Leveraging Functional Service Providers for Enhanced Efficiency in Drug Development

Discover an informative webinar to learn how functional service providers (FSPs) are transforming the clinical research landscape by providing specialized skills, adaptable resources and cost-efficient solutions.

As drug development costs continue to escalate, sponsors need to find less expensive approaches to develop their assets. One way to be more cost-efficient is to outsource some areas of drug development. FSPs have reshaped clinical research by offering specialized skills and adaptable resources.

As trials become more complex, many biotech and biopharma companies are opting for FSPs over full-service outsourcing. FSPs provide numerous advantages such as globalized strategies, expert domain knowledge and efficient management, thus helping balance quality, innovation and cost.

Sponsors engage FSP models when seeking efficiencies. FSP models provide increased operational and resourcing flexibility and different pricing plans in comparison to traditional full-service clinical research organization (CRO) offerings. FSPs deliver capabilities across a broad base, including subject matter experts in the functional areas, which helps accelerate drug development and decrease overall costs.

A sponsor should feel a true partnership with an adaptable provider willing to help achieve high-quality, cost-effective results as clinical trials are becoming complex and require specific expertise.

Register for this webinar today to learn about the strategic advantages, including expert domain knowledge, global strategies and operational flexibility, for biotech and biopharma companies in engaging functional service providers for drug development.

Speakers

Svetlana Kolchinsky, VP, Clinical Development Operations, Catalyst Clinical Research

Svetlana Kolchinsky brings to Catalyst Flex over 20 years of experience in clinical operations and leadership covering all facets of clinical development. Her professional journey began in 2000 at an NIH/NINDS research group. After scientific research, in 2003, Svetlana transitioned into clinical research at Immune Tolerance Network.

In 2008, with a newly acquired passion for clinical research, she joined BioTelemetry (formerly Cardiocore), a cardiac safety core lab. While at BioTelemetry, Svetlana led project management, biometrics and customer support functions. Using her leadership experience and strong project management skills, Svetlana shifted into operational roles within the CRO industry and successfully continued to support a number of in-house accounts. In 2020, she joined Catalyst Clinical Research and has been successfully building effective clinical research teams and leading Catalyst Flex’s clinical development operations.

Message Presenter

Melissa Church, SVP, Strategy & Solutions, Catalyst Clinical Research

Melissa Church has over 25 years of sales, operations and strategy development experience across multiple industries including clinical research, healthcare consulting and technology, and health insurance. Melissa started her professional career with ClinTrials Research before moving to SAS Institute where she worked for six years leading business development and proposal functions.

Her most recent clinical research experience includes nearly three years leading the contracts and proposal development function at PPD. Here she created the first strategic finance team focused on developing innovative pricing models to support client partnerships. After PPD, Melissa moved to UnitedHealth Group where she first worked for Optum and led their Sales Operations division.

Read more...

She also sat on the acquisition integration team and supported the integration of multiple small- to medium-sized businesses. In her last four years at UnitedHealth Group, Melissa led sales operations for the Medicaid business unit and held operational leadership roles.

Read Less...

Message Presenter

Craig McIlloney, SVP, Catalyst Flex, Catalyst Clinical Research

Craig McIlloney brings 25 years of experience in drug development with small and large CROs to his role with Catalyst. As Senior Vice President of Catalyst Flex, Craig is responsible for the global execution of functional services across multiple therapeutic areas.

In his previous roles, Craig has overseen global operations across multiple functions, including but not limited to data management, biostatistics, statistical programming, medical writing, quality, analytics, systems and communications. This has included global expansion across multiple regions and his leadership experience spans activities across various delivery models, including FSP, full-service and hybrid models.

Read more...

He earned a BS (Hons) in Statistics from the University of Glasgow, UK, and an MS in Applied Statistics from Napier University, Edinburgh, UK. He is a Chartered Statistician (Cstat) with the Royal Statistical Society and was previously a Director of the Statisticians in the Pharmaceutical Industry (PSI).

Read Less...

Message Presenter