Peter Tomlinson

Background

About Peter Tomlinson

Clinical development expert specializing in clinical trial development strategy and extensive health and pharmaceutical experience, bringing senior strategic expertise as Chief Medical Officer of Apex Labs Ltd. and as President of AlthoTech Consulting. With a PhD in analytical chemistry, I have helped over 25 biotechnology and pharmaceutical companies develop and execute effective clinical trial strategies. Expertise in Clinical Protocol development, Investigator Brochure development, Chemistry Manufacturing Control (CMC), Good Manufacturing Practices (GMP), and other aspects of new product clinical development. APEX is a patient driven pharmaceutical company transforming mental health care with clinically proven psilocybin treatments. APEX develops and commercializes clinically evaluated psilocybin-derived treatments to tackle the most critical unmet need in depression, anxiety, and PTSD among Veterans and the general public. APEX’s strategy is to develop pharmaceutical products through a phased clinical program evaluating safety and efficacy alongside a robust Early Access Program. AlthoTech Consulting Inc.(AlthoTech) is a Toronto based, world-wide consulting company that specializes in supporting North American pharmaceutical and biotechnology companies in entering and progressing new products into clinical trials. The Company supplies two types of services: the provision of all CMC activities required to supply the clinic with new drug supplies; and Qualified Person specialist support required to import clinical supplies into the EU. AlthoTech’s expertise is the Chemistry Manufacturing Control (CMC) aspects of new product development. The Company assumes responsibility, for its clients, in executing all GMP activities necessary to initiate clinical trials following the declaration of a product candidate. AlthoTech also specialises in clinical packaging and regulatory filings. In addition, AlthoTech is a North American based Qualified Person (QP) under EC regulations (Directive 2001/83/EC), and included on the Royal Society of Chemistry (UK) list of QPs. As a QP, the Company understands the legislation and pharmaceutical issues around importing investigational medicinal products into Europe for clinical investigation. AlthoTech offers QP services in two areas: working with companies wishing to import into Europe clinical supplies manufactured in North America; and, on behalf of European QP Licensed facilities, assessing the suitability of North American manufacturers to manufacture clinical trial supplies for use in European clinical studies.