LSIPMS Director
Lina Garcia
Lina García Is a healthcare regulatory professional, a clinician and a clinical researcher with over 15 years within the life science, regulatory and health care industry. She is certified by all branches of FDA CDER, CBER & CDRH. Her extensive experience in the healthcare regulatory field goes from research and development, animal trials to human clinical trials, clinical trials design in multiple fields, product design, product development, product registration and commercialization. This includes but is not limited to biologics and vaccines, immunotherapy treatments, gene editing, medical devices, laboratory testing, combination products, monograph products and more.
Some of Lina’s institutional, field and government experience were complemented with Dr. Kevin Gilligan and Dr. Richard Giovanelli.
Dr. Gilligan was Lina’s mentor and first acquisition in her first Biotech and research center which she launched during the 2016 Zika epidemic outbreak under the Zika Research & Development Center. Dr. Gilligan was a former BARDA (Biological Advance Research Development Authority) scientist. BARDA is a federal agency branch of ASPR formerly knowing as Assistant Secretary for Preparedness and Response which is an agency under the White House command. Dr. Gilligan was participant in the R&D of Anthrax vaccine and the Ebola vaccine and work closely within the federal government scientific team for the cure of both deadly diseases. Dr. Kevin Gilligan retired from the federal government around 2015 and went to consult for the private sector. It was then when Dr. Gilligan accepted to join Lina’s team and together, they put a platform for the development of the Zika vaccine and internally launched the VRU Vaccine Research Unit.
In 2018, continuing with the support of both Dr. Gilligan as her chief scientist and Dr. Giovannelli as her medical director Lina Launched Trivecta Pharmaceuticals, a Biotech company focused on public health emergencies and the research of multiple diseases, the development of different clinical trials platforms, while aiming to develop her pharmaceutical manufacturing plant and lab and aim to reduce the price and increase accessibility of drugs in the United States. Today, Trivecta Pharmaceuticals counts with several different units including the biological unit, the neurological unit, consumables unit, the women’s health unit, the medical devices unit, the anti-opioids and mental health unit, and is in the works to build their 100k sq.ft. phase 1 manufacturing plant that plans to break ground in 2025 making it the first company to join the proposed Life Sciences Manufacturing Park.
During these previous years, Lina took the roll as Dr. Giovanelli medical assistant as well. Dr. Giovanelli was an orthopedic surgeon who specialized in alternative and regenerative medicine. This gave Lina the opportunity to have live patient experience on regenerative medicine progress, a field that she extremely believes in and supports. Dr. Giovanelli passed away in March 2020 and Dr. Gilligan passed in June 2022 leaving Lina not only devastated but also with the responsibility of carrying on her team and the progress accomplished throughout the years. At that point, Lina took a new role as Trivecta’s Chief Scientific Regulatory Officer, a position she still carries while being the CEO and director of the other organizations.
Lina also serves as an ambassador to FITCE Florida International Trade and Cultural Expo since its inauguration back in 2015. FITCE is the largest government sponsored event and is under the command of Broward County Office of Small Business and Economic Development where they bring together over 70 countries each year at the Greater Broward County Convention Center to promote trade and investment in Florida and in the United States.
In 2023, FITCE’s yearly theme was Life Science, Innovation and Technology where Lina was tapped with the responsibility to bring the agenda together and connect the network within the pharmaceutical industry. For that, with a mutual collaboration among members and with the support of Trivecta Pharmaceuticals, FITCE and Broward County Office of Small Business and Economic Development she launched LSIPMS Life Sciences Industrial Pharmaceutical Manufacturing Symposium, an event designed to shed light on public health emergencies and the revitalization of the pharmaceutical manufacturing supply chain in the United States and in the Americas.
Encouraged by the results and having done proof of concept for the life sciences manufacturing park and once again, proving the need of revitalizing our domestic pharmaceutical manufacturing and securing industrial capabilities in the United States and in the Americas, Lina’s currently continuing her work in designing and developing the life sciences manufacturing park.
Also, Trivecta Pharmaceuticals women’s health unit was proud to launched under Lina’s direction, I Plan Better. IPB is a global women’s health organization platform that started in the United States and aims to develop comprehensive pathways and feasible health solutions towards the future of women’s health including a pilot program that aims to recruit 1 million underserve women to provide them with their monthly hygienic products and birth control pills. This program is subject to funding. Within IPB Lina has the cancer unit combining other cancer designations and collaborations she is currently discussing with different academia organizations. IPB also has a line of birth control and contraceptives line, and personal consumable products needed in every woman’s household. IPB is focused on bringing different prevention, detection and early response campaigns and to start reshaping the future of women’s health.
Lina has participated in several political campaigns in the United States such a governor, senate, presidential and different local – state – federal races. Being raised in her native Colombia where her mother worked for many years for the first family of the city and state that she was raised, a region that has a strong political weight, Lina started campaigning at a very early age which led her to develop a strong political background and gain domestic and international experience in the political arena. She is a complete believer in democracy. She currently lobbies her own public health emergencies and internal health projects and looks forward to delivering in the very near future the life sciences manufacturing park, a project she doesn’t only believes in but is much needed in the United States to start revitalizing and reshaping our domestic pharmaceutical supply chain and better prepare for public health emergencies and the future.
Lina is fully accredited by all branches of The United States Food and Drugs Administration FDA CDRH Center for Devices and Radiological Health, CBER Center of Biological and Evaluation Research and CDER Center of Drugs and Evaluation Research in the following fields and is experienced in:
CFR 21
GDUFA - PDUFA – MDUFA – BsUFA
ICH International Code of Harmonization
FDA GCP-GLP-GMP practices
Neonatal Health
Gene Therapy
Nano Technologies
AUD Alcohol Use Disorder
OUD Opioids Use Disorder
Best Practices for Generic Product Development
Quality Maturity Management
Pharmaceutical Quality
Reporting Drugs Sec 510(j)
Regulatory Best Practices to Global Access to Medicine
Tuberculosis
US-Canada ICH
Advancing Generic Drugs Development
Immunogenicity
FDA Data Submissions - Bioavailability Studies
Drug applications Submissions
Reporting Individual Case Study Reports (ICSR’s)
FAERS ICH E2B R3 Standards (FDA Adverse Event Reporting System)
FDA Inspection of Outsourcing Facilities
FDA’s Labeling Resources for Human Prescription Drugs
FDA – EMA European Medical Agency Parallel Scientific Advice (PSA)
OTC Monograph Reform - Clinical Pharmacology
Neonatal Studies - Drug Master File (DMF)- GDF
Pharmacokinetics Studies & Bioequivalence
BIMO Biomedical Monitoring
Good Clinical practices Compliance
FDA CDRH CBRE CDER Continuous Regulatory Education 2020-21-22-23
Dosage and administration of drugs
Clinical Investigator continuous education 2020-21-22—23-24
You can find some of Lina’s work on her websites at
www.trivectapharmaceuticals.com