Earlier Immunotherapy Commercialization Mitigates Risk & Speeds Scale

April 27, 2021
4 Minute Read

It’s a future that’s still evolving: Think 23andMe except that saliva swab just might save your life. Immunotherapies based on a patient’s unique DNA profile—including Cell and Gene Therapies (CGT) and chimeric antigen receptor T cells (also known as CAR-T cells)—are revolutionizing treatments for a number of diseases where conventional therapies have fallen short.

In some cases, these new therapies are not scaling fast enough to reach those most in need—and that gap may literally be costing lives. The time to fix this is now. And biotechs focusing on commercializing their work through smarter and more agile management will be the ones benefiting the most in the marketplace.

While the focus for many of these firms is—rightly—on the front end of cutting-edge science and clinical trials, attention also needs to be paid to the operational side of the equation on the back end with faster commercialization. Breakthroughs without reach are of little use to patients. There are ways to change this, starting with this basic roadmap below.

Immunotherapies Are Different

First, let’s start with the most obvious comparison and why immunotherapies are different from typical non-personalized mass-produced therapies. Most major pharmaceuticals pretty much follow a paint-by-number process, including a well-established template of clinical trials, approvals, production, distribution, etc. Significant budgets, as well as entire departments and business units, are dedicated to making sure the almost production-line process runs as smoothly as possible. Rinse, lather, repeat. One process for all products.

But templates like that likely won’t work for immunotherapies. Instead of paint-by-numbers, think blank canvas. Immunotherapies essentially have to invent their processes. Based on our work with several clients in this space, we recommend following several steps to help put paint on the canvas.

Plan Your Commercialization Earlier

Timing matters. Too many biotechs wait until Phase III of clinical trials to start their commercialization planning. By then, you may be handling some 20 patients a month. Big mistake. Instead, start planning in Phase II in anticipation of that initial ramp-up but also plan early for Good Manufacturing Practice (GMP) compliance as well as quality assurance. That makes it far easier to scale from those 20 patients per month to 100 or more later.

Not every therapeutic will make it beyond Phase II, but for those that do, earlier planning makes it easier to scale faster while also meeting rigorous biosafety design requirements. To keep this process on track, you’ll need strong project management and controls across the entire business chain—starting early rather than later in trials when you “think you’ve got a winner.” Best to be prepared.

Use Sales and Operations Planning

Where to begin? From our client experience, the best way to start the commercialization process in Phase II is with sales and operations planning (S&OP), which provides the end-to-end business chain requirements and information. This will drive the majority of your operational development and implementation decisions as well as support corporate goals and objectives.
In its simplest form, S&OP is a formal six-stage process that includes:

  • Product & Project Review
  • Demand Review
  • Supply Review
  • Integrated Financial Reconciliation
  • Management Business Review
  • Executive Business Review

The S&OP process allows business units across the enterprise to align and agree on the execution plan to optimize business outcomes and performance.

For example, during the supply review stage with a global pharmaceutical client, we used the Lean Six Sigma methodology and tools for optimization, quality control, and continuous improvement. This enabled our client to launch a first-to-market novel cancer therapy that ultimately reduced the patient end-to-end process time by eight days—from one month to 22 days. Win for the client. A definite win for patients who got much-needed therapies faster.

Integrate Financials

By integrating financial management into the S&OP process you’re better able to align financial plans with operations execution as well as drive cross-functional collaboration across the business chain. The flexibility to easily execute alternate (what-if) scenarios within the S&OP process allows you to better assess and create contingency plans and prepare for the unexpected.

Factor in End-to-End Supply Chain

Sales and operations execution (S&OE) translates the results of tactical planning into the details that will drive near-term actions in the end-to-end supply chain.

For example, we helped another pharmaceutical client establish vein-to-vein cold chain processes and procedures across their entire global supply chain, allowing them to expand from one US-based manufacturing site to seven across the globe. The initiative ultimately helped them support 25 hospitals and clinics in the US and more than 300 globally.

By monitoring actual demand and supply by line item, S&OE can also provide an early warning system to help stakeholders adjust their plans and responses faster and with greater agility.

Link to Enterprise Planning—Rinse, Repeat

Commercialization needs to be included in the big picture. By incorporating your S&OP into your company’s annual corporate strategic planning process, you’re better able to align strategic goals and objectives, while further enhancing collaboration and helping assure financial alignment.

Finally, this sector has come a long way in a relatively short time compared with medical breakthroughs of the past. Immunotherapies today show increasing promise for patients with diseases like lymphoblastic leukemia, spinal muscular and retinal dystrophies, and others.

Many more will follow in the future. But the very nature of personalized medicine means one size will likely never fit all. That creates special challenges for commercialization. Yet, it also creates opportunities that can help biotechs that decide to get ahead of the commercialization curve.

In a nutshell: start earlier, be agile, and iterate these changes into how you do business—so it’s less about staring anxiously at a blank canvas wondering what to create and more about moving closer to the ease of paint-by-numbers. Either way, patients are waiting for your commercialization efforts to succeed. Changing your operations can go a long way in making that happen. And that’s reason enough to start.

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