Welcome Back to the Metis Blog
Written by Li-Anne Roswell Mufson
We've been on Hiatus for a few months, generally having a "Make-Over." We have been doing some fixing up and growing within our company, looking at the blog as well, and at last, we are back!
We now have a title for this Blog Space.
We are calling it...Drum Roll, please, "The Guard Rail." TADA
Why?
In this Blog Space, we discuss topics of interest to people in our industry and what is happening here at our company. At Metis, we offer services in
*Audits/Inspection Readiness, *Consulting Services,*Corporate Training,*Data Management,*Pharmacovigilance,*Quality Management, and *REMS.*
We aim to help organizations keep up with regulatory conditions and industry best practices to ensure patient safety and access to effective therapies.
Metis has passionate, experienced consultants who do this work because we care about keeping the focus on the patients. Our goal is to keep them safe and get them access to effective therapies. We have the most significant impact by helping organizations keep up with global regulatory conditions, Risk Mitigation, and industry best practices. And we see the most crucial part of our mission as keeping the patient first, for us and for our clients.
In other words, we work on the industry Guard Rails.
Our industry needs guard rails. Nowhere is this more evident than in the recent surge of AI use in Life Sciences, which, not so coincidentally, is our topic for today.
We say "new" in quotes because AI is not new; the concept has been around since the 50s, but with the eruption of ChatGpt and generative AI, the use of AI in Life Sciences is exploding.
Today, we want to discuss the intersection of artificial intelligence (AI) and life sciences. While AI is not a new concept, the recent eruption of generative AI and ChatGpt has led to explosive growth in the use of AI in life sciences. This growth is exciting but raises concerns about ethical considerations and responsible deployment.
The ethical deployment of AI is crucial to ensure patient safety and to uphold the highest ethical standards in the pharmaceutical industry. We need to balance technological advancements with ethical considerations. AI has tremendous potential to optimize treatments and unlock profound insights from complex datasets. However, it also poses unique challenges, including data privacy, algorithmic biases, and responsible use of patient information. As Steve Thompson put it so well when he was Metis CEO Michelleanne Bradley's guest on the Queens of Quality Podcast Bonus episode S2.5 E1, "Although this is exciting, we have to act ethically, responsibly…with a multidisciplinary approach..it all sounds really good and fascinating.. but (Michelleanne), you mentioned Guard Rails; we have got to put these things in place to ensure we are applying this technology ethically and responsibly."
In that episode and the others in this bonus series, Michelleanne clearly agrees. AI may be the "shiniest tool in the shed," but that doesn't mean we should leap into using it everywhere without putting guard rails in place. We aim to help organizations keep up with regulatory conditions and industry best practices to ensure patient safety and access to effective therapies.
Check out Queens of Quality podcast episode S2.5E1QoQ
To ensure the ethical deployment of AI in life sciences, we must commit to continuous improvement, transparent model development, and the mitigation of biases. A diverse team of multidisciplinary experts, including scientists, ethicists, data analysts, industry professionals, and more, should work collaboratively to align technological advancements with ethical principles.
The ethical implications of relying on AI for critical decision-making demand meticulous attention and algorithm oversight. Fairness, transparency, accountability, and privacy principles should be non-negotiable in every facet of AI development, deployment, and regulation. Michelleanne quoted Michael Crichton to remind us in Jurassic Park by way of his character Dr. Ian Malcolm, played by Jeff Goldblum, in the movie, "Your scientists were so preoccupied with whether they could, they didn't stop to think if they should." We need to ask ourselves this question.
We can only harness AI's potential to improve patient outcomes and drive innovation by embracing an ethically conscious approach. However, we must uphold the highest ethical standards in the pharmaceutical industry.
In today's fast-evolving landscape, the convergence of Artificial Intelligence (AI) and Life Sciences heralds immense possibilities and intricate ethical quandaries. Understanding the interplay between AI and ethical considerations is essential for professionals entrenched in the Regulatory, Life Sciences, and Pharmaceutical industries. This understanding will steer this transformative journey.
The Current State and Future of AI in Life Sciences
AI is a beacon of innovation in the Life Sciences domain. Its capabilities span from streamlining drug discovery processes to enhancing patient care through predictive analytics. The current landscape paints a promising future where AI optimizes treatments and unlocks profound insights from complex datasets. It is vital to be watchful with our Data Management Systems. Link to DMS
Ethical Dilemmas in AI
However, ethical dilemmas accompany this rapid advancement. Issues such as data privacy, algorithmic biases, and the responsible use of patient information cast a critical spotlight on the ethical deployment of AI in the pharmaceutical realm. We know that patients will suffer if we remove the human element from the equation altogether OR if we don't work to ferret out the human biases inherent in human-provided data and other challenges. Our industry will suffer, too, and we may be throttled to a stop or even move backward before we can move forward.
The Importance of Continuous Improvement in AI
Continuous improvement lies at the core of ethical AI deployment. It needs ongoing algorithm refinement, transparent model development, and bias mitigation. A commitment to oversight ensures that AI systems evolve to become more accurate, fair, and reliable. Nobody can move forward if we do things as we have always done. Check out this episode of Queens of Quality podcast: QoQ 2.5E2
Challenges of Creating Synthetic Patients
Developing synthetic patients and digital replicas of actual patients for research and analysis poses unique challenges. Ensuring these models accurately represent diverse demographics and medical conditions while avoiding biases demands collaborative efforts and stringent ethical considerations. Unaided by AI, humans have done some very unkind things to one another in the name of science while perpetuating harmful biases. The 1932 Tuskegee Airmen syphilis study and the New Zealand 1966 cervical cancer study, to name two, have provided models of unethical practice for a generation of researchers. We need to be sure we don't exacerbate those biases by plugging them into AI.
The Role of AI in Risk Management
AI serves a pivotal role in risk management within the Pharmaceutical industry. Its applications span from early detection of health risks to optimizing clinical trials and facilitating regulatory compliance. However, the ethical implications of relying on AI for critical decision-making demand meticulous attention.
Importance of Multidisciplinary Teams in AI
The ethical deployment of AI in Life Sciences necessitates collaborative efforts by people with diverse expertise. Multidisciplinary teams, comprising scientists, ethicists, data analysts, and industry professionals, bring varied perspectives essential for aligning technological advancements with ethical principles. By our very nature, none of us can "see" our own biases. Michelleanne likens our job to an almost anthropological approach here. The more diverse Multidisciplinary Teams we have working on this, the less likely those biases will slip through to the algorithms unchallenged.
Ethical Considerations in AI
Above all, ethical considerations are the guiding compass for AI integration in the Pharmaceutical industry. Fairness, transparency, accountability, and privacy principles should be non-negotiable in every facet of AI development, deployment, and regulation. We need algorithm oversight, and the FDA will require industry experts to advise on this.
The synergy between AI and Life Sciences presents unparalleled opportunities for the Pharmaceutical industry. However, this convergence demands a delicate equilibrium between innovation and ethics. Balancing technological advancements with ethical considerations is not just a choice but a responsibility that shapes the future of healthcare. Only by embracing an ethically conscious approach can the potential of AI be harnessed to improve patient outcomes, drive innovation, and uphold the highest ethical standards in the Pharmaceutical industry.
So how can we do this? What is the mechanism for maintaining this balance?
We need people from all the diverse specialties, Data people, Clinical people, etc., to get involved now. We also need an Algorithm Review Board, like the IRB, to get engaged before we find ourselves dealing with a catastrophe that causes a reactive regulatory response.
Let's put out the fires before they start.
If you want to become part of this solution, contact us at hello@Metisconsultingservices.com to join the conversation.
Who is Metis?
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.
Everyone within the organization who touches any aspect of a particular process needs to know what these terms mean. People in our industry often use “Quality” and “Compliance” interchangeably. For us at Metis, this is a critical discussion.
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 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.