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.
Meet Mukul Agrawal, Senior Director, Clinical Pharmacology
What do you do at ProPharma? How does your role support improving the health and safety of patients?
As a Clinical Pharmacology SME, I work with clients to help bridge the gap between the science of drug development in the lab and its effective use in the wider patient population. Clinical Pharmacology brings together a range of topics that characterize the interaction between drugs and humans such as pharmaceutical chemistry, biopharmaceutics, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenomics, drug interactions and clinical trials.
Applying the principles of clinical pharmacology, I work with a range of drugs from small molecules to complex biologics, spanning all therapeutic areas and dosage forms with the ultimate goal of delivering the most appropriate drug product formulation and treatment regimen to each patient. A significant portion of a drug product's label is directly influenced by clinical pharmacology and therefore directly impacts patient health and safety. I work closely with the other experts, including regulatory bodies, to carefully develop the content of the labeling to provide the most relevant and accurate information to the prescribers and patients.
I work closely with pharmaceutical clients from early in the drug development program to provide strategic guidance and assistance in putting together a comprehensive clinical pharmacology package to facilitate efficient regulatory submission and approval.
What is one lesson you've learned in this industry that has most helped you?
We work in a highly regulated environment due to the significance of our work in ensuring the well-being of patients. Regulatory authorities are not just policing agencies but rather agencies who work with interested parties in bringing safe and effective treatment options for patients while maintaining the security and integrity of these products. The best course of action when dealing with regulatory bodies is being open and candid and having a collaborative attitude rather than trying to conceal or misrepresent data. The sooner the sponsors engage with the regulators, the better the chances of a successful collaboration. It is also necessary to keep in mind that regulatory authorities have to carefully balance science and regulation and although a perfect overlap sometimes does not exist, a reasonable path forward can usually be found towards a successful outcome.
What do you like best about working with clients?
I work with clients at the forefront of innovation and the excitement of learning and contributing to the success of these innovative therapies is the best part of my work at ProPharma. Each client brings a new idea or product that they are passionate about and that they want to bring to market. There are many projects that require thinking outside the box to come up with a strategy tailored to the unique characteristics of the drug candidate or product. This involves close collaboration between the client, ProPharma experts, and regulatory agencies, to leverage existing technology and knowledge to tailor it to the novel application. Being part of the multidisciplinary team that develops and implements this strategy is very fulfilling for me.
What's your number one goal / focus right now?
My number one goal in my work is to provide the best clinical pharmacology guidance and support to our clients in their drug development programs. By staying current with the latest advances in my field, I can successfully guide our clients as they develop new and innovative therapies. My ability to contribute to the success of my clients depends on my ability and commitment to stay at the forefront of developments in my field.
What is unique about our culture at ProPharma?
ProPharma's culture of innovation, collaboration, and respect for one another is a unique combination in a large company. Although ProPharma is a large company, we maintain the agility and responsiveness of a small company and are therefore able to assist our clients by providing the best solution and the shortest turnaround time. The focus on innovation and continuous learning allows us to stay at the forefront of technical and regulatory developments, and with the collaboration between the experts from the various areas of expertise, we are able to provide a comprehensive solution to our clients. Respect for all colleagues irrespective of their position makes ProPharma a highly desirable place to work.
