Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board.
The potential savings a strong integrated product development (IPD) strategy can provide biopharma companies cannot be underestimated, but the most significant challenge to its success requires a dramatic shift in culture.
One industry analysis found that IPD, when coupled with innovative research and development, had the ability to cut 500 days from a drug development cycle and 25% off the bottom line.
It’s a message being heard by a growing number of U.S. pharmaceutical and biotechnology companies, according to a recent survey of 107 senior leaders.
Commissioned by Pharmalex and conducted by Censuswide, the survey found that almost half the respondents had already implemented an IPD program or were conducting a pilot. Another third planned to do so within the next 12 months.
The respondents work in a range of fields, including biostatistics, clinical, regulatory affairs, patient safety, market access, medical affairs and CMC (chemistry, manufacturing and controls).
Of those organizations that have already rolled out IPD strategies or are conducting pilots, almost all (98%) believe this multidisciplinary approach, which breaks down silos and brings key stakeholders together from a drug’s conception, fosters innovation in research and development and enables better alignment on internal strategy.
Similarly, the vast majority (96%) believe IPD is important for meeting key milestones and identifying where therapies can be marketed earlier (94%).
Culture holding back strategy
However, while there is undoubtedly clear recognition of the benefits of establishing an IPD strategy, industry leaders also report significant barriers to its successful integration. The most substantial – no matter the type, stage or size of the organization – is culture. Almost 40% say that such transformational change would be difficult to achieve within the company’s existing culture.
IPD requires that the traditional compartmentalization that has pervaded the industry be broken down and that teams work collaboratively so that a company has the flexibility to respond quickly and appropriately to challenges at all stages of a drug’s development.
Without a shift in culture, companies remain mired in silos that limit the ability to pivot, and hamper opportunities to save potentially huge amounts of time and money.
With the cost of bringing a drug to market doubling in a decade** – to almost $2.6billion – and the process taking more than 10 years to bring to fruition, industry leaders need to push for critical change in systems and processes.
A lack of integration and coordination affects a development program adversely in several areas, including regulatory submissions, outsourcing and marketing.
The tendency to treat drug development as sequential, moving from one milestone to the next without considering how it affects other functional areas at various stages, does not reflect reality.
Drug development is not linear and requires integrated collaboration across functions and stakeholders to ensure success.
Involving all stakeholders early on
A successful IPD strategy has the power not only to increase innovation, but to help leaders identify risks early and find new opportunities.
It requires a clearly defined target product profile (TPP), or clearly defined destination, which demands input not just from different drug development teams but also from experts in regulatory and market intelligence.
The key elements of a TPP — including defining the treatment’s unmet needs; clarifying beneficial safety and efficacy claims for patients and physicians; and differentiating the drug from existing treatments — form the basis of an integrated product development program.
As the TPP will naturally evolve as the drug develops, it is crucial that the IPD strategy is nimble, collaborative and involves key stakeholders, internally and externally, from the start. This includes, but is not limited to, team members from departments such as non-clinical; regulatory; chemistry, manufacturing and controls (CMCs); toxicology; and statistics.
Of those respondents who have implemented an IPD strategy or pilot program, 54% have involved clinical teams, 44% involved biostatistics and 36% patient safety.
A lack of integration puts companies at significant risk at different stages of the drug’s development, from regulatory submissions to marketing, and has the potential to derail the development.
The IPD strategy requires strong leadership to galvanize a multidisciplinary team capable of challenging assumptions to optimize planning, pivot as required and, ultimately, deliver a successful outcome.
A cross-functional model that engages CMC, for example, in the early stages of an IPD strategy can reduce the bottleneck that frequently occurs on the path to drug launch.
Unlocking the key to innovation
While cultural change is undoubtedly difficult, particularly for larger organizations, the rewards are plentiful — and not just in terms of time and money. By engaging cross-functional teams that can be assembled and disbanded based on a specific deliverable, a company empowers its workforce.
With an efficient and collaborative IPD program, each team is positioned as the primary decision maker at key points of a drug’s development and all team members are made to feel an important part of bringing a drug to market, no matter where they sit in the process. This encourages innovation, which respondents identified as a key part of a successful IPD program, which has a positive impact on research and development.
Respondents cited several other barriers to the implementation of an IPD strategy, although budgetary and resource limitations were not ranked as highly as infrastructure changes needed to effect better decision making. Complex processes and the inability to keep plans current as the situation changes were seen as key obstacles (32%), as was the lack of technology enabling successful collaboration (30%).
An increasing number (58%) of respondents are partnering with external IPD experts to help circumvent these operational challenges and ensure innovation across the board. It is clear, however, that without significant shifts in culture, biopharma companies face considerable hurdles to embed a transformative IPD strategy.
Industry leaders are integral to driving this cultural change by encouraging input and collaboration from internal and external stakeholders, demonstrating the considerable benefits of a strong multidisciplinary team, and designing processes that support its implementation and continued operation.
This holistic approach to drug development will quickly bring about short-term gains through better collaboration, but also has the capacity to deliver long-term benefits — reducing the time and cost it takes to bring new products to market, as well as increasing safety for consumers.
With a successful IPD strategy clearly a win for all involved, it is worth the investment required to ensure a shift to a more collaborative, cohesive and innovative culture.
Mark Lane, Ph.D., is vice president, development consulting and scientific affairs, at PharmaLex. He has extensive experience in leading product development teams and functions accountable for product development across all phases of development.