Clinical development

Clinical development strategy

Our clinical consulting team comprises seasoned pharmaceutical physicians with many years of drug development experience. Our consultants have extensive experience of planning and implementing clinical development programs, both for biotech and multinational companies, for small molecules and biologics, across a range of therapeutic areas.

They have made significant contributions to the development of numerous launched products and have held global responsibilities for marketed medicines. The team’s work spans most aspects of clinical development, including:

  • clinical development strategy
  • clinical development plans
  • understanding current standards of care
  • mapping the competitive landscape
  • selecting indications to best suit the strengths of an investigational agent
  • providing medical support to clients for interacting with the FDA and European medicines agencies
  • operational support
  • preparing dossiers and submissions
  • developing protocols
  • developing target product profiles
  • regulatory support
  • advising on organizational structures, including job descriptions and hiring documents
  • developing and reviewing clinical standard operating procedures
  • clinical governance
  • GCP compliance
  • medical affairs (pre- and post-launch)
  • pharmacovigilance consultancy
  • medical monitoring

Most of our work focuses on oncology. However, it has also included diabetes/metabolism, rare diseases, neurology, respiratory diseases (including asthma), and antibiotics.

Case study: defining a clinical strategy in oncology

Challenge

A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations.

Solution

Our oncology consultant Edward Garmey created a detailed timeline and gap analysis for the company’s initial IND filing and Phase 0-l clinical trial launch. This involved:

  • reviewing relevant documents, including the technology, pre-existing corporate, scientific and clinical goals, and any preclinical data
  • holding interviews with key stakeholders including company founders, the CEO and the internal R&D team
  • reviewing potential target cancer indications and establishing up-to-date standards of care
  • reviewing relevant biomarkers to inform PK/PD activity and patient enrichment strategies
  • preparing a clinical development plan including prioritization of target indications, design of Phase 0-lla clinical trials and proposal for clinical trial investigators and sites
  • developing an interval-to-IND filing gap analysis.

Our consultant presented to the Board and was retained as an ongoing medical advisor to the company. Further case studies regarding the work Alacrita performs in clinical development are available here.

Related Case Studies

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