How this in-depth, comprehensive, and systematic immersion into modern medical product development, and regulation, can benefit your career
Former ACDRS Course participants (alumni) rate the program as a tremendous success and benefit to their work and career. Here's what our alumni have to say about their experience in the Course:
"Participating in the American Course on Drug Development and Regulatory Sciences was a truly enriching experience. The course's structured approach provided deep insights into drug development and the regulatory process. The engaging lectures, real-world case studies, and practical exercises made the learning experience both informative and hands-on. The opportunity to network with experts and peers was invaluable. Overall, this course significantly enhanced my understanding of certain aspects and has undoubtedly benefited my career. I highly recommend it to anyone looking to deepen their knowledge of the biopharmaceutical industry, drug development, and regulatory sciences." —Joe Rappon, VP and Head of Pharma R&D, Alcon
"Attending ACDRS was one of the most rewarding experiences of my educational journey. It has helped me tremendously in my career. I felt so strongly about the value of this program that I joined the ACDRS family as a guest lecturer. It's not just what you gain in the time you spend at the sessions or the exceptional content, it's also the connections you make and the lifelong value you derive from it." —Mike Dyszel, R&D Project Excellence Lead, CSL Behring
"This has truly been the most useful and engaging training that I have ever attended. The content, presenters, and interaction with peers has been outstanding. The opportunity to learn from leaders in the industry is truly unique and provides a perspective that makes the ACDRS course so valuable. Whether you are new to product development, or have some experience in this field, you will undoubtedly find this informative and educational." —Magda Michna, Chief Clinical, Regulatory and Medical Affairs Officer for STAAR Surgical
“I was very fortunate to participate in the ACDRS course early in my career in drug development The course provided real-world examples taught by thought-leaders in the field from academia, regulatory agencies, and industry. Having classmates who also represented these co-operative facets of drug development enriched the experience by providing alternate viewpoints and opportunities for professional interactions.” —Kofi Mensah, Director, Early Development, Bristol Myers Squibb
“I want to tell you and all of the faculty how much I really enjoyed the course. I reference things that I learned in the past few sessions almost daily at work. I have a few colleagues who were considering if they should dedicate the time to the course and I told them that it absolutely is a good investment." —Tricia Blankenbiller, Vice President, Global Clinical Operations, Origin Biosciences
"As an MD/PhD Boarded physician-scientist, I was very impressed how the full Course spanning <12 months covered the wide landscape of diverse topics in development and regulation of medical products! This course has had a profound benefit in my career development and professional network. The complexity of our industry is very easily siloed into functional areas of expertise but a deeper appreciation for the cross-functional interdependencies are most critical for any program’s success. This course is a fantastic overview to learn virtually all the complex facets with first-principle must-know insights! I recommend this course with the highest of enthusiasm!" —Brian Tseng, Expert Consultant, NDA Partners
"Thank you so much for designing such a fabulous course. I personally found it very intriguing and learnt a lot from it. I would strongly recommend this course to my peer toxicologists."
—Anup Srivastava, Toxicology Reviewer, US Food and Drug Administration
"Numerous times I have been able to connect what I have learned in ACDRS to my 'day job.' The commitment of the program to provide an exceptional program with high quality speakers is quite evident." —Karen Looney, Senior Advisor, Diabetes Business Unit, Eli Lilly and Company
"Although I have career experiences from basic science research to pharmaceutical clinical trial support and development, I sought a formal course that could fill the gaps between on the job training and experience in drug development. The ACDRS course, highly recommended by a colleague, provided an A to Z experience which ranged from early to final stages of development. An intensive resource library for self-readings and expert in depth presentations and critical discussions were the foundation for a full exposure to progressive steps in developing a drug. Authors of books and FDA guidance documents, pharmaceutical executives and clinical and foundation professionals were the instructors. The pairing of these expertise with team discovering through case studies resulted in a dynamic learning process that both engaged and fortified my knowledge in statistical modeling, identifying a potential molecule for development, strategies for planning each phase of clinical trials, interpretation of results, go-no go decision-making and a number of other topics. Also this included multi-countries marketing applications and agency policies for a more expansive view of drug development and research planning. The course for me was an amazing experience from instruction and content to fellow participants and self-development that was both demanding and rewarding. The result is I am a more confident and engaged contributor with global understanding of drug development components when I sit at the planning and decision table at my pharmaceutical company. ACDRS did not disappoint. I have a lasting body of knowledge, resources and colleagues to reference and achieved the goal of filling gaps in my drug development knowledge. Thanks ACDRS!" —Deena Kegler-Ebo, Associate Director, Clinical Development, Medical Affairs, Acorda Therapeutics
"ACDRS provides a great opportunity to interact with peers from academia, industries and agencies. I appreciated the approach of walking through the pharmaceutical development process chronologically, using contemporary examples while emphasizing important lessons from history. Expert and engaging speakers challenged my thinking and expanded my knowledge. I especially appreciated the breakout sessions where we had opportunities to problem-solve various scenarios. ACDRS broadened my network and added to my problem-solving toolkit. I would highly recommend ACDRS to those of all experience levels. For me personally, I have always wanted a better understanding of PK/PD and Biostatistics. ACDRS was able to address these topics in engaging discussions supplemented with case examples and challenging exercises to drive growth in the areas." —Nick Langevin, Director, Regulatory Affairs, Sumitomo Pharma