Larka

Novel Treatment Acquisition

Customer Experience - Pharma company acquired a biotech product - recombinant protein - at proof-of-concept phase. They needed support to build a technical development plan.

 
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I Need An Experienced Project Manager.

Context

PharmaCo acquired a biotech product at proof-of-concept phase. The product was a recombinant protein and the company aimed at going into phase 1. They needed support to build a technical development plan from cDNA to phase 3 and to identify CDMOs for both cell-line development and process development.

Company Profile

  • German company
  • 150+ employees
  • Above 400mn EUR of revenue
  • 10 marketed products and 8 in development

Larka's Scope Of Intervention

Larka's project management team covered the following tasks:

  • Phase 1 - Technical development plan
    • Data collection: historical data, expression results, product characteristics, expected volume, number of patients, geographical areas that should be covered during clinical trials
    • Target Product Profile – TPP – definition (primary indication, patient population, treatment duration, administration mode, dosage form, regimen, efficacy, side effects)
    • Technical development plan drafting and risk analysis: definition of master plan and back-up plan, including quality, HSE, economics and throughput criteria
    • Definition of the scope of collaboration with the CDMOs: schedule, productivity, costs, quality, type of collaboration, scope of responsibilities
    • RFPs drafting: Cell line development and Drug substance process development
  • Phase 2 - CDMO Sourcing
    • CDMOs screening and identification, relying on analysts’ desk research and Larka’s extensive database
    • CDMOs RFP management
    • CDMOs proposal analysis and shortlist selection - 3 max
    • Technical audits – due diligence – for selected CDMOs
    • Quality audits
    • Recommendations on short-listed CDMOs based on observations during technical and quality audits, risk analysis, definition of next steps until phase 1 initiation, and validation of the short listing
    • Together with the client, final selection of primary choice of CDMO and backup choice in case primary not available for any reason
  • Management of the project with the CDMO

Conclusion

  • Technical development plan was detailed, accurate and well-structured so the CDMO sourcing process could be fast, relevant and reliable, with clear and understandable RFPs
  • CDMO screening encompassed Europe and North America. Thanks to Larka extensive knowledge of the market, the screening covered 100% of the players (for cell line development and DS process development) so the client could have an exhaustive list of potential suppliers and options
  • CDMOs sourcing process was done within a 12 weeks’ timeframe, from identification to recommendations
  • Client followed Larka final recommendations and is currently working with their CDMO primary choice (CDMO able to develop cell line and DS process)
  • Risk analysis allowed the client and the CDMO to anticipate potential issue, so the project is progressing well
  • Larka is working hand-in-hand with the CDMO to make sure the client is fully satisfied with the project management and progress (data collection, data analysis, technical issues solving, budget monitoring, timelines, reporting)