By Fiona Branton
Bringing drugs, vaccines, and treatments to completion is an extremely expensive proposition, requiring hundreds of millions of dollars and taking years to complete. And as the global economy continues to tighten and approach recessionary proportions, pharmaceutical and biotech companies are facing increasing pressures to reduce the time they spend on developing new drugs and better manage the associated costs.
Drug development is a time-consuming, capital- and resource-intensive process that requires a broad array of medical and laboratory expertise, including toxicology, preclinical evaluation, and clinical trial design and implementation. Drug development also requires specialized laboratory facilities and ever-evolving testing and measurement technologies. In order to maintain an edge in a highly competitive marketplace, many pharmaceutical and biotech companies are looking for new, smarter ways of conducting drug development research. Some of those companies are engaging DDSOs (drug development services organizations) to supplement their in-house resources and expertise. DDSOs provide their clients — pharmaceutical and biotechnology clients of all sizes and types — with a wide range of services and state-of-the-art facilities designed to move new drug candidates from the laboratory into clinical testing and to the marketplace. Some DDSOs focus on specific stages of the drug development process, such as performing biostatistical analysis or clinical trials, while full-service DDSOs offer the entire range of steps involved, from selecting compounds to manufacturing to marketing a completed product. Clients can engage full-service DDSOs for any or all of the services they offer, from consultation on a single phase of a process to outsourcing performance of the entire process.
Project Management Expertise Streamlines Development
Melynda Watkins, senior director of project consulting at Fulcrum Pharma, offers some insights on how pharma companies can benefit from engaging the services of a DDSO. Fulcrum is a DDSO that manages drug development projects for clients ranging from NGOs (nongovernmental organizations) that are focused on finding solutions for neglected diseases to for-profit pharma companies of all sizes seeking the next big commercial breakthrough.
Fulcrum provides the full range of drug development and regulatory expertise necessary to move a drug development program from research to product approval. “We take an integrated team approach to drug development, which is different from a single consultant, since we can provide all aspects of development, from consulting on the selection of drug candidates through nonclinical and pharmaceutical development and all phases of clinical development and regulatory approval,” says Watkins. “Having a company like ours drive a project can better leverage investments in research. We can provide all the steps needed to develop a drug and bring it through clinical trials, at a lower cost than an in-house effort.”
Watkins explains that the fee a client would pay a DDSO to manage and staff a project is generally far less than what it would cost to employ and manage in-house scientists and technicians, not to mention the cost of taking researchers away from more profitable projects. “Our team of researchers can cover the entire range of steps needed to bring a new drug to market, from designing product development plans to quality management, clinical development, and regulatory approval,” explains Watkins.
In addition to its ongoing work in support of for-profit pharma clients around the globe, Fulcrum’s project consultancy group has amassed extensive experience managing large, complex development projects for nonprofit NGOs, including the CPDD (Consortium for Parasitic Drug Development) and MMV (Medicines for Malaria Venture), seeking treatments for neglected diseases. In fact, Fulcrum was instrumental in helping MMV develop a next-generation synthetic peroxide, known as ‘OZ,’ which is a synthetic version of the most effective current antimalarial, artemisinin, and is cheaper and easier to produce. In 2006, MMV named OZ its Project of the Year for the progress its product development team accomplished that year, in part due to the project management and leadership skills provided by Fulcrum.
According to Watkins, Fulcrum’s work with NGOs is a good example of the advanategs of using a DDSO. In particular, she says the project management offered by a DDSO is key when developing vaccines, cures, treatments, and systems for delivering drugs to the people who need them. “NGOs are very lean organizations; very little of their funding goes to management or administrative staff. They need a project management model that will incorporate those functions at the lowest possible cost.” Most drug research consortiums performing the work for NGOs are led by academic researchers from around the globe. “Coordination of these individuals is essential, but difficult under the circumstances. And whether you are a nonprofit or a for-profit company, it’s critical to have solid program management and leadership to keep all the players moving together in harmony,” she explains.
Save Money Through DDSOs’ Supplier Networks
In addition to offering project management services to keep your development efforts progressing, a DDSO can help save millions of dollars on your supplies. DDSOs typically maintain extensive networks of pharmaceutical suppliers and are aware of which suppliers offer the lowest costs. “We can piece together a number of specialized suppliers that together will result in an overall lower cost than going to a one-stop shop,” Watkins states. “Many large pharma companies have certain suppliers they deal with, and they either can’t go outside their established networks, or the time and effort it would take to evaluate specialized suppliers to determine the best combination for a particular project would be too costly for them.” DDSOs’ relationships with both large and niche suppliers enable them to cherry-pick the best providers, in terms of both cost and quality.
Once an appropriate supplier — or set of suppliers — has been selected, a DDSO with a global presence can closely manage all interactions with the supplier. A DDSO will typically get involved in all aspects of supplier management, from negotiating contracts to assisting in protocol writing and study design, study monitoring, report review, and project closeout. “We stay on top of progress so we can quickly address any unexpected issues or events, should they arise,” adds Watkins.
Finally, a DDSO can provide global regulatory affairs expertise to streamline submission management and achieve fast product approval. This is particularly helpful to companies that need to obtain regulatory approval in countries where they do not have an established presence.
“There are common components and steps to all drug development programs, whether they are for a potentially highly profitable medication or a cure for African sleeping sickness,” Watkins concludes. “A DDSO can help any type of client design the best possible program that will achieve that client’s goals, including finding the right balance between minimizing costs and minimizing time to completion. Generally, speeding up the process leads to higher costs, while cutting costs extends your time to market. We have experts on staff who are experienced at finding the right balance between these two conflicting goals.”
If your goal is to continue delivering safe and effective medicines as quickly and efficiently as possible in spite of the troubled economy, it may be worth investigating whether a DDSO could help your company accomplish that goal. You can contract for as much or as little support as you need, without adding the associated costs to your R&D overhead.