Latest Happenings at BioPhia
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.
Risk Based Method Transfer
Jeffrey Staecker, PhD
The article summarizing the CASSS CMC Forum “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” appeared in BioProcess International. The article summarizes the conference where BioPhia Principal Consultant Jeffrey Staecker presented and co-chaired. Jeff’s presentation can be found below and the BioProcess International article can be found at
Quality Risk Management Training
Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and Controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often think of quality risk management as just a tool like FMEA analysis verses an overall QRM approach. This presentation helps explain the important concepts associated with a QRM approach.
Implementing Quality by Design Program for Drug Product Development
Implementing these principles into the pharmaceutical culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp. The following presentation outlines the important concepts needed to implement a practical QbD program.
Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry
S. Anne Montgomery, with Jeff Staecker
BPIs editor in chief spoke with Jeff Staecker, principal consultant at BioPhia, about his view of current outsourcing trends. Those identified in this discussion set the stage for the articles that follow. Issues that affect decisions to outsource include cost, converging quality systems, change management, and staff training/expertise (including statistical capabilities).
Making Decisions with Probability Distributions
An overview of 13 continuous and 5 discrete probability distributions useful for risk assessment and other applications. Includes a description of the probability density, cumulative distribution, and quantile functions of each as well as MS Excel formulae for their evaluation. Methods for generating random samples from these distributions and some additional MS Excel matrix algebra capabilities are described.