Complement Activation in Excorporeal Therapies
Richard Johnson PhD
The committee Roundtable on Biomedical Engineering Materials and Applications (BEMA) held a meeting in June, 2019 focused on “Materials used in the Extracorporeal Space and their interactions with Blood”. This is the presentation on “Complement Activation in Extracorporeal Therapies” that I gave during the meeting.
Medical Device Development and Commercialization
Marc Minkus, Rich Johnson PhD, and Edwin Moore PhD
Medical devices cover a broad range of healthcare products from relatively simple bandages to complex devices. At a presentation to entrepreneurs, students, and University of Illinois faculty at EnterpriseWorks, we provide some of the current best practices that are used in the industry today for development and commercialization of these medical products.
EU MDR Legacy Device Perspective
Randy White, PhD
The regulatory requirements for follow-up with legacy devices on the market continues to change over time and now requires that these devices by kept up to date with current standards and regulations. This article discusses new EU MDR directives related to requirements for keeping legacy devices compliant.
Win – Win Relationship with CRO’s
Shreekant Karmarkar, PhD
Pharmaceutical, biopharmaceutical, and medical device companies extensively use CRO’s to meet their challenging needs in research and development, manufacturing, and stability. However, a successful relationship between the sponsor company and the CRO, even with reputable CRO’s, is not a given. This presentation discusses key strategies that can be implemented to drive a successful relationship between the sponsor company and CRO.
Defining and Building a Robust IND Package
Robin Geller, PhD and Richard Johnson, PhD
The IND is a compilation of preclinical scientific information and plans for clinical development, supporting that a drug is reasonably safe for initial use in humans. This information shows that the new drug exhibits pharmacological activity that supports commercial development. Overall, the IND justifies that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. The main elements of the package include: Animal Pharmacology and Toxicology Studies, Manufacturing Information, Clinical Protocols and Investigator Information.
Long-Acting Injectable Nanoparticle Technologies for HIV
Barrett E Rabinow, PhD
Presented to Chicagoland Pharmaceutical Discussion Group (CPDG), Nov 15, 2018
Long-acting nanoparticle (LA-NP) clinician administered dosage forms are being developed to provide greater dosing compliance for treatment HIV/AIDS. While current LA-NP antiretroviral drugs have the desired 1-2 month duration of treatment effect, they do not adequately sterilize viral sanctuaries in the patient, leading to clinical failure and emergence of resistant strains. Drug tissue levels can be significantly increased by utilizing hydrophobic prodrug derivatives, which increases intracellular trafficking of drugs to endosomes containing the virus within the macrophage.
Defining a CMC Strategy
Edwin Moore, PhD and Richard Johnson, PhD
Developing a robust CMC strategy at early pre-formulation phase of new product development for pharmaceutical and biopharmaceutical product success. Consideration of the customer needs, the physical chemical properties of the molecule, and the critical quality attributes of the proposed product drives development plans. Startup companies that have novel technology for potential break-through products may have little experience developing commercial pharmaceutical products. The slide deck “Defining a CMC Strategy: How and Where to Begin” is an abbreviated version of a presentation given to entrepreneurs at MATTER (https://matter.health/), a Chicago based technology incubator.