Clinician working in the biopharmaceutical field examines something under a microscope as part of an Implementation Science project

Implementation science and its benefits for the biopharmaceutical and biotechnology industries

Helping the biopharmaceutical/biotechnology industries maximise innovations for success.  

Author: Dr Rachel Davis 

The development of medicinal products and associated innovations (e.g. new diagnostic tools or clinical practice procedures) for biopharmaceutical and biotechnology companies is a protracted process. Years of research and money are invested, yet only a fraction of investigational drugs ultimately obtain marketing authorisation. Even then, for drugs that are licensed, multilevel barriers (e.g. uncertainties regarding the long-term safety profile, time constraints or reimbursement issues) can present challenges with uptake, adoption and integration into clinical care. Additionally, patients may struggle with adhering to the new regimen.  Collectively, these factors can lead to sub-optimal patient outcomes and increased burden on the healthcare system.

Implementation science can help the biopharmaceutical/biotechnology industries understand how innovations work in the real world and what can be done to improve their uptake, appropriate use and sustainability, thereby maximising the innovation’s potential for success.  

Key hallmarks of implementation science research include understanding the context in which the medicinal product will be introduced (social, economic and policy circumstances); engagement of key stakeholders (including patients, informal caregivers and healthcare professionals); representativeness of the sample to the population of interest; a focus on real-world settings; and relevant and rigorous evaluation, comprising formative as well as a summative evaluation of process and outcomes.

Dr Rachel Davis, Health Psychologist and Research Scientist - Implemenation Science, Evidera Inc, PPD, a part of Thermo Fisher Scientific, North Carolina, USA

Implementation science research is guided by scientifically informed approaches and methods:

1. Implementation science frameworks: to conceptualise the core components of the implementation process and contextual determinants.

2. Implementation strategies: approaches to facilitate implementation success.

3. Implementation outcomes: measures to evaluate the impact of implementation strategies on the implementation process.

4. Study designs: to simultaneously assess how well the product is working in practice (i.e. clinical effectiveness) and has been implemented into care delivery (i.e. implementation effectiveness). Prominent among these are implementation-effectiveness hybrid designs.

 

Figure 1. Did you know IS studies can help product development and lifecycle management in all these areas?

  • Phase I-IV clinical trial operational efficiencies

  • Licensing and authorisation

  • Launch and marketing

  • Market access

  • Manufacturing and distribution

  • Product adoption, uptake, appropriate and sustained use

  • Patient involvement

  • Patient experience

  • Disease self-management (patient and healthcare professional)

  • Adherence

  • Medication reconciliation

  • Pharmacovigilance

  • Patient and provider satisfaction

  • Scale-up and roll-out

  • Resource savings (time and money)

 

 

Implementation science research studies can be conducted throughout the medicinal product lifecycle (see Figure 1). During early development (i.e. phases 1-3 clinical trials) studies can examine the reasons (and potential solutions) for poor patient recruitment or retention in a clinical trial or causes of medication non-adherence. At the peri-approval stage, implementation science research can provide insights into how to scale up the innovation from the efficacy trial context into real-world clinical care. In the post-marketing period, implementation science research can identify and disseminate promising adaptations that facilitate scale-up of the innovation more effectively or to understand the barriers to longer-term use and to develop interventions to address them. 

Equally, given competitive pressures, biopharmaceutical/biotechnology companies are increasingly investing in adjunctive tools relating to medicinal products (e.g. diagnostic tools; dosing calculators; wearables) that ‘go beyond the molecule’ to improve ease of use, efficiency or quality.  This expanding array of innovations could similarly benefit from implementation science research to support appropriate and sustained use in the real world.

Implementation science research offers vital information that complements and/or extends data traditionally collected in pre-approval clinical trials, and peri- and post-marketing pragmatic studies on a medicinal product’s safety, quality, efficacy and effectiveness.  Sponsors should incorporate implementation science research into their evidence generation plans for new products and be prepared to advocate to internal decision-makers the importance of funding such research.  Successful execution of implementation science studies in the context of the existing research and development paradigm requires inter-disciplinary collaboration, the establishment of internal expertise and the training of clinical trial teams on the meaning, value and conduct of implementation science research.  Building implementation science research capabilities internally, while requiring some upfront investment, will yield significant dividends in the long run in terms of improved uptake, adoption and integration as well as enhanced public health impact through improvements in patient access and adherence to medicines and health outcomes. 

Dr Meredith Y. Smith, PhD
Senior Director, Evidera, Inc., PPD, a part of Thermo Fisher Scientific
Adjunct Assistant Professor, School of Pharmacy
University of Southern California, Los Angeles, CA USA
 
Dr Rachel Davis, PhD  
Research Scientist
Evidera, Inc., PPD, a part of Thermo Fisher Scientific
  
Ms. Nicola Barnes, MA
Senior Research Scientist
Evidera, Inc., PPD, a part of Thermo Fisher Scientific