SPRING - UCSC Extension Silicon Valley

Intellectual Property Essentials
for the Life Science Industry
BUSAD.X491.2 (1.0 quarter unit) MCLE–Minimum
Continuing Legal Education State Board of CA, 10.0 hours.
This course demystifies key intellectual property principles
and applications, emphasizing topics of particular relevance
to the biotechnology, pharmaceutical and medical
device sectors. The instructor explains the basic principles
of patents, and explores their strategic implications in a
variety of contexts, such as securing funding, establishing
barriers to competitor entry, achieving freedom to
operate, technology transfer, federally-funded research
and strategic alliances. Trade secrets, trademarks, copyrights
and contractual agreements are also discussed,
particularly as they apply to the life science industry.
Scientific, engineering, regulatory and business
professionals will benefit from this course.
SOODY TRONSON, J.D., M.S.
SANTA CLARA CLASSROOM
4 meetings: Fridays, 6–9 pm, June 8–29.
Fee: $525 ($52.50 discount for early enrollment).
To enroll, use Section Number 1942.(017)
Medical Device Design and Development
ENGR.X400.006 (2.0 quarter units)
Using real-world examples, the instructor and guest
speakers provide a detailed look at the design and
development process for new medical devices, as well
as insight into the entrepreneurial nature of the medical
device industry. They address medical device hardware
and software design, biomaterials and human factors.
Additional topics include manufacturing, testing, and
strategies to navigate the regulatory pathways.
SUDHI GAUTAM, M.B.B.S., Ph.D.
SANTA CLARA CLASSROOM
3 meetings: Saturdays, 8 am–5 pm, May 5–19.
Fee: $765 ($76.50 discount for early enrollment).
To enroll, use Section Number 19977.(010)
Medical Devices: Regulatory Strategies
and Marketing Pathways
For course description, see page 12.
Molecular Diagnostics
BIOL.X400.414 (1.5 quarter units) CA BRN/LVN Credit—
Provider #CEP13114, 15.0 hours.
This survey course provides a foundation in the basic
science and technologies that underlie the emerging
field of molecular diagnostics, and highlights the potential
impact on the health care landscape. The instructor examines
the role of pharmacogenomics in the development
of new therapeutics and treatment options. He uses case
studies to present the applications of molecular diagnostic
tools in infectious disease identification and early
detection and diagnosis of cancer. Also addressed are
the regulatory challenges that face the new wave of
diagnostic tests, and the changing dynamics of the
molecular diagnostics global marketplace.
Prerequisite(s): College-level biology.
BINAYA PANDA, Ph.D.
SANTA CLARA CLASSROOM
2 meetings: Friday–Saturday, 9 am–5 pm, March 16–17.
Fee: $580 ($58 discount for early enrollment).
To enroll, use Section Number 21972.(006)
Regulation of Drugs and Biologics
For course description, see page 17.
Regulation of Medical Devices
and Diagnostics
For course description, see page 17.
Toxicology Basics for Biotechnology
NATSC.X429.3 (1.5 quarter units) CA BRN/LVN Credit–
Provider #CEP13114, 15.0 hours.
Biopharmaceutical companies expend vast resources
to identify new chemical and biological agents that
have the potential for clinical benefit. However, before
these can be tested and used widely in patients, safety
and acceptable toxicity to critical organs must be
demonstrated. This course surveys the adverse effects
resulting from the interaction of chemical agents with
living systems. Topics include criteria and mechanisms
of toxicity, dose-response relationships, factors influencing
toxic action, acute and chronic effects, kinetics,
metabolism, and toxicity testing. Applications in both
pharmacology and drug development are discussed.
Prerequisite(s): Completion of at least one college-level
chemistry course.
RONALD TJEERDEMA, Ph.D., D.A.B.T.
SANTA CLARA CLASSROOM WITH ONLINE MATERIALS
2 meetings: Friday, 8:30 am–5 pm, June 15;
Saturday, 8:30 am–5 pm, June 16.
Fee: $580 ($58 discount for early enrollment).
To enroll, use Section Number 2310.(013)
Viruses, Vaccines and Gene Therapy
NATSC.X400.003 (1.5 quarter units) CA BRN/LVN Credit–
Provider #CEP13114, 15.0 hours.
Interactive case studies and Web-supplemented lessons
drive our exploration of the interplay of viruses with
their cellular hosts. Building on these foundations, we
examine salient topics in vaccines, gene therapy and
therapeutic viruses. Pertinent and real issues relevant
to the biopharmaceutical industry are also discussed.
Course topics include virus evolution, emerging viruses,
the risks and benefits of vaccines, the polio eradication
campaign, epidemiology of influenza, HIV-1 vaccines,
and the trials and tribulations of gene therapy.
NAY WEI SOONG, Ph.D.
SANTA CLARA CLASSROOM WITH ONLINE MATERIALS
5 meetings: Tuesdays, 6–9:30 pm,
April 24–May 29 (1 no meeting TBA)
Fee: $580 ($58 discount for early enrollment).
To enroll, use Section Number 6974.(011)
Also of Interest
Clinical Trials Essentials:
An Intensive Course
For course description, see page 13.
Biosciences Biotechnology / Clinical Trials
Clinical Trials
Certificate Program
Clinical Trials Design
and Management
Certificate Contact
Applied and Natural Sciences Department, (408) 861-3860
or e-mail program@ucsc-extension.edu.
Program Overview
The Bay Area and Silicon Valley are leaders in the global
biopharmaceutical and medical device industries. The
continued success of these industries relies on clinical
trials—the complex process of ensuring the safety and
effectiveness of new and existing medical products.
The Certificate in Clinical Trials Design and Management
helps professionals gain a solid and practical understanding
of the entire clinical trials process, from drug and
device development to monitoring, as well as a foundation
in the scientific principles, regulations and ethics that are
vitally important to the conduct of clinical research. Because
of its comprehensive curriculum and intense focus on best
practices in the clinical trial process, this certificate is
appropriate for current professionals—clinical research
associates and coordinators, clinical program managers
and physicians, biomedical and research scientists, nurses,
IRB members and administrators, and pharmacists—as
well as those new to the field.
Many courses in this program qualify for re-certification
CEUs for those certified as CCRAs and CCRCs through
ACRP. Most courses also grant BRN credit for nursing
professionals.
Certificate Requirements
To obtain the Certificate in Clinical Trials Design and
Management, you must complete 6 required courses
and 6 units of elective courses, for a minimum total
of 19 units. For GPA requirements and program time
limits, see page 4.
To pursue two bioscience-related certificates in
parallel or sequence, see page 7.
Courses may be taken individually or as
part of the certificate program.
Prerequisites
Successful completion of “Medical/Clinical Terminology,”
an equivalent course, or medical training. We strongly
recommend that students without a medical background
take “Human Physiology in Health and Disease” early
in their studies.
Wireless Access at
UCSC Extension Silicon Valley
Wireless Internet access is provided throughout
our Santa Clara facility. Students may need to install
protective software on their laptops
to use our wireless network.
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