Posted 31 July 2017
By Mary Faderan, PhD, RAC
This article is based on an interview with Cook Research Incorporated (CRI) president Jennifer Kerr and covers a wide range of topics from her education, to how she became interested in regulatory, to her experiences in clinical affairs and her responsibilities at CRI.
Jennifer Kerr, president of Cook Research Incorporated (CRI), has had an impressive career and is involved with many aspects of identification, development, testing, and regulatory approval of innovative medical products. In addition to being president of CRI and vice president, global functional leader for clinical, she is active in a variety of professional organizations with diversified responsibilities. She is currently the US industry co-chair for the International Organization for Standardization (ISO) TC 194 WG4: Biological and Clinical Evaluation of Medical Devices and is a member of the editing committee for the ISO 14155: Clinical Investigations of Medical Devices for Human Subjects–Good Clinical Practices. She is a member of RAPS and earned her Regulatory Affairs Certification (RAC) in 2002. This article captures Kerr's panoramic view from the top with a close up look at her hands-on and collaborative management style.
At CRI, Kerr's primary responsibilities include executive oversight of product development, testing, clinical studies, medical/scientific writing, and regulatory submissions for devices, pharmaceuticals and cell-based therapies. She also oversees and directs the alignment between CRI and the needs of the Cook divisions and other Cook entities. Kerr provides leadership by identifying and communicating Cook needs and priorities and working to assure customer expectations are met. She is responsible for scientific and clinical leadership in the conduct of global clinical studies on behalf of the Cook organization and also for managing resources required to coordinate the overall function of the company, especially in ensuring deadlines are met.
My first question for Kerr was regarding how her education and professional work experience led to her current role. Kerr explained that her career began when she was an engineering major at Purdue University, where she was one of the earliest biomedical engineering/physiology majors at the university. While in that program, she interned at Eli Lilly headquarters in Indianapolis working in their medical device division with a scientist mentor. She worked on developing new medical devices, such as the insulin pump. At Lilly, she also was exposed to and gained knowledge of Good Laboratory Practices (GLPs).
Her internship at Lilly, she said, supported the experience she needed to understand her graduate work, which aimed at bringing medical devices to market. Lilly introduced her to Leslie Geddes, a professor at Purdue, from whom she learned more about medical devices and medical device testing and development. She spent a day with Geddes, who, she said, rewrote her undergraduate program to include classes in physiology. She subsequently became involved with Small Intestinal Submucosa (SIS) technology. She had no way of knowing then that two students who studied SIS, Umesh Patel and Michael Hiles, would one day become the current president and CSO/senior VP at Cook Biotech Incorporated where SIS devices are manufactured. She also conducted a second internship at Dow Elanco where she became familiar with veterinary products, GLPs, learning SOPs, FDA's Code of Federal Regulations (21 CFR) and the Quality Management System (QSM). From this internship, Kerr gained an understanding on why a quality system was necessary to make medical devices.
Cook Research Incorporated (CRI)
CRI is located in the college town of West Lafayette, Indiana. The building houses the regulatory, preclinical and mechanical testing, and clinical affairs departments. CRI serves as the Cook Company CRO and is involved with multiple projects that include clinical studies and animal and mechanical testing of new or modified devices manufactured within the global Cook enterprise.
Back at Purdue, Kerr created a quality system for biomedical engineering center and worked on the human and nonclinical space, such as animal studies, auditing vendors, and GLP studies. Through her continued involvement at Purdue, Kerr also said she had the "privilege" of lecturing graduate students in the BME program in supporting preclinical and clinical courses.
Kerr said she now sees the total regulatory submissions picture from beginning to end.
She is involved in the Investigational Device Exemption (IDE) process from the clinical study to data gathering, submitting annual reports. Today, there are so many studies and the complexity is impressive when one takes into consideration Outside the US (OUS) registrations. Kerr also has been involved in FDA panel meetings, for example, for the abdominal aortic aneurysm device.
On a typical day, explained Kerr, she is involved in a variety of activities. She may start the day on a conference call as she serves on the ISO standards committee to review the global standard mentioned above. Then she may move to a meeting where she discusses security and infrastructure needs at CRI. According to Kerr, every day is a little different, because as CRI president she oversees the CRO company for the Cook Group of companies. She is also asked by sister companies (such as Cook Biotech) for input into strategy in clinical affairs and reviews results of clinical and non-clinical tests. She also looks broadly across the Cook organization, where she is enjoying and is involved in OUS projects, which means working with regulatory authorities in Japan, Australia, China, Canada and the European Union.
Kerr's strategy is to find alternate ways to get what is needed in different areas and to work through problems that may arise pertaining to device-to-market goals. For example, she determines outputs, decides on how to look at data to be able to present them to regulatory authorities, and also supports inspections of her company and other Cook companies, especially with regard to results related to company clinical studies.
Kerr's advice to those who are just starting out in the regulatory/clinical affairs field is to get a university certificate in regulatory affairs or audit a course with emphasis in regulatory affairs, device development or manufacturing. Plenty of opportunities exist in regulatory and clinical affairs, explained Kerr, and one needs to interact with organizations that offer learning opportunities to take best advantage of the space that matches their degrees. It is important, she added, to understand the needs that exist in the effort to bring a device to market. She commended Purdue for recognizing the significance of device manufacturing and design development in the regulatory path, a multimillion dollar commitment.
She also noted the importance of co-ops and internships where students can work toward device creation and production and marketing. Learning may start early as Kerr also brought up the example where CRI hosted 30-40 Girl Scouts who have an interest Science Technology Engineering and Math (STEM) and provided them an early exposure to get the word out.
"We are not building widgets," she said." It's a privilege to impact patient lives."
I asked Kerr to explain the differences between her role in regulatory versus clinical affairs, and whether she prefers one area over the other. Regulatory can be as broad or as narrow as you make it, replied Kerr, and explained how her work is in the clinical space and inputs regulatory, complying with FDA regulations, providing reports, quality systems, design, testing and information and the clinical evidence reports that are gaining more focus OUS. On the business side, Kerr moves products through the pathways provided by regulatory authorities. She looks at complaints and the total product lifecycle management. For example, if through a clinical study a complaint is reported from Europe, there is an obligation to investigate the complaint and provide the information to the manufacturer to address potential reporting obligations to regulatory authorities globally. If there is uncertainty regarding the nature of the complaint and if the product failed, one needs to investigate whether the failure was caused by user error or device-related and the impact upon patient safety.
"Regardless if next generation devices are being developed and studied, if first generation products are still being sold, the manufacturer must keep surveillance and regulatory work going especially if there are patients in follow-up from a clinical study. This could be a pathway of 10-15 years," Kerr said.
According to Kerr, regulatory and clinical affairs are complements to each other. She said that there is a need to recognize experts who understand the regulatory pathways and regulations, as well as the engineering and clinical teams which are important to the process.
"It takes all of us to move forward," she explained. "And, it takes all of us to have good communication where everyone needs to know the impact of changes and be able to assess their impact."
Kerr has had a variety of experiences working with international and domestic regulatory authorities. Her job, she said, is to support the team on the frontline by strategizing and recognizing who needs to be in the conversation in reviewing the documentation/materials, participating in teleconferences or in person, and where necessary, reviewing responses to the authorities. "If I am signing off on a document on behalf of Cook, I want to give input," Kerr said with firmness.
She says that in the past few years she doesn't go to specific meetings as much as she once did. However, one area she is thankful to participate in is the development of international clinical research standards where she engages with regulators from FDA, Japan's Pharmaceutical and Medical Device Agency (PMDA), Germany's Federal Institute for Drugs and Medical Devices (BfArM), the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Australia's Therapeutic Goods Administration (TGA) and raises expectations regarding the standard they are reviewing. In other international settings, she represents Cook in board, committee and in industry organizations.
Kerr regularly conferences her team regarding early feasibility studies, pre- and post-market procedures and reviewing real world data. The work, she said, is enjoyable and improves the process. We are all working for the same goal: safe technology to patients," she said and noted that Cook's motto is "Patients first."
When asked about industry complaints that FDA is stifling innovation, Kerr replied that there is an awareness of the criticism, but she feels that FDA's Office of Device Evaluation (ODE) staff and Office of Compliance are more open and transparent and want to work collaboratively with industry. She also suggested that there is miscommunication in some settings with FDA. However, when FDA reaches out to medical device industries "they remind us that they want to talk to us as often as possible," she stated.
Kerr explained that FDA has asked for help in better understanding of industry's point of view and they encourage industry to bring medical doctors and surgeons to meetings to provide clinical input on the devices being reviewed. She said that FDA reviewers "step into the same space" as industry in the process of device review and it is up to industry to help FDA's review to be more a transparent process. Consequently, Kerr encourages industry to "stand behind our organizations" and invite FDA to "come and visit." She also encourages surgeons and doctors to invite FDA to visit their hospitals and organizations.
Kerr keeps current on changes in regulations and their relevance to CRI's work by means of industry-specific newsletters that land in her inbox daily. She said that the information turns over so quickly that she looks at short email blasts to see what "bubbles to the top" regarding such things as user fees, draft guidance documents available for comment and statutory changes to the regulations for example.
Through consumer and industry interaction, including the ISO technical committees she is working on, Kerr keeps up to date on regulatory authority statements and industry topics where collaboration is invaluable and the neutral environment encourages professionals to debate topics and reach equitable agreements on issues.
She said she pays attention to "real world experiences," such as risk management issues and the impact of FDA 483s in the clinical space. The issues of impending technology transfer are also something Kerr monitors.
Through these efforts, Kerr keeps her team informed about relevant regulations and changes that may impact their work. She stressed the importance of good communication practices between her and her team with an "open door policy" by which a team or individual member of her team are welcome to come and see her at any time.
Kerr added that she is also in communication with FDA, EU, US industry, PMDA and other regulatory authorities.
Kerr stays involved with the different teams at CRI and works to ensure there is an understanding of the importance of the work being done while also listening to concerns and suggestions.
"My job is to remove roadblocks," summarized Kerr.
About the Interviewer
Mary Faderan, PhD, RAC, currently works at Cook Biotech Incorporated (CBI) in the international affairs department as a regulatory scientist. She received her PhD in pharmacology in 1985 and has experience in cancer research (Yale University and Sloan-Kettering Cancer Center), microbiological research (Purdue University), and regulatory affairs (11 years at Cook Biotech Incorporated). She has worked with FDA, Health Canada and the globally recognized competent certification body, TÜV, among other notified bodies in successfully spearheading the registrations, renewals and approvals of CBI devices. Currently, Faderan is working on her Master of fine arts in creative writing and is interested in using her creativity in furthering the mission of her company. She can be reached at email@example.com.
Cite as: Faderan, M. "A View From the Top: An Interview with CRI President Jennifer Kerr." Regulatory Focus. July 2017. Regulatory Affairs Professionals Society.