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Heather Almonte is the Assoc. Director of Clinical Operations for the Immunology and Urgent Care Divisions at Octapharma USA. She is responsible for the oversight of U.S. clinical development and ensures global clinical trial implementation and execution. Prior to joining Octapharma, Heather was a Site Activation Services Sr. Manager at Covance. Her responsibilities included the project management of logistical study aspects.
Heather's therapeutic experience includes cardiology, endocrinology and infectious disease (AIDS), oncology (non-small cell lung carcinoma, multiple myeloma), CNS and rheumatoid arthritis. She received her BS in Pharmacology/Toxicology from the University of the Sciences in Philadelphia, an MBA from Drexel University and a Certificate in Regulatory Affairs from San Diego State University.
Lori has more than 25 years of experience in planning and executing scientific communications programs for the pharmaceutical industry. In 2010, Lori joined JB Ashtin, a premier full-service scientific agency that develops compelling, compliant, and engaging healthcare communication solutions. Prior to JB Ashtin, she held leadership positions in the fields of medical publishing, public affairs, and global pharmaceutical marketing at nitrogen (formerly Dorland Global), Synergy Medical Education, Medical Education Systems, Current Medicine, Inc (now Springer), and Allegheny University of the Health Sciences (now Drexel School of Medicine).This diverse career path supports her in adding strategic value to both commercial and clinical teams. Her broad experience includes developing and implementing national and international investigator meetings and advisory boards, speaker training programs, congress activities, clinical experience programs, and field-force initiatives. Lori also has experience in working with clients to develop highly specialized online communities for the healthcare industry. Lori earned her bachelor of arts degree from Dickinson College in Carlisle, Pennsylvania.
Dirk Karsten Beth is the founder and CEO of Mission3, Inc. He has a successful background in leading successful life science software projects. Mission3 is developing solutions for customers and their regulatory information management needs through technology applications built on Microsoft SharePoint or Cloud based architectures. Dirk has lead Mission3 through expansion into new markets, lead the industry with the first and only SharePoint based RIM solution, and pushed the Life Science industry with new ideas.
Nancy Cardone, Confluent Translations’ Business Development Manager, has been working in the translation industry since 2001 as a project and account manager. At Confluent, Nancy performs a dual role acting as an account manager for existing clients and seeking out new opportunities as business development manager. Nancy has helped clients decrease translation costs by 20% while increasing the return on the investment by up to 50%. She is very detail oriented and client focused allowing her to find the right solution for the situation. Nancy has worked with fortune 500 companies to small privately held start-ups with the same passion. She holds a B.A in Romance Languages from Wheeling Jesuit University and studied abroad in both Spain and Argentina. She is actively involved with many translation, global and civic organizations.
Tia is an Associate Project Manager at MediGuard. She has coordinated and managed the delivery of MediGuard patient reported data for numerous projects for Quintiles and some of their most valued clients. Tia knows how to leverage the MediGuard database in a way that provides answers and solutions to complex queries. Before joining MediGuard, she worked in clinical project management at Quintiles.
Adam Chasse joined RxTrials in 2011 to direct the organization’s growth in all business lines and enhance strategic relationships. Chasse has a long and distinguished career in clinical research. From 1995 until 2011 he served in various roles at international CRO Quintiles; among his many accomplishments, Chasse led the global Prime Sites program, co-developed the global site partnership program and the site startup department, and pioneered the use of site performance data to foster productive relationships with sites. He has served on the Multi-Regional Clinical Trials (MRCT) project steering committee, ACRP’s membership committee, and the Site Solutions Summit advisory board. A regular speaker at industry conferences, Chasse received ACRP’s “Up and Comer” award in 2008.
Scott has more than 20 years of marketing experience in the life sciences and technology sectors. At Acurian, Scott is responsible for development and execution of all strategic and operational marketing initiatives. Prior to Acurian, Scott was Director of Marketing at Liquent, the leading provider of regulatory submission software and services, and at SunGuard Higher Education, a developer of administrative software for colleges and universities. Scott graduated summa cum laude from the S.I. Newhouse School of Public Communications at Syracuse University with a B.S. in advertising and English.
Keith Elliston joined CHDI in April of 2011 as the VP for Systems Biology, where he is responsible for the development, implementation and integration of a state-of-the-art systems biology platform for Huntington’s Disease. This includes the development of computational models that describe the disease, assess disease models, and identify new targets for prosecution. In addition, the systems biology effort will evaluate new therapeutic candidates for their activity on the disease, and will be used to design clinical trials to test their safety and efficacy. Prior to CHDI, Keith was a scientist/entrepreneur in the fields of genomics and systems biology. He co-founded and was President and CEO of Selventa (nee’ Genstruct), a leading Systems Biology company. Previously he was co-founder, President, CEO and Chairman of the Board of Viaken Systems, A Bioinformatics ASP; and SVP of R&D and Chief Scientific Officer of Gene Logic, a first Generation Genomics company that he helped to take public. Keith started his professional career in the Pharmaceutical Industry, as Director of Bioinformatics and Scientific Director and co-founder of the Merck Gene Index Project at Merck & Co., Inc.; and as Section Head of Genomics for Bayer Pharmaceuticals. Keith received his PhD in Molecular Genetics from Rutgers/UMDNJ, and an MS in Genetics from the University of Minnesota.
Johnson & Johnson
Janet Flisak is currently a Director at Johnson and Johnson Pharmaceutical Research and Development. She works in the Global Clinical Operations (GCO) group as a compound program lead focused on oncology development. She is accountable for the successful execution of clinical trials in her assigned programs. She has been with J&J PRD for approximately 10 years. Before her venture at J&J PRD she worked for another big pharma company as a clinical scientist and medical writer.
Janet started her career as a registered nurse working in the acute care setting. She moved to the pharma industry ideally suited to manage trials with her clinical background. She obtained an undergrad from the Wharton School of Business at the University of Pennsylvania. Thereafter she received her MBA from the University of Phoenix.
Joe Gardner received degrees in Biology and Education from Wesleyan University, CT. He trained as a Research Associate in the Dept of Internal Medicine, Immunology and Infectious Diseases, at Yale School of Medicine, New Haven, CT where he studied subcellular localization of neutrophil chemotaxis receptors. He joined Pfizer in 1985 as an Assistant Scientist in the Immunopharmacology Dept. developing assays for chemotaxis and studying T cell development and activation pathways. In 1991, he transferred to the Molecular Genetics and Protein Science Dept, studying T-cell activation pathways where he developed several anti-phosphotyrosine based screens. In 1998, he formed a Molecular Interactions technology group introducing SPR technology to Pfizer research. As Manager of the Molecular Interactions facility he was the project lead for the SH2 domain effort where, using SPR technology, he developed several high throughput assays. In 2002, he assumed management of global reagent antibody outsourcing responsibilities. As a Senior Scientist, he is currently a global lead for the Pfizer External Research Solutions (ERS) group, a centralized global group that manages outsourcing for Chemistry and Biology throughout the US, Europe and Asia. Currently, his role is to manage the outsourcing of reagent antibody generation and characterization for investigators covering early discovery through clinical development and post marketing requests. He develops protocols and strategies to develop antibodies, manages external vendors, identifies new vendors and areas of need, provides guidance to investigators and vendors, and develops and implements continuous improvement processes.
Kathy Goin has 20 years experience in healthcare with a focus in clinical research and development of pharmaceuticals and medical devices. As Trial Manager at Endo Pharmaceuticals, she is responsible for leading and managing cross-functional teams to achieve clinical trial goals. The Endo management team encourages and supports her exploration of clinical trial management processes (often perceived as disruptive) with an aim of improving and innovating efficiency. Her clinical and research experience includes: oncology, cardiology, dermatology, antiemetic therapy, medical imaging, orthopedics, physical rehabilitation and sexual health.
Richard Holland is a former lead developer on the open-source BioJava project and is a founder member of the Open Bioinformatics Foundation. Prior to co-founding Eagle Genomics Ltd. in 2008, Richard worked on the BioMart team at the European Bioinformatics Institute, and before that at both AgResearch (New Zealand) and the A*STAR Genome Institute of Singapore on sequencing database projects. Richard holds a BSc in Computer Science from the University of Otago (New Zealand) and is a member of the British Computer Society (BCS). Eagle Genomics has since become one of the key players in the bioinformatics consulting market and is unique in its approach to using open-source solutions.
Mr. Immel has over 20 years of experience in operations and financial management with extensive experience in software development and innovation for business processes, forecasting and operational system implementation. Prior to founding Clinverse, Mr. Immel was the Chief Financial Officer of Naryx Pharma, a specialty pharmaceutical company, where he was responsible for all accounting, finance, information systems and a variety of operational functions.
Renu Jain is currently the Program Director at Grifols Inc a company focusing on development and marketing of human plasma derivatives. Renu is based in the RTP, North Carolina office where she is overseeing the clinical development of Plasmin, a human plasma derived thrombolytic being evaluated in subjects with lower peripheral arterial occlusion. Her past experience includes working at a private biotech company on personalized immunotherapeutic options in Phase II development for cancer and infectious disease. She has also worked at GSK, a large pharmaceutical company, focusing on the clinical development programs for HIV therapeutic options for children and marketed products in asthma. She has extensive experience in doing all phases of clinical trials across many different therapeutic areas and in many different regions of the world. She is currently overseeing a study being conducted at over 80 clinical sites in 15 countries working with 3 different CROs.
Dr. Jiang has been working in the pharmaceutical industry for 13 years. 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 since year 2000. 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, which in turn delivers best NDA filing quality and timeline. Dr. Jiang also has working knowledge of building and managing high performing project teams that deliver break-through results. Recently, 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 China.
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.
Mary Lynne Kupchella, Esq., is an Outsourcing Lead for Pfizer Inc with operational focus in the oncology therapeutic area. She provides global outsourcing expertise in support of clinical development in categories including CROs, technical vendors, drug supply, specialty lab vendors and companion diagnostics. Ms. Kupchella obtained her B.A. in Biology from Franklin and Marshall College and her J.D. from the College of William and Mary School of Law. She is a member of the New York State Bar and is registered to practice before the United States Patent and Trademark Office.
Inovio Pharmaceuticals
Jessica Lee is Senior Director, Clinical Development at Inovio Pharmaceuticals, Inc. She has over 18 years of experience in devices, drugs, vaccines and combination products from early to late stage development in large and mid size pharmaceutical companies. Her current responsibilities are to lead and manage the clinical development department to ensure timely execution from inception to completion of clinical studies for Inovio.
Rich Malloy is the Director of Clinical Quality Assurance which encompasses Good Clinical Practice (GCP) and Good Clinical Laboratory Practices (GCLP) at ViroPharma Incorporated. Prior to joining ViroPharma Incorporated, he was a director for an early phase CRO and has spent several years in forensic clinical auditing and consulting. He’s worked as a CRS, Project Manager, and Director of Operations as well as spending more than five years in Pharmacovigilance. Prior to entering Pharmaceutical Research in 1993, Rich worked as a study nurse / coordinator and worked as a nurse or respiratory therapist in several teaching hospitals.
Kara Lee McWatters has 20 years of experience in Clinical Research both academic and pharmaceutical. She has held positions of increasing responsibility in project and people management at pharmaceutical companies and CROs. In 2008, she pursued the challenge of Clinical Research Consulting and currently provides trial management and monitoring services for clinical trials. Kara Lee is also a part-time professor at Humber College's Clinical Research Associate Certificate Program in Toronto, Canada where she is able to share her passion for research and learning.
Mr. O’Brien joined Beardsworth in 2001, as the VP Operations and CFO, and for the past five years has held the office of President, CEO. Since 1993, he has held executive positions of management within the healthcare industry, leading biopharmaceutical and medical device companies, raising more than $50 Million in the private and public financial markets in the roles of CFO and/or CEO. Prior to this, Mr. O’Brien held a senior international finance position for eight years with a global high technology company, where he was based in the US and in Europe. He began his career with the accounting firm of Deloitte & Touche, as a certified public accountant, and graduated from Villanova University in 1983.
Darlene Panzitta is Founder & President of DSP Clinical Research. She is an award-winning executive who wants to remake the CRO industry to better serve clients. Since Darlene founded DSP in 1999, the company has earned a national reputation for excellence in clinical trial outsourcing and customer service. Darlene is an expert at virtually every aspect of clinical study management, with extensive therapeutic expertise. Darlene’s articles on best practices in clinical trial outsourcing and management are published in top industry magazines including Applied Clinical Trials. She is a frequent speaker at industry events. Darlene holds a BS in Science and an MS in Biology from Farleigh Dickenson University. She conducted post-graduate coursework in Biomedical Science at the University of Medicine & Dentistry of New Jersey.
Dhiraj Pathak leads the Cloud Infrastructure Services at PwC and consults with clients on Cloud Strategy, Cloud Infrastructure, Cloud Security, Cloud Service Management, and Cloud Sourcing. He has broad industry experience in the life sciences and healthcare sectors.
He has delivered transformational business value spanning IT Strategy, Service Delivery, Enterprise Applications, and Infrastructure. He has built and led global teams for large-scale application delivery, systems integration, and product engineering.
Dhiraj received his undergraduate degree from the Indian Institute of Technology. He received his MS and PhD degrees from Carnegie Mellon University and was a Keck Computational Biology Fellow. He is based in New York.
Dr. Proniuk has over 15 years of experience in pharmaceutical product development. In his current role, he is responsible for preclinical, chemical and pharmaceutical development. Dr. Proniuk has extensive development experience across multiple therapeutic areas and dosage forms and has participated in the submission of 15 INDs/CTAs/IMPDs and 2 NDAs. Dr. Proniuk holds a Ph.D. degree in Pharmaceutical Sciences from the University of Arizona, an M.B.A. from San Diego State University and a Diplom (FH) in Chemical Engineering from the Polytechnical University Isny in Germany.
Evette Riegel, RN is the Senior Director, Clinical Operations and Project Management with Beardsworth where she leads the company’s integration of global services and oncology contract research operations. Her hands-on experience provides a practical and personal perspective on the realities of global outsourcing including the management of the largest global clinical trial in oncology supportive care (CINV) to date involving over 1400 patients and 30 plus sites.
With a career that spans 25 years in the health care arena, Ms. Riegel brings a depth & breadth of experience to her current role. Enhancing her clinical study & project management experience with US and global trials is the valuable insight gained during her 15 years as a critical care nurse.
In addition to her oncology experience, prior to joining Beardsworth, Ms. Riegel was global project manager at Quintiles, a contract research organization. She had previously worked at Discovery Laboratories, ViroPharma and Wyeth where she was involved in adult, pediatric and neonatal infections disease, respiratory, critical care, cardiovascular and diabetes research.
Donald P. Rosen, M.D., Co-founded RadPharm, Inc. in 1998 and served as its Co-CEO, board member and Chief Strategy Officer until 2008. While at RadPharm he was involved with the imaging portion of hundreds of clinical trials, the majority in Oncology. Dr. Rosen practiced as a diagnostic radiologist in Princeton, N.J. from 1990 until 2011. He currently resides in Southern California with his family and is involved in advisory positions within the Clinical trials space. He is on the Board of Directors of ACR Image Metrix. . He has served on the Board of Overseers of Albert Einstein Healthcare Network. He has served on the board of the American Cancer Society and the Breast Cancer Resource Center in Princeton. He has lectured at many Pharmaceutical and Oncology meetings about the uses of diagnostic imaging in Oncology clinical trials. He received his B.A. from the University of Pennsylvania and his M.D. from the University of Cincinnati.
Barry’s focus is on Strategy, Executive, Management and Organizational Development.
Barry has been a successful consultant, facilitator, trainer, manager and coach for over 35 years. He is expert in a number of disciplines including Structural Consulting. He has extensive experience in negotiation and conflict resolution, both individually and organizationally. An excellent mediator, he is trusted by clients to look at situations objectively and to support them in getting the results they want.
His corporate experience includes:
GCI Group, division of Grey Advertising, where he was SVP and head of the global clinical trial recruitment business. Schering-Plough Pharmaceuticals, where he managed Management Training at the corporate level. He also provided facilitation for strategic business planning in Western and Eastern Europe and throughout North America.
Prior to joining Schering-Plough, Barry held a number of positions at Janssen Pharmaceutica, a division of Johnson & Johnson, including National Managed Healthcare Accounts founded Sagotsky Multimedia, a leading distributor of training and development media.
Barry’s hobbies include: martial arts, magic, fly fishing, golf, photography, music, and skiing. He is married and has one son. Barry received his BA and MBA from Rutgers University.
Uwe studied Biology at the University of Düsseldorf. After finishing his doctoral thesis and spending 4 years of pre-clinical research at the University of Munich, he started his industry career in Clinical Operations and Business Development at a mid-sized CRO in 1995.
Uwe studied Biology at the University of Düsseldorf. After finishing his doctoral thesis and spending 4 years of pre-clinical research at the University of Munich, he started his industry career in Clinical Operations and Business Development at a mid-sized CRO in 1995. In February 2000, he joined Grünenthal as Head of CRO Management, where he built up a process framework and team of experts for professional outsourcing and contract management for all R&D departments in Grünenthal.
In the recent years, Uwe’s team and competence areas have been further expanded and he is now leading the Department of “Global Sourcing Management & CDB Business Support”, which is the center of excellence for key business support functions in CDB, including outsourcing & contract management, vendor relationship management, planning & resource management, process improvement and training management.
He became a member of the PCMG (Pharmaceutical Contract Manager Group) in 2000 and shortly afterwards set-up a Germany-based Outsourcing Manager Forum that meets on a regular basis to share experiences and best practices in outsourcing.
Mollie Shield-Uehling directs the business and strategic activities of SAFE-BioPharma Association and serves as the primary liaison with member companies, vendor partners and others in the growing SAFE-BioPharma community. She is a member of the association’s Board of Directors.
Ms. Shields-Uehling has more than 20 years of international trade and biopharmaceutical industry experience. Prior to joining SAFE-BioPharma Association, Ms. Shields-Uehling was principal of Shields-Uehling Associates, an international public affairs consultancy. She previously served in various leadership positions with Bristol-Myers Squibb, Wyeth, the International AIDS Vaccine Initiative (IAVI), and in the White House Office of the U.S. Trade Representative and the U.S. Foreign Commercial Service. She has been recognized by PharmaVOICE Magazine as one of the pharmaceutical industry’s most influential leaders.
Greg is the Director, Clinical Operations with ViroPharma Incorporated where he currently utilizes his expansive experience in product development ranging from clinical operations to commercialization. He has served various roles of increasing responsibility during his 18 years in the industry where he started as a clinical research associate for Phase I – III studies.
Over the years, this grassroots background has enabled Greg to provide perspective to newly defined roles and positions he has filled while working to develop medical science liaison and investigator initiated study programs as well as clinical finance initiatives.
His management background in multiple therapeutic areas of oncology, infectious disease and cardiovascular studies for large Phase II and Phase III programs, which includes companies varying in size from large pharma to private equity specialty pharma, encompasses the aspects of study start-up to product approval.
Greg earned his Bachelor’s of Science degree in Biology from the University of Scranton and has conducted post-graduate coursework in Health Administration at St. Joseph’s University. He has also earned his Certified Clinical Research Contract Professional (CRCP) designation.
Recognizing the need to simplify medical image management in clinical drug and device development, Ven Thangaraj founded Radiant Sage in 2007. Following his vision and under his leadership, Radiant Sage has developed a unique Internet-based clinical trial image management solution and secured partnerships with two of the top five pharmaceutical companies in the world.
With nearly 20 years of experience in the biomedical field, Mr. Thangaraj has extensive background working with companies focused on medical technology and investing in new company ventures. Prior to founding Radiant Sage, he was president of Megasoft’s Life Sciences (Afferenz) and was responsible for developing the business plan and managing all aspects of the business from the P&L to product development, marketing and business development functions. He currently serves as a consultant for Trianz, Inc., which acquired Megasoft in 2009. Before his role with Megasoft, Mr. Thangaraj honed his business and industry expertise by founding numerous companies and developing multiple software programs to aid in medical imaging and medical imaging management.
Mr. Thangaraj earned a B.S. degree in biomedical engineering from the University of Illinois in Champaign-Urbana, Ill. and a second B.S. degree in mechanical engineering from Rensselaer Polytechnic Institute in Troy, N.Y. Throughout his career, Mr. Thangaraj has authored numerous scientific articles and abstracts.
Adair Turner, MS, RAC is the Regulatory Affairs Manager at Mission3. Adair received her BA in Communications from Rutgers University and her MS in Clinical Research Management from Arizona State University. Adair has over seven years of experience in Regulatory Affairs and has worked for companies such as ImClone Systems and Celgene where she led the planning, review, and delivery of over 200 high-quality regulatory submission dossiers in support of the development and registration of anti-cancer compounds worldwide.
Bryant is currently Vice President, Strategic Sourcing with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company. He joined ImClone two years ago to create a Strategic Sourcing team to support all functional areas, with a focus on Clinical Development. Bryant’s team is now sourcing all phase I – III clinical studies for ImClone’s biotech oncology pipeline globally. Prior to this assignment, Bryant was employed with Watson Pharmaceuticals as Vice President, Strategic Purchasing. During his 5 years at Watson; he led the formation of a sourcing team where he and his team successfully implemented a preferred Clinical provider program to support the bioequivalence studies and NME studies for all phases in the clinical area. Prior to Watson, Bryant was varying roles in his 23 years with Pfizer/Pharmacia/Searle/Monsanto where he was in increasing responsibility roles in Strategic Sourcing, Customer Operations, sales and marketing, manufacturing management and engineering.
Academically, Bryant earned a Bachelors degree in Chemical Engineering from the University of Delaware and an MBA with honors from Washington University in St. Louis. He has also earned his Certified Purchasing Manager (CPM) designation.
Brad is a Director of Clinical Imaging and Technologies within Precision Medicine at Pfizer. Since joining Pfizer in 2004 he has been supporting the teams in implementing imaging into their studies ensuring that imaging endpoints effectively support decision making. In addition he helps in the exploration and development of novel imaging biomarkers in order to positively impact the evaluation of the drug pipeline. His experience covers multiple therapeutic areas including atherosclerosis, Alzheimer’s disease, macular degeneration, osteoarthritis, obesity, rheumatoid arthritis, and pulmonary diseases as well as multiple imaging technologies including MRI, X-ray, PET and CT. To facilitate the imaging work he helped design and implement an image management system currently in use across Pfizer. Prior to joining Pfizer he was involved in a number of small medical device companies that applied imaging and image processing in novel ways for patient treatment and diagnosis. He received his B.S. (1988) and M.S. (1991) in electrical engineering at Brigham Young and Northwestern respectively and his Ph.D. (1998) in biomedical engineering at Johns Hopkins were he explored the use of tagged cardiac MRI to evaluate the mechanics of ventricular pacing.
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