Tim Gupton, Chair
Tim Gupton is a CPA and partner with Hughes, Pittman & Gupton, LLP (http://www.hpg.com/partners/gupton) and former partner with KPMG. He has had a broad cross-section of audit, tax, finance, and M&A responsibilities for companies in the biopharma, healthcare services, clinical research, lab services, and medical technology industries. Mr. Gupton joined KPMG in 1972 and Hughes Pittman & Gupton, LLP, in 1992, where his practice has been centered on entrepreneurial business ventures, primarily in the life sciences industry.
Mr. Gupton has served as the start-up CFO for seven biopharmaceutical start-ups in the Research Triangle area. He is currently the CFO for CoLucid Pharmaceuticals, which is developing a new migraine drug. In addition to launching and managing start-ups, Mr. Gupton was a founder and general partner for Research Triangle Ventures, which is an investor in Gentris.
David Drutz, MD, Director
Dr. David J. Drutz has an extensive background in the pharmaceutical and biotechnology industries, having been VP Biological Sciences (drug discovery) and VP Clinical Research (Phase 1, 2a antivirals) at SmithKline & French Laboratories (PA); and VP Clinical Development (anti-infectives, oncology) at Daiichi Pharmaceutical Corporation (NJ). He was also President & CEO of Sennes, Inc. (cancer support therapeutics), Houston, TX; and Inspire Pharmaceuticals (CF, COPD) in RTP, NC. In addition, he was co-founder of Tranzyme Pharma and its Chairman for 11 years.
He has been an international advisor and reviewer for Genome Canada for a number of years and was recently elected to membership of its Science and Industry Advisory Committee (SIAC), which reports to the Board of Directors.
Dr. Drutz is currently a General Partner with Pacific Rim Ventures Co., Ltd., a Japan-based venture capital firm with a portfolio of international investments in the biotechnology industry. He is also a Director of DARA BioSciences, Inc. (DARA:NASDAQ; metabolic diseases), RTP; MethylGene Inc (MYG:TSX; oncology, anti-infectives), Montreal; and Vaxin, Inc. (intranasal vaccines), Birmingham, AL. He holds a current certificate of director education from the National Association of Corporate Directors (NACD).
Dr Drutz was previously professor of medicine and microbiology and chief of the division of infectious diseases at the University of Texas Health Science Center in San Antonio, where he was also founder and director of the Center for Cell Regulation, a NSF Industry-University Cooperative Research Center (IUCRC). He has held similar academic positions at UC San Francisco (UCSF), the University of Pennsylvania, Temple University and Baylor College of Medicine. He is board-certified in internal medicine (FACP) and a fellow of the Infectious Diseases Society of America (FIDSA). He holds B.A. and M.D. degrees from the University of Louisville.
Amelia Wall Warner, PharmD, President
Amelia Wall Warner, PharmD joined Gentris in 2013 as President. Dr. Warner oversees the U.S. operations, leads the development of new service offerings, and develops scientific education and training programs for biobanking and pharmacogenomics. As a key member of the management team, she works with Gentris leaders to set the strategic vision for the company and to ensure it continues to be on the cutting-edge of genomic medicine. Dr. Warner was most recently the Head of Clinical Pharmacogenomics and Clinical Specimen Management for Merck Research Laboratories (MRL). In her position, she oversaw all clinical pharmacogenomics projects, oversaw policies and procedures for biosample collection and storage for clinical trial samples, and was the MRL Pharmacogenomics Expert for the Translational Science Research Network. Amelia was the MRL key expert for global regulation for genetic research and human specimen usage regulation/law. Amelia is the CEO and Founder of Global Specimen Solutions, Inc., a past chair of the Industry Pharmacogenomics Working Group (I-PWG), and a PhRMA representative to ICH E16- Genomic Biomarkers Related to Drug Response. As an industry expert, she has participated in numerous meetings and conferences as a key opinion leader on applying pharmacogenomics in drug development, best practices for collecting, maintaining, and maximizing return-on-investment for clinical sample biobanks in all phases of clinical trials, and appropriate informed consent to enable future use and testing. Dr. Warner completed a residency in Pediatric Pharmacotherapy at St. Jude Children’s Research Hospital with John Rodman, PharmD and a fellowship in Clinical Pharmacology/ Pharmacogenomics at St. Jude Children’s Research Hospital with William Evans, PharmD. Amelia holds a PharmD from the University of North Carolina at Chapel Hill and a Bachelor of Science in Biology from Wake Forest University.
Dr. Howard McLeod, Director
Dr. Howard McLeod is Fred N. Eshelman Distinguished Professor and Director, UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill. Dr. McLeod holds appointments in the Schools of Pharmacy and Medicine, the Carolina Center for Genome Sciences, and the Lineberger Cancer Center. He is Chair of the NHGRI eMERGE network external scientific panel and is a member of the FDA committee on Clinical Pharmacology.
Dr. McLeod also directs the Pharmacogenetics for Every Nation Initiative, which aims to help developing countries use genetic information to improve National Drug Formulary decisions. He has published over 380 peer reviewed papers on pharmacogenomics, applied therapeutics, or clinical pharmacology and continues to work to integrate genetics principles into clinical practice to advance individualized medicine.
Cathy Frieden Lineberry, Director
Ms. Lineberry is currently Principal and Co-Founder of Sunrise Therapeutics, LLC, a firm that provides consulting services on corporate development and strategic business issues as well as on clinical and regulatory issues in drug development. Ms. Lineberry was formerly the Co-Founder and President of Lineberry Research Associates (LRA), a privately held contract research organization and strategic consulting firm that provided drug development services to pharmaceutical and biotech companies both nationally and internationally.
LRA received numerous awards and recognition in the business and scientific community for its sustained growth and success over more than a decade. In addition, the company was highly regarded for its emphasis on corporate culture and community service.
LRA was acquired by Constella Group in November 2006 and Ms. Lineberry subsequently served as Vice President, Strategic Affairs for the new organization. Ms. Lineberry has more than 25 years of cross-functional pharmaceutical experience in basic and clinical research, as well as experience in business development and marketing. Prior to the founding of LRA, Ms. Lineberry was employed at Burroughs Wellcome Co. (now GlaxoSmithKline) for 14 years where she held various positions involving new product development, product management, managed care marketing and sales, Rx-to-OTC switches, and public affairs. As a speaker at industry and trade meetings, Ms. Lineberry covers topics ranging from drug development and product commercialization issues to corporate culture and entrepreneurial leadership strategies.
She served on the planning committee for the CED Biotechnology Forum series and was the 2007 co-chair of the Southeastern BIO Conference. One of Ms. Lineberry’s proudest accomplishments was being asked to speak about the LRA corporate culture at the 2006 Shelton Leadership Forum at NC State. Ms. Lineberry continues to be active in the pharmaceutical and biotechnology community. She is currently an advisor to several firms in the RTP area, including Gentris Corporation and Impact Pharmaceutical Services. She also serves on the advisory board for the Durham Tech Clinical Trials Research Associates program.
In addition, Ms. Lineberry has continued her focus on community service, currently serving on the area Board of the Cystic Fibrosis Foundation and maintaining an association with several area animal rescue organizations. Ms. Lineberry has previous work experience in behavioral and neurological toxicology at the National Institute of Environmental Health Sciences (NIEHS) and academic training in pharmacy administration. She graduated with highest honors with a B.A. in psychology and is Phi Beta Kappa from the University of North Carolina at Chapel Hill.
Michael P. Murphy, M.Sc., Director
Michael P. Murphy, M.Sc. is the President and founder of Conatus Consulting LLC, a medical device regulatory consulting firm located in Raleigh, NC. Michael is an industry pioneer and thought leader in the field of pharmacogenomics, with more than 30 years of scientific and business experience. He is a serial entrepreneur in the personalized medicine space and in 1997 was founder of Intek Labs, the first international pharmacogenomics company. Following the successful acquisition of Intek Labs by PPD (PPGx), Michael was the co-founder, President and CEO of Gentris Corporation. In 2007, Gentris spun off its diagnostic group and Michael served as the President and CEO of ParagonDx, one of the first companies to win FDA approval of a Rapid Genotyping Kit for patients taking the anticoagulant, Warfarin.
Michael is a frequent lecturer and author on pharmacogenomic topics and currently sits on the editorial review board of the journal, Pharmacogenomics. He has expertise in FDA Regulations and Quality Systems for medical device focused companies, and has been responsible for oversight in 7 successful 510(k) submissions and FDA audits and inspections. He has established CLIA-regulated laboratories at four start-up companies, and he serves as an ad hoc advisor to the FDA, CDC (GetRM), EU (EuroGentest), the Clinical and Laboratory Standards Institute (CLSI) and the Association for Molecular Pathology (AMP). Michael received his B.S. and M.S. degrees from San Diego State University and was trained in molecular biology at the Salk Institute.Dr.