PRECLINICAL
DRUG DEVELOPMENT
NGT BioPharma Consultants understand the challenges our clients face when developing preclinical candidate drugs. To succeed in this space, we work collaboratively with our clients and customize our services to efficiently navigate preclinical development’s interdependent processes, enabling initiation of First-in-Human (FIH) studies. Our collective expertise and extensive experience is leveraged toward developing business plans; evaluating risk, intellectual property, and market landscapes; solving complex CMC issues; outsourcing/managing manufacturing and nonclinical study activities, and interacting with US and international regulatory agencies. NGT provides the following Strategic and Operational services:
Strategic
- Analyze financing strategies
- Assess candidate risk and develop mitigation strategy
- Review and assess Intellectual Property
- Evaluate market and competitor landscape
- Identify optimal clinical indications (Target Product Profile)
- Produce Product Development Plans that include:
- Regulatory blueprint
- Nonclinical and clinical development strategies
- Commercialization strategy
- Drug supply plan
Operational
- Prepare business plans, investment solicitation pitch decks, and investor letters of introduction
- Conduct due diligence
- Project planning and management
- Evaluate predictive models and alternatives to animal testing
- Design nonclinical studies and analyze/interpret resulting data
- CMC problem solving, including:
- API and drug product characterization, analytical methods development, solid-state optimization
- Drug synthesis development
- Preformulation/formulation development and dosage form selection
- Coordinate and oversee outsourcing of nonclinical studies, CMC laboratory activities, API/drug product manufacturing, and FIH studies
- Lead regulatory agency interactions
- Prepare for and participate in US Pre-IND meetings
- Produce regulatory submission documents, including Investigator Brochures, US IND, or EU CTA applications
CONTACT
Michael J. Neeb, PhD,
VP Preclinical Development & Business Development
610-999-6494
[email protected]
CASE STUDY – Candidate To Clinic Acceleration
Situation
A pharmaceutical company’s promising lead compound unexpectedly failed in a Phase 1 trial due to insufficient exposure. Despite the trial failure, the company had confidence that the knowledge and experience gained from previous pre-clinical pharmacokinetic (PK) testing and the Phase 1 trial would allow them to quickly and efficiently advance structurally similar compounds.
Solution
NGT’s consultants identified structurally similar compounds from the company’s candidate drug library that met the desired in vitro criteria and had profiled well in a non-human primate PK study. Two of these compounds were selected for testing in healthy human volunteers.
Impact
Focusing on molecules structurally similar to the first asset enabled the company to leverage the lead's preclinical safety package and profile multiple compounds in a new Phase 0/1 study at sub-therapeutic doses. Ultimately, the company selected a new progression compound more quickly and at a lowered cost compared to the original lead compound's development.
