The addition of four new team members with specific technical expertise and patient-centric backgrounds will advance partnerships on end-to-end drug R&D

“From our earliest days as a company, we’ve aimed to have an outsized impact on our collaborators’ success — whether focused on discovering novel kinds of targets like RNA-binding proteins or developing drugs for patients in dire need of effective medicines,” said Rafael Rosengarten, Ph.D., chief executive officer of Genialis. “Now, we are most excited about using our biomarker platform to help bridge from successful early discovery to translational evidence to improved clinical outcomes. We share in our customers’ commitment to finding new opportunities to treat complex diseases that today have painfully few options.”

To aid in this effort, Mojca Valjavec has joined Genialis to lead its compliance & regulatory efforts. Mojca brings decades of experience in diagnostics regulatory & compliance including a focus on software as a medical device (SaMD). Prior to joining Genialis, she worked on regulatory affairs for various European-based biotechs. Already this Spring, Mojca helped Genialis in its successful campaign for ISO 27001 recertification by an independent certification body. This continues Genialis’ strong record of compliance to this important global standard for the past 3 years and sets the stage for certifications for additional standards around quality, software, and other processes critical to the company’s mission.

“AI within SaMD is on the bleeding edge of clinical data science, especially from a regulatory perspective. It is critical that we all, as a community, get this right,” said Valjavec. “The regulations should foster innovation but maintain our responsibilities to patient well-being.”

To bolster its support of clinical biomarker collaborations, Genialis has added two domain experts to its team of applied scientists and alliance managers. Daniel Pointing draws on a unique combination of expertise in oncology clinical trials, AI & data science, and commercialization of diagnostic solutions, to help lead alliances that incorporate the company’s platform. His appointment represents a redoubled commitment to building lasting partnerships in the industry and his main responsibility will be helping Genialis’ partners identify clinical development challenges to solve together and to implement and adopt AI-enabled solutions.

“Articulating a precision medicine strategy requires a wide range of expertise and deep understanding of the various challenges and pitfalls of drug development, with and without biomarker guidance. I am energized by the opportunity to help our partners to design and implement precision medicine strategies, and to ensure Genialis supports their pipelines from inception to market with our biomarker platform,” said Pointing.

Meanwhile, Sukhi Singh, Ph.D., brings to bear his passion and commitment to FAIR (Findable Accessible Interoperable Reproducible) data standards and research data management IT systems, underscoring Genialis’ commitment to providing its partners with scalable data solutions and actionable results. Top KOLs in the data science/ healthcare AI field agree that FAIR guidelines are essential to building world-class data science operations. Sukhi’s attention will focus both on external-facing collaborations and on internal R&D to ensure Genialis’ proprietary biomarker development programs are executed using state of the art bioinformatics and data science best practices.

“Biomarker development entails the analysis of data generated across the life cycle of drug R&D and in real-world settings. Analysis of this data is most likely to succeed when the data themselves are optimally handled. FAIR guidelines ensure that data are processed and organized in such a way to enable the best possible data science outcomes with human and machine-actionable insights,” said Dr. Singh.

Finally, with the end goal of improving outcomes for patients, Robyn Schlicher, Ph.D., has joined Genialis as Director of Business Development & Strategy. Robyn brings over a decade of experience in commercializing precision medicine products and deep experience working on cancer biomarkers. She worked previously on one of the industry’s most defining precision medicine diagnostics, supporting Abbott’s PathVysion HER-2 test at clinical sites. She was also instrumental in launching Natera’s Signatera personalized oncology platform.

“I have built my career and my life around essentially ‘growing up’ with the potential of personalized medicine, from the inception of targeted drug delivery to the development of technologies that study and transform disease at the molecular level. My lifelong commitment to creating solutions for improving the quality of life for all patients and to providing access to individualized treatment options connects me deeply with the company’s mission to find a unique solution for each patient’s unique condition. My years of supporting patients across multiple disease indications has given me the empathy necessary to define, develop and bring to market the transformational products that Genialis builds.”

Read the press release in its entirety here.

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