Holding more than 25 years of experience in the medical sector spread across numerous pharmaceutical and CRO-based clinical research roles, Edel Shaw knows a thing or two about drug development.
Based in Ireland, Edel serves as Director of FSP Solutions at PPD, part of Thermo Fisher Scientific.
The functional service provider (FSP) model has become a very popular approach within the clinical research industry for a number of reasons. In essence, FSPs such as PPD FSP Solutions enable organizations to outsource the functional aspects of the job while retaining control of the job and data. This, Edel explains, facilitates cost and efficiency gains, as well as the ability to be agile and have more control over data.
“Any gap in service or clinical development that a client has, FSP can be able to answer the call,” she says. “No two customers’ projects or requests are ever the same. An FSP solution can provide individually tailored and customized programs to meet the unique requests that we receive from our clients.”
It is therefore easy to see why the appeal of FSP is growing. Between 2018 and 2021, the market utilization of FSP expanded steadily from 28% to more than 40%, with recent data indicating that growth has continued.
In this conversation, Edel outlines some of the key benefits and considerations of working with the FSP model, as well as how the company attracts and retains the skills it needs to continue offering these services.
Julia Douthart: Today we're speaking with Edel Shaw, director of PPD FSP Solutions, part of Thermo Fisher Scientific. Edel, welcome and thank you for stopping by today.
Edel Shaw: Thanks for having me.
Julia Douthart: To get us started, could you tell us a little about yourself and your role at PPD FSP solutions?
Edel Shaw: So, I've been a director with PPD FSP Solutions for over two years now. I'm based in Ireland. My background is: I have a degree BSC Honors in physiology and biochemistry. I've been working in the industry for over 25 years across multiple pharmaceutical and CRO based clinical research roles. My current role as a director in FSP is I'm responsible for the development, execution and optimization of FSP partnerships within PPD.
Julia Douthart: How is the market shifting towards functional service provider (FSP) models and how do these models fit within the future of drug development?
Edel Shaw: So, growth of FSP market has steadily been increasing over the last number of years. In 2018, market utilization was in the region of 28%. In 2021, it has increased over 40%, and recent data indicates the growth of FSP is continuing to rise from research available. There are four or five different reasons why biopharma biotech customers are opting for the FSP model. They include cost and efficiency, the ability to access an agile and more flexible resourcing model to be able to offer better control on their data. As more and more of the FSP models are being conducted in the client's systems and processes to be able to access talent that they wouldn't routinely have access to be able to develop and focus and mobilize technology innovations and also to consider site relationships, which are becoming more and more important as drug development continues to evolve.
The industry is really looking for a model that can partner and adapt to their changing demands, their priorities and challenges. And FSP most certainly provides that answer. We've also seen in recent years as well, the growth in hybrid offerings. So, where part of the services provided in an FSP format where some of the other services being required are utilized in a full outsourced format. So, we see between hybrid and FSP that really the growth and the marketplace is growing to meet the evolving needs of drug development in the 21st century.
Julia Douthart: So, what are some key considerations to look for when choosing an FSP partner?
Edel Shaw: Establishing a successful partnership requires selecting an outsourcing partner that really understands the client's needs and what's important to the client in addition to being customer focused. Key to successful partnerships includes considerations such as the breadth and depth of experience in delivering the service that the client needs. A proven track record in delivering similar projects on time to within budget, and the ability to create a very bespoke tailored solution to exactly match the needs of the client, and also the flexibility to adjust those as the needs to the client change. There's also consideration should be given to the infrastructure that is available to mobilize personnel and to be able to deliver teams where and when they're needed. And that goes hand in hand with a trusted model of recruitment, a global function that is able to deliver the people at the right level in the locations that the client delivers. And the final consideration, I would say, is really looking at the quality and standard of training and onboarding and the ability to customize and create bespoke offerings to the client that match their exact needs.
Julia Douthart: Could you give us a brief overview of the functional service provider model within PPD and some key benefits maybe?
Edel Shaw: So, PPD has been providing FSP services for over 25 years. Our solutions are available in all of the functional service areas required for drug development and can be provided in a number of different costing models. FSP can mean different things to different companies and different clients. Commonly it's understood as a fully dedicated embedded resource within the client. But FSP can also be provided in a unitized model or even in a time and materials format. FSP really provides the answer for clients who are looking to fill from small gaps and individual teams right up to delivering multiple functions across a portfolio of programs. And really everything in between FSP can operate if the client wants to use the supplier's systems and processes, or if they want individuals to come into their organization to use their systems and processes.
Over the last decade, PPD has invested significantly on our FSP business to ensure that our solution is number one in helping our biotech and biopharma clients to meet their development timelines. And we ensure this by giving the model the exact specifications that the client is looking for, delivering top tier talent and bringing with them PPD’s expertise and problem-solving mindset. There's a number of benefits to FSP and FSP really the number one is the flexibility in resourcing as the business needs increase and decrease. FSP is an ideal solution for any client to consider, but there's also the ability for clients to have more control over their data alongside access to highly qualified and trained pool of resources that are available for deployment at any point in time.
Julia Douthart: What kind of organizations need an outsourcing partner and how do you ensure that FSP needs are met?
Edel Shaw: FSP has the flexibility to be able to answer any company's needs from small startups to large multinational pharmaceutical companies. FSP solutions can be the answer. FSP delivers solutions from just a few people to supplement a team in a single service to being able to provide dedicated teams across single or multiple functions and to deliver large scale programs. FSP can provide individuals or teams to act on behalf of the client as their outsourcing team, their program or project managers, operational roles, business leads, therapeutic or clinical teams. Any gap in service or clinical development that a client has, FSP can be able to answer the call. No two customers projects or requests are ever the same. An FSP solution can provide individually tailored and customized programs to meet the unique requests that we receive from our clients. How do we ensure that our needs are met? So PPD has a dedicated solutions team that are based solely and 100% within FSP to help get our partnerships built. We offer dedicated implementation leads and operational delivery leads to ensure that our programs are built in the best way and that they remain on target and on track to deliver for the client.
Julia Douthart: How does PPD’s FSP team train and develop its talent?
Edel Shaw: So PPD prides itself on training and development of our teams. PPD operates and delivers award-winning training across all aspects of our business. Our FSP solution has access to all of the same training that's available to all of our highly qualified talent within PPD. We have a bespoke FSP Academy that helps allow us to abbreviate our core PPD training and really focus on focus the key aspects of the training that is important to the client. So the client's systems and SOPs, their values, their cultures, and all of those soft skills that really help ensure that the person selected is going to be a true representative of the client company. We also have access to a number of award-winning academies. We have specific academies for our clinical development folks, CRA academies specific programs that allow us to take clinicians to bring them into the clinical research field. And as well as that, over the years PPD have built up a wealth of therapeutic area training. We work across many different therapeutic areas and in a huge number of those cases, we have dedicated training academies fueled and populated by our therapeutic experts within PPD that allow all of our teams to get access to that award-winning training too.
Julia Douthart: Edel Shaw thank you for joining us today.
Edel Shaw: Thanks, Julia, for having me.