Innovations in Pharmaceutical Manufacturing on the Horizon Technical Challenges, Regulatory Issues, and Recommendations (2021) / Chapter Skim
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6 Advancing Innovation: Observations, Challenges, Opportunities, and Recommendations
6 Advancing Innovation: Observations, Challenges, Opportunities, and Recommendations
Pages 60-71
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From page 60... ...
In particular, the pre- innovation and underscores the associated challenges in dominant drivers of value for the industry and the pub- achieving the desired future state. The committee then lic are the pharmaceutical products themselves -- not the discusses the implications of technology review that is technologies deployed to manufacture them.
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From page 61... ...
part of both industry and regulators: uncertainties will abound, unexpected control issues will arise, and chal KEY MANUFACURING INNOVATIONS lenges in setting manufacturing ranges and specifications will need to be addressed and overcome. In this report, the committee has described many innovations for manufacturing drug substances and drug Co-Processed Active Pharmaceutical Ingredients products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing As discussed in Chapter 2, innovations in API manunetworks.
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From page 62... ...
As innovative product mo dalities and technologies to manufacture drug substances As discussed in Chapter 3, additive manufacturing or (Chapter 2) and drug products (Chapter 3)
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From page 63... ...
A AND APPROVAL AS THE BASIS OF summary of incentive-related challenges and illustrative ACCEPTANCE AND IMPLEMENTATION OF examples is provided below. MANUFACTURING TECHNOLOGY The most obvious strong incentive for manufacturing innovation occurs when a pharmaceutical product funda An important factor in the pace of manufacturing in- mentally depends on the technology in such a way that
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From page 64... ...
nancial returns were sufficient motivation for manufactur- Manufacturers of pharmaceutical products have exers to develop the necessary technology. The incentives of tensive experience with the constraints and burdens of industry and regulators aligned well, and they agreed that existing manufacturing technologies.
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From page 65... ...
As the examples above illustrate, the realities of geographic areas inevitably is an immense accomplishevaluation and approval of pharmaceutical products and ment subject to many twists and turns. The industry expeassociated manufacturing technologies seriously limit the rience is that queries, interests, and concerns of individual value proposition -- and therefore capability -- for indus- reviewers and institutional health authorities are still varitry to advance and implement the broad spectrum of po- able and seemingly often arbitrary and inflexible.
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From page 66... ...
in public ceutical Product Lifecycle Management.2 The guidance presentations and various reports.3 CDER has also taken is explicitly directed toward the commercial phase of the an important step in supporting innovation through the product life cycle and represents a major effort to address establishment of the Emerging Technology Program in issues that have hindered the full realization of the vision 2014.4 Yet the totality of stakeholder experience that has of a more flexible and agile pharmaceutical manufactur- informed this committee indicates that the role of CDER ing sector that has been advocated for the last 2 decades. in enabling innovation is underdeveloped, and this underThe harmonized regulatory tools, enablers, and guiding development jeopardizes the center's ability to meet its principles described in ICH Q12 include categorization full public-health mission.
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From page 67... ...
all interactions with formality and caution and thus con strain the shared learning opportunities. The perspective Expertise, Capacity, and Culture in the Center for of the stakeholders that informed this committee is that Drug Evaluation and Research although FDA leadership has encouraged the use of novel technologies to strengthen the robustness of the manu The capability of CDER to evaluate risk to patient facturing processes for pharmaceuticals, a disconnect safety associated with novel manufacturing technology is between the podium and the practice of front-line regulalinked to technical expertise, capacity, and a culture that tors erodes the industry's confidence that an investment in actively incentivizes the center's role in alleviating the innovative technology will not derail planned regulatory risk associated with the implementation of innovation.
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From page 68... ...
those facing the original product developer because the • Clarity and consistency in the evaluation of re- cost–benefit analysis rarely justifies changing established sidual risk to product quality. Innovation in process or manufacturing processes for generic drugs except if the analytic technology might introduce new uncertainties original product was manufactured by using an innovafor product quality that cannot be fully eliminated, espe- tive process that must be adopted to produce the equivacially in the case of complex drug products.
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From page 69... ...
To manage demand, CDER development of expertise, expanded capacity, and oppor- could set priorities for suggestions to consider innovative tunities to strengthen FDA's role in incentivizing the use technologies from industry consortia over those from inof the innovative technologies to improve the quality and dividual organizations. Consideration of evaluation also consistency of pharmaceutical manufacturing.
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From page 70... ...
Greater leverage of academic partnerships Technology Program to include innovation that is neutral through the FDA-sponsored Centers of Excellence in to product quality but enables agility, flexibility, and effi- Regulatory Science or encouragement of the formation ciency in the manufacturing process, the supply chain, or of consortia modeled on the Advanced Simulation and control strategy to encourage deployment of innovations Computing Predictive Science Academic Alliance Proin both new products and post-approval modifications. gram, which is sponsored by the Department of Energy, • Increase transparency of the capacity of the could offer additional opportunities to engage directly in ETT and program outcomes to inform expectations of precompetitive research to advance CDER's research and program utility, highlight common themes, and inform personnel-development priorities.
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From page 71... ...
2020b. Barriers to Innovations in Pharmaceutisible, FDA should emphasize advancement of innovative cal Manufacturing: Proceedings of a Workshop -- in manufacturing technology as an explicit purpose and ben- Brief.
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