Drug and Market Development

By Gabriele Schubert, M.S., Medical Writer

Pride makes his Irish accent ring as Dr. Derry Connolly says: "The Regulatory Affairs Certificate Program at UCSD is recommended to companies in Northern California, by companies in North Carolina!"

The director of UCSD Extension's Science and Engineering professional development programs, Dr. Connolly likes what he hears from people packing UCSD classes for a Regulatory Affairs (RA) Certificate. UCSD's RA Program is widely regarded as an important basic training resource for employees of the regional biotech community.

Instituted in Fall 1998, the UCSD "Professional Certificate in Regulatory Affairs for the Drug and Biologics Industry" now serves San Diego's burgeoning and diverse biotech industry with introductions to regulation of drugs and biologics. In August 2000, an "Overview of RA for Medical Device Professionals" will introduce regulations of this third industry sector.

The general curriculum for UCSD's RA Professional Certificate--among seven certificates in biotech processes, from discovery and development to manufacturing and QC-- was originally developed after biotech managers advised UCSD to prepare biosciences majors in issues pertinent to US Food & Drug Administration (FDA) regulations. UCSD students are now the classroom minority, however. Each class of 20 to 25 is filled with employees of medical device, biologics, or pharmaceutical corporations--mostly scientists--and regulatory professionals new to this demanding field. So far, 45 people have enrolled in all the RA Certificate courses.

'Working Expert' Instructors: Trainees Get Condensed RA Info in Five Easy Pieces

"There is a great need in the industry for more trained RA professionals, so everyone benefits from this program," declares Steve Kradjian, one of the original advisors and now a Program Instructor as well as Executive Director of RA for Vical. He points out that "until recently, the concept was absent that one could go to school to gain RA expertise; one gradually discovered the RA field through experience." Gratefully recalling his own mentor, a former FDA senior official at Amgen, he is gratified to share his knowledge. He covers the RA groundwork of history and laws in the first four hours of a 16-hour core course, "Regulatory Requirements."

Four 'working expert' instructors teach "Regulatory Requirements." Connie Kohne, former Director of RA at Agouron Pharmaceuticals and now VP at GenStar Therapeutics, covers preclinical and clinical research regulations in one four-hour session; as well as the final four-hour session on such post-approval issues as adverse-event reporting, which are often seen in the "fine print" when a product is advertised and promoted.

Kathryn Rangus, a principal in Drug & Device Regulatory Services, teaches the product development process focusing on chemistry, manufacturing, and control (CMC). "Since it takes about 12 years to get a product to market," she says, "the four-hour session is intensive." Trainees learn to apply pharmacopoeia definitions, and master files of product processes, to represent their company's human use product specifications in INDs, NDAs, and BLAs.

"The Regulatory Requirements" introduces FDA technical report writing. Informed by the perspectives of biotech patent law and bioethics, as well as a curriculum that presents FDA requirements relevant to product development and approval processes, graduates say they get a real handle on RA work.

"Regulatory Compliance" is a second core course--on using that handle to lift the pan so it never gets too hot. Enrollees value the course's practical suggestions for effectively working with the FDA, from preparation for site inspections, to compliance with post-market controls. Ingrid Cabalza, a UCSD major in biochemistry and cell biology, credits the Regulatory Compliance course for imparting knowledge important to her work as a QC intern at Gen-Probe in San Diego. She thinks of instructor K.A. Ajit-Simh as her second mentor ("though he doesn't know it yet"), and appreciates his "free consulting advice" when she and her classmates ask job-related "hypothetical questions" of this former director of Cytel Corporation, now working as a consultant in great demand.

The "Science of Regulatory Affairs" Specialized Certificate is awarded upon completion of five core courses: Regulatory Requirements and Regulatory Compliance, along with Good Lab, Clinical, and Manufacturing Practices.

Jeanne Dunham (president of BioServ, a contract manufacturing company) teaches GMP. She gained her specialty in setting up manufacturing systems in compliance with GMPs first with Boehringer, and then in work with Hybritech, one of San Diego's original biotech companies. She teaches both a 16-hour seminar and 30-hour (ten-week) version of the GMP course, reflecting her expertise in GMPs for commercial production and contract manufacture. "Basically," she says, "you need to record exactly what you do on each batch record." Ms Dunham emphasizes validation in her detailed how-to course on documentation of specifications and testing procedures for equipment or systems processes. She warns that if a publicly traded company receives a "483" (FDA citation), the public scrutiny is no fun. "To keep it fun" last quarter, she asked trainees to write a process validation on how to make a margarita. You should not copy company files to gain RA expertise, she adds.

Instructors of RA Core Courses: Mentors Shape Master Keys for Trainee Success

Ingrid Cabalza thanks instructor Dunham, her "main mentor," for far more than "breaking down formal GMPs" for her. Ms Cabalza cites her break into professional circles when she set up a student ISPE (International Society for Pharmaceutical Engineering) chapter on the lead of Ms Dunham, an ISPE board member. Ms Cabalza now sits on the ISPE Board as its youngest participant in valuable networking opportunities, and is being encouraged to apply directly to the FDA for her next RA job. Enthusiastically, Ms Cabalza realizes that her use of the UCSD student voucher for the Extension's professional development training in RA has opened a new world of exciting work opportunities. "In Biology, of course, you learn about research institutions like Scripps or the Burnham, but most of my classmates bound for med school, think of the lab as just a pit stop on their way. From my experiences through this UCSD Extension Program, I know RA is a very interesting field which makes good sense as you apply it!"

More than Core Courses: The 24-Unit RA Professional Certificate

Further understanding of the intricacies of biotech operations is provided by the 24-unit RA Professional Certificate. Elective course topics include the subtle influences of corporate finances, as shown in "Pharmaco-Economics and Effectiveness Trials." Trainees often choose to study biotech patent law and related issues in greater depth.

"Most valuable," says instructor Kradjian, "are business skills needed for communicating and interest-based negotiating with the FDA."

The FDA is seeking a regulated collaboration with industry, wherein the industry contact is viewed as the technical expert on product specifics. Together, the FDA and a company can develop agreements on specific applications of rather general regulations. UCSD preparation helps the RA professional learn how to best characterize, for example, the potency of a novel pharmaceutical. UCSD core courses in regulatory requirements and regulatory compliance are filled with casework to enable trainees to anticipate difficulties and avoid citations, and the elective courses for the Professional Certificate build on these skills. According to Dr. Kradjian, "In the current regulated environment, the skills of the RA professional make the difference between an aggressive or mediocre pace to market approvals. Optimizing use of time and money is critical to the welfare of the patient and the company, particularly of small biotechs, and even of the national economy."

Closer to the Heart of the San Diego 'Biotech Zone': The Program's Service Goals

The UCSD RA Program classes recently moved to the San Diego 'Biotech Zone'--into the same building as a major CRO, Parexel, and only blocks from another big CRO, Quintiles. Both CROs will contribute RA experts to classroom discussions of topics. Nearby are also the new headquarters of Novartis, represented on the Advisory Board of UCSD Biotech Certificates Programs, as is Invitrogen. Other Advisory Board members, Monsanto and Dow, together with its hometown subsidiary Mycogen, demonstrate regional strengths in agbiotech (which is expected to "absolutely boom" in the near future). The newest UCSD Certificate in Agricultural Biotech is under development, since the UCSD Biotech Certificates program aims to be comprehensive and progressive in service to all biotech sectors.

RA elective offerings add an August workshop on Electronic Medical Devices, by Barbara-Helene Smith (a Lead Assessor of ISO 9000 regulations). The RA Program also has plans to offer all RA Certificate courses online. The "Regulatory Compliance" core course is already online.

UCSD's Biotech Certificates Program is admired as the most advanced in the UC system. UC Berkeley wants to replicate it, while UCSF has no Extension Program for training of working degreed professionals; UC Davis is struggling with developing this type of program, and so far is focused only on agbiotech; UC Irvine serves local medical device manufacturers but not biopharma with its Biotech Certificate. No other UC Extension offers a RA Professional Certificate, so it is not surprising that people come from all over California to train in the UCSD RA Program's core courses.

The UCSD Extension Science and Engineering professional development Biotech Certificates Program started with a grant for retraining laid-off aerospace engineers. Federal defense cutbacks hit San Diego's large military contractor workforce hard, and UCSD recognized that the out-of-work defense technologists could fill commercial job opportunities in the region's growing electronics and biotech industries.

The RA Certificate Program now serves the thriving biotech industry workforce. "We get a lot of attendees from QA/QC and R&D divisions, a lot of PhD people who've worked in the lab, and clinical people, as well as some patent attorneys thinking of getting into regulatory," sums Ms Rangus. "Initially, we had financial people from accounting firms with biotech customers, or reps from investment/venture firms, trying to get a rough understanding of RA in terms of FDA time-to-approvals... but this program is designed to enable biotech employees to perform a full range of RA work."

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