Anka Ehrhardt

Consultant

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Anka Ehrhardt

Consultant

Dr. Anka Ehrhardt is a biophysicist with a doctorate degree in human physiology. She most recently worked for Bristol-Myers Squibb. Already during her academic career, Dr. Ehrhardt successfully developed technology and technology based methods, such as anisotropy detection based imaging. Later, she headed a technology laboratory at Merck, covering comprehensive instrumentation in high tech fields such as fluorescence, imaging, flow cytometry, electrophysiology and luminescence for the entire range from early discovery to late stage clinical trials across all disease areas. While at BMS, Dr. Ehrhardt directed the Clinical Cytometry team, covering a large portfolio of immunology, immuno-oncology, and other disease area clinical studies. Her work focused on the practicalities of biomarkers as tools to drive the development of urgently needed new medicines. This reaches from securing that biomarker assays are optimized to gather clear data in support of fast well founded decision making to systematically maximizing the information gathered from clinical samples to support hypothesis generation.  Dr. Ehrhardt is currently on the board of different industry organizations, fostering innovation and collaboration between industry, academia and government organizations.

Sean Ferree

Vice President Diagnostic Development

NanoString Technologies

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Sean Ferree

Vice President Diagnostic Development

Sean Ferree, Ph.D., is the Vice President of Diagnostic Development at NanoString Technologies where he manages a team of scientists and engineers developing in vitro diagnostics and companion diagnostics for oncology applications.  Dr. Ferree led the team that developed the Prosigna Gene Signature Assay as the first decentralized multi-gene expression signature for prognosis in early stage breast cancer including submitting and defending the test through regulatory clearance in the US and EU.  Dr. Ferree has spent the last 12 years in roles of increasing responsibility at NanoString, first developing the research-use-only assay, instruments, and software comprising the nCounter Analysis System, then tailoring the platform for use in multiple genomics research applications, and later developing a second generation system suitable for diagnostic applications.  He received his Ph.D. in Chemical Engineering from the University of California, Berkeley and his B.S. in Chemical Engineering from the University of Colorado, Boulder.

Warren Glaab

Director, Systems Toxicology Investigative Laboratory Sciences

Merck Research Laboratories

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Warren Glaab

Director, Systems Toxicology Investigative Laboratory Sciences

Dr. Warren Glaab has worked within Safety Assessment at Merck Research Laboratories for 20 years. Most recently he has served as Director of Systems Toxicology, involved with providing biomarker development support to Safety Assessment, incorporating new model systems and technologies including genomics and proteomics, and investigative toxicology research solutions. Previous experience within the Department of Molecular and Investigative Toxicology group in Safety Assessment included novel assay development and investigational studies to better understand toxicity mechanisms. He earned his Ph.D. in Toxicology at the University of North Carolina at Chapel Hill, conducted research at the National Institute of Environmental Health Sciences in Research Triangle Park, and completed two postdoctoral positions at National Institute of Environmental Health Sciences and at Merck Research Laboratories in West Point, PA.

Sarah Hersey

Head of Precision Medicine and Companion Diagnostics

Celgene

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Sarah Hersey

Head of Precision Medicine and Companion Diagnostics

Sarah is currently the Head of Precision Medicine and Companion Diagnostics for Celgene Corporation.  She has more than 20 years’ of industry experience in leading R&D organizations, CLIA laboratories, device manufacturing, assessment and implementation of technology strategies and development of in vitro diagnostics.   Prior to joining Celgene, Sarah was at Novartis, initially as an Executive Director, Global Program Diagnostics and subsequently moved into the role of Global Head of Future Precision Medicine, leading a team which submitted multiple pre-market applications including one for NGS.   Prior to Novartis, Sarah held multiple roles with increasing responsibility within Johnson and Johnson including Global Head of Operations, Assay Program Leader for Companion Diagnostics Center of Excellence, Director of Materials Process Development and Enabling Technologies.  In addition, her prior experience includes start-up and establishment of a pre-clinical GLP laboratory, technical support and quality assurance.  Sarah has BS and MS degrees in Chemistry and Biology from Northern Illinois University, Regulatory Affairs Certification (RAC) and MBA from California State University.

Kellie Howard

Senior Manager, Method Development

Covance Genomics Services

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Kellie Howard

Senior Manager, Method Development

Kellie is with Covance Genomics Services where she manages a team to support internal development research efforts with specific focus on biomarker discovery.  In this role, she leads the validation of biomarker assays for Next Generation Sequencing (NGS), Sanger sequencing, NanoString, pyrosequencing, ddPCR, and qPCR-based SNP, CNV and gene expression assays.  Her expertise in biomarker development covers oncology, infectious disease, rare diseases and inflammation.  She is also on business advisory teams that evaluate and develop new areas of focus and then direct the proper placement of studies within the global Covance community.  She has extensive experience in the industry and has published widely.  Her academic training includes a PhD and postdoctoral fellowship at the University of Washington and a BS from Auburn.

Bonnie Lafleur

Vice President Data Science Department Head Biostatistics and Bioinformatics

HTG Molecular

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Bonnie Lafleur

Vice President Data Science Department Head Biostatistics and Bioinformatics

Dr. LaFleur is a quantitative scientist with extensive experience in scientific research, statistical method development, and data analysis.  Following her formal training in biostatistics, she pursued an academic research career overseeing the research and development of genomic biomarkers for 15 years while mentoring graduate students and post-doctorates in biostatistics and biomedical sciences.  Since transitioning to the diagnostics industry five years ago, she has focused on statistical methodology around study design and experimentation for biomarker-driven clinical studies working in close collaboration with key opinion leaders in academia and pharma. She has developed regulatory strategies for immuno-oncology companion diagnostic FDA-approved products and has been a key contributor to multiple in vitro diagnostic device submissions.  Dr. LaFleur has published over 90 peer-reviewed publications, holds one US patent, and has three pending patents, which all focus on genomic biomarkers with clinical value.  Her leadership activities include membership on the Board of Directors of the American Statistical Association, and the ASA committee for statistical leadership.

Matthew J. Marton

Director, Companion Diagnostics & Genomics

Merck & Co.

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Matthew J. Marton

Director, Companion Diagnostics & Genomics

Matthew Marton is Director of Clinical Genomics in Merck & Co.’s Molecular Biomarkers & Diagnostics department, where his team has deployed predictive biomarkers as patient enrichment assays on multiple technology platforms in over a dozen Merck clinical studies. His current work focuses on the CoDx strategy of novel genomic assays as molecular diagnostics, and he is a contributor to several CLSI documents involving molecular diagnostic testing in oncology. Prior work at Merck focused on technology/method development and biomarker discovery, with an emphasis on quality control of molecular profiling assays. Earlier in his career, Dr. Marton worked with Drs. Stephen Friend and Lee Hartwell at the Seattle Project, a drug discovery think tank, which led to the founding of Rosetta Inpharmatics, a biotechnology company that was acquired by Merck in 2001. At Rosetta and subsequently at Merck, he led scientific efforts to create a GLP-like high throughput functional genomics laboratory. Dr. Marton completed post-doctoral training at the NIH and holds a PhD from Princeton University and a Certificate in Biomedical Regulatory Affairs from the University of Washington.

John S. Mudgett, Ph.D.

Vice President, Drug Discovery Services

Genesis Biotechnology Group

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John S. Mudgett, Ph.D.

Vice President, Drug Discovery Services

John S. Mudgett, Ph.D. is Vice President, Genesis Drug Discovery Services at the Genesis Biotechnology Group.  Leading the integration of all drug discovery services groups and functions, John brings an enthusiastic vision and decades of internal and external pharmaceutical experience to create and grow a holistic customer facing Services Company.

Dr. Mudgett, was owner of JsM BioScience, LLC, providing science and business development consultation services to Biotech, CRO, and Scientific Conference business.  His services included opportunity assessment, and science and business evaluation for client penetration into the Pharma and Biotech customer base.  

Prior to that, John was External Lead – Pharmacology, Merck Research Laboratories, a position with increasing responsibilities he held for 12 years.  At Merck, he brought extensive experience in the execution of scientific, business development, managerial, financial, Lean Sigma, and IT delivery for translational BioPharma support of a diverse portfolio of programs in the global CRO arena.

John was a founding member of the GEM department, tasked with taking an entrepreneurial approach to partnering with internal research to create an inception-to-impact return on investment with external providers in the US and global arenas.  John was responsible for domestic and global scientific and business development, CRO alliance management, external project management, internal-external collaborations, and delivery of pipeline supporting data for program advancement.  Awarded the Merck Research Laboratories Customer Focus Award, he was recognized for bringing value and experience to both internal and external customer needs and business solutions.

Dr. Mudgett holds Doctorate and Masters degrees from The Pennsylvania State University and a B.S. with high distinction from The University of Maine.  He has completed postdoctoral training at Los Alamos National Laboratory, where he was awarded the Alexander Hollaender Postdoctoral Fellowship Award.  He is a Six Sigma certified greenbelt, and led an effort that returned $30 million to Merck in efficiencies, while increasing the scientific deliverables.

John serves as a Scientific Advisor to the Panel of Scientific Consultants for the International Mouse Phenotyping Consortium (IMPC), funded by the NIH Common Fund.  He also serves as a member of the Scientific Advisory Board for PHENOMIN, the French National Infrastructure for Mouse Phenogenomics.  In addition, John is a member of the BioPharma Research Council committee for helping to organize speakers and conference sessions for upcoming events.  John and his wife Kristine are actively involved in Preschool Advantage, a charitable organization serving children and families of need in obtaining quality preschool access and tuition.  In addition, John is an avid wood craftsman, making custom wood-crafted products.

Mark Roberts

Director, Diagnostics Development

Covance

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Mark Roberts

Director, Diagnostics Development

Mark J. Roberts, received his PhD in Pharmaceutical Sciences from the University of Nottingham (UK) and has worked in the clinical diagnostics arena for over 20 years, holding senior positions in both the in vitro diagnostic and reference laboratory industries. He joined Covance in 2012 to spearhead our Companion Diagnostics initiative, designed to assist pharmaceutical and diagnostic companies in drug – companion diagnostic co-development.

Donald Very

Vice President, Scientific Strategy, Technology and Research

Helomics

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Donald Very

Vice President, Scientific Strategy, Technology and Research

With over twenty-five years of diagnostic assay development and performance qualification experience in such diverse clinical areas as oncology, infectious disease, and metabolic disease, Dr. Very has extensive experience in all phases of diagnostic assay research, development, performance validation, clinical trial design and implementation, and regulatory approval.

Dr. Very is currently Vice President, Scientific Strategy, Technology and Research at Helomics Corporationwhere he is responsible for the identification, evaluation, and implementation of new technologies, assay platforms, and tests to augment the company’s clinical laboratory, comprehensive tumor profiling platform, and contract research offerings.  Prior to Helomics, he was Vice President of Research and Assay Development for Ancera, Inc., where he successfully led efforts to develop quantitative cell, nucleic acid, and protein assays for the company’s proprietary, magnetic fluid-based, diagnostic platform. He also served as Vice President of Immunology and Assay Development for the Institute for Bioanalytics, LLC (IBA).  Responsible for the overall scientific, operational, and research activities of the Institute, he successfully built a profitable contract research business.  Under his leadership, IBA completed over 200 cell, nucleic acid or antibody-based assay development and performance qualification projects in support of the research programs of clients in the pharmaceutical, diagnostic, and biotechnology industries.  Dr. Very also served as a Senior Research Scientist for the Diagnostics Division of Bayer Corporation, where he was responsible for the design and execution of clinical trials, performance validation studies for the AFP, CA 125 II, and CA 15-3 tumor marker assays for the Bayer Immuno 1™ Immunoanalyzer, and the preparation and submission of 510(k) applications to the FDA for these assays.  These activities culminated in the FDA’s approval of all these assays for use in the U.S.  Dr. Very began his career as a researcher and supervisor of the BL-2 and BL-3 laboratories affiliated with the U.S. Army Medical Research Unit in the Republic of Korea.  Managing a staff of six scientists, His team conducted clinical and diagnostic research on hantaviral and rickettsial diseases endogenous to the Korean peninsula.

Dr. Very is a frequently invited speaker at national and international scientific symposia discussing topics ranging from advances in personalized medicine in oncology, the clinical utility of serum biomarkers in the diagnosis and management of disease, the development and performance qualification of multiplexed immunoassays, and the future of the in vitro diagnostic industry.  He received his Bachelor of Science degree in Biology from the University of Notre Dame, a Master of Science degree in Biology from the University of Texas at San Antonio, and a Doctorate in Microbiology/Immunology from Boston University.

Russ Weiner

Executive Director and Global Head Bioanalytical, Biomarkers and Companion Diagnostics

Daiichi Sankyo

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Russ Weiner

Executive Director and Global Head Bioanalytical, Biomarkers and Companion Diagnostics

Russell Weiner is currently Executive Director and Global Head Bioanalytical, Biomarkers and Companion Diagnostics at Daiichi Sankyo. He is an experienced senior level biopharmaceutical professional with direct expertise in drug discovery and development, clinical trial conduct and building regulated bioanalytical (GLP and clinical), molecular biomarker and companion diagnostic organizations. He has over 24 years experience having worked at Bristol-Myers Squibb, Merck and now Daiichi Sankyo in all therapeutic areas with a focus on immuno-modulatory/immuno-oncology (checkpoint blockers) therapeutics. He was directly involved in supporting the development and approval of Erbitux® (cetuximab, ant-EGFR), Orencia® (abatacept, CTLA4Ig), Nulojix® (belatacept, mutated CTLA4Ig), Yervoy® (ipilimumab, anti- CTLA4), Keytruda® (pembrolizumab, anti-PD- 1) and its associated Dako PD-L1 IHC 22C3 pharmDx companion diagnostic assay.  Russ has extensive experience in project leadership,
biologics/biomarker assay development, validation and global deployment (including India, China, Singapore and Japan). He has led early clinical development teams responsible for transitioning multiple small molecule immunology/inflammation therapeutics from discovery through phase 2 proof-of- concept. Russ is a strategic thinker well versed in using biomarkers for early decision making, companion diagnostics for patient selection and is a recognized thought leader on regulated bioanalysis and biomarker assay development.

John Thompson

Research Fellow

Bristol-Myers Squibb

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John Thompson

Research Fellow

TBA

Ronnye Schreiber

CEO

PlanetConnect & Board of Directors, BioPharma Research Council

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Ronnye Schreiber

CEO

Ronnye co-founded PlanetConnect in 1995 and is the company CEO. She is also Co-founder and member of the Board of Directors of the non-profit, BioPharma Research Council (BRC).  She leads teams creating customized internal and external meetings and trade shows for Pharmaceuticals, Telecommunications and AgBio organizations. Past working lives have been spent in labs in Johnson & Johnson, Rutgers Medical School, Sidney Farber Cancer Institute, Arthur D. Little, and Ortho Diagnostics and in libraries and marketing at AT&T and Lucent Bell Laboratories.

Tom Fare

Director of Strategic Alliances

PlanetConnect

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Tom Fare

Director of Strategic Alliances

Tom is Director, Strategic Alliances for PlanetConnect. His role is to engage potential new clients and customers to develop symposia that address existing and emerging needs within their organizations.  He uses his extensive experience in scientific research, development, and licensing to identify meeting themes matched to a client’s objectives and goals.  He also develops ROI models to measure and report on business and employee development for clients and customers.   Tom spent over 13 years with Merck & Co. and over 30 years in biotechnology and technology.  He received his PhD in Electrical Engineering and Science at the University of Pennsylvania.  He has authored or co-authored peer-reviewed papers in fields ranging from circuit design to gene profiling technologies.