Concepts in pharmaceutical entrepreneurship

Abstract

Pharmaceutical entrepreneurship (PhE) is closely linked to innovation and collaboration. PhE improves healthcare and contributes to the evolvement of the pharmacy profession through the proactive identification, creation and pursual of novel pharmaceutical products and processes. The study aims to 1. Investigate the contribution that PhE has to innovation 2. Evaluate the role of education and training in the evolvement of PhE 3. Analyse PhE initiatives which are implemented at a medicines regulatory authority and 4. Identify tools used to measure accountability in PhE. The methodology was divided into four phases: 1. Critical analysis of results obtained from a systematic literature review and structured interviews with pharmaceutical entrepreneurs to identify innovative practices and PhE characteristics, traits and skills 2. Development and validation of a training programme for the advancement of PhE through the identification of established education and training in PhE and responses to structured interviews to identify training aspects to be incorporated in the training programme 3. Retrospective analysis of entrepreneurial activities at the Malta Medicines Authority through a focus group and observational study within the Pharmaceutical Products Entrepreneurship Unit 4. Identification of tools used to measure the accountability of entrepreneurial initiatives through an assessment of the impact and effectiveness of the PhE activities. Results identified five innovative practices related to PhE and thirteen PhE characteristics, traits and skills from twenty-three studies. Innovative practices identified were: Open innovation and collaboration, digital health technologies, precision medicine and genomics, artificial intelligence and patient-centred approaches. PhE characteristics, traits and skills identified were: Autonomy, competitiveness, goal- orientation, innovativeness, an internal locus of control, leadership skills, motivation, people skills, proactiveness, problem-solving skills, risk-taking, social responsibility and strategic planning. A training programme consisting of thirteen modules was developed and validated. The modules were related to: Communication skills, conflict resolution, financial management, human resources, leadership, innovation, market research, marketing, negotiation techniques, project management, public relations, quality improvement and risk management. An innovative framework for PhE in regulatory sciences consisting of eight components was developed. The components in the framework are: Accountability, collaboration, ethics, financial management, innovation, leadership, the regulatory pillars and risk management. The interviews with pharmaceutical entrepreneurs and focus group with representatives from the Malta Medicines Authority confirmed the relevance of a patient-centred approach to PhE. Eight tools used to measure the accountability of pharmaceutical entrepreneurial initiatives were identified: Key performance indicators, financial projections, impact assessments, cost-benefit analysis, SWOT analysis, internal audits, balanced scorecard and business model canvas. The study related to concepts in entrepreneurship in pharmaceutical processes enabled the identification of knowledge and competences needed to develop and advance new pharmaceutical endeavours. In the context of this research, PhE is considered beyond the traditional sense of business and financial planning, but rather as a product of creative thinking, the taking of calculated risk when conducting pharmaceutical entrepreneurial ventures and evidence-based decision making as related to a progressive innovative pharmaceutical scenario.