The Oncotherix team has extensive drug development experience, including the design and conduct of clinical oncology studies, with a track record of strong and productive relationships with the FDA, EMEA, and other regulatory agencies. Together they have submitted 14 Investigational New Drug applications (INDs) and have received regulatory/commercial approval for 6 New Drug Applications (NDAs) and more than a dozen medical devices. They also have previous success with many of the regulatory strategies that will help accelerate InCell-RT development, including Fast Track, Orphan Drug, Priority Review and Accelerated Approval.

 

They have built development teams and early-stage companies from the ground floor, and launched numerous commercially successful pharmaceutical and device products. A few examples of previous executive-level success include Myogen (acquired by Gilead Sciences for $2.5B), Atrix Laboratories (acquired by QTL Inc. for $855M), COBE Cardiovascular (acquired by the Sorin Group for $260M), and Allos Therapeutics (NASDAQ: ALTH).

 

 

The Leadership Team – Experience with a Track Record of Success

Michael J. Gerber, MD − President and Board of Directors

Dr. Gerber has 19 years of experience in the biopharmaceutical industry. He most recently served as Senior Vice President, Clinical Research at Gilead Sciences. Prior to the acquisition of Myogen by Gilead, he was SVP, Clinical Development and Regulatory Affairs at Myogen. Dr. Gerber was responsible for the global development and accelerated NDA approval of Letairis® (ambrisentan) in June 2007 for the treatment of pulmonary arterial hypertension; the development of enoximone for chronic heart failure; and darusentan for hypertension. Prior to that he headed drug development at Allos Therapeutics and was responsible for the development of efaproxiral as a radiosensitizer for various cancers including malignant glioma and metastatic brain cancer. Earlier, he was Executive Director of Somatogen, a biopharmaceutical company developing recombinant human hemoglobin as a blood substitute. Dr. Gerber has submitted five INDs and one NDA, several Orphan Drug and Fast Track applications, and various EMEA regulatory submissions. As a corporate officer he participated in two IPOs (Allos 2000, Myogen 2003) and has helped raise more than $500 million in private and public equity offerings. He has participated in several in-licensing and out-licensing activities for cardiopulmonary and oncology products; as well as the acquisition of Myogen by Gilead in November 2006 for $2.5 billion. Dr. Gerber received his medical degree from the University of Colorado and is board certified in internal medicine, pulmonary and critical care medicine. He completed a postdoctoral fellowship in molecular biology. He is currently an Assistant Clinical Professor of Medicine at the University of Colorado.

 

William D. Dalke, BSME− Device Development and Business Development

Mr. Dalke has been in the medical device industry for more than 20 years in both R&D and business development, resulting in the commercialization of several medical products. Examples include the Angel™ and activAT™ autologous platelet concentration and thrombin systems for enhanced healing, the Revolution™ blood pump replacing heart function during cardiac surgical procedures, and the Synergy™ miniature cardiac bypass system reducing the adverse effects of cardiopulmonary bypass. He identified and completed due diligence both therapeutic and technology opportunities resulting in a number of licensing, distribution and supplier agreements. Mr. Dalke also developed strategic and financial criteria for identifying, evaluating, and screening key merger and acquisition opportunities. He organized and conducted due diligence, performed analysis, and completed agreements related to merger and acquisition activities. With a degree in mechanical engineering, Mr. Dalke began his medical career as a quality engineer with Cobe Cardiovascular, now a part of the Sorin Group. He then moved into research and development where he spent years developing products for cardiac surgical procedures and leveraging existing company technologies in emerging, non-cardiac therapies. Mr. Dalke is an inventor on a number of issued and pending patents related to cardiac perfusion. Most recently, Mr. Dalke has worked in the areas of research and development and business development culminating in positions as Vice President of Research and Development followed by Vice President of Business Development. Most recently he has served as a consultant in the medical device industry.

Christopher Dufton, PhD − Clinical Development and Regulatory Affairs

Dr. Dufton has more than 13 years of experience in clinical research and the biopharmaceutical industry. Most recently, he served as Director of Clinical Research at Gilead Sciences, where he led a cross-functional team responsible for post-launch development of Letairis® (ambrisentan) for the treatment of pulmonary hypertension and idiopathic pulmonary fibrosis. At Gilead, he designed and executed more than a dozen clinical trials, ranging from Phase 1 studies that leveraged product strengths in regulatory labeling to major event-driven outcome trials designed to expand commercial adoption of Letairis®. Prior to joining Gilead, Dr. Dufton led the ambrisentan clinical development program at Myogen where he was responsible for clinical and regulatory activities that led to the accelerated approval of Letairis® (ambrisentan) for the treatment of pulmonary arterial hypertension. At the University of Colorado School of Medicine, Dr. Dufton studied the pharmacology of high-dose chemotherapy agents in patients receiving autologous bone marrow transplantation and hematopoietic stem cell support. Dr. Dufton also conducted clinical research that focused on the use of ⁹⁰Yttrium-conjugated antibodies for the treatment of advanced breast cancer. Dr. Dufton earned his PhD at the University of Colorado at Boulder where he studied molecular signals responsible for cell fate determination in the developing vertebrate central nervous system. Most recently he has served as a clinical and regulatory consultant for the biopharmaceutical industry.

James E. Matsuura, PhD − Drug Manufacturing and Intellectual Property

Dr. Matsuura has more than 15 years of industry experience at Immunex, Biogen, Alza, and PR Pharmaceuticals. At PR Pharmaceuticals, unique drug delivery technologies were developed to formulate a variety of products including PulmoLARTM. At Alza, he was responsible for formulation development in the Duros® Implantable Pump (Omega interferon), Alzamer® Depot Gel and Macroflux® Transdermal drug delivery systems. At Biogen, he was responsible for formulation and process development through clinical manufacturing (for two immunomodulators), and due diligence and research of in-licensed molecules. While at Immunex he characterized the coiled-coil of CD40L protein and developed sustained release formulations of IL-1R, IL-4R and TNFR Fc. Dr. Matsuura has performed research and published in areas ranging from prostatic hyperplasia and prostate cancer, to pharmacology, toxicology, protein chemistry, formulation (of small molecules, peptides and proteins) and drug delivery (platforms include transdermal, injectable sustained release, implantable pumps, and catheter systems). He earned his PhD at the University of Colorado studying protein structural stability and its applications in pharmaceutical formulation and drug delivery. He is a registered patent agent and has served as a consultant in the areas of patent strategy, business development, formulation development, and drug delivery.

 

The Scientific Advisory Board – Innovative Pioneers to Help Guide Development

Maurie Markman, MD − Vice President of Patient Care Services and National Director of Medical Oncology at Cancer Treatment Centers of America, Philadelphia, PA

Dr. Maurie Markman is Vice President for Patient Care Services and National Director for Medical Oncology, Cancer Treatment Centers of America. For more than 25 years Dr. Markman has been engaged in clinical research in the area of gynecologic malignancies, with a particular focus on new drug development and exploring novel management strategies in female pelvic cancers. Prior to assuming his current position Dr. Markman served as Vice President for Clinical Research, University of Texas M.D. Anderson Cancer Center (Houston, TX). Additional previous positions include Director of the Cleveland Clinic Cancer Center, as well as Chairman, Department of Hematology/Medical Oncology at the Cleveland Clinic (Cleveland, OH), and Vice-Chairman, Department of Medicine, Memorial Sloan-Kettering Cancer Center (New York, NY). Dr. Markman has been the primary author, or co-author, on more than 1,000 published peer-reviewed manuscripts, reviews, book chapters, editorials or abstracts, and he has written, edited or co-edited 16 books on various topics in the management of malignant disease, including Atlas of Cancer and the most recent edition of Principles and Practice of Gynecologic Oncology. In addition, Dr. Markman has served on numerous editorial boards, including the Journal of Clinical Oncology and Gynecologic Oncology; and he is currently Editor-in-Chief of Oncology and Case Reports in Oncology.

Kevin O. Lillehei, MD − Chairman, Department of Neurosurgery, University of Colorado

Dr. Lillehei is an internationally recognized neurosurgeon with extensive experience in brain tumor clinical studies. He is Professor and Director of the Neuro-Oncology Program in the Department of Neurosurgery at the University of Colorado School of Medicine, and he directs the Neurosurgery clinics at University of Colorado Hospital. His Neurosurgery residency training was completed at the University of Michigan. Since coming to Colorado his clinical interests have centered on the treatment of central nervous system tumors, including pituitary tumors, benign and malignant gliomas, spinal cord tumors, acoustic neuromas, and complex skull base lesions. Dr. Lillehei also is Director of the Neurosurgery-Neuro-Oncology laboratory with his research interests revolving around the treatment of malignant gliomas. In particular, he is interested in the role of the immune system in intracranial tumor recognition and eradication. Dr. Lillehei also has expertise in the use of convection-enhanced delivery to introduce drugs and biological agents into malignant brain tissues, and he has extensive experience in pre-treatment planning, intra-operative device navigation, and stereotactic techniques to localize devices in the cerebral tissues. Dr. Lillehei is a co-inventor of three of Oncotherix's patents, and he is currently helping Oncotherix with device designs for the InCell-RT brain tumor system.

Svend O. Freytag, PhD − Division Head of Biology in Radiation Oncology, Henry Ford Health System, Detroit, MI

Dr. Freytag is Division Head of Biology in Radiation Oncology and Wendell W. Anderson Chair in Cancer at the Henry Ford Health System. Dr. Freytag has led research efforts in the Department of Radiation Oncology for the past 15 years, including research on gene and radiation cancer therapies, the molecular basis of cancer, and regulation of cell growth and differentiation. His leadership at Henry Ford has resulted in eight NIH grants/awards (including a recent P01 award), four investigator-initiated IND applications, six completed or ongoing clinical trials, eight clinical protocols, six IND-directed toxicology studies, one US patent on their lead product, and more than 65 peer-reviewed publications and book chapters. Prior to joining Henry Ford, Dr Freytag was a faculty member in the Department of Biological Chemistry at the University of Michigan Medical School. Dr Freytag earned a B.S. in biochemistry from Purdue University, received a Ph.D. in biochemistry at Case Western Reserve University School of Medicine, and completed a post-doctoral fellowship in molecular biology at Baylor College of Medicine. Dr Freytag's current research focuses on adenovirus-based suicide gene therapy in combination with radiation therapy for the treatment of prostate, brain, pancreas, and other cancers.

 

M. Abraham Kuriakose, MD, DDS − Professor and Director of Surgical Oncology, Chief of Head and Neck Oncology Services, Mazumdar Shaw Cancer Center, Narayana Hrudayalaya Medical City, Bangalore, India

Dr. Kuriakose is an internationally known surgical oncologist with extensive experience conducting clinical studies in patients with head and neck cancer. His research focuses on novel approaches to improve the control of locally-advanced cancers in the head and neck region, and cancers arising at the base of the skull. Dr. Kuriakose has expertise in pre-treatment planning, intra-operative navigation and stereotactic techniques to localize devices in the head and neck region. He also is investigating therapeutic strategies to eliminate cancer stem cells from these tumors. Prior to moving to the Amrita Medical Center, Dr. Kuriakose was Chief of Head and Neck surgery at New York University, where he now holds a part-time appointment. Dr. Kuriakose is advising Oncotherix on the development of InCell-RT device systems for the treatment of head and neck cancer.