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By Michael “Mickey” Koplove
A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is altering the overall risk profile for our industry, but may be imperceptible without the benefit of historical perspective.
In the industry’s early years, entrepreneurial biopharmaceutical companies either relied on manufacturing partnerships with established companies or invested in developing their own capabilities. To adequately address concerns about large-scale recombinant manufacturing and the unknown safety risks of using recombinant technology to make therapeutic products for use in humans, the FDA required license holders to remain fully responsible for the technical and quality aspects of their licensed product.
The predominant way for prospective license holders to demonstrate responsibility and control was to build and operate the commercial drug substance manufacturing facility, which in itself was novel technology. They would also hire legions of talented scientific and engineering SMEs along with operating personnel. Since downstream operations, like drug product manufacturing, filling and finishing, and product distribution, were like more traditional pharmaceutical operations, it was generally acceptable to contract out those operations to commercially licensed contract manufacturers who would operate under the license holder’s continuous supervision.
This required access to large amounts of capital for a product that was typically in early clinical trials at best. The industry was facing incredible risks in scientific, clinical, regulatory, and business outcomes that would inherently impact the costs and decisions facing corporate boards and investors.
Flash forward to today – recombinant DNA and MAb products are now relatively conventional therapeutics. The FDA and manufacturers are much clearer on their requirements for approval. And innovation continues to accelerate massive growth in the biotech sector.
Additionally, a secondary multidimensional biopharmaceutical support ecosystem has evolved that offers a less risky approach to building and resourcing biopharmaceutical companies. This ecosystem provides emerging biopharma companies with ideas, expertise, and personnel to lead and support the manufacture and delivery of products, while mitigating risks by applying skills efficiently where and when they are needed.
This ecosystem enables growing biopharma companies to focus resources and investment on core areas of scientific and technical expertise. It covers many of the supporting disciplines that are essential, but not typically within proprietary research and applied sciences. These include, but are not limited to:
On-demand experts are a great source of immediate and essential knowledge, while also offering technical training and mentoring for the often-young staff in an emerging biotech organization. In addition, their experience helps management learn how to run more efficiently and avoid pitfalls.
The support ecosystem can be applied creatively to support differing needs. For instance, it is good to be lean, but not too lean. If your senior manufacturing or technical operations staff is heavily committed to existing activities and a critical or strategic project arises, what do you do? You can hire qualified consultants from the ecosystem to maintain day-to-day operations so your senior staff can focus on the more strategic initiatives for a period, or completing that critical project. Or vice versa, you could bring on specialized external support and expertise for the critical project so that there is no interruption to your team’s work managing business operations.
Growing companies can also leverage this ecosystem to access expertise earlier while postponing, or even avoiding, upfront investment in full-time human resources. In the end, selecting an optimal cost-efficient manufacturing strategy can remove very significant capital costs and expenses.
The financial advantages can be significant from avoiding large investments in people and organization before commercial viability is established. However, in the highly uncertain and risky biopharma industry the more important benefit is often realized in maintaining strategic agility and flexibility in the organization. For example, a clinical-stage client was conducting a pivotal trial for their lead program while organizing their BLA submission and beginning commercialization preparations. The company deliberately maintained an ultra-lean organization strategy, supplementing a small internal team with highly qualified external support – an approach that led to real cost savings according to their CFO. However, the true benefit of this strategy was seen when the agency raised concerns about the trial’s safety profile and study design. The company was able to quickly pivot from submission and commercialization activities to IND-enabling expertise for their next program.
If you are looking to connect into the evolving ecosystem for biopharma manufacturing, contact our team at info@convergeconsulting.com today.
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