Nicole Hilgraf

Chemist Transitions to Career in Regulatory Affairs with Help of SDSU Master’s Degree

By Suzana Norberg March 16, 2018

headshot of Nicole Hilgraf

Educated in Europe — Germany, the UK, and Switzerland — Nicole Hilgraf came to the United States in 2001 with a Ph.D. in chemistry to conduct post-doctoral studies at the Scripps Research Institute in La Jolla.

“San Diego was one of the fastest growing biotech hubs at that time, and I decided to stay and joined Vertex Pharmaceuticals as a medicinal chemist,” said Hilgraf. “During my 12-year tenure as a scientist at Vertex, I learned a lot about small-molecule drug discovery and was fortunate to see compounds advance from the original screening hit all the way to drug approval (Kalydeco and Orkambi for cystic fibrosis, and Telaprevir for HCV). I also learned how to successfully manage and lead chemistry teams and how to efficiently work within multidisciplinary team environments.”

By 2014, she wanted to become more involved in the later-stage drug development process, but transferring  within Vertex wasn’t an option, since the San Diego site is involved only in drug discovery.

“I was attracted to regulatory affairs, as this discipline brings together all aspects of drug development, requiring both scientific and regulatory understanding,” said Hilgraf. “Since I did not have much regulatory expertise yet, I decided to become a full-time student again to help fill this gap.”

Only a few weeks after taking her final class in SDSU’s fully online Master of Science in Regulatory Affairs program, Hilgraf landed a management-level job in the industry. She answered a few questions about her journey.

How did SDSU’s Master of Science in RA program meet your expectations/objectives?
My main goal for entering this program was to obtain a sound theoretical foundation of the many diverse areas within regulatory affairs. I believed that a Master of Science degree in RA would help open the door for my career transition into this field. In addition, I felt confident that a strong theoretical foundation would also be a catalyst for an accelerated career path in RA after starting my first job in RA.

This program has met, and even exceeded my expectations: I was able to find my first job in RA only a few weeks after taking my final class at SDSU. Somewhat ironically, I re-joined Vertex Pharmaceuticals at its headquarters in Boston, as my family and I had re-located there a year before my graduation. Due to my strong educational background in RA, Vertex hired me at the manager level, and I feel that this program has prepared me well for my job responsibilities.

How did you find out about SDSU’s program and what was the deciding factor in choosing it?
Before leaving my position as a scientist at Vertex, I spent about a year carefully considering and weighing my options. I reached out to people within my professional network to get connected with RA professionals, and I had many conversations. One organization that stood out for me in this process was the San Diego Regulatory Affairs Network (SDRAN) which offers a six-month mentoring program for people interested to learn more about RA.

Through that program, I connected with both an instructor and two alumni of the SDSU RA master’s program. In discussions with them, I heard about how well this program was designed, and how it was much more detailed and also demanding than other programs offered elsewhere. Initially, I had only planned to obtain the Advanced Certificate in RA from SDSU — but after only taking the first two classes, I had already changed my mind to enter the MS program, as I truly enjoyed the classes and realized their long-term benefits for my second career in RA.

What do you think are the program’s key strengths?
In my opinion, this program has two key strengths: the broad coverage of the many aspects of regulatory affairs, and excellent instructors who are working professionals in this field. With regard to the broad coverage, I feel that this program is well designed with classes covering the many different fields within RA, and also going beyond into relevant neighboring fields (e.g. clinical or ethical considerations). And the breadth of this program does not mean that it sacrifices depth; in contrast, I was positively surprised how deep and detailed we went into subject matter in each class. The second key strength of this program is the fact that RA working professionals are teaching these classes. I liked the many case studies, mock regulatory submissions, and regulatory hot topic discussions in all of my classes. In addition, instructors were always accessible by e-mail and would always respond within one day if I had any questions.

As a working professional, was the online component a critical feature?
I was one of the few non-working professionals in this program since I had decided to become a full-time student again for two reasons: I wanted to complete my MS degree in the shortest time possible, and I also wanted to have the least impact on having enough quality time with my family, especially with my young daughter. The online nature of this program was ideal for my family and me, as I was completely flexible in my time management. In addition, after my family and I relocated to Boston somewhat unexpectedly two-thirds into my program, I appreciated it even more that I could continue my studies from the East Coast without any problems or delays.

How much interaction did you have with fellow students, and are there networking aspects to the program?
Even though this program is fully online, there are many interactions with fellow students through discussion boards and team projects. I would have classes together with some students repeatedly, so we formed a sense of comradery. I even formed a friendship with one of my fellow students from my first two classes, and we recently had lunch together here in Boston even though he still lives in California. When I was starting to look for a job in Boston, I reached out to my graduate advisor, Dr. Lorah Bodie, and she connected me with a few local alumni who offered advice and help during my first job search.

What was your thesis project?
As a chemist, I am intrigued and very supportive of the FDA’s Quality by Design initiative which was started about a decade ago. With this initiative, the FDA is hoping to motivate pharmaceutical manufacturers to build quality into their products from the start throughout the whole manufacturing process, and not just trying to ensure product quality by testing at the end of the process. In my thesis, I was looking at the response of industry to a new initiative from the FDA in which the agency proposed that pharmaceutical manufacturers should submit quality metrics — an indicator of the health of a manufacturing quality system — on a regular basis. Responses from industry and other stakeholders were collected in the Federal Register, and I summarized, analyzed and discussed these responses in my thesis. Overall, responses were quite diverse and controversial, and I enjoyed closely following this real-time interaction and shaping of potentially new regulatory requirements between stakeholders and the FDA.

What did you want to be when you grew up?
I was always fascinated by science and was very determined to become a medical doctor as a child. When I had a choice between taking French or Latin in middle school, the choice was very easy for me as you needed to have had at least three years of Latin classes to enter medical school in Germany. However, in high school I got more attracted to chemistry and biochemistry and ended up studying chemistry instead. Working in a pharmaceutical company closed the loop back to my initial dream of being a medical doctor — although in a different way than I had initially thought.

Anything you’d like to add?
I started my first job in regulatory affairs nine months ago as a regulatory CMC manager at Vertex Pharmaceuticals here in Boston. Over these few months, I have had the opportunity to support one NDA filing and several clinical trial applications (CTAs) and CTA amendments for small molecule drugs. In addition, I had the privilege to be part of a team submitting one of the first CRISPR/Cas9 gene editing CTAs worldwide — a very exciting endeavor within a new, not yet clearly defined regulatory framework.

I am very happy that I took a bold step in 2014 to leave my scientific career and start a career transition into regulatory affairs. The MS program at SDSU was instrumental in helping me realize this successful transition!

Saundra McKinley

Graduate Enhances ‘Dream Job’ with Master of Science in Regulatory Affairs from SDSU

By Suzana Norberg December 7, 2017

headshot of Saundra McKinley

As a project manager for a medical device manufacturer, Saundra McKinley manages multiple projects to comply with requirements all over the world. “This is what allows us to access markets in over 150 countries. It’s an exciting job that genuinely helps patients with cancer gain access to treatment to save lives,” said McKinley. “This is my dream job and a perfect fit.”

Wanting to learn more about the world of regulatory affairs and the specialization her career path requires, McKinley began pursuing her Master of Science degree in regulatory affairs at SDSU’s College of Sciences. Offered in partnership with the College of Extended Studies, the program provides critical ongoing training and education to those involved with the development, testing, manufacturing, and commercial distribution of pharmaceutical, biologic, veterinary, and medical device products.

“The program was eye-opening and made a tremendous difference in my understanding the complexity and areas of specialization in regulatory affairs. I learned so much about what my co-workers and mentors know, and now I’m on par with them,” said McKinley.

She answered a few questions about her experience in the program.

How did you find out about SDSU’s Master of Science in Regulatory Affairs program?
Colleagues had attended SDSU and I asked around for recommendations. This program came highly recommended and I learned it is highly regarded! The administration was so friendly and supportive, I knew this was the way to go. I’m a remote worker, and my employer headquarters are in California. It meant a lot to me to get this degree from the California State University system.

What do you think are the program’s key strengths?
To me, the small class size and highly focused curriculum were perfect for my career intentions. I thought the instructors were typically excellent, with deep industry knowledge and experience. I thought it was amazing to learn in-depth about areas beyond regulation — such as project planning, scientific writing skills, regulatory history, and ethics.

As a working professional, was the online component a critical feature for you?
Absolutely! The program requires a lot of reading and study, and the flexibility that allowed studying as my schedule permitting was essential to me. I was surprised that this course work was very challenging and required a lot of self-discipline to understand, how to apply myself to the objectives, and how to read very carefully. In retrospect, I am delighted with having taken online courses rather than in-person courses.

How much interaction did you have with fellow students?
I met several people who I now consider a part of my network. I learned a lot from my fellow students, and I did have several opportunities for team work on projects, as well as staying in touch to check in as we went through different courses.

What was your capstone project?
My capstone project was on the new European Union Medical Device Regulation. My job is to project manage the implementation of this very large, multi-year project, and the capstone gave me the great experience of explaining the history of the regulation, how to understand the framework, and how to organize for multiple “tracks” of work to comply with the areas of our medical device business that are impacted by the regulation — post-market surveillance activities, clinical evaluation, labeling, Unique Device Identification, economic operators, and the pre-market activities such as technical file maintenance and working with our notified body. [Editor’s note: A notified body, in the European Union, is an entity accredited by a member state to assess whether a product to be placed on the market meets certain standards.] The capstone was a crucial research experience and gave me a wonderful view and opportunity to apply what I had learned in the program to what I will do in my job function for the next several years.

Can you speak to the caliber of instructors?
Some of the instructors were so expert, I am now in their fan clubs. They were terrifically accessible and genuinely interested in my success as a student, and in my career objectives. I was very impressed with the industry expertise they represented.

How did your M.S. degree in Regulatory Affairs impact your career?
My job security is much greater now and I am more respected in my field for having completed this program. The medical device portions of the program were 100 percent applicable, and it was helpful to learn about the pharmaceutical industry. Across both areas of studies, it has meant a lot to me to learn about why the regulations are in place, and how the interplay of regulation and public health drives industry.

What did you want to be when you grew up?
I never knew quite what I wanted to be! After more than a decade as a project manager, I found the perfect niche applying project management skills to regulated industry through this course of study. Now I am what I would have wanted to be when I grew up, if only I had known these things when I was younger!

Anything you’d like to add?
The administration of this program is excellent. I got a tremendous support and encouragement from the program coordinators. The coursework has a laser-focus on regulated medical industry. I recommend this to anyone who is interested in regulatory affairs. It gives both a broad perspective and a targeted focus on specific areas to help a regulatory affairs professional understand the arena, and to understand the various functions and opportunities in this career. Loved it

Deadline for Fall ’18 is August 1st!

Note that the Fall ’18 deadline to apply for the Regulatory Affairs certificate and masters programs is August 1st. Click here for information on how to apply to the advanced certificate program. Click here for information on how to apply to the masters degree program.

Visit us at RAPS!

Planning on attending RAPS Convergence 2018 on October 1st-4th in Vancouver? If so, come see us! We’ll be at Table 5.

May ’17 courses open to Regulatory Professionals!

Regulatory professionals may take our May ’17 elective courses for professional development… [Read more…]

No More GRE?!

The GRE requirement can now be waived for applicants who meet one of the following criterion:

  • have an undergraduate GPA of at least a 3.0 from a U.S. university and 3 yrs. of relevant industry experience
  • have completed three program courses (one of which must be RA 602) with a grade of B or better in each course
  • hold an advanced degree (such as an MBA, MS, MA, Ph.D., JD, etc.) from an institution that is a member of the Council of Graduate Schools.

Contact the Graduate Advisor at lbodie@sdsu.edu for more information.

Testimonials from our Students!

Graduates Ana Freed and Dr. Ken Kern share their thoughts about our program.

Kenneth Kern

Graduate of SDSU’s Master of Science in Regulatory Affairs Now Finds ‘Common ground with colleagues in all aspects of drug development’

By Suzana Norberg December 7, 2017

headshot of Kenneth Kern From biochemistry major at Berkeley, to Harvard Medical School graduate, to cancer surgeon at Johns Hopkins Hospital, Dr. Kenneth A. Kern has been on a trajectory of professional growth his entire life. He’s currently a senior medical director at a pharmaceutical company, designing and overseeing clinical trials that test novel compounds in the treatment of a variety of cancers.

In keeping with Kern’s constant pursuit of excellence, and given that regulatory affairs is an integral part of any drug development program, he recently earned his Master of Science in Regulatory Affairs through San Diego State University’s online program.

“I enjoyed the program so much, that had a Ph.D. in Regulatory Affairs been available, I would have been the first to sign up for it,” said Kern.

In partnership with the College of Extended Studies, SDSU’s College of Sciences also offers an Advanced Certificate in Regulatory Affairs (transferable to an MS degree), and with the USD School of Law a joint Advanced Certificate in Intellectual Property and Regulatory Affairs.

Kern answered a few questions about his journey through the Master’s program.

Please give us an overview of your education and career.
I graduated from the University of California, Berkeley as a biochemistry major, after which I obtained my medical degree from Harvard Medical School. I then trained as a cancer surgeon at Johns Hopkins Hospital, and the Surgery Branch of the National Cancer Institute, a division of the National Institutes of Health. I specialized in research in cancer-related metabolism, and I also spent an additional year of research training in cancer metabolism and nutrition from the University of Cincinnati. After completion of this training, I was a clinical professor of surgery, and obtained a master’s degree in Public Health, from the University of Connecticut.

About 12 years ago I decided to change career paths and, given my background and training in oncology, biochemistry, and metabolism, a career in pharmaceutical drug development focused on oncology was a natural choice. I have worked for two large pharmaceutical companies in early- and late-phase drug development of small molecules in oncology.

What was your goal in entering SDSU’s Master of Science in Regulatory Affairs program, and how did it meet your expectations/objectives?
Regulatory affairs is an integral part of any drug development program. While there are specialized divisions within pharmaceutical companies focused solely on regulatory matters, I believe it’s important that those working on clinical trials not in these divisions to have a thorough understanding of the entire process of drug development. This would include an understanding not only of how to create medications, but also what is involved with registering pharmaceutical drugs for use by physicians and patients, including small molecule drugs and biologics. This principle also applies to medical devices.

A thorough education of this type would include a study of manufacturing, pre-clinical testing, clinical testing, quality control and quality assurance, advertising, interacting with the FDA and EMA, and how to write clearly and effectively.

My objective in entering the SDSU Master of Science in Regulatory Affairs program was to broaden my theoretical and technical skills in all of the areas mentioned above, to help me perform my job even better as a clinical trialist. On a technical level, it meant obtaining more in-depth understanding of Good Manufacturing Practice [GMP], Good Laboratory Practice [GLP], Good Clinical Practice [GCP], and the workings of the FDA in assuring the U.S. public that drugs and devices are both safe and effective for human use. As I mentioned earlier, I have a master’s degree in Public Health, and since the FDA is the world’s largest public health organization, the function and workings of the FDA in protecting the public health are of great interest to me.

I found that the SDSU Regulatory Affairs program did an outstanding job in presenting a comprehensive and thorough education in all aspects of the regulation of drug development. It has helped greatly in my viewing the FDA and its interactions with pharmaceutical companies not as adversarial, but as a collaborative effort to protect the health of the American public.

What are small molecule drugs and biologics, and how do they differ?
“Small molecules” is a generic term for drugs produced by organic chemistry methods, using complex chemical synthesis and organic chemistry reactions in the laboratory.

“Biologics” is a generic term for drugs that are produced from living organisms, for example, therapeutic antibodies. Biologics can only be created from living organisms, as there is no known way to synthesize an antibody in the laboratory. Instead, large (huge) vats of living organisms are genetically engineered to produce specific types of antibodies by altering or inserting specific DNA instructions.

How did you find out about the SDSU’s Master of Science in Regulatory Affairs program?
Through an online search for regulatory affairs programs.

What do you think are the program’s key strengths?
The program is online entirely, yet it sacrifices nothing in quality of its training. This is a critical strength to allow for a working professional to take part in classes. There are some live, web-based meetings, which is also a strong point. The quality of the teaching in each of the 13 classes required to obtain the M.S. degree is extremely high. The material for each of the classes was well researched, always highly relevant, and despite the online aspect it still felt like this was live, classroom training. The program’s training has allowed me to interact with colleagues in all aspects of drug development, even from its earliest stages, and that to me is another of its greatest strengths.

How long did the program take? And if it hadn’t been online, could it even have been an option?
It took me 2.5 years to complete the program, entirely online. I would not have been able to do this without the online option.

What was your thesis project?
An Analysis of Endpoint Thresholds for Granting Breakthrough Therapy Designation and Accelerated Approval in Oncology.

Could you briefly explain your study?
We are fortunate to live in an era when some drugs provide really remarkable treatment effects for cancer patients, far beyond anything seen in prior decades. These types of drugs are felt to provide truly unique therapy because they are so highly effective, generally providing twice the tumor control rates as seen in the past. These drugs are said to reach “breakthrough therapy” levels based on these substantially improved treatment effects seen in clinical trials.

In an effort to register and move drugs reaching “breakthrough” levels of therapeutic effect into the clinic as fast as possible, Congress created regulations in 2012 that are administered by the FDA allowing for special administrative recognition and oversight of the registration process for highly effective medications. These drugs are designated by the FDA as achieving “Breakthrough Therapy Designation” (BTD) and often follow an accelerated regulatory approval pathway.

The exact criteria used by the FDA to determine if a drug should be granted BTD have never been outlined by the FDA. My thesis explored the history and rationale for BTD, and then studied the specific types of clinical trials and treatment effects seen in nine oncology drugs achieving BTD and later 10 accelerated regulatory approvals. The study determined that BTD medications achieve, in general, at least a doubling of tumor control effects on cancer as measured by tumor response rates, progression-free survival rates, or hazard ratios for relapse.

I submitted part of the thesis to the Journal of Oncology Practice, and it was accepted for publication within the next few months. This work will help those in drug development to understand what benchmarks need to be reached by new drugs to achieve the designation of BTD.

How did you feel about the caliber of SDSU’s instructors and their accessibility?
The caliber of the instructors was extremely high, and they were always readily accessible by email.

How has your M.S. degree in Regulatory Affairs impacted your career?
I am involved on a daily basis with decisions related to virtually every aspect of drug development and clinical trial designs in oncology. These discussions span the gamut from the earliest formulation of a drug, such as understanding timelines for API and the creation of research drug formulations, to late-phase, critical decisions and discussions with the FDA when answering questions related to a final protocol, or protocol amendment.

The breadth of training from the SDSU Regulatory Affairs program has really made my job easier, more effective, and more enjoyable, as the training has helped me find common ground with colleagues in all aspects of drug development.

Anna Freed

Student of SDSU’s Master of Science in Regulatory Affairs Program Saw ‘Immediate Difference’ in Career

By Suzana Norberg July 5, 2016

photo of Anna FreedWith a bachelor’s degree in molecular biology, Anna Freed was working in a primarily quality assurance role with a small medical device company two years ago. Today, she manages a team of QA consultants for a large, international client. What happened in between? She took the Master of Science in Regulatory Affairs online program through San Diego State University.

In partnership with the College of Extended Studies, SDSU’s College of Sciences also offers an Advanced Certificate in Regulatory Affairs (transferable to an MS degree), and with the USD School of Law a joint Advanced Certificate in Intellectual Property and Regulatory Affairs.

Freed answered a few questions about her journey through the Master’s program.

What prompted you to take SDSU’s Master of Science in Regulatory Affairs program?
The company I was working for at the time was very small and the QA department also performed regulatory affairs functions. QA and RA are closely related, so you need a good understanding of the regulations and requirements in order to be successful in a QA role. I was still relatively new to QA/RA; I had only two years of experience in the field. My manager had received her M.S. from SDSU’s RA program. She knew I was looking to grow in my career and suggested the program as a way to help me reach my career goals.

What had you hoped to gain and how did the program meet your expectations?
I was really hoping to gain an understanding of the regulations behind the job that I had been performing. The program definitely met my expectations. I learned about regulations behind a variety of topics, but more importantly, I learned how to interpret the regulations and apply them to different companies and situations.

What do you think are the program’s key strengths?
The flexibility and industry focus of the program are definitely its key strengths. The instructors are all industry professionals with a lot of experience to share, and they provide a framework to understanding course topics from a real-world perspective. The program also includes classes that cover both pharmaceutical and medical device regulations, and there’s a variety of electives and special topics to choose from that fit individual needs.

How long did the program take?
It took me two years to complete the classes, and five months for the final capstone (thesis) project.

What was your thesis project?
My thesis project was to develop a program for a company looking to transition from an unregulated, research use only [RUO] company, to a company that manufactures diagnostic Class III devices that are regulated by the FDA. The program I developed is meant to allow customization to any company size and structure and to change the culture of the company with minimal disruption to manufacturing.

What did you think of the caliber of instructors and their accessibility?
All of the instructors were great. They were extremely knowledgeable about their subjects and because they are industry professionals, they included real-life case studies and examples in many classes. The instructors were accessible and answered any questions that came up while I was working on assignments for each class.

Can you speak to the networking aspects of the program?
Every class had students share their LinkedIn profiles and I connected with a few individuals who were working or had worked in the same medical device companies as I. I found it useful to connect with the other students and discuss our career paths and challenges.

How has your Master of Science degree impacted your career?
I saw an immediate difference in my career when I started the program. Starting the program showed my commitment to personal growth to the management team at my previous company, which led to me being designated the lead on several large and very visible projects, which eventually led to a promotion. I got offered a consulting position about a year ago, and was promoted to the management team of the consulting company in the last few months because of my performance and relationships with the client. I now manage a team of QA consultants for a large, international client. I would not have had the necessary knowledge to perform my role if I had not completed the MS program.

Come see us at AWIS SD Open House!

SDSU Regulatory Science will be at the Annual AWIS (Association for Women in Science) SD Open House on Wednesday, October 28th from 5:30pm-8:00pm. We hope to see you there!