Autism Spectrum Disorder and the Pharma & Medical Device World
Written by Michael Bronfman
The team at The Guard Rail (Metis Consulting Services' blog)—your partners in navigating the pharmaceutical and medical device world—is kicking off an exciting new blog series.
We'll be diving into the latest science around unmet medical needs – those areas where smart development can really make a difference. And what better place to start than the current climate and science surrounding Autism Spectrum Disorder (ASD)?
ASD: A Real Opportunity for Small to Medium Players
ASD is a significant and growing area of unmet medical need. For those of you in the pharmaceutical and medical device manufacturing space, especially the nimble small—to medium-sized companies, this presents a unique opportunity. While the big players might be focused elsewhere, your agility and innovative spirit can truly shine here.
ASD is complex and characterized by a wide range of differences in social interaction, communication, and behavior. The number of individuals identified with ASD is increasing, and understanding the latest research is key to continuing to develop effective solutions.
Decoding ASD: What You Need to Know for R&D
Our understanding of ASD has come a long way. Forget old theories—the science now points to a strong biological basis, with genes, brain function, and environmental influences playing crucial roles.
The Genetic Puzzle: Think of ASD as potentially involving many different genes and even variations in the number of copies of certain genes (CNVs). This genetic complexity offers a whole host of potential targets for future therapies. Keep an eye on genes like MECP2 and SHANK3, which are involved in how brain cells connect. This could be your niche!
Inside the Brain: Brain imaging studies are consistently showing differences in specific brain regions in individuals with ASD – areas involved in emotions, memory, and decision-making. This opens up avenues for developing drugs or devices that target these specific neurobiological pathways.
Environment Matters Too: While genes are important, the environment during pregnancy and early childhood also plays a role. Researchers are looking into things like maternal infections and exposure to certain substances. Interestingly, how the environment can actually change gene expression (epigenetics) might hold clues for personalized approaches.
Busting the Myth: Just a quick but crucial point – the idea that vaccines cause autism? Totally debunked. Solid science has shown no link. Let's stick to the facts.
The Growing Numbers: Why This Matters to You
The CDC's latest data shows a significant increase in the number of children identified with ASD – from 1 in 150 in 2000 to about 1 in 36 in 2023. This isn't just about better diagnosis. The diagnostic criteria have broadened, meaning more individuals with a wider range of presentations are being recognized. This highlights the spectrum nature of ASD and the diverse needs within this population.
Your Opportunity: Innovation for a Growing Need
For small to medium-sized pharma and medical device companies, ASD represents a chance to be at the forefront of innovation. Your ability to focus, be agile, and pursue novel approaches could lead to breakthroughs in:
Targeted therapies: Developing drugs that address specific genetic or neurobiological mechanisms.
Medical devices: Creating tools and technologies to aid communication, learning, and daily living for individuals with ASD.
Personalized solutions: Leveraging genetic and environmental understanding to tailor interventions.
The landscape of ASD research is dynamic and full of potential. At Metis Consulting Services, we believe that smaller players can make a significant impact. Let's explore how your unique capabilities can address these unmet needs and contribute to a better future for individuals with ASD and their families. Reach out – we're here to help you navigate this exciting journey!
Next issue we will be discussing more in depth about what does NOT cause ASD.
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Matlock’s Misguided Take on the Opioid Crisis
Written by Dr. Olivia Fletcher
Kathy Bates' revival of the iconic Matlock series has brought back the legal drama we all know and love. As much as we love the reboot, the portrayal of the opioid crisis is deeply flawed and misleading. In the pilot episode, Madeline “Maddy” Matlock suggests the attorneys she works with had confidential client information that would have motivated the FDA to take opioids off the market ten years earlier. This claim is both inaccurate and harmful, as it misrepresents the complexities of the opioid crisis and disregards the ethical obligations of attorneys.
The Opioid Crisis: A Complex Issue
The opioid crisis is a multifaceted public health crisis that has devastated communities around the world. This crisis is a result of a confluence of factors, including addiction, overprescribing, inadequate pain management education, and the illicit manufacturing and distribution of synthetic opioids. While opioids are a valuable tool for managing pain when used appropriately and under medical supervision, their misuse and abuse have led to widespread addiction, societal harm, and death by overdose.
Attorney-Client Privilege: A Cornerstone of the Legal System
The principle of attorney-client privilege is fundamental in our legal system. It protects confidential communications, ensuring that individuals can seek legal advice without fear of disclosure. This privilege is essential for the establishment and maintenance of trust in the legal system to facilitate open and honest communication between attorneys and their clients. Attorney-client privilege only allows the attorneys to divulge communications in the case the client intends to use advice from the attorney to commit further crimes.
As a therapist myself, confidentiality and morality don’t always play nicely together. Confidentiality is the province of ethics, not morality. What may seem Right or Wrong in the micro may not align neatly with what is necessary in the macro. Our legal system requires clients to be able to confide fully in their attorneys in order to assist in their own representation. So while a client cannot ask an attorney for advice on how to hide the body of the next person they murder, they absolutely can tell the attorney they plan to murder someone else and the attorney’s hands are tied. This is the strictest confidentiality in our legal system. No other communication is given such broad protections by our courts. Therapists, physicians, clergy, and even spouses have more exceptions.
The Role of the FDA in Opioid Regulation
The Food and Drug Administration (FDA) plays a crucial role in regulating the safety and efficacy of prescription drugs, including opioids. The FDA approves drugs for use based on rigorous scientific evidence and requires manufacturers to submit post-market surveillance data to monitor the safety of approved products. If the FDA becomes aware of serious safety concerns, it may take action to restrict or withdraw the approval of a drug. As explained in the book, Empire of Pain by Patrick Radden Keefe, the Food and Drug Agents involved in monitoring Purdue Pharma, the company responsible for initially bringing oxycontin to the market, were deeply entwined with the company.
The REMS Program: A Critical Tool for Opioid Risk Management
The Risk Evaluation and Mitigation Strategy (REMS) program is a regulatory tool used by the FDA to manage risks associated with certain drugs. REMS programs can include requirements for prescribers, pharmacies, and patients, such as education and training, monitoring, and restrictions on distribution. Opioids are subject to REMS programs that aim to reduce the risk of abuse and diversion.
The Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) is a program implemented by the FDA to address the risks associated with opioid analgesics. It requires certain actions from healthcare providers and patients to ensure the safe use of these medications.
The requirements of these programs include:
For Prescribers:
Education: All healthcare providers involved in the management of patients with pain, including prescribers, nurses, and pharmacists, must complete accredited continuing education (CE) courses on the safe use of opioids. These courses must be based on the FDA's Opioid Analgesic REMS Education Blueprint.
Patient assessment: Healthcare providers must assess a patient's risk factors for opioid misuse, addiction, and overdose before prescribing opioids. This assessment should include a thorough medical history, physical examination, and consideration of the patient's social and psychological factors.
Treatment plan: If opioids are prescribed, healthcare providers must develop a comprehensive treatment plan that includes:
Clear goals for pain management
A risk assessment and mitigation strategy
A plan for monitoring the patient's response to treatment
A plan for tapering or discontinuing opioids as appropriate
Documentation: Healthcare providers must document their assessment, treatment plan, and monitoring of the patient's response to treatment in the patient's medical record.
For patients:
Education: Patients who are prescribed opioids must receive information about the risks and benefits of these medications, as well as instructions on how to use them safely.
Agreement: Patients must sign a written agreement that outlines their understanding of the risks and benefits of opioids and their commitment to follow the prescribed treatment plan.
Monitoring: Patients must be monitored regularly for signs of opioid misuse, addiction, and overdose. This may include regular follow-up appointments, urine drug testing, and other assessments as appropriate.
Manufacturer requirements:
Manufacturer reporting: Opioid manufacturers must report any adverse events associated with their products to the FDA.
Public education: Opioid manufacturers must also conduct public education campaigns to raise awareness about the risks of opioid abuse and addiction.
Risk vs Benefit
All medications come with risk and side effects. Even the most thorough clinical trials may not make all of these clear in the limited time and population available. One of the key points the FDA focuses on is whether the benefits of the medication outweigh the risks. Midrin, a migraine abortant, was widely prescribed for decades before studies indicated that the Schedule IV substance, dichloralphenazone, which was one of three substances in midrin, was too prone to abuse. That combined with the concerns over liver damage from overuse of acetaminophen led the FDA to remove it from the market. Opioids do provide significant pain relief to patients for whom they are prescribed. It is important not to throw the baby out with the bath water. As we continue to advance pharmaceutical science, we may, hopefully, find a way to relieve pain without the dangers associated with narcotics. Knowing everything we know about the dangers of opioids, they are still considered worth the risk.
Conclusion
While Matlock is an entertaining show, the portrayal of the opioid crisis is deeply flawed and highly misleading. The show's suggestion that attorneys could have prevented the crisis by divulging confidential client information is inaccurate and disregards the ethical obligations of attorneys. The opioid crisis is a complex issue that requires a multifaceted approach, including improved pain management education, increased access to treatment, and stricter regulations on the prescription and distribution of opioids. We have enough misinformation circulating without adding to the detritus, perhaps some accountability is due here.
The Power of AI
This Week, the Guard Rail is thrilled to have our first-ever guest blogger. Metis' COO, Dr. Olivia Fletcher, has written a fascinating article looking deeper into AI and its use as a tool, not a replacement for human input and documentation. This comes on the heels of an exciting week at the RIC(REMS Industry Consortium) annual meeting, where our CEO, Michelleanne Bradley, presented and was on a panel discussing the intricacies of ethics and AI in the Pharmaceutical and Medical Device industries. Enjoy!
The Power of AI: How Large Language Models Are Transforming Document Creation
by Dr. Olivia Fletcher
As the COO of Metis Consulting Services, navigating a world of information and crafting clear, concise documents is essential. Traditionally, this has meant dedicating significant time to research, writing, and editing. However, the landscape is shifting. Large language models (LLMs), like Gemini from Google, are emerging as powerful tools, streamlining the document creation process and allowing human expertise to shine even brighter.
Boosting Efficiency: From Blank Page to First Draft Faster
I have ADHD, and one of my primary executive dysfunctions is task initiation. This can mean that just typing that first word is a gigantic hurdle for me. LLMs can alleviate this initial hurdle by generating drafts based on specific prompts and topics thereby providing a starting point. This can be particularly helpful for:
Emails and Reports: Quickly summarizing key points from complex data sets or research papers allows you to focus on crafting a compelling narrative. LLMs are particularly good at recognizing patterns in data.
Blog Posts and Articles: LLMs can provide a well-structured foundation, outlining the main points and even suggesting relevant sources.
This doesn't eliminate the human touch; it simply removes the initial heavy lifting.
Enhancing Content: Fact-Checking, Research, and Tone
Accuracy and credibility are paramount in any professional setting. LLMs can assist in:
Fact-checking: By integrating with vast knowledge bases, we can verify the accuracy of information and provide citations. However, we are all aware of the case of the attorney who submitted a brief in court crafted by an LLM. That brief, full of fake cases the LLM had invented for the document, is an example of the danger of just letting an LLM run away with the work. The product of an LLM still needs human verification.
Research: LLMs can efficiently scan through mountains of data and present relevant sources, saving you valuable time.
Maintaining Tone: Whether it's a formal report or a casual blog post, we can tailor the writing style to match the intended audience.
Human Expertise: Where LLMs Fall Short and We Excel
While LLMs offer significant advantages, it's crucial to remember that they are still under development. Here's where human expertise remains irreplaceable:
Critical Thinking and Analysis: LLMs can synthesize information, but they cannot replace the ability to critically analyze data, draw conclusions, and identify the underlying significance.
Creativity and Originality: Human ingenuity in crafting unique arguments, presenting information in innovative ways, and weaving a narrative is unparalleled.
Understanding Nuance and Context: LLMs may struggle with the subtle nuances of language and the importance of context in specific situations.
The Future of Document Creation: A Collaborative Approach
The ideal scenario involves a powerful synergy between LLMs and human expertise. Imagine a world where:
LLMs handle the initial groundwork: Drafting emails, reports, and even initial outlines of more complex documents.
Humans take the reins: Editing, refining the content, injecting critical thinking, and ensuring the final product aligns perfectly with the intended purpose and audience.
This collaborative approach allows professionals to:
Focus on higher-level tasks: Freeing up valuable time for strategic thinking, client interaction, and core business functions.
Produce higher quality content: The combination of LLM efficiency and human expertise produces well-structured, informative, and impactful documents.
In Conclusion: LLMs are not here to replace human writers; they are here to empower them. By embracing and utilizing this new technology strategically, professionals like myself can work smarter, not harder, and achieve even greater results.
For more information on AI and the possible thorny issues involved, listen to the Queens of Quality podcast bonus season 2.5 with guests Emily Barker and Steve Thompson S2.5(link )
To start a conversation with Metis Consulting Services, please email us at:
hello@metisconsultingservices.com
*This blog post was written with the help of Gemini, Google’s LLM.
Navigating the Current Regulatory Climate
Written by Michael Bronfman
Need help in the current Regulatory Climate? A consultant can help you get to Compliance and Beyond
To address the challenges faced by biotech companies as they enter new markets, a good consultant can leverage its expertise in navigating complex regulatory environments, ensuring compliance, and optimizing quality systems. Here are some ways Metis Consulting Services could help your organization meet the challenges highlighted in a survey * of over 200 regulatory, safety, and quality directors from small to medium-sized biotechs in the EU (Ireland) and North America (U.S.) :
1. Navigating Complex Quality Requirements
Metis Consulting can assist biotech companies in setting up and optimizing quality management systems (QMS) to meet the specific regulatory and licensing requirements of new markets. By providing expert guidance on local regulatory frameworks, Metis can help clients avoid common pitfalls related to misunderstanding market-specific requirements.
2. Pharmacovigilance Expertise
The survey highlighted pharmacovigilance as a critical challenge. Metis could offer tailored pharmacovigilance services to help biotech companies integrate and scale their pharmacovigilance activities early in the development process. This would include creating robust systems for adverse event reporting, risk management, and regulatory submissions to ensure compliance in various markets.
3. Streamlining Regulatory Approval Processes
With regulatory approval times being a significant challenge, Metis can help companies navigate regulatory submission and approval processes more efficiently. This can include regulatory strategy development, gap analysis, preparation of submissions, and liaison with regulatory bodies to expedite approvals and reduce delays.
4. Cost Management and Market Strategy
To mitigate the higher-than-expected costs and avoid market entry withdrawal, Metis could assist in conducting cost-benefit analyses for entering new markets. This would involve identifying the most cost-effective strategies for market entry, regulatory compliance, and operational scaling in challenging markets like China, Brazil, and others.
5. Early Integration of Key Planning Functions
The survey pointed out the need for early integration of pharmacovigilance, regulatory, and quality planning. Metis could offer integrated consulting services that help biotech companies align their regulatory, quality, and safety strategies from the outset. This proactive approach can help reduce the likelihood of unforeseen roadblocks and inefficiencies as companies scale and enter new markets.
6. Adjusting Strategies for the U.K. and EU Markets Post-Brexit
With heightened focus on the U.K. due to Brexit and the evolving regulatory landscape, Metis Consulting can offer specialized services to help biotech companies navigate post-Brexit regulatory challenges in the U.K. and the EU, ensuring that they remain compliant while maintaining smooth operations across both markets.
7. Success Redefined: Compliance and Investor Relations
As compliance and investor payback become more critical success metrics, Metis Consulting can help biotech companies develop robust compliance strategies that align with the increasingly stringent requirements in the U.S. and other markets. Additionally, Metis could assist companies in crafting strategic plans to demonstrate strong compliance performance, which would be crucial for maintaining investor confidence.
8. Strategic Market Entry and Representation
For companies looking to expand into high-priority markets such as the U.S., U.K., Canada, Brazil, and the Middle East, Metis can provide strategic advice on market entry, representation models (direct vs. partnerships), and regulatory considerations specific to those regions. This could include helping biotech companies decide whether to pursue direct representation or rely on local partnerships, depending on the market's dynamics.
9. Tailored Regional Guidance
Metis can also offer tailored insights into specific regions that are becoming increasingly important for biotech market access. For example, the firm could assist in navigating regulatory complexities in Brazil, which has become a key biotech market in Latin America, or help companies looking to expand into the Middle East, where the biotech sector is growing rapidly.
By offering these comprehensive consulting services, Metis Consulting can position itself as a trusted partner that helps biotech companies overcome regulatory, safety, and quality challenges while successfully entering and expanding in new markets."
* https://www.linkedin.com/pulse/top-pharma-biotech-news-1-january-edition-symmetrictraining-ndtgf/
Why Your Biotech, Pharmaceutical or Medical Device Organization Needs an Independent Consultant
Written by Li-Anne Rowswell Mufson
In today's complex regulatory landscape, biotech, pharmaceutical, and medical device organizations face numerous challenges in bringing products to market while ensuring compliance with evolving standards. Navigating the regulatory complexities and laboratory hurdles often hindering the development journey is daunting. This is where independent consultants, such as Metis Consulting Services, play a crucial role in unlocking the full potential of your products and achieving regulatory success. Consultants offer fresh eyes that pick up on potential pain points that the team may not see on the inside.
R&D Laboratory
Metis Consulting Services offers comprehensive R&D laboratory support, including but not limited to small molecule development, biologics development services, and cross-functional expertise. With their specialized knowledge and experience, they provide valuable insights and guidance to streamline your development processes and overcome technical challenges. For more, Listen to Queens of Quality Podcast “A Journey through the Pharmaceutical Regulation and Quality Design S2:E7
Audits/Inspection Readiness
Preparing for audits and inspections is critical to maintaining regulatory compliance. Independent consultants assist your organization in conducting thorough audits, ensuring inspection readiness, and implementing corrective actions to address any identified issues, ultimately helping to maintain good standing with regulatory authorities.Ffor more listen to Queens of Quality Podcast A Comprehensive Guide to Audits and Compliance in Pharmaceuticals | S2:E2
Clinical Data Management
Effective clinical data management is essential for demonstrating the safety and efficacy of pharmaceutical and medical device products. Independent consultants offer expertise in clinical data management and ensure that your data is collected, processed, and analyzed in compliance with regulatory requirements. For more listen to Queens of Quality Podcast Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson and Emily Barker PT3
| S2:BONUS 3
Corporate Training
Continuous training and development are vital for keeping your team updated with the latest regulatory standards and industry best practices. Independent consultants provide tailored corporate training programs to enhance your staff's regulatory knowledge and skills, ultimately contributing to improved compliance and operational efficiency. For more listen to: Queens of Quality Podcast A Comprehensive Guide to Audits and Compliance in Pharmaceuticals| S2:E2
Regulatory Strategy Advising
Navigating the complex regulatory landscape requires a strategic approach. Independent consultants advise regulatory strategy, helping your organization develop and execute robust regulatory strategies that align with your business objectives and ensure timely product approvals.For more listen to Queens of Quality Podcast” A Comprehensive Guide to Audits and Compliance in Pharmaceuticals” S2:E2
Pharmacovigilance
Ensuring the safety of pharmaceutical products throughout their lifecycle is a vital concern. Independent consultants support your organization in establishing and maintaining effective pharmacovigilance systems, including adverse event reporting, risk management, and regulatory compliance.
Listen to the Queens of Quality Podcast S1 E5 “Pharmacovigilance”
Quality Management Services
Maintaining high-quality standards across all aspects of your operations is essential for regulatory compliance and product integrity. Independent consultants offer quality management services, including quality system assessments, process improvements, and compliance monitoring, to help you achieve and sustain a culture of quality within your organization. Listen to the Queens of Quality Podcast S2 E8, “Embracing Evolution and Growth in Quality.”
REMS/RMPs
Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs) are mandatory programs for post-market activities for designated products. REMS and RMPs (in the 2EU) are designed to manage known or potential risks associated with certain products. Independent consultants with expertise in REMS/RMPs guide these strategies' development, implementation, and evaluation to ensure the safe and effective use of pharmaceutical products. Listen to the Queens of Quality Podcast S2 E6, “Revolutionizing the REMS Industry with Sherice Mills.”
Consulting
The expertise and support independent consultants provide can significantly benefit pharmaceutical and medical device organizations, particularly in navigating regulatory challenges, enhancing operational capabilities, and ensuring compliance with the highest standards. Pharmaceutical consulting provides a bridge between laboratory research and patient care. An alliance of scientific rigor and strategic acumen turns therapeutic concepts into accessible treatments. What are the benefits of using pharmaceutical consultants? They guide your organization's journey from bench to bedside in the biotech, pharmaceutical, and medical device industry. Pharmaceutical consultants don the hat of strategists, advisors, and analysts to steer drug developers through the complex maze of bringing a new drug to market. They are the catalysts for innovation, ensuring that groundbreaking treatments see the light of day and reach the right patients at the right time. If your organization is striving for regulatory success and seeking to maximize the potential of its products, engaging an independent consultant such as Metis Consulting Services is an excellent strategic decision with far-reaching benefits, ultimately leading to the primary goal for all involved: enhanced patient outcomes. FDA Guidance on REMS from May 2024 here
Metis Consulting Services offers a complete and customizable suite of services, including but not limited to
1. Audits/ Inspection Readiness-
3. Corporate Training-
4. REMS-RMP
5. Regulatory Strategy Advising-
7. Quality Management Services-
8. R&D Laboratory Services-
9. Ethical AI
With our support, biotech, pharmaceutical, and device manufacturers can confidently navigate the complex landscape of regulatory requirements and industry best practices, ensuring their products' safety, efficacy, and quality.