B

Speaker and Planning Committee Biographies

Anna D. Barker, Ph.D., served as the Deputy Director of the National Cancer Institute (NCI) and as the NCI’s Deputy Director for Strategic Scientific Initiatives until September 2010. She was a member of the Executive Committee of the NCI and participated in all aspects of strategic planning, decision making, and program implementation to achieve the NCI’s mission. Dr. Barker has led the planning, development, and implementation of a number of strategic scientific and technology initiatives and partnerships that emphasize innovation, trans-disciplinary teams, and convergence of scientific disciplines to enable progress against cancer. These programs also stress the development and application of advanced technologies, the synergy of large scale and individual initiated research, novel partnerships, and translation of discoveries into new interventions to detect, prevent, and treat cancer more effectively.

At the NCI Dr. Barker collaborated on the planning and implementation for the Institute’s major initiative in bioinformatics (the Cancer Bioinformatics Grid); planned and initiated an NCI-wide program to establish biospecimen standards and best practices; and planned and launched the Clinic Proteomics Technology Initiative for Cancer that is focused on the development, standardization, and deployment of the technologies, reagents, and protocols needed to enable the systematic and reproducible identification of cancer biomarkers. She also co-developed The Cancer Genome Atlas (TCGA) Pilot Program jointly with the National Human Genome Research Institute (NHGRI). TCGA’s long term goal is to define all significant genetic changes in most if not all cancers. The pilot phase



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B Speaker and Planning Committee Biographies Anna D. Barker, Ph.D., served as the Deputy Director of the National Cancer Institute (NCI) and as the NCI’s Deputy Director for Strategic Sci- entific Initiatives until September 2010. She was a member of the Execu- tive Committee of the NCI and participated in all aspects of strategic planning, decision making, and program implementation to achieve the NCI’s mission. Dr. Barker has led the planning, development, and imple- mentation of a number of strategic scientific and technology initiatives and partnerships that emphasize innovation, trans-disciplinary teams, and convergence of scientific disciplines to enable progress against cancer. These programs also stress the development and application of advanced technologies, the synergy of large scale and individual initiated research, novel partnerships, and translation of discoveries into new interventions to detect, prevent, and treat cancer more effectively. At the NCI Dr. Barker collaborated on the planning and implementa- tion for the Institute’s major initiative in bioinformatics (the Cancer Bioin- formatics Grid); planned and initiated an NCI-wide program to establish biospecimen standards and best practices; and planned and launched the Clinic Proteomics Technology Initiative for Cancer that is focused on the development, standardization, and deployment of the technologies, reagents, and protocols needed to enable the systematic and reproducible identification of cancer biomarkers. She also co-developed The Cancer Genome Atlas (TCGA) Pilot Program jointly with the National Human Genome Research Institute (NHGRI). TCGA’s long term goal is to define all significant genetic changes in most if not all cancers. The pilot phase 89

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90 NANOTECHNOLOGY AND ONCOLOGY of this program has demonstrated “proof of concept” for large scale dis- ease focused genomics and will move to an expanded phase in late 2009. In addition, under her leadership the NCI planned and deployed the Nanotechnology Alliance for Cancer, a major network in cancer nanotech- nology dedicated to the development and application of nanotechnolo- gies to areas ranging from new generation diagnostics to drug delivery and imaging. More recently, Dr. Barker led a planning effort to enable the convergence of the physical sciences (physics, mathematics, physical chemistry, and engineering) with cancer biology. As a result the NCI will establish a network of Physical Oncology Centers to provide physical scientists and cancer biologists the opportunity to collaboratively study cancer at all scales. All of these programs broadly engage the extramural cancer research communities. She co-led with the FDA the establishment of the NCI–FDA Inter- agency Oncology Task Force (IOTF). The focus of the IOTF is the identifi- cation of scientific and process gaps in the regulatory pathways for cancer interventions—and joint science-based approaches to addressing these barriers. Dr. Barker also leads the NCI’s efforts in strategic international research programs in Latin America and China. Dr. Barker has a long history in research and the leadership and management of advanced research and development in the academic, non-profit, and private sectors. She served as a senior executive at Battelle Memorial Institute for 18 years where she developed and led large groups of scientists and technical staff working in drug discovery and develop- ment, pharmacology, clinical trials, and biotechnology, including several NCI sponsored research programs. As a Senior Vice President at Battelle, she pioneered several programs in cancer research in collaboration with the NCI, including the use of advanced research models for evaluating new drug candidates and novel models for pharmacologic and toxico- logical evaluation. In the private sector, she was a co-founder and CEO of a public biotechnology company focused in experimental therapeutics development of novel agents to control reactive oxygen damage; and a private cancer technology company. She has served as a member of the National Coalition of Cancer Research; a Partner and member of the Board of Directors of C-Change; chairperson of the C-Change Cancer Research Team; founding mem- ber of the Department of Defense (DOD) Breast Cancer Research Pro- gram (BCRP) Integration Panel and chairperson of the BCRP Integration Panel; in a number of capacities for the American Association for Cancer Research (AACR), including the Board of Directors and chairperson of the Public Science Policy and Legislative Affairs Committee for over 10 years; a member of the NCI’s Board of Scientific Counselors, Division of Cancer Etiology, and chairperson of the Cancer Center Support Review Study

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91 APPENDIX B Section; member of private boards of directors; and in varying capacities for a number of additional organizations. Dr. Barker has received a num- ber of awards for her contributions to cancer research, cancer patients, professional and advocacy organizations, and the ongoing national effort to prevent and cure cancer. Dr. Barker completed her M.A. and Ph.D. at the Ohio State Univer- sity, where she trained in immunology and microbiology. Her research interests include experimental therapeutics, tumor immunology, and free- radical biochemistry in cancer etiology and treatment. Edward J. Benz, Jr., M.D., is a pioneering academic hematologist whose early work, showed that messenger RNA defects caused a common con- genital anemia, thalassemia. This was the first demonstration that molecu- lar biology could be applied to the study of human diseases. He has subsequently achieved international renown for his research in the area of human red cell disorders, gene regulation, and membrane biology. He remains an active NIH funded investigator and clinician. As an educator, Benz has been an active teacher and mentor through- out his career. He has trained over 50 mentees in his laboratory, many of whom now hold senior faculty or leadership positions in academia, industry, or private practice. In recognition of his contributions as a men- tor, he was named winner of the 2007 American Society of Hematology Mentoring Award in Basic Science. Benz also has had an impact as a national leader, having served as president of the prestigious American Society of Clinical Investigation and president of the American Society of Hematology. Currently, he is the President of the Association of American Cancer Institutes. He has co-edited the top-rated textbook in the field of hematology, and educated an entire generation about the application of molecular biology to clini- cal medicine through his lectures, review articles, and book chapters. In November of 2000, Dr. Benz was appointed President of Dana-Farber Cancer Institute. He holds the Richard and Susan Smith Professorship in Medicine and is a Professor of Pediatrics and a Professor of Pathology at Harvard Medical School. Steven A. Curley, M.D., is Professor of Surgery, the Charles B. Barker Chair in Surgery, Program Director of the Gastrointestinal Multidisci- plinary Care Center, Chief of Gastrointestinal Tumor Surgery, and Director of the Surgical Oncology Fellowship Program at the University of Texas MD Anderson Cancer Center. Dr. Curley received his undergraduate edu- cation at the University of New Mexico, where he graduated Magna Cum Laude, Phi Beta Kappa with a Bachelor of Science degree in Biology and Biochemistry. He received his medical degree at the University of Texas

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92 NANOTECHNOLOGY AND ONCOLOGY Medical School at Houston, being elected to Alpha Omega Alpha as a junior, and then completed a general surgery residency at the University of New Mexico in Albuquerque. Following residency, he completed a fellowship in surgical oncology at the University of Texas MD Anderson Cancer Center, where upon completion of his fellowship, he joined the faculty. Dr. Curley is a Fellow of the American College of Surgeons and serves in the following groups: Colorectal Cancer Collaborative Clinical Trials, Colorectal Cancer Commission on Cancer Fellowship, Commission on Cancer Liver Disease Site Team, and the American College of Surgeons Hepatobiliary Oncology Group. Dr. Curley’s major areas of interest are surgical treatments for patients with primary and metastatic liver cancers; the role of hepatitis B and C virus in hepatocellular cancer tumorigen- esis; the development of novel treatment approaches for patients with primary and metastatic liver malignancies; neoadjuvant and adjuvant treatment approaches in patients with primary and metastatic hepatobili- ary malignancies; and the development of targeted nanoparticle therapies in patients with advanced malignant diseases. Dr. Curley pioneered the clinical studies leading to FDA approval of radiofrequency ablation to treat unresectable primary and metastatic hepatobiliary malignancies. This has led to multidisciplinary trials to combine resection and radio- frequency ablation with adjuvant and neoadjuvant systemic and regional treatment to further improve patient outcome. He has been involved in the development of radiofrequency ablation equipment and treatment algorithms for patients with unresectable primary and metastatic hepatic malignancies. He has developed novel surgical techniques that have sig- nificantly reduced blood loss and operative time associated with major liver resections. He is principal investigator (PI) on a phase I/II trial studying ADI-PEG 20, a novel targeted drug therapy to treat patients with unresectable cancer. He has initiated a new basic science research program to study biodistribution of carbon nanotubules and gold nanoparticles in normal and tumor tissue, and to use carbon nanotubules and gold nanoparticles as targeted therapy to treat malignant tumors with a novel external radiofrequency field generator. He is also PI of a program to screen high-risk hepatitis B and C virus patients for hepatocellular cancer in the Campania region of Italy. This study has been awarded a European Community Grant to extend the study to other high-risk areas in Europe. Dr. Curley has successfully translated from basic and preclinical studies human clinical trials for hepatic isolation infusion treatments for unresect- able hepatocellular cancer and direct intratumoral injection of a collagen matrix mixed with chemotherapeutic agents. Dr. Curley has served a term as Chairman of the Graduate Medical Education Committee at the Uni- versity of Texas MD Anderson Cancer Center and is currently the Course Director of the Research Ethics seminars and a member of the Clinical

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93 APPENDIX B Council Subcommittee on Clinical Research Funding. Dr. Curley serves as an Associate Section Editor for the Annals of Surgical Oncology. He is also a member of the Editorial Boards for the following journals: Annals of Surgical Oncology, The Cancer Bulletin, International Journal of Surgical Sciences, Cancer Reports, Bulletin of the National Cancer Institute of Italy, Euro- pean Journal of Surgical Science, International Journal of Surgical Investigation. Neil P. Desai, Ph.D., is currently senior vice president of Global Research and Development at Abraxis Bioscience, in Los Angeles, California, where he is responsible for the development of the company’s grow- ing product pipeline and the development of the company’s intellectual property portfolio. Dr. Desai is an inventor of ABI’s nanotechnology and nanoparticle–albumin bound (nabTM) drug delivery platform, was pri- marily responsible for the development of its nantechnology drug, Abrax- ane, and the discovery of the novel targeted biological pathway utilized by nabTM-drugs. This platform has been clinically proven to enhance the efficacy and safety of cytotoxic drugs through a novel targeted biologi- cal pathway and is the first protein-based nanotechnology product to be approved by the FDA for the treatment of cancer. Prior to joining ABI in 1999, Dr. Desai was senior director of biopoly- mer research at VivoRx, Inc., and VivoRx Pharmaceuticals, Inc. (prede- cessor companies of ABI), where he worked on the early discovery and development of Abraxane, developed novel encapsulation systems for living cells, and was part of the team that performed the world’s first suc- cessful encapsulated islet cell transplant in a diabetic patient. Dr. Desai has more than 20 years of experience in the research and development of novel drug delivery systems and biocompatible poly- mers. He holds over 100 issued patents and peer-reviewed publications and has made over 150 presentations at scientific meetings. Dr. Desai holds an M.S. and Ph.D. in chemical engineering from the University of Texas at Austin, and a B.S. in chemical engineering from the University Institute of Technology in Mumbai, India. Joseph M. DeSimone, Ph.D., is the Chancellor’s Eminent Professor of Chemistry at the University of North Carolina at Chapel Hill and William R. Kenan Jr. Professor of Chemical Engineering at North Carolina State University. DeSimone is also an Adjunct Member at Memorial Sloan- Kettering Cancer Center in New York. DeSimone has published over 270 scientific articles and has over 115 issued patents in his name with over 120 patents pending. In 2005, DeSimone was elected into the National Academy of Engi- neering and the American Academy of Arts and Sciences. DeSimone has received 40 major awards and recognitions including the 2009 NIH Direc-

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94 NANOTECHNOLOGY AND ONCOLOGY tor’s Pioneer Award; the 2009 North Carolina Award, the highest honor the State of North Carolina can bestow to recognize notable achievements of North Carolinians in the fields of Literature, Science, the Fine Arts, and Public Service; the $500,000 Lemelson–MIT Prize for Invention and Inno- vation; the 2008 Tar Heel of the Year by the Raleigh News & Observer; the 2007 Collaboration Success Award from the Council for Chemical Research; the 2005 ACS Award for Creative Invention; the 2002 John Scott Award presented by the City Trusts, Philadelphia, given to “the most deserving” men and women whose inventions have contributed in some outstanding way to the “comfort, welfare and happiness” of mankind; the 2002 Engi- neering Excellence Award by DuPont; the 2002 Wallace H. Carothers Award from the Delaware Section of the ACS; 2000 Oliver Max Gardner Award from the University of North Carolina, given to that person, who in the opinion of the Board of Governors’ Committee, “. . . during the current scholastic year, has made the greatest contribution to the welfare of the human race.” Among DeSimone’s notable inventions is an environmentally friendly manufacturing process that relies on supercritical carbon dioxide instead of water and bio-persistent surfactants (detergents) for the creation of fluoropolymers or high-performance plastics, such as Teflon®. In 2002, DeSimone, along with Dr. Richard Stack, a cardiologist at Duke, co- founded Bioabsorbable Vascular Solutions (BVS) to commercialize a fully bioabsorbable, drug-eluting stent. BVS was acquired by Guidant Corpora- tion in 2003 and these stents are now being evaluated in a series of inter- national clinical trials led by Abbott, enrolling over 1,000 patients as of November 2009, for the treatment of coronary artery disease. With the PRINT technology developed in the DeSimone lab, DeSimone’s group is now heavily focused on bringing the precision, uni- formity, and mass production techniques associated with the fabrication of nanoscale features found in the microelectronics industry to the nano- medicine field for the fabrication and delivery of vaccines and therapeu- tics for the treatment and prevention of diseases. DeSimone recently launched Liquidia Technologies (www.liquidia. com) which now employs almost 50 people in Research Triangle Park and has raised over $50 ,million in venture financing. DeSimone’s laboratory and the PRINT technology recently became a foundation for the new $20 million Carolina Center for Cancer Nanotechnology Excellence funded by the National Cancer Institute. DeSimone received his B.S. in Chemistry in 1986 from Ursinus College in Collegeville, PA and his Ph.D. in Chemistry in 1990 from Virginia Tech. Ruth Duncan, Ph.D., Professor of Cell Biology and Drug Delivery, was until September 2008 (when she retired from the University) at the Welsh

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95 APPENDIX B School of Pharmacy, Cardiff University, UK where she was Director of the Centre for Polymer Therapeutics. She currently sits on a number of institutional and international advisory boards and committees, and she holds the honorary positions of Professor Emerita in Cardiff University and Visiting Professor at the University of Greenwich. After Ph.D. studies at Keele University on the mechanism of endo- cytosis (1979), she established an interdisciplinary group (CRC Polymer Controlled Drug Delivery Group) interested in the rational design of polymeric anticancer conjugates. Later after joining Farmitalia Carlo Erba (became Pharmacia) in Milan as Head of New Technologies, she was involved the Project Team Leader responsible for transfer of the first polymer anticancer conjugates and imaging agents arising from this work into clinical trial. She has contributed more than 250 scientific articles and patents, and has been a recipient of many awards including the Pfizer Research Award for Pharmaceutical Sciences, Young Investigator Award of the Controlled Release Society, the Interdisciplinary Award of the Royal Society for Chemistry UK, the Berlin-Brandenburg Academy of Sciences Monika Knutzner Award for Innovative Cancer Research, a Prin- cess Takamatsu Cancer Foundation Lecturer, and the GSK International Achievement Award. In 2009, she received The APSTJ Nagai International Woman Scientist Award and was made a Fellow of the Association of Pharmaceutical Science and Technology (APSTJ) Japan. She is also an elected corresponding member of the Academy of Sciences and Literature, Mainz. In 1996, she established the ongoing series of biennial International Conferences on Polymer Therapeutics: From Laboratory to Clinic (latest 2010 Valencia, Spain). She was elected Co-Chair of the Gordon Research Conference on Drug Carriers in Biology and Medicine in 1998, and in 2004 was elected the Science Chair of the British Pharmaceutical Conference. Ruth Duncan chaired the Steering Committee of the European Science Foundation’s Forward Look on Nanomedicine (2005). She has also acted as Co-Chair of the European Science Foundation Research Conferences (2006 and 2008) and Summer Schools in Nanomedicine (2007 and 2009) and continues to promote interdisciplinary Nanomedicine Research Con- ferences and Training Schools. She is a past member of the CPS subcommittee of the UK Medicines and Health Regulatory Agency and is currently a member of the Euro- pean Medicines Agency AD Hoc Advisory Committee on Nanomedi- cine and the EC DG SANCO SCENHIR working group for definition of “Nanomaterials.” Mauro Ferrari, Ph.D., serves as President and CEO of The Methodist Hospital Research Institute, where he holds the Ernest Cockrell Jr. Distin-

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96 NANOTECHNOLOGY AND ONCOLOGY guished Endowed Chair. He is also Professor of Internal Medicine at the Weill Cornell Medical College, Adjunct Professor of Experimental Thera- peutics at the University of Texas MD Anderson Cancer Center, Professor of Bioengineering at Rice University, Adjunct Professor of Biomedical Engineering at UT Austin, and President of The Alliance for NanoHealth in Houston. Dr. Mauro Ferrari is a founder of biomedical nano/micro-technology, especially in their applications to drug delivery, cell transplantation, implantable bioreactors, and other innovative therapeutic modalities. In these fields, he has published more than 200 peer-reviewed journal arti- cles and 6 books. He is the inventor of more than 30 issued patents, with about thirty more pending in the United States and internationally. His contributions have been recognized by a variety of accolades, including: the Presidential Young Investigator Award of the National Science Foun- dation; the Shannon Director’s Award of the National Institutes of Health; the Wallace H. Coulter Award for Biomedical Innovation and Entrepre- neurship; and the Italiani nel Mondo Award from the Italian Ministry of Foreign Affairs. His career research and development portfolio totals over $50 million, including support from the NCI, NIH, DoD, NASA, NSF, DARPA, DoE, the State of Texas, and the State of Ohio, The Ohio State University, and several private enterprises. He began his academic career at the University of California, Berkeley, where he tenured in Material Science, Civil Engineering, and Bioengineering. Upon recruitment to the Ohio State University, he served as the Edgar Hendrickson Professor of Biomedical Engineering, Professor of Internal Medicine, Mechanical Engi- neering, Materials Science and Associate Vice President, Health Sciences Technology and Commercialization, Associate Director of the Dorothy M. Davis Heart and Lung Research Institute and Director of the Biomedical Engineering Center. Upon recruitment to Houston, he served as Professor and Chair of the Department of Nanomedicine at the University of Texas Health Science Center. Dr. Ferrari also served as Special Expert on Nanotechnology at the National Cancer Institute in 2003–2005, providing leadership into the formulation, refinement, and approval of the NCI’s Alliance for Nano- technology in Cancer, currently the world’s largest program in medical nanotechnology. Dr. Ferrari’s degrees are in Mathematics (Padova, 1985, Italy), and Mechanical Engineering (U.C. Berkeley, M.S. 1987, and Ph.D. 1989). He attended medical school at the Ohio State University (2002–2003). Dr. Ferrari is an academic–entrepreneur, with several companies that originated from his laboratory. He currently serves on the Board of Direc- tor three companies: Nanomedical Systems of Austin TX; Leonardo Bio- systems of Houston Texas, and Arrowhead Research Corporation.

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97 APPENDIX B Rogério Sá Gaspar, Ph.D., is currently Full Professor in Pharmaceutics at the Faculty of Pharmacy at the University of Lisbon and Member of the Coordination Board of iMed.UL, in which he also coordinates the Nano- medicine & Drug Delivery System research unit. He is currently also a consultant to the pharmaceutical industry. Early in his career, both at the University of Coimbra and whilst undertaking his Ph.D. studies at the Université Catholique de Louvain in Brussels, he developed an interest in advanced drug delivery systems. He has continued to work in this area, and he has more than 20 years experience in the design and evaluation of nanoparticles and liposomes for drug (e.g., Leishmaniasis and cancer) and nucleic acid (cytosolic) delivery. At the University of Coimbra he integrated the CNC (Centre for Neurosciences and Cell Biology, Depart- ment of Biotechnology and Molecular Biology) where he started in 1994 the Drug Carriers Unit. Throughout his career, Rogério Gaspar was also called upon to sup- port the development of Portuguese medicines regulatory strategy with his participation on numerous national and European committees, includ- ing his role as Vice-chairman of the Medicines National Committee and Vice-chairman of the Management Board at INFARMED (1996–1999 and 2000–2002 respectively) or as an advisory expert of the European Medi- cines Agency (EMEA) and member of CPMP (now CHMP) in the period 1995–1999. In 2000 Gaspar was chairman of the Working Group on Human Medicines of the European Council (European Union) that concluded the political agreement on the European Clinical Trials Directive (2000). In 2000–2002 he was also member of the Management Board of EMEA. These aspects that give a unique perspective of both nanomedicines research and development and the regulatory process and are responsible for frequent invitations for conferences and working groups in Europe, Asia, and USA (including FDA workshop in nanotechnology, March 2008). In addition, Rogério Gaspar was Chairman of the Spanish–Portuguese Local Chapter of the Controlled Release Society (2002–2005), and member of the expert panel that developed the European Science Foundation’s Forward Look on Nanomedicine (2003–2005). Co-chairman of the 2006 ESF Conference on Nanomedicine, he also chaired the next European Research Conference on Nanomedicine (European Science Foundation, 2008) and chaired the ESF Summer School for advanced Training in Nano- medicine held in Lisbon 2009. After more than 21 years at the University of Coimbra he is since 2006 at the University of Lisbon, where he is starting a number of projects along his main research interests (cancer and inflammation). Piotr Grodzinski, Ph.D., is Director of NCI Alliance for Nanotechnology in Cancer at the National Cancer Institute in Bethesda, Maryland. He

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98 NANOTECHNOLOGY AND ONCOLOGY coordinates program and research activities of the Alliance which dedi- cated $144 million over 5 years to form interdisciplinary centers as well as fund individual research and training programs targeting nanotechnology solutions for improved prevention, detection, and therapy of cancer. Dr. Grodzinski is a materials scientist by training, but like many others found biotechnology and nanotechnology fascinating. In the mid- nineties, he left the world of semiconductor research and built a large microfluidics program at Motorola Corporate R&D in Arizona. The group made important contributions to the development of integrated micro- fluidics for genetic sample preparation with its work being featured in Highlights of Chemical Engineering News and Nature reviews. After his tenure at Motorola, Dr. Grodzinski was with Bioscience Division of Los Alamos National Laboratory where he served as a Group Leader and an interim Chief Scientist for DOE Center for Integrated Nanotechnologies (CINT). In his current capacity at the National Institutes of Health (NIH), he is also co-chairing Trans-NIH Nanotechnology Task Force, which is coordinating the nanotechnology efforts across 27 institutes of the agency with the budget over $200 million per year. Dr. Grodzinski received his Ph.D. in Materials Science from the Uni- versity of Southern California, Los Angeles in 1992. He is an inventor on 15 patents and published 47 peer-reviewed papers, 7 book chapters, and delivered over 100 invited conference presentations. Dr. Grodzinski has been an invited speaker and served on the committees of numerous bio- and nano-MEMS conferences in the past years. Ernest T. Hawk, M.D., M.P.H., head of MD Anderson’s Division of Can- cer Prevention and Population Sciences, leads a division of nearly 500 employees including approximately 80 faculty members within four departments, three centers, and the recently established Duncan Fam- ily Institute for Cancer Prevention and Risk Assessment. The Institute’s resources are helping scientists to accelerate the pace of discovery and the translation of findings to the clinic and community, advancing MD Ander- son’s mission in cancer prevention research, practice, and education. Dr. Hawk was named Boone Pickens Distinguished Chair for Early Prevention of Cancer at MD Anderson in December 2009. Prior to joining the institution in December 2007, he held several positions at the National Cancer Institute (NCI) in Bethesda, Maryland. He began work at NCI in 1996 and most recently served as director of the Office of Centers, Training, and Resources. His other NCI posts included chief and medical officer in the Gastrointestinal and Other Cancers Research Group, medi- cal officer in the Chemoprevention Branch, and chair of the Translational Research Working Group. He has been involved in a wide range of preclinical and clinical

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99 APPENDIX B chemoprevention research, including studies of nonsteroidal anti-inflam- matory drugs, COX-2 inhibitors, and agent combinations. He has earned numerous awards for his work, including the prestigious NCI Research Award for Distinguished Achievement in Cancer Prevention. A native of Detroit, Michigan, Dr. Hawk earned his bachelor’s and medical degrees at Wayne State University and his master of public health degree at Johns Hopkins University. He completed an internal medicine internship and residency at Emory University, a medical oncology clini- cal fellowship at the University of California, San Francisco, and a cancer prevention fellowship at NCI. Dr. Hawk has served as a peer reviewer for 30 different scientific and medical journals; has authored more than 120 articles in leading books and journals including the New England Journal of Medicine, JNCI, Gas- troenterology, Journal of Clinical Oncology, and Circulation; and currently serves as deputy editor for Cancer Prevention Research and member of the scientific advisory committee for Prevention Magazine. James R. Heath, Ph.D., is the Elizabeth W. Gilloon Professor and Pro- fessor of Chemistry at Caltech, and Professor of Molecular & Medical Pharmacology at UCLA, and Director of the National Cancer Institute’s NanoSystems Biology Cancer Center. Heath received a B.Sc. degree in 1984 (Baylor University) and his Ph.D. in Chemistry (Rice University) in 1988 where he was the principal student involved in the Nobel Prize–winning discovery of C60 and the fullerenes. Heath was a Miller Fellow at the University of California, Berkeley, from 1988–1991, and on the Technical Staff at IBM Watson Labs from 1991–1993. In 1994 he joined the faculty at UCLA. He founded the California NanoSystems Institute in 2000 and served as its Director until moving to Caltech. Heath has investigated quantum phase transitions, and he has developed architectures, devices, and circuits for molecular electronics. His group has recently been applying their advances on nano- electronics circuitry toward addressing problems in cancer. He has received a number of awards, including a Public Service Commendation from Governor Gray Davis, the Sackler Prize, the Spiers Medal, the Feynman Prize, the Jules Springer Prize, and the Arthur K. Doolittle Award. He has founded or co-founded several companies, including NanoSys, MTI, MoB, and Homestead Clinical Corporation, and he serves on the board of a number of organizations, including the Board of Scientific Advisors of the National Cancer Institute. Lee Josephson, Ph.D., focuses his research on the chemistry and design of multimodal imaging agents (agents detectable by two modalities), including fluorescent, radioactive, and magnetic nanoparticle probes.

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100 NANOTECHNOLOGY AND ONCOLOGY They have designed a class of reagents termed MSAP’s, or Multimodal, Single Attachment Point reagents, that permit the attachment of multiple reporter groups (fluorochromes, chelates, polymers) at a single point of a targeting substrate. The targeting substrate can be a peptide, protein, or drug. MSAP reagents permit the synthesis of complex, multimodal imag- ing agents in a single step and through the modification at a single site of a targeting substrate. A second, related research interest is development of multimodal probes for imaging cell death. These include the magneto/fluorescent nanoparticle, Anx-CLIO(Cy5.5), a magneto/fluorescent nanoparticle for imaging the phosphatidylserine expressed on apoptotic cells. Another multimodal probe developed for imaging cell death is GadoTO. GadoTO consists of a vital fluorochrome (TO-PRO 1) to which a reporter gado- linium chelate has been attached. GadoTO is the first of a new class of agents termed multimodal vital fluorochromes (MVFs). MVFs consist of two parts: (i) a vital fluorochrome that permeates the porous membranes of necrotic cells and is then retained with cells by binding DNA, and, (ii) a paramagnetic or radioactive reporter that makes the MVF detectable by PET, MRI, or SPECT. An understanding of biology of the cell death response, as it pertains to the binding of the probes they have synthesized, is an important interest of my laboratory. A third research interest is the synthesis and activity self-activating viridin (SAV) prodrugs. These inactive polymeric prodrugs slowly release viridins like wortmannin. SAV prodrugs are highly effective in three classes of animal models; those for asthma, arthritis, and cancer xeno- grafts. SAV prodrugs have been synthesized with multiple fluorescent reporters so that the disposition of the fate of the various components of the prodrug can be monitored in vivo. Kristen Kulinowski, Ph.D., is a Faculty Fellow in the Department of Chemistry at Rice University and Director for External Affairs for the Center for Biological and Environmental Nanotechnology (CBEN). She currently serves as the Director of the International Council on Nanotech- nology (ICON), an international, multi-stakeholder organization whose mission is to develop and communicate information regarding potential environmental and health risks of nanotechnology thereby fostering risk reduction while maximizing societal benefit. She has experience as a chemical researcher, educator, curriculum developer, administrator, out- reach coordinator, and policy fellow. Since 2004, Dr. Kulinowski has been actively engaged in developing and promoting the International Council on Nanotechnology (ICON) which provides a neutral forum in which experts from academia, gov- ernments, industry, and nonprofit organizations can explore questions of

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101 APPENDIX B nanotechnology’s impact on environment, health, and safety (EHS). She directed an effort that resulted in the web publication of the first publicly available database of citations to peer-reviewed papers on nano EHS. Other activities of ICON include a survey of best practices for nanoma- terial handling in the workplace and a public portal of information on nanotechnology EHS. Dr. Kulinowski has extensive experience in science education, partic- ularly in developing innovative curricula at the undergraduate level, and developed Rice’s first introductory undergraduate course on nanotechnol- ogy. From 2002–2004 Dr. Kulinowski served as CBEN Executive Director for Education, developing and managing an educational outreach portfo- lio of programs for audiences that range from middle school children to adults. During this time the center established itself as a national leader in nanotechnology educational outreach. Prior to joining CBEN, she was a lecturer in chemistry at California Polytechnic State University, San Luis Obispo, for three years and came to Rice as an instructor in chemistry in 1998. In 2001, she was selected by the Optical Society of America and SPIE—The International Society for Optical Engineering—as their Congressional Science Fellow and worked in the DC office of a member of the US House of Representatives on issues including weapons of mass destruction, anti-terrorism legislation, and domestic nuclear power security. She was instrumental in shepherd- ing through new legislation on the stockpiling of potassium iodide near nuclear power plants. As a longtime volunteer with American Red Cross Disaster Relief Services, Dr. Kulinowski brought food and water to rescue workers at the Pentagon on September 11, 2001. Dr. Kulinowski is highly sought after as a speaker and has given invited talks on issues of nanotechnology environmental health and safety and science policy throughout the US, Europe, and the Middle East. She has consulted with governments and governmental advisory bod- ies regarding responsible nanotechnology, and she serves as chair of the ASTM International Subcommittee E56.03 on Environment, Health, and Safety. Dr. Kulinowski earned a B.S. in chemistry at Canisius College and her M.S. and Ph.D. in chemistry at the University of Rochester. King C. Li, M.D., F.R.C.P., M.B.A., graduated from Faculty of Medicine, University of Toronto in 1981 and finished his residency in 1986 also at the University of Toronto. Dr. Li is currently a Professor of Radiology at Weill Medical College of Cornell University and MD Anderson Foundation Distinguished Chair of Radiology at the Methodist Hospital in Houston, Texas. Before joining the Methodist he was the Associate Director of the NIH Clinical Center and the Chief of Radiology and the Imaging Sciences Program. Dr. Li was on faculty in Stanford University for 10 years prior

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102 NANOTECHNOLOGY AND ONCOLOGY to joining the NIH. Dr. Li’s main research interest is in molecular imag- ing, molecular image guided therapy, and integrating imaging with tissue analysis for studying systems biology. He has 9 issued and 6 pending patents, has won over 10 different awards from 4 different professional organizations and has given numerous invited lectures. He has published over 100 scientific articles, 5 book chapters, and 1 monograph and has received grants from government, industry, and private sources. Steven K. Libutti, M.D., FACS, received his A.B. from Harvard College and his M.D. from the College of Physicians and Surgeons of Columbia University where he was inducted into the Alpha Omega Alpha medi- cal honor society. He completed his internship, surgical residency, and was Chief Resident at the Presbyterian Hospital in New York. Following residency, he completed a fellowship in Surgical Oncology and Endo- crine Surgery at the National Cancer Institute (NCI) prior to becoming a Clinical Investigator and then Senior Investigator and Chief of the Tumor Angiogenesis Section in the Surgery Branch, NCI. He is currently the Director of the Montefiore-Einstein Center for Cancer Care, Associate Director of the Albert Einstein Cancer Center, and Professor and Vice- Chairman of Surgery and Professor of Genetics at the Montefiore Medical Center and the Albert Einstein College of Medicine in New York. Dr. Libutti has received numerous honors and awards throughout his medical career including the Blakemore Award for Outstanding Research in Surgery, the NCI’s Technology Transfer Award, The NCI Director’s Gold Star Award, the NCI Director’s Intramural Innovation Award, and the NIH Director’s Award. Dr. Libutti has been voted a “Top Doctor in America” and to New York Magazine’s list of the Top Doctors in New York. He has served on the editorial boards for the journals Expert Opinion in Biological Therapy, Molecular Imaging, Translational Medicine, The Cancer Journal, Surgery (Society Editor), Endocrine Related Cancer, Molecular Cancer, and The Journal of Immunotherapy. His research interests include tumor angiogenesis, anti-angiogenic gene therapy, gene expression profiling, regional therapy of malignant tumors, isolation and characterization of unique tumor cytokines, and studies of the tumor microenvironment. Dr. Libutti is a member of numerous professional societies relating to cancer research and served as Chair of the steering committee for the Trans-NIH Angiogenesis Research Program (TARP). Dr. Libutti’s clinical expertise is in the management of malignancies of the liver, pancreas, and GI tract, and in applying laparoscopic surgery to managing patients with cancer. In addition, Dr. Libutti is an internationally recognized expert in endocrine surgery and provides surgical consultation and treatment for

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103 APPENDIX B patients with disorders of the thyroid, parathyroid, adrenal glands, and for endocrine tumors arising in the pancreas. Dr. Libutti has published over 200 peer reviewed journal articles, 16 book chapters, and has been invited to give numerous presentations and lectures. He also holds five US patents. Scott Manalis, Ph.D., received the B.S. degree in physics from the Univer- sity of California, Santa Barbara and the Ph.D. degree in applied physics from Stanford University. He is currently a member of the Koch Institute for Integrative Cancer Research and a professor in the departments of bio- logical and mechanical engineering at MIT. His laboratory uses microscale and nanoscale technologies to develop quantitative and real-time tech- niques for biomolecular detection and single cell analysis. Dr. Manalis was the recipient of the Presidential Early Career Award for Scientists and Engineers (PECASE) from the Department of Defense. He has also been selected by Technology Review magazine as one of the 100 innovators under the age of 35 whose work and ideas “will have a deep impact on how we live, work and think in the century to come.” Scott E. McNeil, Ph.D., serves as Director of the Nanotechnology Char- acterization Laboratory for NCI at Frederick where he coordinates pre- clinical characterization of nanomaterials intended for cancer therapeutics and diagnostics. Prior to joining NCI–Frederick (i.e. SAIC–Frederick), he served for three years as Senior Scientist in the Nanotech Initiatives Division at SAIC where he transitioned basic nanotechnology research to government and commercial markets. He advises industry and state and US governments on the development of nanotechnology and is a member of several governmental and industrial working groups related to nanotechnology policy, standardization, and commercialization. Dr. McNeil’s professional career includes tenure as an Army Officer, with tours as Chief of Biochemistry at Tripler Army Medical Center, as a Com- bat Arms officer in the Gulf War. He is an invited speaker to numerous nanotechnology-related conferences and has six patents pending related to nanotechnology and biotechnology. He received his bachelor’s degree in chemistry from Portland State University and his doctorate in cell biol- ogy from Oregon Health Sciences University. John Mendelsohn, M.D., combines experience in clinical and laboratory research with administrative expertise in preparing the University of Texas MD Anderson Cancer Center for the next century. Since becom- ing president in 1996, he has recruited a visionary management team and implemented new priorities for integrated programs in patient care, research, education, and cancer prevention. For almost three decades,

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104 NANOTECHNOLOGY AND ONCOLOGY Dr. Mendelsohn has been at the forefront in understanding how growth factors regulate the proliferation of cancer cells by activating receptors on the surface of the cells. He developed cetuximab, a specific monoclonal antibody that blocks epidermal growth factor (EGF) and transforming growth factor-alpha binding to EGF receptors, thereby inhibiting activa- tion of receptor tyrosine kinase and preventing the growth factors from stimulating cell growth and division. His research led to the first clinical trial with an antireceptor therapy and an anti-tyrosine kinase therapy. Dr. Mendelsohn was born in Cincinnati, Ohio, and earned a bachelor’s degree in biochemical sciences magna cum laude from Harvard Col- lege in 1958. After spending a year in Scotland as a Fulbright Scholar, Dr. Mendelsohn received a medical degree cum laude from Harvard Med- ical School in 1963. Between 1963 and 1970, he took residency training in internal medicine and completed a research fellowship in oncology at Washington University Medical School in St. Louis, Missouri. From 1970 to 1985, he was on the University of California, San Diego (UCSD) faculty, rising from assistant professor to professor of medicine at UCSD in less than 9 years. He was instrumental in establishing and funding a National Cancer Institute–designated Cancer Center at UCSD, which he directed from its inception in 1976 until he went to Memorial Sloan-Kettering Cancer Center in 1985. At Memorial Sloan-Kettering, Dr. Mendelsohn chaired, reorganized, and expanded its Department of Medicine. He also extended the landmark research that he began at UCSD to clarify at the molecular level how cetuximab alters growth-signaling pathways and cell functions. He also demonstrated the additive antitumor effects of EGF receptor inhibition plus chemotherapy or radiotherapy. As a result of successful clinical trials, the Food and Drug Administration approved cetuximab (Erbitux) for the treatment of colon cancer in 2004 and head and neck cancer in 2006. Dr. Mendelsohn served as the founding editor-in- chief of Clinical Cancer Research, a monthly translational research journal published by the American Association for Cancer Research, and he has been a member of the editorial boards of other leading scientific journals. He has authored more than 200 scientific papers and articles for journals and textbooks and is senior editor of The Molecular Basis of Cancer. His awards include the Joseph H. Burchenal and the Dorothy P. Landon awards from the American Association for Cancer Research and the David A. Karnofsky Prize from the American Society of Clinical Oncology. He is a member of the Institute of Medicine of the US National Academies. John Niederhuber, M.D., is a nationally renowned surgeon and researcher who has dedicated his four-decade career to the treatment and study of cancer—as a professor, cancer center director, National Cancer Advisory

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105 APPENDIX B Board chair, external advisor to the NCI, grant reviewer, and laboratory investigator supported by NCI and the National Institutes of Health. Most recently, Dr. Niederhuber served as Director of the NCI (2005–2010). He has also served as NCI’s Chief Operating Officer and Deputy Director for Translational and Clinical Sciences. In addition, Dr. Niederhuber served as Chair of the National Cancer Advisory Board (NCAB) from 2002–2004. In addition to his management and advisory roles, Dr. Niederhuber has remained involved in research, through his laboratory on the National Institutes of Health (NIH) campus. Under his leadership, the Tumor and Stem Cell Biology Section, which is a part of the Cell and Cancer Biology Branch of NCI’s Center for Cancer Research, is studying tissue stem cells as the cell-of-origin for cancer. Dr. Niederhuber also holds a clinical appointment on the NIH Clinical Center Medical Staff. As a surgeon, Dr. Niederhuber’s clinical emphasis is on gastrointes- tinal cancer, hepatobiliary (liver, bile duct, and gall bladder) cancer, and breast cancer. He is recognized for his pioneering work in hepatic artery infusion chemotherapy and was the first to demonstrate the feasibility of totally implantable vascular access devices. Jonathan Sackner-Bernstein, M.D., is associate director for post market operations in the Center for Devices and Radiologic Health at the US Food and Drug Administration (FDA). At FDA, his charges include oversight of post market operations and serving as champion of the reorganization of the Center for Devices & Radiologic Health (CDRH) into a matrix struc- ture. With that later responsibility comes direct involvement in premarket, compliance and regulatory aspects of medical device development as well. Over the prior 18 years, his experiences have included leadership in cutting edge medical research. Dr. Sackner-Bernstein serves as a consul- tant to the US FDA, serving for 2 years as an ad hoc member of the Car- diovascular and Renal Drugs Advisory committee and now as a standing member of the Medical Devices Dispute Resolution Committee of CDRH. He serves as a safety consultant for large pharma and biotech. As an investigator, Dr. Sackner-Bernstein seeks out innovative approaches, with a particular interest in extending therapies from one therapeutic area to another. Not afraid to speak out when supported by data, as reflected by his recent book Before It Happens to You, he has had sufficient experience to value the power of working within systems and with colleagues to effect solutions to key problems.

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106 NANOTECHNOLOGY AND ONCOLOGY Ralph Weissleder, M.D., Ph.D., is a Professor at Harvard Medical School and Director of the Center for Systems Biology, the newest Massachusetts General Hospital (MGH) thematic research center. He is also the Direc- tor of the MGH Center for Molecular Imaging Research, and is clinically active as an Attending Interventional Radiologist in the MGH Depart- ment of Radiology. He is an active member of many Boston-area research communities, including the Department of Systems Biology at Harvard Medical School, the Broad Institute of Harvard and the Massachusetts Institute of Technology, the Dana-Farber-Harvard Cancer Center, and the Harvard Stem Cell Institute (HSCI). He has published over 500 publications in peer-reviewed journals, has authored and co-authored several textbooks, and holds 15 patents. He is a founding member of the Society for Molecular Imaging Research and served as its President in 2002. His work has been honored with numerous awards including the J. Taylor International Prize in Medicine, the Millennium Pharmaceuticals Innovator Award, the AUR Memorial Award, the ARRS President’s Award, the Society for Molecular Imaging Lifetime Achievement Award, and the Academy of Molecular Imaging 2006 Distinguished Basic Scientist Award. Yuliang Zhao, Ph.D., is Professor and Director, CAS Key Lab for Bio- medical Effects of Nanomaterials & Nanosafety, Institute of High Energy Physics, Chinese Academy of Sciences (CAS), and National Center for Nanosciences and Technology of China. Dr. Zhao’s degrees are in chemis- try and physics. He moved to Chinese Academy of Sciences from RIKEN (Japan) as a Hundred Elite Professor in 2001. He is a founder of CAS Nanosafety Lab, and also one of the earliest scientists who proposed and studied nanotoxicology. He is mainly focused on the biomedical effects of nanostructure/nanoscale materials, including (1) the biomedical func- tions of manufactured nanomaterials, (2) the toxicological effects of nano- materials including identification of nano-hazards, drafting regulatory frameworks and nano-standards for safety issues on nanotechnology, and establishing standard procedures for safety assessment of nano-products for government agencies, (3) surface chemistry of nanoparticles and their novel properties for the purposes of enhancing the biomedical functions or reducing potential toxicity, and (4) molecular dynamics theoretical simulation and modeling the dynamic processes of the interplay between nano-systems and bio-systems.