Lydia-Ann (Harris) Octave, PhD joined the Office of Career Development as part of the Career Exploration Series. Dr. Octave is a Clinical Scientist at bioMérieux.

Dr. Octave began the session by talking about her background and timeline. She is a native of St. Lucia and came to the United States as a student athlete to St. Francis College in Brooklyn, New York. She studied biology and in addition to volleyball, she also participated in student government and other clubs. Her mentors encouraged her to apply to graduate school, and Dr. Octave then entered a PhD program at State University of New York at Buffalo (SUNY Buffalo). She studied protein-DNA binding and gained insight into how certain proteins were able to recognize and bind to DNA sequences. She also gained experience in crystallography, protein binding assays and DNA sequencing. Also, during this time, she participated in graduate student government and other organizations. As her graduation approached, she had a frank conversation with her mentor about her future plans and she decided she wanted to continue in science but branch out from her graduate studies. She chose to do a postdoc at Washington University in St. Louis (WashU) working on Perilipin 5, a protein that surrounds a lipid droplet and regulates how lipid within the lipid droplet is used during oxidation. Dr. Octave overexpressed to the protein to see the effect on metabolism. In this role, she gained experience with mouse models, microscopy, cell/tissue culture and western blots. And during her postdoc years, she also participated in the WUSTL Postdoc Association in a variety of roles, including Secretary and President, helped organize the postdoc symposium and met and interacted with speakers as well as postdocs from other labs and departments.

At this point in the talk, Dr. Octave discussed her status as an international trainee. An additional burden of international students is the need to always remain in status and to have a plan for future work. As a postdoc, she transitioned from her F student visa to OPT status, and then applied one year later for an H1B visa. After a few years on the H1B, she decided to self-petition for her green card under the EB2 category (national interest waiver) and after two years was successful, which helped alleviate the stress of future plans.

After four years as a postdoc, she was promoted to Instructor at WashU. Her work with Perilipin 5 led to investigating the role of FGF21, a fibroblast growth factor protein. The mouse with overexpressed Perilipin 5 had a great increase in FGF21 in several tissues, so her focus shifted to see how these two proteins affect metabolism in both mice and people. She was at the Center for Human Nutrition, which was a great location to explore this. She had access to tissues, clinicians and staff in the department and the ability to initiate and conduct clinical trials in people. She started her own clinical trials and was promoted to Assistant Professor. During her time as an Instructor and then Assistant Professor, she focused on grant writing, determining the most relevant questions, doing the right experiments, it was a constant go-go-go and always looking for the next thing. She often worked seven days a week, as that was the culture of the department, and it was difficult to unplug. She was starting to get burnt out, even though she loved what she did, and she loved the research she was involved in. However, it was taking away from her time with her new daughter. She felt that she was missing out and had to take a good look at her career in academia and about what she really wanted to do. So, she began to look at other career opportunities, and talking to other colleagues who had ventured outside of academic research, which led to her position at bioMérieux.

bioMérieux is a French company located in 44 countries, serving 160 countries and they have about 12,800 employees worldwide. bioMérieux is largely an in vitro diagnostics company. They build software, assays and instruments that are able to diagnose certain infectious diseases. There are two main applications – the primary area is Clinical Diagnostics and a smaller focus Industrial Microbiology. The Clinical Scientist position she accepted at bioMérieux was a good fit for her as it incorporated a lot of the skills and experiences she had gained over the years, both as a clinical and a basic science researcher. Additionally, when Dr. Octave interviewed, she asked about work-life balance, and really investigated that company policies and culture supported this, and it has held true based on her experiences.

In the clinical diagnostics aspect of bioMérieux, there are three departments: immunoassays, molecular biology and microbiology, and Dr. Octave works with immunoassays department. In the process of developing an assay or diagnostic assessment, one group of people does opportunity assessment. They go through the primary literature and look for new biomarkers, new infectious agents – they look for what problem(s) the medical field is experiencing that we can help solve. Then, once the opportunity is identified, it moves to product design and verification where another group of people build the assay or instrument and verify that it works in a controlled setting. Then Dr. Octave, in her Clinical Scientist position, comes in at the validation stage of the assay, where she runs the clinical trial to ensure that the diagnostic will actually do what it is supposed to do in the hands of the client.  For example, she will ensure that the test will detect the biomarker, etc in target populations with a desired specificity or sensitivity. She must ensure that it will work so bioMérieux can make certain claims on the regulatory documents to the FDA or GMED in the EU. Once the product is validated – that it works, that it is specific – the product must be registered and approved by the regulatory agency(s). From there, it moves to product launch & marketing and then post market activities.

So, what does that mean, to validate the product? What is involved? First, Dr. Octave works with a project team to establish the project timeline and overall budget. Team members would include people from research & development (R&D), biostatistics, quality management, and marketing who meet weekly to discuss all aspects of the project. Dr. Octave develops the protocols to effectively test the performance of the product. She also identifies and qualifies principal investigators and trial sites to perform the clinical trials. This includes ensuring that PIs are qualified to conduct the trials and then working with them on patient recruitment, compensation, and consent, as well as working with institutional ethics committees and review boards. She also works with Legal and Finance teams to establish clinical trial contracts and budgets for the clinical trial sites. And then once a site is selected, there is an initiation visit to train site personnel on protocols and administrative procedures. Then Dr. Octave is responsible to ensure adherence to protocols and conduct trial data monitoring. And finally, at the end of the study, she writes the clinical trial reports and works with the PIs on publications, if that was part of the agreement. Once the report is written, the product must be registered to be able to sell in the EU and the US. Regulatory specialists prepare the submissions, but the Clinical Scientist is a major contributor since they are the person who conducted the clinical trial.

In additional to the larger project team, Dr. Octave works with data managers, statisticians, lab techs & with regulatory officials. She manages a small team to coordinate the activities: the data manager pulls data, the statisticians review, lab techs train people to use instruments & help with technical issues and then they work with the regulatory officials to prepare documents. Dr. Octave’s role includes organizing the weekly team meetings and making sure all moving parts are moving forward.

As far as skills gained through her PhD and postdoc that she uses, and are required for her position:

• Effective written and verbal communication skills – extremely important: you are the point of contact between the clinical trial sites and the larger project team at the company
• Extensive collaboration and networking – need to be able to work with a variety of different people from different areas and backgrounds on a project
• Effective time management and prioritization
• Ability to relate to Principal Investigators and familiarity with academic institutions
• Ability to work with ethics committees and academic departments
• Ability to critically assess scientific literature
• Ability to design clinical studies

Additionally, Dr. Octave shared some of the lessons she learned along her career journey:

• Academia prepares you for A LOT more than being a PI
• It is ok to change your mind about what you want to do – but try to have a plan to pursue a new course. Everyone may not agree with your choice, but it’s your choice about what is best for you both personally and professionally.
• It’s great to have contacts in industry, but not required. Don’t be discouraged if you don’t have contacts within a company.
• Getting involved in activities outside the lab may present new career opportunities. It may enhance your abilities in the lab as well.

Dr. Octave wrapped up her presentation and then answered questions from attendees. Questions & conversations covered topics such as:

With no breaks in her timeline between undergrad, grad, postdoc and career, did you feel overwhelmed? Dr. Octave related that the schedule was fine, though at times within a position it was overwhelming. For Dr. Octave personally she was most overwhelmed during her time as an assistant professor. She was giving talks, doing research, writing grants, and trying to be a mom all at the same time. She found she was working all the time, and couldn’t spend enough time with her child, being a mom, which is why she decided to make a change. That schedule works for some people, but for her personally, it was not working, and she was not happy. Dr. Octave was also asked if she had regrets about leaving an assistant professor position, and she said no. Her whole career has had transitions from one thing to another, and she still feels like she’s involved in science and she also still works with academics. There may be things she misses occasionally, like benchwork, but she has no regrets, and she is extremely happy in her current position. As she said, academia prepares you for lots of things – don’t sell yourselves short!

Another person asked, when is the best time to move to industry – after PhD or after the postdoc? Dr. Octave answered that it depends on what you want to do. A postdoc position gives you more experience in writing usually, applying for grants and maybe more independent work and more experience; but that may or may not be needed for what you want to do, depends on the job description.

Another question asked about clinical “stepping stones” to get to a clinical career. Dr. Octave recommended collaborating with PIs doing clinical trials or shadowing a clinical research coordinator to see what they do. You could also ask to work with a PI who does clinical trials, or even look into a clinical research coordinator positions yourself. Another option is to work with the Institutional Review Board (IRB), some have internships available. And another idea is to take the NIH online course: Introduction to the Principles and Practice of Clinical Research (IPPCR).

Dr. Octave was also asked, what are next steps for her career? She replied, becoming an expert in her area (conducting the trials, being a resource for other departments) – expert is a level in her company, and then moving to a leadership position. Within bioMérieux there is the opportunity to move on to different things. She would like to get involved in project management, move further up the product development process to managing the whole process, the clinical scientists, quality engineers, etc.

Dr. Octave’s parting thoughts were: Think about what’s best for you and don’t think of leaving academia as a failure. It’s not a point of no return either, Dr. Octave was offered a position to come back to academia by one of her PIs. It’s always about building relationships. If people can see that you work hard and are good at what you do, you never know what opportunities lie ahead. You can go back and forth if you like.