Tag Archive for: Regulatory

Peter Lacouture Joins Hospira as Medical Director, Pain Management

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.

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Lisa Becker joins AGA Medical as Senior Director of Regulatory Affairs

Life Science Partner recruits former Director, Worldwide Regulatory Affairs at Boston Scientific

Life Science Partner announces the recruitment of Lisa Becker, a senior medical device regulatory executive, to become Senior Director of Regulatory Affairs for the AGA Medical Corporation.

AGA Medical is a 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. AGA Medical was recently acquired by St. Jude Medical.

In her most recent role at Boston Scientific, Becker served as Director of Worldwide Regulatory Affairs for the Cardiac Rhythm Management Division.  During Becker’s long tenure at Guidant/Boston Scientific, she served in numerous regulatory leadership roles of increasing responsibility for the company.  Becker’s early career was spent in the U.S Air Force as a Military Personnel Flight Commander.

“Lisa is an articulate and passionate leader who has built both small highly efficient regulatory teams and managed large complex international regulatory organizations,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “She has an impressive track record of creating innovative systems which utilize data-driven metrics to accelerate the regulatory approval process.”

Becker earned a Bachelor of Science degree in Organizational Behavior with General Engineering Minor from the United State Air Force Academy and a Master of Science degree in Human Resource Management and Information Systems from Chapman University.

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Maria Koullick, PhD, joins AGA Medical as Senior Director of Clinical Affairs

Life Science Partner recruits former Clinical Affairs Executive at ATS Medical, Inc.

Life Science Partner announces the recruitment of Maria Koullick, PhD, a senior clinical trials executive, to AGA Medical to become Senior Director of Clinical Affairs for the company.

AGA Medical Corporation is a 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.  AGA Medical was recently acquired by St. Jude Medical.

Koullick comes to AGA Medical from ATS Medical, a Minneapolis-based company which was recently acquired by Medtronic.  She directed the strategy and executed the company’s clinical programs for surgical valves, repair products and surgical ablation technologies.

Previously, Koullick held similar roles of increasing responsibility at Medtronic’s Cardiac Rhythm Disease Management and Neurological Divisions.

“Maria has a unique international clinical research trajectory – from the Cardiovascular Surgery Center in Moscow to the National Cardiovascular Surgery Center in Osaka to Medtronic,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Her metric-driven skills emerge from her PhD in Biomedical Engineering, but she has also demonstrated her ability to build and lead a team that accomplishes difficult goals.

She will serve the company well in its mission to bring lasting improvements for patients with cardiovascular defects and peripheral vascular disease.”

Koullick earned her Bachelor and Master of Science degrees in Organic Chemistry from the University of Chemical Technology in Moscow, Russia.  She completed her PhD in Biomedical Engineering at the Bakulev Cardiovascular Surgery Center.

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Dr. Scott Treiber joins Hospira as Vice President of Clinical Operations and Medical Affairs

Life Science Partner recruits former Executive Vice President at inVentiv Clinical Solutions

Life Science Partner announces the recruitment of Scott Treiber, PhD, an experienced clinical research leader, to Hospira to become Vice President of Clinical Operations and Medical Affairs.

Hospira is a $5 B global specialty pharmaceutical and medication delivery company based in Lake Forest, Illinois.

Previously Treiber served as Executive Vice President Clinical Development at inVentiv Clinical Solutions.  He had responsibility for all aspects of clinical monitoring and project management, including executive project oversight and client interaction for full service clinical trials managed by the company.   Earlier Treiber held senior-level positions at leading Contract Research Organizations, including PharmaNet, Quintiles, ICON and Premier Research.

“Treiber has a depth of experience in clinical development organizational management in a wide range of therapeutic categories including neuroscience, cardiovascular, general medicine and oncology,” noted Tom Callaway, MD, President of Life Science Partner.  “His global CRO background will serve the company well as it transforms its business to a more diversified pharmaceutical company including a portfolio of biosimilar drugs.”

Treiber earned his Bachelor of Science Degree in Biology from the University of Iowa and his PhD in Biology from the University of California Santa Cruz.  He completed his MBA from Ellis College, New York Institute of Technology.

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Seema Kumbhat, MD, joins Hospira as Medical Director, Device Development – Clinical Decision Support

Life Science Partner recruits former Vice President, Medical Affairs at McKesson Provider Technologies

Life Science Partner announces the recruitment of Seema Kumbhat, MD to Hospira to become Medical Director, Device Development – Clinical Decision Support.

Hospira is a $5 B global specialty pharmaceutical and medication delivery company based in Lake Forest, Illinois.   In this new role, she will be responsible for the customer-relations and the clinical-insights into Hospira’s increasingly sophisticated drug delivery systems.

Kumbhat comes well prepared for the role, as she has led clinical teams and customer relationships in the leading healthcare IT companies.  As Vice President of Medical Affairs at McKesson Provider Technologies, Kumbhat served as the key clinical liaison across large healthcare systems and physician practices for the company.

Earlier, Kumbhat served as Enterprise Clinical Manager and Physician Consultant for GE Healthcare IT Solutions where she managed a team of content experts in software configuration for specific clinical specifications.  She joined industry directly from her surgical residency program to help EPI Systems develop their surgery, anesthesia and enterprise medical record systems.

“Kumbhat is articulate and passionate about making healthcare IT solutions that serve the physicians and hospital-based caregivers with efficiency and real-world solutions,” noted Tom Callaway, MD, President of Life Science Partner.  “Her broad background as a physician liaison and her direct experience in the field of product development and customer support will be a great asset to the Medical Device team at Hospira”

Kumbhat earned her Bachelor of Science Degree (Magna cum Laude) from the University of Miami and her Medical Degree with Research Distinction in Surgery at the University of Miami School of Medicine.

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Steve McQuillan Joins Medtronic’s AF Solutions as Vice President of Clinical and Regulatory Affairs

Life Science Partner recruits former Lead Director of Clinical Affairs at Boston Scientific Cardiac Rhythm Management Division.

Life Science Partner announces the recruitment of clinical affairs executive Steve McQuillan to Medtronic’s Cardiac Rhythm Disease Management Division (CRDM), the largest and oldest business unit of the global $13.5 billion medical device company.

With the recent acquisitions of Ablation Frontiers and CryoCath Technologies, the newly formed CRDM Business Unit, AF Solutions, brings breakthrough therapeutic choices and tools to physicians and their patients with atrial fibrillation.

In his most recent role at Boston Scientific Cardiac Rhythm Management (CRM) Division, McQuillan was responsible for developing and implementing the CRM and Electrophysiology clinical strategy for all US-based clinical trials.   He had a steady and successful rise through his tenure at the Guidant CRM organization prior joining Boston Scientific.   In his new role, McQuillan will provide strategic leadership, oversight, and overall management of the regulatory and clinical activities for the new atrial fibrillation division.

“McQuillan is a passionate, highly motivated executive with wide-ranging clinical and regulatory experience in the CRM space” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Along with his strong relationships with Electrophysiology thought-leaders worldwide, he will bring strong clinical development leadership and quality execution to Medtronic’s CRDM Division.”

McQuillan received his Bachelor of Arts Degree in Biometry and Statistics from the University of Minnesota, Twin Cities.

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Life Science Partner Recruits Robert Superko as Vice President of Medical Affairs for Celera

Co-Founder of Berkley HeartLab to Lead Medical Affairs at Celera

Life Science Partner announces the recruitment of Robert Superko, MD, most recently Executive Director of Genomics and Human Health at St. Joseph’s Hospital of Atlanta’s Translational Research Institute, to Celera.

Celera is a healthcare business delivering personalized disease management through a combination of products and services incorporating proprietary discoveries, including a clinical services business, Berkley HeartLab (BHL).  Celera commercializes a wide range of molecular diagnostic products and technologies to provide personalized disease management in cancer and liver diseases.

Dr. Superko is a world leader in the field of metabolic heart disease diagnosis and treatment, and genomics, which is the ability to tailor treatment specifically to a patient based on their genetic makeup.  He has published over 100 manuscripts and 19 textbook chapters and is the author of BEFORE THE HEART ATTACKS, a book written for the lay public explaining advanced aspects of heart disease.

In his role at St. Joseph’s Hospital, Dr. Superko continued his research to identify patients’ genetic susceptibility to heart disease, cancer and other chronic disease states. A co-founder of BHL, Dr. Superko will serve as Vice President of Medical Affairs where he will be the key medical spokesperson for the company’s products and services and the key liaison with physician and research collaborators, including academic medical centers, pharmaceutical companies, and the FDA.

“Superko will bring his deep scientific knowledge, world-renowned reputation, and great passion for understanding the genetic basis of cardiovascular disease to the company,” noted Tom Callaway, President of Life Science Partner.  “There is no better person to prepare Celera’s market for the emerging revolution in personalized disease management.”

Dr. Superko earned his Bachelor of Science degree in Biology from University of California, San Diego, and his Medical degree from the State University of New York, Stony Brook.  He completed his Internship and Fellowship in Internal Medicine at the University of California, Davis.

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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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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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Lode Debrabandere to Lead Autoimmune Business Unit at Osiris Therapeutics

Life Science Partner brings clinical development and marketing talent to help launch first stem-cell therapy

Life Science Partner announces today the recruitment of Lode Debrabandere, PhD, former vice president, Neuroscience Business Unit of Bristol-Myers Squibb Company to Osiris Therapeutics to become general manager of Osiris Therapeutics’ Autoimmune Diseases business unit. 

Osiris is a privately-held biopharmaceutical company developing innovative technology for isolating and expanding messchymal stem cells (MSCs) derived from donated bone marrow for therapeutic drug products.

In the past few years, Osiris has transformed from an early-stage, research-focused organization to a commercially-focused enterprise – as it prepares to complete trials and launch Prochymal in autoimmune -related disorders including the treatment of acute graft-versus-host-disease in patients receiving bone marrow transplantation, Crohn’s Disease, and other related diseases such as rheumatoid arthritis.

“Osiris fits Debrabandere like a glove,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “He has significant global regulatory and clinical development experience – and demonstrated global marketing strategy expertise that will accelerate the successful launch of Prochymal to help these patients.”

At Bristol-Myers Squibb, Debrabandere led an interdisciplinary team to evaluate the company’s portfolio of products and programs – and then implemented a market-driven realignment of resources to expand into infectious diseases and CNS.  Earlier he led U.S. marketing and global clinical development for UCB Pharma where he led the co-promotional agreements with Pfizer and Alza to rapidly grow sales of Zyrtec and Ditropan, respectively.  He began his career as a trainee to the CEO of UCB Pharma before joining the global company in clinical development, rising to director of global clinical operations.

A native of Belgium, Debrabandere  earned his Pharm.D and PhD (Pharmaceutical Sciences) and his MBA at University of Leuven.

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