LATE-STAGE CMC,
CLINICAL DEVELOPMENT & COMMERCIALIZATION

Late-Stage Clinical Development and Commercialization, NGT BioPharma Consultants

NGT BioPharma Consultants is mindful that contemporary drug development emphasizes quality data, informed decision-making, and speed. Early- and late-phase development are intended to be seamlessly integrated and, at times, combined. Our expert consultants and interconnected provider network are highly experienced in the many integrated facets of late-phase development, beginning at or before Phase 2 and continuing through registration, commercial launch, and life cycle management.

The NGT team coordinates and manages client-customized API/DP process development/supply, clinical development, regulatory strategy/submissions, and quality/compliance programs to expeditiously attain marketing approval and achieve commercial success. We work collaboratively with our customers to mitigate risk while maximizing their drug products’ safety, efficacy, and commercial value. NGT provides the following Strategic and Operational services: 

Strategic

  • Develop global clinical development and regulatory strategic plans through registration and commercialization
  • Explore opportunities for US and EU accelerated development and approval, eg., orphan drug/rare disease designation, expedited programs such as PRIME (EU), fast track/breakthrough therapy designation, priority review, and phase consolidation
  • Assess whether API and drug product manufacturing processes and methods are ready for pivotal clinical studies and commercial validation and launch
  • Ensure pivotal studies and clinical endpoints address clinical needs, regulatory guidelines, and market access requirements
  • Optimize pre-approval and post-approval regulatory plans, including regulatory agency engagement plans
  • Outline clinical pharmacology and nonclinical plans to support late-phase clinical trials and completeness for registration
  • Manage life-cycle indications taking into consideration market/competitor activities
  • Establish Quality Risk Management (QRM) strategies

Operational

  • Prepare and/or review essential clinical trial documents, e.g.;
      • Clinical study synopses and protocols/protocol amendments
      • Patient information, informed consent, and case report forms
      • Clinical Study Reports (CSR)
      • Investigator Brochure (IB)
  • Develop, review and submit regulatory documentation, e.g.;
      • Investigational applications and updates (g., IND, CTA, IMPD)
      • Meeting requests and briefing books for regulatory agency meetings (e.g., EOP2, pre-NDA, pre-BLA)
      • Marketing applications (g., NDA, ANDA, BLA, MAA)
      • Annual reports, amendments and supplements
      • Drug Master Files (DMFs)
  • Manage regulatory agency interactions on behalf of the sponsor
  • Oversee clinical studies and interpret clinical data
  • Optimize commercial formulation and dosage manufacturing process
  • Develop and review the proposed product labeling for regulatory submission
  • Develop and integrate market access insights into clinical and commercial decision-making
  • Oversee the outsourcing of, e.g., clinical studies, safety/tox studies, CMC development, and API/DP manufacturing
  • Validate/qualify facilities, utilities, equipment, analytical methods, processes, and computer systems

COMMERCIALIZATION 
Leo Adalbert 
Head of CommercializationLeo Adalbert, NGT BioPharma Consultants860-333-9023
[email protected]

LATE-STAGE CMC & CLINICAL DEVELOPMENT 
Michael K. O’Brien, PhD
President & CEOMike K. O'Brien NGT BioPharma Consultants860-207-8135
[email protected]

CASE STUDY – Late-Stage Development Report

Situation

A start-up company with an asset ready to enter Phase 3 enlisted the support of NGT’s consultants to prepare an end of Phase 2 product development report, which was to include an assessment of the company’s CMC strategy and an articulation of the steps necessary to achieve the commercial cost of goods target. The start-up company executives indicated that the report was also to be presented to a potential commercial partner.

Solution

NGT’s consultants created a regulatory and technology development report that included levers to reduce the cost of goods and a framework for finalizing the API and DP commercial processes. NGT’s consultants also performed an eCTD submission gap assessment (e.g., evaluation of critical process parameters, critical quality attributes, and material attributes) and provided a regulatory starting material strategy. In addition, a digital validation lifecycle management solution was introduced to fulfill validation requirements, including customized risk and knowledge management processes.

Impact

The commercial partner endorsed the cost of goods reduction proposal and other CMC recommendations enabling the start-up company to secure the finances necessary to proceed into Phase 3.