharmaceutical industry training). The most common relevant organisations that participants belonged to were NZBio and the NZ Association of Clinical Research (NZACReS) ARCS, followed by the American Association for Cancer Research (AACR) and the NZ Institute of Chemistry (NZIC). Other relevant organisations were the NZ Society of Oncology, the Biometrics Society and the Royal Society of NZ. Nine participants (15%) had received national or professional society awards recognising the quality and contributions of their drug development activities. These awards included NZBio Biotechnologist of the Year, New Zealand Order of Merit, and other awards from organisations such as the Royal Society of New Zealand. Table 26 summarises the drug development outputs that participants had contributed to in the previous 3 years. The most common drug development outputs produced were internal reviewed documents by 80.0% of participants (e.g., reports, study protocols) and conference presentations by 73.3% of participants. Other outputs included reports and presentations outside the organisations (e.g., to regulatory authorities, feasibility reports, company reports) and conducting training courses. 4.4.2 Participants’ Capabilities Participants were provided with a list of capabilities associated with drug development and asked to indicate which ones they could personally undertake. Merely understanding the process involved was not sufficient for a participant to be able to indicate capability in that field. Once a capability was indicated, participants were asked to specify whether the source of their competency in that area was from their qualifications, job experience or both. The number (N) of participants responding to each of these options for the source of their competency is given for each capability. The results of these questions are summarised in Table 27. As could be expected, the drug discovery groups’ expertise is focused on discovery and chemistry/scale-up manufacturing. The drug development companies have extensive expertise in clinical protocol development, regulatory affairs and intellectual property management. The support services organisations have strengths in clinical trial monitoring and management, case report form preparation, database/data management, safety data management, regulatory affairs, clinical protocol development and acting as a study site. All three categories of participants have expertise in the more generic capabilities of project management and report preparation. Fifteen participants indicated that they had capability in an additional area of drug development. Two drug discovery group participants had extra capabilities; one as an expert witness for intellectual property litigation cases, and the other had responsibility for the whole preclinical development process. Two drug development company representatives had expertise in fundraising; one also had general management experience. Eleven of the support services organisation participants nominated capabilities in fundraising and strategic/regulatory management (N = 4), licensing and business development (N = 2), pre-clinical research and documentation (N = 2), developing applications for a new chemical entity (N = 1), distribution of study drugs (N = 1) and patient recruitment for clinical trials (N = 1).

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1 Introduction
1.1 Background
1.2 Rationale
1.3 Objectives
1.4 Organisation of the Thesis Literature Review
2 Literature Review
2.1 Drug Development
2.2 Evaluation of Expertise
2.3 Enablers and Barriers of a Drug Development Industry
2.4 Benefits from a Drug Development Industry
2.5 Linking Expertise, Enablers and Barriers, and Economic Benefits
3 Methods
3.1 Development of Theoretical Frameworks
3.2 Data Collection
3.3 Data Analysis and Statistics
Results
4 Results
4.1 Participant Response Rate
4.2 Participant Characteristics
4.3 Organisation Characteristics
4.4 Expertise
4.5 Enablers and Barriers
4.6 Economic Benefits for New Zealand
Discussion
5 Discussion
5.1 Reliability and Generalisability
5.2 New Zealand’s Expertise for Drug Development
5.3 Enablers and Barriers
5.4 Economic Benefits
5.5 Linking Expertise, Enablers and Barriers, and Economic Benefits
5.6 Limitations of the Research
Conclusions
6 Conclusions
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