The Asea product was previously known as MDI-P, which was developed in the early 1990s by Medical Discoveries, Inc. to treat HIV/AIDS. Extensive pre-clinical research was conducted demonstrating MDI-P's effectiveness against HIV and other diseases without toxicity. The company pursued FDA approval but faced financial difficulties. The technology was later acquired by Global Clean Energy Holdings to pursue other applications.
The Industry funded IIT from the CRO perspective: Optimizing the interface between the industry and the Sponsor- Investigator.
Presented by Ran Frenkel, CEO, Pharma Focus Israel at the First European Investigator Initiated Trials Conference in Barcelona, Spain.
According to FDA Draft Guidance for Industry in Electronic Submission and Study Data Technical Conformance Guide, the pharmaceutical companies will need to provide CDISC Electronic submission to FDA. The paper will explain Data Standard Catalog which will dictate FDA Standards. The paper will discuss how to prepare CDISC electronic submission and what to prepare in CDISC electronic submission.
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
Me rck’s new product development & launch strategy for First Economy
Merck was developing a new strategy to market its diabetes drug Januvia. The strategy involved using fewer sales representatives and increasing digital and online advertising. Merck found its sales force was more productive using these new methods, such as video detailing in doctors' offices. Merck also emphasized better targeting of physicians and increasing disease education for patients through tools like diabetes maps. The product manager for Januvia faced a dilemma in deciding whether to position the drug earlier or later in the progression of diabetes. Januvia saw strong initial launch with 14% of new Type 2 diabetes prescriptions. Merck competed against other diabetes drugs and was considering expanding into alternative treatment areas like insulin delivery devices, which showed a growing global market.
The best Medical Affairs organizations are evolving from a support-only function to a strategic partner of the business. Explore a common set of Medical Affairs challenges with other leaders from Pharma, Biotech, and Medical Device companies.
Pharmacovigilance in USA and Europe_Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document provides an overview of medical device regulations in the European Union. It discusses the 27 EU member states and 3 additional EFTA states. It describes the EU directives for medical devices and how they differ from US regulations. The document outlines the classification system for medical devices in the EU and the conformity assessment procedures required for each class. It also discusses technical documentation requirements, CE marking, post-market surveillance, and the role of the Authorized European Representative.
Highlights From 7th Medical Science Liaison/MSL ConferenceExL Pharma
Current trends, issues and challenges facing MSL's in the pharmaceutical industry. Presented at the 7th MSL Best Practices conference, April, 2010. For further information, please visit www.exlpharma.com
The Industry funded IIT from the CRO perspective: Optimizing the interface between the industry and the Sponsor- Investigator.
Presented by Ran Frenkel, CEO, Pharma Focus Israel at the First European Investigator Initiated Trials Conference in Barcelona, Spain.
According to FDA Draft Guidance for Industry in Electronic Submission and Study Data Technical Conformance Guide, the pharmaceutical companies will need to provide CDISC Electronic submission to FDA. The paper will explain Data Standard Catalog which will dictate FDA Standards. The paper will discuss how to prepare CDISC electronic submission and what to prepare in CDISC electronic submission.
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
Me rck’s new product development & launch strategy for First Economy
Merck was developing a new strategy to market its diabetes drug Januvia. The strategy involved using fewer sales representatives and increasing digital and online advertising. Merck found its sales force was more productive using these new methods, such as video detailing in doctors' offices. Merck also emphasized better targeting of physicians and increasing disease education for patients through tools like diabetes maps. The product manager for Januvia faced a dilemma in deciding whether to position the drug earlier or later in the progression of diabetes. Januvia saw strong initial launch with 14% of new Type 2 diabetes prescriptions. Merck competed against other diabetes drugs and was considering expanding into alternative treatment areas like insulin delivery devices, which showed a growing global market.
The best Medical Affairs organizations are evolving from a support-only function to a strategic partner of the business. Explore a common set of Medical Affairs challenges with other leaders from Pharma, Biotech, and Medical Device companies.
Pharmacovigilance in USA and Europe_Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document provides an overview of medical device regulations in the European Union. It discusses the 27 EU member states and 3 additional EFTA states. It describes the EU directives for medical devices and how they differ from US regulations. The document outlines the classification system for medical devices in the EU and the conformity assessment procedures required for each class. It also discusses technical documentation requirements, CE marking, post-market surveillance, and the role of the Authorized European Representative.
Highlights From 7th Medical Science Liaison/MSL ConferenceExL Pharma
Current trends, issues and challenges facing MSL's in the pharmaceutical industry. Presented at the 7th MSL Best Practices conference, April, 2010. For further information, please visit www.exlpharma.com
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
The document summarizes the Study Data Tabulation Model (SDTM), which defines a standard structure for submitting human clinical trial data to regulatory authorities. SDTM organizes data into domains based on three general classes: Interventions, Events, and Findings. Each observation within a domain contains identifier, topic, timing, and qualifier variables to describe essential details. Qualifier variables are further categorized, and the Submission Metadata Model specifies seven attributes for each variable to ensure consistent interpretation.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Clean file can be declared when all required data management activities have been completed as per the data management plan. This includes final reconciliation of external vendor data, completion of coding and discrepancy management activities, and signing off of all CRFs by the principal investigator. The data management team's role in clean file includes performing manual reviews, ensuring reconciliation of safety databases, and communicating any issues to monitors during the clean file declaration process.
The document provides an overview of Novartis including:
- Its mission is to discover, develop, and market innovative products to prevent and cure diseases while providing returns for shareholders.
- Key facts about its history, people, top brands, product mix, presence in different countries, and financial data including $56.6 billion in total sales in 2012.
- It invests heavily in R&D with locations around the world focusing on areas like rare/neglected diseases and responsible research practices.
CDISC's CDASH and SDTM: Why You Need Both!Kit Howard
CDISC's clinical data standards are widely used for clinical research, but many people wonder why there seem to be two standards for collected data: the Clinical Data Acquisition Standards Harmonization (CDASH) standard and the Study Data Tabulation Model (SDTM) standard. This poster steps through four significant reasons that reflect the differences in philosophy, intermediate goals and broad-scale uses. Examples illustrate each reason and how they affect your studies.
The document discusses key considerations for developing medical devices with a global market strategy in mind. It outlines common mistakes made during development like poor reimbursement planning, lack of human factors research, and unclear regulatory pathways. It emphasizes the importance of bringing together all development disciplines like regulatory, compliance, testing, and reimbursement in a unified strategy from the beginning. Finally, it discusses best practices like working closely with regulatory agencies early, having a platform for evolution, and maintaining strong communication across functions and stakeholders.
Medical affairs department for small organizationDr. Zubair Ali
The document summarizes the drug development process and the role of medical affairs departments within pharmaceutical companies. It discusses the various phases of clinical drug trials from phase I to phase IV. It then outlines the structure and responsibilities of medical affairs, including clinical research, pharmacovigilance, medical information services, statistics management, and providing medical support to marketing and sales teams. A key part of medical affairs is the medical science liaison program which aims to educate medical professionals and support clinical trial recruitment through relationship building.
Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately.
ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.
See more: http://bit.ly/medaffairs
The document discusses how artificial intelligence can be applied in clinical trials to improve efficiency and outcomes. It provides examples of how AI is currently used across different stages of drug development, from data aggregation and analysis to patient recruitment and monitoring. The use of AI and machine learning applied to real-world data is highlighted as a way to better understand diseases, select appropriate patients and sites, and design more effective clinical trial processes and studies. Case studies are presented showing how several companies are already using AI to match patients to suitable trials, analyze cancer patient data to identify eligibility, and create more personalized treatments.
This document provides an overview of the U.S. Food and Drug Administration's Food Safety Modernization Act and its future impact on food importers and manufacturers in Asia. It discusses key components of the act related to prevention, inspections and compliance, import safety, and enhanced partnerships. The act aims to shift the U.S. food safety focus from response to prevention. It establishes standards for food production and imports and increases inspections of domestic and foreign facilities. Foreign manufacturers will face greater oversight and responsibility to meet new food safety requirements.
Canada medical device approval chart - EMERGOEMERGO
1. To market medical devices in Canada, manufacturers must classify their device according to regulations, implement an ISO 13485 quality management system with additional Canadian requirements, and obtain ISO 13485 certification from an accredited registrar.
2. Manufacturers then prepare license applications, supporting documents, and pay fees, with process times ranging from 1-8 months depending on device class.
3. Licenses must be renewed annually by meeting regulatory requirements and paying fees to avoid revocation.
This document summarizes key efficacy endpoints used in oncology clinical trials, including for solid tumors and non-solid tumors like acute myeloid leukemia. For solid tumors, the best overall response (BOR) is assessed using RECIST criteria to evaluate tumor shrinkage or progression based on target and non-target lesion measurements. Key time-to-event endpoints discussed include overall survival (OS), progression-free survival (PFS), and time to progression (TTP). For acute myeloid leukemia, response is assessed based on blood counts and bone marrow blast percentage according to International Working Group criteria, with endpoints like complete remission rate and event-free survival. Surrogate endpoints are also discussed.
management of clinical trials: sponser perspective from falgun vyasFalgun Vyas
The document discusses standard operating procedures (SOPs) that are written instructions to standardize clinical trial functions, the importance of protocols that define trial objectives and methodology, selecting qualified clinical investigators and training them on GCP guidelines and the trial protocol, and monitoring investigator sites through periodic monitoring and audits to ensure compliance.
The document discusses the role and responsibilities of Medical Affairs departments within pharmaceutical companies. It describes how Medical Affairs operates medical information functions, provides insights from research to brand teams, cultivates relationships with key opinion leaders, and oversees publication planning and medical writing. Medical Affairs contributes to promotional review and provides market intelligence. The functions of Medical Affairs are organized globally and sometimes by business unit or therapeutic area at the local level. Key areas of specialization within Medical Affairs include medical services, medical research, and medical liaisons.
The Argus J system provides several key benefits for safety case management in Japan, including supporting a single global database, Japanese and English languages, and compliance with Japanese regulatory requirements. It allows translation between English and Japanese case data through features like a split translation window and auto-encoding matching data. The system also supports Japanese-specific needs through fields, code lists, and the ability to generate regulatory reports required by the Japanese Pharmaceuticals and Medical Devices Agency.
The document discusses key aspects of clinical trial strategy and design. It covers the different phases of clinical trials (Phase I, II, III) and provides guidance on optimizing trials at each phase. Phase I focuses on safety and dosing, Phase II evaluates efficacy and further safety, and Phase III confirms efficacy in a larger patient population. The document emphasizes establishing a detailed clinical development plan with timelines and costs to help guide development decisions and reduce risks.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Dyadic International is a global biotechnology company focused on improving and applying its proprietary C1 gene expression platform, a patented genetically modified strain of the fungus Myceliophthora thermophila, to address opportunities in human and animal health markets. The C1 platform can help bring biologic drugs to market faster, in greater volumes, and at lower cost than existing platforms like CHO cells. Dyadic pursues R&D collaborations and licensing arrangements to develop and manufacture biopharmaceuticals using the C1 platform.
MedDRA - the Medical Dictionary for Regulatory Activities - is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding these data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products.
The document summarizes the Study Data Tabulation Model (SDTM), which defines a standard structure for submitting human clinical trial data to regulatory authorities. SDTM organizes data into domains based on three general classes: Interventions, Events, and Findings. Each observation within a domain contains identifier, topic, timing, and qualifier variables to describe essential details. Qualifier variables are further categorized, and the Submission Metadata Model specifies seven attributes for each variable to ensure consistent interpretation.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Clean file can be declared when all required data management activities have been completed as per the data management plan. This includes final reconciliation of external vendor data, completion of coding and discrepancy management activities, and signing off of all CRFs by the principal investigator. The data management team's role in clean file includes performing manual reviews, ensuring reconciliation of safety databases, and communicating any issues to monitors during the clean file declaration process.
The document provides an overview of Novartis including:
- Its mission is to discover, develop, and market innovative products to prevent and cure diseases while providing returns for shareholders.
- Key facts about its history, people, top brands, product mix, presence in different countries, and financial data including $56.6 billion in total sales in 2012.
- It invests heavily in R&D with locations around the world focusing on areas like rare/neglected diseases and responsible research practices.
CDISC's CDASH and SDTM: Why You Need Both!Kit Howard
CDISC's clinical data standards are widely used for clinical research, but many people wonder why there seem to be two standards for collected data: the Clinical Data Acquisition Standards Harmonization (CDASH) standard and the Study Data Tabulation Model (SDTM) standard. This poster steps through four significant reasons that reflect the differences in philosophy, intermediate goals and broad-scale uses. Examples illustrate each reason and how they affect your studies.
The document discusses key considerations for developing medical devices with a global market strategy in mind. It outlines common mistakes made during development like poor reimbursement planning, lack of human factors research, and unclear regulatory pathways. It emphasizes the importance of bringing together all development disciplines like regulatory, compliance, testing, and reimbursement in a unified strategy from the beginning. Finally, it discusses best practices like working closely with regulatory agencies early, having a platform for evolution, and maintaining strong communication across functions and stakeholders.
Medical affairs department for small organizationDr. Zubair Ali
The document summarizes the drug development process and the role of medical affairs departments within pharmaceutical companies. It discusses the various phases of clinical drug trials from phase I to phase IV. It then outlines the structure and responsibilities of medical affairs, including clinical research, pharmacovigilance, medical information services, statistics management, and providing medical support to marketing and sales teams. A key part of medical affairs is the medical science liaison program which aims to educate medical professionals and support clinical trial recruitment through relationship building.
Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately.
ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.
See more: http://bit.ly/medaffairs
The document discusses how artificial intelligence can be applied in clinical trials to improve efficiency and outcomes. It provides examples of how AI is currently used across different stages of drug development, from data aggregation and analysis to patient recruitment and monitoring. The use of AI and machine learning applied to real-world data is highlighted as a way to better understand diseases, select appropriate patients and sites, and design more effective clinical trial processes and studies. Case studies are presented showing how several companies are already using AI to match patients to suitable trials, analyze cancer patient data to identify eligibility, and create more personalized treatments.
This document provides an overview of the U.S. Food and Drug Administration's Food Safety Modernization Act and its future impact on food importers and manufacturers in Asia. It discusses key components of the act related to prevention, inspections and compliance, import safety, and enhanced partnerships. The act aims to shift the U.S. food safety focus from response to prevention. It establishes standards for food production and imports and increases inspections of domestic and foreign facilities. Foreign manufacturers will face greater oversight and responsibility to meet new food safety requirements.
Canada medical device approval chart - EMERGOEMERGO
1. To market medical devices in Canada, manufacturers must classify their device according to regulations, implement an ISO 13485 quality management system with additional Canadian requirements, and obtain ISO 13485 certification from an accredited registrar.
2. Manufacturers then prepare license applications, supporting documents, and pay fees, with process times ranging from 1-8 months depending on device class.
3. Licenses must be renewed annually by meeting regulatory requirements and paying fees to avoid revocation.
This document summarizes key efficacy endpoints used in oncology clinical trials, including for solid tumors and non-solid tumors like acute myeloid leukemia. For solid tumors, the best overall response (BOR) is assessed using RECIST criteria to evaluate tumor shrinkage or progression based on target and non-target lesion measurements. Key time-to-event endpoints discussed include overall survival (OS), progression-free survival (PFS), and time to progression (TTP). For acute myeloid leukemia, response is assessed based on blood counts and bone marrow blast percentage according to International Working Group criteria, with endpoints like complete remission rate and event-free survival. Surrogate endpoints are also discussed.
management of clinical trials: sponser perspective from falgun vyasFalgun Vyas
The document discusses standard operating procedures (SOPs) that are written instructions to standardize clinical trial functions, the importance of protocols that define trial objectives and methodology, selecting qualified clinical investigators and training them on GCP guidelines and the trial protocol, and monitoring investigator sites through periodic monitoring and audits to ensure compliance.
The document discusses the role and responsibilities of Medical Affairs departments within pharmaceutical companies. It describes how Medical Affairs operates medical information functions, provides insights from research to brand teams, cultivates relationships with key opinion leaders, and oversees publication planning and medical writing. Medical Affairs contributes to promotional review and provides market intelligence. The functions of Medical Affairs are organized globally and sometimes by business unit or therapeutic area at the local level. Key areas of specialization within Medical Affairs include medical services, medical research, and medical liaisons.
The Argus J system provides several key benefits for safety case management in Japan, including supporting a single global database, Japanese and English languages, and compliance with Japanese regulatory requirements. It allows translation between English and Japanese case data through features like a split translation window and auto-encoding matching data. The system also supports Japanese-specific needs through fields, code lists, and the ability to generate regulatory reports required by the Japanese Pharmaceuticals and Medical Devices Agency.
The document discusses key aspects of clinical trial strategy and design. It covers the different phases of clinical trials (Phase I, II, III) and provides guidance on optimizing trials at each phase. Phase I focuses on safety and dosing, Phase II evaluates efficacy and further safety, and Phase III confirms efficacy in a larger patient population. The document emphasizes establishing a detailed clinical development plan with timelines and costs to help guide development decisions and reduce risks.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Dyadic International is a global biotechnology company focused on improving and applying its proprietary C1 gene expression platform, a patented genetically modified strain of the fungus Myceliophthora thermophila, to address opportunities in human and animal health markets. The C1 platform can help bring biologic drugs to market faster, in greater volumes, and at lower cost than existing platforms like CHO cells. Dyadic pursues R&D collaborations and licensing arrangements to develop and manufacture biopharmaceuticals using the C1 platform.
The document discusses a proposed non-profit approach to developing ibogaine into an FDA-approved medication for treating drug abuse. Key points include: (1) It would cost an estimated $5 million over 5 years to fund the necessary clinical research; (2) A non-profit is the best strategy given ibogaine's status as a Schedule I drug; (3) The FDA can be trusted to evaluate research based on science rather than politics and has approved studies of other Schedule I drugs.
The document discusses the Investigational New Drug (IND) application process. An IND application is required for a pharmaceutical company to conduct clinical trials of an unapproved drug and ship the drug across state lines. The IND application contains information on preclinical animal and toxicology studies, clinical trial protocols, manufacturing details, and the qualifications of investigators. It must be approved by the FDA before clinical trials can begin.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
Megazyme Inc. is requesting information from Getafix Laboratories to conduct due diligence on Rivatmine, a drug for Alzheimer's patients. They request documents on intellectual property, regulatory status, pre-clinical testing, pharmacology studies, toxicity studies, clinical trials data, manufacturing information, and regulatory filings to evaluate the drug's development and commercial potential. This includes information on patents, marketing authorizations, DMF filings, GLP compliance, pharmacology, genotoxicity tests, PK/PD studies, efficacy tests, chronic toxicity plans, safety pharmacology, carcinogenicity plans, reproductive toxicity, clinical trial protocols, IND application records, and investigator brochures.
The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September ...Merry D'souza
The 10 most innovative pharma and biotech solution providers, 2020 september 2020; Insights Success has published The 10 most innovative pharma and biotech solution providers.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
Investigational New Drug Application enabling studies.pptxNikitaBankoti2
The document provides information on Investigational New Drug (IND) applications. It defines an IND as a submission to the FDA requesting permission to study an investigational drug product in humans. Key points include:
- An IND application contains preclinical and clinical data to demonstrate it is reasonably safe to study the drug in humans.
- It allows the sponsor to initiate and conduct clinical trials of the investigational drug.
- The IND application process helps ensure the safety of clinical trial subjects and that clinical studies will yield valid results to determine a drug's safety and effectiveness.
Dr. Jules Mitchel, President of Target Health Inc., presents "How Creative Can One Be When Working with the FDA to Optimize the Drug and Device Development Process?" at the October 29 iCAN-Global Entrepreneur's Breakfast Forum.
Clinical research involves organized studies on human subjects to evaluate the safety and efficacy of new drugs, medical devices, and other therapies. It is a critical part of the drug development process, accounting for two-thirds of the total time and costs. India has become an attractive location for clinical research due to its low-cost yet skilled workforce, large patient populations, and established expertise in pharmaceuticals and business processes. The clinical research sector in India is growing rapidly, driven by global outsourcing trends and capabilities within the Indian pharmaceutical industry.
The Application Integrity Policy (AIP): A Little History.Michael Swit
This document summarizes the FDA's Application Integrity Policy (AIP), which was established in 1991 in response to fraud in generic drug applications. The AIP allows the FDA to defer review of any application where they have questions about the reliability of the data, until those questions are resolved. Companies that fall under the AIP must cooperate with investigators, identify wrongdoers, conduct an internal review, and submit a corrective action plan signed by the CEO to address procedures and controls to prevent future issues. Few companies have survived being placed on the AIP, as it often coincides with criminal prosecution and civil litigation that can damage a company.
This Slide explains US-FDA requirements for IND. It will answer; What is an IND ?What are the IND Phases ?What is the IND Content?When FDA Terminates an IND ?Are cGMP Required for IND ?What Studies are exempt from IND?
Disseminate Clinical Data Early to Support Payer Coverage DecisionsTodd Berner MD
This document summarizes Todd Berner's presentation on early dissemination of clinical data to support payer coverage decisions. The presentation discusses comparative effectiveness research standards and how cost, comparators, and ambiguous results should be handled. It also addresses tailoring drug development to patient heterogeneity and biomarkers. Developing an open dialogue with payers throughout drug development is emphasized to demonstrate clinical and economic value. Field teams can establish relationships, disseminate outcomes data, and conduct research to support products. The goal is for clinical programs to demonstrate value through meaningful endpoints and real-world evidence.
The document discusses risk assessment and management for new product planning in the pharmaceutical industry. It notes that [1] managing risk for new products is important given high development costs and failure rates, [2] forecasts often overestimate commercial potential which can lead to problems, and [3] using a target product profile and decision analysis can help capture development options and quantify risk.
NanoViricides is developing nanomedicine-based drugs to treat various viral diseases like influenza, HIV, hepatitis C, and Ebola. The company has 9 drug candidates in development that have shown safety and efficacy in animal studies. NanoViricides' first drug to enter human trials will be FluCide for influenza, which completely protected animals against lethal viral exposure without toxicity.
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
This document discusses developing a new antiviral drug to treat COVID-19. It notes that current treatments are not fully effective and an oral drug is needed that can cure early infections. The company, AntiRNA, plans to develop drugs that interfere with viral RNA methylation, an approach they have previously used successfully against other viruses. Their proposed approach involves first synthesizing and testing prototype drugs in vitro and in vivo in Phase 1, then synthesizing derivatives and testing them in Phase 2. If successful, the potential market could be in billions annually given the lack of existing treatments. The company founders have extensive experience in antiviral drug development.
Chelation Partners is solving sepsis with DIBI, and iron binding polymer that augments a natural defense to infections. It slows infections and the over-reaction of the immune system known as cytokine storm, which kills patients. It is immune to antibiotic resistance and effective against a very broad spectrum of disease causing microorganisms.
Study demonstrates the health value of magnetsIgor Laskin
A study conducted by researchers at the University of Virginia found that magnets can reduce swelling when applied to injured tissue. In experiments with rats, magnets significantly reduced swelling in hind paws that had been treated with inflammatory agents to simulate injury. This suggests that magnets could be used to treat common injuries like sprains and bruises, helping reduce pain and speed recovery time. The researchers plan further clinical trials and tests with athletes to optimize the strength of magnetic fields for different injuries. If successful, magnetic therapy could provide a low-cost alternative to ice packs for reducing swelling from everyday injuries.
We offer the concept of the wellness home as a way to give the body what it needs to stay healthy and maintain wellness by incorporating technologies into the home which provide our body with:
1. clean air-
2. pure water-
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1. June 12, 2012
Findings of research into the history of ASEA
Note: None of the statements in this document have been reviewed or endorsed by
ASEA Corporate, and are solely based on findings in publicly available information:
Press releases, SEC filings, and Industry analyst publications.
SUMMARY
The Asea product was previously known as MDI-P, which was developed and initially
patented in the early 1990s by a development-stage Bio-Tech Company, Medical
Discoveries, Inc., a publicly traded company, which was closely watched and thought of as
promising by industry analysts.
MDI-P was initially discovered and used as an anti-bacterial for dental instruments outside
the human body. Because of its effectiveness in treating certain viruses, bacteria and fungi
without levels of toxicity, it was initially targeted at treating HIV in humans. The vision of the
company was to provide the world a cure for AIDS.
The company was granted multiple patents for not only the product MDI-P, but the
manufacturing process of creating the electrolyzed solution, which also had to be proven to
satisfy and comply with all associated FDA regulations.
The company proceeded for several years with the FDA process for an IND (Investigational
New Drug) application, and proceeded accordingly. The process is well-known, documented,
and required extensive pre-clinical testing for efficacy and toxicity, with several million dollars
being spent on the clinical research.
Pre-clinical results are well-documented, providing evidence that MDI-P was effective in lab
tests, and animal tests for an even wider array of health-related issues, blood disorders and
diseases - HIV, Cystic Fibrosis, Heart Disease, Asthma, and other blood-related disorders,
to name a few.
SEC filings assert the company’s belief that MDI-P had much broader applicability.
(See below for some examples of publicly available information.)
Results of the company’s efforts to satisfy FDA requirements to provide LD50 data, which is
required for all New Drug applications, demonstrated that MDI-P could not be proven to be
harmful in testing to the point of a “Lethal Dose”. Some believe that this is the point at which
the company realized that MDI-P would not be classified as a drug at all, and ceased the path
for a New Drug application.
Note: The path for FDA approval requires a lot of time and funding. The financial impact of
the process appears to have affected the ability of the company to satisfy FDA requirements
as well as the financial viability of the company. The financial decline of the company is also
well documented in SEC filings.
The company was sold to Global Clean Energy Holdings, Inc.
2. Asea executives tell the rest of the story.
Verdis Norton was on the Board of Medical Discoveries, Inc , and learned enough about
MDI-P to invest in the assets, to first pursue the “pharmaceutical path” and subsequently
make the investment to found the Asea company.
Dana-Farber Cancer Institute To Investigate Mechanism Of AIDS Treatment
January 5, 1999
Medical Discoveries, Inc. and the Dana-Farber Cancer Institute (DFCI), a teaching affiliate of
Harvard Medical School (HMS) and an NIH-approved AIDS Research Laboratory, have
signed a "Research Support Agreement" to confirm and extend the anti-HIV activity of the
novel drug therapy, MDI-P.
Preliminary studies of Medical Discoveries' MDI-P treatment have demonstrated a decrease
in the production of HIV-1. The Research Plan will further investigate the mechanism by
which MDI-P inactivates the virus, and will define its cellular and viral specificity. Importantly,
the DFCI will be testing the activity of MDI-P against resistant strains of HIV and against fresh
samples of HIV taken from the patient.
All research under this agreement will be conducted under the direction of Dr. Robert
Finberg, the principal investigator of the study, a professor of Medicine at HMS and chief of
Infectious Disease at the DFCI.
Dr. William J. Novick, vice president and chief technical officer of Medical Discoveries says
the MDI-P research is important because the treatment works on mechanisms which are
different from those targeted by currently approved anti-retroviral agents. "We can
categorically say that this drug is not an enzyme inhibitor," Novick says. "I feel very strongly
that the potential of this drug against the resistant strains of HIV is every bit as good as
against the normal wild strains."
For more information: Dr. William J. Novick, vice president and chief technical
officer, Medical Discoveries, Inc., telephone: (801)-771-0523
3. PHARMACEUTICAL DRUG DISCOVERY AND DEVELOPMENT ACTIVITIES
MDI has completed a series of validation testing at the Dana-Faber Cancer Institute, a
Harvard Medical School teaching Affiliate and National Institute of Health (NIH) approved
HIV/AIDS Testing Laboratory.
These tests confirmed and extended previous research and testing which demonstrated that
MDI-P is shown to be capable of killing HIV in cell cultures without mortality to the cells.
A six-month Research Grant with the Dana-Farber Cancer Institute to further extend and
confirm the anti -HIV/AIDS activity of MDI-P is in progress. In this Research, MDI-P is being
analyzed for effectiveness in killing laboratory strains of HIV-1; clinical specimens of HIV; and
resistant strains of HIV-1. These test results continue to support the effectiveness or MDI-P in
killing the HIV Virus.
During its current research testing, the Company has become aware of the need to address
certain technical issues regarding the electrolysis equipment used to produce MDI-P during
initial manufacture.
MDI has temporarily suspended validation testing at the Dana-Farber Cancer Institute of its
novel drug "MDI-P" targeted at the HIV/AIDS disease due to certain technical issues.
Although the testing performed during the last quarter, which demonstrated MDI-P to be
capable of killing HIV in cell cultures without mortality to the cells, remains valid, the
Company has decided to temporarily suspend further investigation until such time as these
technical issues are resolved. Work is already in progress to develop a permanent solution to
these minor technical issues.
Toxicology studies initiated in October of 1998 were completed during the first quarter. A final
report will be available upon completion by the Company of final payments to the testing
Laboratory. MDI has also initiated microbiology studies during the first quarter; however,
these studies have been suspended pending availability of appropriate levels of funding.
Progress of the Company's plan for submission to the FDA of an IND Application has been
delayed, and continuation depends on the ability of the Company to successfully address
certain technical issues, and the ability of the Company to obtain sufficient funding enabling
the completion of the toxicity, microbiology, and chemical characterization studies in various
stages of progress. See "Additional Funding is Required" section below. While results to date
continue to show promise, the Company can provide no assurance the technology will
eventually be proven.
4. Excerpt from Edgar On-Line for Medical Discoveries Inc.
Item 1. Description of Business
OVERVIEW
We are a development-stage bio-pharmaceutical company engaged in the research,
validation, development and ultimate commercialization of a patented anti-infective
technology. Our electrolyzed solution of free radicals represents a novel approach to treating
our initial target indication, HIV. We plan in the near future to conclude our pre-clinical work
and enter the clinic in our initial target indication. If our HIV clinical trials are successful, we
plan to develop this therapy for additional target indications.
Our product, called MDI-P, appears to have the ability to destroy certain viruses, bacteria
and fungi without any associated toxicity both in animals and in cell-based assays. We are
committed to the development of MDI-P as an anti-infective therapeutic product for in-vitro
and in-vivo applications. Our highest priority is to develop and commercialize MDI-P as a
pharmaceutical for the treatment of HIV. We are in the process of completing pre-clinical
development and plan to file an Investigative New Drug application (IND) with the Food and
Drug Administration (FDA) for MDI-P as an HIV treatment. If the FDA approves the IND, we
will begin a Phase I clinical test at the Harvard School of Medicine using a protocol designed
by Dr. Bruce Dezube. We expect to add additional indications for the use of MDI-P in the
future as we complete our pre-clinical development.
To date, we have not generated significant revenues from operations or realized a profit.
Through December 31, 2003, we had incurred a cumulative net loss since inception of
$14,141,763. We are currently attempting to secure capital commitments to finance the
completion of our pre-clinical analysis, file our IND for MDI-P as an HIV therapeutic,
determine additional potential indications for MDI-P, and to otherwise continue research and
testing of our technologies in order to secure required approvals to bring products to market.
In that we are a development stage company, we will increasingly require additional funding
to continue the development of our technology and to finance submittal of our testing and
trials to the appropriate regulatory agencies in order to secure approvals for product
development and sales.
RECENT DEVELOPMENTS
Sepsis Study Reaffirms Anti-Infective Strength and Low Toxicity of MDI-P.
In March, 2004, we received a study on sepsis that reaffirms the anti-infective strength and
low toxicity profile in pre-clinical mouse models of MDI-P. In the MDI-sponsored study, the
goal was to test the efficacy of MDI-P in inhibiting inflammatory responses in mice, induced
by bacteria that cause sepsis, a severe illness caused by infection of the bloodstream by
toxin-producing bacteria. The study used 25%, 50% and 100% MDI-P solutions to inhibit
inflammatory processes that generally lead to septic shock. MDI-P was evaluated against
both a saline control group of mice and a positive control group that had been given
Gentamicin, an established antibiotic treatment for sepsis. The study confirmed that 100%
dose strength of MDI-P offered substantial benefit to the mice when compared to both the
placebo and to Gentamicin, but without the apparent toxicity profile that Gentamicin exhibits.
While HIV is our initial target indication, this report is significant.
5. In the US, sepsis is the leading cause of death in non-coronary ICU patients, and recent 1998
data from the Centers for Disease Control show that it is the 11th leading cause of death
overall. Despite enormous investments in intensive care, sepsis has been associated with
mortality rates ranging from 28% to 50%. It is estimated that more than 700,000 cases of
severe sepsis occur in the US each year, resulting in more than 200,000 deaths.
Extrapolated to a global population, this represents several million cases of severe sepsis
annually worldwide with a mortality of up to 1 million cases. This research is one of several
studies on pre-clinical models of infectious diseases that mimic human disease, being
conducted by Dr. Emil Chi, Director of the University of Washington Medical School’s
Department of Histopathology. This and Dr. Chi’s other studies will help support our IND for
HIV.
Asthma (Press Release by Medical Discoveries, Inc)
2004 MAY 20 - (NewsRx.com & NewsRx.net) -- Medical Discoveries, Inc., (MLSC)
(MDI) announced the receipt of its second in a series of preclinical reports from
Dr. Emil Chi, chairman of the department of histopathology at the University
of Washington Medical School.
This trial, one of several studies on models of disease which mimic human
disease, focused on MDI-P as a potential therapeutic agent for the treatment of
the symptoms of asthma.
In the late 1990s, Chi developed a now-standard mouse model to assess asthma
therapeutic agents for efficacy and toxicity. This model is believed to have at
least an 80% predictive value of results in humans.
In the study, 36 female mice were examined in a chronic asthma model, using
various doses of MDI-P as a therapeutic agent as measured against saline
control. Samples of bronchial lavage lung fluid and tissue were taken from all
mice, with assays performed in airway mucus build-up and eosinophil infiltration,
a prime blood cell measure of asthmatic attacks.
More than 70% of the MDI-P-treated mice exhibited no increase in mucus
secretions, comparable with saline control animals, with a marked reduction in
eosinophil infiltration. Untreated asthmatic mice, in contrast, had more than a 9-
fold increase in mucus build-up as compared with saline controls. Further, no
toxicity was found in the MDI-P treated mice.
MDI President and CEO Judy Robinett commented: "To the best of our knowledge
of other published studies in clearing mucus plugs in the same mouse model,
there is no product on the market or soon to be released from pharmaceutical
pipelines which accomplishes a similar clearing of mucus plugs in the majority of
treated chronic asthmatic mice. From this test, we speculate that MDI-P may
prove to be a very beneficial agent exhibiting minimal toxicity for
addressing asthma attacks."
Robinett continued: "This study and the other preclinical studies of MDI-P are
required for filing our investigational new drug (IND) application later this year
7. guidelines and demonstrated that MDI-P was free of systemic toxicity
in two animal species, using repeated drug administration at dose
levels which were several magnitudes above the expected dose in
humans. The only adverse effect noted was a local irritation at the
injection site. This will be carefully monitored in any future
human trials. The conclusion of these studies marks a major step
forward in the development of MDI-P for human use."
Formed in 1992, Medical Discoveries, Inc. is a publicly traded
(OTC Bulletin Board: MLSC) biopharmaceutical research company (as
defined in SFAS No. 7) engaged in the research, development and
validation of a new class of drugs, based upon the company's
patented and proprietary electrolysis technologies.
MDI is developing active anti-viral (HIV/AIDS), anti-bacterial and
anti-fungal agents for a variety of applications.
Excerpt
Regarding
UCLA
Studies
UCLA
Test
Results
Support
MDI-‐P
As
An
Effective
Anti-‐Bacterial
Agent
Tapping
first
into
the
sterilization
and
veterinary
treatment
industries,
Medical
Discoveries
intends
to
generate
cash
flow
in
the
near
term
to
fund
the
commercialization
of
MDI-‐P
as
a
broad-‐spectrum
anti-‐bacterial
agent.
“There
is
an
urgent
need
to
find
new
anti-‐
bacterial
agents
that
are
effective
against
multiple
drug-‐resistant
bacteria
and
against
new,
emerging
infections,”
states
P.B.
Fernandes,
Vice
President
of
biomolecular
screening
and
drug
discovery
at
Bristol-‐Myers
Squibb
Pharmaceutical
Research
Institute.
According
to
Fernandes,
the
antibacterial
market
is
significant
with
yearly
global
sales
estimated
at
over
$20
billion.
A
series
of
preliminary
studies
were
completed
in
April
evaluating
MDI-‐P
as
a
potential
broad-‐
spectrum
anti-‐bacterial
agent.
Conducted
at
the
UCLA
(University
of
California,
Los
Angeles)
Clinical
Microbiology
Laboratory,
the
studies
successfully
demonstrated
the
ability
of
MDI-‐P
to
eliminate
in
vitro
(outside
the
human
body)
several
types
of
antibiotic
resistant
bacteria,
including
Staphylococcus
aureus,
E.
coli,
and
Enterocooccus
faecalis,
the
three
most
common
causes
of
hospital-‐
acquired
bacterial
infections.
The
next
step
for
MDI
is
to
complete
in
vivo
testing
per
FDA-‐recommended
criteria,
enabling
the
company
to
market
its
product
within
the
United
States.
“The
results
of
the
UCLA
studies
have
helped
to
materially
enhance
the
potential
of
MDI-‐P
as
a
revolutionary
antibacterial
agent
for
many
emerging
bacterial
juggernauts,”
says
Zidell.
“We
look
forward
to
completing
the
testing
phase
for
MDI-‐P
as
a
bactericide
and
intend
to
translate
the
significance
of
these
results
into
bottom-‐line
success
over
the
long
term.”
He
also
indicates
that
the
results
of
the
studies
also
form
a
basis
for
understanding
the
mechanistic
action
of
MDI-‐P
and
will
be
included
in
the
company’s
IND
(Investigational
New
Drug)
submission
to
the
Food
and
Drug
Administration
for
MDI-‐P’s
application
as
an
HIV/AIDS
therapy.