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Biology and CMC Strategies in the Nonclinical Development of Pharmaceuticals (Applied Drug Development Core Course)
previously titled: Preclinical and Drug Product Design Strategies
April 19-23, 2010
The Lowell Center
610 Langdon Street
Madison, WI

On Campus Short Courses for the Pharmaceutical Industry


This program has been developed and will be presented in cooperation with the Lenor Zeeh Pharmaceutical Experiment Station in the School of Pharmacy at the University of Wisconsin-Madison.

More information about the Pharmaceutical Experimental Station

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Registration
Goals & Objectives
Special Offer for Academic Institutions
Short Course Program General Information
Who Should Attend
Contents
Instructors
More Information

Registration

Your registration options are as follows:

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Register Online. Login in using your user account. If you don't have a user account creating one is free & easy.
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Download the registration form, complete & mail to:

Applied Drug Development
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705

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By phone at 608.262.3130 or toll-free at 877-947-4255 using a credit card for payment.
fax

Download the registration form, complete & fax to 608.262.2431 using a credit card for payment.

Short Course Program General Information

Limited Enrollment

Enrollment is limited to 50 registrants (first 25 for the CMC Track and first 25 for the Biology Track).

Course Location

Courses are presented at the Lowell Center on the University of Wisconsin-Madison Campus. Spring time in Madison and the beauty of the on-campus location provide a relaxing atmosphere for learning. Evenings can be used to explore the University and the city. For more information about Madison, WI see www.visitmadison.com.

Accommodations

A block of rooms is available at the Lowell Centerl which is next to the University of Wisconsin campus. The approximate cost per night is $100. Information about the Lowell Center and other hotels within walking distance will be sent to individuals when they receive their registration confirmation.

Registration Fee

Tuition for the 2010 program will be $1,995.00. Cancellations after April 2 are non-refundable. Cancellations prior to April 2 are subject to a $75 administration fee. In the event that an accepted applicant cannot attend, a substitute may be sent by the same company. Early bird discounts ($1,995 - $300 = $1,695) are offered to individuals registering prior to April 2, 2010.

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Goals & Objectives

The purpose of this course is to provide the learner a survey of the process of non-clinical drug development from lead molecule characterization and preclinical evaluation, to the FDA approval of a new drug product. Within this context, the learner will become familiar with the key science and technologies that support the drug development process. The course will use examples for both small and large molecules and will address issues from discovery to NDA/BLA filings. This unique course features two tracks:

  1. the CMC (chemistry, manufacturing and controls) aspects of development, as carried out by pharmaceutical chemists and technologists, industrial pharmacists and engineers; and
  2. the biology side of the development process as carried out by toxicologists, pharmacologists, pharmacokineticists, clinical project managers, and others.

In each track, the course looks at the scientific and regulatory requirements as well as the interaction required by all stakeholders in the technical development of a new drug entity and their activities as driven by regulatory requirements. This focus on the science of drug development is intended to help the learner 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 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.

View 2009 evaluation results.

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Special Offer for Academic Institutions

Extension Services in Pharmacy at the University of Wisconsin School of Pharmacy has instituted a new policy for industrial professional development programs to encourage greater participation by faculty, graduate students and post doctoral students at academic institutions. Programs will be offered at a significantly reduced price, based on space availability. For information about any specific course please contact Dr. James E. De Muth by email.

Who Should Attend

Scientists and technical managers who are either new to drug development or who are interested in obtaining a contemporary review of the drug development process. Attendees should include BS/MS/PhD level pharmaceutical scientists, chemists, biochemists, engineers, and biologists (toxicologists, pharmacokineticists, pharmacologists) and related scientists in the R&D environment, as well as manufacturing, clinical and regulatory affairs specialists, project managers involved in drug development, and their respective technical management.

Instructors

Sharon A. Baughman, Ph.D.
Independent Biotechnology Consultant, Ventura, CA

Ronald R. Burnette, Ph.D.
Associate Professor, School of Pharmacy, University of Wisconsin, Madison, WI

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

Edmund (Ed) Elder, Jr., R.Ph., Ph.D.
Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin-Madison

Christopher P. Rogers
Associate, Intellectual Property Group, Quarles and Brady LLP, Madison, WI

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

Richard A Pyter, Ph.D.
CMC Consultant and Adjunct Professor, University of Wisconsin, Madison, WI

Mark Sacchetti, Ph.D.
Scientific Director, Zeeh Pharmaceutical Experiment Station
School of Pharmacy, University of Wisconsin-Madison

For More Information

James E. De Muth, Ph.D., Course Coordinator
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705
(608) 262-3130
FAX (608) 262-2431
Send Email

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2010 Contents

Monday, April 20

*** Combined Session – Biology and CMC Tracks***

8:30am

Opening Plenary Session

Welcomes

James E. De Muth, Ph.D.
Professor, School of Pharmacy, University of Wisconsin-Madison

8:40am

Introduction to the Drug Development Process
The drug product development process: it takes a team.

9:00am

The Regulatory Environment
The FDA considered as a “key customer.”

9:30am

Drug Development on a Global Stage
Is satisfying the FDA good enough for European and Japanese regulatory agencies?

9:50am

Break

10:10am

Stages of Research and Development
How does “R” develop into “D,” and why does it get so expensive?

10:35am

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”

11:00am

Introduction to the Biology Track
The pre-clinical scientist must work with CMC to establish clinical product safety.

11:30am

Introduction to the CMC Track
Defining “CMC” and why CMC scientists support and interact with the pre-clinical program.

12:00pm

Lunch

1:00pm

Plenary Session on Development Candidate Selection

Physical and Chemical Factors in Candidate Selection and Optimization
The key physicochemical factors that distinguish “lead compounds” from “development candidates.”

2:15pm

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

2:45pm

Break

3:00pm

Biopharmaceutical Factors in Candidate Selection and Optimization: Basic Pharmacokinetics and Pharmacodynamics
The effective delivery of drug administered to animal and man must be quantified.

5:00pm

Adjournment

6:00pm

Reception: Alumni Lounge, Pyle Center

Sponsor:

MDS Pharma Services
Lincoln, NE

7:00pm

Dinner

Tuesday, April 21

***CMC Track***

***Biology Track***

8:30am

The “first ‘C’” in “CMC” -- Preformulation and characterization of API
How the chemical structure of the drug candidate influences its formulation and delivery, considering both small molecules and biologicals

8:30am

Introduction (Preclinical Drug Development - 'Early Development' to IND filing)
Preclinical development stage-gates, the role of a project team and how are they are composed.

 

 

9:00am

Small Molecule Therapeutics: Pharmacology & Pharmacokinetics
Understanding of pharmacology and pharmacokinetics to add value to the development of a small molecule drug candidate. The elements of a basic pharmacology and pharmacokinetics IND database.

9:30am

Chemical Properties and Chemical Stability
How physical properties influence dosage form design. How chemical properties drive the “developability” of a new drug candidate.

10:15am

Break

10:30am

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

10:30am

Break

11:20am

Anatomy of the Dosage Form
From “Target Product Profile” to Bottle: general aspects of formulation and dosage form..

10:45am

Small Molecule Therapeutics: Toxicology Aspects

The issues, strategy options and means of execution needed to accomplish a successful IND safety program.

12:00pm

- Lunch -

1:00pm

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

1:00pm

Introduction (Preclinical Drug Development - IND Filing to NDA Filing)
Brief review of the regulatory process. Stage-gates and iterative decision-making: Risk & Impact.

1:30pm

Small Molecule Therapeutics: Pharmacology & Pharmacokinetics
The elements of a basic pharmacology and pharmacokinetics NDA database and what issues should be considered when expanding the pharmacology and pharmacokinetics database. What, When, Who & How?

2:45pm

Break

3:00pm

Break

3:00pm

Small Molecule Therapeutics: Toxicology Aspects
The issues, strategy options and means of execution needed to accomplish a successful NDA safety program.

3:15pm

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

4:00pm

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

4:45pm

Open Discussion with Instructors
A chance to pose questions from lab science to program strategy.

4:30pm

Adjournment

5:00pm

Adjournment

 

- Evening Free to Explore Madison -

Wednesday, April 22

***CMC Track***

 

***Biology Track***

8:30am

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

8:30am

Biotechnology Therapeutics: Pharmacology & Pharmacokinetics ('Early Development' to IND filing)
Understanding of pharmacology and pharmacokinetics to add value to the development of a biotechnology-derived drug candidate. The elements of a basic pharmacology and pharmacokinetics IND database.

9:30am

The “second ‘C’” in “CMC” -- Analytical Methods Development and Quality Control
Typical approaches to small and large molecule API and Drug Product analysis, from early analytical methods to Quality Control

9:30am

Biotechnology Therapeutics: Toxicology Aspects ('Early Development' to IND filing)
The issues, strategy options and means of execution needed to accomplish a successful IND safety program?

10:30am

- Break -

11:00am

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

10:45am

Biotechnology Therapeutics: Pharmacology & Pharmacokinetics ( IND to BLA)
Elements of a basic pharmacology and pharmacokinetics BLA database and what issues should be considered when expanding the pharmacology and pharmacokinetics database. What, When, Who & How?

12:00pm

- Lunch -

1:00pm

Clinical Supplies Manufacturing and Packaging, and Quality Assurance
From Preclinical product to Clinical product—the GMP jump

12:45pm

Biotechnology Therapeutics: Toxicology Aspects ( IND to BLA)
The issues, strategy options and means of execution needed to accomplish a successful BLA safety program?

1:45pm

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

2:15pm

Final CMC Remarks and Discussion
A preview of tomorrow’s case studies

2:15pm

Open Discussion of Current Scientific and Regulatory Issues Associated with Drug Development

3:00pm

- Break -

3:30pm

Bus to laboratory tour


Laboratory Tour
- PPD’s cGMP and Bioanalytical QC Laboratory Services-
Middleton, WI

6:30pm

- Adjournment after returning from laboratory tour -

 

- Evening Free to Explore Madison -

Thursday, April 23

*** Combined Session – Biology and CMC Tracks***

8:30am

Plenary Session on Case Studies and Preparing for an NDA

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

9:15am

Introduction to Case Studies
Product Life Cycle Management and Post-marketing Obligations

10:00am

Break

10:15am

Case Studies – Patient, Technology, Regulatory & Competitor Considerations - Xolair ®

11:30pm

Introduction to Project Team Role Playing and Plan Development
Creation of groups to role play as project teams to evaluate information needed and activities required for planning a successful pre-IND.

12:00pm

Lunch

1:00pm

Case Study
Patient, Technology, Regulatory & Competitor Considerations - Actonel ®

2:00pm

Case Study
Patient, Technology, Regulatory & Competitor Considerations - Avastin ®

3:00pm

Break

3:15pm

Case Study
Patient, Technology, Regulatory & Competitor Considerations - Sonata ®

4:15pm

Group Activities: Preparation for Friday’s Project Team Role Playing

5:00pm

Adjournment

6:00pm

Reception: University Club

Sponsor:

Covance, Inc.
Madison, WI

7:00pm

Dinner

Friday, April 24

*** Combined Session – Biology and CMC Tracks***

8:30am

Plenary Session on Moving Forward Toward the Submission of the NDA 

Managing Intellectual Property Issues during Drug Development
What concerns are likely to arise with respect to patens:  yours or
another company's?

9:40am

Break

9:55am

Submitting the NDA and Post Marketing Surveillance
 If the NDA is “in,” is the development scientist finished with the program?

10:30am

Planning for pre-IND Success
Presentatons of project plans by Teams on their proposed timeline for integrating Biology and CMC activities that lead to the IND.

11:30am

Adjournment

 

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