Who is Metis?

Welcome to the first Metis Consulting Services blog post – A Biopharmaceutical solutions organization.

Who is Metis? Metis was founded six years ago by Michelleanne Bradley– President and CEO of Metis, with more than 20 years of experience in the biotech and pharma industry. She has focused on the Quality and Pharmacovigilance sectors for most of those years.

Vice President Jennifer DiMarco has over 25 years of experience in Quality and Compliance, specializing in post-marketing activities such as Pharmacovigilance, HCP Engagement, and Commercial. Jennifer has participated in and led dozens of health authority inspections worldwide. She designed the first SMF accepted by the EMA.

Michelleanne founded Metis because she wanted to lead a company focusing on consultant and client success. Ethics are her passion, and putting the patient first is her priority. She takes pride in bringing teams together to work harmoniously toward that common goal. Metis is named after the Goddess Metis, the mother of Athena. We have a large group of experienced Professional Consultants who are passionate about the patient’s best interest and driving clients’ success. Metis consultants are experienced in worldwide markets to meet client needs.

I am Li-Anne Rowswell Mufson, a Program Researcher here at Metis And pretty new to Metis and the pharmaceutical and biotech industry in general. I have what you might call the newcomer perspective.

Compliance and Quality

In this post, we share our approach to defining the difference between Compliance and Quality as it relates to biotech, medical device, and pharmaceutical companies. We will also discuss why Compliance and Quality are essential in the pharmaceutical industry. I’m sure if you are reading this blog, you already know what Quality Assurance and Compliance are and how they relate to what you do in your department. Still, it may be a little fuzzy, and you have some anxiety over the whole subject. We’ve got you. Let’s get down to basics.

The pharmaceutical industry is highly regulated. Regulatory agencies require pharmaceutical companies to meet specific standards of Quality and Compliance. So it is essential to thoroughly understand what these words mean and how they are related. The purpose of Quality Assurance is to ensure that the end result of the product being manufactured/developed/tested/marketed has the desired effect on the patients. QA goes further to ensure that the product will meet (or exceed) all requirements and relevant regulations. In other words, Quality guarantees Compliance.

Quality and Compliance

Michelleanne asserts that we need to set the foundation by defining these terms. For her, the difference between Quality and Compliance is that Quality is the action and Compliance is the output. If Quality systems are in place, you have a Compliant output. Jennifer adds that Compliance is the strategy and Quality is the tactics; in other words, Quality is a verb, as one of Jennifer’s mentors put it. You “do Quality” so you are Compliant in relation to the regulatory environment. Quality is the tactics used to comply with that regulatory environment: the standard, code, or regulation (GXPs, for example.)

Metis can help Industry standards and regulations across international and governmental arenas can be complicated. They are constantly evolving. By developing those Quality systems (tactics) and getting them in place, the team will be in Compliance with those standards and regulations. And although the Quality Department is the driver of those systems, Quality and Compliance are everyone’s responsibility. The ultimate target for everyone is to assure patient safety by delivering medicine or medical devices with the required quality, safety, and efficacy.

Why use Metis?

Everyone within the organization who touches any aspect of a particular process needs to know what these terms mean. Often people in our industry use “Quality” and “Compliance” interchangeably. For us at Metis, this is a critical discussion to have. If we think of the work an organization does as being similar to building a house, Jennifer says we might call Quality the foundational piece, the framework. ”The architectural plans, and perhaps the roof becomes the Compliance piece as you are metaphorically building.” Jennifer – who thinks in pictures – loves this metaphor because it evokes such a strong visual image. “It is the structural framework,” adds Michelleanne. “Without the structural framework, you are always putting out the fires instead of preventing them.”

When is a House a Pharmaceutical Organization?

When Michelleanne bought her house, there was no kitchen. Just about everything, everywhere you looked, needed work. It was a real fixer-upper. So she took inventory and set her priorities. Her top priority was the roof. Michelleanne had a colleague who knew she loved to cook and repeatedly asked, “Why don’t you do the kitchen first?” She explained why the roof was her top priority: “You can have a fabulous kitchen, but if the roof caves in, you’ll be picking debris out of your dinner.” The “house = your pharmaceutical organization” analogy is a good one. Let’s say your department is the kitchen – with granite surfaces and a new Sub Zero fridge. You have your shop in order! But if there is lousy plumbing – in this case, let’s say IT, which impacts every department – or it isn’t functioning well, then It’s just no good! You can’t cook in your fab kitchen!

At Metis, we help the whole house function together. Let’s have a conversation around what you need.