SERVICES
Portfolio Management
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Target identification, prioritization and selection process
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Strategy development (portfolio, non-clinical, clinical, BD, Regulatory)
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Program/portfolio timelines (non-clinical, CMC, clinical, reg) from discovery to launch
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Identify and management of CROs, CMOs & consultants (incl. cost negotiations)
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Develop and maintain Dashboards, budget
Non-clinical Support
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Design, monitor and execute studies (screening, pPOM, pPOC)
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Biomarker identification and development
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Design, monitor & execute GLP PK/TK, Tox studies (rodents, large animals)
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Study reports suitable for regulatory filing
Regulatory & CMC Support
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Briefing packages for pre-IND, EOP1, EOP2 meetings, NDA (non-clinical)
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IND and NDA non-clinical sections
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Management of CMC campaign and process improvement
Other
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Develop materials for investor & BOD presentations
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Patent applications
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Advisory board & scientific meetings
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Support clinical study designs and biomarker development
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Poster & oral conference presentations & manuscript writing