Tag Archive for: Regulatory

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.

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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.

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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. 

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.

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David Ramsingh, MD Joins Edwards Lifesciences as Vice President, Clinical & Medical Affairs – Critical Care

Life Science Partner is pleased to announce the recruitment of David Ramsingh as Vice President, Clinical & Medical Affairs – Critical Care at Edwards Lifesciences.

Edwards is a global leader in patient-focused medical innovations. Recently, their Critical Care division has expanded its role in AI-supported predictive software solutions that allow ICU physicians to make better patient care decisions. In doing so, the team sought an integrative leader to oversee clinical research activities, including clinical trials, data management, and systems development to help with future product approval. An anesthesiologist and researcher in hemodynamic monitoring and echocardiology, Ramsingh has a combination of skills which positioned him for this opportunity.

David Ramsingh, MD

Ramsingh will direct multiple functions within clinical and medical affairs, oversee research activities around clinical trials, data management, and system development for future product approvals. In addition, he will oversee Edwards’ high standard of professional education through its Global Professional Development program.

Ramsingh possess valuable skills and experience, having come from Loma Linda University and University of California at Irvine, where he developed an innovative teaching program for anesthesiologists to apply whole-body, point-of-care ultrasound exams. At Loma Linda, his research focused on the use of ultrasound technology to improve perioperative care.

As the Director of Clinical Research and Perioperative Ultrasound at Loma Linda University Medical Center, Ramsingh spent most of his time leading a research team that he developed to focus on hemodynamic monitoring devices, partnering with corporate sponsors such as Edwards, Masimo, and General Electric. Ramsingh earned his medical degree from the Medical College of Georgia. He completed his residency in anesthesiology at Loma Linda University, and he was a cardiothoracic fellow at the University of California in Los Angeles.

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.

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Doug Kelly, MD, MBA Joins FDA’s Center for Devices & Radiological Health as Deputy Director for Science

Life Science Partner is pleased to announce the recruitment of Doug Kelly, MD, MBA as Deputy Director for Science to the Food and Drug Administration’s Center for Devices and Radiological Health (FDA, CDRH).

FDA, CDRH is responsible for protecting and promoting public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. They provide the community with accessible science-based information about the products they oversee and facilitate medical device innovation by advancing regulatory science.

Doug Kelly, MD, MBA

The CDRH also provides industry with predictable, consistent, and transparent regulatory pathways to assure consumer confidence in the devices marketed in the United States.

With the tremendous advancements in technology and a new age for telemedicine and remote patient monitoring, the CDRH is also focusing on advancing their field of digital health. Housed within the CDRH is the Office of Strategic Partnerships and Technological Innovation. This unit provides leadership for all scientific collaborative and emerging technology, including the new division of Digital Health, which focuses on providing leadership and oversight in the development, review, and implementation of new software services that are aimed at healthcare.

Doug Kelly is a leader in the field of innovative medical technologies. After earning his medical degree from Albert Einstein College of Medicine and his MBA from Stanford University, Kelly was one of the founding members of Ligand Pharmaceuticals, where he served as the Manager of Business Development and helped recruit their Scientific Advisory Board and manage relationships with corporate partners. In 1996, he helped create a new venture fund, Alloy Ventures, and identified new opportunities for investments in seed- and later-stage medical device, drug discovery, biotechnology and healthcare IT companies.

Dr. Kelly will play a critical, external-facing role for the CDRH and the Office of Strategic Partnerships and Technological Innovation by collaborating with leaders in industry, academia, and healthcare innovation, leveraging his wealth of experience in the medical device investment community.

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.

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Nora York Joins Canary Medical as Senior Director, Regulatory & Quality Assurance

Life Science Partner is pleased to announce the recruitment of Nora York to join Canary Medical as Senior Director of Regulatory & Quality Assurance.

Canary Medical is an innovative medical technology company commercializing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to generate real-time insights about the performance and safety of these products.

York will be responsible for developing Canary’s regulatory strategy in concert with the other leaders of the team. Her role will involve implementation, oversight, and maintenance of Canary’s regulatory affairs organization.

Nora York

Before joining Canary, York was the Director of Regulatory Affairs & Quality Assurance for SynergEyes, an advanced technology specialist company for hybrid contact lenses. She also spent two years as the Head of Regulatory Affairs for Philips Volcano Corporation in San Diego, where she was in charge of the development and execution of regulatory strategy and submission of several 510(k) applications for the company’s Image-Guided Therapy systems.

“York is a proven performer in quality and regulatory circles in Southern California” notes Tom Callaway, President of Life Science Partner. “Her recruitment to this emerging team will ensure the processes and rigor required in innovative implantable devices.”

York earned her bachelor’s degree in Biology at the University of Texas in Dallas.

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.

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Rosalind Fabunmi, PhD Joins Edwards Lifesciences as Senior Director, Medical Affairs

Life Science Partner is pleased to announce the recruitment of Rosalind Fabunmi, PhD as Senior Director, Medical Affairs with Edwards Lifesciences.

Edwards is committed to focusing on the patient journey from diagnosis to treatment to lifetime outcome, and Fabunmi has a rare combination of skills and experiences which make her highly qualified for her new role. With compelling data on the high individual and societal costs of valvular disease, Edwards is seeking to address the significant unmet need for care.

Rosalind Fabunmi, PhD

Fabunmi will lead Edwards’ evidence development and publication strategy in order to call attention to the prevalence and costs of valvular disease. Importantly, she will also serve as the public face of the company on these issues, engaging key opinion leaders to address the broad lack of awareness.

Fabunmi joins Edwards already possessing subject matter expertise in structural heart disease. Earlier in her career, she served in medical affairs roles for transcatheter aortic valve replacement technologies with Medtronic. Notably, she has also served in medical affairs roles in the pharmaceutical industry, working on heart failure products with Merck and Amylin Pharmaceuticals.

Most recently, Fabunmi served as Senior Director, Medical Affairs with the diabetes company Zafgen. The pharmaceutical industry has blazed the trail on burden of disease data and its use, so Fabunmi’s combination of medical device and pharmaceutical experience in Edwards’ disease space makes her exceptionally qualified for this role. In a career primarily focused on medical affairs, Fabunmi’s experience also encompasses health economics and outcomes research, rendering her almost unique in terms of the skills she brings to Edwards.

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.

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Dave Booth Joins Be The Match as Vice President of Quality Assurance and Regulatory Affairs

Life Science Partner is pleased to announce the recruitment of Dave Booth as Vice President of Quality Assurance and Regulatory Affairs with Be The Match.

Booth is a seasoned quality executive with a broad background in building and leading global quality teams within the medical device industry. At Smiths Medical, Booth was Head of Quality for the Infusion Systems Business Unit, responsible for both Pre-market and Post-market Quality, overseeing customer-facing quality concerns, and establishing a new product quality leadership function.

Dave Booth

At Greatbatch Medical, he created new processes and an organization for Design Assurance and Product Monitoring for their Orthopedic business. Previously, Booth led the Quality Systems and Compliance organization within Medtronic’s Cardiac Disease Rhythm Management business.

Booth understands how to build and lead a quality organization and to prepare a company to enter a new regulatory environment. Throughout his career, Booth has overseen teams ranging from small post-market groups to large, multi-site Operations Quality teams. Trained as a statistician, Booth often approaches problem solving by applying his analytical skills in conjunction with insights stemming from his extensive experience in the industry.

Booth will play a pivotal role in helping Be The Match during its next stage of growth and development. The organization is best known as the world’s largest provider of unrelated matched bone marrow donors for life-saving therapies. As allogenic-derived cell therapies are revolutionizing the treatment of cancer and genetic illnesses,

Be The Match is preparing to become the preferred supplier of hematopoietic cells to enable these therapies. Booth’s leadership skills and his years of experience managing interactions with the FDA render him well-suited to prepare Be The Match for the regulatory rigors of FDA oversight they will face as they move into the cell therapy space.

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.

Press Release PDF

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Chris Fang joins Humacyte as Chief Medical Officer (CMO)

Life Science Partner is pleased to announce the recruitment of Chris Fang, MD, MBA, MHSc as Chief Medical Officer of Humacyte.

Fang’s expertise in biologics and medical devices will be an invaluable asset for Humacyte, a pioneering regenerative medicine company. Humacyte’s lab-grown, acellular blood vessels have been awarded FDA fast-track status for their use in dialysis grafts. The company is launching a series of trials to demonstrate their efficacy in general vascular repair/replacement, including in coronary, peripheral, and saphenous veins.

With a strong background in clinical trials, health economics and product development, Fang will spearhead Humacyte’s pursuit of additional indications for their flagship product, HUMACYL®.

Chris Fang

Fang has over twenty years of experience as a physician leader in the medical device and pharmaceutical industries. Prior to joining Humacyte, Fang founded Amaris Partners, an international consultancy which facilitated investment from principally Asia-based partners into U.S.-based companies that develop and implement novel medical technologies.

Before founding Amaris, Fang served as a Board Member and Worldwide Vice President, Strategic Medical Affairs and Medical Sciences for Johnson & Johnson DePuy for the Asia Pacific Region. In this role, Fang managed the clinical evidence strategy and product safety worldwide with responsibilities for new product development, reimbursement and business development.

Fang also served as the Medical Adviser to the Regenerative Medicine Business Unit and chaired the Worldwide Pipeline Committee responsible for the approval of investigator-initiated studies.

“Fang has a broad understanding of clinical trial management and development in pharmaceuticals, medical devices and regenerative medicine, combined with deep expertise in the regulatory approval process” notes Tom Callaway, MD, MBA, Founder of Life Science Partner. “His experience working in the Asian Pacific region will also be an asset to Humacyte as the company expands into these markets.”

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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Chie Iwaishi Joins Edwards Lifesciences as Vice President, International Regulatory & Clinical Affairs

Life Science Partner is pleased to announce the recruitment of Chie Iwaishi to Edwards Lifesciences (NYSE:EW) as Vice President, International Regulatory and Clinical Affairs, where she will lead the expansion of this Irvine-based company in the Japan and Asia-Pacific region.

Iwaishi’s three decades of leadership in regulatory and clinical affairs will be an invaluable asset for Edwards Lifesciences, a global leader in in patient-focused medical innovations for structural heart disease, critical care and surgical monitoring. The company’s heart valve offerings encompass both surgical and transcatheter therapies for heart valve replacement and repair.

Chie Iwaishi

In addition, Edwards’ pipeline of future technologies is focused on the less invasive repair or replacement of the mitral and tricuspid valves of the heart, which are more complex and more challenging to treat than the aortic valve that is currently the focus of many of the commercially approved valve technologies.

Iwaishi is a distinguished expert in regulatory and clinical affairs, with particular expertise in Japan, China, and the broader Asia-Pacific region. She possesses keen knowledge of the regulatory and cultural paradigms, launched the first drug eluting stent in China, and has considerable senior global leadership experience and business acumen. In her new role, she will spearhead Edwards Lifesciences’ regulatory and clinical programs in Asia, which the company has identified as a key strategic initiative.

“Iwaishi’s deep understanding of regulatory affairs, with many successful PMAs and 510ks, and her well-practiced leadership of large globally-dispersed teams will be a tremendous asset to Edwards Lifesciences as they continue to expand on a global stage,” notes Tom Callaway, President and Founder of Life Science Partner.

Iwaishi joins Edwards Lifesciences from Abbott (formerly Alere Inc.), a rapid point-of-care diagnostic tests manufacturer, where she served as Vice President, Regulatory Affairs Asia Pacific and led their global strategy development and regulatory compliance in Japan, China, Korea and India. She also led the regulatory diligence for Alere’s $1.3 billion acquisition. Earlier in her career, Iwaishi served in regulatory affairs roles of escalating responsibility, working primarily with Class II and Class III medical devices in the cardiovascular space.

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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