Service

Support & Concepts for Innovative Cancer Drug Development           

Create New Horizons

Hentsch Consulting provides drug development advisory services to life science customers for innovative drug development (NCE/NBE) focussing on cancer drug development, but also comprising inflammatory disorders.

Our goal is the successful translation of your research into effective drug development processes by identifying, defining and implementing a thorough strategic and regulatory path for your product development targeting a coordinated development and approval process.

Please find below an overview of our key areas of expertise.

• Clinical Development (GCP)
  • Drug Development Strategy
  • First-In-Man-Studies to Advanced Stage Development
  • Key Opinion Leader Identification and Management
  • CRO Management
• Personalized Medicine
  • Translational Research
  • Biomarker Development, Companion Diagnostics
  • Targeted Therapies (NCEs, NBEs)
• Regulatory Affairs
  • Regulatory Strategy
  • National and Central Scientific Advice Processes (incl. FDA, EMA and national authorities, e.g. BfArM)
  • Orphan Drug & INN Designations
• Oncology & Inflammation R&D
• Epigenetics R&D (e.g. chromatin modulating agents)
• Preclinical Development (GLP)
• CMC development (GMP)
• Biotech Start-up Support
• Business Development
  • In/Out Licensing
  • Due Dilligence Processes

Generally, support provided by Hentsch Consulting can be categorized in three main groups, differentiated by the level of operative involvement into your R&D drug development processes.

• 1st Level : Evaluation of R&D programs

R&D project analyses, assessments and evaluations. This level of service supports customers in processes of evaluating internal or external R&D programs, assessing their status and chances in order to deliver recommendations on the further path of these developments.

• 2nd Level : Supervision of drug development processes

To allow for a more extended support of your drug development projects, we also offer to operationally work together on a part time basis with your teams. This may comprise an organizational workflow of regular meetings, up to part time operative integration at your site.

• 3rd Level : Management of drug development processes

This level involves an advanced operational inclusion of our services and expertise on a temporary basis as an integrative part of your development team comprising an operative presence at your site. Functionally, also possible leadership roles can be envisioned (e.g. acting CDO function and/or service).

Already in the earliest phase of discussions with our customers it is most important to us to jointly evaluate what added value our services could bring to your projects. Only once a clear common understanding of the needs and goals of a development path, and also a premium effect of our contribution has been identified and jointly agreed, the collaborative and operative services will be started.