Translational Science and Strategy/Development Implementation
Project Leaders & Project Management Leader Oversight
Target Product Profile, cross-functional development plan generation and translation between phases
Research
- Due diligence/gap analysis, incl. competitive landscape
- Portfolio prioritization
- Target validation & lead selection
Translation
Preclinical development
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Design and develop CTA/IND enabling package:
Preclinical tox/ADME, translational work, IB -
Regulatory strategy and interactions
Translation
Early clinical development
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CTA/IND
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Indication prioritization and selection
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Early-stage clinical development and scenarios, including translational activities, FIH and POC trial designs, KOL interactions and SAB boards, endpoint selection
Broad coverage across therapeutic areas and therapeutic modalities:
small/large molecules, oligonucleotides, cell & gene therapy, vaccines, combi with medical devices
Management of strategic and translational activities from research to early clinical development including but not limited to:
Portfolio management, resource capabilities and organizational growth plan
Overall project management / leadership
Translational science, incl. biomarker strategy
Preclinical and early-clinical development plans
Preclinical study management
Regulatory interactions (e.g., PIP,…)
Chloë Scheldeman
Senior R&D Manager, Scientific Development
A senior Pharmacist and scientist at heart with a Ph.D. and Postdoc in Pharmaceutical and Medical Sciences with excellent communication and writing skills and Project Management experience.
As a scientist, my role is to support the scientific development of our client’s healthcare product. Basically, I will provide scientific advice tailored to the specific needs of a client, be it pre-clinical or clinical. Sometimes clients have a very specific need, e.g. support in the set-up of pre-clinical studies or a need for strategic development advice.
I am often involved in cross-functional teams. For example, we supported a client in preparing for Scientific Advice with regulatory authorities to obtain input on the design of their pivotal PhII/III study. To that purpose, we assembled a team consisting of the right experts, a CMC, Medical, Clinical and Scientific expert, each to provide their advice and consolidate it together with the client’s CMC and pre-clinical data in a briefing book outlining the client’s proposed strategy. And this also underscores the strengths of 2 Bridge: we can provide you with a complementary team of experts to guarantee you the right expertise at the right time, avoiding unnecessary recruitment and waste of time.
”Excellent science is the foundation for and the common thread during the development of a healthcare product.