3rd Central Labs & Diagnostics Partnerships Forum -

3rd Central Labs & Diagnostics Partnerships Forum
March 20 - 21, 2017
Philadelphia, PA

Assess diagnostic, biomarker and personalized medicine needs to strategically partner with the right central lab, accelerate patient enrollment, and pace ahead of competitors

Faculty – 3rd Central Labs & Diagnostics Partnerships Forum

Patrick Bennett, M.S., MBA
Executive Director, Biomarker Lab, PPD LABORATORIES

Chris Clendening
Executive Director, Global Project Management and Technical Operations, PPD LABORATORIES

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The pharmaceutical industry spans a large number of disease states with multiple etiologies. For more than 25 years, Chris has been involved in many aspects of research, development, protocol design, statistical analysis and clinical trials exposure. Initially he was heavily involved in basic research, where his focus was in neuropharmacology and diabetes research. Later in his career his focus was shifted to microbiological research in burned patient models. This research focused primarily on different microorganisms and how different variables in the host impact the rate of growth and ultimately lead to sepsis. Additionally, this was paired with analysis of different therapeutic agents to aid in the faster recovery of patients, and of how some antibiotics may cause a detriment depending on the organism infecting to host. At the same time there was a focus on wound healing. This included looking at specific patient populations entering the hospital to grade wound healing and follow the patient for years, annually reassessing their status and correlating with the patient demographics looking for trends in certain segments of the population while correlating with scientific data. Chris then moved into a small biotech company where he was responsible for drug formulation and assay development as well as the design of clinical trial protocols. In this environment Chris was involved in the clinical aspect of trials and was awarded several patents during his tenure.

In 2006 Chris then joined PPD as a project manager and quickly moved through the organization, developing specialized groups for the technical development of database design for central lab. As a result Chris held multiple positions, including Manager of Technical Operations and Global Associate Director of Project Management. Chris moved into the Global Director of Operations role in 2011,  where he was responsible for coordinating operational deliverables with clients and scientific personnel. His role spanned multiple disciplines, including logistical shipments of kits and samples globally. In addition to the logistical aspects, he also oversees all aspects of CAP Bio Repository services within the organization. In this role he developed unique innovative technologies to close gaps in the industry with regard to data collection and sample chain of custody leading to the development of the Preclarus Invetsigator Site Portal. In 2017, Chris was appointed the global head of Project Management and Project Design at PPD and directly interfaces with clients to identify trends and needs that can then be realized at PPD to further increase the efficiencies of clinical trials across the globe.

Allyson Gunsallus
Senior Clinical Outsourcing Manager, MEDIVATION

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Allyson Gunsallus is an outsourcing professional and attorney with more than five years of leadership experience in complex clinical contract management and alliance building. In 2012, She received a J.D. from Duke University School of Law and a master’s in global business law through a joint degree program at Sciences Po. After law school, she continued her career in vendor outsourcing by joining Gilead Sciences, Inc., where she was consistently recognized for superior achievement within the Clinical Contracts & Finance Department. In 2016, she joined Medivation Inc. (now Pfizer Inc.) as a Senior Clinical Outsourcing Manager. There, she has provided structure for the RFP process for a new oncology program and has helped develop scalable processes for future success through cross-functional collaboration. She is also the vendor relationship manager for clinical lab vendors, serving internal clients during audit and CAPA processes and leading the organization toward issue resolution and mitigation.

Elias Jackson, Ph.D.
Director of Scientific Public Relations, VYRIPHARM BIOPHARMACEUTICAL

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Dr. Elias Jackson is the co-founder, President of Research and Development and Director of Scientific Public Relations for Vyripharm Biopharmaceuticals, a precision medicine biotechnology firm that develops drugs to target cancer, PTSD, drug addiction and other metabolic diseases. He was previously a professor and research faculty member at the Cardiovascular Research Center at the Yale University School of Medicine, and is a graduate of The University of Texas Medical Branch at Galveston.

Ly Kawaguchi
Director of Clinical Outsourcing, ULTRAGENYX, INC.

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Ly has a B.S. in environmental toxicology. With more than 20 years of experience in the biotech/pharmaceutical area, Ly has an extensive background in both clinical and preclinical outsourcing and contracts negotiations. Her expertise also includes clinical and preclinical outsourcing and contracts, study management, strategic sourcing, CRO vendor management, quality/compliance, and strategic partnership and governance structures establishment with the external vendors. She has built and managed multiple teams at Genentech, Allergan and currently at Ultragenyx, where she most recently developed the clinical site budget and CTA management group.

Kamala Maddali, DMB, Ph.D.
Vice President, Global Biopharma Market Development, Collaborations and Companion Diagnostics, CANCER GENETICS, INC.

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Dr. Kamala K. Maddali is currently Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics at Cancer Genetics Inc. In addition, Dr. Maddali is the Vice Chair of the Philadelphia Chapter of Women in Bio. She is also a Scientific Advisory Member for the International Cancer Advocacy Network. She brings a lot of strategic value from her previous roles at Quest Diagnostics, Quintiles and Merck Schering Plough in the arena of biomarkers and companion diagnostics. Dr. Maddali holds a Ph.D. in pharmacology from the University of Missouri-Columbia and a DVM from Acharya N.G. Ranga Agricultural University in India.

Director of Clinical Operations, Trial Support and Strategic Outsourcing, ROCHE MOLECULAR SYSTEMS INC.

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Hal Mann, Director, Clinical Operations, Strategic Outsourcing & Trial Support, ROCHE MOLECULAR SYSTEMS INC.

Hal has 25 years of clinical research experience ranging in perspective from the study site, small and large CROs, large pharma, and, currently, large diagnostics. During his 15 years with GlaxoSmithKline in RTP, NC, Hal spent six years designing and conducting clinical trials before joining the Global Resourcing group focusing on supplier management and strategic outsourcing. In 2013, Hal joined Roche Molecular in Northern CA as the Director of Clinical Trial Support and Strategic Outsourcing in Medical and Scientific Affairs, where he heads clinical laboratory, medical writing, TMF and material logistics, and outsourcing.

Jonathan Reuter
Associate Director, Global Procurement R&D, Clinical Labs, BRISTOL-MYERS SQUIBB

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Jonathan Reuter, Associate Director, Global Procurement – Clinical Labs, Bristol-Myers Squibb

Jonathan is the Associate Director of R&D Global Procurement responsible for Clinical Laboratory services at Bristol-Myers Squibb, including Central and Specialty Laboratories, Biorepository, and Tissue Procurement. He previously supported Vendor Strategy & Management at Schering Plough and Merck, before joining BMS in 2010 to support the Central Lab space.

In 2011, he took on the additional responsibility of Specialty Labs and partnered with BMS scientific teams to implement robust biomarker category strategies throughout each technology area. In 2011 and 2014, respectively, he added the additional responsibilities in Biorepository and Tissue Procurement, and has recently put in place a category strategy that will integrate these two book ends of R&D to put forth an integrated category strategy to enable and enhance Translational R&D in all phases at BMS.

Jonathan earned his B.S. in business and finance from Monmouth University.

John "JJ" Spegele
Vice President, Business Solutions and Enterprise PMO, COVANCE CENTRAL LABORATORY SERVICES (CLS)

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Mr. John “JJ” Spegele has worked in the CRO industry since 2004 and has held executive positions in general management and IT at both Covance and Quintiles. Currently, JJ is a member of the Covance Central Laboratory Services executive team serving as the VP for Business Solutions. In addition to his CRO experience, he has worked in the pharmaceutical industry at Eli Lilly in manufacturing IT reporting to the CIO and as industry consultant and practice lead. JJ lived and worked outside the U.S. for a number of years in Asia, Europe and the Middle East.

Mr. Spegele graduated from the U.S. Naval Academy and has dual master’s degrees in both computer science and information systems. He is currently pursuing a Ph.D. in biomedical health informatics at Indiana University.

Amelia Wall Warner, PharmD, RPh

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Amelia Warner, PharmD, RPh, is the Founder and CEO of Global Specimen Solutions, Inc., an innovative company offering informatics solutions and specialty CRO services for translational medicine, future biomedical research and human specimen research. Amelia brings more than 15 years of experience and expertise building and incorporating personalized medicine strategies for clinical pharmacogenomic research. She has developed optimized approaches for pharmacogenomics, human specimen research and biobanking. Amelia leads international teams focused on optimizing genetic sample collection, data generation and data transfer globally and continues to work on international policy for both genetic specimens and human specimen research.

Keith Wharton, M.D., Ph.D.
Molecular Pathologist, NOVARTIS

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Keith Wharton, M.D., Ph.D., is a Molecular Pathologist in Preclinical Safety/Translational Medicine at Novartis Institutes for BioMedical Research in Cambridge, MA, USA. A board certified pathologist, he directs tissue biomarker activities for early stage clinical trials across multiple therapeutic areas. Prior to joining biopharma in 2009, at UT Southwestern he held positions of increasing responsibility as Associate Dean, pathology course director, attending pathologist, and leader of an NIH-funded laboratory studying intercellular communication in development and cancer. Following completion of the Medical Scientist Training Program at UCLA, he served a pathology residency and completed a HHMI-funded postdoctoral fellowship in developmental biology at Stanford. He has >30 peer-reviewed publications and numerous honors and awards. In 2015 he coedited and contributed chapters on outsourcing pathology in clinical trials, next generation sequencing in anatomic pathology, and the fundamentals of disease to the book, “Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development” (http://www.springer.com/us/book/9781493926800). He is broadly interested in the molecular control of health and disease, technologies that advance understanding of disease, and drug and diagnostics development.

Irina Wietek, Ph.D.
Manager, Clinical Data Management, SHIRE

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Irina Wietek has more than 15 years of experience in the field of clinical data management and currently is a Manager, Clinical Data Management at Shire. In this role she manages CDM-related activities on a program level for therapeutic area Hemophilia and is responsible for the oversight of CRO-managed projects. Prior to this she held various positions in clinical data management at Baxter and Baxalta (Baxter spinoff). She started her industry experience at the Data Management department of Quintiles, Germany.

Irina holds a Ph.D. degree in molecular biology from Julius-Maximilians-University of Wuerzburg in Germany. As part of her biochemistry studies she completed a training program in clinical laboratory and immunology at Medical University in Sofia, Bulgaria.

Brenda Yanak
Former Precision Medicine Lead, Clinical Innovation and BP, Specimen Management and Imaging, PFIZER

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Brenda advises senior executives regarding opportunities to innovate the clinical development space. She has held leadership roles in science, operations and IT at both Merck and Pfizer, and also acted as a management consultant at IBM’s Pharma Strategy Team. She recently led an effort to operationalize precision medicine through building the infrastructure to support Pfizer’s Human Tissue and Biospecimens Policy.

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