Tag Archive for: Chief Medical

Cathy Srebalus-Barnes, PhD Joins Hospira as Senior Director, Bioanalytical Sciences

Former Director, Bioproduct Analytical Development at

Eli Lilly and Company

Life Science Partner announces the recruitment of Cathy Srebalus-Barnes, PhD, an experienced bioanalytical executive, to become Senior Director, Bioanalytical Sciences, Global Biologics R&D for Hospira, Inc.

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.

In her new role at Hospira, Inc., Srebalus-Barnes will lead a global scientific team responsible for bioanalytical method development and bioanalytical characterization activities supporting Hospira’s growing biosimilars pipeline.

Srebalus-Barnes has spent much of her career at Eli Lilly and Company, where she was most recently responsible for leading three teams of scientists that included Analytical Development, Trace Analysis and Bioassay groups.  She oversaw the complete downstream process for Phase II – ready for III preparation for therapeutic biotechnology products in clinical and commercial development.  Previously, Srebalus-Barnes served as Director, Bioprocess Virology and Purification Development, where she was responsible for two groups managing the purification process development and viral safety procedures for all biotechnology products in development.

Barnes earned a Bachelor of Science Degree in Chemistry from West Virginia University and her Doctorate from Indiana University in Analytical Chemistry.

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Nancy Grygiel joins Allergan as Senior Director, Corporate Compliance, International

Life Science Partner recruits former Director of Global Compliance Program at Mylan Pharmaceuticals

Life Science Partner announces the recruitment of Nancy Grygiel, an experienced global compliance executive, to Allergan, Inc. to become Senior Director, Corporate Compliance, International for the company.

Allergan is a technology-driven, multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices in the areas of eye care, neurosciences, medical dermatology and urologics.

In Grygiel’s previous role at Mylan Pharmaceuticals, a Pennsylvania-based company developing generic and specialty pharmaceuticals, she was responsible for overseeing the global compliance program operations across North American, Asia Pacific, Europe and Middle East, and India and China.

Prior to joining Mylan, Grygiel practiced as an International Business Transactions and Immigration Specialist at the Law Offices of Paul S. Haar in Washington, DC.

“Nancy is an articulate and passionate compliance officer with a personality and communication skills that allow her to succeed in four languages,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Her vast international experience and global compliance background will serve Allergan well in its mission to commercialize important new therapies that make a real difference.”

Grygiel earned her degree in Legal Studies from the Universidad De Buenos, Aires and then received her Master of Law Degree from Georgetown Law Center.

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Thomas Nikolai to Join Hospira as Senior Director, External Biologics Collaborations and Partnerships

Life Science Partner recruits former Director, Biologics, Parenteral Products at Abbott Laboratories

Life Science Partner announces the recruitment of Thomas Nikolai, MS, MBA, to become Senior Director, External Biologics Collaborations and Partnerships for Hospira’s biosimilars division.

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.

Nikolai leaves Abbott with over 20 years of leadership experience in biologics process development, technical operations and manufacturing support.  In his most recent role, Nikolai served as Director, Biologics, Parenteral Products, where he was the Global CMC leader for commercial and late-stage biologic drug products including Humira, Abbott’s blockbuster arthritis drug.

“Nikolai is a passionate and results-driven professional with a progressive technical management career in the biopharmaceutical industry.” noted Tom Callaway, MD, Founder and President of Life Science Partner.  “He brings a wealth of knowledge and leadership to the biologics team at Hospira and will serve the company well as it provides biosimilar versions of the world’s most critical biological drugs.”

Nikolai received his Bachelor of Science Degree in Chemical Engineering and Bioengineering from the University of Wisconsin, Madison and his Masters of Science in Biochemical Engineering from the University of Minnesota, Twin Cities.  He earned a Masters in Business Administration from the University of Wisconsin, Parkside.

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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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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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