With broad and deep experience across major and small pharmaceutical and device companies, principal consultant Ms. Lori MacCausland, MS develops and executes regulatory strategies based on regulatory legislation and building positive professional relationships motivated to deliver safe and meaningful therapies for patients.

After conducting benchtop research Hemophilia Factor VIII, Ms. MacCausland began her regulatory career leading a large 120 person R&D and CMC Genzyme team in the successful QMS construction, BLA filing, and plant FDA site inspection for Ceredase to treat Gaucher’s rare disease. Then, she hosted an end of Phase II meeting Pharmavene and FDA meeting and completed a phase III study to enable Shire to successfully submit the NDA she led the formulation of for anticonvulsant Carbatrol. Subsequently at a mid-size CRO Biometrics Research Institute (BRI), Ms. MacCausland won business, develop regulatory strategies, and conducted global Phase I- IV clinical studies on time and within budget in broad pharma, diagnostics, and device therapeutic areas.

More recently, Ms. Lori MacCausland joined GSK in December 2021 as Senior Director, Global Regulatory Affairs Biological Combination Device Vaccines and met all corporate objectives while maintaining an excellent reputation with CBER and CDRH. GSK Global Medical acknowledged her with the “Silver Award.” She led all US FDA development and lifecycle activities for a US Boostrix, Kinrix, Infanrix, Pediarix, Hiberix, and Tetanus. For US Boostrix, as the US Authorized Agent FDA strategist and communicator, Ms. MacCausland obtained CBER approval for third trimester immunization as a second indication, launched a post-marketing-commitment US registry study, obtained CDRH approval of a new device presentation, and led the co-administration approval of Shingrix to the label by answering numerous data and clinical FDA information requests. She was responsible for life cycle management including safety and annual reports and providing information to global applications. Ms. MacCausland was the US Lead on an international GSK R&D team to develop a next generation Boostrix vaccine global strategy plan, including clinical protocol summaries applicable for a US IND, and she developed the Meeting Request Letter for a German authority PEI Scientific Advice Meeting. In this role reporting to Belgium, she educated EU staff on US FDA and CDC requirements, guidances, SOPs, toxicology requirements, CDISC data standards, and communications surmounting past delays by the Agency to proceed with GSK applications. Ms. MacCausland provided manufacturing advise to maintain quality and tried to ensure specifications were met in a vaccine production technology transfer from the US to Belgium.

Previous at Emergent BioSolutions as the Director Regulatory Affairs on 2 federal government combination device projects, Ms. MacCausland led a multi-departmental team consisting of manufacturing, quality, commercial, clinical, and non-clinical, was the spokesperson to the Army and BARDA representatives, and lifted a US FDA IND clinical hold for a cyanide poisoning anecdote project. She led negotiations with a CMO, and the filing and development team for an IND to use Ketamine in an autoinjector in pain management for US soldiers. She developed budgets and contingency schedules to meet the high administrative government program management requirements.

Ms. MacCausland possesses PMI PMP training and adept experience in program management reporting to the C-Suite, including championing new business processes. At GSK, she managed the schedule and was the US RA approver for a major FDA Hiberix vaccine submission to change the manufacturing facility, update the label and packaging, and change the device presentation requiring expertise in complex company Veeva Vault processes. Maneuvering within the Boston Veterans Administration system requirements, she developed and led varied research project contracts, timelines, and budgets. At Thermo Fisher as the Core Team Lead and Program Director, she launched 3 new products using the company product stage gate commercialization process including the budget, marketing plan, timeline, and all product technical deliverables to create the regulatory quality file. She led program timelines to develop PERI courses and conduct research at the Degge Group in partnership with clients like the American Red Cross and NIH.

Her career reflects her ability to provide effective solutions to biotechnology as a technical consultant. In personalized medicines, she was instrumental on an Alexion team partnered with Rady’s Childrens Hospital and Clinithink focused on the development of novel AI digital outcome measures for diagnosing rare diseases where the project set a Guinness Book of World Record for fastest genetic diagnosis. For a small software as a medical device (SaMD) company to enable physicians and patients to better understand and manage neurological disease progression, she devised a quality management plan. Assisting the CEO at a private company developing therapeutic antibodies and functional assays, Ms. MacCausland developed an overall program plan to acquire venture capital. Within Genzyme Sanofi manufacturing quality, she revamped Oracle processes to prevent further Consent Decree fines. She prepared Abiomed for a Japanese authority device audit. At combination device Intarcia, she used her clinical data analysis experience to conduct an interim protocol analysis with the FDA, CRO, IT, and executive management to adjust the protocol to prevent study halt. Ms. MacCausland is a strong asset with experience in launching innovative technology and applying knowledge of current Global regulations in quality, manufacturing, regulatory, clinical, business development, budgets, and program management. She is an expert scientific writer and editor, and a technocrat.

Ms. MacCausland earned a Master of Science degree in regulatory technical writing and professional communication and computer programming from Northeastern University, Boston, MA and a Bachelor of Science degree in botany, zoology, and art from the University of Maine. She is a member of the Regulatory Affairs Professionals Society (RAPS) and the Digital Medicine Society (DiME). Her business is in the U.S. Eastern Standeard Time zone and accomodates global online schedules.