LifeSciences Step Into the Future of Life Science — We’re Already There

Life Sciences
LifeSciences
Step Into the Future of Life Science —
We’re Already There
Explore the broad array of courses and
certificate programs to meet the continuing
education needs of the life sciences
community, support high-level skills
development for industry professionals
and career transition for those interested
in entering the biotechnology field.
spot
light.
New! Structural Biology
in Drug Discovery
Explore the applications of structural
biology in the discovery of new
therapeutics. This new course will improve
your knowledge of the drug discovery
process and explore the fundamentals of
macromolecular structure biology
See page 224 for details or
visit extension.ucsd.edu/lifesciences.
Explore Advanced Topics in Regulatory
Affairs
This capstone course will help you
examine current and often complex
Regulatory Affairs issues impacting
regulated biopharmaceutical industry.
Hear from leading professionals with
broad industry and FDA experience.
See page 226 for details or visit
extension.ucsd.edu/ra.
220 Iextension.ucsd.edu
Good Manufacturing Practices (GMP)
Learn the FDA’s basic Good Manufacturing
Practices regulations through readings,
reference materials and handouts. Specific
topics include the Food Drug and Cosmetics
Act, the regulatory structure, the drug GMP,
and state and federal requirements.
See page 224 for details or visit extension.ucsd.edu/ra.
Discover the importance of Biomarkers
Discover the major “Biomarkers”
theoretical concepts and practical issues
involved in conducting both disease related
biomarkers as well as research in clinical
diagnosis and drug discovery.
See page 224 for details or visit
extension.ucsd.edu/diagnostics.
Molecular Diagnostics and Personalized
Medicine
Discover the new emphasis on patient
personal care based on developments
in molecular diagnostics and metabolic
technologies used to identifying biomarkers.
Review the molecular markers of diseases,
drug effectiveness, ethical issues and the
economic impact arising from the future of
diagnostics.
See page 224 for details or visit
extension.ucsd.edu/diagnostics
Contact Us
Life Sciences | Phone: (858) 534-9353
Email: [email protected]
Director: Hugo Villar | Phone:(858) 534-9354
Learn more > extension.ucsd.edu/lifesciences
Winter 2015 I
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Life Sciences
Biotech Project Management
Specialized Certificate
Obtain project management skills specifically for the biotech industry. This joint online
certificate, offered through UC San Diego Extension and University of Washington Extension, is intended for product managers, manufacturing managers, quality managers and
clinical research or regulatory specialists engaged in biotech product design, development and control.
Program Features
•Online format
•Capstone project that simulates the clinical development cycle
•Development and presentation of a detailed project plan that can be added to your
professional portfolio
Next program begins in April 2015. Now accepting applications!
For more information:
(858) 534-9353 | [email protected] | extension.ucsd.edu/biotechpm
Instructor Spotlight
Laura Guy, M.S., RAC
Student Spotlight
Marie Beltran
“At high-visibility project meetings, I grew
to admire the skill sets that various project
managers employed to yield measurable
results to complete critical deadlines. I
appreciated the overall program structure
of the Biotechnology Project Management
Certificate, the highly qualified instructors,
and the commitment and unique perspective that my classmates brought to team
assignments. This program has provided additional career paths to consider as I embark
on my next professional venture.”
Winter 2015 I
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Laura Guy is the owner of Regulatory
Liaisons, LLC which provides Regulatory
Affairs and Quality System services to
innovators and manufacturers of
pharmaceutical, biologic, cosmetic, and
medical device products. Her areas of
expertise include establishing compliant
Quality Systems, GXP auditing, training, and
FDA submissions for INDs, NDAs, IDEs, and
510(k)s. Laura has been teaching at UC
San Diego Extension since 2009. She will
be teaching the following courses in Winter
2015: “Good Manufacturing Practices” and
“Overview of Regulatory Affairs for Medical
Device Professionals”.
Certificate
Programs
SPECIALIZED
• ADMET Process
• Biofuels Processes
• Biofuels Science
• Biostatistics
• Biotechnology Project Management
• In Vitro Diagnostics
• Quality Assurance & Control
• Regulatory Affairs Essentials
• SAS Programming
PROFESSIONAL
• Drug Discovery and Development
• Life Sciences Information Technology
• Regulatory Affairs for the Biomedical
Industry.
extension.ucsd.edu
I 221
contents courses
TABLE OF CONTENTS
Bioinformatics & Life Sciences IT . . . . . 222
Life Sciences
Pattern Recognition for Bioinformatics. . . . . . . . . . . 222
Perl For Bioinformatics II. . . . . . . . . . . . . . . . . . . . . 222
Biostatistics. . . . . . . . . . . . . . . . . . . . . . . 222
CDISC: Standards in SDTMs and ADaMs. . . . . . . . . 222
Biostatistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
SAS Programming I: DATA Step
and PROC Fundamentals . . . . . . . . . . . . . . . . 223
SAS Programming II: Advanced
DATA Step Programming. . . . . . . . . . . . . . . . . 223
Clinical Biostatistics. . . . . . . . . . . . . . . . . . . . . . . . . 223
Biotech & Pharmaceutical
Operations . . . . . . . . . . . . . . . . . . . . . . . 223
Introduction to QA/QC for Drugs & Biologics. . . . . . 223
Good Manufacturing Practices. . . . . . . . . . . . . . . . . 223
Diagnostics. . . . . . . . . . . . . . . . . . . . . . . 224
Biomarkers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Molecular Diagnostics and
Personalized Medicine. . . . . . . . . . . . . . . . . . . 224
Drug Discovery & Development. . . . . . 224
Structural Biology in Drug Discovery . . . . . . . . . . . . 224
Drug Metabolism . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Introduction to Pharmacology. . . . . . . . . . . . . . . . . 224
Predicting & Selecting Promising
Drug Compounds. . . . . . . . . . . . . . . . . . . . . . 224
Medicinal Chemistry of Leading Drugs. . . . . . . . . . . 225
Applied Immunology. . . . . . . . . . . . . . . . . . . . . . . . 225
General Life Science. . . . . . . . . . . . . . . . 225
Cell and Molecular Biology. . . . . . . . . . . . . . . . . . . 225
Introduction to Genetics and Human Disease. . . . . . 225
Industrial Biotechnology. . . . . . . . . . . . 225
Introduction to Biofuels. . . . . . . . . . . . . . . . . . . . . . 225
Regulatory Affairs. . . . . . . . . . . . . . . . . 226
Overview of Regulatory Affairs
for Medical Device Professionals. . . . . . . . . . . 226
Regulatory Compliance for Drugs & Biologics . . . . . 226
Good Laboratory Practices. . . . . . . . . . . . . . . . . . . . 226
Advanced Topics in Regulatory Affairs. . . . . . . . . . . 226
Specialized Certificates . . . . . . . . . . . . . 227
ADMET Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Biofuels Processes. . . . . . . . . . . . . . . . . . . . . . . . . . 227
Biofuels Sciences. . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Biostatistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Biotechnology Project Management . . . . . . . . . . . . 228
Clinical Trials Administration . . . . . . . . . . . . . . . . . . 228
Data Mining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Geographical Information Systems. . . . . . . . . . . . . . 229
In Vitro Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . 229
Quality Assurance and Control. . . . . . . . . . . . . . . . . 230
Regulatory Affairs Essentials. . . . . . . . . . . . . . . . . . 230
SAS Programming. . . . . . . . . . . . . . . . . . . . . . . . . . 230
Professional Certificates . . . . . . . . . . . . 231
Drug Discovery and Development . . . . . . . . . . . . . . 231
Life Sciences Information Technology. . . . . . . . . . . . 232
Regulatory Affairs for the Biomedical Industry. . . . . 233
BIOINFORMATICS & LIFE SCIENCES IT
SEE ALSO
•Professional Certificate in Life Sciences
Information Technology—p. 232
HANDS-ON
Pattern Recognition for
Bioinformatics
Pattern recognition is becoming increasingly important in the age of automation
and information handling and retrieval. This
course focuses on algorithms for pattern
recognition that can be applied to problems in bioinformatics and biotechnology,
including laboratory imaging, microscopy,
and gene expression arrays. The processing of
intensity histograms, edge and feature detection, Fourier and deconvolution filters, and
3D tomography will be described. Statistical
methods will be introduced and applied to
hypothesis testing. Methods for clustering
and categorizing expression patterns will be
evaluated and extended to proteomic, genetic
interactions and the analysis of metabolic
networks. Computer simulation modeling
methods, systems analysis, and problems of
integration for cellular imaging data will be
introduced.
IN-CLASS
Instructor: Philip C. Miller, Ph.D.
Instructor, UCSD; Senior Software Engineer, Sony.
Section: 105824-5003 Course No. BIOL-40157
Time/Date: M 6:00-9:00 p.m., Jan. 5-Mar. 16;
no mtg. Jan. 19, Feb. 16 (9 mtgs.)
Location: UCSD Extension University City Ctr.,
6256 Greenwich Dr., San Diego
Credit: 2 units in Biology
Fee: $525 No refunds after: Jan. 12 (hov/fia)
Perl For Bioinformatics II
Perl is a powerful and flexible language with a
quick development cycle that makes it perfect
for fast-paced and fluid problem domain.
This course extends Perl for Bioinformatics
I to include examples of graphical user
interface development, web development,
and database loading. Learn how biological
sequences flow from the screen, to the web,
and through various analysis pipelines.
ONLINE
Instructor: David Michael Scott, B.S., MSTOM
e-commerce consultant.
Section: 105786-5003 Course No. BIOL-40242
Time/Date: Jan. 12-Mar. 16
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $550 No refunds after: Jan. 19 (hov/fia)
BIOSTATISTICS
SEE ALSO
•
Specialized
Certificate
Programming—p. 230
in
SAS
CDISC: Standards in SDTMs and
ADaMs
˜Clinical Data Interchange Standards
Consortium (CDISC) is a non-profit organization that has established standards to support the acquisition, exchange, submission
and archive of clinical research data. The primary objective of this course is to provide the
skills and tools necessary to apply the CDISC
standards when processing clinical data used
for FDA submissions. Specifically, this course
will focus mapping raw datasets to CDISC’s
Study Data Tabulation Models (SDTM) and
Analysis Dataset Models (ADaM). CDISC
is an important system to learn because it
becomes a requirement in 2014 for selected
clinical studies. Further Reading: Understand
the New CDISC Standards (blog). Note:
Prior knowledge of clinical trials is suggested.
ONLINE
Instructor: Sunil K. Gupta, M.S.
Principal SAS CDISC Consultant, Gupta
Programming.
Section: 105341-5003 Course No. BIOL-40293
Time/Date: Jan. 26-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 2 units in Biology
Fee: $525 No refunds after: Jan. 31 (hov/cah)
Biostatistics
Biostatistics provides the basic framework for
thinking about data in a rigorous fashion.
This course is intended as both a refresher
course and a first course in the application
of statistical thinking. Descriptive and inferential statistics will be covered, with topics
including basic probability, discrete and continuous distributions, descriptive statistics,
confidence intervals, hypothesis testing, correlation, simple regression, and chi-square
tests.
ONLINE
Instructor: Peter Sifferlen, MBA, BSME
Independent Business Analysis Consultant.
Section: 105284-5003 Course No. BIOL-40049
Time/Date: Jan. 5-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 12 (hov/cah)
Intellectual Property
Develop a foundation in securing and
maintaining patents, copyrights and
trademarks. See page 208.
222 Iextension.ucsd.edu
Winter 2015 I
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This course provides the tools necessary to
write SAS programs to perform elementary
data management, analysis, and reporting all
while stressing good programming practices.
The objectives are to provide the skills necessary to create and document data sets, manage and reshape data, write simple reports,
and compute basic statistics on data set variables. A secondary objective is to provide the
basis for more advanced work, including data
analysis, advanced programming techniques
for data management, and interactive applications development. Note: ‘Introduction
to Programming’ or knowledge of basic
programming concepts is required. Students
must download and install SAS® OnDemand
for Academics: Enterprise Guide. There is no
additional cost for this product. Registration
and download information will be provided
by the instructor on the start date.
Clinical Biostatistics
Clinical Biostatistics presents the analysis of
data in a more advanced setting as applied
to clinical and medical studies. Students are
expected to have a clear understanding of
elementary statistics topics and a basic understanding of the SAS programming language
before taking this course. Topics include multiple linear regression, ANOVA & ANCOVA
models, multiple comparisons, logistic
regression, non-parametric methods, and a
brief overview of repeated measure models
and survival analysis. Note: Completion of
Biostatistics and SAS Programming I: DATA
Step and PROC Fundamentals’ or one year
of related experience is required. Students
must download and install SAS® OnDemand
for Academics: Enterprise Guide. There is no
additional cost for this product. Registration
and download information will be provided
by the instructor on the first day of class.
ONLINE
Instructor: Justina Mary Flavin, B.A.
Statistical Programming Consultant.
Section: 105342-5003 Course No. BIOL-40190
Time/Date: Jan. 5-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 10 (hov/cah)
ONLINE
Instructor: Arthur Li, M.S.
Biostatistician, City of Hope; Instructor, Department
of Preventative Medicine, USC.
Section: 105340-5003 Course No. BIOL-40253
Time/Date: Jan. 12-Mar. 14
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 17 (hov/cah)
SAS Programming II: Advanced
DATA Step Programming
BIOTECH & PHARMACEUTICAL
OPERATIONS
˜The course provides an in-depth theo-
retical aspect of how SAS DATA step processes during the DATA step compilation
and execution phases. Course topics include
understanding how the program data vector
(PDV) works, BY-group processing, writing
loops in the DATA step and array processing.
In addition, data cleaning techniques, various ways of combining data sets and some
useful data management SAS procedures
are also introduced. Many programming
work-related examples will be demonstrated
and students will also have opportunities to
practice solving real-life problems via exercises and assignments. Note: Completion of
‘SAS Programming I: DATA Step and PROC
Fundamentals’ or one year of SAS programming experience is required. Students must
download and install SAS® OnDemand for
Academics: Enterprise Guide.
ONLINE
Instructor: Arthur Li, M.S.
Biostatistician, City of Hope; Instructor, Department
of Preventative Medicine, USC.
Section: 105343-5003 Course No. CSE-41183
Time/Date: Jan. 12-Mar. 14
Location: ucsdextension.blackboard.com
Credit: 3 units in Computer Science & Engineering
Fee: $650 No refunds after: Jan. 17 (hov/cah)
Introduction to QA/QC for Drugs
& Biologics
This introductory course in Quality
Assurance/Quality Control (QA/QC) for
Drugs & Biologics provides guidance in the
following areas: 1) understanding the importance and underlying principles of QA/QC;
2) developing a cost-effective, risk-managed
QA/QC strategy for products through the
different phases of clinical development and
into commercialization; 3) handling biosafety, potency, and impurity profile issues
for biologic/biopharmaceutical products; 4)
setting appropriate and meaningful product specifications and expiration dates; 5)
managing manufacturing process changes;
6) identifying pressures on QA/QC groups
today; and 7) meeting FDA’s expectations for
the role of Quality Systems.
ONLINE
Instructor: K. A. Ajit-Simh
President, Shiba Biotechnology.
Anjali Simh
Section: 105776-5003 Course No. BIOL-40038
Time/Date: Jan. 5-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 12 (hov/fia)
Good Manufacturing Practices
Learn the FDA’s basic Good Manufacturing
Practices regulations through readings, reference materials and handouts. Specific topics
include the Food Drug and Cosmetics Act,
the regulatory structure, the drug GMP, and
state and federal requirements. Be prepared
to review and respond to a FDA warning letter as a learning tool.
ONLINE
Instructor: Laura E. Guy, M.S., RAC
Owner, Regulatory Liaisons, LLC.
Section: 105775-5003 Course No. BIOL-40000
Time/Date: Jan. 5-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 12 (hov/fia)
Life Sciences
SAS Programming I: DATA Step
and PROC Fundamentals
Take Your Next Step
with Center for Life/
Work Strategies
UC San Diego Extension’s Life/Work Center
provides resources for professionals who want
to align their goals, skills, and interests for a
more rewarding life.
Free Resources Available
• Online Self-Assessment
• Quarterly Career Strategy Sessions
• Quarterly Career Clinics
Visit extension.ucsd.edu/careers
Winter 2015 I
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extension.ucsd.edu
I 223
DIAGNOSTICS
SEE ALSO
•Specialized Certificate in In Vitro
Diagnostics—p. 229
Life Sciences
Biomarkers
“Biomarker” is an emerging topic of discussion in clinical diagnosis and drug discovery.
This course covers both major theoretical
concepts and practical issues involved in
conducting both disease related biomarker as well as drug discovery related biomarker research. You will learn about the
various tools available for biomarker discovery, together with biomarker requirement
and classification and criteria for evaluating
potential markers. Issues in epidemiologic
study design, analysis, ethical/legal concerns
will also be discussed.
IN-CLASS
Instructor: Monisha Sundarrajan, Ph.D.
Sr. Scientist in Research Applications, BD
Biosciences.
Section: 105774-5003 Course No. BIOL-40258
Time/Date: Th 6:00-9:00 p.m., Jan. 8-Mar. 5
(9 mtgs.)
Location: Rm. 102, UCSD Extension Complex
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 15 (hov/fia)
Molecular Diagnostics and
Personalized Medicine
The emphasis of clinical practice is slowly
shifting from one-disease and one-treatmentfits-all to more personalized care based on
molecular markers of disease risk, disease
subtype, drug effectiveness, and adverse drug
reactions. Through the use of case studies,
this course will review the genetic, genomic, proteomic, and metabolomic technologies being applied for biomarker discovery
and molecular diagnostic development. The
emerging role of the FDA in personalized
medicine will be addressed. The economic
impact and ethical issues arising from this
next generation of diagnostics will also be
discussed. The class is designed as a survey
course and is appropriate for researchers and
individuals in the business of biotechnology
who possess a basic science background.
Learn the Science
and Craft of Brewing
Taught by leading professional brewers,
scientists, and experts in San Diego, this
part-time and weekend Professional
Certificate in Brewing will prepare you to
enter the booming brewing business in
San Diego in 18 months to 2 years.
See page 178 for details.
224 Iextension.ucsd.edu
IN-CLASS
Instructor: Nicholas F. Paoni, Ph.D.
Biotechnology Consultant; Instructor.
Section: 105807-5003 Course No. BIOL-40251
Time/Date: W 6:00-9:00 p.m., Jan. 14-Mar. 11
(9 mtgs.)
Location: Rm. 102, UCSD Extension Complex
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 21 (hov/fia)
DRUG DISCOVERY & DEVELOPMENT
Structural Biology
in Drug Discovery
˜Get an overview of the application of
structural biology in the discovery of new
therapeutics. This course is for research scientists who want to improve their knowledge
of the drug discovery process and will explore
the fundamentals of macromolecular structure biology with an emphasis on how those
principles can be applied to the discovery of
therapeutic agents. The course starts with
a survey of macromolecular structure and
a detailed analysis of certain protein classes
that have been found to be important for
drug purposes. We will describe how structural information can be used to optimize
therapeutic proteins such as antibodies. The
course will discuss how computational techniques can be used to identify small molecule
ligands by applying docking techniques
ONLINE
Instructor: Hugo Villar, Ph.D., MBA
President, Altoris, Inc.; Science and Technology
Director, UCSD Extension.
Section: 105667-5003 Course No. BIOL-40299
Time/Date: Feb. 2-Mar. 16
Location: ucsdextension.blackboard.com
Credit: Not for credit
Fee: $525 No refunds after: Feb. 9 (hov/fia)
Drug Metabolism
Approximately one out of every 1,000 compounds identified in preclinical studies is
eventually found suitable for human use.
This creates a need to shorten the time and
cost to increase the “hit” rate of finding drug
candidates. This course will give you a comprehensive understanding of the biochemical aspects of drug metabolism in the drug
discovery process and related pharmaceutical
principles. Topics include pharmacokinetics, Phase I and II drug metabolism, factors affecting drug metabolism, and recent
advances in drug metabolizing and absorption technology. The goal of this course is to
give students a full appreciation of the drug
metabolism aspects of the NDA process as
well as an ability to predict drug metabolism
and distribution of new chemical entities.
ONLINE
Instructor: John Cashman, PhD
Director and Founder, The Human BioMolecular
Research Institute.
Martin W Rowbottom
Section: 105778-5003 Course No. BIOL-40170
Time/Date: Jan. 5-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 12 (hov/fia)
Introduction to Pharmacology
Gain an introduction to classical pharmacology. This course will emphasize the understanding of drug effects on organ systems
and drug use as clinical therapeutics. Topics
covered include: receptor structure/function
and signal transduction pathways; pharmacokinetics—rates of drug absorption, distribution, metabolism, and excretion (ADME);
pharmacodynamics—dose-response relationships of drugs and their mechanism of action;
and a survey of major systems physiology and
pharmacology including renal/cardiovascular pharmacology, neuropharmacology, and
chemotherapy. Note: For students with a
bachelor or graduate degree in biological or
chemical sciences.
IN-CLASS
Instructor: Jelveh Lameh, Ph.D.
Director of BioPharma Services, Genoptix Medical
Laboratory.
Section: 105788-5003 Course No. BIOL-40047
Time/Date: Tu 6:00-9:00 p.m., Jan. 20-Feb. 24
(6 mtgs.)
Location: UCSD Extension University City Ctr.,
6256 Greenwich Dr., San Diego
Credit: 2 units in Biology
Fee: $525 No refunds after: Jan. 27 (hov/fia)
Early enrollment advised.
Predicting & Selecting Promising
Drug Compounds
Learn the process and considerations in
predicting and selecting the most promising alternative among various candidate
drug compounds. In a very practical way,
this course applies the principles taught in
previous courses related to the likelihood of
positive absorption, distribution, metabolism, excretion and toxicology/patient safety
outcomes of each compound. This course
will include the use of in vitro studies utilized to predict in vivo outcomes in both test
animals and humans Note: A preliminary
background in drug metabolism, pharmacokinetics and toxicology is recommended.
Data Mining
Learn how individuals in a variety of
industries design, build, verify and test
predictive data models.
See page 229 for details.
Winter 2015 I
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Medicinal Chemistry of Leading
Drugs
Explore the drug discovery process using
case histories in various therapeutic areas.
Following an analysis of the leading prescription drugs and their physicochemical properties which ensure they are ‘drug-like’, case
histories will focus on target identification
and validation, design and synthesis of relevant molecules, structure activity relationships and a summary of the pharmacokinetic
properties of the selected drugs. Therapeutic
areas which will be discussed include antihypertensives, anxiolytics and antidepressants,
anti-viral agents and antihyperlipidaemia
agents and will cover both earlier drugs in
the field as well as the most recent advances.
IN-CLASS
Instructor: Warren Wade, Ph.D.
Director of Medicinal Chemistry, BioBlocks, Inc.
Section: 105826-5003 Course No. BIOL-40161
Time/Date: Th 6:00-9:00 p.m., Jan. 22-Feb. 19
(5 mtgs.)
Location: UCSD Extension University City Ctr.,
6256 Greenwich Dr., San Diego
Credit: 1 unit in Biology
Fee: $295 No refunds after: Jan. 29 (hov/fia)
Applied Immunology
Innovative immunological approaches aimed
at modifying immune response will continue
to play a significant role in the future of biomedical, medicine, biotechnology, and the
pharmaceutical industries. This course will
examine newer techniques and applications
in the immunology field as they pertain to
medical diagnostics and biotechnology. It
will cover current principles and theories
being developed, antibody structure and
function, innate and adaptive immunity, cells
involved in the immune response, complement, antigen-antibody reactions, and antibody detection for the diagnosis of infectious
disease.
Center for Life/Work Strategies
Get a career boost with resources
and workshops to complement your
certificate courses.
See page 223 or
extension.ucsd.edu/careers
Winter 2015 I
(858) 534-3400
ONLINE
Instructor: Todd Braciak, Ph.D.
Assistant Member, Laboratory of Molecular
Immunology and the Division of Immune
Regulation, Torrey Pines Institute for Molecular
Studies.
Section: 105777-5003 Course No. BIOL-40043
Time/Date: Jan. 5-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 12 (hov/fia)
GENERAL LIFE SCIENCE
SEE ALSO
•Specialized Certificate in Biotechnology
Project Management—p. 228
Cell and Molecular Biology
Get an overview of what is currently known
in cellular and molecular biology and its
application in biotechnology in this introductory course. In this course, you will start
with a review of necessary basic chemistry
concepts, cover the molecules and processes
essential for living systems and reach a basic
understanding of biotechnology and the fundamental techniques it uses. Topics covered
include: DNA and protein structure and
function, elementary genetics, cell structure,
cell cycle, inheritance and DNA sequencing.
ONLINE
Instructor: Robert E Enns, Ph.D.
Drug resistance research and 3 usage patents, Oregon
State University and UCSD.
Section: 105783-5003 Course No. BIOL-40234
Time/Date: Jan. 12-Mar. 16
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $550 No refunds after: Jan. 19 (hov/fia)
Introduction to Genetics and
Human Disease
Genetics is a fascinating topic that is frequently in the news. “Learn valuable health
and ancestry information” and “Discover
your genetic risk for disease” are just a few
of the advertisements for direct-to-consumer
genetic test kits. This course demystifies
genetics and is open to anyone who wishes
to learn more about inherited traits, their
variation, and how they are transmitted
between generations. It will provide an introduction to the principles of genetics with an
emphasis on human disease. Topics include:
fundamental concepts of Mendelian inheritance; basic principles of molecular genetics;
inheritance patterns of genetic diseases; the
human genome project; and the potential of
personalized medicine.
ONLINE
Instructor: Lisa Lievense, M.S.
Adjunct Professor.
Section: 105780-5003 Course No. BIOL-40280
Time/Date: Jan. 12-Mar. 16
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $550 No refunds after: Jan. 19 (hov/fia)
INDUSTRIAL BIOTECHNOLOGY
SEE ALSO
•
Specialized Certificate
Processes—p. 227
•
Specialized Certificate
Science—p. 227
in
Biofuels
in
Biofuels
Life Sciences
ONLINE
Instructor: Ajay Madan, Ph.D., DABT
Vice President, Preclinical Development, Neurocrine
Biosciences.
Section: 105779-5003 Course No. BIOL-40219
Time/Date: Jan. 26-Mar. 9
Location: ucsdextension.blackboard.com
Credit: 2 units in Biology
Fee: $525 No refunds after: Feb. 2 (hov/fia)
Introduction to Biofuels
The course will cover the current production and utilization of energy, as well as the
consequences of this use, examining finite
fossil energy reserves, how food and energy
are linked, impacts on the environment and
climate, and the social and economic impacts
of our present energy and food production
and use. Students who choose to continue
on in the “Introduction to Biofuels” companion course, will more specifically learn
the growing field of biofuels by learning the
basics of renewable biofuel production. The
topics covered will include the chemistry of
biofuels, the biology of important feedstocks,
the biochemical, genetic and molecular
approaches being developed to advance the
next generation of biofuels and the economical and global impacts of biofuel production.
ONLINE
Instructor: Stephen P. Mayfield, Ph.D.
Director, San Diego Center for Algae Biotechnology.
Section: 106168-5003 Course No. BIOL-40261
Time/Date: Feb. 9-Mar. 20
Location: ucsdextension.blackboard.com
Credit: 3 units in Biology
Fee: $295 No refunds after: Feb. 14 (hov/avy)
Technical Communication
Bring any of these courses
to your workplace!
Discover a new career in Technical
Communication! Learn about the
industry and our online certificate
program at a free, online information
session.
See corporate training on pages 20-21.
See page 182 for details.
extension.ucsd.edu
I 225
REGULATORY AFFAIRS
Life Sciences
Overview of Regulatory Affairs
for Medical Device Professionals
Get a comprehensive picture of the medical
device regulatory process. The focus will be
on FDA laws and regulations required to successfully develop and commercially market
medical devices in the United States. Topics
include: product development/approval
process (IDE, 510(k), PMA), post-market
controls, state and federal site inspections,
enforcement activities, and suggestions for
working proactively with the FDA. Note:
Designed for individuals new to the medical
device and biotechnology industries or those
considering a career in Regulatory Affairs or
Project Management.
Good Laboratory Practices
By addressing fundamental regulatory compliance principles relative to the FDA’s current Good Laboratory Practice regulations,
this course will show how GLP’s affect the
conduct of non-clinical laboratory research,
QA audit programs and FDA inspections.
You will gain an in-depth understanding of
specific critical GLP requirements such as
the role of the QAU, study director, test and
control articles. Preparation for FDA GLP
inspections and current inspection trends,
basic elements of GLP documentation, and
considerations for lab facilities, equipment,
and animals are covered.
Certificate
Programs
Life Sciences
SPECIALIZED
• ADMET Process
• Biofuels Processes
• Biofuels Science
• Biostatistics
ONLINE
Instructor: Laura E. Guy, M.S., RAC
Owner, Regulatory Liaisons, LLC.
Section: 105787-5003 Course No. BIOL-40080
Time/Date: Feb. 2-Mar. 16
Location: ucsdextension.blackboard.com
Credit: 2 units in Biology
Fee: $525 No refunds after: Feb. 9 (hov/fia)
ONLINE
Instructor: Alice K. Robison, Ph.D.
Director of Compliance, Cato Research.
K. A. Ajit-Simh
President, Shiba Biotechnology
Anjali Simh
Section: 105781-5003 Course No. BIOL-40085
Time/Date: Jan. 12-Mar. 16
Location: ucsdextension.blackboard.com
Credit: 2 units in Biology
Fee: $525 No refunds after: Jan. 19 (hov/fia)
Regulatory Compliance for Drugs
& Biologics
Advanced Topics in Regulatory
Affairs
• Drug Discovery and Development
Regulatory Compliance is the level of activity
that provides assurance to the sponsor and
the regulatory agency that all phases of drug
development are conducted in compliance
to the good practice regulations as mandated
by the Federal Food, Drug, and Cosmetic
(FD&C) Act. In this course, you will learn
the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development.
You will also examine how a pharmaceutical or biotechnology company can use the
graded approach when following the good
manufacturing practice (GMP) regulations
for manufacturing, testing and control of
clinical supplies and commercial products.
ONLINE
Instructor: K. A. Ajit-Simh
President, Shiba Biotechnology.
Anjali Simh
Section: 105782-5003 Course No. BIOL-40101
Time/Date: Jan. 12-Mar. 16
Location: ucsdextension.blackboard.com
Credit: 2 units in Biology
Fee: $525 No refunds after: Jan. 19 (hov/fia)
Need to improve your
English proficiency?
Please see ESL courses starting
on page 123 for more details.
226 Iextension.ucsd.edu
This capstone course will help you examine
current, often complex, Regulatory Affairs
issues impacting regulated biopharmaceutical
industry. Presented by leading professionals
with broad industry and FDA experience,
this class will provide you with the opportunity to learn about and examine critical
development decisions and practices at leading companies. A final project is required,
where you will develop and present analysis
of a significant RA topic to a panel of instructors and peers. Note prerequisite: Regulatory
Requirements for Drugs and Biologics
• Biotechnology Project Management
• In Vitro Diagnostics
• Quality Assurance & Control
• Regulatory Affairs Essentials
• SAS Programming
PROFESSIONAL
• Life Sciences Information Technology
• Regulatory Affairs for the
Biomedical Industry.
IN-CLASS
Instructor: Steven A. Kradjian, RAC
Regulatory Affairs Consultant.
Section: 105827-5003 Course No. BIOL-40110
Time/Date: W 6:00-9:00 p.m., Jan. 14-Mar. 11
(9 mtgs.)
Location: UCSD Extension University City Ctr.,
6256 Greenwich Dr., San Diego
Credit: 3 units in Biology
Fee: $650 No refunds after: Jan. 21 (hov/fia)
Project Management Essentials
in Science and Technology
Learn effective project management skills
relevant to the life science, engineering
and technology fields.
See page 55 for details.
Winter 2015 I
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SPECIALIZED CERTIFICATE
ADMET Process
Biofuels Processes
The
ADMET
processes—Absorption,
Distribution, Metabolism, Excretion, and
Toxicology—form one of the foundations of
all modern drug discovery and development. It
has been reported that 50% of drug failures in
development and clinical trials are due to poor
ADMET properties. In order to minimize these
costly failures, the paradigm of drug discovery
and development has therefore been shifting to
examining and optimizing these properties as
early as possible. This requires virtually every
organization that embarks on the challenge of
creating pharmaceutical solutions to health or
agricultural concerns to become expert at analyzing these processes.
Accordingly, successful professionals in the field
must be aware of and proficient in the examination of each of these processes, and employers
must ensure the continued development of a
workforce capable of understanding and facilitating systems and environments where these
processes can be researched and evaluated with
integrity and efficiency.
Despite the core importance of the ADMET
processes to pharmaceutical science, few scientific, regulatory or business professionals possess a complete understanding of the elements
of ADMET. Traditional science education
prepares research specialists in one or two processes, but not the full complement and cycle.
To the extent that scientific professionals understand and can incorporate ADMET concepts
into their research and development projects,
they are increasingly able to provide successful solutions to the R&D challenge, and they
become more valuable to their organizations.
Individual courses in each of these processes
offered by Extension over the past few years
have confirmed the interest of the profession in
strengthening understanding and application of
each process element.
The Biofuels Processes Specialized Certificate
provides students with comprehensive view of
the landscape of biofuels research and production, analysis and downstream processing, as well
as project management and other business skills
required to excel in a management-level biofuels
position. This program is entirely online.The
Biofuels Processes Specialized Certificate is aimed
at training professionals for roles in the growing biofuels industry. Professionals may act as
project managers, business development or other
support roles that do not require direct hands
on experience with the experimental techniques
used in biofuels research.
Conditions for Admission
The primary audience for the program is practicing professionals with a science degree, currently working in the pharmaceutical field.
Professionals with legal, business or clinical
backgrounds, or science professionals considering entering the pharmaceutical field, may also
be attracted to the program.
Required Courses (All 4 courses are required.)
•Drug Metabolism (BIOL-40170)
•Pharmacokinetics (BIOL-40176)
•Predicting & Selecting Promising Drug
Compounds (BIOL-40219)
•Toxicology (BIOL-40189)
Cert. ID: 106404-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9353
Email: [email protected]
Winter 2015 I
(858) 534-3400
Why Biofuels
Biofuels research and development in the San
Diego region constitutes an increasingly robust
cluster of economic activity and employment
opportunities. A 2011 analysis, conducted
by the San Diego County of Governments’
(SANDAG) economic bureau, reports that
for the algae sector alone, the industry currently provides the San Diego region with 466
direct jobs and $81 million in direct economic
activity and $157 million in total economic
activity annually. With increasing pressure on
fossil fuels and the movement to develop clean,
renewable alternative energy, the biofuels sector
is set to grow at an impressive pace.
Certificate & Course Fees:
The total cost of this program is approximately
$2425. Fees are paid at the course level, with
the exception of the $60 certificate fee. Prices
of the courses range from $540 to $795. Fees do
NOT include books or materials.
New! Our Energy Future Massive Open
Online Course
With the support of Google, Food & Fuel for
the 21st Century and the Center for Energy
Research at UCSD have teamed up to create a
Massive Open Online Course (MOOC),
titled “Our Energy Future”. This 10-week course
aims to provide knowledge on general topics of
energy including, energy production and utilization, renewable energy, climate change, social
and economic effects of energy, and energy as it
relates to water and food security.
Certificate Guidelines
The Biofuels Processes Certificate is offered
entirely online.
Required Courses (All four are required.)
•Introduction to Biofuels (BIOL-40261)
•Downstream Processing and Refinement of
Biofuels (BIOL-40268)
•Project Management Essentials in Science
and Technology (BUSA-40862)
•Biomass Production (BIOL-40278)
SPECIALIZED CERTIFICATE
Biofuels Science
The Biofuels Science Specialized Certificate is
aimed at training professionals for field and laboratory roles in the growing biofuels industry. It
provides students hands-on technical knowledge
and experience in laboratory techniques used in
biofuels production, analysis and processing.
Students choose from one of the following specialization tracks:
• Molecular Biology
• Aquatic Microbiology
• Analytical Chemistry
Why Biofuels?
Life Sciences
SPECIALIZED CERTIFICATE
Biofuels research and development in the San
Diego region constitutes an increasingly robust
cluster of economic activity and employment
opportunities. A 2011 analysis, conducted by the
San Diego County of Governments’ (SANDAG)
economic bureau, reports that for the algae sector
alone, the industry currently provides the San
Diego region with 466 direct jobs and $81 million in direct economic activity and $157 million
in total economic activity annually.
With increasing pressure on fossil fuels and the
movement to develop clean, renewable alternative energy, the biofuels sector is set to grow at an
impressive pace.
Conditions for Admission
Application is required. Visit website for details.
extension.ucsd.edu/biofuelsscience
Required Core Courses (Both courses are
required.)
•Introduction to Biofuels (BIOL-40261)
•Biomass Production (BIOL-40278)
•Biomass Production Lab (BIOL-40921)
Required Track Courses (Choose one track.)
Molecular Biology (Both courses are required.)
•Genetics and Physiology of Photosynthetic
Microorganisms (BIOL-40262)
•Photosynthetic Microorganisms Molecular
Biology Laboratory (BIOL-40265)
Aquatic Microbiology (Both courses are
required.)
•Aquatic Ecology (BIOL-40264)
•Aquatic Microbiology Laboratory (BIOL40266)
Analytical Chemistry (Both courses are
required.)
•Chemistry and Biochemistry of Biofuels
(BIOL-40263)
•Analytical Chemistry Laboratory (BIOL-40267)
Cert. ID: 106409-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9351
Email: [email protected]
Cert. ID: 106404-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9351
Email: [email protected]
extension.ucsd.edu
I 227
SPECIALIZED CERTIFICATE
Life Sciences
Biostatistics
The field of biostatistics has become an indispensable tool in improving our understanding
of biological process and has a direct impact in
ensuring the safety and efficacy of pharmacological and biotechnology products. Biostatistians
can be found beyond pharmacological or medical research in various fields and industries.
In addition, the application of biostatistics is
expanding to include several relatively new
fields, such as medical imaging, ecological forecasting, and statistical genetics.
The emphasis of the specialized certificate is in
the application of statistical techniques to the
analysis of clinical data. The course sequences
starts with a refresher of basic statistical concepts in Biostatistics to more advanced topics,
including the use of the dominant software
for statistical analysis in the field. Students
will develop a clear, solid understanding of
statistical methods and their applications, along
with a good understanding of the available
software tools needed to carry out the work.
The students will cap their certificate by learning about the purpose of clinical trials and how
Biostatistics is applied to the development,
analysis and completion of the clinical trial
process including an overview of ICH/FDA
statistical regulations, planning and writing the
statistical section of the protocol, development
and writing of the Statistical Analysis Plan, analyzing clinical trial data and writing the results
section of the clinical study report.
Industry Requirements
Upon completion of the program, biostatistics
jobs frequently cross into data analysis and
quality control assurance. Beyond clinical trials, biostatisticians often work closely with
other professionals to develop policies, conduct
market research, and implement cost controls,
such as economists, insurance analysts, marketing specialists, and in the development of new
computer programs.
Required Courses (All four courses are
required. The courses should be taken in the order
suggested.)
•Biostatistics (BIOL-40049)
•SAS Programming I: DATA Step and PROC
Fundamentals (BIOL-40190)
•Clinical Biostatistics (BIOL-40253)
•Biostatistical Methods in Clinical Trials
(BIOL-40254)
Other Courses of Interest (Not required
for certificate.)
•CDISC: Standards in SDTMs and ADaMs
(BIOL-40293)
•Introduction to R Programming (CSE41097)
Cert. ID: 106412-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9356
Email: [email protected]
SPECIALIZED CERTIFICATE
SPECIALIZED CERTIFICATE
Biotechnology
Project Management
Clinical Trials Administration
The biotech industry has a distinct set of requirements for the project manager. Managing various discovery, development, testing and manufacturing processes within a highly-regulated
and creative environment poses unique project
management challenges, not usually covered in
foundation curriculum or traditional industry
experience.
Seattle and San Diego are two west coast centers
of the biotechnology industry with the ability
to address this professional challenge. The joint
online Biotech Project Management Specialized
Certificate Program through UC San Diego
Extension and University of Washington
Extension is intended for product managers,
manufacturing managers, quality managers and
scientific, clinical research or regulatory specialists engaged in biotech product design, development and control. The program is ideal for
individuals who are trying to move into the biotech industry by learning project management
processes for completing and delivering a biotech product within budget and on schedule.
Conditions for Admission
Participants must have a BS or BA and a
minimum of 2 years of project-related work
experience. The Fall 2014 program will begin
on September 26, 2014. Applications are currently being accepted. To apply, please visit
the University of Washington’s Biotech Project
Management certificate website.
Certificate Guidelines
Participants will take 2 online courses developed and offered by UW Extension and two
biotech courses offered from UCSD Extension.
When students complete all 4 courses, they will
receive a UW-UCSD joint certificate.
Please Note
Tuition is paid on a course-by-course basis.
Estimated tuition for the program is $4,000,
excluding textbooks.
Required Courses - University of
Washington
•Project Management Standards & Processes
(PTNR-UW901)
•Biotechnology Project Capstone (PTNRUW902)
Required Courses - UC San Diego
Extension
•Project Management within a Scientific/
Research Environment (BUSA-40693)
•Applying Project Management Principles
to Biomedical and Pharmaceutical Product
Development (BUSA-40694)
The UCSD Extension Specialized Certificate
in Clinical Trials Administration is modeled
on the top-rated UCSD Extension Professional
Certificate in Clinical Trials Design and
Management, the premier 200+ hour series
of courses. The Intensive program consists of
more than 100 hours of instruction through
two sections, combining classroom instruction
as a cohort and distance learning courses to be
completed at your place of residence.
Developed in partnership with leaders in the
biotechnology/biomedical research industry,
the program’s highly accelerated format offers
immediately applicable knowledge of the clinical trials process.
Audience:
•managers-in-training and others who want to
refine or update skills
•research associates and coordinators
•biomedical and research scientists
•nurses and allied health professionals
•statisticians and database administrators
•international clinical trials professionals
•individuals with degrees in science, psychology, or related areas whom are entering the
field
Certificate Guidelines
Part 1: Intensive Workshop, FPM 40273,
offered Spring, Summer, and Fall quarters. This
is followed by:
Part 2: Follow-On Program, FPM 40272; package includes 3 online classes and the Capstone
workshop (also available via distance learning
for students residing out of region) for one fee
of $995. Must Take FPM 40273 before FPM
40272.
Please Note
Continuing Education hours awarded:
40 hours for Intensive Workshop; an additional 70 hours for the “package” of three
online courses and the Follow-On Workshop.
Applicable to ACRP and SoCRA education
hours requirements.
Required Courses
•Clinical Trials Intensive Workshop (FPM40273)
(FPM 40272 FOLLOWS FPM 40273)
•Clinical Trials Administration Program
(FPM-40272)
Cert. ID: 101558-5003 Application Fee: $60
Contact: Healthcare & Behavioral Sciences,
(858) 534-9261
Email: [email protected]
Cert. ID: 106413-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9353
Email: [email protected]
For information and to review the schedule of costs of attendance in a certificate program, visit extension.ucsd.edu/costofattendance.
228 Iextension.ucsd.edu
Winter 2015 I
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SPECIALIZED CERTIFICATE
SPECIALIZED CERTIFICATE
Data Mining
Geographical
Information Systems
In Vitro Diagnostics
Modern scientific and commercial databases
can contain massive volumes of data. Within
these records lies important information that
can only be effectively analyzed using techniques associated with the growing discipline
of data mining. This powerful technology is
capable of the extraction of predictive information from large amounts of data.
Data mining tools predict future trends and
behaviors, allowing users to make proactive,
knowledge-driven decisions. They explore databases for patterns, finding predictive information
that experts may miss because it lies outside their
expectations or their searching abilities. Data
mining is a process that uses a variety of data
analysis tools to discover patterns and relationships in data that may be used to make valid
predictions. Increasing, data mining is becoming
a fundamental component of all facets of business commerce, as well as Scientific discovery.
The Data Mining certificate is designed to
provide individuals in business and scientific
communities with the skills necessary to design,
build, verify and test predictive data models.
Conditions for Admission
Knowledge of statistics and probability theory
is required. A foundation in a programming
language and advanced mathematics such as
linear algebra is recommended.
Prerequisite (General knowledge of statistics is
recommended.)
•Introduction to Statistics (CSE-41069)
Required Courses (All four (4) courses
required. It is recommended you take the courses in
the order listed.)
•Data Mining I: Basic Methods and
Techniques (CSE-40768)
•Data Preparation for Data Mining (CSE-40969)
•Data Mining II: Advanced Methods and
Applications (CSE-40769)
•Data Mining III (CSE-40977)
Elective Courses (Choose one)
•Advanced Web Analytics: Harnessing the
Predictive Power (CSE-41195)
•Data Mining for Scientific Applications
(CSE-40770)
•Hadoop Essentials (CSE-41185)
•Introduction to R Programming (CSE-41097)
•Predictive Analytics (CSE-41098)
•Predictive Models with PMML (CSE-41184)
•SAS Programming I: DATA Step and PROC
Fundamentals (BIOL-40190)
•SAS Programming II: Advanced DATA Step
Programming (CSE-41183)
•Text Mining (CSE-41151)
Geographical Information Systems (GIS) is a
relatively broad term that can refer to a number
of different technologies, processes, and methods. It is attached to many operations and has
many applications related to engineering, planning, management, transport/logistics, insurance, telecommunications, and business.
For that reason, GIS and location intelligence
applications can be the foundation for many
location-enabled services that rely on analysis,
visualization and dissemination of results for
collaborative decision making.
There is booming application of these technologies. They range from simple GIS systems
embedded in most mobile devices to applications in engineering, planning, public health,
demographics, environmental and conservation, transport/logistics, insurance, law enforcement, telecommunications, marketing, and
multiple other business applications.
The GIS certficate will teach students the theoretical underpinnings of GIS in order to make
informed use of existing GIS applications and
gain skills needed to construct new applications
in the physical or social realms. The full range
of GIS capabilities is covered, including data
capture, analysis, modeling and cartographic
representation.
The skills gained will be highly practical with
good, hands on, understanding of the software
used in GIS. In addition, we will provide the
students with a project of interest to them or
their employers once they master basic concepts
and tools used in GIS.
Required Courses (All five (5) courses are
required. Courses must be taken in the order listed
below.)
•GIS I: Introduction to GIS (CSE-40991)
•GIS II: Spatial Analysis (ECE-40246)
•GIS III: Geodatabase Design (ECE-40247)
•GIS IV: 3-D Display and Analysis of Spatial
Data (ECE-40248)
•GIS Capstone Project (ECE-40272)
Cert. ID: 106446-5003 Application Fee: $60
Contact: Engineering,
(858) 534-9357
Email: [email protected]
Molecular diagnostics, or in vitro diagnostics,
are rapidly becoming critical to the delivery
of healthcare. In vitro diagnostic products are
intended for use in diagnosis of disease or other
conditions and play a significant role in prevention, monitoring, diagnosis, and treatment.
DNA expression patterns, or biomarkers, can
now provide information for the design of new
treatments, monitor a treatment’s effectiveness
as it is studied in a clinical trial, and predict a
patient’s response to a new treatment. Molecular
diagnostics provide a reliable way to determine
the course of action for many diseases.
It focuses on patterns and uncovers changes,
improving a clinician’s ability to find irregularities.
Some common products that are in-vitro diagnostics include drug tests and blood tests for
glucose, liver enzymes, and levels of electrolytes.
This certificate provides an overview of the field
from discovery to commercialization of different
diagnostic products. You will learn how to use
genomic information to discover biomarkers
and how to move through stages of validation
and into the studies that are needed to obtain
regulatory approval.
This certificate is designed to be applicable to
a range of professionals in the diagnostics field,
from sales to regulatory affairs and quality assurance professionals, bench scientists in different
branches of biology, and bioinformatics professionals among others.
Life Sciences
SPECIALIZED CERTIFICATE
Required Courses (All 3 courses required.)
•Biomarkers (BIOL-40258)
•In Vitro Diagnostics Product Development
(BIOL-40244)
•Overview of Regulatory Affairs for Medical
Device Professionals (BIOL-40080)
Elective Courses (Six (6) units required.)
•Biotech Operations (BIOL-40277)
•Genomic Sequencing Technologies (BIOL40237)
•Introduction to QA/QC for Drugs &
Biologics (BIOL-40038)
•Molecular Diagnostics and Personalized
Medicine (BIOL-40251)
Cert. ID: 106456-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9353
Email: [email protected]
Cert. ID: 1064345003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9356
Email: [email protected]
For information and to review the schedule of costs of attendance in a certificate program, visit extension.ucsd.edu/costofattendance.
Winter 2015 I
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I 229
SPECIALIZED CERTIFICATE
SPECIALIZED CERTIFICATE
SPECIALIZED CERTIFICATE
This program is designed for the chemist,
bio-chemist or biologist in the pharmaceutical
and biologic industry new to quality assurance
and control, and is beneficial to senior year
undergraduates and graduate students (using
concurrent enrollment) interested in a career
in QA/QC.
The program focuses on the quality requirements for the production and control of biologics and drugs, and the differences between
quality control and quality assurance and their
interaction with manufacturing. It highlights
the importance of implementing and maintaining a quality system during the early stages of
drug development, including the plethora of
documents and controls necessary to make such
a system effective.
Guidelines and regulations from the FDA and
the California State food and drug branch regulate the production of drug products. Quality
Assurance (QA) monitors the manufacturer’s
compliance to these guidelines and regulations.
Instruction covers how to write, issue and
control SOPs; manufacturing directions; and
how to review and archive a batch history and
other relevant documents. Emphasis is placed
on conducting inspections and vendor audits
for compliance to cGMPs to include contract
manufacturers, bulk pharmaceutical chemical
manufacturers and contract test laboratories.
The program covers cGLPs and their applications to audits of facilities that provide toxicological services. Details on compiling, writing
and archiving audit reports is provided.
This program provides a comprehensive and
balanced education focusing on the key areas
of Regulatory Affairs. Provided as an introduction to the field, this program was developed
from increasing demand in the local biotech
community.
To completely master the field of Regulatory
Affairs, a Professional Certificate is recommended.
The certificate program is comprised of four
courses: two are required and two are selected
from the list of electives.
SAS is a software suite used in the statistical
analysis of data, data preparation, reporting,
data mining and analytics. As the leader in
business analytics software and services, SAS
helps organizations access and transform large
amounts of data into insights and knowledge
that can be used in the discovery of new and
exciting opportunities. SAS can be used to manage and retrieve data from a variety of sources
and perform a myriad of statistical analyses on
it. Having applications in a variety of industries,
SAS is used for operations research, project
management, quality improvement, forecasting
and decision-making. The language’s flexibility
is what makes it suitable for a variety of vertical
applications and programming.
Developed and taught by seasoned SAS practitioners with over 70 years of collective experience, this certificate program includes over 120
hours of instruction. The program concludes
with a project-based capstone course, allowing
students to demonstrate their applied knowledge
through a technical paper and presentation.
The SAS Programming certificate is aimed at
those seeking to have a deep understanding of
this powerful statistical programming language.
Upon completion of this program, graduates
will have gained a thorough understanding of the
various aspects of SAS and how it can be applied
to a variety of industries and professions.
Life Sciences
Quality Assurance and Control
Conditions for Admission
Complete the application and pay application
fee.
Required Courses
•Introduction to QA/QC for Drugs &
Biologics (BIOL-40038)
•Advanced QA/QC for Drugs & Biologics
(BIOL-40021)
•Good Manufacturing Practices (BIOL40000)
•Regulatory Compliance for Drugs &
Biologics (BIOL-40101)
Cert. ID: 106477-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9353
Email: [email protected]
Regulatory Affairs Essentials
Conditions for Admission
Complete the application and pay application
fee.
Required Courses
•Regulatory Requirements for Drugs &
Biologics (BIOL-40102)
•Regulatory Compliance for Drugs &
Biologics (BIOL-40101)
Electives (5 units are required.)
•Good Clinical Practices (FPM-40204)
•Good Laboratory Practices (BIOL-40085)
•Good Manufacturing Practices (BIOL40000)
•Overview of International Regulatory Affairs
(BIOL-40255)
•Overview of Regulatory Affairs for Medical
Device Professionals (BIOL-40080)
•Electronic Submissions in Life Sciences Planning for Success (BIOL-40260)
Cert. ID: 106481-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9353
Email: [email protected]
SAS Programming
Certificate Benefits:
•Enable the students to develop applicable and,
potentially, publishable programs in SAS
•Industry neutral curriculum allows for students to apply knowledge to their field of
interest
•Project-based capstone course will meet standards to merit a presentation at a national
conference, such as the SAS Global Forum,
SAS Regional Forums or other conferences
in a relevant vertical segment.
•Hands-on comprehensive training designed
to immerse the student in the skills needed to
successfully get started or advance their career
Required Courses (All six (6) courses are
required.)
•SAS Programming I: DATA Step and PROC
Fundamentals (BIOL-40190)
•SAS Programming II: Advanced DATA Step
Programming (CSE-41183)
•PROC SQL using SAS (CSE-41190)
•SAS Macro Programming (CSE-41191)
•Output Delivery System (ODS) and Data
Visualization Essentials using SAS (CSE41192)
•SAS Programming Capstone Project (CSE41193)
Cert. ID: 106483-5003 Application Fee: $60
Contact: Science & Technology,
(858) 534-9356
Email: [email protected]
For information and to review the schedule of costs of attendance in a certificate program, visit extension.ucsd.edu/costofattendance.
230 Iextension.ucsd.edu
Winter 2015 I
(858) 534-3400
PROFESSIONAL CERTIFICATE
Drug Discovery and Development
This environment requires that scientists not
only be deeply trained in their area of specialty,
but also possess a broad background, vocabulary, and appreciation of the possibilities and
limitations of related disciplines. This professional certificate is designed to help meet that
need.
To help students gain a greater understanding
of the pharmaceutical industry, the core curriculum includes key background material in
biology or chemistry and a general overview of
the drug discovery and development process.
The addition of electives allows the student
to round out their certificate education with
courses that are most appropriate to their current or future career needs.
Guidelines
This certificate is intended for individuals with
educational backgrounds in chemical and biological sciences at the bachelor, masters, or
Ph.D. level interested in entering or becoming
more effective at working in the pharmaceutical
or biotechnology industry.
Advisors
John Cashman
President and Founder
Human BioMolecular Research Institute
Dan DiSepio, Ph.D.
Principal Scientist, Group Leader,
Development
Johnson & Johnson PRD
Grace Furman, Ph.D.
CEO & President
Paracelsus, Inc.
Jelveh Lameh, Ph.D.
Director, BioPharma Services
Genoptix
COURSE TITLE
PAGE
CRS. NO.
UNITS
FA
WI
SP
SU
BIOL-40125
BIOL-40047
BIOL-40161
BIOL-40176
BIOL-40170
BIOL-40189
BIOL-40219
BIOL-40918
3
2
1
3
3
3
2
2
O
O
n
n
n
O
O
O
n
O
n
O
BIOL-40195
BIOL-40258
3
3
n
n
BIOL-40133
BIOL-40116
BIOL-40251
BIOL-40015
BIOL-40186
BIOL-40299
2
3
3
3
3
0
n
O
O
n
n
O
O
O
O
REQUIRED COURSES
Preclinical Drug Discovery & Development
Introduction to Pharmacology
Medicinal Chemistry of Leading Drugs
Pharmacokinetics
Drug Metabolism
Toxicology
Predicting & Selecting Promising Drug Compounds
Target Identification & Validation
ELECTIVE COURSES (A total of 5 units required.)
Analytical Chemistry
Biomarkers
High Throughput Screening Methods
in Drug Development
Medicinal Chemistry Intensive Program
Molecular Diagnostics and Personalized Medicine
Overview of the Drug Development Process
Stem Cell Biology
Structural Biology in Drug Discovery
O
Life Sciences
Modern drug discovery utilizes multidisciplinary project teams and attempts to simultaneously move forward with as many aspects
of the overall drug discovery and development
process as possible.
n
L=La Jolla M=Mission Valley O=Online U=University City n=Location TBA
Nicholas F. Paoni, Ph.D.
To Enroll in Courses
John Saunders, Ph.D.
For details on enrolling in individual courses,
consult the general information section, pages
249-255. To enroll by mail, you may use the
enrollment form on the inside back cover or
call the Registration Office at (858) 534-3400.
Consultant
Paoni Consulting
Vice President Medicinal Chemistry
Neurocrine Biosciences
Robert Ternansky, Ph.D.
Consultant
To Register in the Certificate
Program
Certificate registration is required to complete
the program. Candidates are encouraged to
enroll in the certificate program as early as possible to take advantage of program benefits. See
pages 242-246.
Cert. ID: 106342-5003
Application Fee: $60
Contact: Science & Technology, (858) 5349353
E-mail: [email protected]
Ajay Madan, Ph.D., DABT
Sr. Director, Development
Neurocrine Biosciences
For information and to review the schedule of costs of attendance in a certificate program, visit extension.ucsd.edu/costofattendance.
Winter 2015 I
(858) 534-3400
extension.ucsd.edu
I 231
PROFESSIONAL CERTIFICATE
Life Sciences
Life Sciences Information Technology
Researchers have become increasingly reliant
on Information Technology tools to reduce
the costs and boost the productivity of life sciences research and development. Information
Technology tools and bioinformatics research
and development are key to remaining competitive for biotechnology and pharmaceutical
companies. For that reason these companies
are expanding IT capabilities by developing
in-house programs, acquiring companies, and
partnering with IT companies, bioinformatics
firms, and consulting firms.
Increasingly, companies and research organizations are seeking workers with formalized
training that have the skills of both computer
and life scientists.The Life Sciences Information
Technology Certificate aims to provide professional with backgrounds in the Life or
Computer Sciences with the knowledge necessary to cross over and be conversant on both
areas. The certificate provides an ample spectrum of job opportunities within the software,
biotechnology and pharmaceutical industry,
from providing researchers with technical IT
support, to database administration, to research
in bioinformatics, or programming applications
for the industry.
The different focus areas within the certificate
permit specialization in IT support, bioinformatics research or programming applications
for the life sciences industry.
Program Benefits
•Master the programming languages used to
build informatics applications in the life sciences industry.
•Integrate chemical and biological information to deploy the complex information
systems used in the life sciences industry.
•Gather and mine genomic information using
state of the art tools to aid in bioinformatics
research.
•Manage information technology projects in
the life sciences industry by conversing in the
language of chemical and biological research
and of the information technologies.
Guidelines
Before starting the core courses, the students
should ensure they have a degree of proficiency
in programming with a scripting language and
database query languages, as well as a basic
understanding of the life sciences industry.
Advisors
Simon Craw, Ph.D.
Senior Director of IS and IT
ACADIA Pharmaceuticals Inc.
COURSE TITLE
PAGE
CRS. NO.
UNITS
FA
WI
SP
SU
RECOMMENDED COURSES (Proficiency in these areas is strongly recommended. Up to 2 classes will count towards
certificate.)
Introduction to Molecular Biology
Understanding Biopharmaceuticals
PERL for Bioinformatics
Introduction to SQL Programming Concepts
BIOL-40001
BIOL-40148
BIOL-40158
CSE-40933
3
3
2
3
n
O
n
n
n
O
n
L
BIOL-40236
CSE-40845
CSE-40770
3
2
3
O
O
O
O
CORE COURSES (All three courses required.)
Bioinformatics
Biological Database Design
Data Mining for Scientific Applications
FOCUS AREAS (Choose one focus area. Requirements are outlined in each focus area.)
RESEARCH INFORMATION SERVICES (All three courses required. Choose an additional 9.5 units from other focus
areas to complete the 24 units required for the certificate. )
Cheminformatics
BIOL-40240
2
O
O
Laboratory Information Management Systems
BIOL-40188
2
Project Management Essentials
BUSA-40064
3 L, O, U O, U O, U O, U
BIOINFORMATICS DATA MINING (All three courses required. Choose an additional 8.5 units from other focus areas to
complete the 24 units required for the certificate. )
Pattern Recognition for Bioinformatics
Databases and Genome Analysis
Genomic Sequencing Technologies
BIOL-40157
BIOL-40131
BIOL-40237
2
3
3
n
O
n
n
O
O
BIOPROGRAMMING (16.5 units of study required for this focus area to meet the 24 units required for the certificate.
You must choose one course from another focus area.)
Biostatistics
SAS Programming I: DATA Step and PROC
Fundamentals
Clinical Biostatistics
C/C++ Programming I : Fundamental
Programming Concepts
C/C++ Programming II : Dynamic Memory
and File I/O Concepts
In Vitro Diagnostics Product Development
C/C++ Programming III : Intermediate Programming
with Objects
Java for Bioinformatics
Perl For Bioinformatics II
Structural Biology in Drug Discovery
BIOL-40049
3
O
O
O
O
BIOL-40190
BIOL-40253
3
3
O
O
O
O
O
O
CSE-40475
3
O
n
O
n
CSE-40476
BIOL-40244
3
2
n
n
O
n
n
O
CSE-40477
BIOL-41244
BIOL-40242
BIOL-40299
3
3
3
0
O
n
O
O
O
O
L=La Jolla M=Mission Valley O=Online U=University City n=Location TBA
Ping Du, Ph.D.
Director, Informatics
Allergan, Inc.
Scott Kahn, Ph.D.
Chief Information Officer
Illumina, Inc.
Darryl Leon, Ph.D.
Senior Application Specialist
Life Technologies
Paul A. Rejto, Ph.D.
Director of Computational Biology
Pfizer Global R&D, La Jolla Laboratories
Steven Stelman, Ph.D.
Bioinformatics R&D Manager
ActiveMotif
Helge Wessig, Ph.D.
Director, Bioinformatics
ActivX Biosciences
To Register in the Certificate
Program
Certificate registration is required to complete
the program. Candidates are encouraged to
enroll in the certificate program as early as possible to take advantage of program benefits. See
pages 242-246.
Cert. ID: 106363-5003
Application Fee: $60
Contact: Science & Technology, (858) 5349353
E-mail: [email protected]
To Enroll in Courses
For details on enrolling in individual courses,
consult the general information section, pages
249-255. To enroll by mail, you may use the
enrollment form on the inside back cover or
call the Registration Office at (858) 534-3400.
For information and to review the schedule of costs of attendance in a certificate program, visit extension.ucsd.edu/costofattendance.
232 Iextension.ucsd.edu
Winter 2015 I
(858) 534-3400
PROFESSIONAL CERTIFICATE
Developed to educate professionals in the FDA
imposed regulation issues pertinent to the pharmaceutical and biological industry, this certificate covers a broad range of necessary technical
and business skills. It is designed for regulatory
and quality professionals and those involved
directly in drug development, including chemists, pharmacologists, and biologists.
This program, which grew from demands by
local biotech professionals and the advisory
board, offers a well-rounded curriculum and
provides career growth and opportunities for
students interested in the field of Regulatory
Affairs. Issues that influence laboratory, clinical
trials, manufacturing practices and procedures
are discussed. In addition, the fundamentals
of bioethics provide a framework for ethical
decisions.
Our knowledgeable team of instructors includes
executive level regulatory professionals, a previous FDA inspector, and consultants with up to
20 years experience in quality and compliance
with U.S. FDA and ICH requirements. With
this breadth and depth of experience, instructors expose students to many real workplace
examples.
Program Benefits
Professional certificate programs from the
University of California have enjoyed increasing recognition among employers as evidence of
academic advancement for post-baccalaureate
professionals with a strong applied workplace
focus. For those making career transitions, it
offers university-accredited certification for the
knowledge and skills acquired as part of this
program. For those with significant experience
in the field, but who do not have a primary
degree, the professional certificate provides formal academic documentation of initiative and
commitment to tackle and complete this type
of advanced certified education program.
COURSE TITLE
PAGE
CRS. NO.
UNITS
FA
WI
SP
SU
BIOL-40101
BIOL-40102
BIOL-40000
BIOL-40085
BIOL-40015
FPM-40204
BIOL-40071
BIOL-40110
2
2.5 3
2
3
3
2
3
O
O
O
O
O
O
O
O
n
O
O
O
O
n
O
BIOL-40195
BIOL-40201
BIOL-40244
BIOL-40255
3
3
2
2
n
O
n
O
n
BIOL-40080
2
O
O
REQUIRED COURSES (All eight (8) courses are required.)
Regulatory Compliance for Drugs & Biologics
Regulatory Requirements for Drugs & Biologics
Good Manufacturing Practices
Good Laboratory Practices
Overview of the Drug Development Process
Good Clinical Practices
Introduction to Bioethics
Advanced Topics in Regulatory Affairs
O
O
O
ELECTIVES (Four units are required)
Analytical Chemistry
Good Documentation Practices
In Vitro Diagnostics Product Development
Overview of International Regulatory Affairs
Overview of Regulatory Affairs for Medical
Device Professionals
Life Sciences
Regulatory Affairs for the Biomedical Industry
O
L=La Jolla M=Mission Valley O=Online U=University City n=Location TBA
Advisors
K.A. Ajit-Simh, M.S.
Vice President, Quality Systems
Arena Pharmaceuticals, Inc.
To Register in the Certificate
Program
Ingrid Cabalza, RAC
Quality Assurance Associate
Gen-Probe, Inc.
Certificate registration is required to complete
the program. Candidates are encouraged to
enroll in the certificate program as early as possible to take advantage of program benefits. See
pages 242-246.
Laura Guy, M.S., RAC
Cert. ID: 106379-5003
Steve Kradjian, RAC
Application Fee: $60
Contact: Science & Technology, (858) 5349353
E-mail: [email protected]
Allen McCutchan, M.D.
To Enroll in Courses
Principal
Regulatory Liaisons, LLC.
President and Chief Executive Officer
Conventus Biomedical Solutions, Inc.
Professor of Medicine, Division of Infectious
Diseases
UCSD School of Medicine
Brian Miyazaki, RAC
Associate Director, Regulatory Affairs
Amylin Pharmaceuticals, Inc.
For details on enrolling in individual courses,
consult the general information section, pages
249-255. To enroll by mail, you may use the
enrollment form on the inside back cover or
call the Registration Office at (858) 534-3400.
Kathy Rangus
President
Drug and Device Regulatory Services
Camille Shore, Ph.D.
Sr. Director, Regulatory Affairs
Versartis Inc.
For information and to review the schedule of costs of attendance in a certificate program, visit extension.ucsd.edu/costofattendance.
Winter 2015 I
(858) 534-3400
extension.ucsd.edu
I 233
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