Prof. Thomas Bieber, MD, PhD, MDRA
Höhenweg 101
53127 Bonn
Germany
Prof. Thomas Bieber, MD, PhD, MDRA
Höhenweg 101
53127 Bonn
Germany
Overall clinical development strategy and integrated evidence plan
Drawing on extensive experience as a consultant and member of advisory boards for numerous small and large pharmaceutical companies, Professor Bieber has played a pivotal role in the successful development of many currently approved drugs in dermatology and allergy. He can contribute his expertise to shape your clinical development strategy and integrated evidence plan. Serving as a guide, he will assist in crafting a customized path leading to a successful marketing authorization and launch.
Design of clinical trials
Having served as a Principal Investigator (PI) in hundreds of clinical trials, he offers significant expertise in designing various types of trials across the entire clinical development plan, spanning from Phase 1 to Phase 4. Whether your intention is to streamline a traditional Proof of Concept (PoC) study (Phase 2a) by incorporating patients into a well-designed Phase Ib or to optimize pivotal Phase 3 studies within a regional or ICH-compliant global development plan, his guidance can prove instrumental. His proficiency extends to the reflection and design of post-marketing studies, including Post-Authorization Safety Studies (PASS) and Post-Authorization Efficacy Studies (PESS, as in the case of conditional approval). Additionally, he possesses expertise in pediatric investigational plans (PIP and PSP) and adaptive trial designs.
Regulatory aspects
The drug regulatory framework forms the cornerstone of your clinical development strategy and plan. Leveraging his regulatory background, BDC consulting activities will inevitably incorporate regulatory aspects into any strategic considerations
Market access issues
In certain global regions, medication access is progressively governed by third-party payers. In Europe, Health Technology Assessment Agencies (HTA) pose a unique challenge as they assess the added value of new drugs on a national level, representing a sort of fourth hurdle in drug development strategy. Proficient in shaping numerous HTA dossiers in recent years, BDC expertise will assist you in optimizing your market access strategy and navigating the evolving European HTA landscape, which is gradually moving towards a more harmonized procedure.
Advice for investors
The healthcare market continues to be a growing and attractive sector for well-informed investors. The rise of new technologies has facilitated the development of innovative diagnostic and therapeutic approaches, driven by numerous start-ups and small companies. These entities gradually implement research and development efforts originating from pharmaceutical companies. With its specific background and experience, BDC can assist potential investors in identifying promising projects that merit support.
