ABOUT OUR SPEAKERS:

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	Diana L. Anderson, PhD, President & CEO, D. Anderson & Company Diana L. Anderson, Ph.D., founder, president and CEO of D.L. Anderson International, Inc., is internationally known for her experience and expertise in patient recruitment and retention for the clinical trials industry. She is a frequent guest speaker at industry conferences, including those sponsored by the Drug Information Association (DIA) and the Association of Clinical Research Professionals (ACRP). Additionally, she has addressed audiences around the world, including Australia, Canada, China, England, France, Israel, Japan, Ukraine, and the United States. Dr. Anderson is a board member of The Center for Information and Study on Clinical Research Participation (CISCRP), chairman of the Board of the Academy of Clinical Research Professionals and past-chairman of the Board of ACRP. She has also served on the boards of the American College of Rheumatology and the Arthritis Foundation, among others. Dr. Anderson holds a doctorate from Texas Woman’s University. Throughout her career, Dr. Anderson has authored four books including “International Patient Recruitment Regulatory Guidelines, Customs and Practices,” “A Guide to Patient Recruitment and Retention” and “50 Ways to Cope with Arthritis.” In 2006, PharmaVOICE magazine named Dr. Anderson one of the “100 Most Inspiring People” in the life sciences industry. She was recognized as a finalist for the Ernst & Young Entrepreneur of the Year Award in 2007 and won a Women of Influence Award™ from the Women’s Business Enterprise National Council (WBENC) in 2009.
	Andrew C. Chang, PhD, Executive Director, PharmaNet Consulting Dr. Andrew Chang has more than nineteen years of experience in the development of biologics and pharmaceuticals. At his current capacity as an Executive Director, PharmaNet Consulting, Dr. Chang has advised clients on top-level strategic planning and evaluations related to biological-product development in the US, Europe and Asia on how to efficiently bring products from R&D to market approval. He has consulted on regulatory submissions from pre-IND to marketing applications; regulatory pathways including assessing the possible regulatory jurisdiction, orphan drug designation, and fast track and accelerated approval; FDA and EMEA requirements on chemistry, manufacturing and control (CMC); immunogenicity risk assessment for therapeutic protein products; viral safety for naturally derived (including blood products) or recombinant protein products; comparability studies in supporting manufacturing changes during either product development or post-marketing; and strategic planning for developing biosimilars. He has created programs to educate clients on quality related issues (e.g., specification, stability, quality by design, process validation, potency standard and assays, and impurities), and on current Good Manufacturing Practices (cGMP). Dr. Chang provides simulated pre-approval inspections to assess whether clients are in compliance with cGMP and their readiness for the FDA inspection. His consulting services assisted clients on their product approvals after first cycle review by regulatory authorities. Prior to joining PharmaNet in 2006, Dr. Chang served more than eleven years at the US FDA, most recently as an Associate Director for Policy and Regulation and Senior Regulatory Scientist in the Division of Hematology, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER). He is known nationally and internationally for his significant scientific and regulatory contributions to the development, approval and post market surveillance of recombinant and naturally-derived products. During his tenure at the FDA, Dr. Chang had served as the primary product reviewer on over forty original IND submissions and hundreds of amendments. He had served as the review committee chairperson for the licensures of four new and novel recombinant and naturally-derived products, and for the approval of hundreds of post-marketing supplements. In 2002, the FDA recognized Dr. Chang as the FDA regulatory expert in the regulation of new and novel recombinant products as well as naturally-derived biological products. He clearly is considered one of the foremost regulatory experts in recombinant and naturally-derived protein products. While at FDA, Dr. Chang was known as a leading FDA and CBER spokesperson and has presented the FDA perspective at many national and international meetings. In addition, he has served on numerous committees, such as the FDA Committee for Follow-On Protein Pharmaceuticals, CBER’s Chemistry, Manufacturing and Control (CMC) Coordinating Committee (CMCCC), CBER representative at CDER Manufacturing Science Working Group, CMC Review Template Working Group, FDA Comparability Working Group, and CBER Working Group for Manufacturing Changes. Dr. Chang also served as the FDA deputy topic leader for ICH Q5E guideline, and the FDA observer for European and US Pharmacopeia’s Expert Groups on Blood and Blood Derived Products. Furthermore, he worked closely with CBER’s Office of Compliance and Biologics Quality on FDA inspection program including Team Bio and CBER pre-license/approval inspections. His formal scientific training includes a Doctor of Philosophy degree in Biochemistry from the State University of New York, 1991, and a Bachelor of Sciences degree in Pharmaceutical Chemistry from the China Pharmaceutical University, 1982. Supplementing his academic degrees, Dr. Chang also studied at the National Institute of Allergic and Infectious Diseases, National Institutes of Health as a postdoctoral fellow from 1991 until he joined CBER in 1995. Consulting Expertise: Regulatory considerations for natural, recombinant, and combination products, product comparability, follow-on/biosimilar protein products, viral safety, immunogenicity, cGMP audit, and interpretation of FDA regulations, policies, and guidance.
	Graeme Currie, Vice President Clinical Operations, Sepracor Graeme Currie, Ph.D. joined Sepracor as Vice president of Clinical Operations in October 2008. Prior to that he served as the Vice President of Clinical Operations at PDL Biopharma where he sponsored many initiatives around clinical operational excellence in relation to protocol development, study management and globalization of clinical research. Before joining PDL BioPharma, Dr. Currie was director of clinical research at Gilead Sciences where he managed clinical research activities and helped develop a new treatment for Chronic hepatitis B, Hepsera (Adefovir Dipivoxil). Dr. Currie has 17 years of experience in clinical development and has held clinical research positions with Wellcome Research Laboratories, Quintiles and Ipsen International in Europe where he managed clinical programs worldwide. Dr. Currie holds a Ph.D. from the Aston University in the United Kingdom.
	Jovianni DiCarlo, Global Clinical Development Director, Immunomix, Inc. Jovianna DiCarlo is the Director of Global Clinical Development for Immunomix, Inc. an emerging biotechnology company headquartered in Lancaster PA. Ms. DiCarlo has 20 years experience driving new pharmaceutical therapeutics and devices through the entire development process from conceptualization, feasibility assessment, through clinical development to commercialization. She remains passionate about actively contributing to technology application configuration & interface development, and the integration, adoption and implementation of intelligent technology applications to efficiently support biosurvelliance, clinical operations, and clinical research & development initiatives.
	David Facklam, Senior Director Global Operations, Astellas Pharma Global Development David Facklam is currently Senior Director, Global Development Operations at Astellas Pharma Global Development, Inc. Mr. Facklam is responsible for the management of the US clinical operations group. This group has responsibility for executing Phase 1b through Phase 4 clinical trials for Astellas’ global and local projects, which encompass studies in the following therapeutic areas: immunology, CNS, oncology, anti-infectives, cardiovascular, metabolic, urology and GI. Mr. Facklam has over 25 years of pharmaceutical development experience with previous stints at The Upjohn Company, Chugai-Upjohn, Inc. and TAP Pharmaceuticals.
	Lawrence Florin, Section Director US Clinical Outsourcing, AstraZeneca Lawrence Florin, Section Director, US Clinical Outsourcing with AstraZeneca, possesses a wide breadth of operational, sales and marketing and corporate development experience serving in a series of senior management roles across multiple organizations. This experience ranges from helping to startup and grow CROs and associated lines of business to supporting the creation of novel patient recruitment methodologies to founding and leading multiple site management organizations. This broad background is complemented by a significant amount of practical clinical development and project management leadership experience spearheading dozen’s of clinical (regional and global) development programs.
	Diana M. Gáler, Ph.D., DABT, CPC, President, Gáler Coaching for Excellence As a scientific executive in the Pharmaceutical industry, Dr. Diana Gáler learned early that the best results were achieved when teams were created to maximize the positive contributions of their members and led with clarity of purpose and a focus on results. With more than 25 years at senior levels in Pharmaceutical R&D, Dr. Gáler has a proven record of delivering results and leading organizations through strategic planning and change. Over her career she led and sponsored cross-site, multinational, multi-cultural and multi-company teams that consistently delivered results. After taking an early retirement from Pfizer Inc Dr. Gáler followed her passion to energize the careers of leaders and help them create successful, engaged teams by becoming an Executive and Team Coach. The Institute of Professional Excellence in Coaching (iPEC) has certified her as a Professional Coach (CPC) and Master Practitioner in the Energy Leadership Index (MP-ELI). Dr. Gáler received her B.Sc. and M.Sc. degrees in Biochemistry from McGill University and her Ph.D. from New York University. She has been a Diplomate of the American Board of Toxicology since 1988. Her coaching practice, Gáler Coaching for Excellence serves clients mainly in the East Coast and is based in Connecticut. Her website and blog can be found at www.theteamdoc.com.
	Christopher C. Gallen, M.D., Ph.D., Executive Vice President of Research & Development, CombinatoRX Dr. Christopher Gallen is the Executive Vice President of Research and Development and Chief Medical Officer at CombinatoRx. He has an extensive track record in clinical and corporate development and has been instrumental in developing several commercially successful therapeutics. Prior to the merger with CombinatoRx in December 2009, Dr. Gallen was the President and CEO of Neuromed Pharmaceuticals where he successfully led the company through several rounds of financing totaling $78 million, signed a major partnership deal with Merck & Co., and acquired the US rights to Phase 3 NMED-1077 from ALZA Corp, followed by conduct of a successful pivotal trial, submission of the NDA, conduct of a successful Advisory Committee with PDUFA date pending. Prior to joining Neuromed, Dr. Gallen was Vice President and Chief of Operations, Clinical Research and Development at Wyeth Research, in charge of global clinical operations and was a key driver in the re-engineering of Wyeth Clinical Research and Development. Prior to Wyeth, Dr. Gallen was VP of Clinical Research at Pharmacia responsible for overseeing global CNS development, clinical operations for all specialties in the Western Hemisphere and was also a leader in the successful re-engineering of Pharmacia leading to a position of Site Head for the Kalamazoo R&D Site overseeing all aspects of R&D for CNS and Infectious Diseases. Previous positions include a variety of roles at Premier Research Worldwide where he was a started and a drove a successful IPO allowing him to grow the company to international status. As Senior Director of Medical and Scientific Services at Quintiles International Clinical Research Corporation Dr. Gallen medically drove the pivotal trials for several successful therapeutics. Dr. Gallen received his M.D. and Ph.D. (Biochemistry) from the Emory University School of Medicine in Atlanta, Georgia and completed residencies in Psychiatry at Stanford and in Neurology at UCSD and is best known scientifically for work in his laboratory that revealed the first proof of human cerebral plasticity.
	Art Gertel, Vice President, Strategic Regulatory Consulting, Medical Writing and QA, Beardsworth Art Gertel, Vice President Strategic Regulatory Consulting, Medical Writing, and QA has more than 30 years of experience in the pharmaceutical industry. Art has had a broad range of primarily management-level responsibility in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support. He has been involved in developing and integrating global clinical study standards in collaboration with multinational professional organizations and regulatory authorities. He headed the Medical Communications Department at Schering-Plough, with responsibility for preparing all new drug applications, worldwide; directed the Medical and Scientific Communications Department at Hoffmann-La Roche; led the Project and Portfolio Management functions of the Advanced Phase (Phases IIIb and IV) group at Quintiles. In addition, he headed the clinical trials operations at iKnowMed, with the charge of applying the company’s electronic data capture technology to pharmaceutical clinical trials. He received undergraduate education in Biology and Psychology at the University of Pennsylvania and pursued graduate studies in Behavioral Medicine at New York Medical College, and Pharmaceutics at Temple University. He served as President of the American Medical Writers Association (AMWA): a biomedical communications professional association comprising more than 4,000 members, worldwide. He is a frequent lecturer and teacher at Drug Information Association (DIA), European Medical Writers Association (EMWA) and AMWA meetings and is very active in the Clinical Data Interchange Standards Consortium (CDISC) efforts to standardize clinical data. Art is a Fellow of AMWA and EMWA and is the 2009 recipient of the prestigious American Medical Writers Association’s, Harold Swanberg Distinguished Service Award.
	Joanne Jiang, VP, Business Development and International Project Management, Fountain Medical Development Dr Jiang has been working in the pharmaceutical industry for 14 years. She is frequently invited to write articles on clinical development and outsourcing for international journals. She has been invited to speak at IBC, ChinaTrial Summit, Bio, Biopartnership, Biopharma and other international conferences. She started her career in preclinical pharmacology area at Bayer pharmaceutical and Eli Lilly, working as research scientist, lab head and project leader. She further developed expertise in drug development and project management through her tenure as global project manager. From year 2000 to 2007, at Aventis and then Daiichi Sankyo, she managed drug development and life cycle management projects, encompassing preclinical to phase IV activities. She especially focused on clinical trial planning and management, integrating marketing plans and regulatory strategy that enables optimal trial design. Dr. Jiang also has working knowledge of building and managing high performing project teams that deliver break-through results. Dr Jiang co-founded Fountain Medical Development, a contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in Asia. Dr. Jiang holds a PhD in pharmacology and toxicology from Indiana University, and an MBA from University of Michigan Dearborn. Dr. Jiang was an Executive Council for Sino-American Pharmaceutical Association. She is also a member of Project Management institute and Drug information association.
	Ying Jiang, Director of Client Operations, TTC, llc Ying Jiang received her Bachelor of Science in Pharmaceutical Marketing and Management from the University of Sciences in Philadelphia. She is the Director of Client Operations at TTC,LLC, a database company that provides cost control and time management solutions for pharmaceutical and biotechnology industries. Ying has been assisting TTC clients in planning, forecasting, budgeting and negotiating investigator budgets, as well as outsourcing costs globally, including emerging markets such as China and India.
	Dianne C. Kikta, PhD, MBA, Vice President, Global Clinical Strategic Resourcing, Pfizer Dianne Kikta received her PhD in Medical Sciences, with an emphasis in Physiology and Pharmacology, from the University of South Florida, College of Medicine, in 1979. She completed a National Institutes of Health-funded post-doctoral fellowship at the University of Florida, College of Medicine, in Cardiovascular and Endocrine Physiology, in 1983 and then continued her academic career as a Research Scientist at the Bockus Research Institute, at the Graduate Hospital of the University of Pennsylvania. Dr. Kikta was also an Adjunct Assistant Professor in the Department of Physiology at the University of Pennsylvania, College of Medicine. In 2000, Dr. Kikta obtained an MBA from Villanova University, College of Commerce and Finance. In 1988, Dr. Kikta left academia and joined Wyeth Research as a Clinical Writer. She has held positions of increasing responsibility, and is currently Vice President, Global Clinical Strategic Resourcing at Pfizer (formerly Wyeth). In this capacity, she is responsible for providing strategic oversight of opportunities for flexible resourcing for the clinical organization to meet objectives efficiently, especially through offshoring and outsourcing. Throughout her professional career, Dr. Kikta has been involved in innovation and change initiatives. At Wyeth, specifically, she has been involved in some capacity with most change initiatives within the clinical research organization over the past 10+ years—most recently as the sponsor for an initiative to determine how to work more effectively 24/7. Through this initiative, a novel approach to expanding into India, allowing the clinical organization to achieve more in a 24-hour period and thus eliminating significant bottlenecks in the clinical development process was implemented through a successful partnership. In addition, she was the sponsor for an initiative to streamline the translations process at Wyeth. In recognition of her innovative ideas and for successfully leading new groundbreaking concepts with this partnership, Dr. Kikta and the Learn and Confirm Implementation Team were presented the prestigious 2007 President’s Achieving Excellence Award at Wyeth.
	Vito Losito, PhD, CEO & President, EntraLogix Clinical Group Inc. Dr. Vito Losito, a biotech talent with 16 years of expertise spanning medical research, clinical trials and clinical information technology systems, has successfully built an integrated community based clinical trial organization, achieving quality data through process compliance and technological innovation. As CEO and President of EntraLogix Systems Group Inc, Vito’s diverse background, vision and leadership has been integral over the past five years in establishing a Toronto based clinical trial site network of 85+ private practice investigator clinics, 7 regional/community hospitals and at the hub a leading edge operational excellence facility. Vito believes that operational excellence is the driver of optimal performance and that optimal performance is the precursor of total achievement. Under Vito’s leadership EntraLogix has developed processes and technological tools that drive total performance. Success is measured by the fact that the Start-up department at EntraLogix successfully completes site selection and site start-up in as little as three weeks with use of a proprietary Sharepoint portal and streamlined workflow processes. EntraLogix has implemented a wide variety of patient recruitment strategies resulting in acheivement of target enrolment in 92% of clinical trials. Most importantly, under Vito’s guidance EntraLogix has developed a process compliance and quality assurance program that includes a high fidelity clinical trial training simulation lab and eStudy Binder a proprietary electronic investigator regulatory site binder. A recent independent audit has shown that adherence to process and procedures resulted in no major findings. On an annual basis the EntraLogix network participates in 100+ Phase II-IV in nine specialty areas. Vito’s commitment to workflow process, procedure and technological innovation has been reflected in his positions as Director of Clinical Trials at the Centre for Cardiovascular Research at the Toronto General Hospital, Clinical Trial Process Systems Manager at Leo Pharma Inc. and Director of Regulatory Affairs and Process Compliance at Cytochroma Inc. Applying the same principles of total achievement to community activities Vito has served on the Board of Directors for the Project Management Institute Southern Ontario Chapter and The Linden Fund for Neonatal Intensive Care Units. Vito is a past recipient of the American Heart Association Young Investigator Award, Canadian Cardiovascular Society Young Investigato Award and The Heart & Stroke Foundation of Canada Young Investigator Scholarship. Vito earned his Bachelor of Science Honors degree in Human Physiology from York University in Toronto, Master of Science in Molecular Biology from the University of Windsor and his Doctor of Philosophy in Molecular Biophysics from the University of Toronto's Institute of Medical Science.
	Christian Milliet, Senior Manager Clinical Operations, Novartis Christian Milliet has over 12 years of international experience in the pharmaceutical industry. He joined Novartis in 2002 and has held several positions of increasing responsibility. He is currently Senior Manager - Clinical Operations, where he manages global clinical development programs. Previously he worked for Serono and Covance. Christian graduated from Webster University in 1996.
	Ryan Nichols, Partner, Excend Consulting Group Ryan Nichols has been a partner at Excend Consulting Group since December of 2003. The firm has provided consulting services to over 170 clients worldwide. The firm assists its clients in commercializing, out-licensing, and in-licensing technologies. Key practice areas include valuating portfolios of technologies, conducting market assessments, and in developing new potential licensing and commercial relationships. Mr. Nichols has managed consulting initiatives for leading businesses including Johnson & Johnson, the University of Illinois Office of Technology Management, the Canadian Department of Agriculture, the University of Utah Technology Transfer Office, San Diego State University, among others. Mr. Nichols expertise spans a deep repertoire of business functions including strategic planning, IP commercialization and licensing, business case development, marketing conceptualization, marketing implementation, market research, and branding. Mr. Nichols has managed client accounts throughout North America, South America, and Africa. Mr. Nichols is fluent in both Spanish and English. Mr. Nichols has a degree in political science from Brigham Young University.
	Raymond Panas, Ph.D, Director of International Clinical Development, Sucampo Pharmaceuticals Since 1995, Dr. Raymond Panas has been working in the pharmaceutical industry and currently serves as the Director of International Clinical Development for Sucampo Pharma Americas, Inc. in Bethesda, Maryland (USA) and oversee clinical operations for Sucampo Pharma Europe, Ltd. in Oxford, England (UK). Over the past many years, he has monitored and managed numerous clinical trials and worked on New Drug Applications (US) and Marketing Authorization Applications (EU). Dr. Panas received his PhD in Public Health from Walden University, MPH in Community Health Services from the University of Pittsburgh Graduate School of Public Health, and BS in Biology and Economics from the University of Pittsburgh. He is licensed as a Certified Clinical Research Associate by the Association of Clinical Research Professionals and as a Technologist in Immunology by the American Society for Clinical Pathology. In 2009, he joined George Washington University as an Assistant Professor in the School of Medicine and Health Sciences. He is also a Contributing Faculty for Walden University in the College of Health Sciences. Dr. Panas has contributed to and/or presented several posters, oral presentations, and publications. He has served as an officer or board member for several organizations, and he is currently a member of the American Public Health Association, American Society for Clinical Pathology, Association of Clinical Research Professionals, Drug Information Association, and Who’s Who in Medicine and Healthcare.
	Ginny Payeur, Vice President Business Development, PSI Ginny Payeur has used her background in nursing and pharmaceutical sales to sell pharmaceutical development services since 1992. She introduced PSI to the US market beginning in 2001; before studies run outside of the US, Western Europe and Asia were considered acceptable. Today she oversees the sales of PSI services in fast-enrolling regions and at US and Western European KOL sites.
	Ross D. Pettit, Vice President Operations, ARIAD Pharmaceuticals Ross D. Pettit has been Vice President, Clinical Operations at ARIAD Pharmaceuticals since September 2007. He is responsible for the execution of all clinical trials globally, focused on novel therapies in Oncology. From 2002 to 2007, Mr. Pettit held various senior positions at Coley Pharmaceutical Group, most recently as Vice President, Clinical Operations, working closely with Coley’s oncology partner, Pfizer, Inc. in the co-development of immunotherapeutics in oncology. From 1997 to 2002, he held medical affairs, regulatory and clinical development positions at Serono, Inc. From 1994 to 1997, Mr. Pettit held clinical research positions with Otsuka America Pharmaceuticals. Prior to Otsuka, he served as data analyst and project manager with Parexel International from 1988 to 1992. Mr. Pettit received his M.B.A. from the University of Phoenix in Arizona and his B.Sc. from Kingston University in London. Ross speaks regularly on such topics as patient recruitment and retention, metrics, and global conduct of studies. He is an active member of the Drug Information Association and currently serves as a track chair (Clinical Research) for the Annual Meeting.
	Stephan Reynier, MSc, Project Director Drugs & Biologics, Voisin Consulting Stephan Reynier joined Voisin Consulting in June 2006 as Project Director. He works on projects involving the design and the implementation of a regulatory strategy for the development of drugs and biologics. Stephan Reynier is more specifically responsible for the set up and management of Expanded Access Programs (EAPs), French Temporary Authorization of Use (ATUs) and other compassionate use in other countries. He is also responsible for the set up of Clinical Trial Applications (CTAs), the management of the ongoing Regulatory tasks during clinical trials, and support or management of Pre- and Post- MAA pharmacovigilance tasks, EudraVigilance Registration and reporting. Stephan Reynier gained a 10-year international experience in the pharmaceutical and biotechnology industry. Before joining Voisin Consulting, Stephan Reynier was Associate Director Medical Affairs Operations Europe, Gilead Sciences, since 2002, focusing on Peri- Approval research programs. He worked as International Clinical Project Manager and Clinical Operation Manager at Parexel International, during several years. He began his career as a Clinical Research Associate at Parexel in 1996. Stephan Reynier received an engineering degree from ENS.BANA (Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l’Alimentation). ENS.BANA covers indepth courses ranging from biology and food science to chemistry and mathematics. He developed international experience while working in Toronto, Canada for 4 years and received a Master of Applied Sciences form the University of Toronto in 1995.
	Luis Rios-Nogales MD, PhD, Regional Medical Director, AstraZeneca Latin America, Inc Luis joined AstraZeneca Latin America Inc. in September 2007 and is currently their Regional Medical Director. He is also responsible for the Clinical Research Region Latin America and works very close with Clinical Development. Luis is a trained Neurosurgeon who received all of his degrees with honors. First, Luis got a MBA from the University of Tennessee, Knoxville. Later, he received both a MD and a PhD degree in Germany. He joined the pharmaceutical industry in 1990 to become a Medical Director in CardioVascular for Hoechst's AG International Sales Division. During his 13 years with Aventis Pharma, he gained experience working as Area Medical Director, Pharma Head in Ecuador, Regional Marketing Manager AI, Marketing Head in Mexico, Global Brand Manager for CV in NJ, New Product Development CV and Thrombosis and lastly, Therapeutic Area Head for CardioVascular and Thrombosis. He joined GSK as their VP and Head for Clinical Development and Medical Affairs in Latin America. Before AstraZeneca, he was the VP and Corporate Head for Boston Scientific's Medical Science and Chief Medical Officer for their Endosurgery Division. Luis is married with 3 children 22 to 28 year old.
	Archana Sah, BPharm, MS (Pharm), PMP, Global Clinical Project Manager, Cell Therapeutics Archana Sah is a global clinical program manager with 15 years of experience in clinical development across therapeutic areas. Ms. Sah holds Bachelors and Masters degrees in Pharmacy and a Project Management Professional (PMP) certification from the Project Management Institute. She is currently placed with Cell Therapeutics Inc. in Seattle, WA.
	Miklos L. Schulz, Ph.D, President & CEO, SciAn Services, Inc. Dr. Miklos Schulz is the President and CEO of SciAn Services Inc., a Canadian CRO established in 1986, specializing in strategic consulting in clinical drug development, study design, bio-statistics, data management and information systems targeting the Biotech industry. To date, SciAn has completed over 600 clinical studies covering most indications and clinical development phases. Miklos has been a senior drug development, study design and statistical consultant to a number of Canadian, US and European pharmaceutical and biotech companies supporting products in oncology, CNS, inflammatory diseases, diabetes, anti-virals, transplantation and women’s health. He has some 30 publications to his credit in the fields of applied statistics, metabolism, and clinical research / drug development. Miklos’ continuing research interests lie in study designs, applied biostatistics, in general with special expertise in pharmacokinetics and -dynamics. Currently is involved in developing efficient study designs and using practical and cost efficient approaches to data collection and integrity. Miklos is on the technical advisory board for the International Consortium on Anti-Virals and leads the advisory practice at SciAn Services in North America and globally.
	Michael Schwartzman, Associate Director Outsourcing Alliance Management, Daichii Sankyo Michael Schwartzman has worked in the pharmaceutical industry for 17 years, beginning his career at Covance where he worked in a variety of roles including Clinical, Finance, and Contracts. In 2002 he joined the Outsourcing Management group within U.S. Medical Affairs at Aventis and in 2007 joined Daiichi Sankyo as Associate Director, Global Strategic Outsourcing.
	Lori Shields, Vice President, Data Operations, Medidata Solutions Worldwide Lori Shields brings more than 18 years of experience in client services, database management and software design to her role as Vice President of Operations, Trial Planning at Medidata Solutions. In this role, Lori is responsible for Data Quality and Analytics and Clinical Data Coding, Client Relations and product management of Medidata CRO Contractor and Medidata Grants Manager offerings. Lori previously served as vice president of operations for Fast Track Systems Inc., where she was responsible for implementing electronic data collection and storage, launching the company's customer care team and overseeing the conversion of PICAS® to TrialSpace Grants Manager, a solution which provides contracting and budgeting professionals with access to the largest, most up-to-date and relevant database of investigator grants and costs. Lori also managed projects within data analysis and validation, product management and client relations. Lori has been featured as a speaker at MAGI (Model Agreement Group Initiative) conferences and has also held various speaking roles at Drug Information Association (DIA) and the Center for Business Intelligence Clinical Trial Forecasting and Budgeting Conferences. Lori was honored to be named one of the PharmaVoice 100 Most Inspiring People in 2009. Lori received her B.A. in 1984 from Shippensburg University.
	John Strony, MD, Section Head Thrombosis/ Cardiovascular, Merck Research Laboratories Dr. Strony attended Temple University, Medical School in Philadelphia, PA and trained in Internal Medicine at the Medical College of Pennsylvania / Hahnemann University. Dr. Strony’s Cardioolgy Fellowship was at the University of Minnesota where he trained for general and nuclear cardiology and interventional cardiovascular disease. Dr. Strony holds active board certifications in Internal Medicine, Cardiovascular Diseases, and Interventional Cardiology. Since 1987 Dr. Strony has held faculty appointments with and worked as an Interventional Cardiologist at the University of Minnesota, Medical College of Virginia, and Case Western Reserve University. He was director of the clinical cardiology research program at Case Western Reserve University. Dr. Strony currently holds the academic position of Assistant Clinical Consulting Professor at Duke University. Dr. Strony is a member of the American Heart Association where he is a member of the Thrombosis and Clinical Cardiology Councils and is a Fellow in The American College of Cardiology. While in practice, Dr. Strony held basic science research with the National Institutes of Health, American Heart Association, and the Department of Veterans Affairs in the field of laser-tissue interaction and thrombosis and hemostasis. Dr. Strony has also acted as design consultant to numerous device companies and has performed numerous pre-clinical studies involving coronary and carotid artery stent development. Dr. Strony conducted the core pre-clinical development work for Integrilin on behalf of COR Therapeutics. Dr. Strony joined Schering-Plough in 1998. As a member of the Clinical Cardiovascular group at Schering-Plough, he worked on the Integrilin, Zetia, Vytorin and Thrombin Receptor Antagonist clinical development programs. In November 2009, Dr. Strony was appointed Section Head – Thrombosis for Merck Research Laboratories where he will continue his work on Integrilin, Thrombin Receptor Antagonist, and Betrixaban clinical development programs.
	Kimberly Townsend MBA JD CPA, Senior Counsel, Director of Government Affairs, Welch Allyn, Inc. Kimberly Townsend is Senior Counsel, Director of Government Affairs for Welch Allyn, Inc., one of the world’s leading manufacturers of innovative medical diagnostic equipment and flexible patient monitoring systems headquartered in Skaneateles Falls, New York. Ms. Townsend provides a full range of legal services to the Company. Her practice emphasizes government affairs, and corporate and employment matters. Prior to joining Welch Allyn, Ms. Townsend was a tax consultant with Ernst & Young LLP, a national accounting firm. She is an adjunct professor in the Whitman School of Management at Syracuse University as well as the Syracuse University College of Law. Ms. Townsend is admitted to the New York, New Jersey and Washington, D.C. bars. She serves in leadership positions on several not for profit boards and committees. Ms. Townsend received her BS and MBA from the Whitman School of Management and her JD from Syracuse University College of Law. She is a 2009 MPA candidate at the Maxwell School of Public Administration.
	Mark Tulchinsky, MD, MBA, General Manager & Medical Director Eastern Europe, Medpace Mark earned his degrees in medicine in 1997 and in business administration in 2005. Prior to joining Medpace, Mark worked at a Russian CRO and a global CRO in 1998. Dr. Tulchinsky has worked primarily in the metabolic area dealing with ACS, Hypertension, CHF, stable angina, diabetes, and dyslipidemia studies. He also has experience working with oncology, GI, asthma, and COPD clinical research. Seventy per cent of the trials were phase III and the rest were phase II international (Pan European/Global) studies. Trial size varied from 80 sites in Russia to greater than 1000 sites worldwide. These sites enrolled 6.000 to 17,000 patients respectively. Mark served as project manager and country manager, and managed deferent vendors like IVRS, drug-depots, translation companies, and central Labs. Mark joined Medpace in August 2006 and has been working as a general manager for Russia, Ukraine, Hungary, Scandinavia, and Bulgaria since then. Additionally, Mark has served as Eastern European CTM for diabetes and CHD studies. He has provided medical in-services and general orientation training to associates. Dr. Tulchinsky has firsthand knowledge and experience in emerging markets. He was the first CRA based in Siberia, then he was the first CTM based in Russia. During this time he was responsible for Western European sites, and he`s been managing European entities and associates out of Russia. With the depth of his experience working with emerging markets, Dr. Tulchinsky excels at cutting cost, time, and regulatory issues to effectively bring agents to market.
	Alexander P. Woollcott, Esq., Chair, Gobal Sourcing & Procurement Practice, Thompson Hine LLP Alex is a partner in the firm's Corporate Transactions & Securities practice group, and chairs the firm's rapidly growing Global Sourcing & Procurement practice. With over 22 years of experience as a transactional lawyer, his practice focuses primarily in the following areas: on-shore and offshore sourcing relationships and transactions, procurement and licensing, distribution channel relationships, supply chain solutions, logistics, technology and IT solutions, strategic alliances and joint ventures, and market channel relationships. Alex is widely regarded as an emerging leader in the global sourcing industry and is frequently invited to speak at national conferences on outsourcing. He has significant experience in public sector/private sector sourcing and procurement transactions, and in telecommunications, wireless and media industry transactions. Alex is also well-known nationally for his work in representing companies and senior executives in connection with executive employment agreements; severance agreements; and non-competition, non-solicitation and trade secret protection covenants. He works with a diverse base of clients throughout the United States, ranging from emerging growth companies to established public companies and municipal and other government entities.