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SERVICES

Strategizing

Portfolio Management

  • Target identification, prioritization and selection process

  • Strategy development (portfolio, non-clinical, clinical, BD, Regulatory)

  • Program/portfolio timelines (non-clinical, CMC, clinical, reg) from discovery to launch

  • Identify and management of CROs, CMOs & consultants (incl. cost negotiations)

  • Develop and maintain Dashboards, budget

Non-clinical Support

  • Design, monitor and execute studies (screening, pPOM, pPOC) 

  • Biomarker identification and development

  • Design, monitor & execute GLP PK/TK, Tox studies (rodents, large animals) 

  • Study reports suitable for regulatory filing

Regulatory & CMC Support

  • Briefing packages for pre-IND, EOP1, EOP2 meetings, NDA (non-clinical)

  • IND and NDA non-clinical sections

  • Management of CMC campaign and process improvement

Other

  • Develop materials for investor & BOD presentations

  • Patent applications

  • Advisory board & scientific meetings

  • Support clinical study designs and biomarker development

  • Poster & oral conference presentations & manuscript writing

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