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TLI 52100: Drug Discovery

Geanie Umberger, Ph.D. – Course Director


gumberger@purdue.edu

Course Information

The course will be conducted on the Purdue University campus, in Wilmeth Active
Learning Center, room 3127 on Fridays from 2:30 to 5:30pm. There will be several special
lectures posted on Blackboard that the student will be required to review on their own
time.

Office Hours: By appointment only

Course Description

The purpose of this course is to provide students an education in the important aspects
of Drug Development as it relates to regulatory affairs, including quality control and
quality assurance. Individuals completing this course will be able to describe
information about drug development and innovation and explain how this information
relates to discovery and registration of drugs.

Today, pharmaceutical companies must conduct drug discovery, development, and sales
in a highly regulated, ever-changing environment with competition and pricing pressures
increasing. Integrated management systems for innovation, discovery, development,
quality control, quality assurance, compliance, intellectual property protection, and
business improvement are critical elements for success in this complex and evolving
environment. The cost of poor quality and the penalties for non- compliance are
unacceptable in today's drug development business. Knowledge of effective
manufacturing principles and practices is a critical part of getting things "right the first
time”.

This course is required for both the graduate certificate Biotechnology Quality and
Regulatory Compliance and the M.S. degree in Biotechnology Innovation and Regulatory
Science.

Course Outcomes and Objectives

• Learning Outcome 1: Students will learn the overall process of drug


development, including the major steps such as discovery, toxicology and
formulation.
o Students will learn how many drugs are under development and the
attrition rate

o Students will learn the major components of clinical trial design within
drug development

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o Students will learn ADME and how it contributes to drug development

o Students will learn how to file an IND and the factors involved in making a
product decision during the drug development process, including the
factors involved in moving a compound to an IND and subsequently
moving a compound to phase II

• Learning Outcome 2: Students will learn the role of a quality system in the
process of drug development and how the process of drug development is
regulated.

o Students will learn validation, methods, Good Manufacturing Practices,


clinical trial design and toxicology within the context of a quality system
of drug development

o Students will learn the role that the FDA plays in the process of drug
development.

o Students will learn how a quality system operates by learning the process
for FDA review of documents during drug development

• Learning Outcome 3: Students will learn the ethical considerations of drug


development, including the critical analysis, IRB, and evaluation of ethical
situations
• Learning Outcome 4: Students will learn how the drug development process has
been adapted for devices, diagnostics and biologics, including specific examples
for each

o Students will learn about the design process as it relates to the


development of a device and the importance of quality of design

• Learning Outcome 5: Students will learn how the drug development process has
been adapted for global applications, including WHO, EMEA, ICH

• Learning Outcome 6: Students will learn how innovation is applied to the drug
development process

Reference and reading materials:

The course textbooks are New Drug Development: A Regulatory Overview by Mark
Mathieu (ISBN-13: 978-1882615858) and Global New Drug Development: An Introduction
by Jan Rosier, Mark Martens, and Josse Thomas (978-1-118-41488-0) will be used to
provide a foundational background. Purdue students can access primary literature and
databases online through the Purdue Libraries: https://www.lib.purdue.edu/

Materials for the course, such as online lectures, case studies, and the major project, as
well as other current reading material and resources as provided by the speakers will be
provided through the Purdue course management system, Blackboard Learn
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(BBL) http://www.itap.purdue.edu/learning/tools/blackboard/

Course Requirements

We will use a blended pedagogical approach for course delivery. Class time will focus on
interactive and engaging sessions with professional experts from industry, including
current topic lectures, case studies, and discussions. The speakers will address the
organization and functioning of a specific component or facet of the drug discovery
and development process. Each speaker will discuss an important topic and address
how their work relates to the work of other groups involved in the drug development
process. All lectures will end with time for questions. The majority of the student’s
grade will be from the development of an Investigational New Drug (IND) application.

We will put presented materials on BBL (unless the presenter does not give us
permission), and if possible we will attempt to do this in advance. Some course material
will be on BBL, and the student is responsible for reviewing the material on their own
because it may be useful for you as you develop respective sections of your Investigational
New Drug (IND) project. Details on your major project will be provided on the first day of
class. You will be required to work in small groups to develop the materials on the project,
but each person will be required to complete and present a section of the overall project
as part of their grade. The team will also provide input on the performance of their
respective team members, which will count for 5% of the student’s grade.

General Course Policies

Contacting Dr. Umberger –


Email: The easiest and best way to reach me is to email gumberger@purdue.edu
and set up a time that works mutually for both of our schedules.

Submission of Assignments, Missed, or Late Work: Assignments must be submitted via


email to Dr. Umberger at gumberger@purdue.edu.

Late assignments will receive a grade reduction unless special arrangements have been
made with the instructor, preferably in advance. If prior arrangements have not been
made, or the Dean of Students has not provided you an excuse allowing work to be
made-up, or the reason for the late assignment is covered under University policy,
missed or late assignments will receive a 10% reduction in grade per day, until the
assignment is submitted. See policy below regarding arriving late/leaving early.
Assignments can be accepted early.

Several of the classes have case studies included as part of the lecture. Students will
receive class participation point for these exercises. If you are unable to attend class
on these dates, you must contact the instructor to arrange a time to do the case study
outside of class.

Grade Complaints: Grade complaints must be submitted in writing to the instructor


within 1 week after the graded material is returned to the student. Grade complaints
will be subject to an entire regrade. All grades will be posted in Blackboard.
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Use of Technology: Computers and other technologies are welcome in class when
related to the current topic and course discussions but please be professional and keep
cell phone or other uses of technology, i.e. texting, social media, to a minimum as it may
be distracting to both your fellow classmates and instructors.

Class Participation: You should attend all classes. Please see a more detailed description
of Purdue’s attendance policy below. You are expected to be both punctual and
prepared for group activities and discussion. In addition, you are expected to stay for
the entire class period. It is simply a matter of courtesy to your fellow students and the
instructors. Class discussions enhance and clarify your understanding of course
material.

Students who are absent are still responsible for knowing course material and getting
assignments and announcements regardless of attendance. Past experience shows that
successful students were those who attended class, participated in discussions, and
completed all assignments and quizzes.

Evaluation of Student Performance:

Assigned Readings.
As needed, readings from various sources may be assigned to provide more
information and background on the course concepts. Details on accessing these
materials and/or taped lectures will be posted on Black Board Learn.

Class Participation Points:


There will be several case study exercises that the speakers will have you conduct. You
will receive class participation points based upon how well you engaged and was
involved in the discussions.

IND Project:
A mock Investigational New Drug application project will be used to evaluate your
understanding of course material and provide you with an additional opportunity to
apply knowledge from the lectures to a project that is relevant to the current field of
drug discovery. Depending upon how well the individual team do on their written and
oral IND project, a team will be asked to do either a mock New Drug Application (NDA)
or a follow-up IND response to the FDA mock panel. The instructor will notify each
team if their team will modify their IND project or move onto the NDA phase. Each
student’s submission will be evaluated based on its own merits, coupled with group
input, and quality of presentation before the mock FDA panel. The student must
identify in writing which sections of IND activity/sections the team members
performed. This will aid the instructor in weighing the contribution of each team
member, as well as the quality of their respective work.

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Grading:
The final grades for the course will be determined by a total accumulation of points
from all activities and assignments. Individual progress toward course learning
outcomes and final grades will be computed based on the following weights:

Assignments Percent
IND Project 1 20
IND Presentation 1 10
Successfully Advancing Project to NDA 10
IND/NDA Project 2 25
IND/NDA Presentation 2 10
Attendance, Class Participation, Case Studies 15
Team Evaluation 5
Homework Assignment 5
Total 100

Grading Scale:

Grade GPA Value % Range


A+ 4.0 96.0-100
A 4.0 93.0- 95.9
A- 3.7 90.0-92.9
B+ 3.3 87.0-89.9
B 3.0 83.0-86.9
B- 2.7 80.0-82.9
C+ 2.3 77.0-79.9
C 2.0 73.0-76.9
C- 1.7 70.0-72.9
D+ 1.3 67.0-69.9
D 1.0 63.0-66.9
D- 0.7 60.0-62.9
F 0.0 <60.0

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Class Schedule
Please note: syllabus and schedule are subject to change per the discretion
of the instructors.
Course Introduction
Jan. Introduction to Class Project
11th History of FDA & Regulations Impact Drug Development
Overview of Drug Development
Jan.
Clinical Trials and Good Clinical Practice
18th
Jan. IND & NDA - Overview & their Review Process
25th FDA Meetings & Communications
Feb.
Discovery Chemistry/Early Phase Development
1st
Feb.
CMC, Manufacturing, and Supply Chain
8th
Feb.
Toxicology and ADME
15th
Feb. IRB and Special Populations
22nd Bioethics
Mar.
Labeling, REMS, and Safety/Pharmacoviligence
1st
Mar.5th IND Submission Due via Email by Noon
Mar. Individuals present pre-IND submissions
8th
March 9th Last Day to Withdraw from Class
Mar.
15th
Spring Break
Mar.
Overview of the Regulatory Process for Devices and Diagnostics
22nd
Mar.
Overview of the Regulatory Process for Devices and Diagnostics
29th
Apr. Abuse Potential
5th Patents & Protection of Proprietary Information
Apr.
Health Economics & Pricing of Drugs
12th
Apr.
Risk Management
19th
Apr.
23th
Project Due via Email by Noon

Defend Project Before Mock FDA Panel


26-Apr
No Final Exam Will Be Given

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Purdue University Policies
Purdue Honor Code:

As a Boilermaker pursuing academic excellence, I pledge to be honest and true in all that I do.
Accountable together - we are Purdue. You may also refer to this link to learn more on the honor code.
https://www.purdue.edu/provost/teachinglearning/honor-pledge.html

Academic Dishonesty:
Please refer to Purdue’s student guide for academic integrity for additional information:
http://www.purdue.edu/odos/aboutodos/academicintegrity.php Purdue prohibits "dishonesty in
connection with any University activity. Cheating, plagiarism, or knowingly furnishing false information to
the University are examples of dishonesty." [Part 5, Section III-B-2-a, University Regulations] Furthermore,
the University Senate has stipulated that "the commitment of acts of cheating, lying, and deceit in any of
their diverse forms (such as the use of substitutes for taking examinations, the use of illegal cribs,
plagiarism, and copying during examinations) is dishonest and must not be tolerated. Moreover, knowingly
to aid and abet, directly or indirectly, other parties in committing dishonest acts is in itself dishonest."
[University Senate Document 72-18, December 15, 1972]

Academic integrity is one of the highest values that Purdue University holds. Individuals are encouraged to
alert university officials to potential breaches of this value by either emailing integrity@purdue.edu or by
calling 765-494-8778. While information may be submitted anonymously, the more information that is
submitted provides the greatest opportunity for the university to investigate the concern.
Use of Copyrighted Materials:

Among the materials that may be protected by copyright law are the lectures, notes, and other material
presented in class or as part of the course. Always assume the materials presented by an instructor are
protected by copyright unless the instructor has stated otherwise. Students enrolled in, and authorized
visitors to, Purdue University courses are permitted to take notes, which they may use for individual/group
study or for other non-commercial purposes reasonably arising from enrollment in the course or the
University generally. We request that you do not make course notes or materials available for others to
purchase via a commercial note taking service. Please see the University Regulations on these policies below.
Purdue prohibits "dishonesty in connection with any University activity. Cheating, plagiarism, or knowingly
furnishing false information to the University are examples of dishonesty." [Part 5, Section III-B-2-a,
University Regulations] Furthermore, the University Senate has stipulated that "the commitment of acts of
cheating, lying, and deceit in any of their diverse forms (such as the use of substitutes for taking
examinations, the use of illegal cribs, plagiarism, and copying during examinations) is dishonest and must
not be tolerated. Moreover, knowingly to aid and abet, directly or indirectly, other parties in committing
dishonest acts is in itself dishonest." [University Senate Document 72-18, December 15, 1972]

If students observe or have knowledge of academic dishonesty, they may either notify the professor or can
report it to the Office of the Dean of Students (www.purdue.edu/odos), call 765-494-8778, or email
integrity@purdue.edu.

Notes taken in class are, however, generally considered to be “derivative works” of the instructor’s
presentations and materials, and they are thus subject to the instructor’s copyright in such presentations and
materials. No individual is permitted to sell or otherwise barter notes, either to other students or to any
commercial concern, for a course without the express written permission of the course instructor. To obtain
permission to sell or barter notes, the individual wishing to sell or barter the notes must be registered in the
course or must be an approved visitor to the class. Course instructors may choose to grant or not grant such
permission at their own discretion, and may require a review of the notes prior to their being sold or
bartered. If they do grant such permission, they may revoke it at any time, if they so choose.

Attendance:

Purdue University policy states that all students are expected to be present for every meeting of classes in
which they are enrolled. All matters relative to attendance, including the make-up of missed work, are to be
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arranged between you and the instructor. If students are not present, satisfactory completion of course
assignments will be hindered and the course grade will be negatively impacted. Only the instructor can
excuse a student from a course requirement or responsibility. When conflicts or absences can be anticipated,
such as for many University sponsored activities and religious observations, the student should inform the
instructor of the situation as far in advance as possible. For unanticipated or emergency absences when
advance notification to an instructor is not possible, the student should contact the instructors as soon as
possible by email as listed in the syllabus. When the student is unable to make direct contact with the
instructor and is unable to leave word with the instructor’s department because of circumstances beyond the
student’s control, and in cases of bereavement, the student or the student’s representative should contact
the Office of the Dean of Students. The link to the complete policy and implications can be found at:
http://catalog.purdue.edu/content.php?catoid=8&navoid=8220

Grief Absence Policy for Students:

Purdue University recognizes that a time of bereavement is very difficult for a student. The University
therefore provides the following rights to students facing the loss of a family member through the Grief
Absence Policy for Students (GAPS). GAPS Policy: Students will be excused for funeral leave and given the
opportunity to earn equivalent credit and to demonstrate evidence of meeting the learning outcomes for
missed assignments or assessments in the event of the death of a member of the student’s family.

CAPS Information:

Purdue University is committed to advancing the mental health and well-being of its students. If you or
someone you know is feeling overwhelmed, depressed, and/or in need of support, services are available. For
help, such individuals should contact Counseling and Psychological Services (CAPS) at (765)494-6995 and
http://www.purdue.edu/caps during and after hours, on weekends and holidays, or through its counselors
physically located in the Purdue University Student Health Center (PUSH) during business hours.

Mental Health Statement


If you find yourself beginning to feel some stress, anxiety and/or feeling slightly overwhelmed, try
WellTrack, https://purdue.welltrack.com/. Sign in and find information and tools at your fingertips,
available to you at any time.

o If you need support and information about options and resources, please see the Office of the
Dean of Students, http://www.purdue.edu/odos, for drop-in hours (M-F, 8 am- 5 pm).
o If you’re struggling and need mental health services: Purdue University is committed to
advancing the mental health and well-being of its students. If you or someone you know is feeling
overwhelmed, depressed, and/or in need of mental health support, services are available. For help,
such individuals should contact Counseling and Psychological Services (CAPS) at (765)494-
6995 and http://www.purdue.edu/caps/ during and after hours, on weekends and holidays, or by
going to the CAPS office of the second floor of the Purdue University Student Health Center (PUSH)
during business hours.

Violent Behavior Policy:

Below is Purdue’s policy prohibiting violent behavior.


Purdue University is committed to providing a safe and secure campus environment for members of the
university community. Purdue strives to create an educational environment for students and a work
environment for employees that promote educational and career goals. Violent Behavior impedes such
goals. Therefore, Violent Behavior is prohibited in or on any University Facility or while participating in any
university activity.
Please see the following website for additional information:
htp://www.purdue.edu/policies/facilities-safety/iva3.html

Emergency Situations:
In the event of a major campus emergency, course requirements, deadlines and grading percentages are
subject to changes that may be necessitated by a revised semester calendar or other circumstances beyond
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the instructor’s control. Here are ways to get information about changes in this course.
Course web page on Blackboard http://www.itap.purdue.edu/learning/tools/blackboard/
Instructors’ email gumberger@purdue.edu

In the event of a major campus emergency, course requirements, deadlines and grading percentages are
subject to changes that may be necessitated by a revised semester calendar or other circumstances beyond
the instructor’s control. Relevant changes to this course will be posted onto the course website or can be
obtained by contacting the instructors or TAs via email or phone. You are expected to read your
@purdue.edu email on a frequent basis.

EMERGENCY NOTIFICATION PROCEDURES are based on a simple concept – if you hear a fire alarm inside,
proceed outside. If you hear a siren outside, proceed inside.

• Indoor Fire Alarms mean to stop class or research and immediately evacuate the building.
Proceed to your Emergency Assembly Area away from building doors. Remain outside until police,
fire, or other emergency response personnel provide additional guidance or tell you it is safe to
leave.
• All Hazards Outdoor Emergency Warning Sirens mean to immediately seek shelter (Shelter in
Place) in a safe location within the closest building.
“Shelter in place” means seeking immediate shelter inside a building or University residence.
This course of action may need to be taken during a tornado, a civil disturbance including a shooting or
release of hazardous materials in the outside air. Once safely inside, find out more details about the
emergency*. Remain in place until police, fire, or other emergency response personnel provide additional
guidance or tell you it is safe to leave.

*In both cases, you should seek additional clarifying information by all means possible…Purdue Emergency
Status page, text message, Twitter, Desktop Alert, Albertus Beacon, digital signs, email alert, TV, radio,
etc.…review the Purdue Emergency Warning Notification System multi-communication layers at
http://www.purdue.edu/ehps/emergency_preparedness/warning-system.html

EMERGENCY RESPONSE PROCEDURES:


• Review the Emergency Procedures Guidelines
https://www.purdue.edu/emergency_preparedness/flipchart/index.html
• Review the Building Emergency Plan (available on the Emergency Preparedness website or from
the building deputy) for:
o evacuation routes, exit points, and emergency assembly area
o when and how to evacuate the building.
o shelter in place procedures and locations
o additional building specific procedures and requirements.

EMERGENCY PREPAREDNESS AWARENESS VIDEOS


• "Shots Fired on Campus: When Lightning Strikes," is a 20-minute active shooter awareness video that
illustrates what to look for and how to prepare and react to this type of incident. See:
http://www.purdue.edu/securePurdue/news/2010/emergency-preparedness-shots-fired-on-campus-
video.cfm (Link is also located on the EP website)

MORE INFORMATION
Reference the Emergency Preparedness web site for additional information:
https://www.purdue.edu/ehps/emergency_preparedness/

Non-discrimination

Purdue University is committed to maintaining a community that recognizes and values the inherent worth
and dignity of every person; fosters tolerance, sensitivity, understanding, and mutual respect among its
members; and encourages each individual to strive to reach his or her own potential. In pursuit of its goal of

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academic excellence, the University seeks to develop and nurture diversity. The University believes that
diversity among its many members strengthens the institution, stimulates creativity, promotes the exchange
of ideas, and enriches campus life.

Purdue University prohibits discrimination against any member of the University community on the basis of
race, religion, color, sex, age, national origin or ancestry, genetic information, marital status, parental
status, sexual orientation, gender identity and expression, disability, or status as a veteran. The University
will conduct its programs, services and activities consistent with applicable federal, state and local laws,
regulations and orders and in conformance with the procedures and limitations as set forth in Executive
Memorandum No. D-1, which provides specific contractual rights and remedies. Any student who believes
they have been discriminated against may visit www.purdue.edu/report-hate to submit a complaint to the
Office of Institutional Equity. Information may be reported anonymously.

In the event of a major campus emergency, course requirements, deadlines and grading percentages are
subject to changes that may be necessitated by a revised semester calendar or other circumstances. Contact
Geanie Umberger gumberger@purdue.edu or the course TAs there are questions about course changes or
other inquiries.

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