Tag Archive for: OHT7

Suso Platero, PhD, to become Division Director of Molecular Genetics and Pathology at the FDA’s Office of Health Technology 7

Life Science Partner has recruited Suso Platero, PhD, to become Division Director of Molecular Genetics and Pathology at the FDA’s Office of Health Technology 7 (OHT7).

In this role, Dr. Platero will oversee the regulatory evaluation of molecular diagnostic products and companion diagnostics, ensuring rigorous scientific and regulatory standards are applied to cutting-edge innovations in oncology, immuno-oncology, and rare diseases. 

Suso Platero, PhD

In this role, Dr. Platero will oversee the regulatory evaluation of molecular diagnostic products and companion diagnostics, ensuring rigorous scientific and regulatory standards are applied to cutting-edge innovations in oncology, immuno-oncology, and rare diseases. 

Platero has over twenty years of experience in drug discovery, diagnostics, and precision medicine. As the former Chief Scientific officer at Discovery Life Sciences and Vice President of Biomarkers and Companion Diagnostics at Vertex Pharmaceuticals, he developed biomarker-driven strategies to support clinical trials and regulatory submissions.   

Career Highlights and Contributions

Platero has over twenty years of experience in drug discovery, diagnostics, and precision medicine.

As the former Chief Scientific officer at Discovery Life Sciences and Vice President of Biomarkers and Companion Diagnostics at Vertex Pharmaceuticals, he developed biomarker-driven strategies to support clinical trials and regulatory submissions.   

Platero has always been on the cutting edge of developing companion diagnostics. At Janssen Pharmaceuticals, he led the team that discovered and developed the companion diagnostic for Balversa©, approved by the FDA. 

At LabCorp and Covance, Dr. Platero created and headed the Biomarker Solutions Center, where he led a team responsible for developing and commercializing companion diagnostics for global regulatory approval. 

“Platero joins a team of leaders that we have recruited for FDA oversight of this rapidly changing field of IVD diagnostics,” notes Tom Callaway, MD, MBA, Founder of Life Science Partner.  “Throughout his career, Dr. Platero has collaborated with key opinion leaders and regulatory agencies to accelerate the development of precision medicine approaches in oncology and immunology.”

Dr. Platero holds a PhD in Cell and Molecular Biology from St. Louis University, where he focused on the functional analysis of chromatin domains in eukaryotic cells. He also earned a Master of Science in Cell Biology and Molecular Biophysics from Columbia University and a Bachelor of Science in Chemistry and Microbiology from the University of Pittsburgh.

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

FDA Regulatory Leadership For Medtech/IT Convergence

Life Science Partner has partnered with the FDA to recruit leaders that can create innovative pathways for early-stage companies to be better prepared for the regulatory review and clearance process. In close collaboration with Jeff Shuren, MD, JD, Head of the Center for Devices and Radiological Health (CDRH) for the FDA, Life Science Partner recruited Doug…

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Christine Vietz to become Deputy Office Director, Personalized Medicine | FDA

Life Science Partner has recruited Christine Vietz, PhD, formerly Senior Vice President of Product Development at Foundation Medicine, to become the Deputy Office Director, Personalized Medicine, for the FDA’s CDRH OHT 7 (In Vitro Diagnostics).

Vietz will oversee the 60+ person Division of Molecular Genetics and Pathology, and will continue to build out the emerging organization of regulatory scientists  comprising the Personalized Medicine Team.

As the leader of the Personalized Medicine Team, she will also serve as a liaison to the medical device industry, as well as to the scientific and healthcare communities for personalized medicine related issues.

Christine Vietz, PhD FDA

Under Vietz’s leadership, OHT7 seeks to grow its expertise in genetically based disease diagnosis and identification of targets for therapeutic intervention.

Vietz has over 20 years of leadership experience across diagnostic assay development, regulatory affairs, and clinical laboratory operations. 

Under Vietz’s leadership, OHT7 seeks to grow its expertise in genetically based disease diagnosis and identification of targets for therapeutic intervention. Vietz has over 20 years of leadership experience across diagnostic assay development, regulatory affairs, and clinical laboratory operations. 

Career Highlights and Contributions

Before joining the FDA, Dr. Vietz served as Senior Vice President of Product Development at Foundation Medicine. Her leadership enabled the company to achieve multiple industry firsts, including securing FDA approval for the FoundationOne CDx pan-tumor comprehensive genomic profiling assay under the Breakthrough Devices Program.

During her tenure at Foundation Medicine, she developed the regulatory strategy and built the diagnostic development teams that continued to expand Foundation Medicine’s IVD portfolio with approval of the liquid biopsy assay, FoundationOne Liquid CDx, as well as the many subsequent companion diagnostic claims added to the approved assays over the subsequent years. 

“Christine stands out in her extraordinary ability to bring cutting-edge diagnostics tied to biopharmaceuticals development through the regulatory process,” said Tom Callaway, MD, founder of Life Science Partner. “Patients will have better outcomes thanks to the FDA’s forward-thinking, particularly in this era of AI and personalized therapeutics.“

Vietz earned her PhD in Biomedical and Medical Engineering and her Bachelor of Science in Chemical Engineering from the University of Rochester. Vietz’s commitment to innovation, regulatory excellence, and operational efficiency makes her uniquely suited for her new leadership role at the FDA.

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

David McMullen, MD, Recruited as Director, Office of Neurological and Physical Medicine Devices (OHT5), FDA Center for Devices and Radiological Health (CDRH)

Life Science Partner has recruited David McMullen, MD, to serve as Director for The Office of Neurological and Physical Medicine Devices (OHT5), Center for Devices and Radiological Health (CDRH) at the Federal Drug Administration.  The CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring…

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