Incubation centre for biocsciences – BIOCentre, HAMAG BICRO and EEN proudly announce a guest lecture of Mr. Jim McGough from Edge One Medical, Chicago, Illinois – USA. Mr. McGough will present the latest trends and share his experiences in pharmaceutical industry related to combination products and digital pharmaceutics.
Lecture will take place on Friday, 25.10.2019. at 13:00 o’clock in BIOCentre, biosciences incubation and commercialization centre – Borongajska cesta 83H, Kampus Borongaj, Zagreb.
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Mr. McGough is a Principal Advisor for the US National Institute of Health’s (NIH) Commercialization Accelerator Program and an Industry Expert for the National Cancer Institute (NCI) I-Corps Program, as well as one of the evaluators in a Medtech Innovator program, the largest and the most respected global accelerator for medical device, digital health and diagnostic companies.Jim co-Founded a private company EdgeOne Medical in 2012. that supports the device development for companies that are ranked among top 10 global Biopharma companies as well as many Medical Device, Diagnostic, and emerging Biotech firms. EdgeOne Medical was recently named as one of top 10 Medical Device Testing Labs in 2019 (link). Mr. McGough is also a Strategic Advisor to the Digital Therapeutics Alliance, the Trade Association for Digital Therapeutics with member companies Novartis, Sanofi, Merck, Pear Therapeutics, et al. He is also an Angel Investor and an advisor to several MedTech and Digital Health ventures in the US and Europe.Combination products
According to US Food and Drug Administration Agency, combination products are “therapeutic and diagnostic products that combine drugs, devices, and/or biological products”. Combination products are the latest trend in pharmaceutical industry resulting from fast technological advances that merge product types and blur the historical lines of separation between classical medical product definitions. These products can have different regulatory pathway for each component, impacting thus he regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.Digital therapeutics
Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx products incorporate advanced technology best practices relating to design, clinical validation, usability, and data security. They are validated by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
Digital therapeutics empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe, and effective data-driven interventions.
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