University of Wisconsin–Madison

An Introduction to the Drug Development Process

Chemistry, Manufacturing, and Controls

This 100% online course provides a comprehensive introduction to the drug development process. The course consists of 3 live webinar lectures and 18 learn at your own pace units.

Developing a new chemical entity (NCE) for humans can take more than ten years. It can cost close to a billion dollars and involve many steps. There are many pitfalls along the way. Less than 10% of drug development projects will lead to an FDA approval. Even though the odds of success are steep, it is not impossible. Several tactics can help save time and money in the drug development process. A well-trained workforce can improve decision-making and optimize the CMC process.
Woman with pipette in lab working on drug development process The convenient online learning platform is ideal for busy professionals. This course will give you tools and training optimize your CMC process. The series of online lectures will cover all aspects of drug development. You will learn strategies for all stages of the drug development funnel from lead selection through post-market activities. The course material is application based and designed to develop practical skills. You will learn through many therapeutic examples. These examples will help you address real-world drug discovery challenges. Learn to develop the right framework for candidate selection, evaluation, and NDA filings. You will also learn to address manufacturing and regulatory considerations as well.

Upon completion, you will have a drug development toolkit at your disposal. You will become an effective contributor to the drug development process. Your team will benefit from optimization and an improved chance of success.

This course is suitable by itself or as part of the Applied Drug Development Certificate. The course fulfills one of three required courses in the certificate. We recommend beginning your Applied Drug Development Certificate with this course.

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.

Registration Information

Register

Refund Policy

Course date:Jan 24, 2019 - May 2, 2019
Location:
Course fee:

$1550/$1750 after 1/10/2019
$850 academic and non-profit

Refund Policy: All requests for refunds, less a $75 administrative fee, will be honored if received prior to January 10, 2019. No refunds will be provided after that date.

Course Objectives

Goals and Objectives (each lecture will have its own set of learning objectives):

The purpose of this distance education course is to provide the attendees with a comprehensive overview of the process of nonclinical drug development from lead molecule characterization and preclinical evaluation, to the approval by various agencies of a new drug product. Within this context, the attendee will become familiar with the key science and technologies that support the drug product development process. The course will use therapeutic examples and will address issues from discovery to NDA filings. This focus on the science of drug development is intended to help the participant better understand how, where and with whom to follow up appropriately with his/her work responsibilities. Upon completion of the program the learner will be able to:

1) Contribute to the overall product development plan with activities that are relevant to his/her respective discipline;

2) Better understand and explain the relationships and interdependencies between the chemical, biological and clinical disciplines that must collaborate effectively;

3) Better anticipate the challenges, choices and key decision-making steps that face the development team in bringing a new drug product to market; and

4) Apply a broader understanding of the development process to bring about more effective problem solving to the development program.

Course Outline

Module 1

Opening Live Webinar - Thursday, January 24, 2019 (approximately 1.5 hours)
Noon - 1:30 PM CST
Module Title: An Introduction to the Drug Development Process

Objectives:

1.To provide a broad overview of the course materials and the relationship between design, development, manufacturing and regulatory considerations;

2. To describe the relationship and roles of different disciplines on the drug development process;

3. To discuss the Investigational New Drug (INA) applications and how it evolves into a New Drug Application (NDA) or a Biologic License Application (BLA).

Welcome
Eric Buxton, PhD, Moderator
Clinical Associate Professor, School of Pharmacy
University of Wisconsin, Madison, WI

Introduction to the Drug Development Process (Unit 1)
The drug product development process: it takes a team
Richard Pyter, PhD
Adjunct Professor
School of Pharmacy, University of Wisconsin, Madison, WI

An Introduction to the Investigational New Drug Application (Unit 2)
The evolution between two key regulatory documents: the “IND”
and how it evolves into the “NDA”or “BLA”
Edmund Elder, RPh, PhD
Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin, Madison, WI

Module 2

Asynchronous presentations (approximately 15.5 hours)
Module title: The Stages of the Drug Development Process: Chemical, Design, Delivery and Control Considerations

Objectives:

1. Describe the structure, responsibilities and communication with of the Food and Drug Administration;

2. Discuss the biology issues and types of pharmacokinetic and toxicology studies required during the development process;

3. Identify key physical and chemical factors that can affect the probability of successful development of a drug candidate;

4. Describe how chemical and physical properties influence the formulation of a drug product, its stability and manufacturability;

5. Discuss ways for the to improve the properties of the active pharmaceutical ingredient (API);

6. List the factors to consider when choosing an appropriate route of administration and formulating the drug product;

7. Compare and contrast differences between small and large molecules with respect to research and development, manufacturing and quality control; and

8. Describe what is meant by specifications as it relates to a certificate of analysis.

Unit A

The Regulatory Environment on a Global Stage

Jeanine L. Bussiere, PhD, DABT
Executive Director, Toxicology
Amgen Inc., Thousand Oaks, CA

Unit B

Stages of Research and Development and Associated
Biology Issues that Need to be Considered

Jeanine L. Bussiere, PhD, DABT

Unit C

Relevant Physical and Chemical Factors in Lead Optimization and Candidate Selection

Richard A. Pyter, PhD
Adjunct Professor, Pharmaceutical Sciences Division
School of Pharmacy, University of Wisconsin, Libertyville, IL

Unit D

Preclinical Studies Supporting Candidate Selection and Optimization
Jeanine L. Bussiere, PhD, DABT

Unit E

The first ‘C’ in “CMC” – How Do the Chemical Structure and Associated Physical Chemical Properties of an API Influence Its Formulation into a Drug Product
Richard A. Pyter, PhD

Unit F

Chemical Stability in Drug Development

Mark Sacchetti, PhD
Scientific Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin, Madison, WI

Unit G

Options for Optimizing API Properties

Mark Sacchetti, PhD

Unit H

Anatomy of the Dosage Form

Richard Pyter, PhD

Unit I

Oral Drug Delivery and Dosage Forms

Ed Elder, RPh, PhD

Unit J

Parenteral Delivery

Eugene J. McNally, PhD
Executive Director, Strategic Product Development PPD, Inc.,
Middleton, WI

Unit K

Other Dosage Forms

Richard Pyter, PhD

Unit L

The second 'C' in "CMC" - Analytical Methods Development and Quality Control

Eugene J. McNally, PhD

Unit M

Drug Product - Analytical Controls for Different Dosage Forms - Setting Specifications for the Certificate of Analysis

Eugene J. McNally, PhD

Module 3

Webinar - Thursday, March 21, 2019 (approximately 2 hours)
Noon - 2:30 PM CST
Module Title: An Exercise Review, Case Study and Open Discussion

Objectives:

1. To review the questions posed during setting specifications for the certificate of analysis;

2. To apply course information to a patient case study; and

3. To provide an opportunity for questions or clarification on materials in the first asynchronous portion of the course.

Review of Control Exercise

Eugene J. McNally, PhD

Case Study #1
Leader to be determined

Discussion and Questions on Any Materials Presented

Opportunity for participants to ask questions/clarification of faculty on any of the information presented up to this point in the course.

Jeanine L. Bussiere, PhD, DABT
Edmund Elder, RPh, PhD
Eugene J. McNally, PhD
Richard A. Pyter, PhD
Mark J. Sacchetti, PhD

Module 4

Asynchronous presentations (approximately 5.5 hours)
Module title: Manufacturing and Regulatory Considerations in the Drug Development Process

Objectives:

1. Describe considerations in development of a reliable and scalable drug substance manufacturing process;

2. Discuss the evolution of a potential drug product during the clinical stages of development;

3. List the basic components involved with information transfer from development to manufacturing;

4. Discuss various regulatory submissions including an Investigational New Drug Application and a New Drug Application; and

5. List the various pathways for approval of a drug marketing application and approval for generic drugs and biosimilars.

Unit N

The "M" in "CMC" - Process Development for API and Drug Product

Ed Elder, RPh, PhD

Unit O

Clinical Supplies: Manufacturing, Packaging, and Quality Assurance

Richard A. Pyter, PhD

Unit P

Technology Transfer and Scale-up to Production/QC and the "Commercial" Product

Ed Elder, RPh, PhD

Unit Q

Regulatory Submissions

Ed Elder, RPh, PhD

Unit R

Post Marketing Surveillance

Jeanine L. Bussiere, PhD, DABT

Module 5

Live Webinar (approximately 2.5 hours)
Thursday, May 2, 2019
Noon - 2:30 PM CST
Module title: Case Studies and Course Review

Objectives:

1. To apply course information to several patient case studies; and
2. To provide an opportunity for questions or clarification on materials during the entire course.

Welcome Back and House Keeping

Eric Buxton, PhD, Moderator

Final CMC Remarks and Any Updates

Edmund Elder, RPh, PhD

Case Study #2 - drug to be determined

Discussion Leader - Edmund Elder, RPh, PhD

Case Study #3 - drug to be determined

Richard Pyter, PhD

Open Discussion
Opportunity for participants to ask questions/clarification of faculty on any of the information presented in the course.

Jeanine L. Bussiere, PhD, DABT
Edmund Elder, RPh, PhD
Eugene J. McNally, PhD
Richard A. Pyter, PhD
Mark J. Sacchetti, P.D

 

Instructors

Jeanine L. Bussiere, PhD, DABT
Executive Director, Toxicology
Amgen Inc., Thousand Oaks, CA

Edmund Elder, R.Ph, PhD
Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin, Madison, WI

Eugene J. McNally, PhD
Executive Director, Strategic Product Development PPD, Inc.,
Middleton, WI

Richard A. Pyter, PhD
Adjunct Professor, Pharmaceutical Sciences Division
School of Pharmacy, University of Wisconsin, Libertyville, IL

Mark J. Sacchetti, PhD
Scientific Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin, Madison, WI

More Info

Live webinars will be hosted using "GotoWebinar". The will be held starting at 12:00 PM central. Each of the three webinar lectures will be approximately one hour long and will be followed by a question and answer (Q&A) session. The lecturer will answer questions posted by the participants to clarify points raised in the lecture, to discuss related topics not covered in the lecture, or to discuss case studies. These questions will be submitted online through the webinar software.

Participants will need a computer with a high-speed internet connection and speakers/headphones. Viewing instructions and the link for the presentation will be posted to the course page prior to the first webinar. Details for connection testing will be posted on the course page and emailed to registrants.

Program Coordinator

Eric Buxton, PhD

Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 265-2259
eric.buxton@wisc.edu

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