Paediatric Drug Development: The Role of Extrapolation, Modelling and Simulation
Published Feb 16, 2024
Published 11th January 2024
In the ever-evolving landscape of pharmaceuticals and regulatory affairs, DLRC welcomes a visionary leader, Alisdair Falconer, the newly appointed Director of Regulatory Consulting.
With a passion for science and a commitment to societal betterment, Alisdair’s career has led him on a journey from the laboratory bench to directorship of a global regulatory consultancy. His illustrious career trajectory stands as a testament to the profound impact of regulatory affairs on the drug development process. In this exclusive Q&A interview, we delve into Alasdair’s motivations, insights, and strategic vision as he assumes his pivotal role at DLRC.
“I have always had a love for science and a desire to pursue a career in an industry that has a positive impact on society. I was inspired to undertake an industrial placement in Medicinal Chemistry after reading an article about the discovery of Salbutamol while I was studying at the university. Following the conclusions of my studies, I wished to transition from being a bench chemist, so I started to explore Regulatory Affairs. Regulatory Affairs plays a pivotal role in the drug development process, making it a perfect fit for fulfilling my career ambitions and I have never looked back.”
“I have always been open to working on a broad range of projects in regulatory affairs throughout my consulting career, whether it involves operational activities or supporting innovative products getting to market. Additionally, I spent four years placed at pharmaceutical companies giving me another view of the development process. These experiences have provided me with a holistic understanding of what it takes to successfully deliver projects to clients in the field of Regulatory Affairs.
Furthermore, over the years, I have come to increasingly appreciate the significance of organizational culture. This is particularly important in consulting, where the services our people provide are our product. The consulting teams that perform the best in my experience are consistently those with the most positive culture. While it may not always be feasible to keep everyone satisfied at all times, I’ve found that when people feel supported and valued, they are much more likely to consistently deliver at or above the level of excellence expected by our clients.”
“There is a wonderful culture here at DLRC that has served as the driving force behind our team’s commitment to delivering a high-level service. This dedication has subsequently fueled the incredible growth of the organisation over the past few years. When speaking with the team, there is a lot of praise for how the leadership has skillfully managed the recent expansion, with a strong focus on preserving that very culture.
As we continue to expand, my objectives involve developing governance and processes that optimize the delivery of our services, aligning them with our clients’ needs and supporting innovation within the organization. However, I believe that this must be accomplished in a way that upholds our distinctive culture. This, in turn, will ensure that we not only meet and exceed customer expectations but also continue to experience sustainable growth.”
“I believe that ensuring people feel valued and heard is critical for establishing a positive work culture.
In terms of feeling valued, I consider it important to support the team’s development and help individuals achieve their career objectives to the best of our abilities. Flexibility is also a crucial aspect of this value, allowing individuals to effectively balance their home and work lives. I believe DLRC already demonstrates a strong commitment to this value in its culture.
Regarding the value of ensuring individuals’ voices are heard, I intend to maintain an open-door policy that encourages people to share their ideas openly and feel confident in speaking candidly when necessary. I prefer direct communication whenever feasible with team members, aiming to foster familiarity and confidence to better facilitate this value.
I also believe it is crucial to embody these values in my own work, as doing so will help these principles permeate throughout the Consulting team.”
“I want them to know that we have a brilliant team of experienced, enthusiastic, and innovative Regulatory Affairs experts who are passionate about making medicines available to patients. This passion is evident in everyone I speak to, and it drives the innovative and creative spirit within the team.
Our team is committed to discovering the best regulatory pathways and establishing logical justifications, even in cases where the rules have yet to be clearly defined, all in pursuit of this goal. They consistently go beyond fostering collaboration and, when necessary, to challenge regulatory authorities to achieve these objectives. This commitment enables us to provide an industry-leading service to our customers.”
“I would advise them to develop a solid and thorough understanding of Regulatory Affairs. While pursuing their goals, they should also maintain an open-mindedness towards embracing a diverse range of tasks. This will provide them with a genuine grasp of the profession and the industry’s requirements.
Another crucial aspect is learning how to manage people effectively and elicit their best performance. Being ready to attentively listen to others and genuinely comprehend their perspectives is equally important.
Lastly, aspiring decision-makers should acquire an understanding of the business drivers in the pharmaceutical industry, comprehending how these factors influence regulatory affairs and impact their organisation.”
Alisdair Falconer’s appointment as Director of Regulatory Consulting represents an exciting opportunity for DLRC, further enhancing our commitment to innovation, expertise, and leadership. His journey from a passionate science enthusiast to a seasoned regulatory expert serves as an inspiring narrative for aspiring professionals in this field. As Alisdair steps into his prominent role at DLRC, his commitment to fostering a positive work culture, prioritising values that elevate individuals and their contributions, and delivering unparalleled service to clients stands as testament to his dedication and vision for the future.
Curious about how our services can benefit your organisation? We’re here to assist you in navigating the regulatory landscape and achieving your goals. Reach out to our team using the link below to explore how DLRC can tailor our expertise to meet your specific needs and drive success in your projects.