Product Development: Due Diligence, Strategy & Study Management for NCE in EU

Customer profile

Small European based Research and Development company intending to develop and register their first NCE targeting Non-Alcoholic Fatty Liver Disease (NAFLD) & Steatohepatitis (NASH).
This drug was not authorised anywhere in the world.

Customer Challenges

• Due to the size and nature of the company, they possessed expertise in drug development, but have very little expertise in pre-clinical and clinical regulations.
• Initial data collected had not been validated against the latest regulations for compliance.
• The client lacked experience in selecting Clinical Research Organisation (CRO) for pre-clinical & clinical studies.
• Client did not have in house pre-clinical & clinical experts to design a development plan for required studies.
• Client had limited ability to manage all the necessary studies and data analysis required for pre-clinical and clinical requirements.

Scope of work provided:

Due Diligence

• With the client’s existing data, PLG conducted a due diligence identifying possible gaps that could exist.
• PLG conducted robust literature searches using regulatory requirements and similar product types precedents to create a development plan for the product, inclusive of Good Laboratory and Good Clinical Practices (GLP & GCP).

Product Development

• PLG created the development plan and initiated contact with several CROs on behalf of the client to select the appropriate candidate to carry out the pre-clinical studies.
• Currently PLG is managing on behalf of the client the 180-day toxicology programme with upcoming studies, including 28 days of repeat dose toxicity, Safety Pharmacology, Metabolite Profiling, PK & Genotoxicity studies.

The client benefited from:

• A team of highly skilled and experienced pre-clinical & clinical experts to assess current data and design development plans.
• Qualification & Selection of CRO to conduct studies.
• A robust Project Management plan with allocated milestones to keep the project on track.
• In conjunction with the above SMEs, a dedicated Project Management team to assist in the collection of study data and keeping the client in constant communication for timely updates.

Added-value

• Specific Subject Matter Expert resources dedicated to the client’s project.
• A cost-effective solution with centralized project management & offshore operational resources.
• KPI: 80-90% reduction in the manpower needed due to automation instead of manual processes.

PLG success factors

• Flexibility in working with the client’s preferred schedule of payment.
• PLG’s holistic understanding of the client’s “wants and needs”, while managing the client’s realistic expectations.