Tag Archive for: Federal Drug Administration

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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Troy Tazbaz joins the FDA to lead the Digital Health Division and Center of Excellence

Former Oracle SVP, Troy Tazbaz will lead the effort to advance AI and ML for healthcare and help orchestrate a new regulatory environment for digital healthcare.

Life Science Partner announces the recruitment of the FDA’s new Division Director for Digital Health and Director for the Digital Health Center of Excellence to prepare the agency to partner with innovators and create regulatory guidance for the application of Artificial Intelligence within the convergence of healthcare IT and medical devices.

Formerly, the Senior Vice President, Industry Business Unit for Oracle, Troy Tazbaz will step into this new critical role created within the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health (CDRH).

Troy Tazbaz

“A thought-leader within the integrated world of cloud-based AI technology, Tazbaz is a thoughtful problem solver with a track record of successfully bridging multiple constituencies to accelerate AI adoption to improve efficiencies including patient care outcomes”

Tom Callaway, MD, Founder of Life Science Partner

Tazbaz will partner with a broad range of national and global government agencies, institutions, academia, and various organizations representing patients, consumers, and healthcare professionals. Tazbaz will be responsible for building the FDA’s key resources for establishing digital health guidelines and efficient regulatory pathways for the integration of digital and cloud-based technologies.

Tazbaz joins the FDA after recently serving as Senior Vice President of Strategy and Operations for Industry Business Unit responsible for developing Oracle’s industry-specific operating technologies. Earlier in his tenure at Oracle, he led various strategic initiatives such as global cloud data center expansion planning, developing Oracle’s industry strategy, and the launching of Healthcare Business Unit.  

Life Science Partner is pleased to continue their partnership with the Center for Devices and Radiological Health at the FDA on leadership projects underway for the Office of Product Evaluation and Quality.

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare information technology fields.

Learn More About Chief Medical or Regulatory Leaders

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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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 Kelly, MD, MBA as Deputy Director for Science to the FDA’s CDRH Office.

Since the creation of his role in August 2020, Dr. Kelly has already made a significant impact on improving FDA/innovator communication and accelerating patient access to high-quality, safe, and effective medical devices.

Doug Kelly, MD, Deputy Director for Science, FDA, CDRH
Doug Kelly, MD, Deputy Director for Science, FDA, CDRH

Dr. Kelly has been instrumental in partnering with top leaders from industry and academia to expedite the regulatory clearance process to assure consumer confidence and advance innovative technologies.

“Through his serial entrepreneurship experience, Dr. Kelly understands the regulatory pathway obstacles that innovators face.”

Tom Callaway, MD, Founder of Life Science Partner

In May 2022, Dr. Kelly spoke as the key note speaker at the AdvanSE Conference in Atlanta, GA where he presented CDRH’s role in the COVID-19 response, the future of the Medical Device User Fee Act and its introduction to TPLC TAP (Total Product Life Cycle Advisory Program); a new team of experts focused on providing strategic advice actively coordinated with FDA review teams and across the MedTech ecosystem.

Doug Kelly, MD, and Tom Callaway, MD, at AdvanSE 2022

Most recently, Life Science Partner recruited David McMullen, MD, to serve as Director, Office of Neurological and Physical Medicine Devices (OHT5) for the CDRH where Dr. McMullen is the technical authority and principal advisor for ninety individuals responsible for the total product life cycle (TPLC) review of neurological, neurointerventional and neurodiagnostics devices, as well as responsible for a separate group focused on neuromodulation and physical medicine devices.

“Co-leading The BRAIN Initiative at NIH, McMullen has demonstrated the leadership to oversee various multi-faceted programs simultaneously and evaluating cutting-edge technologies such as computer-brain interfaces.”

Tom Callaway, MD, Founder of Life Science Partner

McMullen’s team will oversee premarket evaluations, compliance and quality parameters, and surveillance programs for all neurological products and devices and be engaged in the decision-making process on device submissions, classifications, petitions, 501(k)s, PMAs, IDEs and all supplements and amendments to submissions.

Life Science Partner is pleased to have recruited Dr. Kelly and Dr. McMullen as transformative leaders contributing to the FDA CDRH ’s mission to accelerate the adoption of innovative technologies to improve the healthcare of patients.

David McMulen

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Medical or Regulatory Leaders

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:

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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 consumer confidence in devices marketed in the U.S.

David McMullen, MD

The Office of Health Technology 5 (OHT5) is within CDRH’s Office of Product Evaluation and Quality (OPEQ) and is responsible for the total product life cycle review of neurological and physical medicine devices.

As Director for OHT5, McMullen will serve as the technical authority and principal advisor to the OPEQ Director on the total product lifecycle of devices including premarket evaluation, compliance and quality, and surveillance programs for neurological products. 

Career Highlights and Contributions

Since 2016, McMullen has served as the Program Chief for the National Institute of Mental Health (NIMH) within the Neuromodulation and Neurostimulation Program, Division of Translational Research (DTR).

His oversight included device development and biomarker discovery grants as well as clinical trials ranging from first-in-human to critical studies designed to gain FDA regulatory approval. McMullen’s experience includes acting as co-leader for the NIH BRAIN Initiative team and as the NIMH point of contact to the FDA on devices.

“McMullen’s neurovascular and neurostimulation expertise combined with his working relationships within the FDA make him a natural fit for his new leadership role at the Office of Neurological and Physical Medicine Devices,” states Tom Callaway, MD, MBA, Founder of Life Science Partner.

In his new role at OHT5, McMullen will be tasked with navigating the complexities and multiple constituencies of the FDA’s neuroscience device regulatory division and industry agencies while managing a 90 plus person office.

McMullen earned his Bachelor of Science degree in Psychology and Neuroscience from Duke University and his Doctor of Medicine from Rutgers Robert Wood Johnson Medical School.

About Life Science Partner Executive Search

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies.

Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Medical or Regulatory Leaders

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:

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