Business Advisory Board Leader

 

Christopher Schaber

CEO, Soligenix, Inc

Christopher J. Schaber, Ph.D., has been the President and Chief Executive Officer at Soligenix, Inc. (Formerly DOR BioPharma Inc.) since August 30, 2006. Dr. Schaber has more than 29 years of  experience in the pharmaceutical and biotechnology industry. Prior to joining the company, Dr. Schaber served from 1998 to 2006 as an Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, preclinical and clinical research and medical affairs, as well as coordination of commercial launch preparation activities.

Previously, he held positions of Executive Vice President of Drug Development and Regulatory Compliance since April 1999 and Chief Development Officer and Vice President of Regulatory Affairs and Quality Assurance Quality Control since June 1998. From 1996 to 1998, he was a co-founder of Acute Therapeutics, Inc., and served as its Vice President of Regulatory Compliance, Quality Assurance and Drug Development. He served as a Director of Worldwide Regulatory Affairs and Operations for Ohmeda PPD, Inc. from 1994 to 1996.

Scientific Advisory Board

 

Keith Cengel, MD, PhD

Associate Professor of Radiation Oncology,
Hospital of The University Of Pennsylvania

Dr. Cengel is a leader in multiple clinical trials in cancer giving rise to a breakthrough in lifetime expectancy using Photodynamic therapy.  With 18+ years of experience in medicine, he has also conducted clinical trials in radiation therapy, Hodgkin’s Lymphoma, and pancreatic cancer.   His work uses insights gained from pre-clinical studies to design early phase interventional trials for patients with cancers that are difficult to treat using current standard modalities.  In addition to his clinical duties, he is engaged in research on modulating the therapeutic index of radiation therapy and photodynamic therapy.  He is engaged in defining the molecular mechanism of mutant K-Ras mediated radio resistance in human pancreatic and colorectal carcinoma cells.

Tim Zhu, PhD

Professor of Radiation Oncology,
Hospital of The University Of Pennsylvania

Dr. Zhu is heavily involved in clinical trials and is an ABR and ABMP board-certified medical physicist (PhD in Physics).  He is the associate director of PDT Physics, in charge of all PDT related physics aspect of PDT clinical protocols. His specialty includes external beam radiation therapy, IGRT/IMRT, PDT, small field dosimetry, MU calculations, TSE/TBI, in-vivo radiation dosimetry, and Machine QA.  His research focuses on PDT physics, in-vivo dosimetry, and external beam treatment planning. The first area involves the development of explicit and implicit dosimetry of PDT and light fluence rate calculation. The second area involves the development of diode in-vivo dosimetry for point dose, EPID and Cherenkov imaging for real-time and planar dose of Radiation beams. The third area involves development of benchmark database for external beams (electron, photon, and proton) and image co-registrations. As a board certified Physicist in radiation oncology, he has been involved in the development of computational treatment planning system for external beams, medical imaging registration, radiation dose calculation, and patient motion monitoring

Theresa Busch, PhD

Professor and Associate Director of Radiation Biology Division of Oncology Research,
Hospital of The University Of Pennsylvania

Dr. Busch has performed translational research in the study of tumor microenvironment as it relates to Photodynamic therapy for more than 20 years.  She has characterized the physiologic (oxygenation and blood flow), pharmacologic (Photosensitizer levels), and dosimetric (light distribution) properties of tumors undergoing PDT that predict for effective therapy versus early recurrence.  This includes work in many murine models of cancer.  Moreover, her research extends to studies of tumor physiology and PDT dosimetry as a part of multiple clinical trials of PDT at the University of Pennsylvania.  Her research centers on the study of biophysical limitations of treatment response to PDT. This includes the study of heterogeneities in the distributions of oxygen, photosensitizing drug, and light.   Furthermore, noninvasive monitoring has shown PDT effect on tumor oxygenation and blood flow during the illumination period to be predictive of an animal’s long-term response to therapy. Such findings are extremely relevant to clinical PDT applications, where significant heterogeneity in hypoxia and photosensitizer distributions among the tumors of PDT patients will contribute to variable therapeutic outcomes. Indeed, she has documented a relationship between biochemical (PSA) response to PDT in prostate cancer patients and levels of photosensitizer drug and light energy in their prostates.

Regulatory

 

Susan Alpert, MD, PhD

SLA Consultants

Dr. Albert previously served as senior vice president, chief regulatory officer at Medtronic and was responsible for all of the company’s global regulatory efforts. Prior to joining Medtronic, Dr. Alpert served as vice president of regulatory sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the director of the Office of Device Evaluation. She is a former director of the FDA's Office of Device Evaluation. She serves on the board of advisors for the Medical Technology Leadership Forum (MTLF) and is also a past Chair of the Regulatory Affairs Professional Society and a Fellow in that society. Dr. Alpert also serves on the Executive Committee of the Clinical Trials Transformation Initiative (CTTI).

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