December 6, 2023
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
I review and evaluate clinical development programs for, mostly, emerging and medium-size biotechnology companies - assessing their adequacy for a successful engagement with the Food and Drug Administration (FDA), from a scientific and medical perspective. A key objective is to identify any gaps in their programs and to make recommendations for strengthening and describing them in a clear and compelling way, increasing the chances of FDA agreement to allow their advancement.
I really enjoy the sheer variety and complexity of the programs that our clients bring to us. The degree of creativity and innovation can be incredible! The people in our client companies come from all over the world. They are smart, driven and bring an energy to program discussions that is infectious. Helping them successfully navigate the engagement process with the FDA is challenging - and gratifying.
Advancing pharmaceutical product development programs with finite resources remains a huge challenge. Identifying the right people with the knowledge and experience designing and executing clinical programs to achieve program milestones in an environment with finite resources who also communicate well and are not afraid to roll-up their sleeves is significant challenge for emerging companies. ProPharma continues to identify and hire talented scientists who are experts in their field but are also grounded by the realities of drug development.
Wow – so many lessons! Developing new medicines is a team effort that depends on the leadership of team leaders as well as individual team members. Just as important as the right strategy is the need to engage stakeholders – enabling them to ask questions and to make suggestions and, of course, to always focus on the needs of patients.
ProPharma is a unique organization consisting of experienced and knowledgeable people who are committed to scientific excellence, who understand the pressures that our clients face to advance their products. The people are also genuinely nice and fun to work with!
November 2, 2023
Expert Consultant, Regulatory Sciences Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a...
December 14, 2023
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...