UCSF

The Course

The American Course on Drug Development and Regulatory Sciences (ACDRS) is a nonprofit educational course that enables you to understand how to incorporate the latest innovative medical product development strategies, methodologies, and tools.

meeting participants

The course emphasizes integrated product development that is science-based, efficient, economical, high quality, and rapid, leading to better and safer medical products for patients.

Enrollment is open for 2021 ACDRS DC (Cycle 13). Contact [email protected] to receive email updates. 

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Who should attend?

This course is for:

  • the biopharmaceutical industry and its service industries
  • academic and government scientists and
  • decision-makers and policy-makers

who have a good grounding in drug development basics and can benefit from a more in-depth, comprehensive, and systematic immersion in modern medical product development, regulation, and market introduction.

The course specifically targets the following professionals:

  • Drug discovery and non-clinical development team leaders

  • Drug discovery and translational scientists from academia and industry

  • Drug and medical device product and clinical development team leaders and members

  • Clinical pharmacology and development team leaders

  • Clinical scientists

  • Therapeutic area and technology platform managers

  • Regulatory scientists from industry, academia and government

  • Portfolio, program, and project managers and team leaders

  • Knowledge transfer, partnering, licensing and legal experts

  • Heads of research and/or product development and business executives

  • Investors from venture funds and financial institutions

Why participate?

  1. ACDRS provides a detailed examination and comprehensive review of drug development with emphasis on state-of-the-art techniques and tools to enhance the efficiency and effectiveness of drug development. Course content:
    1. Meets today’s training gap in medical product discovery and development.
    2. Aims to advance integrated product development that is science-based, efficient, high quality, and rapid.
    3. Emphasizes requirements and best practices for the rational and rapid development of new products for the global marketplace.
    4. Incorporates online learning.
  2. ACDRS participants leverage their current expertise. They are all:
    1. In the biopharmaceutical and service industries, academic and government scientists and decision- and policy-makers who already have a good grounding in the basics.
    2. Looking for a rigorous, in-depth, comprehensive, and systematic immersion into modern medical product development, regulation, and market introduction.
  3. ACDRS builds knowledge and new networks. Participants:
    1. Integrate workplace goals with the education needed to better accomplish those goals.
    2. Gain in-depth knowledge on timely topics important to the successful development of medical products into the future.
    3. Actively engage in lectures, workshops, panel discussions, and team-oriented case studies.
    4. Build an international network of colleagues.
  4. ACDRS content is comprehensive and interconnected. Program content includes:
    1. Discovery and development of new medicines
    2. Biopharmaceutical sciences
    3. Clinical pharmacology, pharmacometrics and trial methodology
    4. Good clinical practice and ethics
    5. Pharmacovigilance and epidemiology
    6. Biostatistics and exploratory/confirmatory trial design
    7. Regulatory affairs and optimization
    8. Health economics
    9. Program, project and portfolio management
    10. Marketing and novel therapeutic approaches
  5. ACDRS faculty members are recognized international experts. Their backgrounds include:
    1. Regulatory sciences and policy
    2. Medical product discovery and development
    3. Product evaluation and business practices from United States and European universities, pharmaceutical, biotechnology, and device companies and regulatory authorities (including the FDA, EMA, MHRA, PMDA, and other regulatory agencies)

Learning objectives

You will be able to understand how to incorporate the latest innovative biopharmaceutical development strategies, methodologies and tools to:

  • Be prepared for future developments and changes of the global pharmaceutical, health economics and business environments, as it impacts product selection, product development, regulatory and business evaluations.
  • Design, evaluate and manage integrated product development programs and the resulting pharmaceutical R&D portfolio.
  • Devise timely Go/No Go decision-making criteria and procedures based upon critical analyses of non-clinical and clinical data sets leading to improved success rates for new drug candidates and devices.
  • Incorporate into milestone decisions, including early-on, the potential commercial value of development candidates/products and their return on investment.
  • Address real-world challenges encountered during the development, manufacturing, review, and commercialization of FDA-regulated medical products.
  • Prepare and critique an integrated product development plan.
  • Optimize and critique clinical and non-clinical protocols.
  • Incorporate integrated product safety management programs.
  • Incorporate present and future regulatory policies, guidances, and opportunities into US FDA meetings with sponsors and NDA and BLA reviews.
  • Participate in decision making discussions with a comprehensive knowledge of medical product development from discovery to market. 
  • Effectively understand and network a given corporation’s structure and functions.
  • Understand the legal basis of regulatory authorities and current developments.
  • Prepare for the next career step.

Participant testimonials

"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, Senior Director, Global Portfolio & Program Management, Mallinckrodt Pharmaceuticals

"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."
Magda Michna, Chief Global Clinical and Regulatory Affairs Officer, AcuFocus, Inc.

“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, MD, PhD, Director, Early Development, Bristol Myers Squibb

"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, Associate Director, Regulatory Affairs, Boehringer Ingelheim

“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, Vice President, Global Clinical Development Neurology

"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

Details at a glance

When

  • For Cycle 13: March 2021 to December 2021

Where

The location can change from year to year. Previously:

  • 2019-2020 Cycle 12: Washington DC

  • 2018-2019 Cycle 11: Washington DC

  • 2017-2018 Cycle 10: Washington DC

  • 2016–2017 Cycle 9: Washington, DC

  • 2015–2016 Cycle 8: Washington, DC

  • 2014–2015 Cycle 7: Washington, DC

  • 2013–2014 Cycle 6: San Francisco, CA

Schedule details available on each cycle’s page.

Commitment

  • six sessions spanning 9-10 months

  • each in-person session is three days (virtual/online is five half-days)

  • each in-person day is eight hours (virtually/online is four hours)

  • 14 case studies

  • one certificate course examination

  • includes “team” involvement in mentored, case-oriented workshops

  • includes online learning

  • eight hours per session is spent preparing for the case study workshops

Audience

Professionals involved in the medical product development process

Eligibility

You must:

  • have a higher university degree, such as MD, PharmD, PhD, Master’s, or JD  (Applicants without terminal degrees but with extensive product development will be considered)

  • have a primary interest in medical product discovery, development, regulation, or related activity.

  • have at least one year of work experience in medical product development.

  • be qualified via standards and nominations by submitting a one-page curriculum vitae to [email protected] prior to or immediately following registration.

Registration fee

  • $13,500 before or on the early registration deadline

  • $15,000 after the early registration deadline

  • A discounted fee for a limited number of participants from academia and government is available. Please contact [email protected].

Administrative details

  • Enrollment is limited; we encourage you to register well in advance.

  • If you cancel before the cancellation deadline specified on the cycle details page, the fee less $900.00 for administrative expenses will be returned. There will be no substitute registrants or refund on cancellations made after the cancellation date.

  • Should a course session be postponed due to events beyond our control, your tuition will be applied to a rescheduled session.

Certification

A certificate is awarded upon completion of the course.

How to attend

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participants socializing with refreshments

See 2021 ACDRS DC (Cycle 13).

For questions, email [email protected].