Partnership Development Management Organization(PDMO) – CDMO alternative for Gene and Cell Therapy, Virus and Biologics Mfg.

PDMO – Partnership Development Management Organization

The following is simplistic introduction to a CDMO alternative. This new PDMO concept is to enable the same capability as a CDMO with added flexibility to control manufacturing while enabling speed into the clinic. The main goal is to provide autonomy in dedicated client CMC space while leveraging interconnected manufacturing infrastructure to save money, control of schedule and new pipeline product introduction. The partnership development management organization (PDMO) is being introduced to bridge an existing gap between building infrastructure and CDMO.

As an alternative to CDMO a new class organization is arising called a Partnership Development Management Organization which provides a new way to outsource product development and manufacturing. Before diving into what is the value of PDMO there is still value in using a CDMO in many situations. Let us examine the current market status and when a CDMO is the right choice

Working with a CDMO
FDA and Global Regulatory requirements have been put in place for biotherapeutic production to ensure safety and efficacy for therapeutics going into clinical trials. If the regulatory requirements and quality systems needs required more resources and expertise than those available in-house and if your product manufacturing is robust and ready to be transferred a CDMO may make sense for you and your organization. Choosing the right CDMO will be combination of timing, fit and costs.

Is a CDMO the right fit?
A CDMO with the right expertise and phase appropriate systems maybe harder to find than it looks. The current demand for these CMO outstrips the current availability and capacity that according to Deloitte a CDMO wait times can be as long 12 to 24 months. In most cases to secure the space and schedule slot, will require a company to pay a reservation fee with the hope that the availability and science coincide. The wait time, the initial investment and the risk of the product not being ready when the CDMO schedule clears, represents risk that should evaluated as part of the fit analysis. A CDMO makes a lot of sense if the science is ready, and availability of space is consistent the risk assessed milestones from potential client.

A CDMO may also be fit if you can wait for capacity to become available or if your strategy is based on unpredictable demand and you have only one product in your pipeline leveraging CDMO maybe the right decision. However, if speed to clinical trial is important and you company has more than one product and you want to protect your IP while controlling your schedule and resources you might want to consider looking into a PDMO.

What is a PDMO?
In talking to one investor, he basically sees it as Weworks for CMC for gene and cell therapy, biologics, and viral production.

PDMO provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical and commercial start. Simply speaking a PDMO behaves more like a cGMP incubator space with all regulatory, systems capabilities and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.

A PDMO provides a company with their own space so there is no need to build expensive facility. Providing flexibility to protect IP, manage schedule, resources and new product introduction reducing overall cost and risks.

PDMO like Ocyonbio Puerto Rico, Sterling and Resiliance provide cGMP spaces that can be customized to meet client process requirements and special needs. Each client will get their manufacturing space configured to their unique process and the client will own the space not unlike owning apartment in a building.

The client will have control of their space, schedule and can control their cost by using their own resources to produce the product based on their requirements. The PDMO model also allows the client to leverage existing connected infrastructure like quality systems, laboratory, warehouse, shipping and receiving to reduce capital investment. The clients’ main investment will be for the dedicated space required to support CMC requirements.

Unlike a CDMO, the PDMO provides the ability for client to use the facility for their entire pipeline. This reduces the cash bleed that is typical for a CDMO where they charge for each product that is introduced into their system. A typical new product introduction with technical transfer, engineering runs, aseptic validation and ten clinical runs can range from $20-30 million dollars. If the client has three products this will translated into $60 million dollars for CMC alone.

In the PDMO model the client pays an initial fee for the customization of the manufacturing space and a monthly service fee that is resembles that in a CDMO reservation fee. In this example, the PDMO eliminates $20 million dollar per product that will be incurred in a CDMO proposal. In a company with three products this can translate significant savings which makes a PDMO ~50% less expensive. The image below represents a simple comparison of the cost of PDMO vs CDMO. The CDMO cost are cumulative while the PDMO investment are absorbed as new products are introduced into dedicated space

Location…Location matter in short and long run?
The location of both the CDMO and PDMO matter in significant way, as this will affect company financials and cash flows.

If either the CDMO or PDMO are located areas where there are available grants, tax advantages the PDMO model becomes even more impactful.

For example, if the PDMO is in California, the state will provide tax and employee incentive to incoming companies. In most cases, the states will provide incentives once the company becomes profitable.

To maximize the value proposition of a PDMO an idea location will provide tax, employee, equipment, and materials incentives that can be monetized reducing cash flow and while providing capital to enable another molecule in your pipeline. The PDMO should be in a highly regulated environment that has quality mindset to meet the rigorous requirements established FDA, EMA, and other global regulatory bodies. The location must have both an existing infrastructure, resources, education system to enable the speed required for start-up.

Ocyonbio, Resiliance and Sterling PDMO models creates another alternative to CDMO or building your own expensive facility.

As always would love to hear your thoughts and comments on this initial post. Feel free to connect with me

Robert Salcedo

President & CEO Biosciencescorp :Robert.Salcedo@biosciencescorp.com



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