“We are committed to high quality deliverables and optimal patient treatment, by providing a personal investment in each project that we take on.”
As the founder of Pharma Start, Dr. Christina Fleming provides the company’s strategic direction by leveraging her 20+ years of biopharmaceutical and Clinical Research Organization (CRO) industry experience. Dr. Fleming’s experience includes building, managing and leading Clinical Development, Medical Writing, and Pharmacovigilance Divisions at Searle (formerly Pharmacia, now Pfizer), TAP (now Takeda), Neopharm Inc, and Baxter Healthcare as well as developing the outsourcing/CRO consulting services at several CROs. This experience led her to create and develop Pharma Start into a highly successful and unique outsourcing organization. Dr. Fleming is a 2010 recipient of PharmaVoice’s Top 100 Most Inspiring People in the Life Sciences Industry award and is a member of DIA, AMWA, and RAPS. Dr. Fleming earned her Bachelor of Science (BS) in Biology at Saint Mary’s College and her Doctor of Philosophy (PhD) in Pharmacology from the University of Illinois at Chicago.
” ‘Winging It’ is not a project plan; communication, foresight, and flexibility create project success.”
Marcy Komocsar has over 15 years of pharmaceutical, device, and biotechnology experience. Marcy’s career includes positions of increased responsibility in the safety and medical writing departments at Searle (Pharmacia, now Pfizer), Allos Therapeutics, Takeda (TAP) Pharmaceuticals, and Baxter Healthcare. In 2006, Marcy transitioned to the outsourcing and CRO space, directing Medical Writing groups. At Pharma Start, Marcy leads a team of writers, editors, and document specialists who have finalized >25 NDAs/505(b)(2)s, and hundreds of CSRs, peer-reviewed journal articles, manuscripts, abstracts, and conference posters. Marcy’s team of professionals has a high rate of FDA approval and dossier acceptance. Marcy is a graduate of Indiana University School of Nursing and a current member of the Drug Information Association (DIA), Women in Bio, the National Association of Professional Women, and the American Medical Writers Association (AMWA).
“Constant learning is a must in this global quality and regulatory landscape.”
Thomas McGrady has 25+ years of experience in Quality and Regulatory in the pharmaceutical, biotechnology, and medical device industries. Tom has served in QA/RA leadership roles at the plant, divisional, and corporate levels at companies such as Astellas US, Baxter Healthcare, and completed project work for companies such as Abbott Laboratories, Cardinal Health, and Pharmacia. He is highly experienced in GxP regulations, technology, and system validation and possesses expertise in the development and management of global quality systems. Tom earned his Bachelor of Science (BS) in Microbiology from Purdue University and his Master of Business Administration (MBA) in Finance from the University of Illinois (Chicago).
“I enjoy bridging the gap between science and medicine. “
Dr. Paulson has over 25 years experience in the pharmaceutical industry and contributed to submissions of numerous sNDAs, NDAs and INDs for both large and small molecules including Celebrex and HUMIRA. Her work has resulted in numerous publications and several patents. Dr. Paulson was most recently Director of Clinical Pharmacology and Pharmacometrics at Abbott Laboratories. Prior to Abbott, she held positions in Clinical Pharmacology and Drug Metabolism at NeoPharm and Searle/Pharmacia. She is an adjunct professor in the Department of Pharmacology and Biological Chemistry at Northwestern University Feinberg School of Medicine