Drug Development Solutions
Burt Consultancy, LLC. provides strategic, and phase-specific, drug development consultancy services. It has a wide network of multi-disciplinary subject-matter experts ready to be mobilized to manage your asset's developmental needs.
Check our AAPS Phase-0 webinar at: AAPS-webinar-Phase-0
The core expertise of this drug development consultancy is in early phase clinical development, CNS drug and device development, and drug development life-cycle management, based on leadership roles in industry, academic CRO, and consultancy projects. The scope is further expanded through consultancy experience and collaborative network expertise across all phases of development, all therapeutic areas (including rare diseases and pediatrics), with small molecules and biologics.
Drug development is an emerging area of professional specialty. To be successful, clinical development experts have to connect and mobilize multi-disciplinary collaborations. Such collaborations should be specifically tailored to the needs of the test article, the healthcare system, and the competitive environment. In addition, they should lead to feasible and efficiently executed programs, and, most importantly, to meaningful and actionable results. Our international multi-disciplinary network of drug development experts is here to make this vision a reality for your developmental programs.
Early-phase clinical development programs is core expertise. It includes IND/eIND applications, Phase-0 /Microdosing approaches (https://rdcu.be/b61rf), and Proof-of-Concept (POC) programs (i.e., late Phase-1 / early Phase-2. In particular, support at the POC stage, and Phase-0 first-in-patient studies is valuable since it provides specialized drug development consultancy assistance at the stage with the highest attrition rates, almost twice that of Phase-1 and Phase-3 stages. In addition, the POC stage is most vulnerable to error since studies are typically small, short, and under-powered.
Burt Consultancy specializes in CNS drug development, including the development of antidepressants, mood stabilizers, anti-psychotics, and neurodegenerative agents. Such drug development consultancy services include regulatory, study design, 'pharmaco-omics', clinical pharmacology, and modeling and simulation expertise among others. In addition, the consultancy services capitalize on experience with cutting-edge developmental methodologies and the most treatment-resistant patients.
The drug development consultancy services include strategic support such as life-cycle management. This is applied at each stage of development by considering a range of stage-specific tests. Capitalizing on emerging knowledge about the test article and competitive environment, such tests are meant to exploit potentially important developmental opportunities. This is done in a timely fashion by subject-specific experts who are connected in real-time to the development team. Burt Consultancy provides sponsors with such support (see examples under 'Portfolio).
A highly qualified international inter-disciplinary collaborative team at your disposal to provide strategic, scientific, methodological, and operational consultations in clinical research and drug development
We want to hear from you about your assets, your challenges, your needs. Let our collective expertise bring the solutions your development programs need. Contact us!