Gisela joined Oncocyte in October 2021 as the firm’s Chief Operating Officer and was promoted to President and Chief Operating Officer in August 2022. She brings a wealth of knowledge and first-hand experience, leading large-scale operations at global pharmaceutical and diagnostics companies.
Having spent over a decade at Roche-Genentech, her roles included compliance operations, sales and marketing, product development and strategy, and finance, culminating as Senior Vice President and Global Head of Clinical Operations. At Roche-Genentech, Gisela led over 3,000 employees located in over 60 countries, driving drug-development innovation while focusing on R&D productivity across over 400 late-stage and post-approval evidence-generation clinical trials with nearly 100,000 patients. In addition, she managed and facilitated patient access and support services for the full Genentech portfolio.
“I have a big passion for how we can really support patients getting access to care. And if you lead with that interest in mind, the rest will follow.”
Gisela joined Oncocyte most recently from the role as General Manager, Precision Oncology at Exact Sciences, where she oversaw the merger integration of Genomic Health and the OncotypeDX® portfolio and the commercial launch of OncotypeMAP™, as well as business development and pipeline strategy for future assays and technologies in next generation sequencing, liquid, and minimal residual disease.
“The patient continuum intrigues me. Am I predisposed to cancer? Do I have cancer, and if so, what is the best treatment option? What is my risk of recurrence? What’s exciting about Oncocyte is that we have a portfolio. It’s innovative and can answer some of these questions in a targeted, precise way.”
At Oncocyte, Gisela will oversee all operational aspects of the Company’s product portfolio, including the pending launches of VitaGraft™ for liver and kidney transplant rejection monitoring and gaining reimbursement and the launch of DetermaIO™, DetermaTx™, and DetermaCNI™.
Gisela was named the 100 Most Inspiring People in the Life-Sciences Industry by PharmaVOICE in 2019. What she finds most exciting about Oncocyte is their ability to move quickly, be agile, and exact real change for patients. Gisela has extensive experience at larger organizations like Roche/Genentech and Exact Science, where she focused on operational excellence and global change management to drive commercial and drug development innovation. She has extensive experience implementing processes to build, transform, and grow resilient businesses. Oncocyte expects to benefit from these learnings as the Company transitions into a commercial organization.
“We can be bold! We can move fast! Large organizations can over-engineer and get bogged down by red tape. I’m excited to be part of an organization where we can put the right balance of governance and structure in place, but we can be agile, we can iterate, and really have a positive impact on patients.”
Gisela believes that the changing regulatory landscape in the diagnostic market creates a substantial opportunity for Oncocyte. She expects increased FDA oversight as emerging biomarker technologies and personalized medicine that have significant patient impact continue but believes that a diverse LDT business backed by strong clinical data represents a significant near-term opportunity for the Company. Longer-term, she aims to steer Oncocyte towards more effective and efficient ways to gain regulatory clearance or approvals for the Company’s core products.
Gisela does not see compliance and regulation as a burden but more as an opportunity for a nimble player like Oncocyte to outpace slower-moving competitors.
"The paradigm is shifting; technology is moving quickly. Pharma and biotechs are realizing they need biomarkers and companion diagnostics to expand their markets through more precise treatments leading to better outcomes. The mindset towards partnerships is changing. We are well-positioned to take advantage of several emerging trends.”
Oncocyte is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.
Forward-Looking Statements
Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
