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Module 1
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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
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Module 2
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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.
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Module 2
Unit A
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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
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Module 2
Unit B
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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
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Module 2
Unit C
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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
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Module 2
Unit D
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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
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Module 2
Unit E
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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
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Module 2
Unit F
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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
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Module 2
Unit G
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Options for Optimizing API Properties
What options are available to the chemist and pharmaceutical scientist to improve API properties?
Mark Sacchetti, PhD
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Module 2
Unit H
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Anatomy of the Dosage Form
From "Target Product Profile" to Bottle; general aspects of formulation and dosage form.
Richard Pyter, PhD
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Module 2
Unit I
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Oral Drug Delivery and Dosage Forms
The science behind designing the effective oral dosage form, liquid and solid.
Ed Elder, RPh, PhD
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Module 2
Unit J
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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
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Module 2
Unit K
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Other Dosage Forms
When more specific routes of delivery are in order, such as oral inhalation, nasal, topicals and transdermals.
Richard Pyter, PhD
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Module 2
Unit L
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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
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Module 2
Unit M
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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
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Module 3
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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.
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Module 4
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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.
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Module 4
Unit N
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The "M" in "CMC" - Process Development for API and Drug Product
Developing a reliable, scalable manufacturing process.
Ed Elder, RPh, PhD
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Module 4
Unit O
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Clinical Supplies: Manufacturing, Packaging, and Quality Assurance
From preclinical product to clinical product - the GMP jump.
Richard A. Pyter, PhD
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Module 4
Unit P
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Technology Transfer and Scale-up to Production/QC and the "Commercial" Product
Effective technology transfer is a team sport.
Ed Elder, RPh, PhD
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Module 4
Unit Q
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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
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Module 4
Unit R
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Post Marketing Surveillance
If the NDA is "in", is the development scientist finished with the program?
Jeanine L. Bussiere, PhD, DABT
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Module 5
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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
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