In the ever-changing biopharmaceutical and biotechnology clinical development landscape, the functional service provider (FSP) model has evolved, enabling companies of all sizes and capabilities to be successful. The art of FSP is that it provides flexible, scalable, fit-for-purpose models.
Some organizations may focus on the science, so they choose a traditional FSP model of managing specific functional activities, thus increasing productivity and streamlining processes, which enables them to balance their execution and expertise and keep their projects on the right path. Other companies may need to scale rapidly and accelerate development of another portfolio of projects. They may choose an integrated single-source solution with a global network of multi-functional comprehensive capabilities that can simplify, accelerate and de-risk their unique needs.
The FSP model of old was a simple outsourcing arrangement. The modernized approach to FSP is a partnership that grows and pivots to support a business strategically, in a specific function and often in a specific therapeutic area, that places a focused FSP team with the project team, functioning alongside them. An FSP service offering allows separation of core/non-core capabilities within an organization and allows for a choice of functional partners who specialize in services, such as Clinical, Regulatory, Biometrics (DM, BIOS and MW), and Drug Safety for a scalable team to operationalize functional service(s) alongside an in-house team as a collaborative partner.
Register for this webinar to learn about how agile and scalable FSP models can remove the burdens of employment, day-to-day management requirements, and operational delivery.
In this webinar, participants will learn answers to questions such as:
- What are some of the different types of FSP models and their characteristics?
- When might a company choose one model over another?
- What are key considerations when choosing an FSP partner?
- How are FSP partnerships governed and measured?
Kymberli Shropshire, Global Head of Functional Service Partnerships, TFS HealthScience
Ms. Kymberli Shropshire has extensive experience in the drug development industry and has worked as an executive leader in a variety of functions, including alliance management, data operations, contracts, proposals and site management. Kymberli has specific expertise in managing transformational models in the biopharmaceutical and biotech space. She is responsible for the operational delivery of global partnerships and relationship management. Kymberli spent over 20 years working for two of the top five global Clinical Research Organizations and a top US Academic Research Organization. In her current role at TFS HealthScience CRO, she is responsible for driving forward the delivery of operational strategy to support client-partners.
Ian Kovacs, Exec. Director of Safety and Pharmacovigilance, TFS HealthScience
Mr. Ian Kovacs is a highly motivated business leader with a proven record of accomplishment in establishing and maintaining profitable and compliant pharmacovigilance systems and leading operational teams. He has over 20 years’ operational and leadership experience in all areas of pharmacovigilance (including EU QPPV) and medical information gained within both pharmaceutical companies and CROs.
Ian is a strategic leader, driven by the ability to develop and lead motivated and effective teams. He is highly motivated to support companies with developing and executing their pharmacovigilance strategies whilst improving compliance and efficiently identifying and communicating risk to patients. Ian has excellent communication skills and is well versed in liaising with patients and regulators alike and fostering long-lasting relationships with other industry leaders.
Ian has a degree in pharmacology and a PhD in Haematopathology, during which he was shortlisted for a Young Investigators Award by the British Society for Haematology.
Alison Sampson, Head of Pediatrics, Rare Diseases, Orphan Products Europe, TFS HealthScience
Dr. Alison Sampson has over 20 years of clinical research experience. She has a project management background, leading both clinical and cross-functional teams. Alison has experience of a wide variety of therapeutic areas, with particular expertise in rare diseases in neonates and adolescents.
Currently, Alison oversees clinical trials involving rare disease, pediatric patients or orphan drugs. Her department works with centers of excellence, patient groups and registries to promote study awareness. She has presented ideas for tailored recruitment strategies incorporating advertising and social media at therapeutic and rare disease congresses. She has developed significant expertise over the last few years using these strategies to boost recruitment and raise awareness in rare, pediatric and hidden patient populations.
Prior to entering clinical research, Alison studied Chemistry and is a Chartered Scientist and a Fellow of the Royal Society of Chemistry.
Dorothy Blythe, Principal Clinical Data Manager, TFS HealthScience
Ms. Dorothy Blythe has 37 years of project management experience spanning a breadth of roles across the pharmaceutical industry. Specifically, she has managed four patient assistance programs, the marketing of a hypercholesterolemia drug, research and preparation of institutional reimbursement strategies, as well as management of countless clinical trials. Her clinical trial experiences include responsibility for a portfolio of vaccine trials, hands-on management of Phase 1 adaptive designs for oncology candidates, and large cardiovascular endpoint trials.
Dorothy has worked with FSP partners to develop processes and KPIs and has done this from the perspectives of both sponsors and CROs. She also served on the review board for proposed trials, where she represented the interests of the Data Management organization, ensuring best practices were built into trial designs.
Dorothy received her BS in Biology from Albright College and an MBA from St. Joseph’s University.
Who Should Attend?
This webinar will benefit senior-level executives at large and mid-sized biopharmaceutical companies with responsibility for selecting a CRO provider, with relevant job titles including Directors, VPs and Department Heads involved in:
- Clinical Development
- Therapeutic Development
- Research & Development
- Regulatory Affairs
- Clinical Operations
- Data Management
- Medical Writing
What You Will Learn
Join this webinar to learn:
- Why the functional service provider (FSP) model was made for mid-size pharma and biotech companies
- How an FSP model can help to retain expertise and gain continuity along the way
- How to relieve the technology burden, offering seamless operating procedures
TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries and supports customers with comprehensive solutions including Functional Services (FSP) Model: Single Service, provides functional service support at all stages of the clinical development process and Outsourcing, to provide customers with strategic customized, embedded functional solutions with a focus on therapeutic experience.
TFS HealthScience provides a client-centric FSP solution that enables our partners to focus on core product development. We are prepared to work alongside you to provide fit-for-purpose solutions through your drug-development journey, offering a customized outsourcing model. TFS HealthScience is known for gaining an in-depth knowledge of our customer’s products, procedures, and systems that, together with the seamless integration of our therapeutic and operational expertise, ensure our partners benefit from embedded team optimization and cost savings.
TFS demonstrates industry-leading functional capabilities in:
- Clinical Operations
- Clinical /Post-Marketing
- Safety Management
- Data Management/ Data Science
- Medical Writing
- Quality Assurance Management & Training
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