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Volume 39, Issue 1
Pharma companies are increasingly expanding their portfolios into digital health solutions. To find the right partners, there are several key considerations that inform their evaluation and selection.
Pharma manufacturers are expanding their portfolios into digital health solutions. To find the right partners, there are a number of key considerations that inform their evaluation and selection.
Depending on the key business drivers for a given digital health project (e.g., digital therapeutics, digital endpoints/biomarkers, remote monitoring, etc.), there is a typical structure and approach to take from project initiation to final selection of a partner. First, define the business need. This may be driven by a franchise team, a therapeutic area, or even an individual molecule or brand team and should include a preliminary view on the target geographies for launch. From there, establish an evaluation lead and form a cross-functional team. Typically, the leads are from the corporate business development function, but may also involve a procurement organization. To select the members of the cross-functional team, consider the nature of the business need to determine the mix of representation from: commercial, clinical, technical, legal, regulatory, and IT. This team is then accountable for any due diligence and evaluation activities.
Once the team is formed, define the solution’s target product profile. This is especially critical for digital therapeutics where there is a clinical endpoint. For non-therapeutic digital solutions, this may simply be a requirements document. Once there is some product definition, perform a landscape assessment to look for any possible existing solutions, companies, or products that may be worth considering. Finally, establish the evaluation criteria and weighting, meet with the companies as a team, evaluate them against the criteria, and make a final recommendation.
As part of the commercial strategy, define the business need and provide commercial input to the target product profile. Further, the commercial strategy should include a preliminary launch strategy that includes target markets and launch sequencing, and business models (e.g., standalone reimbursable solutions vs. brand-supportive solutions), to help guide other team members in their evaluation. Alignment with regional affiliates and their preliminary reimbursement strategies is critical at this point.
For the clinical development aspects, evaluate potential solutions against the molecule/brand portfolio requirements and define the target indication for use and patient population. Establish the efficacy success criteria against a standard of care in the selected therapeutic area. Then, focus on assessing the clinical viability of potential solutions. This is critical when evaluating licensing or acquisition of existing solutions. Define a preliminary clinical strategy that describes the likely efficacy-directed and registration-directed clinical studies, and health authority registrations.
The technical development team should evaluate the potential partner’s development organization, structure and development approach, as well as seeking evidence of their capability to comply with health authority and other standards and regulations (e.g., IEC 62304, ISO 13485, IEC 62366, ISO 14971, GDPR, HIPAA, HITRUST, etc.). Further, this team should evaluate the partner’s quality systems, design controls, risk management, and other lifecycle management processes and procedures. Key to digital projects is assessing the partner’s support of mobile OSs, handsets, browsers, etc. for clinical and launch platform support.
The legal team typically focused on contracts and intellectual property at this stage. They define the licensing/purchasing strategy and evaluate the partner’s existing agreements and encumbrances. Define the preliminary IP strategy (e.g., patenting approach, trade secret expectations, etc.), perform a preliminary IP landscape evaluation based on the target product profile, and assess the relevant patents held by potential partners.
The IT cybersecurity/data privacy team develops a preliminary solution architecture in order to understand the roles and responsibilities of each party and any data interfaces between the partner and the pharma company . This team should also evaluate the partner’s existing IT infrastructure to understand their organization, technical design, outcome of recent evaluations or audits, and generate a preliminary gap analysis against the pharma company’s corporate/global standards.
Due to the novelty of the some of these digital health solutions, there is often a lack of regulatory clarity in many markets. The regulatory team should develop a preliminary strategy based on the target product profile to establish: is the solution regulated as a medical device; the registration strategy (e.g., 510(k), CE Marks, de novo, etc.) A thorough evaluation of the partner’s regulatory capabilities and capacity is critical to determine how much of the regulatory work the pharma team must own.
As digital health solutions proliferate, pharma is taking an increased interest in partnering or acquiring technologies that are synergistic with their portfolios. As such, it is critical for pharma to define the business need and strategic approach in order to guide a cross-functional team in the evaluation and selection of technology providers and solutions. While the regulatory framework is unclear in some cases, we have an opportunity to shape the environment to enable these technologies to transform our industry.
Paul Upham is Director, Smart Device Technology Center, Roche/Genentech