Alone together, civil war, same difference, unbiased opinion, and the "hindsight is always 20/20" feels oxymoronic. What space will excipients occupy in our consciousness in the next decade?
Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “...Ajaz Hussain
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”?
Uncertainty Management: Chaos to Continual ImprovementAjaz Hussain
In its 19th century origin, the current US pharmaceutical regulatory system underestimates the inherent complexity in making pharmaceutical products. Recurring errors, shortages, and warning letters serve as a “red flag,” reminding us that some assumptions we hold as “truths to be self-evident” are not. From an oxymoron to a discipline, pharmaceutical regulatory science is unfolding a fascinating journey from chaos to continual improvement.
Strengthening the National System for Excipient Risk Mitigation Ajaz Hussain
Today the assurance of continual supply, authenticity, quality, and functionality of pharmaceutical materials active and so-called "inactive" excipients is at risk that needs to be mitigated. This presentation seeks to bring attention to the prevalent "inactive" mindset that is so difficult to change. At the precipice, we do change. Are we there yet?
Repurposing in the Chaos of 2020 and Validity of Scientific EvidenceAjaz Hussain
Having been focused on manufacturing challenges for most of 2020, taking a time out to think about how best to garner "new prior knowledge" needed to facilitate development of evidence for repurposing option for the SARS-COV-2 cases and COVID-19 disease.
Sustain and Build a Quality Culture in Today's RealitiesAjaz Hussain
What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems.
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
Challenge: As a system or cohort, we can do more to adequately appreciate that “systems” proficiency is a stage in adult development that most struggle to achieve.
Leadership for the 21st Century Pharmaceuticals @ University of Lisbon Octob...Ajaz Hussain
Meaning-making is a process, how stable and capable is your process?
Leaders know the way, go the way and show the way (John C. Maxwell)
21st Century Cures personalized, patient-centric and based on real-world evidence
Pharmaceuticals are medicines superior to placebo in clinical trials and in the real world
Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “...Ajaz Hussain
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”?
Uncertainty Management: Chaos to Continual ImprovementAjaz Hussain
In its 19th century origin, the current US pharmaceutical regulatory system underestimates the inherent complexity in making pharmaceutical products. Recurring errors, shortages, and warning letters serve as a “red flag,” reminding us that some assumptions we hold as “truths to be self-evident” are not. From an oxymoron to a discipline, pharmaceutical regulatory science is unfolding a fascinating journey from chaos to continual improvement.
Strengthening the National System for Excipient Risk Mitigation Ajaz Hussain
Today the assurance of continual supply, authenticity, quality, and functionality of pharmaceutical materials active and so-called "inactive" excipients is at risk that needs to be mitigated. This presentation seeks to bring attention to the prevalent "inactive" mindset that is so difficult to change. At the precipice, we do change. Are we there yet?
Repurposing in the Chaos of 2020 and Validity of Scientific EvidenceAjaz Hussain
Having been focused on manufacturing challenges for most of 2020, taking a time out to think about how best to garner "new prior knowledge" needed to facilitate development of evidence for repurposing option for the SARS-COV-2 cases and COVID-19 disease.
Sustain and Build a Quality Culture in Today's RealitiesAjaz Hussain
What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems.
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
Challenge: As a system or cohort, we can do more to adequately appreciate that “systems” proficiency is a stage in adult development that most struggle to achieve.
Leadership for the 21st Century Pharmaceuticals @ University of Lisbon Octob...Ajaz Hussain
Meaning-making is a process, how stable and capable is your process?
Leaders know the way, go the way and show the way (John C. Maxwell)
21st Century Cures personalized, patient-centric and based on real-world evidence
Pharmaceuticals are medicines superior to placebo in clinical trials and in the real world
How to Prepare for the New World of Pharmaceutical Development and Manufactu...Ajaz Hussain
An unprecedented level of uncertainty, erosion of trust, and the increasing likelihood of multiple systems crumbling – CAHOS!
Information is not knowledge, and information not processed carefully is infectious and, perhaps, poses a higher risk than COVID-19.
Self is "being-whole" (mind and body, conscious and unconscious, to know and to believe), and self-authoring is a measure and a stage of development.
Pharma professionals have a duty of care to assure others; they do so when they are self-assured. This webinar is to continue building a "community of knowledge."
NIPTE, A Community of Knowledge at 2019 Research ConferenceAjaz Hussain
The nation’s “Pharmaceutical Technology” faculty: Distributed (as it should be) but sparsely, integrated with NIPTE
Nation’s attention on its pharmaceutical technology faculty
Increasing awareness of threats and vulnerabilities
Impactful solutions
The NIPTE Model: Team Science & Education for Pharmaceuticals
Integrating systems: Solutions for the real-world
Industrial Policy and NIPTE: Goodbye NIPTE Ajaz Hussain
1. Grab a chair when the music stops
2. Formulate Pharmaceutical Science Evidence in the Real-World
3. Personalize consequence of the systemic, harmful, societal underappreciation of pharmaceutics, industrial pharmacy, and pharmaceutical engineering
4. I am off to find a jungle to write my first novel
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Meaning making measurement maturity and management mokshaAjaz Hussain
Power without wisdom is a recipe for disaster. “Your problem is not technology. The problem is you. You lack the will to change” (The Day the Earth Stood Still (2008). “I think we need to do some very serious soul searching,” Woodcock (2020). Adequate, well-controlled, qualified by training and experience, fairly, responsibly (FD&C Act). “Only at the precipice do we evolve.” Is this our moment? Profiteers learn to be patient. Exploitation & Exploration: Bottom and Toplines, the ambidextrous. Quality is integral; warrant connects quantitative evidence with claims. Cease dependence on inspection via maturity of self, systems, & societies. You can find the way forward [to maturity] in the heart. Sense within to awaken. Dil Se! By heart.
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
From Roadblocks to Roadmap 2017, with a 2020 VisionAjaz Hussain
In 2015 FDA reorganized OPS to the Office of Pharmaceutical Quality (OPQ) and added an emphasis on One Quality Voice. In 2017 novel pharmaceutical technologies, the aspirational 21st Century Cures Act, and the President-elect Trump’s Administration are juxtaposed to re-shape, perhaps radically so, the Critical Path transformation underway since the beginning of this century. How will the Nation’s life-science research priorities change? What should be the next steps to optimally integrate 21st Century Quality, Cures and the Voice of Patients? What can/should NIPTE do next? Do better? Do more -be the third leg of the stool? This report, From Roadblocks to Roadmap 2017, with 2020 Vision, reviews and reflects on strategic directions emphasized by NIPTE in 2016. It recommends ways to strengthen the Voice of NIPTE to advocate its mission more persuasively and to facilitate its members apply their full potential in the interest of the Nation.
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
Digital Pharma Manufacturing RoundtableKronberg, Germany, March 17 2017
A story about manufacturing two products, medicinal product and documented data, and a “little secret”
The IFPAC Session: Controlling excipient impact during the product lifecycle.
Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter.
This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release.
Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
The 10 most trusted vaccine solution providers, 2020Merry D'souza
In this edition, ‘The 10 Most Trusted Vaccine Solution Providers, 2020’ CIO Look has shortlisted various healthcare organizations which are playing an important role towards the global healthcare system.
How to Prepare for the New World of Pharmaceutical Development and Manufactu...Ajaz Hussain
An unprecedented level of uncertainty, erosion of trust, and the increasing likelihood of multiple systems crumbling – CAHOS!
Information is not knowledge, and information not processed carefully is infectious and, perhaps, poses a higher risk than COVID-19.
Self is "being-whole" (mind and body, conscious and unconscious, to know and to believe), and self-authoring is a measure and a stage of development.
Pharma professionals have a duty of care to assure others; they do so when they are self-assured. This webinar is to continue building a "community of knowledge."
NIPTE, A Community of Knowledge at 2019 Research ConferenceAjaz Hussain
The nation’s “Pharmaceutical Technology” faculty: Distributed (as it should be) but sparsely, integrated with NIPTE
Nation’s attention on its pharmaceutical technology faculty
Increasing awareness of threats and vulnerabilities
Impactful solutions
The NIPTE Model: Team Science & Education for Pharmaceuticals
Integrating systems: Solutions for the real-world
Industrial Policy and NIPTE: Goodbye NIPTE Ajaz Hussain
1. Grab a chair when the music stops
2. Formulate Pharmaceutical Science Evidence in the Real-World
3. Personalize consequence of the systemic, harmful, societal underappreciation of pharmaceutics, industrial pharmacy, and pharmaceutical engineering
4. I am off to find a jungle to write my first novel
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Meaning making measurement maturity and management mokshaAjaz Hussain
Power without wisdom is a recipe for disaster. “Your problem is not technology. The problem is you. You lack the will to change” (The Day the Earth Stood Still (2008). “I think we need to do some very serious soul searching,” Woodcock (2020). Adequate, well-controlled, qualified by training and experience, fairly, responsibly (FD&C Act). “Only at the precipice do we evolve.” Is this our moment? Profiteers learn to be patient. Exploitation & Exploration: Bottom and Toplines, the ambidextrous. Quality is integral; warrant connects quantitative evidence with claims. Cease dependence on inspection via maturity of self, systems, & societies. You can find the way forward [to maturity] in the heart. Sense within to awaken. Dil Se! By heart.
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_QualityAjaz Hussain
25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding and risk-based regulatory decisions on Quality by Design. How good are the scientific explanations in regulatory submissions? Scientific explanations yield understanding; quality of explanations differ.What role can Chemometrics, Pharmacometics and Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox., Clinical, Public Health) perspectives on risk is important. Opportunities; only when the disciplinary divides are bridged. Within the regulatory realm how we set specifications and assess risk have progressed incrementally; at this rate the Vision 2020 may be expected to be visible broadly over time, by 2020?
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
From Roadblocks to Roadmap 2017, with a 2020 VisionAjaz Hussain
In 2015 FDA reorganized OPS to the Office of Pharmaceutical Quality (OPQ) and added an emphasis on One Quality Voice. In 2017 novel pharmaceutical technologies, the aspirational 21st Century Cures Act, and the President-elect Trump’s Administration are juxtaposed to re-shape, perhaps radically so, the Critical Path transformation underway since the beginning of this century. How will the Nation’s life-science research priorities change? What should be the next steps to optimally integrate 21st Century Quality, Cures and the Voice of Patients? What can/should NIPTE do next? Do better? Do more -be the third leg of the stool? This report, From Roadblocks to Roadmap 2017, with 2020 Vision, reviews and reflects on strategic directions emphasized by NIPTE in 2016. It recommends ways to strengthen the Voice of NIPTE to advocate its mission more persuasively and to facilitate its members apply their full potential in the interest of the Nation.
Part 1: FDA Trends
Background: The little secret – swept under the rug? No more!
Challenge or opportunity: Unprecedented juxtaposition – at the Tipping Point!
Questions: What consideration are needed for building your validation roadmap? Three options: Pathfinder, Standard or Emergency; what will you choose?
Part II: A higher level of confidence in quality assurance : State of Control (stability, capability with statistical confidence)
Case example: Challenges of implementing a roadmap to process capability for some currently commercialized products.
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
Digital Pharma Manufacturing RoundtableKronberg, Germany, March 17 2017
A story about manufacturing two products, medicinal product and documented data, and a “little secret”
The IFPAC Session: Controlling excipient impact during the product lifecycle.
Excipients enable the delivery of actives as a pharmaceutical product. Quality by Design requires that the impact of excipient variability on finished product quality be minimized, or, as paraphrased by Tobyn: - What matters doesn’t vary, and what varies doesn’t matter.
This parallels the current practice of categorizing excipients into critical vs non-critical, the assumption being that the latter do not impact the finished product Critical Quality Attributes. This binary classification of criticality has been criticized as too simple and it is not uncommon to observe excursions in finished product quality correlating with variability of a so-called non-critical excipient. The complexity of the excipients, and the products into which they are formulated, contributes to this uncertainty. For excipients, what varies may not have mattered prior to approval, but may come to matter later in the product lifecycle, especially for continuously manufactured products with real time release.
Excipients, even if fully compliant and manufactured under GMP, represent a reservoir of special cause variability in finished product quality. By definition this can only be addressed via the Control Strategy. Risk management requires continuous multivariate monitoring of finished product and raw materials to maintain quality and model fidelity.
The 10 most trusted vaccine solution providers, 2020Merry D'souza
In this edition, ‘The 10 Most Trusted Vaccine Solution Providers, 2020’ CIO Look has shortlisted various healthcare organizations which are playing an important role towards the global healthcare system.
Signal detection and their assessment in clinical trialsClinosolIndia
Signal detection and assessment in clinical trials refer to the process of identifying potential safety concerns or unexpected events related to a study intervention, treatment, or medical product. It involves monitoring and analyzing data collected during the trial to detect any patterns, trends, or signals that might indicate a safety issue. This proactive approach helps ensure the safety of participants and enables timely interventions if necessary.
Here's an overview of the process of signal detection and assessment in clinical trials:
WTO and sanitary and phytosanitary measures.
Presentation for master students of international business. Preparation time: 2 hours. Presentation time: 10 minutes
Presentation can be viewed at: http://www.youtube.com/watch?v=MdzdT1kRV_c
Genetic Technologies Limited is a diversified molecular diagnostics company
developing tools for the prediction and assessment of cancer risk to help physicians
proactively manage patient health. The Company’s lead products, ‘GeneType for
Breast Cancer’ and ‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s development pipeline
includes new tests for Type 2 diabetes, cardiovascular disease, prostate cancer, and
melanoma. Listed on the ASX in 2000 and NASDAQ in 2005, Genetic Technologies
has been a leader in the development and commercialization of genetic risk
assessment technology for 20 years.
While many companies are contributing to the battle against the pandemic, Deep Tech startups are trying to overcome scientific challenges to help with prevention, testing or treatment in novel and scalable ways.
This live event organized by SOSV brings together investors who have backed dozens of relevant startups, to get a sense of:
- The variety of solutions being developed,
- Their potential outcomes,
- The broader role and opportunities of deep tech investment.
SPEAKERS
- Seth Bannon, Founding Partner, Fifty Years
- Jun Axup, PhD, Chief Science Officer & Partner, IndieBio / SOSV
- Alex Morgan, MD PhD, Partner, Khosla Ventures
MODERATORS
- Julie Wolf, PhD, Communications Director, IndieBio / SOSV
- Benjamin Joffe, Partner, SOSV
COVID-19 PORTFOLIO
- Fifty Years: www.fifty.vc/covid
- SOSV: www.sosv.com/covid-startups/
- Khosla Ventures: www.khoslaventures.com/khosla-ventures-entrepreneurs-are-responding-with-amazing-diversity-to-covid-19-solutions-for-societys-needs
Artificial Intelligence in PharmacovigilanceClinosolIndia
The integration of Artificial Intelligence (AI) into pharmacovigilance has emerged as a transformative force, revolutionizing the monitoring and assessment of drug safety. This article provides a comprehensive overview of the application of AI in pharmacovigilance, elucidating its impact on the identification, evaluation, and management of adverse drug reactions (ADRs). AI-driven algorithms, machine learning, and natural language processing empower automated signal detection, enabling more efficient and proactive risk assessment. The review explores the utilization of AI in mining diverse data sources, including electronic health records, social media, and scientific literature, to enhance the sensitivity and specificity of ADR detection. Additionally, the article delves into the role of AI in streamlining case processing, automating data validation, and facilitating trend analysis, thereby optimizing the pharmacovigilance workflow. Challenges, such as data quality and interpretability of AI-generated insights, are critically examined, alongside ongoing efforts to address these concerns. The regulatory landscape and the incorporation of AI technologies into pharmacovigilance guidelines are discussed, highlighting the evolving framework for ensuring patient safety. As AI continues to evolve, its synergy with traditional pharmacovigilance practices opens new avenues for enhanced surveillance and proactive risk management in the dynamic field of drug safety.
Marking the beginning of our Centennial year is the publication of our Healthcare and Bio- Life Science Real Estate Report, (formerly Medical Office Report) – Year End 2020 for your review.
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdfAjaz Hussain
Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review?
Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.”
What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response?
Ομιλία – Παρουσίαση: Αχιλλέας Γραβάνης, Professor of Pharmacology, School of Medicine University of Crete
Researcher IMBB-FORTH, Affiliated Research Professor, Center of Drug Discovery, Northeastern University
Τίτλος Ομιλίας: «Η φυσική ιστορία μιας Ακαδημαϊκής Βιοτεχνολογικής spin off στην Ελλάδα»
This presentation was given at a March 2013 meeting of the HEA STEM Special Interest Group on teaching ethics to bioscience students. The meeting was hosted at the University of Northampton, UK, and the principal focus was on teaching about Ethics and Risk.
Professor Joe Perry is a member of the European Food Safety Authority (EFSA).
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
10 Most Innovative CRO’s To Watch In 2022.pdfinsightscare
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5. Confirmed allergic
reactions to
vaccines are not
frequently
attributed to the
active
ingredients but
rather to the
excipients. Why?
◦ Immediate hypersensitivity to PEG has
been reported, including life-threatening
allergic reactions
◦ Caballero ML, Quirce S. Excipients as potential agents
of anaphylaxis in vaccines: analyzing the formulations
of the current authorized COVID-19 vaccines. J
Investig Allergol Clin Immunol 2021; 31:1-8.
◦ Ocáriz, M.L. and Zubeldia Ortuño, J.M., 2021. Safety of
new MRNA Vaccines Against COVID-19 in Severe
Allergic Patients. J Investig Allergol Clin Immunol, 31(2).
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6. Excipient
Adjuvants
◦ Hydroxypropyl
cellulose induced the
highest level of virus-
specific antibody
production (higher
than that of alum)
◦ Front. Microbiol., 24
January 2019 |
https://doi.org/10.3389
/fmicb.2019.00019
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Ajaz | Insights 6
7. PERBILLIONVACCINATIONS
HOWMANYSEVERE
REACTIONSCONSISTENT
WITHANAPHYLAXIS
EXPECTED?
The incidence rate of confirmed anaphylaxis in this
study is larger than that reported by the Centers for
Disease Control and Prevention based on passive
spontaneous reporting methods (0.025-0.11/10 000
vaccinations). 2% reported some allergic symptoms;
however, severe reactions consistent with anaphylaxis
occurred at a rate of 2.47 per 10 000 vaccinations.
Blumenthal KG, Robinson LB, Camargo CA, et al. Acute Allergic
Reactions to mRNA COVID-19 Vaccines. JAMA. Published online
March 08, 2021. doi:10.1001/jama.2021.3976
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9. Excipients:
In our
consciousness?
3/10/2021 9
◦ Industry Pharma Professional
◦ R&D
◦ Regulatory
◦ Manufacturing
◦ Quality Unit
◦ Purchasing and others
◦ Regulatory Agency
◦ Review (CMC, Pharm- Tox, Clin Pharm, Clinical)
◦ Inspection (CGMP, GLP, GCP)
◦ Policy and others
◦ Excipient Supply Systems
◦ Health-care
◦ Public Health
◦ Patients, Providers, Payers,…
◦ Academic
Ajaz | Insights
10. Mindboggling EXCIPERIENCE!
Sigma X per billion, X= “defects” or “errors type 1 & 2”
1 691462000
2 30838000
3 66807000
4 6210000
5 233000
6 3400
7 19
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11. EXPERIENCE∈ CL
EXCIPERIENCE!
Experience is to feel emotions, professionals do so with confidence, within their qualified confidence level.
! exclamation point a rhetorical device; from Latin io!, an exclamation of delight or triumph.
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22. Designing particles
for inhalation
◦ components distribution within dried particles,
functionality and behavior of excipients during
drying. https://doi.org/10.1016/j.powtec.2021.02.031
3/10/2021
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