How implementation science can inform commercialization strategies in life sciences 

October 2025 | Written by Winnie Chi, PhD

When a life sciences clinical development program shows promising results and a launch plan is underway, regulatory approval and economic value assessment are only part of the commercialization journey. To support market uptake and achieve real-world success, it is helpful to look beyond clinical trial data and consider real-world evidence (RWE) around current treatment options, patient care-seeking behaviors, physician prescribing practices, and how payers and policymakers enable access. Understanding these dynamics allows companies to identify and address evolving barriers to accelerate adoption of evidence-based interventions into routine practice. 

Accelerate evidence-based intervention adoption through implementation science

It can take 10 years or more for a new therapy to go from national coverage determination (i.e., national-level coverage by the Medicare program) to integration into routine clinical practice [1,2]. Health services research and implementation science help facilitate adoption of evidence-based interventions faster by forging partnerships between life sciences companies and patients and their care providers. 

Implementation science, a focus of health services research, is a method to increase uptake of evidence-based interventions in real-world settings to improve individual and population health. On a broader level, health services research examines how healthcare is organized, delivered, and financed, identifying comprehensive solutions that reflect the perspectives of relevant stakeholders. Implementation science in health services research focuses on identifying strategies to promptly move evidence-based interventions into everyday care by taking into account patient experiences and provider delivery challenges that may differ from clinical trial populations. It provides insights to help ensure that:

  • Patients and caregivers receive the resources needed to access and adhere to evidence-based interventions.

  • Physicians understand the impact of treatment on patient outcomes and their implications for success in value-based contracts.

  • Payers recognize both the effectiveness and health and economic value of the treatment.

With an implementation science approach, commercialization teams can design proactive strategies such as physician outreach, patient education, patient support programs, and access initiatives well before launch. By anticipating barriers and tailoring solutions, including localized nuances in patient behaviors and provider practices, life sciences companies can bridge gaps between regulatory approval and real-world adoption using sustainable, equitable, patient-centered strategies.

Systematically evaluate health-related access and utilization to inform successful strategies for adoption

Health services research draws upon widely recognized frameworks, such as the Andersen behavioral model, to guide the translation of evidence-based interventions into real-world practice. Three primary factors summarized in the Anderson model describe the real-world influences on adoption of evidence-based interventions:

  • Predisposing factors: characteristics such as demographics, beliefs, or social structures that influence a person’s likelihood of seeking care

  • Enabling resources: logistical or structural supports that facilitate access, including healthcare coverage, provider availability and accessibility, and transportation

  • Perceived need: an individual’s understanding of their own health status and the perceived benefits or urgency of treatment

By systematically examining these factors at the patient, provider, and system levels, programs can identify barriers and facilitators to promote adoption into everyday practice. The result is a comprehensive list of factors and their interactions that can influence patient access and market uptake. Using this information, life sciences companies can proactively devise strategies to address hurdles, reinforce facilitators, and effectively partner with other healthcare stakeholders.

Illustrative example: Evaluate potential market hurdles for the adoption of evidence-based oral formulations of injectable drugs

Injectable drugs historically have been the only or preferred mode of administration for conditions such as rheumatoid arthritis, insulin-dependent diabetes, osteoporosis, certain infectious diseases, psychiatric disorders, and some cancers. Many life sciences companies are developing oral alternatives to improve patient convenience and simplify care delivery requirements while maintaining clinical effectiveness. Many challenges with oral formulations, such as poor absorption, variable metabolism, precise dosing, and maintaining safety and efficacy have been overcome in recently approved therapies, offering promise for the introduction of oral versions across numerous indications.

However, it may be naive to assume that convenience, proven clinical effectiveness, or favorable formulary placement alone will drive adoption of oral forms of injectable medications. Health services research addresses this challenge by identifying barriers to uptake and can help facilitate the design of targeted strategies to streamline commercialization, encourage care providers and patients to switch to oral formulations when appropriate, and support real-world success.

Applying Andersen’s model to understand key patient and provider considerations affecting adoption of oral formulations

 

Predisposing factors

Considerations

Example strategies life sciences can pursue

Patients with low health literacy, physical limitations, or low vision who may struggle taking oral drugs independently
  • Make instructions for oral formulation labels easy to follow by using infographics 
  • Create caregiver education programs 
  • Partner with health plans’ case managers  
  • Collaborate with health plans to improve medication adherence

Patient culture and beliefs (e.g., in some cultures, taking pills is perceived as a sign of weakness, impacting the patient’s mental health and roles in social circles)
  • Design communication addressing misconceptions 
  • Partner with health plan community health workers, local community leaders, care liaisons

Other interfering comorbidities or conditions (e.g., substance abuse)
  • Request pharmacists to review medications  
  • Implement health plan-initiated referrals to integrated services that address substance use problems

Enabling resources

Considerations

Example strategies life sciences can pursue

Different provider incentives among local care providers that may discourage oral use, as care providers may be participating in multiple value-based contracts with different payers
  • Quantify the cost of care savings associated with transition to oral formulations under value-based contracts (e.g., improved adherence, increased effectiveness, reduced spoilage, total cost of care)

Physician recommendation of oral vs injection (familiarity and trust)
  • Use academic detailing to provide independent and data-driven education materials and provider outreach  
  • Provide education for care providers on health plan clinical guideline and medical policy updates

Reliable mail delivery and convenient access to retail pharmacies
  • Provide coverage for mail order or subsidized transportation assistance to pick up oral drugs at pharmacies

Patient awareness of the availability of oral formulations
  • Conduct health plan member outreach during touch points

Availability of adherence tools and support programs

  • Design patient support programs including reminders, co-pay assistance, and adherence tools

Patient-perceived need

Considerations

Example strategies life sciences can pursue

Direct experience of benefits or equivalence of oral formulations

  • Seek and share patient or advocacy group feedback regarding perceived benefits

  • Create shared decision-making tools to clarify treatment necessity and outcomes

Translate evidence into practice

Successfully bringing a new drug or formulation to market requires more than regulatory approvals and favorable formulary placement. It requires identifying and addressing the needs and priorities of patients, caregivers, care providers, and payers and establishing a partnership with these stakeholders to effectively accelerate adoption of evidence-based interventions. Even after some market uptake, the ongoing evaluation of solutions can help life sciences companies understand the reasons for initial success and inform future adoption strategies.

By proactively gaining a clear understanding of (1) who the stakeholders are, (2) their priorities and needs, and (3) the strategies that should be implemented and how, life sciences companies can rely upon health services research to ensure that new medical interventions not only reach the market faster but are also used effectively, equitably, and consistently in real-world practice.
 

References

  1. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st Century. Washington (DC): National Academies Press (US); 2001. 

  2. Sexton ZA, Perl JR, Saul HR, Trotsyuk AA, Pietzsch JB, Ruggles SW, et al. Time from authorization by the US Food and Drug Administration to Medicare coverage for novel technologies. JAMA Health Forum. 2023 Aug 4;4(8):e232260. doi: 10.1001/jamahealthforum.2023.2260. PMID: 37540524; PMCID: PMC10403784.