TABLE I

Main Survey Questions

SECTION A – Definitions
GxP—good laboratory, clinical, manufacturing, research practices
ICH—International Conference on Harmonization
Innovation—the introduction of new technologies or methodologies
Open Innovation—the practice of leveraging the discovery of others and not rely exclusively on own R&D for innovation
Pervasive Technologies—smart, implantable devices used for product tracking, remote patient monitoring or drug delivery
Pharma Transformation—is concerned with ongoing disruptive changes currently shaping the operational concepts, organization, and technologies impacting pharmaceutical innovation and the ability to meet the demands of a changing healthcare environment
Post-market Surveillance—regulatory agency risk assessment activities that take place after approval of the drug product
Pre-market Assessment—regulatory agency risk assessment activities that take place prior to approval of the drug product
Product Lifecycle—all phases in the life of the product from the initial development through marketing until the product's discontinuation
Quality—the degree to which a set of inherent properties of a product, system or process fulfils requirements
Quality Risk—a GxP activity that if not performed properly may have the potential to result in adverse events impacting product quality, data integrity or patient safety
SECTION B – Participant DetailsLikert scale used?
1. Expert identification code:No
2. Organization name:No
3. Regulatory domain of expertise:No
4. Organization type:No
5a. Experience in:No
5b. Years of Experience:No
6. Quality domain of expertise:No
SECTION C – Pharmaceutical Transformation Triggers and Risks
7. Which of the following is a key driver for the current Pharmaceutical Transformation?No

  • Business Environment

  • Regulatory Environment

  • Open Innovation

  • Other (please specify):

8. Which of the following Open Innovation trends do you think is currently practiced in the pharmaceutical industry? * e.g. Clinical Studies, Safety Reporting, IT Data Centers, etc.No

  • Commercial Partnerships

  • Increased In Licensing

  • Research Partnerships

  • Research Information Sharing

  • Focus on Combination Products

  • Focus on Biological Products

  • Focus on Pervasive Technologies

  • Outsourcing of Data Management

  • Other (please Specify):

9. Lack of which of the following will pose a GxP Risk in an Open Innovation environment?No

  • Effective Due Diligence

  • Effective Product Transfer

  • Multidisciplinary Regulatory Knowledge (e.g. for combination products)

  • Effective Product Characterization

  • Data Security and Integrity

  • Technology Validation (means obtaining proof of fitness for intended use)

  • Other (please Specify):

SECTION D – Open Innovation and Regulatory Compliance
10. Open Innovation will have significant impact on external partner/alliance selection and oversight?Yes
11. Open Innovation will have significant impact on legal framework for exchange of research information?Yes
12. Open Innovation will have significant impact on data management in the context of data security, integrity and privacy?Yes
13. Biological/Biotech products will become major part of the project and product portfolio?Yes
14. Prevalence of pervasive technologies will require multidisciplinary knowledge and skills to deal with convergent scientific disciplines (e.g. smart implantable drug delivery devices)?Yes
15. Existing regulatory approaches are adversely impacting the innovation drive in the industry?Yes
16. Regulatory approach that is responsive to new discoveries while maintaining safety and efficacy standards will improve innovation drive?Yes
17. Regulatory initiatives such as FDA's Critical Path and EMA's Innovation Task force (ITF) will have a significant impact in industry's innovation drive?Yes
SECTION E – Assessment of Transformation-Induced Quality Risks
a) GxP Due Diligence of External Partners and Alliances
    18. What is the likelihood that problems with due diligence process will result in adverse GxP compliance outcomes when selecting external alliances/partners?Yes
    19. What part(s) of the product lifecycle is most at risk of adverse compliance outcomes?No
b) Product Transfer
    20. What is the likelihood that problems with product transfer* process will result in adverse GxP compliance outcomes? *Internally within a company or between the company and external partners.Yes
    21. What part(s) of the product lifecycle is most at risk of adverse compliance outcomes?No
c) Multidisciplinary Regulatory Approach
    22. What is the likelihood that insufficient multidisciplinary quality knowledge/expertise across a range regulatory situations* will result in adverse GxP compliance outcomes? *e.g. combination products that may require regulatory knowledge of diagnostics, drugs and devicesYes
    23. What part(s) of the product lifecycle is most at risk of adverse compliance outcomes?No
d) Biological/Biotech Products
    24. Are Biological/Biotech products more complex and difficult to characterize than chemically synthesized products?
        • Yes/NoNo
    25. What is the likelihood that poor process understanding and product integrity* controls will result in adverse GxP compliance outcomes? * contamination controls, stability controls, sterility assuranceYes
    26. What part(s) of the product lifecycle is most at risk of adverse compliance outcomes?No
e) Data Security and Integrity
    27. What is the likelihood that externalization of GxP data creation, storage and maintenance will result in adverse GxP compliance outcomes?Yes
    28. What part(s) of the product lifecycle is most at risk of adverse compliance outcomes?No
f) Technology Validation
    29. What is the likelihood that technology* validation supporting product lifecycle will result in adverse GxP compliance outcomes? * relating to manufacturing and laboratory automation and information management systemsYes
    30. What part(s) of the product lifecycle is most at risk of adverse compliance outcomes?No

  • Likert measurement scale was used for questions in Table 1 that are tagged as “Yes”. For questions 19, 21, 23, 26, 28, 30 the following response options were used:

  • • Pre-market Evaluation

  • • Marketing Approval

  • • Post-market Surveillance

  • • Don't Know