WHY NOW? THE URGENCY TO CHANGE THE CLINICAL OPERATING MODEL…
While today is an exciting time for the biopharma industry in terms of scientific innovation (e.g. immuno-oncology, targeted therapies, RNAi, stem cells), growing R&D pipelines1, and the increasing number of FDA approvals2, a consistent challenge remains – the rigorous and costly clinical development effort required to bring a new product to market.
Clinical development is the lengthiest, most operationally complex, and most expensive part of the R&D lifecycle. During this phase, key activities and critical decisions take place that largely determine total program investment, probability of success, and time to market for a particular drug therapy. Failure to efficiently execute a clinical development program can mean a significant loss of market share, cost overruns, FDA labeling restrictions, increased patient burden, shortened patent life, or product rejection.
"The clinical trail business model has not kept pace with potential for efficiency gains through technological advances or centralized coordination."3
Consequently, the ability to efficiently execute clinical programs on a consistent basis is a true source of competitive advantage and is necessary to realize the full potential of today’s promising R&D pipelines.
Despite this, many companies today are experiencing sub-optimal performance in clinical trial execution. We believe there are several reasons for this:
- Excessive use of “decision by committee” resulting in a lack of clear accountability, compounded by multiple layers of review and approval and ultimately longer cycle times
- R&D functional silos (extending across scientific and operational communities and externally with vendors and key partners) that impede operational efficiency
- Bloated organizational structures and duplicative functions due to repeated mergers and acquisitions
- Excessive risk aversion (i.e. a “cover every base” approach not fully recognizing the negative impact on cycle time and cost)
- Evolving industry regulations
- More risk averse FDA less likely to approve a drug with any safety issues unless there are clear medical benefits that significantly outweigh the risks
- Increased requirement for large Phase III outcomes trials, greatly increasing development cost and time
- Greater compliance burden associated with changing technology and data standards
"Typically 90% of a drug's development costs are in Phase III trials. These costs skyrocketed in recent years, exacerbating an already serious problem."4
WHAT DOES TRANSFORMING CLINICAL OPERATIONS LOOK LIKE?
In response to the above challenges, leading companies are moving away from legacy operating models that do not incorporate the flexibility, agility, and innovation needed to be successful in today’s dynamic drug development environment. These companies have restructured their clinical R&D operations organizations, developed innovative new approaches to trial design and execution, increased the level of external partnering and collaboration, and applied standardization across processes, data and technologies.
Each organization needs to assess their unique situation to determine how best to move forward (e.g. how much change to implement, where, when, how fast, etc.). A comprehensive capabilities and situation assessment should include questions such as:
- How confident are we that our current capabilities are sufficient to meet all of our pipeline objectives for clinical development over the next 5- or 10-year period?
- How do we compare to our industry peers on key metrics such as protocol complexity, site performance, cost per patient, regulatory approval time, etc.?
- Are there innovative processes and technologies we could take advantage of to accelerate clinical data collection and analysis while ensuring top quality and compliance?
- How effectively do we interface with key partners from academic research centers, other biopharma or medical device companies, industry consortiums, contract research organizations (CROs), government, nonprofit research networks, and patient advocacy groups?
Extensive planning and coordination is required to transform from a legacy structure with fragmented processes and technologies into a cohesive end-to-end operating model. A successful transformation is best implemented as an integrated program rather than a series of unrelated or loosely related initiatives. The planning phase should include a detailed assessment of interdependencies, risk, and change management across the entire anticipated program. In addition, clear governance structures should be put in place at the appropriate time, both for program implementation and for ongoing “future state” operations.
Furthermore, a transformation effort needs to involve all key stakeholders in addition to operations – therapeutic areas, data management, biostatistics, early development, regulatory, IT, etc., and include regional representation for companies with global operations.
A CLOSER LOOK AT THE COMPONENTS OF THE “NEW” CLINICAL OPERATING MODEL
Transformation of the Clinical Operating Model centers around three core elements:
- Organizational Structure
- Business Processes & Methodologies
- Clinical Operations Data & Technology
R&D organizations that transform clinical trial operations can achieve dramatic results in terms of cost-efficiency and cycle-time reduction.
Core Element 1: Organizational Structure
Transformation Focus: Break down functional and political barriers to enhance interactions and improve coordination internally between scientific and operational communities, and engage more effectively with external partners.
Core Element 2: Business Processes & Methodologies
Transformation Focus: Innovate, streamline, and simplify operations to improve quality, productivity, and cycle-time performance.
Core Element 3: Clinical Operations Data & Technology
Transformation Focus: Define an end-to-end data management strategy to improve data quality and compliance in response to current business processes and regulatory trends. Select technology platform(s) to support this strategy, replacing disparate legacy systems where appropriate.
HOW DO YOU GET FROM HERE TO THERE?
Transforming your organization’s clinical operating model, while also “keeping the pipeline flowing “can be a daunting task. Given the size and complexity of the business functions, processes, tools, and data flows involved, it is important to understand how each of these components tie-into and impact one another. Furthermore, each organization must understand, address, and eventually overcome potential barriers to transformation, such as:
- Unclear or outdated perspective on how the organization’s clinical development performance compares to peers in industry
- Complexity of learning and adopting new eClinical tools and development processes
- Incomplete view of technical and organizational interdependencies and how they impact one another
- Lack of understanding of how to migrate from legacy platforms to new technologies (e.g., data mapping, cutover timing, validation, decommissioning, etc.)
- Insufficient employee capacity to push through a transformation while concurrently performing ongoing operations tasks
- Limited resources with key skill sets needed to drive transformation (e.g., business analysis/planning, business process design, IT design, program management, organizational change management, etc.)
These barriers are best overcome by taking a comprehensive approach that includes all three core elements of transformation, as further described below.
The organizational structure needs to evolve so that it can best support the transformation goals of operational efficiency, agility and innovation. These efforts should focus on driving improved decision making by removing unnecessary handoffs and review cycles, providing clear accountability, and establishing strong governance. The organization should be designed to establish an optimal level of engagement between operations teams and internal therapeutic area partners, Medical Affairs, and other functional scientific groups.
The development of the organizational design must also consider how to best engage with key external partners, such as CROs, staffing agencies, and technology vendors. Traditionally, outsourcing decisions have been made in an isolated manner, optimized only for the needs of a given trial or perhaps therapy program, or at best for a given therapeutic area. Today’s complex environment requires a strategic approach that can leverage and balance opportunities for improvements in cycle time, cost performance, and quality across the entire R&D organization. This typically involves applying both functional and programmatic outsourcing, considering both scientific and operational needs.
A strategic outsourcing model typically includes moving to a smaller, more manageable number of preferred partners. In conjunction with this, the workload can be more actively managed so that the “peaks” can be externalized and a more stable in-house staff level can be matched to the baseline demand.
Introducing a new organizational design typically involves changes to individual roles and responsibilities, as well as to the underlying structure of the organization. Supporting employees through this aspect of transformation demands particular attention to organizational change management.
Business Processes & Methodologies
The clinical operations organization at many pharmaceutical companies today has been impacted significantly via one or more mergers, acquisitions, and/or consolidations. As a result, many business processes are not harmonized or executed consistently across the various functions and/or geographic regions. Also, business processes may have evolved to be overly complex, with major gaps or areas of duplication, and with unclear accountability, governance, and compliance oversight. Process training and support is often limited and not updated in concert with ongoing changes.
In addition to streamlining business processes, clinical operations groups should invest in developing new tools and methods that can drive additional development value. For example, adaptive trial design and structured protocol authoring are innovative approaches that can be supported by eClinical tools to increase patient enrollment and retention, reduce regulatory risk, speed data collection and analysis, and decrease cost-per-patient.
In the study execution area, transitioning to risk-based monitoring can significantly reduce the overall monitoring effort (e.g. fewer site visits with targeted source document verification). Implementing mobile device based monitoring can drive additional cost reduction and also can reduce the travel burden on patients.
Clinical Operations Data & Technology
Replacing disconnected legacy systems and data/document repositories with integrated platforms based on robust data standards will improve data flow, cycle time and quality. The first step is a comprehensive assessment, with all impacted functions having a seat at the table. Rushing the selection of a new technology solution (e.g. a new CTMS or eTMF system) based on a past relationship or incomplete requirements can result in design and functionality gaps, compliance risks, and challenges to user adoption. A clear understanding of business needs must drive decisions such as “keep vs. replace” for legacy systems and selection for new technology solutions. When the technology strategy and roadmap is based on a thorough understanding of business needs, subsequent phases (e.g. defining functional requirements and system architecture) can proceed more smoothly.
Successfully implementing the technology side of a transformation requires more than just new platforms and systems. Teams must also focus on various complementary activities that are critical to ensure clinical data quality, and accessibility, at a reasonable cost. Examples of such activities include defining end-to-end clinical data standards, mapping and consolidating data repositories, and establishing a data governance model. To minimize the potential for delays, re-work and compliance issues, these activities should be planned and implemented as part of a coordinated program. The program scope should encompass all relevant data domains, elements, consumers, and sources. Particular attention should be focused on how to best align with current Health Authority regulations, industry standards, and reference models.
Today, there is great excitement about recent scientific breakthroughs that will lead to dramatic improvements in human health. Nonetheless, the overall environment remains one in which bringing a new drug to market is a risky and challenging endeavor. Despite recent improvements in the number of FDA approvals, the Phase III-to-FDA approval success rate remains only about 65%, with less than half of the approved drugs (~40% in 2014) being first-in-class.6 At the same time, the cost and complexity of clinical development continues to rise.
In response to this situation, leading biopharma companies are transforming their legacy clinical operating models to become leaner, more agile, and more innovative organizations. These companies understand the imperative to better align scientific and operational communities, streamline and standardize their business processes, integrate innovative technology solutions, and strengthen governance and decision-making processes.
Having successfully led several clinical transformation efforts, North Highland understands how to overcome organizational barriers to change. Equipped with the necessary leadership skills, strategic R&D perspectives, and hands-on execution experience, we are ready to partner with you to catalyze your clinical transformation program. We are fully focused on helping our clients identify and realize tangible business benefits; since we guarantee our work, our success depends on your success.
To learn more or have a discussion, please contact:
Principal, R&D Client Lead
1. 2015 pipeline estimated at $493B per EvaluatePharma® World Preview 2015
2. 50 FDA NME and biologic approvals in 2014, per EvaluatePharma® World Preview 2015
3. “Examination of Clinical Trial Barriers for Drug Development” published by the U.S. Department of Health and Human Services, 2014.
4. "Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials” by Avik S.A. Roy, a senior fellow at the Manhattan Institute for Policy Research, 2012.
5. "Drug Developers Actively Improving Efficiency of Clinical Trials" by Sandra Peters, Tufts Center for the Study of Drug Development, April 26, 2011
6. FDA/CMS Summit, CDER New Drug Review 2014 Update