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In recent years, the Pharma and Biotech industries, and the broader healthcare market, have seen some key players successfully bringing new therapies to market significantly faster than previously. A key enabler of this has been successful harnessing of expedited approval pathways, which can reduce asset development and approval timelines by half or up to two-thirds of historical levels. The clear benefits of expedited timelines, along with cost-driven pressure to deliver returns quickly, is eliciting widespread attempts in pursuing alternative and more innovative asset development approaches – from the way clinical trials are designed over the clinical operations itself to regulatory strategies for leveraging expedited approval pathways in respective indications.
Lately, novel therapies have broken new ground in terms of accelerated asset development and have sparked broad, and oftentimes heated, public discourse – Covid-19 vaccines and novel cancer therapeutics as a case in point. On the side of regulatory authorities, this development is facilitated by an increasing willingness to foster accelerated trials and their readouts, primarily in areas of high unmet need. Concurrently, at the company level, PharmaCos and Biotech are increasingly confident using such opportunities including adaptive trials and expedited pathways, given strong precedence and success of first movers. As the competition across therapeutic areas and modalities becomes more fierce, PharmaCos and Biotechs implement concerted and targeted measures to capitalize on clinical acceleration opportunities to remain competitive.
A three-layered deployment framework for success
The factors determining the successful delivery of accelerated clinical development processes and outcomes will vary from company to company, based on a range of factors: their current practices and performance, strategic priorities and evolving drug portfolio and timelines, current asset governance, and the appetite and readiness for transformation at each level.
That said, each PharmaCo or Biotech should look to drive acceleration across three distinct but synergistic deployment layers: Company-wide acceleration across assets in a largely asset-agnostic manner, additional acceleration for assets in the highest priority tier, and individual asset acceleration via tailored solutions, independent of tier priority.
Focusing on the company-wide and individual asset layer, the main three types of acceleration levers are clinical trial design, clinical operations, and regulatory approaches, with higher relevance on trial design at the asset level. This contrasts to acceleration approaches within the highest priority tier, which benefits primarily from additional resource allocation, faster decisions, and greater attention within the company.
For holistic acceleration of asset development, it’s important not to neglect any of the three layers. Otherwise, acceleration attempts will have less impact.
Determining the suitable acceleration approach
The business case for accelerated clinical development is obvious, especially as the pharma industry moves toward more complex and costly novel therapies targeted at smaller populations where there is great need.
To maximize the opportunities, maintain competitive advantage, and contain risk, companies need a tailored approach to this transformation. By following a formal framework distilled from emerging best practice, PharmaCos and Biotechs can give themselves the best chance at focusing their investments, optimizing outcomes, and showing the wider organization what is possible.
How companies should best address acceleration will require deep analysis and strategic planning, however, as leading companies are already making demonstrable headway, it’s important not to put this off any longer. Culturally, the four key success factors needed for successful acceleration are:
- aStrong commitment and support by top management (including sign-off on the risk approach)
- bClear acceleration aspirations and an environment that encourages innovative thinking
- cDare-to-fail culture supporting teams to take ambitious actions
- dEmpowerment of asset teams to challenge legacy approaches
Dr. Marcel Stangier also contributed to this report.
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