Scientific Affairs
Scientific Affairs that Make a Difference
The regulatory landscape for drug approvals can often be a labyrinth to navigate through when trying to bring novel, life-saving medicines to the marketplace and to patients in need. With this in mind, the BioPharma team recognizes the value of our in-house expertise, having spread our wings over a diverse number of clinical drug development programs for multiple therapeutic areas. Led by Dr. John Oldenhof and his 18+ years of being involved in innovative clinical development program design, BioPharma believes the blending of our expertise together with our clients proves to be a potent and effective strategy in the advancement of medical research.
The Scientific team at BioPharma includes a subset of seasoned Pharmacokinetic Scientists and Clinical Research Scientists responsible for drug development and protocol design across multiple regulatory markets. Together, this team can advise on creative methodologies and innovative early-stage clinical development plans for all drug programs from generic equivalents to novel chemical entities. Designs include:
- First in Human (FIH)
- Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD)
- Absolute bioavailability
- Safety and Tolerability
- Food Effect study
- Age and gender
- Dose proportionality
- Drug-Drug and Alcohol interaction studies
- Human Abuse Potential/Abuse Deterrent Assessment
- Medical Cannabis
- Pharmacokinetics/Pharmacodynamics (PK/PD)
- Exploratory clinical models for Proof-of-Concept decision making
- BA/BE for all dosage forms (including solid oral formulations, transdermal patches, inhalation products and deport injections)
All study designs and clinical development plans at BioPharma are supported by our panel of expert Medical Physicians, that ensure foremost, that the safety and well-being of our study volunteers is priority. Whether the strategy is to dose a generic drug equivalent in healthy volunteers versus a patient panel or proceed with a new drug candidate, our Physician team’s primary objective is to maintain the health and welfare of our subjects with ethical considerations driving their decisions. By understanding the drug product’s pharmacokinetics, pharmacodynamics, mechanism of action and potential serious or adverse events, our Physicians provide safe, reliable, data driven solutions to clinical development programs.
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