Tag Archive for: Medical Devices

Pam Simons joins AGA Medical as Senior Director of Clinical Affairs

Life Science Partner recruits former Vice President, Clinical and Regulatory Affairs at Uptake Medical

Life Science Partner announces the recruitment of Pam Simons, an experienced medical device clinical and regulatory executive, to AGA Medical to become Senior Director of Clinical Affairs for the company.

AGA Medical Corporation Plymouth, Minnesota based medical device company focused on the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.

In Simons’ previous role at Uptake Medical, a Seattle-based company developing non-surgical treatment for emphysema and COPD, she was responsible for worldwide efforts in clinical and regulatory affairs for the company.  Previously, Simons held a similar role at First Circle Medical where she led development and execution of the company’s global clinical development from Phase I to commercialization.

“Simons is a high energy individual with a demonstrated track record of success in development and execution of clinical strategy and regulatory approval for innovation Class II medical devices,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “With her passion and experience, she will serve AGA Medical well in its mission to bring lasting improvements for patients with cardiovascular defects and peripheral vascular disease.”

Simons earned her Bachelor of Science degree in Radiologic Sciences from the University of North Carolina at Chapel Hill.

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Steve Walsh joins Carticept Medical as Vice President of Research and Development

Life Science Partner recruits biomaterials expert to lead synthetic cartilage product development

Life Science Partner announces the recruitment of Steve Walsh, PhD, a senior biomaterials technology and development expert, to Carticept Medical to become Vice President, Research and Development for the company. 

Carticept Medical is an Atlanta-based medical device company developing novel therapies designed to address the shortcomings of current conservative and surgical treatment options for patients with osteoarthritis or cartilage injuries.

In his previous role at Cyrolife, another Atlanta-based biotechnology company, Walsh was responsible for leading Biomaterials Technologies and Product Development for the company’s implantable biological devices, surgical adhesives and biomaterials for use in cardiac, vascular, general and reconstructive surgery.

Before his tenure at Cyrolife, Walsh served as Manager of the Implantable Device Development Engineering Group at BioControl Technology in Indiana, PA.   In his new role at Carticept, Walsh will have key responsibility for managing R&D efforts for the company’s synthetic cartilage products and the pipeline portfolio of novel therapeutic solutions.

“Walsh is a talented biomaterials scientist with a deep intellect and passion for his work,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “His deep knowledge base and broad development and process abilities will greatly benefit the important clinical and commercial efforts at Carticept.”

Walsh earned his Bachelor of Science in Plastics Engineering at the University of Lowell in Lowell Massachusetts and his Masters and Doctor of Philosophy degrees in Macromolecular Science at Case Western Reserve University in Cleveland, Ohio.

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Gene Jung joins the Global Cardiovascular Innovation Center as Senior Director of Product Development

Life Science Partner recruits Senior Cardiovascular Product Development Executive.

Life Science Partner announces the recruitment of Gene Jung, formerly Vice President of Engineering at ProRhythm, to the newly created Global Cardiovascular Innovation Center (GCIC) based in Cleveland, Ohio.

Headquartered on the campus of The Cleveland Clinic, GCIC was launched with a $60 million grant for the State of Ohio to develop and commercialize new cardiovascular products.  GCIC will utilize the considerable clinical, research and commercialization capabilities of the GCIC member organizations in northeast Ohio and focus on developing technologies in partnership with established cardiovascular-focused companies and in newly-formed start-up companies.

In Jung’s most recent role at ProRhythm, he was responsible for developing the company’s High Intensity Focused Ultrasound (HIFU) technology into a commercial product for Atrial Fibrillation.

Previously, Jung was a Medical Device Consultant in Tokyo where he designed and developed intra-vascular coronary products for numerous Japanese Medical Device Companies.   Prior to his work in Japan, Jung served as Research and Development Director at the Image Guided Therapy Division at Jomed Corporation in San Diego.

“Jung has a broad view of medical device technology from early-stage physician-driven innovation though product commercialization,” noted Tom Callaway, MD, founder and president of Life Science Partner. “His extensive technical leadership background across multiple cardiovascular platforms and his strong industry and physician networks will serve GCIC well.”

Jung earned his Bachelor of Science Degree in Mechanical Engineering from the University of Arizona in Tucson, AZ.

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Shubhayu Basu to join the Global Cardiovascular Innovation Center as Director of Product Development

Life Science Partner recruits Innovative R&D Scientist.

Life Science Partner announces the recruitment of Shubhayu Basu, PhD, formerly Group Lead for New Business Ventures at Abbott Vascular, to the newly created Global Cardiovascular Innovation Center (GCIC) based in Cleveland, Ohio.

The organization was launched with a $60 million grant for the State of Ohio to develop and commercialize new cardiovascular products.  GCIC will focus on developing technologies in partnership with established cardiovascular-focused companies and in newly-formed start-up companies.

In Basu’s former role at Abbott Vascular (formerly Guidant), he was responsible for creating and implementing processes for identifying emerging technologies and various disease spaces and opportunities against the company portfolio and growth landscape.   Previously, he served as Group Lead, Research and Development, Cardiac Therapies for the company.

Prior to joining Guidant/Abbott, Basu was a Biodesign Innovation Fellow at Stanford University’s Biodesign Program in Palo Alto, CA.

“Basu will join another LSP recruit – Gene Jung – who shares his passion about new technologies and their application in patient care,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “His ability to work with complex technologies to identify commercial opportunities and to oversee their development is a perfect fit for the GCIC team.”

Basu earned both his Bachelor and Masters Degree of Technology in Biochemical Engineering and Biotechnology at the Institute of Technology in New Delhi, India.  He received his PhD in Chemical Engineering at the Ohio State University in Columbus.

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Brian Lundstrom joins Windy Hill Medical as Chief Executive Officer

Life Science Partner recruits former Senior Vice President, Business and Commercial Development from ACADIA Pharmaceuticals

Life Science Partner announces the recruitment of Brian Lundstrom, an experienced biopharmaceutical business development executive, to Windy Hill Medical to become Chief Executive Officer for the company.

Windy Hill Medical is a California-based medical device and pharmaceutical company focused on the development of products to reduce the risk of developing breast cancer in patients deemed to be at high risk.

In Lundstrom’s previous role at ACADIA, a San Diego-based biopharmaceutical company developing small molecule therapeutics for the central nervous system, he was responsible for developing partnerships, particularly with Asian and European pharmaceutical companies, for the company’s four clinical-stage and preclinical programs.

Prior to joining ACADIA, Lundstrom served as Vice President of Business Development and Humanized Polyclonal Antibody Program Manager for Genzyme Corporation in the areas of Oncology, Hematology Transplantation and Immunology. 

In his new role as Chief Executive Officer, he will lead the Company through an additional round of financing, the development and expansion of the clinical trial program, and commercialization of its product portfolio.

“Lundstrom is an experienced and effective global biopharmaceutical manager with a broad background in business development and partnering,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “With his passion and experience, he will serve Windy Hill well in its mission to bring lasting improvements for patients with early-stage breast cancer.”

Lundstrom earned his Master of Science degree in Chemical Engineering with an immunology and molecular biology focus from the Danish Technical University in Lyngby, Denmark.  He attended the Copenhagen Business School and earned a diploma in Economics in International Management.  Lundstrom received his PhD in Biochemistry from Odense University and then attended the Monterey Institute of International Studies in Monterey, CA for an MBA program.

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Jay Millerhagen joins St. Jude Medical Atrial Fibrillation Division as Senior Director, Clinical Affairs

Life Science Partner recruits former Senior Executive of Boston Scientific Cardiac Rhythm Management Division.

Life Science Partner announces the recruitment of medical device executive Jay Millerhagen to St. Jude Medical, a global cardiovascular medical device company, based in St. Paul, Minnesota.

St. Jude’s Atrial Fibrillation Business Unit designs, manufactures, and markets specialty cardiovascular devices for the electrophysiology segment of the cardiac rhythm management market and for the interventional cardiology market.

Millerhagen was most recently Director of Patient Management Business Alliance at Boston Scientific Cardiac Rhythm Management (CRM) where he managed business alliance strategies for key products and partnerships and clinical data initiatives for the division.  Prior to Millerhagen’s Business Alliance role, he directed Heart Failure Market Development for CRM.  There, he assembled and managed a large marketing team responsible for Guidant/Boston Scientific’s HF product line and led the development, recruitment and oversight of the COMPANION trial.

“Millerhagen has moved from early stage product development to clinical development to successful product launch in the CRM arena” noted Tom Callaway, MD, founder and president of Life Science Partner.  “As a highly strategic ‘best athlete’ in the CRM Business, he will bring experienced clinical development leadership and quality execution to the St. Jude’s Atrial Fibrillation Division.

Millerhagen earned a Bachelor of Arts in Physiology and Psychology from Concordia College in Moorhead, Minnesota and a Master of Science in Exercise Physiology from St. Cloud State University.  He received an MBA in General Management from the University of St. Thomas in St. Paul, Minnesota.

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Mark Phelps to join LifeSync Corporation as Vice President of Research and Development

Life Science Partner announces recruitment of former Senior Director, Product Development and Technology at Medtronic, Inc.

Life Science Partner announces the appointment of Mark Phelps, a senior technology development leader, to LifeSync Corporation as the Vice President of Research and Development.

LifeSync is an early stage medical device company focused on the continued development, marketing and sales of the first wireless electrocardiogram (ECG) data communications system appropriate for hospital and outpatient settings.

In his most recent role at Medtronic, a global leader in the development of medical technology, Phelps managed the Electronic Systems Technology, New Therapies and Diagnostics Division of Medtronic’s Microelectronics Center in Tempe, Arizona.

His team’s contributions to technology development impacted the wide range of electrophysiology products including pacemakers and external defibrillators.  Well versed in medical device development, Phelps was previously Senior Manager of Tachyarrhythmia Product Development for the company.  Before joining Medtronic, Phelps managed Strategic Product Development for Motorola.

“Phelps is the prototype of a forward-thinking scientist and technology innovator,” noted Tom Callaway, President of Life Science Partner.  “He will be a visionary leader in building innovative technologies for LifeSync in its mission to enable the future of healthcare for improved patient outcomes.”

At LifeSync, Phelps will be focused on developing a world-class engineering team building the next-generation biological data sensors, transmission devices and integrated systems.   He will serve as senior technical advisor and provide insight on how the technology can serve customer needs and direction in expanding the company’s platform.

Phelps earned his Bachelor of Science and Master of Electrical Engineering from Florida Institute of Technology (FIT) in Melbourne, Florida.  He received a PhD in Electrical Engineering from FIT as well.

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Randy Jones joins Windy Hill Medical as Vice President, Preclinical Development

Life Science Partner recruits former Vice President of Biology Services of Ricerca Biosciences

Life Science Partner announces the recruitment of Randy Jones, PhD, an experienced pharmaceutical development executive, to Windy Hill Medical to become Vice President, Preclinical Development. 

Windy Hill Medical is a California-based medical device and pharmaceutical company focused on the development of products to reduce the risk of developing breast cancer in patients deemed to be at high risk.

In Jones’ previous role at Ricerca, a preclinical chemistry and biology services company, he was responsible for the operational and profit and loss responsibility for all areas of the Biology Division as well as new business development and the integration of IND/NDA programs in biology and chemistry.  Previously, Jones served as the Director of Toxicology at the Arkansas Division of Charles River Laboratories.

“Jones is an experienced and effective general manager, unflappable in style, with a broad understanding of the pharmaceutical industry and how to build successful teams,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “With his experience in medical devices as well as biopharmaceutical services, he will serve Windy Hill well in its mission to bring lasting improvements for high risk patients.”

In his role as Vice President of  Preclinical Development, Jones will have responsibility for overseeing the continued pharmaceutical development of Windy Hill Medical’s expanding portfolio of compounds under development for the localized therapy of breast cancer.  He will provide commercialization strategy and regulatory oversight to the Windy Hill team.

Jones earned his D.V.M at Iowa State University and his PhD in Pharmacology and Toxicology from the University of Georgia in Athens.

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Mark Low joins the Global Cardiovascular Innovation Center as Managing Director

Life Science Partner recruits Senior Leader from the Cardiovascular Medical Device Industry.

Life Science Partner announces the recruitment of Mark Low, a senior cardiovascular medical device executive, to the newly created Global Cardiovascular Innovation Center (GCIC) based in Cleveland, Ohio. 

Headquartered on the campus of The Cleveland Clinic, GCIC was launched with a $60 million grant for the State of Ohio through its Wright Center of Innovation program to develop and commercialize new cardiovascular products.  Working with the GCIC’s Board of Directors and Commercialization Advisory Board, Low will build a team to utilize the considerable clinical, research and commercialization capabilities of the GCIC member organizations in northeast Ohio.

GCIC will be focused on developing technologies in partnership with established cardiovascular-focused companies and in newly-formed start-up companies.

Low has spent most of his career developing new cardiovascular technologies in both small, venture-backed companies and large medical device companies.   He has most recently provided market analysis, strategy and business development services for cardiovascular applications and technologies as an independent consultant.  Previously, Low was Vice President of Business and Market Development for Sonus Pharmaceuticals, Inc., a drug delivery and specialty pharmaceutical company in Bothell, Washington.  Earlier he led the market development of intra-vascular ultrasound (IVUS) at Hewlett Packard.

“Low is a well-networked and experienced marketing and commercialization executive in the field of cardiovascular technologies,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Working with GCIC and its affiliate institutions, Low will connect technology leaders at Cleveland Clinic and Case Western with corporate leaders and venture funding sources.”

Low earned a Bachelor of Arts in Natural Science from Johns Hopkins University, a Master of Science in Physiology from the Medical College of Wisconsin, and a Master of Science in Technical Communication from Rensselaer Polytechnic Institute.

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Jane Weiss Doerr joins Windy Hill Medical as Director of Clinical Affairs

Life Science Partner recruits former Senior Director, Program Management for Genzyme Corporation

Life Science Partner announces the recruitment of Jane Weiss Doerr, RN, MSN, a seasoned oncology clinical trials executive, to Windy Hill Medical as Director of Clinical Affairs.

Windy Hill Medical is a California-based medical device and pharmaceutical company focused on the development of products to reduce the risk of developing breast cancer in patients deemed to be at high risk.

In Doerr’s previous role at Genzyme, a global biotechnology company developing advanced technologies for the treatment of numerous debilitating diseases, she managed a multi-disciplinary global product development team delivering oncology products to the market.  Previously, Doerr was Director and Product Team leader for ILEX Oncology, Inc. where she was responsible for numerous oncology products in various stages of development.  She also served as Senior Vice President for Oncology Research Partners, a national network of academic and community physicians focused on cancer care.

“Jane has a wealth of experience in the oncology clinical and biopharmaceutical industry and is well-grounded as a strategic thinker and operational leader,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “She is very passionate about bringing lasting improvements in healthcare for patients with cancer.”

In her role as Director of Clinical Affairs, Doerr will have the responsibility for managing all phases of Windy Hill’s global clinical trials for the expanding portfolio of compounds under development.  She will collaborate with academic thought leaders, provide strategic direction to the company and build a world-class clinical development team with an eye toward successful FDA and European approvals.

Doerr earned her Bachelor of Science in Nursing at the University of Texas Health Science Center School of Nursing in San Antonio, Texas.  She received a Master of Science in Nursing from the University’s Graduate School of Biomedical Sciences.

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