Tag Archive for: Chief Medical

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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Steve Hamburger, PhD, joins Exoxemis, Inc. as Vice President, Clinical and Regulatory Affairs

Life Science Partner recruits former Oncology Regulatory Officer for Johnson & Johnson, Pharmaceutical and Research & Development.

Life Science Partner announces the recruitment of Steve Hamburger, a global regulatory and drug development executive, to Exoxemis, Inc.

Exoxemis is an early-stage biopharmaceutical research and development company focused on prevention and treatment of serious infections and the significant and growing problem of microbial drug resistance.  The company’s myeloperoxidase (MPO) technology is a versatile platform that can be leveraged into multiple product areas, including medical, biodefense, industrial, veterinary, disinfectant, and agricultural applications.

In Hamburger’s most recent role at J & J, he was responsible for a cross-functional regulatory and drug development team and served as a global regulatory officer for the Oncology and Hematology division.  His portfolio included the key biologic PROCRIT.  Previously, he served in a similar role as the strategic and operational leader for the anti-cancer drug DOXIL.  Prior to his tenure at J & J, Hamburger was Senior Regulatory Research Scientist, Oncology and US Regulatory Affairs for Eli Lilly and Company.

“Steve is an experienced regulatory strategist with a broad therapeutic background in the pharmaceutical industry including the areas of infectious diseases, cardiology and oncology,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “He’s a passionate and self-directed individual with a long track record of successful interactions with key global health authorities that will greatly benefit Exoxemis’ platform and opportunity.”

Hamburger received his Bachelor of Science degree in General Science and Biochemistry from the University of Iowa in Iowa City.   He earned a Master of Science in Biology from Butler University in Indianapolis, Indiana and his PhD in Pharmacology and Toxicology from the Indiana University School of Medicine.

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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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Ross Tonkens, MD, Chosen to Lead Clinical Development at Regado Biosciences

Life Science Partner recruits pharmaceutical veteran and cardiology specialist as chief medical officer

Life Science Partner announces the recruitment of  Ross Tonkens, MD, FACP, to become the chief medical officer of Regado Biosciences.  Tonkens joins the company from Quintiles Transnational where he served as senior director, medical and scientific services and global scientific head for cardiovascular therapeutics.

Regado Biosciences is a biopharmaceutical company developing antidote-controlled therapeutics via simultaneous rational design of drug-antidote pairs.  Regado is initially focusing on the acute care antithrombotics market, with its lead product – REG1 anticoagulation system – the first specific direct-acting, antidote-controlled anticoagulant.

Tonkens is uniquely qualified to lead clinical and regulatory development due to his broad experience leading global teams in the cardiovascular therapeutic category.  Since 2001, Tonkens has managed a global team of cardiovascular, pulmonary and critical care physicians who oversee drug and device trials for Quintiles’ clients.  In addition, he managed four cardiologists based in Europe and a global portfolio of trials.

“For Regado, Ross was an exceptional find,” says Life Science Partner, founder and president Tom Callaway, MD. “In addition to his clinical trial experience, his role at Quintiles allowed him to work with many early-stage companies – and develop the strategic skills to determine what’s possible to make great science commercially feasible despite finite resources.”

A cardiologist by training, Tonkens combines experience in academic research with strong business analytical skills and accomplishments in corporate pharmaceutical environments.

Tonkens earned his undergraduate and medical degrees from Yale. He continued his training in Los Angeles, as an intern at Cedars-Sinai and residency in diagnostic radiology and internal medicine at UCLA.  He returned to Cedars Sinai for his cardiology fellowship.

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Hospira Recruits Kurt Gunter, MD, to Lead Cell Therapy Initiatives

Life Science Partner recruit offers valuable experience in regulatory and commercialization strategy

Life Science Partner announces the recruitment of Kurt C. Gunter, MD, as medical director, cell therapy of Hospira, a Chicago area based medical products company.  Hospira is a specialty pharmaceutical and medication delivery company launched from the core global hospital products business of Abbott Laboratories. 

With the recruitment of Gunter, Hospira now has a leader in the field of cell therapy to provide scientific and medical leadership for technology assessment and investment, and manage key relationships with academic and research institutions.  He will have the critical responsibility for representing the cell-therapy companies seeking investment and/or partnership.

“Kurt has a broad background in cell and gene therapy – with a specific expertise in developing regulatory guidelines for the field,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Few can match his experience in the use of cells for new therapies that hold out the promise to cure intractable diseases.”

As the vice president and medical affairs/governmental relations of ZymeQuest, Gunter led the clinical strategy of a biotechnology company removing A and B antigens from red blood cells to create “universal donor” blood.  Previously, he held a similar role at ViaCell, a cord blood banking and cell therapy company.  His first commercial experience was as vice president, clinical and regulatory for Transkaryotic Therapies (TKT) supervising all regulatory filings for its orphan drug program.

His earlier career was as a researcher and clinical pathologist at Children’s National Medical Center, George Washington University Medical School, and the FDA, where he was acting director, division of cellular and gene therapy.  A recognized leader in the field, he was appointed as the industry representative to the standards-setting organization, the FDA Cellular Tissue and Gene Therapy Advisory Committee.

Gunter earned his BS at Stanford and his MD at University of Kansas School of Medicine, where he also completed his residency.  He continued his anatomical pathology training at University of Maryland and was a biotechnology fellow in molecular immunology at the National Cancer Institute.

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Hal Mathews, MD to Become VP Medical Affairs for Medtronic Sofamor Danek

To Lead Clinical, Regulatory, Reimbursement Strategy and Physician Relations

Life Science Partner announced today the recruitment of Hallet H. Mathews, MD, to become vice president, medical affairs for Medtronic Sofamor Danek. 

Medtronic Sofamor Danek is the world’s leading orthopaedic company which develops and manufactures products that treat a variety of disorders of the cranium and spine, including traumatically induced conditions, degenerative conditions, deformities and tumors.  Medtronic Sofamor Danek markets its products worldwide and has FY2003 revenue of approximately $1.3 billion.

A leader in the field orthopaedic basic and clinical research, Mathews is a board-certified orthopaedic surgeon.  He is the Founder and President of MidAtlantic Spine Specialists, a multi-disciplinary, multi-specialty group that incorporates Orthopaedic, Neurosurgery and Pain Management & Rehabilitation specialties in Richmond and Williamsburg, Virginia.

“He is a demonstrated clinical leader and general manager – as he now oversees a 10,000 square foot clinic with 45 employees in Richmond and a smaller clinic facility in Williamsburg,” said Tom Callaway, MD, founder and president of Life Science Partner.  “In addition, he has already established strong relationships with the Sofamor Danek clinical investigators worldwide, having participated in and led clinical trials for many of Medtronic’s products.”

In his new role, Mathews will oversee clinical development and regulatory affairs for the Company, with an emphasis on working with business units to identify potential drug or device technologies with strong clinical indications, managing the regulatory strategy globally and overseeing Medtronic Sofamor Danek’s relationships with physicians worldwide.

  Medtronic Sofamor Danek is the leader in the use of biological materials, including the first product using a bioengineered bone morphogenetic protein, INFUSE, which was approved by the Food and Drug Administration (FDA) for use with titanium interbody implants in the lumbar spine.

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Russ Ellison, MD, Senior Pharmaceutical Executive Joins FibroGen as Vice President, Clinical Development

Leading Clinical Development of Novel Compounds for Anemia and Fibrosis

Life Science Partner announced today the recruitment of Russell Ellison, MD, to become Vice President, Clinical and Medical Affairs at FibroGen, a biotechnology-based drug discovery company using its expertise in the fields of tissue fibrosis and Hypoxia-Inducible Factor (HIF) biology to discover, develop and commercialize novel therapeutics for fibrotic disorders, anemia, ischemic disease, cancer and other areas of unmet medical needs.

FibroGen also develops and produces recombinant human collagens and gelatins using unique production technology that provides the basis for FibroGen’s proprietary cosmetic dermal filler and biomaterials supply business.

“Russ was attracted to FibroGen due to its extensive portfolio of compounds marching steadily toward the clinic and their potential to dramatically improve the lives of patients with anemia and other life-threatening diseases,” said Thomas H. Callaway, MD, Founder and President of Life Science Partner. “His combination of FDA regulatory experience and global medical affairs made him a perfect fit for this emerging pharmaceutical company,” he added.

Prior to his recruitment to FibroGen, Ellison was Vice President, Medical Affairs and Chief Medical Officer of Sanofi-Synthelabo USA, with responsibility for building its best-in-class medical affairs, regulatory and safety teams. He oversaw the clinical development of key products such as Plavix and Ambien, and was renown for reducing project development timelines and improving relations with managed care companies.

Ellison was recruited to Sanofi from Hoffmann La Roche. As Vice President, Medical Affairs and the Chief Medical Officer, he oversaw a 300-member organization that oversaw clinical trials, managed medical strategy, intervened on behalf of the company with regulatory agencies and developed clinical development strategies in sync with the company’s commercial strategies for its compounds in development. He was noted by his peers as a rare physician who understood the business aspects, as well as the clinical implications of the pharmaceutical industry.

A Canadian physician, Ellison has a global understanding of drug development and registration, as well as the challenges of reimbursement and clinical acceptance of new drugs. At FibroGen, his skills will be valuable as he builds the clinical and regulatory teams and moves the products from the pre-clinical to clinical development phase.

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Life Science Partner Announces Placement of Sara Toyloy at Medtronic Vascular

Life Science Partner announces the placement of Sara Toyloy, as vice president, regulatory affairs with Medtronic Vascular in Santa Rosa, California.

Toyloy will work with the senior staff, business units, and geographic areas to set worldwide strategic direction for quality, regulatory affairs, and clinical research.

Toyloy was most recently director, clinical and regulatory affairs for Guidant Vascular. Toyloy began her career in the medical device industry as toxicology and immunology technician with Northview Pacific Laboratories. She later moved into quality assurance, joining Advanced Cardiovascular Systems as preclinical research associate. Toyloy also participated in the development of the artificial heart in Salt Lake City.

Toyloy, who lives in the San Francisco area, earned her bachelor’s in biological sciences from California State University. She is a native of the island of St. Vincent in the Caribbean.

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