| Literature DB >> 36082329 |
N Nurlaela Arief1, Aurik Gustomo1, M Rahman Roestan1, Aghnia Nadhira Aliya Putri2, Muthya Islamiaty1.
Abstract
Purpose: This paper aims to explore core competencies and analyze the digital leveling implementation of Pharma 4.0 in Indonesian Pharmaceutical companies. Method: This study uses a mixed-method Delphi study conducted in the first two rounds. The first and second rounds aimed to determine the core competencies of the Pharmaceutical Industry to face the Pharma 4.0 era. In the first round, FGD was conducted involving 12 participants, and semi-structured interviews were carried out with 10 participants in the second round. Alongside Delphi, this research also employs NVIVO as a tool for content analysis. Furthermore, in the third round, a survey was conducted to determine the leveling of the digital implementation of Pharma 4.0, involving 215 senior management participants representing 34 national pharmaceutical industries. Result: The study revealed eight core competencies needed by human capital in the pharmaceutical industry to face the Pharma 4.0 era: critical thinking, bioinformatics, entrepreneurial thinking, digital skills, intrapreneurial skills, research skills, regulatory compliance, and data ethics. Regarding digital leveling implementation, this study found five main levels: level 1 (simplification), level 2 (automatization), level 3 (integrated system), level 4 (digital transformation), and level 5 (disease prediction). This study also affirms that most of the pharmaceutical industries in Indonesia are at level 2 (mean = 4.2) and level 1 (mean = 4.0). Several pharmaceutical industries are at level 3 (mean = 3.5), and a few others are at level 4 (mean 3.2) and level 5 (mean = 1.4). Research implication: This study is the first to analyze the leveling of digital implementation in Pharma 4.0. The results showed that core competencies could be used as a benchmark to develop employee skills. This current study provides the essential data for core competency development and digital leveling implementation for the pharmaceutical industry and government in preparing Pharma 4.0.Entities:
Keywords: Core competency; Delphi study; Digital levelling implementation; Indonesia; NVIVO; Pharma 4.0
Year: 2022 PMID: 36082329 PMCID: PMC9445282 DOI: 10.1016/j.heliyon.2022.e10347
Source DB: PubMed Journal: Heliyon ISSN: 2405-8440
Figure 1Research methodology.
Delphi rounds and participants.
| Organization | Pharma Sector | Established | 1st round FGD | 2nd round Interviews | 3rd round Survey |
|---|---|---|---|---|---|
| Pharma A | Bio-Pharma | 1971 | 3 | 2 | 95 |
| Pharma B | Vaccine | 1980 | 3 | 2 | 35 |
| Pharma C | Natural –Herbal | 1918 | 3 | 2 | 53 |
| Pharma D | Chemical – Active Pharmaceutical Ingredients (API) | 1985 | 3 | 4 | 32 |
| Total Number of Participants | 12 | 10 | 215 | ||
Experts FGD participants.
| Participants (P) | Job Title | Sector | Conduction |
|---|---|---|---|
| P1 | Human Resource Business Partner | Bio-Pharma | Day 1 (21 December 2020) |
| P2 | CEO | Bio-Pharma | |
| P3 | Business Development Manager | Bio-Pharma | |
| P4 | Head of Strategic Planning | Vaccine | |
| P5 | EVP & CAO | Vaccine | |
| P6 | Telehealth Co-Founder | Vaccine | |
| P7 | Digital Health Expert | Natural –Herbal | Day 2 (22 December 2020) |
| P8 | Country Manager | Natural –Herbal | |
| P9 | Tribe Leader of eHealth | Natural –Herbal | |
| P10 | Product Manager | Chemical – Active Pharmaceutical Ingredients (API) | |
| P11 | Head of Talent Acquisition and Senior HRBP | Chemical – Active Pharmaceutical Ingredients (API) | |
| P12 | HR and General Affairs Executives | Chemical – Active Pharmaceutical Ingredients (API) |
Semi-structured interview participants.
| Participant (P) | Job Title | Sector | Date |
|---|---|---|---|
| P1 | Human Capital Director | Natural – Herbal | 1 March 2021 |
| P2 | Former CEO | Chemical – Active Pharmaceutical Ingredients (API) | 5 March 2021 |
| P3 | Country Director | Chemical- Active Pharmaceutical Ingredients (API) | 13 March 2021 |
| P4 | Digital Transformation Director | Bio-Pharma | 15 April 2021 |
| P5 | Operation Director | Vaccines | 20 April 2021 |
| P6 | Digital Health Expert | Natural –Herbal | 7 May 2021 |
| P7 | Business Development Director | Chemical- Active Pharmaceutical Ingredients (API) | 7 May 2021 |
| P8 | Product Manager | Chemical- Active Pharmaceutical Ingredients (API) | 21 May 2021 |
| P9 | Strategic Planning Director | Bio-Pharma | 21 May 2021 |
| P10 | HR Executives | Vaccines | 9 June 2021 |
Competency description and definition from FGD and semi-structured interview.
| Theme | Code | Definition |
|---|---|---|
| Intrapreneurial skills | Collaboration, stakeholder management, partnership | Ability to work together to optimize potential and achieve common goals |
| Entrepreneurial thinking | Entrepreneurship, innovation, dynamics, adaptive, responsive, learning ability | Ability to have creative thinking, create innovation, and implement it |
| Critical Thinking | Cognitive, critical skills, data analytics, problem-solving | Ability to respond fast to recent changes or challenges |
| Digital skills | Digital mindset, digital literacy, technology savvy | Ability to continuously update with the contemporary digital technology, understand it, and use it effectively |
| Bioinformatics | Biotech, tele-pharmacy, precision medicine | Ability to process the information for pharmaceutical industry development |
| Regulatory compliance | Regulatory intelligence | Ability to constantly update, understand, and comply with national and international regulations |
| Data ethics | Data ethics, data security | Ability to protect data and follow the data ethic of the public health information |
Keywords frequency NVivo.
| Definition | Theme | Code | The excerpt | Words Count | |
|---|---|---|---|---|---|
| FGD #1 | Interview #2 | ||||
| Ability to work together to optimize potential and achieve common goals | Intrapreneurial skills | Collaboration | Collaboration in functions not only internal but external, e.g., vaccine distribution involves various ministries, institutions, companies, and related agencies. The narrative starts with an ecosystem-based business. | 2 | 3 |
| Stakeholder Management | Since the type of industry is predicted as oligopoly and most use market focus and customer focus as a growth strategy, we need a combination with talent because knowledge accumulation is necessary to produce new products. Competency characteristics will be related to business strategy. | 2 | 2 | ||
| Partnership | A partnership strategy is very important because the industry cannot develop itself. People in the Pharmaceutical Industry not only have technical skills (mastery of operations, etc.), but soft skills such as negotiation, etc., are also required. | 2 | 2 | ||
| Ability to have creative thinking, create innovation, and implement it | Entrepreneurial thinking | Entrepreneurship | We need to have core competencies in accordance with the company purpose: character, cognitive ability, critical skills, behavior, innovation, and soft skills. | 4 | 5 |
| Innovation | We are already part follows the innovative factory program and the R&D. However, because we need to follow the complicated regulations, development becomes hampered because everything must work following SOPs. | 5 | 6 | ||
| Dynamics | Millennials play a role urgent in facing change because millennials can study fast and adapt; they also have more soft skills to self-development | 2 | 2 | ||
| Adaptive | HR 4.0 is very disruptive. The HR team must prepare team members as well as possible if there is opportunity and potential. Industry 4.0 is related to big data: velocity, volume, & variety. At this time, recruitment can be conducted online. Very data-driven and used primarily in the recruitment process. Match behavior and profile personnel very much depend on big data. | 3 | 4 | ||
| Responsive | For pharmacy, the most dominant variable is time to market and lower cost. Especially when we are prepared for vaccines and diagnostic tools, we cannot depend on continuing imports (because flight delays, lockdown, etc. are very troublesome). If referring to the 4.0 industry, we need to speed up the time of the product to the market. Existing processes need to have a shortcut to speed up the system. | 3 | 4 | ||
| Learning Ability | The development could be conducted by the employee by themselves, such as through LinkedIn and or with one-on-one coaching, in which we actually have a culture of learning. We expect some programs can align with the performance, so the learning process can be performed effectively. | 3 | 4 | ||
| Ability to analyze the problems, share insight for decision-making, and respond fast to recent changes or challenges | Critical Thinking | Cognitive | We need to find the extent to which robotics, IoT, and other technology roles in the operation process, which of course, require different competencies. | 6 | 4 |
| Critical Skills | We need competence from Core Industry Pharmacy: Production, QC, QA, and R&D, ensuring that the product is made appropriately on schedule (efficient) and effective. Thus, in the implementation in industry, all systems must be integrated to facilitate monitoring anytime and anywhere; one of them is vaccine covid; smartphone distribution can already monitor distribution. | 6 | 6 | ||
| Data Analytics | The use of big data is very urgent for looking at those who only have registered in the recruitment process. For example, our company already uses a talent pool integrated with the government personnel department to set specifications in the recruitment process. Until the moment, HR people should not originate from a pharmacy background. However, one must understand pharmacy. HR is rotated to understand the whole process in pharmacy. | 8 | 8 | ||
| Problem Solving | When a pandemic occurs, we no longer just collaborate with other industries. We collaborate with Research Institutions and Agencies and global partners to produce vaccines. Research ability is still low compared to the ability of production, though we need it the most. | 6 | 7 | ||
| Ability to continuously update with the contemporary digital technology, understand it, and use it effectively | Digital skills | Digital Mindset | Digital mindset and analytical thinking are also a must-emphasis in every HR. Not only coding and programming that matters. | 7 | 7 |
| Digital Literacy | Digital knowledge such as approach blockchain and big data would immensely assist the therapeutic process. Required knowledge across dimensions like precision medicine knowledge, genomics, and biotechnology. | 8 | 7 | ||
| Technology Savvy | Industry 4.0 has a big influence on pharmacy: 1) In retail pharmacy, it is necessary to look for customer behavior and demand. The pandemic, which keeps going, is a challenge. Using apps online makes it easier for the customer. (2) Supply chain: integrated distribution process is important. This is because the supply chain at the pharmacy level is not yet effective until now, especially in the process of managing cold chain products. Warehousing and transportation management have also become an issue (3) Laboratory: With a pandemic, labs could be conducted from home. So, making a small kit lab is important (4). Manufacturing: start running IoT implementation. | 7 | 7 | ||
| Ability to process the information for pharmaceutical industry development | Bioinformatics | Biotech | The Pharma industry must also understand bioinformatics such as molecular docking for manufacturing processes in medicine. We also need the existence of novel integrated intelligent biotechnology. | 5 | 6 |
| Tele-pharmacy | Seeing the current trend, pharmacy has moved towards tele pharmaceutical. With the transformation that moves so fast, it requires high adaptability in technology. | 4 | 5 | ||
| Precision Medicine | From the pandemic, we learn to create vaccines in a short time, but it also needs to be accurate. Precision prediction is a challenge ahead. Currently, there are very few multinational companies that can do that. For example, to predict what kind of viral genetic mutation. Therefore, the development process and related research should continue to be carried out. The prediction in question would be better if it could predict a new disease that is not an existing disease (COVID-19, bird flu, etc.) | 5 | 5 | ||
| Ability to constantly update, understand, and comply with national and international regulations | Regulatory Compliance | Regulatory intelligence | Pharmaceutical companies must be able to optimize technology in order to increase access and tracking. However, human resources must possess regulatory compliance expertise. Human resources must be adaptable and innovative. | 6 | 6 |
| Ability to protect data and follow the data ethic of the public health information | Data ethics | Data Ethics | In the clinical trial process because it is a separate process that is not carried out by quality control. The related competencies are clinical trial data ethics, pharmacovigilance, GTCP, regulatory compliance. | 6 | 6 |
| Data Security | We need to expand on the supporting, technical, and connected parts with the integrated system where corporations already implement the system. | 4 | 4 | ||
Figure 2Word cloud of NVivo.
Figure 3Hierarchy chart by nodes from NVivo.
Qualitative data coding.
| Respondent | Quotation | Code |
|---|---|---|
| Q1 | Agility, change management, digital mindset | |
| Q2 | Innovative, leadership, business acumen, learning capability, entrepreneurship, respect, persistence, critical skills, purposeful, | |
| Q3 | Digital mindset, technology savvy, data analytics, purposeful | |
| Q4 | Tele-pharmacy, cognitive ability, soft skills, entrepreneurial skills, learning, and self-development | |
| Q5 | Intrapreneurship skills, entrepreneurship skills, data analytics, cognitive ability, soft skills, purpose, digital mindset, analytical thinking, persistence | |
| Q6 | Innovative, agile, intrapreneurship, bioinformatics. | |
| Q7 | Technological savvy, bioinformatics, precision medicine | |
| Q8 | Biotechnology, research skills, technology adoption | |
| Q9 | Tele-pharmacy, data science, data analytics, agility. | |
| Q10 | Digital mindset, responsive, innovative, adaptive, dynamics | |
| Q11 | Learning agility, innovation, regulatory compliance | |
| Q12 | Technological savvy, digital mindset |
Measurement tools for digital levelling in pharmaceutical industry.
| Digital Levelling | Description | Var | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|---|---|
| Level 1 – Simplification | SOP Simplification | L1.1 | O | O | O | O | O |
| Testing and Production Process Simplification | L1.2 | O | O | O | O | O | |
| Bureaucracy Simplification | L1.3 | O | O | O | O | O | |
| Bio Process (R&D, Production, QA, QC, and Packaging) simplification | L1.4 | O | O | O | O | O | |
| Supply Chain Simplification | L1.5 | O | O | O | O | O | |
| Level 2 – Automatization | Self-Operated Production Process | L2.1 | O | O | O | O | O |
| Process, Environment, and Utility Control Automation | L2.2 | O | O | O | O | O | |
| Automation Testing and Production | L2.3 | O | O | O | O | O | |
| Automation in Regulatory Control | L2.4 | O | O | O | O | O | |
| Automation in Detecting Process Failures (CMA, CPP, and CQA) | L2.5 | O | O | O | O | O | |
| Automation in the Reporting Process | L2.6 | O | O | O | O | O | |
| Automation in Product Research and Development | L2.7 | O | O | O | O | O | |
| Level 3 – Integrated System | Integrated Quality Management System | L3.1 | O | O | O | O | O |
| Supply Chain Track and Trace System | L3.2 | O | O | O | O | O | |
| Integrated Continuous Manufacturing | L3.3 | O | O | O | O | O | |
| Integrated Performance Measurement | L3.4 | O | O | O | O | O | |
| Process and Regulatory Integration | L3.5 | O | O | O | O | O | |
| Level 4 – Digital Transformation | Big Data and Genomics in Drug Discovery | L4.1 | O | O | O | O | O |
| Digitization of Clinical Trial Process such as Virtual Trials | L4.2 | O | O | O | O | O | |
| Use of Connected Devices and Robots in Manufacturing | L4.3 | O | O | O | O | O | |
| Real-Time Regulatory Updates | L4.4 | O | O | O | O | O | |
| Digital Marketing | L4.5 | O | O | O | O | O | |
| AI and Big Data in the Decision-Making Process | L4.6 | O | O | O | O | O | |
| Digital Supply Chain and E-Procurement | L4.7 | O | O | O | O | O | |
| Level 5 – Disease Prediction | Prediction of New Disease Discovery that has the potential to become an epidemic or pandemic | L5.1 | O | O | O | O | O |
| New Drug Discovery Predictions | L5.2 | O | O | O | O | O | |
| Predicted Upcoming Regulatory Developments | L5.3 | O | O | O | O | O | |
| Expected Level | Expected Level for Indonesia Pharmaceutical Industry in Next five years | EL | O | O | O | O | O |
Digital levelling- level 1 result.
| Variable | L1.1 | L1.2 | L1.3 | L1.4 | L1.5 | Overall Mean |
|---|---|---|---|---|---|---|
| 4 | 5 | 3 | 5 | 5 | ||
| 2 | 1 | 1 | 3 | 3 | ||
| 4.3 | 3.4 | 3.1 | 4.6 | 4.5 | 4 | |
| Pearson Correlation | 0.79∗∗ | 0.76∗∗ | 0.82∗∗ | 0.83∗∗ | 0.69∗∗ | |
| Sig | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Digital leveling- level 2 result.
| Variable | L2.1 | L2.2 | L2.3 | L2.4 | L2.5 | L2.6 | L.27 | Overall Mean |
|---|---|---|---|---|---|---|---|---|
| 5 | 5 | 5 | 5 | 5 | 5 | 5 | ||
| 2 | 3 | 4 | 3 | 4 | 3 | 4 | ||
| 4.2 | 4.4 | 4.5 | 4.1 | 4.6 | 4.3 | 3.9 | 4.2 | |
| Pearson Correlation | 0.73∗∗ | 0.71∗∗ | 0.83∗∗ | 0.84∗∗ | 0.79∗∗ | 0.79∗∗ | 0.79∗∗ | |
| Sig | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Digital levelling- level 3 result.
| Variable | L3.1 | L3.2 | L3.3 | L3.4 | L3.5 | Overall Mean |
|---|---|---|---|---|---|---|
| 4 | 5 | 4 | 4 | 4 | ||
| 2 | 3 | 2 | 2 | 1 | ||
| 3.2 | 4.2 | 3.3 | 3.6 | 3.1 | 3.5 | |
| Pearson Correlation | 0.69∗∗ | 0.72∗∗ | 0.81∗∗ | 0.83∗∗ | 0.76∗∗ | |
| Sig | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Digital levelling- level 4 result.
| Variable | L4.1 | L4.2 | L4.3 | L4.4 | L4.5 | L4.6 | L4.7 | Overall Mean |
|---|---|---|---|---|---|---|---|---|
| 4 | 3 | 3 | 4 | 5 | 4 | 5 | ||
| 2 | 1 | 1 | 3 | 3 | 1 | 2 | ||
| 3.1 | 2.4 | 2.3 | 3.5 | 4.2 | 2.7 | 3.9 | 3.2 | |
| Pearson Correlation | 0.73∗∗ | 0.86∗∗ | 0.82∗∗ | 0.73∗∗ | 0.64∗∗ | 0.75∗∗ | 0.84∗∗ | |
| Sig | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Digital levelling- level 5 result.
| Variable | L5.1 | L5.2 | L5.3 | Overall Mean |
|---|---|---|---|---|
| 2 | 1 | 1 | ||
| 1 | 1 | 1 | ||
| 2.1 | 1 | 1 | 1.4 | |
| Pearson Correlation | 0.74∗∗ | 0.78∗∗ | 0.83∗∗ | |
| Sig | 0.00 | 0.00 | 0.00 |
Figure 4Digital pharma levelling in Indonesia.
Figure 5Leveling of digital pharma implementation in Indonesia.