Standard of Care Costs vs Study-Related CostsTrialJoin
In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When we’re talking about budgeting for a study, there are many separate items and things to be considered.
One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where it’s required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study.
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
Most Common Clinical Research Site Worries and ComplaintsTrialJoin
All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
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.
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…
New Drug Application - How to Speed Up FDA ApprovalTrialJoin
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end?
After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here we’ll discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved.
Standard of Care Costs vs Study-Related CostsTrialJoin
In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When we’re talking about budgeting for a study, there are many separate items and things to be considered.
One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where it’s required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study.
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
Most Common Clinical Research Site Worries and ComplaintsTrialJoin
All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
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.
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…
New Drug Application - How to Speed Up FDA ApprovalTrialJoin
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end?
After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here we’ll discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
Solutions for your pharmaco genetic testing & web site linkArney Benson
Now that knowing your DNA/PharmacoGenetics is key to a lifetime benefit, see the Best Practices Solution, while making some additional dollars in reimbursement revenues.
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?
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
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?
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.
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
Digital Pharma Manufacturing Roundtable Kronberg, Germany, March 17 2017
A story about manufacturing two products, medicinal product and documented data, and a “little secret”
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)
A platform for assurance & efficiency - Ajaz at USP PCM Mumbai 2017Ajaz Hussain
Why? Assurance is a critical to quality attribute
What? The Little Secret which erodes assurance patients need
How? Rapid development, design space and real-time control; mind shift
Practical and Succinct Solutions to Coding - Select Data, Inc. RachelBuckleySelect
Discussing increasing numbers of Complexities in Home Health that challenge reimbursement and the financial and quality outcomes bottom line;
Exploring Regulatory Issues and Agency Finances
Making Connections Between Coding, the POC, and Keeping Your Reimbursement;
Looking at Potential Impending Audits and Queries and their Impact;
and ICD-10…Will you be ready or will you be one of the agencies expected to have significant delays in payment?
Finding study leads, sharing them among sites and avoiding the enrollment of ...TrialJoin
Finding new study leads is always a good thing, especially for new clinical research sites. In many cases, there can be multiple research sites in one area. When this occurs, a couple of problems might arise. First, sometimes sites share the contact information of project managers to other sites, and second, some patients can get enrolled in more than one site for the same study.
In this article, we’ll tell you if sharing study leads is something that can be done without consequences, and we’ll also elaborate on the topic of avoiding duplicate patients. Even though it sounds complicated, there are simple solutions that can help you deal with these two types of situations.
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
Solutions for your pharmaco genetic testing & web site linkArney Benson
Now that knowing your DNA/PharmacoGenetics is key to a lifetime benefit, see the Best Practices Solution, while making some additional dollars in reimbursement revenues.
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?
Question Based Development to Quality by Design to Continued Process Verification
Does your QbD program delivery confidence in CQA’s?
Does it reduce the risk of development failure?
Does it provide a process which is stable and ‘in control’?
Does it reduce risk of GMP noncompliance?
Are we asking the right question and at the right time?
Insights on Culture of Quality What have I Learned 22 September 2015Ajaz Hussain
Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
What “norms” provide reasons to rationalize cGMP deviations?
How a company can re-build lost credibility? Better option improve credibility?
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?
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.
Regulatory Aspects of Continuous Pharmaceutical ManufacturingAjaz Hussain
Digital Pharma Manufacturing Roundtable Kronberg, Germany, March 17 2017
A story about manufacturing two products, medicinal product and documented data, and a “little secret”
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)
A platform for assurance & efficiency - Ajaz at USP PCM Mumbai 2017Ajaz Hussain
Why? Assurance is a critical to quality attribute
What? The Little Secret which erodes assurance patients need
How? Rapid development, design space and real-time control; mind shift
Practical and Succinct Solutions to Coding - Select Data, Inc. RachelBuckleySelect
Discussing increasing numbers of Complexities in Home Health that challenge reimbursement and the financial and quality outcomes bottom line;
Exploring Regulatory Issues and Agency Finances
Making Connections Between Coding, the POC, and Keeping Your Reimbursement;
Looking at Potential Impending Audits and Queries and their Impact;
and ICD-10…Will you be ready or will you be one of the agencies expected to have significant delays in payment?
Finding study leads, sharing them among sites and avoiding the enrollment of ...TrialJoin
Finding new study leads is always a good thing, especially for new clinical research sites. In many cases, there can be multiple research sites in one area. When this occurs, a couple of problems might arise. First, sometimes sites share the contact information of project managers to other sites, and second, some patients can get enrolled in more than one site for the same study.
In this article, we’ll tell you if sharing study leads is something that can be done without consequences, and we’ll also elaborate on the topic of avoiding duplicate patients. Even though it sounds complicated, there are simple solutions that can help you deal with these two types of situations.
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
Physician Online Ratings: Consumerization of HealthcareTrustRobin
Consumers are using patient feedback from rating and review sites like Healthgrades, Vitals, Facebook and hundreds of other sources to help select a physician, the same way they would use reviews on TripAdvisor to find the best travel destination.
Moving towards transparency is vital in today’s world of healthcare consumerism.
Organizations must meet their patients’ need for accurate health and physician information that they can trust.
Need and Urgency for Harmonization and One Quality VoiceAjaz Hussain
We are in the Experience Economy in which the demand for Assurance is increasing exponentially. Our quality systems are improving linearly, and we are falling behind in delivering the assurance needed by patients to realize therapeutic benefits of medicine we deliver. Industry's need to continually improve is urgent, but their ability to do so remains constrained despite the FDA initiatives. To realize FDA's vision of an agile pharmaceutical manufacturing systems ... Without the need extensive regulatory oversight, industry should be encouraged to "self-author" "performance standards" and regulators should harmonize on the global accessibility of the self-authored performance standards.
#AAPS2017 Need and Urgency for Harmonization and One Quality Voice. A. S. Hussain. Insight, Advice & Solutions LLC.
Generic non-biological complex drugs DIA CMC Workshop 2017Ajaz Hussain
#DIACMC17
Assigned title for the talk by the organizers: “The need of conducting clinical study for assuring safety and efficacy, as well as a lack of immunogenicity for generic NBCDs”
SUMMARY
Integrated analytical, product and process development to reduce uncertainty in ‘pharmaceutical equivalence’ is the foundation on which confidence in generic drugs rests
Need to leverage the context: RLD “Prescribe-ability” and lot-lot “Switchability” is acceptable
The “sameness” mindset (as opposed to an “equivalence” mindset) poses challenges to evidence ‘synthesis” (not “piece meal” check the box ) in ANDA submissions
Integrated evidence must a priori account for posed/anticipated “legal challenges” intrinsic to the US system
Clinical assessment of Therapeutic Equivalence of generic product intended (i.e., designed) to be equivalent to RLD should only be needed in rare circumstances
When there is a need to provide assurance to non-scientists stakeholders
Currently the FDA’s GADUFA Research and efforts by many in the sector are predominantly focused on developing a “test of bioequivalence”
For most complex products such a test, in and of itself, may be insufficient to ensure therapeutic equivalence over generic product life-cycle
Congenital Heart Disease Global Clinical Trials Review, H1, 2012ReportLinker.com
Congenital Heart Disease Global Clinical Trials Review, H1, 2012
Summary
GlobalData's clinical trial report, 'Congenital Heart Disease Global Clinical Trials Review, H1, 2012" provides data on the Congenital Heart Disease clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Congenital Heart Disease. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Congenital Heart Disease. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Hyperalgesia Global Clinical Trials Review, H1, 2013ReportLinker.com
Hyperalgesia Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Hyperalgesia Global Clinical Trials Review, H1, 2013" provides data on the Hyperalgesia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Hyperalgesia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Hyperalgesia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Slides presented by me at the Korean-American Professional Association in Life Sciences (KAPAL) 5th Annual Meeting in Rockville, MD. Slides discuss the recent reorganization of the Center for Drug Evaluation and Research at the FDA
Anal Fissure Global Clinical Trials Review, H1, 2013ReportLinker.com
Anal Fissure Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Anal Fissure Global Clinical Trials Review, H1, 2013" provides data on the Anal Fissure clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Anal Fissure. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Anal Fissure. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
Excipient Knowledge Management Mumbai 12 March 2015 Part 1 & 2Ajaz Hussain
Why attention to excipient knowledge management (specifically their functionality) is critical to mitigating risks (or to leverage opportunities) posed by the rapidly increasing complexity and uncertainty
Note: Knowledge management in the context of ‘intellectual property’ is not the focus of this talk
Similar to Trends in Warning and NOV Letters 2013 (20)
Excipient Knowledge Management Mumbai 12 March 2015 Part 1 & 2
Trends in Warning and NOV Letters 2013
1. Alan Bergstrom
Senior Director, Commercial Regulatory Affairs
CBI Promotional Compliance
October 7, 2013
Trends in Recent Warning and NOV
Letters Issued by OPDP
2. The content, views, and opinions in this presentation are my own
and do not in anyway represent the views or opinions of Daiichi
Sankyo, Inc.
8. 8
What is substantial evidence?
•Evidence consisting of adequate and well-
controlled investigations
•21 CFR 314.126 describes the characteristics of
adequate and well-controlled trials
•21 CFR 202.1(e)(6) and (e)(7) describes multiple
ways materials are or may be false and
misleading
9. 9
What are some red flags to OPDP?
•Open-label studies
•Post-hoc subgroup analyses
•Meta-analyses
•Comparative studies
From: Substantial Evidence and Other Standards, by Elaine Hu Cunningham, Senior Regulatory
Review Officer ,OPDP, at DIA Marketing Pharmaceuticals 2012.
10. 10
Examples of letters for 2013
•Retrospective
• Doxil website NOV dated May 22, 2013
•Meta-analysis
• Marplan website NOV dated May 6, 2013
•Retrospective (in support of a Comparative Claim)
• Clozapine article detailer NOV dated April 8, 2013
11. 11
Retrospective study
“The references cited to support claims on
the website concerning CA-125 consist of
retrospective evaluations of primary data
performed in a post-hoc manner,
retrospective single institution chart reviews,
a retrospective sub-group analysis, and
exploratory studies that cite sponsor’s data
on file. Retrospective studies and institutional
chart reviews do not constitute substantial
evidence or substantial clinical experience
to support the claims and presentations…”
Unsubstantiated claim
12. 12
Meta-analysis
“The reference cited to support these claims is a publication which describes a literature
review and meta-analyses examining the efficacy of several MAOIs, including
isocarboxazid (Marplan). The meta-analyses …may have produced a biased sample of
studies since failed or negative clinical trials are often not published in the medical
literature.”
Overstatement of Efficacy
13. 13
Retrospective study
“…claims of superiority must be supported
by two adequate and well-controlled head-
to-head clinical trials…”
“The study…presents the results of a
retrospective Positive and Negative
Syndrome Scale (PANSS)-derived five-factor
analysis of data…”
“…a single, retrospective, PANSS-derived
five-factor analysis…does not constitute substantial evidence or substantial clinical experience…”
Unsubstantiated Superiority
15. 15
Promotion of Investigational Agents
21 CFR 312.7 “A sponsor or investigator, or any
person acting on behalf of a sponsor or
investigator, shall not represent in a promotional
context that an investigational new drug is safe or
effective for the purposes for which it is under
investigation…”
16. 16
Promotion of Investigational Agents
CBA Research Inc.
“The above referenced claims make numerous positive and definitive
conclusions about CBT-1, such as its ability to reverse multi-drug resistance in
cancer cells and to improve patient outcomes, while reducing the toxic side
effects of chemotherapy and decreasing treatment failures.”
18. 18
Video News Release
ParaPRO LLC
Natroba (spinosad) topical suspension, 0.9%
•Omits ALL risk information including warnings
and precautions, and the most frequently reported
AEs
•Unsubstantiated superiority claims – “game
changing medication, one that doesn’t require nit
combing to be effective”.
•Fails to adequately communicate the full
indication
19. 19
Key Takeaways
•Omission/minimization of risk still leads the list of
violations
•Unsubstantiated claims/efficacy/superiority a
close second
•Increased focus on investigational agents and
Press Releases/VNRs (?)
•Important to read the letters issued by OPDP
