- What is your job title and affiliation?
I am currently an independent consultant. I started my practice in 2003 and named it BioDecisions Consulting. Prior to starting my own company, I served as the Vice President of Research & Development for LifeScan, a Johnson & Johnson Company, and before that I was Senior Vice President of R&D at Dade Behring.
- Briefly tell us about your educational and career background
I had the opportunity to start working in a laboratory when I was a sophomore in college. I majored in chemistry but got introduced early to biochemistry and clinical chemistry through my part time jobs. I spent half my time in a basic research lab and the other half in a small clinical laboratory that supported a twelve-bed clinical research center. After graduating from college I began my career as a research technician. With encouragement from the laboratory staff I returned to school and completed a PhD in biochemistry. My area of focus was enzyme mechanisms, first studying dehydrogenases and later the proteins involved in coagulation. I spent four years at Henry Ford Hospital as a postdoctoral fellow. I was about to transition to a research fellow when a family move took me to Miami and my career in the in vitro diagnostics (IVD) industry. I joined ‘American Dade’ in 1981 as a Senior Scientist in R&D. I enjoyed the challenges of product development and the reward of seeing my products in clinical use. Over the years my responsibilities increased and shifted more to R&D leadership and technology management. In 1987 I became Vice President of R&D for what was then the Dade Division of Baxter Diagnostics. I remained in R&D leadership roles until my recent transition to a consultant.
- What are your Board certifications?
My career path did not involve formal training in clinical chemistry although my interests have always been in the clinical areas. When I joined Dade I started studying for the Board exam but quickly realized it was not a necessary credential for the particular career path I had chosen so I never took the exam. In retrospect, I wish I had continued on and become Board certified. It would have created more career opportunities and options.
- With which professional societies/organizations (e.g. AACC) are you involved?
Until recently I was a member of American Chemical Society. In the early years of my career it was the professional society I most identified with. In 1981 I joined AACC and it has been my home ever since. I have also been active in the National Committee for Clinical Laboratory Standards (NCCLS) now known as the Clinical and Laboratory Standards Institute (CLSI) where I currently participate as a member of the Strategic Planning Committee and Alternative Business Model Task Force. At times when my jobs responsibilities have involved other disciplines I have been a member of American Society of Microbiology and participated in the American Association of Blood Banks and International Society of Thrombosis and Hemostasis ISTH programs. I have also had the opportunity to be involved with the International Federation of Clinical Chemistry (IFCC) activities as the Industry Representative for Dade Behring. I served for four years as the Industry Representative and Secretary of IFCC’s Executive Committee of the Education and Management Division.
- Just for fun, tell us a few interesting facts about yourself:
I am married and we have one grown son, David, who is also in R&D as a computer scientist for a start-up company.
- Favorite activities/hobbies
I really don’t have any single hobby that is a passion. In my free time I enjoy reading, gardening, travel, and on occasion, I try my hand at needlework. One of my goals is to finish all of my unfinished counted cross-stitch projects, someday!
- Favorite places you have traveled
My husband and I love to travel and over the years my job has taken me to many wonderful parts of the world. In addition to all the fantastic and varied spots in the US, our favorite trips have been to Africa. Safari trips to Kenya and Botswana have been magical.
- Favorite book/movie
I confess to reading mostly mass media books. I love serial killer books, mysteries, and spy stories and read most of the popular writers in that genre. However, after my recent experience as the delegation leader for the AACC/People to People Clinical Laboratory Scientists Ambassador delegation to South Africa, I came home and devoured Nelson Mandela’s autobiography “Long Walk to Freedom”.
- Most fun/adventurous thing you’ve ever done
While pondering this question I realized I haven’t been very adventurous but one of the fun activities we’ve enjoyed over the years have been family ski trips and on some days they can be adventurous.
- What area(s) do you specialize in?
My areas of focus have morphed during my career. I started out studying enzyme mechanisms with a particular interest in coagulation. Over the years I have tried to stay involved with hemostasis when possible but my expertise in enzymes led me to a hands-on career in R&D developing enzyme immunoassays and later Immunochemistry Systems. As my R&D leadership responsibilities increased my interests broadened to include other areas of the clinical laboratory and the quality control process. I was involved in the development of large automated chemistry systems and specialized systems for microbiology, coagulation, plasma proteins, platelet function as well as many immunochemistry formats including specialized systems for cardiac markers and infectious disease. We also developed a number of important reagents such as laboratory quality control products and blood bank antisera. Development of products such as these required an interest in many new and old technologies.
Along the way my interests also grew into the study of product development process and the leadership of R&D organizations. My consulting practice focuses in these areas along with technology assessment and integration of technology and strategic planning.
- What initiated your interest in this (these) area(s) and how did you eventually choose this (these) area(s) for your career?
For me, my interest in technology development and training in protein chemistry provided an excellent technical background for immunoassay development. It was a fun time and the reward of seeing the products you develop in everyday clinical use is addictive. I remember an early company orientation lecture where the importance of everything you do was emphasized. The product you develop might be used to help diagnosis a friend, parent or child. I’ve always kept that in mind.
The evolution of my career into R&D leadership enabled me to expand my responsibilities to include the development of an effective organization that developed quality products on time and on budget, the participation in a management and strategic planning process that was critical to the company I was a part of, and the mentoring of younger scientists and engineers. It required me to stay close to the customer and understand their needs so that the products we developed had the required performance features.
- What are your clinical and research interests?
My career has required me to be more of a generalist. I’ve needed to learn about many clinical areas and have not had the opportunity to focus on a particular one. My roots are in hemostasis but my industrial hands-on experience was in the development of immunoassays for a number of analytes in a variety of clinical areas. Technology development, especially detection technology and assay formats have always been of particular interest to me.
My recent research interests have focused more on the discipline of quality product development and R&D leadership. The literature is extensive. During my career I have been fortunate to be exposed to some of the best thinkers in this area through consultants, hands-on projects and educational programs including a Technology Management program at MIT that I sometimes jokingly refer to as “R&D School”. Another area of research is the study of customer centered product development. It is important to develop products that meet the clinical need but how do you determine what those needs are and what are the priorities if technology or timelines force trade-offs. These decisions are not always easy.
- What, in your opinion, has been the most important contribution you have made to the field of laboratory medicine?
For me personally, it has been the development of quality products that provide the clinical information required by the clinical laboratorian and clinician to better care for the patient. I also hope that my involvement and leadership roles in AACC have contributed to the profession and the practice of laboratory medicine.
- Are there specific aspects of practicing laboratory medicine that you find unappealing?
Since my career is in R&D I’ll answer this question from my experience in R&D and product development. I have truly enjoyed the career path I chose and I enjoyed both the routine and the new and exciting. Nothing jumps out as unappealing. As in all scientific disciplines there is an attention to detail that is required in the product development process. I have always understood the criticality of this when developing products and documenting the development process. When one considers a career in a regulated industry you must be prepared for this important aspect of the process.
- What were some of the most rewarding and/or challenging moments of your career?
It has been rewarding to see products you helped develop in everyday use. It has also been rewarding to have the opportunity to be a mentor and to see the younger scientists and engineers you worked with develop into major contributors to the field. Another great day was the Opening Ceremony at the Annual Meeting when I stepped to the podium as the AACC President.
The more challenging times were associated with dealing with product performance issues. It requires rapid trouble-shooting and problem solving. You know that laboratories are depending upon the quick resolution of these issues so they can continue to deliver quality results.
- What excites you about practicing laboratory medicine everyday?
On an everyday basis it is rewarding to know you are involved in health care and your contributions are important to patients and their families. It is a very exciting time in laboratory medicine. We are at the brink of a new era of technology development. The role of the diagnostic laboratory has the potential to increase significantly. For the R&D scientist, new technologies and available materials continue to make the development of new tests and systems or upgrades of existing assays very challenging, rewarding and exciting.
- What are your predictions for advances in laboratory medicine and/or your area over the next ten years?
Over the next decade we will begin to see the impact of the human genome project as well as the study of the human proteome move from the research bench to clinical practice. It takes time for basic and applied research developments to move into routine clinical practice but you can already see the potential as diagnostic testing becomes a more important component of risk assessment, selection and monitoring of therapies and eventually identification of disease predisposition. New technologies such as protein and nucleic acid-based microarrays and the simplification of complex analytical instrumentation are enabling the study of gene expression and the identification of new biomarkers. It will be our job to correlate this new diagnostic information with disease and therapy.
- What do you see as the challenges facing young scientists in laboratory medicine?
It is a great time for young scientists. All careers have challenges. As in all professions we must demonstrate the value we contribute. It is important to stay involved with the rapid advances in technology and clinical areas and look for ways to contribute to patient care.
- What specific goals would you recommend that young scientists in your discipline set for themselves? Any suggestions on how to achieve them?
For scientists interested in a career in the IVD or Biotech industry I would encourage them to follow their interests. Personal goals are individualized and will emerge with experience and after an exploration of the options. There are a variety of careers options for young scientists within the world of diagnostics. They touch on many areas of expertise including quality assurance, regulatory compliance, product development, clinical and performance evaluation, customer support and troubleshooting, and others. We all share the common goal of contributing to the practice and profession.
- Describe how you have been able to give back or contribute to the organizations and the profession in general through your involvement in AACC.
AACC’s vision is to provide leadership in advancing the practice and profession of clinical laboratory science. Becoming involved and supporting the organizations that support your profession is an important way of giving back. You can contribute in so many ways but the development of educational programs and materials is certainly one of the more significant ways to get involved. Share your expertise by networking at meetings or contribute to listservs discussions. For me I have been able to bring my experiences and expertise to the programs I have been involved with and to the governance practices of the association.
- How did you get started in these organizations and what advice do you have for young people wanting to get involved?
Let me use AACC as the example. I first got involved with my Local Section. In the early 1980’s the Florida Section met monthly for a lecture and dinner. It was a great opportunity to meet the clinical laboratorians in the area and scientists that worked at other companies while learning more about laboratory medicine. Before I knew it I was stuffing envelopes and working through the rungs of local section leadership. I looked for opportunities to get involved at an association level and did that through what is now known as the House of Delegates. By serving on committees I soon realized that I could play a role in the future of the Association. Volunteering is often addictive. Once you get started you quickly see the value. My advice is to get involved. Raise your hand and say you want to contribute. SYCL is a great place for a younger member to get involved. You won’t have to worry about waiting for an opening on a committee. When I was president I was extremely pleased when someone called or emailed and said ‘I want to contribute” and I worked very hard to find a way for them to get more involved.
- Do you have any other specific comments or advice that you like to provide to the members of SYCL?
It is very important that the voice of the younger members be heard. I am so pleased that SYCL exists and we now have a group of members who can work with the Association leadership to promote the practice of clinical laboratory science and the value of the profession. It is important that the Association listen to the needs of the younger members and develops services and education programming to aid in their career development. We need more young scientists to enter the field. SYCL members can also serve as evangelists and help spread the word with students and younger scientists about the exciting future of our profession.