Volume 1, Issue 2 Spring 2005

Special points of Interest: Program Interests

New MPTX Course Offered Students, Faculty & Staff

Alumni Relations

Get involved with Regulatory

Inside this Issue:

Introduction 1

Current Events 2

Students 2 Alumni 2 Faculty/Staff 3

Regulatory Affairs Events 4

Keep in Touch 4

REGULATORY SCIENCESchool of Pharmacy

NEWSLETTER

What a terrific Fall we have had in the Regulatory Science program! We have been able to implement many new program features for our students. Perhaps the one that has everyone smiling is the distance program. We are now able to offer all of our site-based course lectures on the web. This has added much flexibility for our LA-based students, and has allowed us to expand our offerings to a small but growing cadre of distance students. As part of our program, we are giving two new courses for the first time. The first, MPTX 522: Clin-ical Design, will be given in the Spring term. Dr Edyta Frackiewitz has spent many years in the area of clinical

New MPTX Clinical Design Course We are offering a new MPTX course this Spring called MPTX 522:Introduction to Clinical Trial Design and Statistics. The course will be taught by Dr. Edyta Frackiewicz, Dr. Frances Richmond, Dr. Gil Burckart, and other experienced clinical professionals. The clinical design course will help

you to understand the design of clinical trials and methods for the statistical analysis of your data. Because the course covers research design and statistics, students will be able to substitute this course for the PM 510 statistics course. MPTX 522 will also highlight the unique

features of clinical trials in specialized populations such as AIDS, cancer, pediatrics, and psychiatry. Current trends for accelerating drug development will also be covered. We feel this course will be an important addition to our program curriculum!

trial design and delivery and will be an active part of our program this Spring. The second course, titled MPTX 524, is the brainchild our new Associate Director, Dr Roger Clemens. Dr Clemens is taking on the challenge of ensuring that our program has a new concentration in Food Science and Regulation. Those of us who love food may wonder what it is like to work in the food industry. It may become a very real option, because the border between foods and medical products is becoming blurred. We welcome Roger to our program, and hope that you will make an effort to meet him soon.

This Spring, we anticipate that more than 100 students will be in our classroom, as MS students, limited students or auditing students. The diverse backgrounds of all of these students should give you a wonderful opportunity to network. We are now holding talks on developing a regular networking event that will be held outside of the normal class constraints, for those of you who have done your time here, but would like to stay connected through after-hours activities. This event will be a relaxed combination of social interaction and regulatory discussion.

Dr. Frances RichmondDirector, RegulatoryScience Program

Springing into the New Year!

This year we have also made a special effort to promote your program by hosting a booth at the RAPS meeting and at MDDI. It is a great opportunity to reach out to new students, but also to see our graduates. We are always so happy to see you and hear your great stories of personal and professional accomplishments!

Dr. Frances Richmond

Page 2 M.S. Regulatory Science Program, School of Pharmacy

Japanese Pharmacist Visits our Program

RegSci Alumni Watch

We have new staff member, Ally Xu, who is here to help manage our new distance program! Ally W. Xu gradu-ated with a MBA from Marshall School of Busi-ness, USC, in 2003. She earned a bachelor degree in pharmacology from Medical College of Fudan University in China, and had worked in the pharmaceutical industry for 11 years. Her working experiences started from being the pharmacist in

the Chinese State Food and Drug Administration in 1991. Later she joined GlaxoSmithkline as the sales representative and supervisor. The accumulated sales and marketing experience and the strong market demand for new drugs in 1990s pushed her to set up her own business. Ally used to work as the South China Sales and Marketing Manager in a joint-venture pharmaceutical company

in China for 5 years. Before joining Regulatory Science program, she worked with other colleagues in Regulatory Affairs on research projects for the Asian educational market. Now, we welcome Ally as the distance manager in the Regulatory Science program! Ally is looking forward to contributing her passion and experiences to this exciting educational program.

During fall of 2004, the Regulatory Science Program was very pleased to host a young pharmacist from Japan, Ms. Sari Nakagawa. She received her degree at Kyoto Pharmaceutical University and is now an integral part of the pain-management care team at the Kyoto-Katsura Hospital. Her team works with terminally ill cancer patients and also manages infection control within the hospital.

A typical work day begins at 8:00 A.M. and ends at 9:00 P.M., during which Sari works directly with the patients, providing palliative, physical, nutritional and mental support. She feels the rewards of her work come from communicating with patients and their families on a very deep level, and being able to help them through very difficult times. Ms. Nakagawa is an accomplished violinist, painter,

sports enthusiast, and a conscious environmentalist. Her immediate plans are to use the knowledge she gained at the USC School of Pharmacy, the Regulatory Science Program and Norris Cancer Hospital, and to implement some positive changes with her hospital team. Sari would very much like to return to Los Angeles in the future and gain a PharmD Degree. We look forward to having her infectious joie de vivre with us again!

What’s everyone been doing since graduation? It seems Justin Keating (Fa ‘04) is working for Boston Scientific Headquarters in Tokyo, Japan. WOW... congratulations Justin! Also, Adi Garg (Fa ‘04) graduated and is working in the RS program as our computer specialist.

Another recent alumnus, Bonnie Perkins (Fa ‘04) just moved to Santa Rosa, Ca. to work at Medtronic Vascular in the Regulatory Affairs department. Garrett Pilcher (Sp ‘04) is also working with Bonnie. Neeta Chandwani (Fa ‘04) is working as an Engineer at St. Jude Medical in Sylmar, Ca..

Arman Nadershahi (Fa ‘04) is currently at AMI-USC, where he serves as the General Counsel and Intellectual Property Manager. Finally, Michael Johnson (Fa ‘04) just moved to Irvine and is now working at Biosense Webster as a RA specialist. Congrats to our new graduates! We are so proud of you all!

Dean Chan, School of Pharmacy at 2004 Graduation Ceremony

RegSci Alumni Watch

experiences started from being the pharmacist in

doing since graduation? It seems Justin Keating (Fa ‘04) is Dean Chan, School

During fall of 2004, the Regulatory Science Program was very pleased to host a young pharmacist from Japan, young pharmacist from Japan, Ms. Sari Nakagawa. She received her degree at Kyoto Pharmaceutical University and

in the RS program as our computer specialist.

Sari, Christine & Kathy during the 2004 holiday season

Meet Ally, our New Distance Manager memberhere to helpnew distance program ated with a MBA from Marshall School of Busi-ness, USC, in 2003. She

Meet Ally, our New Distance Manager

Ally Xu, the new Regu-latory Science Distance Manager

Volume 1, Issue 2 Page 3

Dr. Roger Clemens, Faculty & Professor

Welcoming Dr. Roger Clemens

Dr. Loeb: Future of the medical device industry

plans on supportingour program as a faculty member in teaching courses, the dietary supplements course especially, and managing certain program needs. We welcome his presence and look forward to his expertise in food and dietary supplements as we expand our program with the distance courses.

adjunct professor and Director of the Laboratory for Analytical Research and Services in Complimentary therapeutics. It is Dr. Clemens’ 25 years of experience in the food industry and academe that makes him a perfect fit to support food and dietary supplement specialties in and outside the classroom here in our program. Dr. Clemens

We are thrilled about a new addition to our program. Dr. Roger Clemens will be working with us in the Regulatory Science Program. Dr. Clemens interests range from pediatric nutrition, food safety and toxicologyregulation of dietary supplements. Dr. Clemens has been with USC in the School of Pharmacy for several years where he is an

In a MD&DI article discussing progress of the device industry, Gerald Loeb, the director of the Medical Device Development Facility at the A. E. Mann Institute for Biomedical Engineering at USC, recounted the days where the cochlear implant project had just started

taking form. He said there were no rules regarding the regulation of devices or their research and design control and attributed the evolution of regulatory changes since 1976 to the growth of projects using the implants. He also said that his position at the Mann Institute is aimed at

managing the challenges of regulatory requirementsand reimbursement policies, by “providing a halfway house” to support activities appropriate to both the university and the business world.

Allen M. Hans is the president of Allen Hans and Associates Inc. Medical Devices Consultants and teaches the MPTX 515 QA Regulatory Science course. In an article in MD & DI magazine, he discussed the advances in the field of medical devices over the

past 25 years. Quoting the example of the high-reliability cardiac pacemaker as the by-product of ideas for aerospace satellites, he said medical devices are increasingly the beneficiaries of technology from the

aerospace industry. Al Hans also attributed the progress to entrepreneurial endeavor and expansion of basic sciences. He wished the industry the very best for the years to come.

Madalasa, Avyaya, Kathy, Dr. Richmond, and Dr. Loeb at the RAPS 2004 Conference

Madalasa, Avyaya,

Dr. Roger Clemens,

Monica Sandberg & Judy Quick on a Field Trip to Orange County FDA

Speaker Al Hans on Technological Advancement

Monica Sandberg

M.S. Regulatory Science Program, School of Pharmacy

1540 Alcazar Street, CHP G32

Los Angeles, CA 90089

Ph. (323) 442-3521Fax. (323) 442-2333

Email: regsci@usc.edu

Frances Richmond, PhD Program Director

Kathy Knodel, MSProgram Coordinator

Christine BrowningProgram Assistant

Adi Garg, MSTechnical Specialist

Contributing AuthorAarthi Sivaraman

Keeping in touch...

We’re on the Web! Visit Us:

http://regulatory.usc.edu

Upcoming Regulatory Affairs Events•Global Harmonization for Medical Devices (OCRA)

US.....................................................................................................January 2005•Southern California Section of the Institute of Food Technologists (SCifts) Pasadena, CA, US........................................................................March 15, 2005

•RAPS 2005 West Coast Symposium & Tabletop Exhibition San Francisco, CA, US............................................................March 22-24, 2005

•Regulatory Science & MDDE Career Fair UPC, USC, CA................................................................................April 15, 2005

•Eighth Annual FDA/OCRA Educational Conference Orange County, CA, US…………....……………….................June 15-16, 2005

•USC/DIA Three-day short course “Regulation of Medical Devices” HSC, USC, CA......................................................................................June 2005

It is always exciting to bring in a new year with family and friends. We hope that you and your loved ones celebrated the holidays with joy and happiness.

Don’t forget that we would love to hear from you - Do you have any New Year’s resolutions? We would love to hear about any new events in your life. Feel free to stop in anytime and say hello. It is always nice to see your friendly faces outside the classroom!

Also, if you plan on moving or changing your address/contact information, please let us know.

All of our students, speakers, faculty and staff make the Regulatory Science Program so special to us.

As a growing program we thrive from your suggestions and comments. If you feel you have something to say, contact us:

SUGGESTIONS/COMMENTS/QUESTIONS?Contact our staff directly in the Regulatory Science Program. We will do our best to accommodate your needs and recommendations.

INTERESTED IN PARTICIPATING AS A GUEST SPEAKER?Let us know. You may wish to contact us with your background and interests in guest speaking. We welcome all backgrounds.

Regulatory Science ProgramUniversity of Southern California1540 Alcazar St. CHP G32Los Angeles, Ca. 90089

As a growing program we thrive from your suggestions and comments. If you feel you have something to say, contact us:

SUGGESTIONS/COMMENTS/QUESTIONS?Contact our staff directly in the Regulatory Science Program. We will do our best to accommodate your needs and recommendations.

INTERESTED IN PARTICIPATING AS A GUEST SPEAKER?Let us know. You may wish to contact us with your background and interests in guest speaking. We welcome all backgrounds.