Elite BioPharma Consulting
Comprehensive Clinical Development Consulting

Founded in 2019, Elite BioPharma Consulting (Elite) is a Boston based boutique consulting firm whose primary focus is to collaborate with clients to provide superior consulting services for their clinical development operations.

Elite’s founders, Jill C. Bossi, Shawna H. Evans, and Connacht M. Peterson use their combined 70 years of industry experience to provide clients with personalized, clinical development operations services. The Elite team has global industry experience across a wide variety of therapeutic areas in drug and device development.

“We partner with our clients to help drive excellence in their clinical development process, from Investigational New Drug (IND)/Investigational Device Exemption (IDE) application through New Drug Application (NDA)/Premarket Approval Application (PMA) filing,” says Connacht.

A major differentiator for Elite is that they act as an extension of their clients’ teams to fulfill resourcing needs. For instance, some clients have an internal team but require added support or a higher level of expertise for a specific project. There are also new biotech companies that do not have a clinical development department and are morphing between the preclinical phase into research and development. Elite can provide the unique infrastructure that companies need to keep activities and trials on track. Elite specializes in clinical operations and leadership services but can also aid in other functional areas such as medical writing, high-level regulatory support, and clinical monitoring services.

Elite also collaborates with clients when their clinical trials do not go as expected and added expertise is needed to steer a development program back on track. This niche model has served clients well, especially during the recent global ‘Great Resignation.’

Elite consultants can easily fill a high-level VP/ Head of Clinical Development Operations role or a more task-oriented role (i.e., Clinical Research Associate for regional monitoring) to drive program success for clients.

As an example, Elite worked with a small biotech client who had a good departmental infrastructure in place but needed more resources to adequately maintain oversight of their contract research organization (CRO) and seven ongoing clinical trials. When a client outsources a clinical study, they transfer overall responsibilities and obligations to the CRO. Ensuring that the CRO adheres to these responsibilities and obligations is critical to the success of the clinical trial and is required by regulatory agencies like the FDA. Elite stepped in to fill this operational gap verses the client hiring full time employees.

“We are not a temporary staffing firm or CRO. Instead, we offer our clients internal stability for short and long-term projects. We strategically match each client with our network of trusted consultants based on capabilities and culture. We become their clinical development team.” states Jill.

Recently, a Chinese biotech company with no prior U.S. presence partnered with Elite to execute their clinical development program for a complex immuno-oncology asset. With Elite’s expertise, the sponsor opened a U.S. IND in January 2020 with Elite consultants filling roles as the Head of Clinical Operations and Head of Regulatory. The IND was developed and submitted in April 2020 and cleared with no hold comments from the FDA. Elite further provided a U.S. CRA to conduct site management and monitoring services for the entire U.S. program. Despite the challenges presented by Covid-19, three sites were activated by June 2020, and patients started enrolling in September 2020, exceeding the targeted study timelines. The Elite team developed and submitted two additional protocols in 2021 for solid tumors including glioblastoma. Elite provided a full U.S. based team (project management and monitoring) to support and manage all three studies in-house on behalf of the sponsor.

“Elite is a small, lean, highly experienced team that can operationalize projects fast and efficiently. Unlike a full-service CRO, we do not require multiple layers, and we can flex up and down with project needs,” says Shawna. “The result is delivery of clinical programs on time, with quality and within budget.”