As the number of therapeutic molecules in development has more than doubled – from about 6,000 to in excess of 13,000¹, the number of contract development and manufacturing organizations (CDMOs) has also significantly increased. With more CDMOs to choose from, pharmaceutical companies must prioritize CDMO selection criteria to find the right partner for their new drug development project.
With many molecules and new drugs failing, concurrently testing multiple drugs is crucial to success and the reason why many pharmaceutical companies use CDMOs. Developing a new drug takes time—an average of 10 to 12 years—and can cost upward of $5.5 billion dollars, making the selection of the right CDMO critical.
CDMO Selection Criteria: Finding the Right Partner
Consider the following CDMO selection criteria to ensure your choice of CDMO is based on the strategy of the project and the needs of your pharmaceutical company:
- Your Drug’s Development Stage. The stage of your drug development is likely a key deciding factor for whether or not a sponsor will move forward with a CDMO rather than keep it in house. Know what questions to ask and details to share with your CDMO to get a proper estimate, set clear expectations and develop a realistic timeline.
- Range of Services. It’s important to understand your company’s approach to outsourcing, or, if this is your first time considering a CDMO partner, to begin outlining your expectations for using a CDMO. Does all outsourcing need to happen with one vendor, or can various CMOs, CDMOs and CROs assist in bringing your new drug to the marketplace?
- Transparency regarding costs. With the median final cost of bringing a new drug to market sitting at 985 million getting an accurate outline of expected costs is crucial to keeping development and manufacturing costs in check.
- Speed and Quality of development and production. Your timeline and the desired speed-to-market is a key consideration in choosing a CDMO, but not at the cost of sacrificing quality.
Your Drug’s Development Stage
Will you be working with a CDMO for discovery and drug development all the way through approvals and commercialization? Will your work with a CDMO for commercial manufacturing begin with preclinical development or with clinical research?
Selecting the right CDMO partner depends heavily on the stage of drug development the sponsor is in.
• Discovery: Defining the disease or condition you are targeting and identifying the biochemical mechanism that will best treat it is first. Drug candidates are then tested for their interaction with the disease or condition they are meant to treat, and primary compounds are identified.
• Development: The development of a new drug includes product characterization, such as molecule size and shape, as well as strengths and weaknesses (function, toxicity, bioactivity and bioavailability). The formulation, delivery method and package development, must also be defined, including the dosage amount, storage and shipment factors and packaging impacts, including heat, light and time, as well as extractable and leachable studies. Other development considerations include pharmacokinetics and drug disposition, preclinical toxicology testing and IND application, bioanalytical testing, and clinical trials (Phase I, II and III).
• Regulatory review and approval. Sending data for your new drug on to regulatory review is a key step in drug development—one that is made easier when you work with a CDMO with rigorous data management protocols in place to show your product meets safety, efficacy and quality standards.
• Commercialization and marketing. After your product is approved, will your CDMO be able to scale up production from development and testing into commercialization, or will you need to work with another partner to bring your new product to market?
The stage of your drug development will impact the amount of material needed, which may impact the choice of CDMO based on their capacity and facility space to produce the desired amount. In addition, an experienced CDMO can help you gain a better understanding of an achievable timeline based on factors for cGMP manufacturing and beginning clinical trials.
Range of Services
According to Industry Standard Researcher’s development and commercial outsourcing models sponsors indicated preference for using the same CDMO for development and commercial manufacturing. It is imperative for sponsors to define whether or not every phase of drug development, testing, approval, and manufacture needs to live with a single CDMO.
Using an all-in-one CDMO has its advantages, such as improved communication with fewer players to transition details to and better timeline management with less risk for overlap when moving from one vendor/stage to the next. Though, sometimes using a single CDMO for your new drug development and manufacturing isn’t possible due to a variety of constraints, such as capacity and availability during certain stages of development, and the flexibility needed to adapt quickly to meet Phase I timelines. Keep in mind that if you use more than one CDMO, you may be required to pay royalties to transfer from one CDMO to another, so be sure to factor those costs into your total new drug development costs.
Review the stages of development and identify which stages will stay in house and which ones will be outsourced and to whom:
• Pre-formulation
• Formulation development
• Stability studies
• Method development
• Pre-clinical and Phase I clinical trial materials
• Late-stage clinical trial materials
• Formal stability
• Registration batches
• Commercial production
Don’t forget to evaluate the technology and science needed for your new drug development and determine whether or not your potential CDMO partner has experience in the formulation technologies you need.
Transparency regarding costs.
Your selection of a CDMO based on its range of services and how much of your new drug development you have with one vendor may help keep your costs lower, but may not be possible due to time constraints. When you receive final cost calculations from potential CDMOs, be sure to ask if their final figures include estimated out-of-pocket expenses and capitalized costs.
Keep in mind that drug development processes may vary significantly due to findings in early-stage drug development and results from clinical trials. This makes drug development costs highly unpredictable, and the use of an experienced CDMO even more crucial to keeping costs in check.
Work with your procurement team to develop a checklist of questions to ask your potential CDMO partner, including whether or not you need to pay royalties when the project transitions from one CDMO partner to another, how they handle scope changes and whether or not they proactively share costs associated with scope changes, re-work due to molecule failures in early-stage testing, etc. and their overall approach to providing open-ended communication regarding expenses and expectations.
Speed and Quality of Development and Production
When you are launching a new drug with the goal of speed-to-market or being first-to-market, working with an experienced CDMO can be the difference between making it to market on time or not making it at all.
Be sure to ask about and get a good picture of your potential CDMO partner’s availability and capacity right now, as well as their current experience and capabilities. Identify any changeovers or transfer of information, data, processes and new setup time if you are using more than one CDMO vendor.
A CDMO who has experience working with a wide array of molecules and for various pharmaceutical companies can help identify potential issues or watchouts as you develop processes or scale up, and can use design of experiments (DoE) techniques during process design to reduce risks as your new drug development progresses. Experienced CDMOs also tend to have stronger scientific and technical teams (such as for complex injectables development and manufacture) who use their expertise to advance your drug to the next stage, as well as the technologies and facilities equipped to handle your specific drug development processes. Don’t be afraid to talk to the CDMO’s current clients, consultants and colleagues to get to know the CDMO’s working style and potentially identify any issues in quality.
Choosing the Right CDMO is Vital to the Success of Your Project
Ascendia Pharmaceuticals is a CDMO that specializes in the invention and development of specialty pharmaceutical products and novel formulation technologies. Providing formulation, analytical, and manufacturing services to pharmaceutical companies, we work collaboratively with drug sponsors to provide innovative solutions to challenging drug delivery problems and to create advanced medicines.
Our technologies include nano-emulsions, amorphous solid dispersions, oral controlled release, self-emulsifying drug delivery systems (SEDDs) and production of nano-particles. Ascendia provides development and testing services—from pre-formulation through to manufacture of pilot clinical supplies.
As a specialty CDMO, Ascendia offers expertise in a wide variety of development programs. We have the capability to work on early-stage formulations of programs as diverse as peptides, high-potency molecules, nano-particles, animal health products, and parenteral dosage forms.
Ascendia Pharmaceuticals provides its partners with complete CDMO services from pre-formulation to clinical manufacture. Contact us today to learn more.
References
- Informa Healthcare (2016). Blockbuster Trends and Rising Stars of Global R&D: Pharmaprojects Pharma R&D Annual Review 2016.