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Course Date: 15 September 2014 to 17 November 2014 (9 weeks)
Students will learn the process of drug discovery and development through specific examples of case studies to better understand the issues facing the challenges of delivering a new drug on the market. At the completion of this course you will be able to have a better understanding of how a small or large molecule becomes a pharmaceutical drug.
Dr. Williams Ettouati received his Doctorât d' État en Pharmacie from Université René Descartes, Paris V and a Master Arts Biology, University of California, Santa Barbara.
He is currently Director, Industry Relations and Development and Health Sciences Associate Clinical Professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) at the University of California San Diego.
Dr. Ettouati’s role at the Skaggs School of Pharmacy is to develop and secure strategic collaborations, ranging from drug discovery to corporate sponsored fellowships for Pharm.D. students with pharmaceutical and biotechnology companies.
Before joining the Skaggs School of Pharmacy and Pharmaceutical Sciences, Dr. Ettouati spent twenty years in the pharmaceutical and biotechnology industry.
Dr. Ettouati has proven and extensive experience encompassing multiple functional disciplines in pharmaceutical executive management, in areas such as business development, licensing, marketing and new product planning strategy in biotech and pharmaceutical companies.
Dr. Ettouati served as CEO, President & Co-Founder, Director, GeneProt and Ceptyr early-stage drug discovery biotech companies. In addition, he was Chief Business Officer for several biotech firms such as Hawaii Biotech, responsible for all partnering activities; Vice President Business Development for Syrrx, Aurora/Vertex, Vice President Marketing at DepoTech and product management at Syntex (now Roche), ICI (now Astra-Zeneca). Finally, Dr. Ettouati had an established pharmaceutical consulting practice with many private and public clients.
Joseph D. Ma, PharmD is an Assistant Professor of Clinical Pharmacy in the University of
California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences. He received his Pharmacy Doctorate from the
University of California, San Francisco and completed a post doctoral
fellowship in clinical pharmacology at Bassett Healthcare, Cooperstown,
NY. He was then employed at Amgen from
2004-2007 in the Early Development Department.
His current research interests are in validating methods of evaluating drug-drug
interactions. His current clinical
practice site is the Doris A. Howell Service at the UCSD Moores Cancer Center,
which specializes in symptom management, pain control, and addressing
psychological, spiritual and social issues.
The University of California San Diego, Skaggs School of Pharmacy and
Pharmaceutical Sciences Drug Discovery, Development & Commercialization
course focuses on drug discovery, development and commercialization.
In this course, you will learn about the complete process of drug discovery,
development, pharmacoeconomics, biosimilars, regulatory affairs, managed
markets, portfolio management and strategic marketing of a new pharmaceutical
Students will also learn that shifting the current drug discovery paradigm
from ‘finding new-entity drugs’ to ‘combining existing agents’ may be helpful
for overcoming the current financial challenges that exist in the pharmaceutical/biotech
The following course objectives will be:
1. Understand the pharmaceutical and biotechnology market a changing
2. Understand the major aspects of the drug discovery process, starting
with target selection, to compound screening to designing lead candidates.
3. Recognize current modern drug discovery based on the lock-and-key theory,
which attempts to use one single compound to hit one target to combat the
4. Increase understanding of the various drug discovery tools and methods
that are used for finding, identifying and designing a new drug.
5. Define and understand the regulatory responsibilities for drug discovery,
including but not limited to, an Investigational New Drug Application (IND),
New Drug Application (NDA), and product labeling.
6. Incorporate study design methods for consideration in the design
of clinical protocols to access safety, tolerability, and efficacy in multiple
7. Identify the critical components for development of a commercialization
strategy and a marketing plan to launch a new drug.
Will I get a Statement of Accomplishment after completing this class?
Yes. Students who successfully complete the class will receive a Statement
What resources will I need for this class?
For this course, all you need is an Internet connection, and the time
to read, write, and discuss, with your peers.
What is the coolest thing I'll learn if I take this class?
This course aims to help everyone think about what it takes to develop
a new drug. In the context of stringent regulatory and marketing
regulations and an increasingly competitive landscape, greater emphasis
is need to be placed on when and how each phase of a pharmaceutical products
lifecycle is managed in order to maximize return on investment.
You will learn how to develop a Life Cycle Strategic Plan (LCSP)
and look at all the key decision gates in drug discovery, development
and commercialization including go/no-go decisions for development of a
Asking the right questions at the right time is the key to strategic drug
The LCSP presentation will include the different sections ranging from
draft product label, marketing research, pre-clinical, clinical development,
manufacturing, regulatory and legal strategy, intellectual property strategy,
marketing, SWOT analyses, pricing, reimbursement, finance and commercialization
and sales strategies including potential partnering strategy.
Week 1: - Pharmaceutical & Biotechnology
Industry Landscape, Williams Ettouati, Pharm. D.
- Drug Discovery & Development Process: Life Cycle Strategic
Plan, Williams Ettouati, Pharm.D.
Week 2: - Drug Discovery: Proteomics, Genomics, Philip Bourne,
- Compound Selection & Preclinical Studies, Ronald Christopher, Ph.D.
Week 3: -
Challenges in Fragment Based Drug Discovery for Protein Kinases, Stephen
Burley, M.D., Ph.D.
- Key Concepts in Drug Delivery, Brookie Best, Pharm.D.
Week 4: - Regulatory Considerations When Filing an Investigational
New Drug Application, Susan Trieu, Pharm.D.
- Clinical Study & Start-up activities, Joseph Ma, Pharm.D.