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 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 Drug Product 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 15, 2020 - Dec 31, 2022
Location:
Course fee:

$1300
$1050 two or more from same company

$650 for academic and non-profit
$325 for graduate student 
Please contact Eric Buxton to qualify for the academic and graduate student rate.

This course is online and self-paced. You may register at any time and complete the curriculum at your own pace by December 31, 2022

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

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 (IND) applications and how it evolves into a New Drug Application (NDA) or a Biologic License Application (BLA).

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

An Introduction to the Investigational New Drug Application 
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

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.

Module 2
Unit A

The Regulatory Environment on a Global Stage
The FDA considered as a "key customer", but is satisfying the FDA good enough for European and Japanese regulatory agencies?

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

Module 2
Unit B

Stages of Research and Development and Associated
Biology Issues that Need to be Considered
How does "R" develop into "D", and why does it get so expensive? The pre-clinical scientist must work with CMC to establish clinical product safety.

Jeanine L. Bussiere, PhD, DABT

Module 2
Unit C

Relevant Physical and Chemical Factors in Lead Optimization and Candidate Selection
The key physicochemical factors that are evaluated and often assist in distinguishing "lead compounds" from "development candidates".

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

Module 2
Unit D

Preclinical Studies Supporting Candidate Selection and Optimization
The basics of testing API in animals and how these relate to CMC.

Jeanine L. Bussiere, PhD, DABT

Module 2
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
How the chemical nature of a drug candidate influences its formulation and delivery.

Richard A. Pyter, PhD

Module 2
Unit F

Chemical Stability in Drug Development
The importance of chemical stability in the development of new drug candidates.

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

Module 2
Unit G

Options for Optimizing API Properties
What options are available to the chemist and pharmaceutical scientist to improve API properties?

Mark Sacchetti, PhD

Module 2
Unit H

Anatomy of the Dosage Form
From "Target Product Profile" to Bottle; general aspects of formulation and dosage form.

Richard Pyter, PhD

Module 2
Unit I

Oral Drug Delivery and Dosage Forms
The science behind designing the effective oral dosage form, liquid and solid.

Ed Elder, RPh, PhD

Module 2
Unit J

Parenteral Delivery
Designing the injectable when required, for small molecules and large-molecule biologicals.

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

Module 2
Unit K

Other Dosage Forms
When more specific routes of delivery are in order, such as oral inhalation, nasal, topicals and transdermals.

Richard Pyter, PhD

Module 2
Unit L

The second 'C' in "CMC" - Analytical Methods Development and Quality Control
Typical approaches to small and larger molecule API and Drug Product analysis, from early analytical methods to Quality Control.

Eugene J. McNally, PhD

Module 2
Unit M

Drug Product - Analytical Controls for Different Dosage Forms - Setting Specifications for the Certificate of Analysis
Appropriate product control, from manufacture to expiration.

Eugene J. McNally, PhD

Module 3

Module Title: An Exercise Review and Case Study

Objectives:

1. Review the questions posed during setting specifications for the certificate of analysis and

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

Review of Control Exercise
Review of exercises at the end of Unit M on setting specifications

Eugene J. McNally, PhD

Case Study #1  Sonata
Case study looking primarilyl at the product's description, PK/DMPK sections and the storage conditions.

Module 4

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.

Module 4
Unit N

The "M" in "CMC" - Process Development for API and Drug Product
Developing a reliable, scalable manufacturing process.

Ed Elder, RPh, PhD

Module 4
Unit O

Clinical Supplies: Manufacturing, Packaging, and Quality Assurance
From preclinical product to clinical product - the GMP jump.

Richard A. Pyter, PhD

Module 4
Unit P

Technology Transfer and Scale-up to Production/QC and the "Commercial" Product
Effective technology transfer is a team sport.

Ed Elder, RPh, PhD

Module 4
Unit Q

Regulatory Submissions
Anticipating the development cycle on the way to NDA and common technical document preparation, and how "compliance requirements" change the course of development.

Ed Elder, RPh, PhD

Module 4
Unit R

Post Marketing Surveillance
If the NDA is "in", is the development scientist finished with the program?

Jeanine L. Bussiere, PhD, DABT

Module 5

Module Title: Case Study

Objective:

1. To apply course information to a patient case study.

Final CMC Remarks
Highlights on previous sections and a preview of upcoming case study.

Edmund Elder, RPh, PhD

Case Study #2 - Avastin
Case study looking primarily at the product's indications and usage, dosage and administration (especially preparation), warnings and precautions (especially infusion reaction), immunogenicity, description, and storage conditions.

Edmund Elder, RPh, PhD

 

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

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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