Liprostin Group is an early stage pharmaceutical company with technology to treat Vascular and Pulmonary Diseases. We are preparing for an emergency FDA meeting so that we can conduct a Proof of Concept to treat COVID-19 lung problem patients and rapidly move to Trials III for an FDA approved treatment.
The study analyzed that the systemic lupus erythematosus pipeline comprises of 57 drug candidates, of which four drug candidates are in Phase III stage, 21 drug candidates are in Phase II stage, 20 drug candidates are in Phase I stage, 11 drug candidates are in Pre-Clinical stage and one drug candidates is in the Discovery stage.
Mylan is a global pharmaceutical company founded in 1961 with a mission to provide access to high quality medicines worldwide. It has grown significantly over the years, including through acquisitions like Matrix Laboratories in India in 2007 that made Mylan one of the largest API manufacturers. Mylan and Pfizer's Upjohn division recently announced a merger to form a new company called Viatris, which will combine Mylan's generics portfolio and Upjohn's off-patent brands. The new company will have leadership from both Mylan and Pfizer and sell products in 165 markets worldwide.
The document discusses the FDA drug approval process and lists some drugs that have been withdrawn by the FDA. It describes the multi-phase approval process including pre-clinical testing in animals, followed by three phases of clinical trials in humans. It can take over a decade for a drug to be approved. Several drugs are mentioned that were withdrawn from the market due to serious safety issues discovered after approval, such as thalidomide causing birth defects, phenformin causing fatal lactic acidosis, and rofecoxib increasing heart attack and stroke risk.
Schedule Y provides requirements and guidelines for permission to import and manufacture new drugs for sale or to undertake clinical trials in India. It outlines the application process and requirements, including pre-clinical data that must be submitted. It describes the responsibilities of sponsors, investigators, and ethics committees for clinical trials. Clinical trials must progress through Phases I-IV and special population studies may be required. Post-marketing surveillance is also addressed. The purpose is to regulate new drugs and ensure clinical research is properly conducted according to good clinical practice standards.
This document defines combination products and medical devices and discusses their classification and regulatory requirements. Combination products involve two or more regulated products combined in a single package. Medical devices are instruments or articles used for diagnosis, prevention, monitoring or treatment of disease. The document outlines the classification of medical devices into Classes I-III based on risk and the regulatory pathways of 510(k), reclassification, product development protocol, de novo review, and premarket approval.
This document provides guidelines for conducting clinical trials and importing or manufacturing new drugs for sale according to Schedule Y of the Drugs and Cosmetics Act of 1940 in India. It outlines the application process and required data to be submitted, including chemical/pharmaceutical information, pre-clinical toxicology and pharmacology studies in animals, protocols for human clinical trials through various phases, and post-marketing surveillance requirements. Ethics committee approval and informed consent of participants are necessary. Manufacturers must establish the drug's quality, safety, and efficacy primarily through clinical trials conducted in India.
The document summarizes Schedule Y, which outlines the requirements and guidelines for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the regulatory bodies involved, including the Central Drugs Standard Control Organization and various guidelines and regulations. It provides an overview of the application process for clinical trials and requirements for trials, including ethics committee approval and informed consent. It also summarizes recent updates to clinical trials regulations in India.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
The study analyzed that the systemic lupus erythematosus pipeline comprises of 57 drug candidates, of which four drug candidates are in Phase III stage, 21 drug candidates are in Phase II stage, 20 drug candidates are in Phase I stage, 11 drug candidates are in Pre-Clinical stage and one drug candidates is in the Discovery stage.
Mylan is a global pharmaceutical company founded in 1961 with a mission to provide access to high quality medicines worldwide. It has grown significantly over the years, including through acquisitions like Matrix Laboratories in India in 2007 that made Mylan one of the largest API manufacturers. Mylan and Pfizer's Upjohn division recently announced a merger to form a new company called Viatris, which will combine Mylan's generics portfolio and Upjohn's off-patent brands. The new company will have leadership from both Mylan and Pfizer and sell products in 165 markets worldwide.
The document discusses the FDA drug approval process and lists some drugs that have been withdrawn by the FDA. It describes the multi-phase approval process including pre-clinical testing in animals, followed by three phases of clinical trials in humans. It can take over a decade for a drug to be approved. Several drugs are mentioned that were withdrawn from the market due to serious safety issues discovered after approval, such as thalidomide causing birth defects, phenformin causing fatal lactic acidosis, and rofecoxib increasing heart attack and stroke risk.
Schedule Y provides requirements and guidelines for permission to import and manufacture new drugs for sale or to undertake clinical trials in India. It outlines the application process and requirements, including pre-clinical data that must be submitted. It describes the responsibilities of sponsors, investigators, and ethics committees for clinical trials. Clinical trials must progress through Phases I-IV and special population studies may be required. Post-marketing surveillance is also addressed. The purpose is to regulate new drugs and ensure clinical research is properly conducted according to good clinical practice standards.
This document defines combination products and medical devices and discusses their classification and regulatory requirements. Combination products involve two or more regulated products combined in a single package. Medical devices are instruments or articles used for diagnosis, prevention, monitoring or treatment of disease. The document outlines the classification of medical devices into Classes I-III based on risk and the regulatory pathways of 510(k), reclassification, product development protocol, de novo review, and premarket approval.
This document provides guidelines for conducting clinical trials and importing or manufacturing new drugs for sale according to Schedule Y of the Drugs and Cosmetics Act of 1940 in India. It outlines the application process and required data to be submitted, including chemical/pharmaceutical information, pre-clinical toxicology and pharmacology studies in animals, protocols for human clinical trials through various phases, and post-marketing surveillance requirements. Ethics committee approval and informed consent of participants are necessary. Manufacturers must establish the drug's quality, safety, and efficacy primarily through clinical trials conducted in India.
The document summarizes Schedule Y, which outlines the requirements and guidelines for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the regulatory bodies involved, including the Central Drugs Standard Control Organization and various guidelines and regulations. It provides an overview of the application process for clinical trials and requirements for trials, including ethics committee approval and informed consent. It also summarizes recent updates to clinical trials regulations in India.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
The document provides information on India's drug regulatory system. It states that the Drug Controller General of India heads the Central Drug Standard Control Organisation, which regulates drugs in India. The objectives of the drug regulatory authority are to ensure medicinal products are of acceptable quality, safe, and effective. It also discusses new drug approval processes, definitions of new drugs, application forms and fees for various regulatory processes like clinical trials, manufacturing, and import of drugs.
Five drug development strategies to combat SARS-CoV2Anton Yuryev
Slides were presented at webinar on “Opportunities & Challenges in Drug Discovery and Development” organised by Elsevier in collaboration with Dr Reddy’s Institute of Life Sciences, Hyderabad on July 16th,2020
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
This document discusses various FDA approval pathways for drugs, biologics, and medical devices. It describes the New Drug Application (NDA) process for drug approval, the Biologics License Application (BLA) process for biologics approval, the Premarket Approval (PMA) process for high-risk Class III medical devices, and the 510(k) process for clearance of lower-risk Class I and II medical devices. The key FDA regulations and goals of demonstrating safety and effectiveness for intended uses are also summarized.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
The document summarizes Schedule Y of the Drugs and Cosmetics Act, which covers requirements for permission to import or manufacture new drugs in India and conduct clinical trials. It discusses rules for applications, responsibilities of sponsors, investigators and ethics committees. It also outlines the regulatory authorities involved and fees for applications. Requirements include preclinical and clinical data to be submitted along with applications for marketing approval or conducting trials.
Pharmaceutical industrial management covers topics like quality assurance, quality control, good manufacturing practices, good laboratory practices, and total quality management. Quality assurance aims to prevent defects and ensure products meet requirements, while quality control detects defects. Good practices provide guidelines for manufacturers to consistently produce high quality and safe products. Process and analytical method validation are important to demonstrate that procedures are suitable and reliable for their intended purposes. Documentation and change control are also important parts of pharmaceutical quality systems.
The document summarizes Schedule Y of the Drugs and Cosmetics Rules, 1945 which outlines the regulations and guidelines for permission to import or manufacture new drugs in India. It discusses the key aspects covered including application process using Form 44, regulatory authorities involved, fees, important considerations for human clinical trials and periodic safety update reports (PSURs). Bioequivalence studies are required to show equivalence to reference formulations for systemic drugs approved elsewhere.
Combinational products & medical devicesSHUBHAMGWAGH
This document provides an overview of regulations for combination products and medical devices in India. It defines combination products as those composed of two or more medical products like drugs, devices, and/or biologics. The regulatory authorities in India that oversee drugs and medical devices are described, including the Drugs Controller General of India and Central Drugs Standard Control Organization. The document outlines some key proposed regulations like the Indian Medical Device Regulatory Act, which would classify medical devices into four risk-based categories and establish design, manufacturing, and post-market surveillance requirements. It also discusses the role of pharmacists in understanding medical device safety and being involved in their regulation.
The document summarizes Schedule Y, which outlines recent amendments made to the Drugs and Cosmetic Act to facilitate drug discovery in India. The amendments cover two broad areas: animal pharmacology and animal toxicology. They establish requirements for permission to import and manufacture new drugs for sale, undertake clinical trials in India, and ensure clinical trials are approved and documented properly.
The document discusses non-clinical drug development and the Investigational New Drug Application (IND) process. It explains that pre-clinical development involves determining a drug's safety profile before human clinical trials. An IND must be submitted to regulatory authorities for approval before testing an unapproved drug in humans. The IND contains information on pre-clinical data, clinical protocols, manufacturing, and other details to ensure the safety of trial participants. Regulators review the IND to verify reasonable safety before allowing clinical studies.
The document compares key differences between the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and the Indian GCP guidelines. It outlines differences in requirements for investigator qualifications, use of standard operating procedures, responsibilities for data analysis, essential documents, monitor responsibilities, drug labeling, and document retention between the two sets of guidelines. The Indian GCP guidelines have additional requirements compared to the ICH-GCP guidelines in several of these areas.
This document discusses the regulatory process for biologics in the United States and Europe. It provides information on the sources and types of biologics, as well as the differences between biologics and chemical drugs. It also describes the regulatory authorities, approval processes, and requirements for a Biological License Application in the US. Finally, it compares the US and European guidelines regarding preclinical studies and requirements for approval of biologics.
This document discusses new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the US Food and Drug Administration (FDA).
It begins with an overview of the drug development process, then describes the goal and contents of an NDA, including clinical data from trials and information on safety, efficacy, and manufacturing. It also classifies types of NDAs.
The document then discusses ANDAs for generic drugs, noting they do not require new clinical trials but must demonstrate bioequivalence to the brand drug. It covers patent certification requirements for ANDAs.
In conclusion, the key differences between NDAs and ANDAs are summarized, with ANDAs taking less time and money but
The document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. Key acts and amendments established safety testing requirements for drugs, created the FDA, and defined the modern drug approval process including preclinical research and multi-phase clinical trials. The modern system aims to balance drug accessibility while ensuring safety and efficacy through a rigorous review and oversight process from development through post-marketing.
The document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize regulations for pharmaceutical drug development and registration among regions to ensure safety and efficiency. It provides guidelines on topics like carcinogenicity testing, genotoxicity testing, and toxicokinetics. The ICH involves regulatory authorities and the pharmaceutical industry from the European Union, Japan, and the United States who work together to establish common technical guidelines.
The document provides summaries of 22 drugs that were approved by the FDA in 2010. The drugs treat a variety of conditions from multiple sclerosis to diabetes to skin infections. Most are small molecules but some are biologics. The largest markets are expected to be in treatments for multiple sclerosis, diabetes, osteoporosis, and replacing the blood thinner warfarin. Manufacturers receiving multiple approvals include Novartis, Amgen, Boehringer Ingelheim, and Genzyme.
An abbreviated new drug application (ANDA) is submitted to the FDA to obtain approval for a generic drug version of an already approved brand name drug. The ANDA process allows for generic drugs to be approved without repeating clinical trials, as long as the generic drug is proven to be bioequivalent to the original drug. If approved, a generic drug application allows the applicant to manufacture and market a safe, effective and lower-cost alternative to the original brand name drug. The ANDA review process focuses on demonstrating bioequivalence rather than requiring new clinical trial data.
OxfordSM's pharma case studies - providing a call to actionOxfordSM
Brand teams have to be increasingly innovative when finding ways to prompt patients and physicians to intervene at the right time.
Campaigns such as GSK’s Greatest Season Ever for FLONASE®, implemented last year in the United States which made the decision to prepare for the allergy season easier for patients by linking the proactive purchase of the brand to the start of the baseball season.
Providing A Call To Action:
We find that examples from within and outside of healthcare can often prompt this innovation. They act as a way of bringing in new perspectives and allowing teams to explore new avenues and new ideas.
So, in the spirit of hoping this will prompt some new ideas in your brand team, here are our favourite case studies that speak to the need to provide a call to action.
OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.
The document provides information on India's drug regulatory system. It states that the Drug Controller General of India heads the Central Drug Standard Control Organisation, which regulates drugs in India. The objectives of the drug regulatory authority are to ensure medicinal products are of acceptable quality, safe, and effective. It also discusses new drug approval processes, definitions of new drugs, application forms and fees for various regulatory processes like clinical trials, manufacturing, and import of drugs.
Five drug development strategies to combat SARS-CoV2Anton Yuryev
Slides were presented at webinar on “Opportunities & Challenges in Drug Discovery and Development” organised by Elsevier in collaboration with Dr Reddy’s Institute of Life Sciences, Hyderabad on July 16th,2020
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
This document discusses various FDA approval pathways for drugs, biologics, and medical devices. It describes the New Drug Application (NDA) process for drug approval, the Biologics License Application (BLA) process for biologics approval, the Premarket Approval (PMA) process for high-risk Class III medical devices, and the 510(k) process for clearance of lower-risk Class I and II medical devices. The key FDA regulations and goals of demonstrating safety and effectiveness for intended uses are also summarized.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
The document summarizes Schedule Y of the Drugs and Cosmetics Act, which covers requirements for permission to import or manufacture new drugs in India and conduct clinical trials. It discusses rules for applications, responsibilities of sponsors, investigators and ethics committees. It also outlines the regulatory authorities involved and fees for applications. Requirements include preclinical and clinical data to be submitted along with applications for marketing approval or conducting trials.
Pharmaceutical industrial management covers topics like quality assurance, quality control, good manufacturing practices, good laboratory practices, and total quality management. Quality assurance aims to prevent defects and ensure products meet requirements, while quality control detects defects. Good practices provide guidelines for manufacturers to consistently produce high quality and safe products. Process and analytical method validation are important to demonstrate that procedures are suitable and reliable for their intended purposes. Documentation and change control are also important parts of pharmaceutical quality systems.
The document summarizes Schedule Y of the Drugs and Cosmetics Rules, 1945 which outlines the regulations and guidelines for permission to import or manufacture new drugs in India. It discusses the key aspects covered including application process using Form 44, regulatory authorities involved, fees, important considerations for human clinical trials and periodic safety update reports (PSURs). Bioequivalence studies are required to show equivalence to reference formulations for systemic drugs approved elsewhere.
Combinational products & medical devicesSHUBHAMGWAGH
This document provides an overview of regulations for combination products and medical devices in India. It defines combination products as those composed of two or more medical products like drugs, devices, and/or biologics. The regulatory authorities in India that oversee drugs and medical devices are described, including the Drugs Controller General of India and Central Drugs Standard Control Organization. The document outlines some key proposed regulations like the Indian Medical Device Regulatory Act, which would classify medical devices into four risk-based categories and establish design, manufacturing, and post-market surveillance requirements. It also discusses the role of pharmacists in understanding medical device safety and being involved in their regulation.
The document summarizes Schedule Y, which outlines recent amendments made to the Drugs and Cosmetic Act to facilitate drug discovery in India. The amendments cover two broad areas: animal pharmacology and animal toxicology. They establish requirements for permission to import and manufacture new drugs for sale, undertake clinical trials in India, and ensure clinical trials are approved and documented properly.
The document discusses non-clinical drug development and the Investigational New Drug Application (IND) process. It explains that pre-clinical development involves determining a drug's safety profile before human clinical trials. An IND must be submitted to regulatory authorities for approval before testing an unapproved drug in humans. The IND contains information on pre-clinical data, clinical protocols, manufacturing, and other details to ensure the safety of trial participants. Regulators review the IND to verify reasonable safety before allowing clinical studies.
The document compares key differences between the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and the Indian GCP guidelines. It outlines differences in requirements for investigator qualifications, use of standard operating procedures, responsibilities for data analysis, essential documents, monitor responsibilities, drug labeling, and document retention between the two sets of guidelines. The Indian GCP guidelines have additional requirements compared to the ICH-GCP guidelines in several of these areas.
This document discusses the regulatory process for biologics in the United States and Europe. It provides information on the sources and types of biologics, as well as the differences between biologics and chemical drugs. It also describes the regulatory authorities, approval processes, and requirements for a Biological License Application in the US. Finally, it compares the US and European guidelines regarding preclinical studies and requirements for approval of biologics.
This document discusses new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the US Food and Drug Administration (FDA).
It begins with an overview of the drug development process, then describes the goal and contents of an NDA, including clinical data from trials and information on safety, efficacy, and manufacturing. It also classifies types of NDAs.
The document then discusses ANDAs for generic drugs, noting they do not require new clinical trials but must demonstrate bioequivalence to the brand drug. It covers patent certification requirements for ANDAs.
In conclusion, the key differences between NDAs and ANDAs are summarized, with ANDAs taking less time and money but
The document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. Key acts and amendments established safety testing requirements for drugs, created the FDA, and defined the modern drug approval process including preclinical research and multi-phase clinical trials. The modern system aims to balance drug accessibility while ensuring safety and efficacy through a rigorous review and oversight process from development through post-marketing.
The document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize regulations for pharmaceutical drug development and registration among regions to ensure safety and efficiency. It provides guidelines on topics like carcinogenicity testing, genotoxicity testing, and toxicokinetics. The ICH involves regulatory authorities and the pharmaceutical industry from the European Union, Japan, and the United States who work together to establish common technical guidelines.
The document provides summaries of 22 drugs that were approved by the FDA in 2010. The drugs treat a variety of conditions from multiple sclerosis to diabetes to skin infections. Most are small molecules but some are biologics. The largest markets are expected to be in treatments for multiple sclerosis, diabetes, osteoporosis, and replacing the blood thinner warfarin. Manufacturers receiving multiple approvals include Novartis, Amgen, Boehringer Ingelheim, and Genzyme.
An abbreviated new drug application (ANDA) is submitted to the FDA to obtain approval for a generic drug version of an already approved brand name drug. The ANDA process allows for generic drugs to be approved without repeating clinical trials, as long as the generic drug is proven to be bioequivalent to the original drug. If approved, a generic drug application allows the applicant to manufacture and market a safe, effective and lower-cost alternative to the original brand name drug. The ANDA review process focuses on demonstrating bioequivalence rather than requiring new clinical trial data.
OxfordSM's pharma case studies - providing a call to actionOxfordSM
Brand teams have to be increasingly innovative when finding ways to prompt patients and physicians to intervene at the right time.
Campaigns such as GSK’s Greatest Season Ever for FLONASE®, implemented last year in the United States which made the decision to prepare for the allergy season easier for patients by linking the proactive purchase of the brand to the start of the baseball season.
Providing A Call To Action:
We find that examples from within and outside of healthcare can often prompt this innovation. They act as a way of bringing in new perspectives and allowing teams to explore new avenues and new ideas.
So, in the spirit of hoping this will prompt some new ideas in your brand team, here are our favourite case studies that speak to the need to provide a call to action.
OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.
This document provides an overview of pharmacovigilance and the Pharmacovigilance Program of India (PvPI). It defines pharmacovigilance as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. The document outlines the historical events that led to the development of pharmacovigilance, including the sulfanilamide and thalidomide disasters. It describes the vision, mission, aims, and objectives of PvPI in India to improve patient safety related to medicine use. Key aspects of PvPI covered include adverse drug reaction reporting processes and the expansion of PvPI to include additional medical areas over time.
Vasilios Papademetriou is a cardiologist and professor of medicine at Georgetown University who has collaborated extensively with the biomedical industry. He discusses several career pathways for medical students in the biomedical industry, including doing clinical trials sponsored by industry, serving on advisory boards, and collaborating on research. He provides examples of physicians who have successfully worked with industry to develop new drugs and devices.
The document discusses the development of Juxtapid for the treatment of homozygous familial hypercholesterolemia (HoFH). It describes how Bristol-Myers Squibb initially developed lomitapide (Juxtapid) but discontinued development. The University of Pennsylvania then obtained rights and collaborated with Aegerion Pharmaceuticals to develop Juxtapid for HoFH. With orphan drug designation and support from government funding, Aegerion completed clinical trials and received regulatory approval for Juxtapid to treat HoFH. The development of Juxtapid illustrates how perseverance, collaboration, and leveraging resources can help develop treatments for rare diseases.
Antisense Therapeutics is a biotech company developing antisense drugs to treat diseases. It has two drugs that showed positive results in Phase 2 clinical trials. ATL1103 for acromegaly was partnered with Strongbridge Biopharma who will fund further development and commercialization in exchange for milestone payments up to $124 million plus royalties. ATL1102 showed positive results for multiple sclerosis in a Phase 2 trial. The company is working to establish an early access program for ATL1102 in Europe to potentially generate near-term revenue while seeking a partner for a Phase 2b trial. Antisense Therapeutics believes its antisense technology platform has potential applications for cancer and diabetic complications as
A Little Bit of Everything, Quick & Snappy: Probiotics to Advances in the Car...PASaskatchewan
As pharmacists, you are rarely faced with a consistent patient population with similar problems and questions. More likely, each patient you interact with has unique and varied concerns that you must be ready to address in an instant. This session reflects the diversity of patients a pharmacist will face in day-to-day practice and covers a range of topics in a quick and snappy format. This session will cover the evidence as it relates to concurrent probiotic and antibiotic use, second line treatment for patients with type 2 diabetes, and explore new utilization strategies of using drugs traditionally used in the treatment of type 2 diabetes for patients with type 1 diabetes.
Alström syndrome is a rare genetic disease characterized by childhood obesity, insulin resistance, and fibrosis of multiple organs. There are currently no approved treatments. PBI-4050, a drug candidate from Prometic being developed for fibrosis, has potential as a novel treatment for Alström syndrome given its multi-organ anti-fibrotic activity. An ongoing proof-of-concept study of PBI-4050 in the UK represents the first clinical trial in Alström syndrome patients. Regulatory pathways like orphan drug designation and the EMA's PRIME program aim to facilitate development of treatments for rare diseases by providing scientific advice, accelerated assessment, and incentives for further research.
Drug repurposing is the process of applying already-approved drugs and compounds to treat a different disease. Also synonymously called drug repositioning; however, there is a difference. Identifying, developing, and commercializing new uses for existing or abandoned drugs Finding new uses outside the scope of the original medical indication for existing drugs or developing new indications for existing drugs or biologics
The regulation of medicines in AustraliaTGA Australia
View this presentation for information on:
*the different categories of medicines
* registered (higher risk) medicines and how they are regulated
* listed (lower risk) medicines and how they are regulated
* accessing unauthorised medicines
* medicines advertising
* changing medicine technologies
Clinical trials and new drug developmentRahul Bhati
- The drug development process involves several phases of clinical trials and regulatory approval before a new drug can be approved and marketed. Key phases include pre-clinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy, and proper dosing.
- After successful Phase III trials, companies submit a New Drug Application to regulators like the FDA with all clinical trial data. If approved, the drug is monitored in Phase IV post-marketing trials and surveillance.
- The overall process takes an average of 8-12 years and costs $500-600 million, with only about 20% of candidate drugs ultimately being approved due to rigorous testing requirements.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
New class of therapeutic agents called soluble guanylate cyclase (sGC) stimulators.
Impairment of NO synthesis and signaling through the NO-sGC–cGMP pathway is involved in the pathogenesis of pulmonary hypertension.
Dual mode of action,
Directly stimulating sGC independently of NO, and
Increasing the sensitivity of sGC to NO.
vasorelaxation , antiproliferative and antifibrotic effects
Primary biliary cholangitis (PBC) Epidemiology and Compitive landscape_Thelan...Thelansis
This document provides epidemiological data on primary biliary cholangitis (PBC) in China from 2018 to 2030. It estimates that the number of new PBC cases diagnosed annually in China will increase from 20,145 in 2018 to 21,108 in 2030. The total number of prevalent PBC cases in China is estimated to increase from 105,542 cases in 2018 to 110,588 cases in 2030. The document also summarizes the current treatment landscape and pipeline for PBC in China and other major markets.
IntelGenx is a drug delivery company that develops improved versions of approved drugs using its proprietary drug delivery platforms, VersaFilm and AdVersa. Some of its pipeline products include Rizaport for migraines, Tadalafil VersaFilm for erectile dysfunction, Loxapine VersaFilm for schizophrenia, and Montelukast VersaFilm for mild cognitive impairment. The company has completed clinical trials demonstrating its products offer benefits over existing drugs such as increased bioavailability and reduced side effects. IntelGenx licenses its products to partners and retains manufacturing rights to generate revenue through milestone payments and royalties.
IntelGenx March 13, 2017 Investor PresentationItelGenx
This presentation provides an overview of IntelGenx Corp., a drug delivery company focused on oral thin film technologies. Key points include:
- IntelGenx has a pipeline of product candidates using its VersaFilm drug delivery technology, including products for migraines, erectile dysfunction, schizophrenia, and repurposing drugs for brain diseases.
- The company has completed construction of a new manufacturing facility to produce oral thin films and lower costs.
- Management believes IntelGenx is well positioned for growth due to its drug delivery expertise, business model focusing on drug repurposing and first-to-file generics, and competitive manufacturing capabilities.
This document discusses a patented formulation technology from TSRL that can modify the release properties of water-insoluble drugs to provide extended or delayed delivery. The technology is supported by an issued US patent that expires in 2033. Proof-of-concept studies in humans have demonstrated the ability to increase exposure and modulate the pharmacokinetic profile of simvastatin using a delayed release formulation. The technology offers a low-cost option for partners to test formulations and has the potential to improve therapies for conditions that follow circadian patterns or require lower and less toxic doses.
Similar to Liprostin Group - Vascular - Pulmonary Diseases (20)
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
1. Multilamellar Liposome
LiprostinTM is our Multilamellar Liposomal Drug Delivery System.
LiprostinTM treats Vascular and Pulmonary Diseases with PGE-1.
Licensed the Patent
2. LiprostinTM is Prostaglandin (PGE-1) encapsulated in a
patented multilamellar liposome.
PGE-1 is Alprostadil – an FDA approved Generic Drug
• Vasodilator - increases blood circulation
• Potent Anti-inflammatory
• Anti-thrombotic - reduces formation of blood clots
• Promotes the growth of capillaries
3. Advantage LiprostinTM
Infused raw PGE-1 dissipates in about 70 seconds.
LiprostinTM post infusion is flat for 5 min. / declines by 50% next 5 min.
LiprostinTM in-vitro has half-life of 1 to 2 hours.
Liposome is charged to target Inflammation.
Delayed delivery maximizes PGE-1 effectiveness:
Treats Peripheral Artery Disease (PAD)
Possible COVID Lung Disease treatment
• Acute Respiratory Distress Syndrome
• Mitigation of Cytokine Storm Inflammation
High Pressure Liquid
Chromatography (HPLC)
7. Large Potential Market
Diabetic Foot Ulcers
$9-13 billion cost to payors
Lower Extremity Amputations
$4 billion cost to payors
Can be treated with LiprostinTM
8. Earlier Successful Clinical Trials 1, 2 a-b-c
Phase I Clinical Safety Trial: demonstrate drug safety with no
serious side-effects and no adverse events.
Phase II - A Clinical Trial: evaluate the safety and efficacy of
intravenous administered LiprostinTM in patients with
Peripheral Occlusive Arterial Disease.
Phase II - B Clinical Trial: to test effectiveness in treating
intermittent claudication (pain) and determine Maximum
Walking Distance before pain returned
Phase II – C Clinical Trial: treat Peripheral Vascular Disease
(“PVD”) and venous ulcers.
10. • Method for Treating Vascular Disease by Administering
a Liposomal Prostaglandin Composition
• Encapsulation of PGE-1 in a liposome solves the
problems of instability, short in vivo half-life, and rapid
degradation experienced with PGE-1 in its raw form.
Patent claims include treatment of:
Peripheral
Vascular
Disease
Critical
Limb
Ischemia
Intermittent
Claudication
Walking Pain
PATENT 9,962,393 B1
Issued 5-8-18 to David P Summers, Licensed to Liprostin Group, Inc.
11. The contract manufacturer encapsulated
Prostaglandin (PGE-1) into a Multilamellar
Liposome in the absence of a buffer.
Freeze Dried it for stability and shelf life
It was intravenously infused in clinical trials
The proprietary Liposome used in these trials is
now patented and licensed to Liprostin Group, Inc.
Sample for Clinical Trials
12. Liposome Patents using partition enhancing buffers likely expired.
Our Licensed Patent: multilamellar liposomal technology
made in the absence of a partition enhancing buffer (issued 2018)
The liposome targets inflammation and remains effective during its
1 to 2-hour half-life – which raw PGE-1 cannot do.
If Prostaglandin is used in USA with a liposome – others should
obtain a license from Liprostin Group, Inc.
Importance of Patent
13. Competition – Blood Thinners
Asprin Cilostazol® (Pletal®) Trental® (Pentoxifylline®)
• No therapeutic benefits, or ability to stop the disease
• Does not promote healing of wounds
• Does not promote growth of capillaries
14. Our Primary Strategy
• Find Pharma partner who sub-licenses the patent and develops
our method for Treating Vascular Disease by Administering a
Liposomal Prostaglandin Composition / encapsulated PGE-1.
• Alprostadil is PGE-1, and is an FDA approved Generic Drug
• Pharma
• Up-front payment
• Milestone payments
• Royalty on sales
• Pays development & FDA registration costs
• Markets product
15.
16. The COVID-19 pandemic has killed 373,337 persons as of May 31, 2020.
Deaths are primarily caused by acute respiratory distress syndrome
(ARDS) and by cytokine storm syndrome—i.e., a state of
hyperinflammation leading to multiorgan failure.
We have an approach to ameliorate that inflammatory problem using
PGE-1 and believe that our own FDA Trials 1, 2 a-b-c, and the science as
published in third-party research supports its use in clinical trials.
We want to immediately conduct a Proof of Concept.
17. Our Development Strategy
1. COVID Lung Problem – pursue it now
• Need FDA accelerated IND approval – we have Regulatory Expertise
• Conduct Proof of Concept (POC) – test 10-20 COVID patients
• With success BARDA funding for larger FDA study and New Drug App.
• https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx
• Pharma Partnership fallback in case Proof of Concept stalls
2. Pharma Partnership – pursue it now & in August
• Chinese – Gerald Yakatan Ph.D. connects in August when in China
• Other – Namrata Chand will start calling our list (20 – 30 prospects)
• OBJECTIVE – Cash Sub-License Fee / Royalty for us
• Trials financed and managed by Pharma Partner
3. Clinical Trials – best to have a Pharma partner
• If pathway 1 and/or 2 fails, then we fund and manage the trials
• Clinical Trials III -- Efficacy & Safety – larger sample size
22. COVID-19 ARDS and Cytokine Storms
•COVID-19 invades respiratory cells and kills them.
•Triggers Cytokine / immune system response.
•Cytokines coordinate subsequent inflammation.
•Inflammation targets infected cells.
•Too many Cytokines cause "cytokine storms" that
rampage through the blood, destroying lung tissue,
clogging airways, and cutting off oxygen supply.
•Acute Respiratory Distress Syndrome (ARDS) can result.
•ARDS / Cytokine Storms primary cause of COVID death
23. PGE-1 - potent suppressor of inflammation
• PGE-1 is a potent suppressor of inflammation, vasodilator,
platelet anti-aggregator, cytoprotective to normal cells,
inhibitor of viral replication.
• Encapsulated PGE-1 in our Multilamellar Liposome has a
half-life of 1 to 2 hours vs. 70 seconds for raw PGE1.
• Multilamellar Liposome is charged to target Inflammation.
• Extended half-life improves anti-inflammatory response.
24. Example of White Paper Third-Party Research
Clinical effect of Alprostadil in patients with septic shock associated with acute respiratory distress syndrome
https://core.ac.uk/display/120225699 http://www.plamj.org/index.php/plamj/article/view/1626/1614
2017 – CONCLUSION -- Alprostadil® = PGE-1
Alprostadil can improve the lung function in patients with septic
shock associated with Acute Respiratory Distress Syndrome
(ARDS), can shorten the time of mechanical ventilation, ICU and
hospital stay, and can reduce the mortality rate, which may be
associated in that Alprostadil reduces systemic inflammatory
reaction and enhances immunity by improving microcirculation.
25. Proof of Concept (POC)
• Obtain Accelerated FDA Investigational New Drug (IND) Application
• Need hospital willing to treat COVID-19 patients.
• We provide samples for 10-20 COVID-19 hospitalized patients.
• POC may only last 1-mo. contingent upon available patients.
• IF POC successful (hospital determines success threshold),
THEN apply to BARDA or OTHER for larger trial funding.
• OBJECTIVE is to acquire FDA New Drug Application.
• IF POC stalls, THEN find Pharma partner for our vascular disease
treatment and prepare for Trials III -- Efficacy and Safety.
26. Regulatory Team (all are founders)
Gerald J. Yakatan, Ph.D. – FDA Regulatory Expert
• During 1966, he founded IriSys, Inc.
• IriSys is a contract pharmaceutical product development and FDA consulting firm
• Plans and engages in FDA meetings for U.S. and international clients
• Pharmaceutics Chair at the University of Texas at Austin
• Vice President for Product Development Worldwide at Warner Lambert/Parke Davis
• Founder and CEO at Tanabe Research Labs, USA
Jackie R. See M.D., F.A.C.C. – Co Principal Investigator
• Chief Scientific Medical Advisor, Stem Cell Save The Children, LLC.
• Board-Certified Internist, a Fellow of the American College of Cardiology
• Pioneer of the specialty of Interventional Cardiology
• Founded teaching program of Interventional Cardiology at UC Irvine School of Medicine
• He invented the encapsulation of PGE1 with Liposomes for erectile dysfunction treatment
• Licensed in 2004, his patent (now expired), to David P. Summers for Liprostin
27. Scientific Advisors
Undurti N Das, MD, DSc, FAMS, FRSC: Physician/Scientist
• Dir. of Bioscience Research Centre, GVP Medical College and Hospital, Visakhapatna, India
• Lipid-based drugs for cancer, lupus, diabetes mellitus, and drug resistant microbes
• Published 500 research papers, published 4 books, and has 5 USA patents
• Founding Editor of Lipids in Health and Disease journal by BMC, London
• Research Professor, Surgery, Nutrition, Physiology, SUNY Medical University, Syracuse, NY
• MD-1981 in Internal Medicine; DSc-in Biotechnology both from India
28. Management Team (all are founders)
Leo Womack – Chairman & Secretary
• Founding member of Houston Angel Network (HAN) -
• Served as its President and Chairman and an active member
• Chairman of Petrolia Energy, a public oil and gas exploration company
• Active in the Biotech space
David P. Summers Ph.D. – President, Co-CEO, Director
• Inventor / scientist who developed LiprostinTM
• Received over 30 Biotech and Nutraceutical Patents
• In 2016, he filed three LiprostinTM related patents ( first is now granted )
• Founded three public healthcare companies with combined sales of $100 million
Bruce Badeau – Venture Architect – Co-CEO, Director
• Wrote the business plan for AngioSoma, the predecessor of Liprostin Group, Inc.
• Led the move away from the public entity controlling Summers IP
• Organized Liprostin Group, Inc.
• In 1996 Founded First Sovereign Equity Research, financial modeling, and deal structuring
29. Directors (all are founders)
C. Richard Piazza – Director
• Founded La Jolla Capital Partners, a healthcare Investment Banking Firm.
• Executive with 38 years in medical devices, pharmaceutical, and biotechnology
• CEO of Ohmeda, Smith & Nephew Pharmaceuticals, Marquest & VitaGen
• Served advisory boards of Advamed, Biocomm, and BioHouston
• Helped FDA and Congress craft the FDA Modernization Act for Medical Devices
Howard R. Asher – Director
• Founded Regulatory Affairs Certified Advisor, an FDA focused consulting firm.
• Globally recognized expert in life sciences, healthcare and regulatory affairs
• Began his career in life sciences in 1969 with Pfizer, followed by Baxter and Bayer.
• Founded Advanced Bioresearch Associates, FDA Regulatory Affairs and CRO firm
• Sun Microsystems - Group Director of Global Life and Health Sciences.