Tag Archive for: Chief Scientist

Life Science Partner announces the newest recruit for emerging CDMO:

Wheeler Bio, a CDMO, retained Life Science Partner to recruit their Chief Development Officer to lead their process development team and accelerate their platform as a technological leader within the CDMO space. Beginning in January 2023, Brian Berquist, PhD, will lead the team in Wheeler Bio’s newstate-of-the-art Oklahoma City facility, where they have revolutionized the speed of drug discovery and democratized the innovation-to-impact process.

Brian Berquist

Berquist’s solid scientific background and ability to problem-solve in an entrepreneurial environment makes him well-suited for the R&D and innovation advancements he will undertake at Wheeler Bio.

Tom Callaway, MD, Founder of Life Science Partner

In his new role as Chief Development Officer, Berquist will oversee operations including cell line development, cell culture process development, purification development, analytical development, and formulation development. He will serve as Wheeler Bio’s scientific subject-matter expert and will lead his team in the continuous improvement of advancing the company’s R&D and technology platforms.

Prior to joining Wheeler Bio, Berquist served as the Vice President of Process Development and Analytical Sciences for iBio CDMO where he directed the process development and analytical sciences divisions for both development and characterization of proprietary products and services. Earlier in his career, Berquist served in key scientific and research roles for Caliber Biotherapeutics and Texas A&M Health Science Center.

Berquist holds a Bachelor of Science degree in Biochemistry and Molecular Biology from the University of Massachusetts, and he earned his PhD in Molecular Medicine and Molecular and Cellular Biology from the University of Maryland.

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.

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.

Read More About Life Science Partner’s Recruitment for 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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Life Science Partner is pleased to announce the recruitment of Chris Elliot to Tier One, where he will be a part of a team of professional design engineers as a Senior Embedded Software Engineer.

Tier One is an engineering design firm consisting of top-tier, professional engineers with exceptional talent. The group provides solutions in product development for custom software and electronics. They have developed their credibility in the industry with their streamlined process in bringing products to market.

Chris Elliot

By having a diverse range of engineers who are highly proficient in their specialty, Tier One is able to fulfill a wide variety of market needs and solve problems quickly.

Elliot will be responsible for creating custom software solutions that target embedded devices for clients. His expertise will be critical for providing technical advice and guidance to internal and external teams, and he will be an integral member of a complete engineering team at Tier One.

Among some of his many notable accomplishments and past careers, Elliot started his own consulting group to design and develop website architecture and solve unique software, firmware, and hardware problems. He also worked for the Weather Channel, where he developed video and audio platforms for the company’s broadcasting services. Previously, he was a Software Task lead for Georgia Tech Research Institute, where he was responsible for software and systems engineering projects for the Department of Defense.

With the recruitment of Elliot to Tier One, the company will be able to meet the needs of their clients and continue to provide exceptional service. Elliot brings a wealth of knowledge and experience to the team, and his role will synergize well with the senior engineers.

Chris Elliot earned his Bachelor of Science, in Electrical Engineering from Georgia Institute of Technology.

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 scientists enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Canary Research and Development Team

­­Life Science Partner is pleased to announce the successful placements of Canary Medical’s Senior Research & Development team.

Canary Medical is an innovative MedTech company modernizing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to remotely gather biometric data and transmit it back to physicians via the cloud to give real-time insights about the performance and safety of these products.

Partnering with Canary at its very inception, Life Science Partner recruited Chief Technology Officer Jeff Gross, VP of Technology Development Mark Phelps, VP of Research and Development Peter Schiller, VP of Operations Balakrishnan Shankar, and Senior Director of Regulatory Affairs & Quality Assurance Nora York. In turn, we worked with these leaders to recruit their technical teams who have been superstars in the fields of electronics, medical devices, and cloud software. These 7 talented, senior R&D engineers will help propel the company’s platform in telemedicine and medical devices.

The recruitment of Lan Herrington as Senior Quality Manager, Luis Dogue as Manager of Data Software, Kevin Gemmell as Senior Biomedical Engineer, David Mejia as Senior Manufacturing Engineer, Matthew Sturtevant as Senior Electromechanical Engineer, Ryan Peck as Senior Quality Engineer, and Reghu Rajan, MBA as Senior Systems Engineer will drive Canary Medical toward commercialization while pursuing their technology’s vast array of potential applications beyond the orthopedic space. They each bring to the company a track record of success and a combined expertise in the orthopedic and cardiovascular space with a broad range of experience from the medical device, healthcare, and information technology industries.

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.

Life Science Partner is pleased to announce the recruitment of Mark Adler, MBA to Canary Medical, where he will serve as Vice President of Product Development.

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.

Canary Medical logo

Adler will be driving further miniaturization and reduction of power for Canary’s implantable technology, advancing commercialization efforts in the orthopedic space, and providing technical support and management direction for the company’s cross function leadership to support its business objectives.

Mark was previously the Vice President at JenaValve Technologies, where he managed the development of the company’s next-gen aortic valve delivery system. He has consulted for companies such as Glucovation, Aortica, Nano-Structures, Medina Medical, Proteus Digital Health, and Micell Technologies. Among his many leadership positions, he was the Director of Sensor Engineering at Medtronic Diabetes, where he focused on the company’s glucose sensor. Also notable was his role at Dexcom as the Senior Director of Developmental Engineering and Operations, where he worked on their Class III continuous glucose monitoring system.

“Adler is well-versed in the transformation of early-stage to commercial ready technology,” notes Tom Callaway, Founder and President of Life Science Partner. “He has managed large and small research and development teams, with a heavy emphasis on later stage product development and manufacturing.”

Mark Adler earned a Bachelor of Technology Degree in Mechanical Engineering from Rochester Institute of Technology and an MBA from Argosy University in Seattle, WA.

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.

Life Science Partner is pleased to announce the recruitment of Mark Phelps, PhD to Canary Medical, where he will serve as Vice President of Technology Development.

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.

Canary Medical logo

Phelps will be driving technology reduction to practice for Canary’s cardiovascular applications, delineating smart implant technologic and business opportunities, providing technical leadership to the Canary Management team, and providing strategic input into building Canary’s infrastructure and business.

Mark Phelps

Previously at Medtronic, Phelps managed the Research and Development team as the Vice President of R&D for Patient Monitoring & Diagnostics. Before that, he was the Senior Program Director for Diagnostics & Monitoring where he worked on a new product line for Medtronic’s wireless implantable cardiac monitor.

“Phelps has shown his ability to be a technology innovator and forward-thinker,” notes Tom Callaway, Founder and President of Life Science Partner. “Given his background at companies such as Medtronic, TASER and LifeSync, Phelps has a proven track record of building innovative technologies to enable future improvements in healthcare.”

Phelps earned his Bachelor of Science, Masters, and PhD in Electrical Engineering from Florida Institute of Technology (FIT) in Melbourne, Florida.

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.

DANVERS, Mass., Oct. 08, 2015 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced that Seth Bilazarian, M.D. will be appointed as Vice President of Interventional Cardiology Programs, effective October 8, 2015.

“We are excited to welcome Dr. Seth Bilazarian to Abiomed, where he will add a specialized interventional cardiology perspective to the executive team that will further strengthen our mission to recover hearts and save lives. Seth has over 20 years of experience practicing interventional cardiology in the cath lab and has developed an expertise in hemodynamic support. His insight and knowledge will richly enhance our ongoing training and education initiatives for the new standard of care,” said Michael R. Minogue, President, Chairman and Chief Executive Officer, Abiomed.

“I am thrilled to become part of the Abiomed team. As a user, I am very familiar with the benefits of Impella and know it is transforming the standard of care in treating complex patients. I am eager to collaborate with expert and experienced physician users in interventional cardiology and heart failure to develop best practices for use of the Impella platform in Protected PCI,” said Seth Bilazarian, M.D.  “Educating physicians more broadly on the safe, effective and appropriate use of this technology will also be a focus. I am equally enthusiastic about the opportunity to begin working with industry colleagues to bring new devices within the Impella platform to market and continue the collaborative mission of recovering hearts.”

Dr. Bilazarian is a clinical and interventional cardiologist and has performed coronary and peripheral interventions at Lahey Clinic, Boston University Medical Center and Massachusetts General Hospital and was Director of the Cardiac Catheterization Laboratory (Cath Lab) and Chief of the Cardiovascular Steering Committee at Lawrence General. Most recently, he was the Director of Clinical Cardiology Research Program and Clinical Cardiologist at Pentucket Medical Associates, LLC. He also serves on the faculty as an instructor in medicine at Harvard Medical School, where he has taught since 1995 and is the founder and director of the largest community based cardiac research program in the Partner’s network.

Dr. Bilazarian is board certified in cardiovascular medicine, nuclear cardiology, vascular ultrasound, interventional cardiology, and vascular and endovascular medicine. Dr. Bilazarian is an active participant in outpatient clinical trials in congestive heart failure, hypertension, heart disease prevention, diabetes, anemia, atrial fibrillation, anti-inflammatory strategies for vascular prevention and anticoagulation and anti-platelet therapies. In 2008, he was appointed as physician advisor to the cardiac device panel of the Food & Drug Administration.

In addition to his clinical practice, Dr. Bilazarian is an active blogger in the physician community. His blog, “Practitioner’s Corner with Dr. Seth Bilazarian” was established in 2009 and is hosted on theheart.org and MedScape (http://goo.gl/k5lZqA). He has written over 100 blog posts that cover various topics across the wide spectrum of interventional cardiology.

Dr. Bilazarian received a Bachelor of Science in Engineering in Chemical Engineering from Tufts University and MD from University of Massachusetts Medical School. He completed his internship and residency at The Johns Hopkins Hospital in Baltimore, and cardiology and interventional cardiology fellowship at Boston University Hospital and Boston City Hospital.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support.  Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart.  For additional information please visit: www.abiomed.com.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including statements regarding our expectation of a smooth transition to a new Vice President and Chief Financial Officer, the Company’s expectations of continued commercial growth, and future opportunities, including the opportunity to become the standard of care.

The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company’s filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K.

Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

For more information, please contact:

Aimee Genzler
Director, Corporate Communications
978-646-1553
agenzler@abiomed.com

Ingrid Goldberg
Director, Investor Relations
igoldberg@abiomed.com

Life Science Partner recruits former Vice President, Chemical and Pharmaceutical Sciences at Icagen, Inc.

Life Science Partner announces the recruitment of Mark Suto, PhD, an experienced scientist and drug discovery executive, to the Southern Research Institute in Birmingham, Alabama.

Southern Research Institute.  With a focus on the discovery and advancement of new, small-molecule therapeutics from the design stage to the clinic, Southern Research’s Drug Discovery Research Division has accomplished innovative research in the areas of cancer, infectious disease and neuroscience.

Suto was previously Vice President at Icagen, a biopharmaceutical company focused on the novel small molecule drugs that target ion channels in diverse therapeutic areas. He was responsible for leading discovery and development chemistry activities, including medicinal, bioanalytical and computational chemistry for the company.  Previously, he served as Executive Vice President and Chief Scientific Officer at Neurion Pharmaceuticals.

“Suto is a passionate and articulate individual, with an impressive background in drug discovery,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “He will bring infectious enthusiasm along with 28 years of large pharmaceutical and biotechnology experience to the team at Southern Research.”

Suto earned his Bachelor of Science Degree and PhD in Medicinal Chemistry from the State University of New York at Buffalo.

Life Science Partner recruits former Vice President of Manufacturing and Manufacturing Engineering at GluMetrics

Life Science Partner announces the recruitment of Mark Adler to become Director, Research and Development, Sensors Engineering for Medtronic Diabetes.

Medtronic Diabetes is the world leader in insulin pump therapy and continuous glucose monitoring.

In his most recent role at GluMetrics, Adler was responsible for building the intensive care unit glucose sensor product portfolio for the emerging medical device company.  He has a broad background in breakthrough device development in many different platforms – including coating vascular stents at Devax and creating a new sensor platform at DexCom as Senior Director of Manufacturing Operations and Engineering.  This new role is somewhat of a homecoming, as he was previously the Director of Advanced Engineering at Medtronic AVE.

Mark Adler

In his new role at Medtronic Diabetes, Adler will be responsible for determining and executing the overall strategic technology plan for the sensors development organization, as they help build the next-generation sensors and cutting edge continuous glucose monitoring solutions.

“Adler is a passionate, highly motivated engineering executive with an impressive background in sensor development for the diabetes market” noted Tom Callaway, MD, founder and president of Life Science Partner.  “He has broad management experience across all functions of a medical device organization and will bring leadership and quality execution to Medtronic Diabetes’ portfolio of continuous glucose monitoring solutions.”

Adler received his Bachelor of Technology Degree in Mechanical Engineering from the Rochester Institute of Technology and his Masters in Business Administration from Argosy University, Seattle.

Life Science Partner Recruits Pain Clinical Specialist from Purdue Pharma and Co-Founder of Magidom Discovery

Life Science Partner announces the recruitment of Peter Lacouture, PhD, to become Medical Director of Pain Management for Hospira.

Hospira is a global specialty pharmaceutical and medication delivery company that develops, manufactures and markets products that help improve the safety, effectiveness and costs of patient care.  The company recently acquired Javelin Pharmaceuticals to take advantage of the synergies between Javelin’s main product candidate, DylojectTM ,a post-operative pain management drug and Hospira’s proprietary sedation agent PrecedexTM.

In 2001, Lacouture co-founded Magidom Discovery, a pharmaceutical services company focused on all aspects of research and development for pain management drug development.  This followed his long tenure at Purdue Pharma where he served as the Senior Director of Clinical Research.  In his new role at Hospira, Lacouture will have overall responsibility for the clinical development of the expanding portfolio of pain drugs under development, as well as leading the decision process regarding the potential clinical utility and regulatory strategy of pain management compounds.

“Lacouture has a strong background in clinical development of acute pain drugs – both as the leader of compounds in development in a major leader in the space, as well as with small companies as a consultant,” noted Tom Callaway, MD, President of Life Science Partner.  “His considerable network of key opinion leaders in the space will serve Hospira well as it continues to expand it considerable portfolio of pain managements drugs and systems.”

Lacouture earned a Bachelor of Arts degree in Chemistry from the College of Holy Cross, Worcester.  He received his Masters in Pharmacology/Toxicology and his PhD in Pharmacology/Physiology from the Massachusetts College of Pharmacy and Allied Health Sciences, Boston.