Scientific Perspective Consulting Inc.
Scientific insights through a strategic lens
Scientific Perspective Consulting
Expert clinical research and regulatory affairs consultancy services for pharmaceutical clients.
Scientific insights through a strategic lens.
Extensive experience in the planning, design, conduct, interpretation and justification of pharmacokinetic and statistical data of clinical studies.
Experience with products covering a vast array of therapeutic areas, and a wide variety of dosage forms including small molecule solids and liquids, transdermal products, nanoparticle medicines, and large molecule biological products.
Expertise in bioavailability / bioequivalence pharmacokinetic studies through the oversight of thousands of studies in healthy and patient populations, for products intended to be registered in numerous global markets.
What we offer
About Us
We specialize in providing scientific consulting services to the pharmaceutical industry.
Julie Szirtes serves as the Principal Consultant.
Julie has accumulated over 22 years' experience in the planning, design, conduct, interpretation and justification of clinical research studies, with distinct expertise in bioavailability / bioequivalence pharmacokinetic studies. She has overseen several hundreds of studies in healthy and patient populations. She served as authorized Clinical Trial Sponsor on many global BA/BE studies, overseeing studies from planning, to execution, to reporting, to submission stage.
She has managed personnel with various expertise: pharmacokinetic scientists, bioanalytical scientists, biostatisticians, SAS programmers, medical writers, project managers.
Julie received her M.Sc. degree in Pharmaceutical Sciences from the University of Toronto, where the focus of her research was evaluating alterations in CYP450 enzymes and P-glycoprotein and the associated impact on drug absorption through the gastrointestinal tract in the presence of inflammatory processes and diseases.
Our services include clinical strategy, study design, regulatory support, and more.
Our Services
Publications
· Novakovic J, Szirtes J, Fields A, Tsang YC. (2018). Clinical endpoint bioequivalence studies are not sensitive: A perspective from generic drugs. Clin Pharm Therap 105(2).
· Kalitsky-Szirtes J, Shayeganpour A, Brocks DR, Piquette-Miller M. (2004) Suppression of drug metabolizing enzymes and efflux transporters in the intestine of endotoxin-treated rats. Drug Metab Dispos. 32(1):20-27.
· Rocca AS, LaGreca J, Kalitsky J, Brubaker PL. (2001). Monounsaturated fatty acid diets improve glycemic tolerance through increased secretion of glucagon-like peptide-1. Endocrinology 142(3): 1148-1155.
· Sukhai M, Yong A, Kalitsky J, Piquette-Miller M. (2000). Inflammation and interleukin-6 mediate reductions in the hepatic expression and transcription of the mdr1a and mdr1b genes. Mol Cell Biol Res Comm. 4(4):248-256.
· Tang W, Yi C, Kalitsky J, Piquette-Miller M. (2000). Endotoxin downregulates hepatic expression of P-glycoprotein and MRP2 in 2-acetylaminofluorene-treated rats. Mol Cell Biol Res Comm 4(3):90-97.
· Joseph JW, Kalitsky J, St-Pierre S, Brubaker PL. (2000). Oral delivery of glucagon-like peptide-1 in a modified polymer preparation normalizes basal glycemia in diabetic db/db mice. Diabetologia 43:1319-1328.
"I've had the opportunity to collaborate closely with Julie on multiple projects over the past 10+ years. Julie's deep understanding of pharmacokinetics, coupled with her scientific mindset, has been instrumental in advancing the projects through R&D stages. She is a creative thinker who approaches challenges with enthusiasm and a fresh perspective, bringing forth innovative solutions. She is detail oriented and ensures every aspect of her work is thorough, and of the highest standards. Julie's expertise, collaboration, and a commitment to excellence makes her an invaluable asset to any project or team." E.FK. (Director, Biopharmaceutics and Statistics)
Testimonials
"I have had the privilege working very closely with Julie more than 10 years. She was my supervisor, mentor, guide and role model. She was instrumental in my personal and professional growth. Julie and I worked on many challenging projects together from inception to successful completion. She is an expert in the field of pharmacokinetics, clinical research and regulatory affairs. She has excellent leadership style, where she brings the team alongside her to grow together. Her out-of-the-box thinking, dedication to work, attention to details and highest quality technical writing always impressed me. She is full package with greatness, kindness, expertise and professionalism. I highly recommend Julie for any technical and leadership position." A.R. (Senior Scientist / Lead Pharmacometrician)
"I had the privilege of working closely with Julie for over 10 years. Julie is an outstanding leader with great work ethics. Not only is she the type of person who can do it all, she does it all with the highest quality in mind. Throughout my time working under Julie’s supervision, I have been consistently impressed by her dedication, professionalism, and ability to inspire and motivate the team. I personally owe her for inspiring me to step outside my comfort zone on several occasions and for always providing me her full support. Julie has exceptional scientific skills and expertise. Her attention to details and critical thinking skills are outstanding. She possesses a broad and in-depth understanding of the scientific and regulatory aspects of the pharmaceutical industry. In addition to her technical skills, Julie is a great leader who genuinely cares about the well-being and professional growth of her team members. Julie’s mentorship has been instrumental in my own personal and professional development. I highly recommend Julie for any leadership position. She is definitely a great asset to any company." A.O. (Senior Pharmaceutical Scientific Leader)
"Perfect! When Julie writes a justification, there is no room left for comments! Great Job!" T.V. (Senior Director)
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