Data in the Dawn of Precision Medicine
Sandra Merkel DeJames, Ph.D.
Director, Commercial Strategy and Execution
Dr. Merkel DeJames is an expert in the relevance of data internationally, across pharmaceuticals, agriculture, energy and life sciences, She received her Ph.D. in Biology (interdisciplinary degree, with competencies in biochemistry, biophysics and bioengineering), Post-Doctoral training at the UNC School of Medicine.
She formerly served as Head of Regional Development for Novozymes, North America, Inc. She is the Founder of NC Elite Volleyball, Inc. focused on developing young athletes 10-18 years of age, to the peak of their ability. Sandy also serves on several boards: NCSU Institute of Emerging Issues National Advisory Board and Finance Committee, NC Bio Board of Directors, and Eisenhower Fellowships Board of Directors Trustee Delegate.
Additional Speakers - scroll down for bios
Rodolphe Barrangou, Ph.D., Associate Professor, CRISPR Lab Lead, North Carolina State University
Michael Daniele, Ph.D., Assistant Professor, Department of Electrical & Computer Engineering, NCSU and Joint Department of Biomedical Engineering
Joanne Gere, Executive Director, BioPharma Research Council
Chris Hare, CEO, The nTeTe Group
Chris Hoecke, Healthcare Industry Analyst, Mallard Research
Russ King, Medical Device Quality and Regulatory, MethodSense
David Kroll Ph.D., Journalist, Forbes Magazine, Take As Directed
Frances Ligler, D.Phil., D.Sc., Lampe Distinguished Prof. of Biomedical Engineering
NCSU College of Engineering and UNC-Chapel Hill School of Medicine
Joe Magno, Executive Director, NC Center of Innovation Network
James Melton, Synecor
Stefano Menegatti, Ph.D., Assistant Professor, Department of Chemical and Biomolecular Engineering, North Carolina State University
Kelci Miclaus, Ph.D., Advanced Analytics R&D Manager, JMP Life Sciences, SAS
Rodolphe Barrangou, Ph.D.
Department of Food, Bioprocessing and Nutrition Sciences
North Carolina State University,
For more than 10 years, Dr. Barrangou has focused on CRISPR-Cas systems, and their use for bacterial genotyping, building prokaryotic immunity, and Cas9-mediated genome editing in industrial bacteria. He is a co-founder of Intellia Therapeutics.
Dr. Barrangou earned a BS in Biological Sciences, a MS in Biological Engineering, a MS in Food Science from NC State University, a PhD in Genomics from NC State University and a MBA from the University of Wisconsin-Madison. After 9 years in R&D and M&A at Danisco and DuPont, he joined the Faculty at NC State University in 2013.
Michael Daniele, Ph.D.,
Assistant Professor, Department of Electrical & Computer Engineering,
NCSU and Joint Department of Biomedical Engineering
Many organ-on-chip models lack the necessary microvasculature to conduct proper pharmacological studies. Models of the brain, skin, heart, and colon require complex vascularity to model an accurate physiology. Accordingly, a microfluidic fiber fabrication device was developed to prepare synthetic blood vessels with well-defined anatomies. These blood vessel models can be integrated into tissue scaffolds containing select cells to recapitulate organ function. These vascularized models will be of particular use to study intravenous drug delivery, disease pathologies and the mechanisms in which both drugs and foreign bodies transit the critical blood-tissue barriers of the body.
The nTeTe Group
Chris Hare heads The nTete Group a strategy and innovation licensing consulting company founded in 1999. He is also Partner in Thingovation an Internet Of Things company and Partner in QED Global Partners a professional services development company. He was formerly partner in MoveableCode a media and connected device strategy business. He is on the board, an advisor or mentor to a range of companies in the US, UK, Sweden, Israel, Japan. Public clients have included the UK Government - UK Trade and Investment. Previously he was CEO of Data Transfer and Communications a UK based Wireless Security IP company. Prior to this he created and led Sony Ericsson’s Industry Collaboration team reporting to the COO then to the CTO. Previously he headed Sourcing for Sony Ericsson’s largest Business Unit with a spend of over $8.5Bn. Prior to this Chris was President of Digit Wireless a start-up in Boston. He has over 25 years experience in a range of management roles in the wireless industry. Other history includes work with Lucas, TRW, Ericsson, LG, Sony and other companies in telecommunications/manufacturing.
Healthcare Industry Analyst
As the principal of Mallard Research, Mr. Hoecke currently works as a healthcare industry analyst with a focus on biotechnology and drug development. His analysis utilizes extensive experience in both academic research and industrial settings to produce valuation models for biotech products and the companies that develop them. An in vitro-diagnostics scientist, Mr. Hoecke has 15 years of experience in various aspects of research, product development and manufacturing technical-support in a GMP environment. He has participated in the conduct of IVD clinical trials and carried out the validation of assays in both manufacturing, QC and research settings. In the last several years Mr. Hoecke has also utilized his experience and technical understanding by serving as an analyst for a firm that provides technical expertise in support of patent and trademark litigation. These cases have involved pharmaceuticals, aerospace and network/storage technology. Prior to his work with Mallard, Mr. Hoecke worked as a research and then senior scientist, and later as a marketing support specialist at American Diagnostica of Sekisui Medical Group. Prior to that, Mr. Hoecke was a research scientist at Biomerieux, where he was involved in product development, as well as in the management of process validation and manufacturing support efforts, participating in an intensive site- wide FDA compliance initiative.
Medical Device Quality and Regulatory
Russ King is the president and managing partner of MethodSense, a life science consulting firm with offices in the US and Europe. King works with medical device, biotech and pharmaceutical companies to develop quality, regulatory and technology solutions. King’s experience spans compliance operations, quality support and risk remediation. He has consulted for many global medical device and healthcare enterprises, including IBM, St. Jude Medical, Teva and Intertek. He works with organizations to develop business processes that meet quality and regulatory requirements. King’s skill set has become increasingly important as more companies integrate technology into their businesses and products. King is adept at simplifying complex concepts, and he is instrumental in helping clients understand the risk involved with FDA compliance. His knowledge and powerful communication skills guide clients to operational efficiency that reduces risk and can save thousands of dollars.
David Kroll Ph.D.
Forbes Magazine, Take As Directed
David is a science and medical writer, pharmacologist, pharmacy and medicine educator, public speaker, and media commentator on drugs and supplements. With more than 20 years of experience in medical science education and academic research laboratory leadership, he writes primarily for Forbes Pharma & Healthcare and Take as Directed, his blog.
Frances S. Ligler, D.Phil., D.Sc.
Lampe Distinguished Professor
Department of Biomedical Engineering
UNC-Chapel Hill and NC State University
Frances S. Ligler is the Lampe Distinguished Professor in the Department of Biomedical Engineering at NC State and UNC Chapel Hill and a member and Councillor of the National Academy of Engineering. She earned a B.S. from Furman University and both a D.Phil. and a D.Sc. from Oxford University. She has 400 full-length publications and patents, which have led to eleven commercial biosensor products and over 13,000 citations. Elected a Fellow of SPIE in 2000, of AIMBE in 2011, and of AAAS in 2013, she was awarded the Presidential Rank of Distinguished Senior Professional by President Bush (2003) and the Presidential Rank of Meritorious Senior Professional by President Obama (2012). In 2014, she was awarded an honorary doctorate from the Agricultural University of Athens, Greece.
NC Center of Innovation Network
During his career Mr. Magno has successfully launched, grown, and sold a number of high technology enterprises. He also has served as an executive in large private sector companies, academic research organizations, and government. Currently he serves as the Executive Director of the North Carolina Center of Innovation Network. NC COIN is a 501(c)3 charitable organization missioned to inform, educate, and bring together all those interested in growing organizations engaged in the STEM disciplines, grow the State’s STEM economy and improve the human condition.
Stefano Menegatti, Ph.D.
Assistant Professor, Department of Chemical and Biomolecular Engineering
North Carolina State University
Dr. Menegatti earned his Ph.D. in Chemical Engineering at NC State University under the supervision of Prof. Ruben G. Carbonell. His doctoral work focused on the development of peptide affinity ligands for purifying biotherapeutics and the design of novel and inexpensive in vitro and in vivo diagnostics. As a postdoctoral fellow at UC Santa Barbara, he worked with Prof. Samir Mitragotri on novel strategies for targeted drug delivery, including nanoparticle platelet mimetics, targeted delivery of synergistic combination of anticancer drugs using polymer carriers, DNA-peptide carriers, and liposomes, and transdermal drug delivery with skin-permeating peptides. His research group focuses on the constrained (cyclic and polycyclic) peptides and peptide-mimetics to develop (i) stimuli-controlled adsorbents for purifying labile protein therapeutics, (ii) delivery strategies to overcome difficult body barriers, and (iii) model “smart” polymers to study the solution phase behavior of synthetic macromolecules.
Kelci Miclaus, Ph.D.
Advanced Analytics R&D Manager, JMP Life Sciences
Dr. Miclaus manages the development team and release cycles for the JMP Genomics and JMP Clinical software solutions. She also researches and implements new statistical methods for analyzing biological/genomic data and clinical trials safety/efficacy data that are incorporated in software releases of JMP Genomics and JMP Clinical respectively. Miclaus earned her PhD in statistics from North Carolina State University with a focus on biometrics and statistical genetics. While obtaining her degree, she held internships at Merck Research Labs, GlaxoSmithKline, and worked part-time for SAS testing and developing JMP and JMP Life Sciences products.
Amelia Warner, PharmD
CEO & Founder
Global Specimen Solutions, Inc.
Dr. Amelia Warner founded Global Specimen Solutions, Inc. in 2013 with the vision of radically improving translational science through powerful new pipeline data management analytics. Prior to GSS, Amelia served as CEO, President and Director of the Board for Gentris Corporation, where she led a financial and operational turnaround resulting in the successful sale of Gentris to a public company. Amelia served as the Head of Clinical Pharmacogenomics and Clinical Specimen Management for Merck Research Laboratories (MRL). She also served as the MRL Pharmacogenomics Expert for the Translational Science Research Network and was the MRL Key Expert for Global Regulation for Genetic Research and Human Specimen Usage Regulation/Law. She served as Chair of the Industry Pharmacogenomics Working Group and a PhRMA Representative to ICH E16- Genomic Biomarkers Related to Drug Response.