Women in Pharma: Navigating the Career Jungle Gym

(Moderator) Laura Gunter, President, NCBIO

Laura Gunter leads the North Carolina Biosciences Organization as its president and directs the work of the life science advocacy association in conjunction with its Executive Committee and Board of Directors. NCBIO promotes policy initiatives that encourage the growth and success of life science companies doing business in the state by advocating for the industry before the NC General Assembly and the NC Congressional delegation. She works closely with state and federal partners on the advocacy and policy front.

Before becoming president, Gunter served as NCBIO’s membership development and government affairs director where she recruited new members to the organization; created forums, meetings and networking events for members; and coordinated outreach to state and federal legislators.

Before joining NCBIO, Gunter served as business development director for NCBiotech and as a technical sales representative for Fisher Scientific. She received a bachelor’s degree in chemistry from the University of Virginia and earned a Master’s in Business Administration from the University of North Carolina at Chapel Hill.

Karen Makhuli, Vice President, Clinical Operations, Trillium Therapeutics

Ms. Makhuli joined Trillium Therapeutics in June 2021, as Vice President, Clinical Operations.  She has more than 20 years of experience in clinical operations, drug development and transformative leadership roles.   She has led clinical trial programs at all phases of the life cycle, from Phase 1 through post approval. She has broadened her experience leading patient advocacy programs.  She is currently is responsible for overseeing a critical clinical operations department at Trillium.

She was formerly at G1 Therapeutics were she built and led the clinical operations and logistic departments.  She contributed to the successful approval of their drug candidate, Cosela™.   Karen has also held clinical operations roles at Triangle Pharmaceuticals and Gilead Sciences, following its acquisition of Triangle.  During her tenure, she worked extensively with government and non-government agencies (NGOs) to support access to HIV treatments in developing countries.

Ms. Makhuli received her B.S. in biology from Le Moyne College in Syracuse, NY.

Christy Shaffer, General Partner, Hatteras Venture Partners

Seasoned entrepreneur and biotech executive, Christy Shaffer, Ph.D. has 30 years of experience in the life science industry. Following her career as a clinical scientist, international project leader and Associate Director of Pulmonary and Critical Care Medicine at Burroughs Wellcome Co., she joined Inspire Pharmaceuticals in 1995 as the first, full-time employee. She was responsible for raising over $300m for the company, including taking the company public in 2000. As President and CEO, Christy grew the company from 20 scientists to nearly 250 employees with revenues of over $100 million. Under her leadership, Inspire was named as “Best Place to Work for Scientists” by the Scientist magazine, and “Best Place to Work in North Carolina.” Christy retired from Inspire in 2010 and the company was acquired by Merck in 2011. She joined Hatteras in 2011 as the Managing Director of Hatteras Discovery and became a general partner in 2016.

Christy currently serves as a board member of five Hatteras portfolio companies: Artizan Biosciences (Chair), Clearside Biomedical, GrayBug Vision (Chair), Trefoil Therapeutics, and Perfuse Therapeutics. Christy is a receptor pharmacologist by training, earning her Ph.D. in Pharmacology from the University of Tennessee Health Science Center, Memphis TN in 1985. She received her post-doctoral training at The Chicago Medical School and the University of North Carolina at Chapel Hill.

COMMUNITY AND BOARD ENGAGEMENTS:

Christy was a member of the initial Innovation Circle for Entrepreneurship at UNC-Chapel Hill from 2010 – 2013. She has served on numerous non-profit boards including the NC Biotechnology Center, the Biotechnology Institute, BIO, PhRMA the Cystic Fibrosis Foundation and the CFF Therapeutics’s Inc., the NC School of Science and Math Foundation Board and the Morehead Planetarium and Science Center. She received the Lifetime Women in Business Award by the Triangle Business Journal in 2016 and was named one of the top BizWomen to Watch in December, 2016. Christy currently serves on multiple non-profit boards including the Chordoma Foundation, the Council for Entrepreneurial Development, the Burroughs Wellcome Regulatory Initiative Advisory board and RTI International.

Tinaya Gray, Sr. Director, Project Delivery, ICON

Tinaya has over 25 years of clinical research experience, primarily at CROs working in hematology and oncology. She enjoys the excitement and discovery of early phase oncology and working with new and emerging biotech companies to move novel therapies through their clinical development. She has supported several new drug approvals in her career as a seasoned operations leader at PRA Health Sciences – now ICON.  She has been active in her community for the same period as a board member, networker, and volunteer for several community organizations and campaigns. Currently, Tinaya is also helping to lead some of the company’s DE&I initiatives and view this work as aligned with her overall goals of advancing public health for all while adding value to our partnerships. She is a graduate of Rutgers University in NJ, where she received a BS in Biology and a BA in Africana Studies.

Tracie Locklear, PhD, Research Assistant Professor, North Carolina Central University

Tracie Locklear has been a Research Assistant Professor at North Carolina Central University in the Department of Pharmaceutical Sciences since February 2019.  She is a translational scientist and experienced clinical researcher with a PhD in Pharmacognosy (Natural Products research). Her research interest is in health disparities, particularly women’s health. She previously worked at Duke Clinical Research Institute in the department of Center for Learning Health Care and later the Health Outcomes department as a Clinical Trials Coordinator and Project Manager. She now leads the new Clinical Research Sciences Program within the NCCU Department of Pharmaceutical Sciences.