When is the Right Time to Think About Commercialising Advanced Therapies?

Hosted in partnership with AmplifyBio, the roundtable covered a critical question in the industry: when is the right time to think about commercialisation?

With discussion directed by J. Kelly Ganjei, President & CEO of AmplifyBio, other moderators present included:

• Jaehyung Yoon, Executive Vice President, Finance & Strategy at AmplifyBio
• Jerry Hacker, Executive Vice President & Chief Commercial Officer at AmplifyBio

Herein, the Phacilitate team reflects on some of the key topics raised for discussion, including key early considerations for commercialisation, opportunities for automation and pain points that need to be overcome.

What Main Issues Affect Commercial Outcomes?

It is a common mistake for people to rush in to establishing a commercialisation strategy. It is critical to think about commercialisation as early as possible when you are developing your product. Your development goals may change depending on your commercial strategy, for example, is your product goal full commercialisation, or sale/M&A before that point? Delaying addressing key issues until milestones such as Phases I–III are reached is a common and dangerous practice and can compound risks such as human error or product characterisation when you try to scale.

A related issue here is that academic professionals can be either unaware of important commercial factors or unable to afford them. This often leads to the creation of a company unable to withstand the realities of commercial operation. The ability to progress to commercialisation from an academic starting point is certainly compounded by the difficulties and lack of funding for grants, but the pathways to automation are often expensive even for biotech companies with larger access to capital. Despite so much innovation coming from the academic world, financial constraints are significant and impact product scalability at many levels.

“Tech moves fast; flexibility is critical.”

What Do You Think of When You Consider Commercial Planning?

Scaling out a process carefully is a complex process, and should always be a priority. The cost of goods and the hours required in cleanrooms are also high on the list of pain points that are relevant to automation efforts. With biotechs so commonly transferring tech from academics, an early analysis of the eventual scalability of a product is vital. For autologous therapies, it is further compounded since you don’t have ultimate control of your manufacturing demand and patient supply chain. Patients will in large part determine your demand, and there are a multitude of factors affecting enrolment. Starting materials and availability of other API’s can have a similar effect on campaign manufacturing.

Academics tend to look for checklists for commercialisation, which is difficult due to the sheer number of variables across the variety of products. Moving to more of a process of collaboration with subject matter experts that may have historically been siloed would help.

What is Your Definition of Automation?

Definitions still vary, which is problematic. Some professionals prefer self-contained devices, whereas others use nested solutions to automate pain points in a more modular manner.

This suggests a new understanding of automation wherein we can consider it as an effort made across entire processes (not just devices and equipment) instead of something that’s acquired through the implementation of single products.

“Tech is great; collaboration and networking are even better.”

What Are the Major Barriers to Early Automation? Is Financial Justification One of Them?

Processes become cheaper as more standardised elements are used. Academics tend to resist the adaptation of standards early as the process at that stage is more experimental in nature, but standardization is nevertheless a prerequisite for lowering costs.

Fortunately, both investors and vendors are becoming more sophisticated in this area and are increasingly interested in commercial strategy and the presence of a robust process across all phases. From the moderators’ experience, this has created new opportunities for collaboration between academics and vendors, providing a roadmap for lowering the bar for  this common hurdle.

With autologous therapies, one batch is made for one patient. Despite existing autologous products remaining vital to patients today, there are still limitations. Platform technology could change, such as a move towards allogenic, or a move away from technologies that are inherently difficult to scale. Recent success and adoption by clients of automation are helping to address this gap by providing case studies and examples of closed systems in the market and alleviating safety concerns.

Identifying your clinical dose early as part of your commercial strategy is also quite important and valuable. If you can identify the dosage needed to elicit a positive clinical response, this will help define your scale up process, and ultimately help shape your manufacturing strategy. However, this obviously can vary, with some conditions requiring huge numbers of drug product, creating complex manufacturing requirements. The earlier you know this the better.

In context with mid to long-term manufacturing capacity, your initial thought processes and decisions will be incredibly impactful down the line. Early automation can, for instance, drastically cut down on manufacturing space and staffing requirements and will give investors comfort that you have thought through how to build a sustainable product and platform.

What’s a Pain Point You Are Shocked Hasn’t Been Solved Yet?

The group agreed that we still rely on paper too much! Although digital solutions exist, they are often too expensive or not flexible enough for many companies.

Another point raised was that filling and finishing manually is a surprisingly common practice that we would have hoped to moved past at scale by now.

Some of those in the industry are surprised at how prevalent the use of cytokines to culture stem cells is, despite having potential options that can bypass this and scale better.

Finally, the ‘human factor’ is too often a weak link in any process. We must know where our expertise ends and another person’s starts. Tech is great; collaboration and networking are even better.

This feature was produced in partnership with AmplifyBio.