The Technologists

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These technology leaders are taking computer-based and enabled solutions to the next plateau and in doing so they are reducing the time needed to conduct clinical trials, cutting the cost of clinical development, and ensuring that the products that do make it to market are properly evaluated for safety and risk outcomes. Each of these inspiring technologists shares the same goal: improving the lives of millions of people.

The PharmaVOICE 100 July/August 2006

Dr. Richard Piazza Seamlessly, E-Clinical If one were only to review his curriculum vitae, it would be easy to imagine Richard (Rick) Piazza, Pharm.D., in a scholarly setting, wearing elbow patches on his tweed jackets and a pocket protector. But the VP of product strategy at etrials Worldwide Inc. is anything but a staid academician. Dr. Piazza has pizzazz; he is an energetic and inspiring member of the etrials team, who enjoys improving the clinical-trial process, providing accurate data quickly, and ultimately expediting the delivery of important therapies to patients. And he combines these important people-centric missions with a general appreciation for other aspects of life, including cycling, going to the beach with his family, and reading as much as he can. Starting out as a retail pharmacist, Dr. Piazza learned how to work under pressure and that it is possible to have a positive impact on people when you treat them the way you’d like to be treated. Having held a variety of top-level positions throughout his career, Dr. Piazza has experience in the management of large-scale clinical trials and product development of electronic systems for clinical trials. Described as a pharma-technology guru, Dr. Piazza manages short- and long-term product direction and all research and development efforts. With etrial’s products ranging from EDC and IVR to e-diaries and CTMS, Dr. Piazza not only manages all of these separate e-clinical tools but also designs each to integrate with one another as well as outside data streams, making the entire process seamless and the products easy to use. His peers describe him as a pharma-technology guru, and for Richard (Rick) Piazza, Pharm.D., VP of Product Strategy at etrials Worldwide Inc., that’s just fine because his goal is to be part of the solution, not part of the problem. Personal data Born Oct. 2, 1958, in New Jersey Education B.S. in pharmacy, Masters in pharmacology, and Doctorate in clinical pharmacy (Pharm.D.) First Job Retail pharmacist Family Wife, Katherine; Daughter, Emily; Son, Christopher Hobbies Music, playing guitar, cycling, and spending time with the family On His Reading List The Lovely Bones by Alice Sebold, The Food Taster by Peter Elbling, The Historian by Elizabeth Kostova, The Five People You Meet in Heaven by Mitch Albom, and Wicked by Gregory Maguire Nosa Omoigui Overcoming Data Overload Traditional technologies and search engines have been unable to keep up with the pace of information growth primarily because they lack the intelligence to “understand,” semantically process, mine, infer, connect, and contextually interpret information to transform it to — and expose it as — knowledge. Recognizing the inefficiencies inherent in the life-sciences industry because of the explosive growth of data, Nosa Omoigui drew on his insights to develop a technology that directly addresses these problems. The creation of Nervana, and its semantic-search technology, came at a time when the industry was in dire need of an intelligent solution to the problem of how to handle the vast expansion of digital information. Yet for Mr. Omoigui, the timing and formation of a company was far from easy. He started Nervana from scratch with no team, virtually no money, and at an extremely difficult time — around 9/11. But with a determination to take on challenges and perseverance despite formidable obstacles, Mr. Omoigui has devised a solution that enables people to ask questions in context of their meanings — in other words a semantic search — and receive relevant, timely insights. Mr. Omoigui, chairman and CEO, is passionate about his technology and has six patents and 20 pending patents, including two for the “information nervous system” on which Nervana’s technology is based. Founder, Chairman, and CEO of Nervana Inc., Nosa Omoigui’s business success stems from his willingness to take on challenges and persevere despite formidable obstacles. Personal data Born Sept. 16, 1971, in Lagos, Nigeria Education M.S. in electrical and computer engineering from Carnegie Mellon University Hobbies Jazz, traveling, soccer, tennis, rafting, and sailing On His Reading List Blueprint to a Billion by David Thompson; Michael Faraday: A Biography by L. Pearce Williams; and The Da Vinci Notebooks by Leonardo Da Vinci Dr. Mark A. Goldberg A Collaborative Approach A pioneer in the field of technology-enabled clinical development and an internationally recognized telemedicine expert, Mark A. Goldberg, M.D., has helped biopharmaceutical and medical device companies advance clinical research by combining medical knowledge and development expertise with information technology for more than 12 years. He has inspired medical, clinical, and technology experts throughout Parexel to help client companies improve the speed and efficiency of their clinical development programs by using medical-imaging techniques, interactive Web/voice response systems, and industry-leading systems for clinical-trial management. Dr. Goldberg joined Parexel in 1997, establishing the company’s medical-imaging group. He also was involved in founding Perceptive Informatics to deliver technology solutions that improve the development and commercialization processes for the biopharmaceutical industry. Before joining Parexel, Dr. Goldberg served as president and director, and helped to found WorldCare, a telehealth spin-off from Massachusetts General Hospital. His broad experience in telemedicine also includes serving on the board of the American Telemedicine Association and as the association’s president from 1998 to 2000. Dr. Goldberg was also founding editor-in-chief of the peer-reviewed Telemedicine Journal. As president of Parexel’s Clinical Research Services and Perceptive Informatics business units, as well as a member of the company’s business review committee, executive committee, and information systems steering committee, Dr. Goldberg has been a key contributor to Parexel’s growth and business performance. Mark A. Goldberg, M.D., President of Clinical Research Services and Perceptive Informatics Inc., the technology subsidiary of Parexel International, has been helping biopharmaceutical and medical-device companies advance clinical research by better leveraging information technology for more than 12 years. Personal data Born March 6, 1960, in Malden, Mass. Education S.B. in computer science and engineering from Massachusetts Institute of Technology and an M.D. from the University of Massachusetts Medical School First job Fellowship to work on local area networking technology at MITRE Corp. Biggest Industry Challenge For large pharma companies to re-engineer their R&D strategies and processes to be competitive in the face of scientific advances that yield personalized treatments Dr. Gadi Aharoni Focused on Technology With a long-held conviction that technology can benefit the industry, Gadi Aharoni, Ph.D., has helped turn Algorithmic Research Inc. (ARX) into a successful and profitable company. But that’s not enough for Dr. Aharoni; he won’t be satisfied until ARX is synonymous with digital signatures Since taking the helm of ARX in 2001, Dr. Aharoni has focused the company’s efforts on providing standard electronic signature (PKI-based) solutions to the life-sciences industry. Thanks to his focus, the company is now well-positioned to help organizations comply with the many regulations the industry faces, including 21 CFR Part 11 and GxP, and ensure the data integrity of signed documents and document owner identity. Dr. Aharoni, who led the acquisition of ARX from Cylink Corp. in 2001, draws on a wealth of management and technology experience to lead the company as its CEO. Before joining ARX, he spent three years in various posts at Cylink. In 1996, he cofounded Orcast, which developed a conditional access system for digital-television broadcasting. Dr. Aharoni’s academic prowess could almost be considered a family affair — his father was a professor of physics at the Weizmann Institute, where his mother also worked as an accountant. Dr. Aharoni has a twin brother, who also has a Ph.D. in computer science, and an older brother who has a Ph.D. in physics (optics). Gadi Aharoni, Ph.D., CEO of Algorithmic Research Inc., has long believed in the value of technology to assist the biopharmaceutical industry in meeting its goals. Personal Data Born in Rehovot (The Weizmann Institute), Israel Education M.Eng. in computing from the Imperial College of Science and Technology, United Kingdom,and a Ph.D. in computer science from the Hebrew University of Jerusalem, Israel First job Artillery officer in the Israeli Army Hobbies Archeology and collecting ancient coins — Persian, Greek, Roman, and especially Jewish coins David Evans a technology innovator, David Evans has been leading the industry for more than 20 years. During that time, he has had a significant impact on solutions for use in a variety of different applications, such as centralized core lab, data capture, and electronic submissions. As the architect and developer of the first electronic submission to the FDA in 1985, Mr. Evans is recognized industrywide as a visionary for developing and implementing complex process and systems solutions. From this initial experience more than 20 years ago, it has been Mr. Evans’ career-long pursuit to facilitate and ease the collection, processing, analysis, reporting, submission, and review of clinical-research information for the purpose of advancing public health. His vision is still clear, and his passion is more intense than ever to achieve this goal. Over the years, Mr. Evans has gained extensive experience in corporate development, clinical-data management, clinical-trial management, complex clinical-data warehousing, regulatory data analysis, automated data capture, regulatory quality management, and clinical business process engineering. Now as chief information officer at Octagon Research Solutions, he draws on these areas of expertise and his naturally composed, professional approach to problem solving to tackle industry challenges. Highly regarded by colleagues and peers as a calm, secure, honest, professional, and knowledgeable leader, Mr. Evans is an inspiration to those he interacts with. Mr. Evans is a firm believer that the electronic information standards currently available, such as eCTD, SPL/PIM, and CDISC, are the way forward for improving efficiencies, decreasing costs, increasing productivity, and ultimately shortening time to market. And he continues to search for new ways to drive efficiencies in clinical research and development by improving electronic submissions. Already, Mr. Evans has been responsible for more than 70 electronic submissions and complex clinical-data warehouses, and he was also a pioneer in the CANDA field, the forerunner to electronic submissions. David A. Evans, Chief Information Officer at Octagon Research Solutions Inc., is leading the way to drive efficiencies in clinical research and development by continuously searching for ways to improve electronic submissions. A Pioneer in Systems Solutions Education B.S. in biology from Ursinus College and an M.S. in biomedical engineering from Drexel University Career Highlight Architect and developer of the first electronic submission to the FDA in 1985 Toughest Task Evangelizing a vision to a group of skeptics Hobbies Singing, gardening, and Sudoku

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