PDA Southeast Chapter: Fall Conference

Henry Ames has over two decades of broader supply chain experience. Most recently, Henry served as the General Manager for Sensitech - the global leader in cold chain management solutions servicing the life sciences industry. In this GM role, Henry was responsible for corporate strategy, business development, strategic marketing, product management, program management and the sales organization. Henry joined Everstream Analytics in early 2023 to lead their life sciences vertical. Prior to Sensitech, he was a principal at Megunticook Management, a venture capital firm in Boston. MA with $150 million under management and investments in promising communications, media, and technology companies. Henry earned an MBA from the F.W. Olin Graduate School of Business at Babson College, and a double major in Business Management and Entrepreneurship from Florida State University. Henry also serves as the President of the Easton Community Corp. (ECC) a 501C (2) entity supporting thirteen non-profits in the town of North Easton, MA.

Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in quality risk management and compliance with 21 CFR Part 11. Live Oak focuses on training and employee empowerment in critical thinking, with the goal of improving the quality of medicines through good data management.

Christopher Fortier is the President of 503B Outsource Compounding at Nephron Pharmaceuticals. Prior to joining Nephron, Fortier was the Chief Pharmacy Officer for 10 years at Massachusetts General Hospital in Boston and prior to that an Associate Director of Pharmacy at MUSC Health in Charleston, SC.

Fortier has served in healthcare leadership roles for numerous state and national professional organizations, has been published in multiple healthcare journals, and has been featured in a variety of media outlets including NBC Nightly News, the Associated Press, the Wall Street Journal, National Public Radio, Bloomberg, and the Washington Post.

Fortier received his Doctor of Pharmacy from the University of Connecticut and completed a PGY-1/PGY-2 Health-System Pharmacy Administration Residency at the MUSC Health. He has given over 100 national and international presentations, is a course coordinator at Harvard Medical School, and has academic appointments at the University of North Carolina – Chapel Hill, the University of Connecticut, and Northeastern University. Fortier is a Fellow of the American Society of Health System Pharmacists (ASHP) and has also been certified as a Pharmacy Executive Leader by ASHP.

Fortier serves as chair of the University of Connecticut School of Pharmacy Board of Directors and vice chair of United Way of Greater New Bedford Board of Directors.

Julia is a Pharm.D. candidate student at the University of South Carolina College of Pharmacy. She has three years of experience in the pharmaceutical industry and endeavors to specialize in Compliance and CGMP after graduation.

Mike has over 25 years of pharma, device, and combination product and process development. He is currently a Sr. Director with AstraZeneca within their Biopharmaceuticals Development Group. Mike is active within industry including being a past member of PDA’s Science Advisory Board and has also instructed graduate courses on topics such as Data Analysis and Pharma and Device Quality Systems. Mike is a master black belt with a BS from WPI, an MS from Tufts University and doctorate from Northeastern University.

Dom Reigle is the Head of Quality Systems at SpringWorks Therapeutics located in Durham, NC. He has 22 years of experience in the industry at companies such as Merck, bluebird bio and Novartis in both sterile and non-sterile environments. At SpringWorks he has led the successful implementation of phase appropriate Quality Systems to ensure SpringWorks Therapeutics is prepared for commercial operations. Outside of work he enjoys spending time at the coast of NC with his wife and two children. He obtained his BS in Biology from Albright College in 2001 and MS in Quality Assurance and Regulatory Affairs from Temple University in 2006.

Dr. Kara Renai King is a leadership expert who has extensive experience in the biopharmaceutical industry in both traditional and contract development manufacturing organizations. Her experience ranges from early drug product development to commercial operations. She has held leadership roles in Quality, Tech Ops and Drug Product Operations (from bulk product manufacturing to finishing). Dr. King delivers value to organizations through her servant leadership style complimented by her strong foundation in science, strategic mindset, and the ability to create an environment that fosters joy, creativity and innovation. Hallmarks of her leadership are building high performing teams, elevating leadership capability, and delivering results. Dr. King sits on the board of Eastern University and the International Leadership Association (ILA). She holds a Bachelors degree in Biology from Hampton University, a Masters degree in Cell Biology & Biotechnology from University of the Sciences, and a Doctorate in Organizational Leadership from Eastern University. Dr. King also has a heart for the community in which she lives and works. She utilizes her skills, experience and resources to invest in the local community and help others achieve their dreams.

Her mottos are: 1. Average is never my goal, 2. To whom much is given, much is required, and 3. G.R.I.T.- Greatness Requires Intentional Transformation. GRIT is her superpower.

Laura joined NCBiotech’s Life Science Economic Development team in 2017. In her current role as Vice President of LSED, she partners closely with North Carolina’s economic development community, universities, community colleges, and local industry to advance workforce development efforts and support life science companies seeking to expand or relocate to NC. Laura’s previous experience with faculty-entrepreneurs at the University of North Carolina Eshelman School of Pharmacy provides her with an added appreciation of the breadth of North Carolina’s life science ecosystem. Laura earned her bachelor’s degree in biology from Furman University in Greenville, SC, and completed her Ph.D. in Genetics and Molecular Biology at UNC-Chapel Hill.

Melissa has more than 20 years of pharmaceutical and biotechnology quality management and operations experience, including large-scale operational integration activities. Melissa now serves as the Chief Quality Officer and Leadership Team member in Global Product Supply at Bristol Myers Squibb. In this current role she directly oversees biologics, cell therapy and small molecule pharmaceutical quality, quality control & analytical Services, corporate, R&D, supply chain & and in-market quality along with product quality and BMS’s global quality strategy and business Execution. Melissa previously was Chief Quality Officer for Biogen Inc. with oversight of Pharmaceutical and R&D Quality operations across biologics, small molecule, antisense oligonucleotide, and gene therapy operations. Melissa also led the development and implementation of quality systems to ensure international compliance related to GxP activities. In addition to serving in various other Quality leadership roles, Melissa has served on the Boards of the Parenteral Drug Association (PDA) and Rx-360, an international consortium focused on pharmaceutical and medical device supply chain security. She holds dual degrees in Biological Sciences and Biochemistry from North Carolina State University and a Global Executive MBA from Duke University.