Tag Archive for: Regulatory

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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Rajesh Malik Chosen To Lead Clinical Development – Adherex

Life Science Partner places pharmaceutical veteran and oncology specialist as chief medical officer

ATLANTA, Georgia – September 7, 2004 – Life Science Partner announces the placement of Rajesh K. Malik, M.B., Ch.B. as chief medical officer at Adherex Technologies, Inc., in Research Triangle Park, North Carolina. With the position, Malik takes responsibility for the clinical development efforts behind Adherex’s growing portfolio of oncology products. He will

guide decisions about clinical utility, formulate regulatory strategies for the U.S. and Europe, lead the clinical trials design team, and promote physician advocacy. A biopharmaceutical company, Adherex discovers and develops cancer therapeutics through its pioneering platform for tumor vascular targeting.

“For Adherex, Raj was an exceptional find,” says Life Science Partner, Founder and President Thomas H. Callaway. “In addition to his original insights into anti-angiogenesis, which is at the core of Adherex’s product portfolio, he has a successful record of regulatory submission on three continents and he fully understands the commercialization process.”

A pediatric oncologist by training, Malik combines experience in cutting-edge academic research with strong business analytical skills and accomplishments in corporate pharmaceutical environments large and small.

Prior to Adherex, Malik was executive director at EMD Pharmaceuticals, a subsidiary of Germany-based Merck KGaA. As part of senior management at EMD, Malik led global project management for single oncology products and served on the company’s combined business and clinical operations team to guide global oncology product strategy.

As associate director at Bristol Myers Squibb, Malik held responsibility for the clinical development strategy for oral taxane worldwide and provided clinical oversight for Erbitux in Europe.

Malik also spent seven years as an assistant professor at the University of Virginia, where his research focused on signal transduction across the interface of integrins and extra cellular matrix.

Malik holds a medical degree from the School of Medicine and Biomedical Sciences at the University of Sheffield, Sheffield, U.K. He is licensed in pediatrics in North Carolina and Virginia.

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Life Science Partner Announces Four Major Placements for Medtronic during 2002

Thomas H. Callaway, MD, announces Life Science Partner’s completion of four major searches for Medtronic during 2002. The four executives recruited to the world’s leading medical device company include:

Reggie Groves, General Manager, Patient Management, Cardiac Rhythm Management – formerly Global Managing Partner, Enterprise Services, Scient.

Chris Hadland, Vice President, Quality, Medtronic Vascular – formerly VP, Operations and Quality of Timm Medical Technologies and Director, Regulatory Affairs, Mallinkrodt.

Sara Toyloy, Vice President, Regulatory Affairs, Medtronic Vascular – formerly Senior Director, Clinical and Regulatory Affairs, Guidant Vascular.

Scot Webster, Vice President, Quality, Medtronic Corporate – formerly GM, Global Compliance and Regulatory Affairs, GE Medical and Director Quality, GEMS Asia.

This list of new Medtronic senior managers joins a list of previous recruiting efforts including Pete Wehrly (Division President, Interbody Technologies, Medtronic Sofamor Danek), Jeff Balagna (CIO), Steve Oesterle (SVP, Medicine and Technology), and Bill Hawkins (President Vascular/SVP).

“As an emerging leader among recruiters in the life sciences industry, we value our relationship with key clients such as Medtronic who trust us to provide them with top-flight candidates and excellent services,” noted Tom Callaway.

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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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