Tag Archive for: Diagnostics and Research

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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Heather Creran Joins Lineagen as Chief Operating Officer (CEO)

Life Science Partner has recruited Heather Creran to become the Chief Operating Officer for Lineagen, an innovative genetics diagnostics company for neurodevelopmental disorders.

Creran’s depth of operational leadership experience will be a great asset for Lineagen, whose painless cheek swab test can detect hundreds of genetic conditions which can give rise to developmental delay and autism spectrum disorder. Lineagen’s test results are customized to help patients, parents and providers fully understand diagnoses and develop a healthcare management program which is tailored to the individual patient’s needs.

Heather Creran

“Throughout her career, Creran has demonstrated a knack for strategic thinking and operational success,” emphasized Tom Callaway, President and Founder of Life Science Partner. Creran comes to Lineagen with extensive experience in highly relevant leadership roles. Most recently, she served as President and Board Director for Emory Genetics Laboratory, a joint venture between Emory University and the US Clinical Diagnostics Division of Eurofins Scientific, an international provider of bioanalytical testing and genomics services. Also of note is Creran’s experience as President and CEO of the cancer diagnostics company SCI Laboratories.

Creran looks forward to leveraging her passion for operational excellence to pursue accelerating growth and success at Lineagen.

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 as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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Fred Siebert Joins Beckman Coulter as Director, Global Clinical Affairs

Life Science Partner is pleased to announce the recruitment of Fred Siebert to Beckman Coulter as Director, Global Clinical Affairs. Beckman Coulter is an innovative diagnostics and life science company that creates the world’s most efficient diagnostic laboratories. It is part of the Danaher group of families.

In this new role, Siebert will be responsible for the development and execution of a consolidated global clinical trials strategy for the company. This work is of particular importance to the company in the context of changing European regulatory requirements and continued growth of the company’s clinical activities in Asia.

Siebert brings deep experience in global clinical trials for molecular diagnostics and biopharmaceuticals, most recently at OvaScience, where he oversaw their clinical programs as Vice President of Clinical Operations.

Earlier in his career, Siebert held a variety of clinical affairs leadership roles at Abbott Molecular, where he led the company’s first companion diagnostics partnership and earned the Abbot Chairman’s Award for his contributions.

“Fred in in a great position to leverage his clinical insights and global diagnostics experience to further Beckman Coulter’s global leadership in IVD,“ notes Tom Callaway, MD, President and Founding Partner at Life Science Partner. “We look forward to seeing the continued growth and geographical expansion of the company’s clinical programs under his able leadership.”

Siebert earned a BSc in Medical Technology  from Eastern Kentucky University.

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 as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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Leica Biosystems Recruits Dan Schrock to Senior Director, Global Clinical Affairs

Life Science Partner is pleased to announce the recruitment of Dan Schrock to Leica Biosystems to serve as Senior Director, Global Clinical Affairs.

Leica Biosystems is a global leader in clinical diagnostics technologies providing a full suite of anatomic pathology products and laboratory workflow solutions for cancer diagnostics. Utilizing this platform, the company provides customized companion diagnostics solutions for pharmaceutical companies developing novel oncology drugs. Leica Biosystems is part of the Danaher group of companies.

Schrock previously served as Sr. Manager, Alliances with Illumina in San Diego, where he was responsible for managing corporate partnerships for the development of companion diagnostics for oncology drugs. Prior, Schrock led clinical affairs programs in IVD and CDx with Ventana Medical Systems, Abbott Laboratories, and Cepheid.

In his new role, Schrock will be responsible for overseeing Leica’s clinical research programs, providing strategic leadership to the company’s evolving clinical affairs function, and managing partnerships with pharmaceutical companies for the continued development and testing of companion diagnostics for personalized medicine.

“Companion diagnostics development is core to the Leica’s clinical strategy, so this leader must have a solid grounding in not only clinical trials leadership, but also diagnostics development and pharmaceutical partnering. It’s quite rare to see this combination of clinical trials excellence and CDx expertise in the same individual,” noted Tom Callaway, MD, MBA, President of Life Science Partner. “Dan is ideally suited for this important role and we expect him to be an asset to the company for many years to come.”

Schrock is a chemist by training and earned his Bachelors and Masters degrees in Chemistry from Illinois State University.

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 as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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Frank Stokes Joins Castle Biosciences as Chief Financial Officer

Life Science Partner is pleased to announce the recruitment of Frank Stokes to Castle Biosciences as Chief Financial Officer.

Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible decisions about their treatment and follow up care based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma and uveal melanoma, with development programs in other underserved cancers.

Frank Stokes CFO Castle Biosciences

Stokes previously served as Chief Financial Officer for Hammock Pharmaceuticals, maker of therapies for women’s health and urology. Prior, he was a senior investment banker at Leerink Swan, where he focused principally on diagnostics and biopharmaceuticals.

“Frank brings financial acumen, expertise in capital markets, success with mergers and acquisitions, and a deep knowledge of the diagnostics industry—all of which will help our team continue our mission to improve patient care decisions and deliver shareholder value,” commented Derek Maetzold, President and CEO of Castle Biosciences.

“With two commercial products, a robust pipeline, and a strong base of clinical data, Castle Biosciences is well-positioned to leverage his strengths as we target our combined U.S. market opportunity of nearly $2 billion and continue to deliver strong growth in revenue and test volumes.”

Stokes received a B.S. in business administration followed by MBA and J.D. degrees from the University of North Carolina at Chapel Hill.

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 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 Our CFO Recruitment
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Francis Ota, MBA, Joins Lineagen as Chief Financial Officer

Former Executive Vice President, Finance MDxHealth

Life Science Partner recruited Francis Ota to become the Chief Financial Officer at Lineagen, an innovative genetics diagnostics company for neurodevelopmental disorders. Ota joins Lineagen after serving as the Executive Vice President of Finance for MDxHealth, a publically owned Belgium based diagnostic company with a US CLIA lab that develops epigenetic tests for cancer assessments.

During his tenure at MDxHealth, Ota played a key role in generating profitable growth, raising capital and negotiating M&A transactions. Earlier in his career he held financial leadership roles at Focus Diagnostics (acquired by Quest), QUAD Research, and Medtronic among others.

“As a global leader in finance, Ota has overseen the financial management of a CLIA laboratory from rapid growth through exit via acquisition,” states Tom Callaway, MD, President of Life Science Partner. “With his solid understanding of the reimbursement and revenue management challenges of a CLIA lab, Ota will serve as a critical member of Lineagen’s leadership team.”

Ota earned his Bachelor of Science Degree in Finance and International Business from the University of Colorado and his MBA from the University of California.

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Judi Jaeger Joins Beckman Coulter as Director, Global Clinical Affairs

Former Vice President, Clinical Affairs at Elixir Medical

Life Science Partner has recruited Judi Jaeger to become Director, Global Clinical Affairs at Beckman Coulter reporting to Kim Oleson, Vice President of Clinical Affairs for Danaher’s Life Sciences and Diagnostics Platform.

“With first-hand leadership experience in the clinical development of two world-leading Class III devices and the ability to build and lead global teams, Jaeger’s scientific background in complex technologies and the regulatory intricacies will set her up to thrive and deliver at Beckman Coulter,” states Tom Callaway, MD, President and Founder of Life Science Partner.

During her clinical career, Jaeger was a critical part of Medtronic’s clinical team’s success in getting the Resolute product approved globally as well serving as key role for the worldwide approval of Johnson & Johnson/Cordis’ Cypher coated stent.

Jaeger earned her Bachelor of Arts Degree as a Psychology Major from Rutgers University in 1986.

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Conner Childers, JD, Joins Beckman Coulter as Vice President, Head of Global Compliance

Former Healthcare Compliance Policy Director at Amgen

Life Science Partner partnered with Beckman Coulter to recruit Conner Childers, JD, to serve as Vice President, Head of Global Compliance for Beckman Coulter.  He will report to Curt Brueske, JD, General Counsel.

In his most recent role at Amgen, Childers had direct responsibility for building the compliance program so that the company was prepared to respond to the company’s first Corporate Integrity Agreement.  Working across Amgen’s U.S. operations, Childers recruited and led a team that made compliance part of the corporate commercial objectives.

“With his Amgen experience in building new compliance programs in partnership with business units, Childers has the right balance of leadership and influence to build an effective Beckman Coulter compliance organization,” states Tom Callaway, MD, Founder and President of Life Science Partner. “His legal and organizational background including a career as a Naval Officer have given him the skills and ability to build and lead world class teams.”

Childers earned his Bachelor of Arts Degree in Government from Claremont McKenna College and his Juris Doctorate from the University of Arizona, College of Law.

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Susan Blank Joins BioConfirm Laboratories as Chief Medical Officer

Founder and Chief Medical Officer of Atlanta Healing Center and President of the Georgia Society of Addiction Medicine

Life Science Partner is pleased to announce the recruitment of Susan Blank, MD, Founder and Chief Medical Officer for the Atlanta Healing Center to become the Chief Medical Officer for BioConfirm Laboratories-a new company based in Atlanta committed to providing personalized physician-led solutions and services for patients and clinicians surrounding addiction and substance abuse.

With her entire career focused on the treatment of addiction and behavioral health with a true passion for healing through comprehensive programs, Life Science Partner identified Blank as a key expert for establishing the therapy platform at BioConfirm.

As an active expert and advocate for addiction recovery, Blank can be heard nationwide every Tuesday on her weekly radio show “Detailing Addiction” on America’s Web Radio. “Her passion, enthusiasm, and in depth knowledge of comprehensive addiction therapy will be a major asset to BioConfirm’s growth,” states Tom Callaway, President and Founder of Life Science Partner.

Blank earned her Bachelor of Arts degree in Psychology from Augusta College and she completed her MD from the Medical College of Georgia.

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