Alp Drug discovery and development
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The document discusses the drug discovery process and crisis. It outlines how drugs work by binding to proteins, and how new drugs were traditionally discovered from plant extracts or serendipitously, but are now discovered through large-scale compound screening and rational design based on target structures. The development of a new drug can take decades and billions of dollars. While concerns exist that we may be running out of drugs, continued basic research into human biology, new drug design technologies, and gene therapy methods offer promise for developing new medicines to address this crisis.
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Drug discovery challenges and different discovery approaches
The document discusses several challenges in drug discovery and different discovery approaches. It outlines issues with the traditional high-throughput screening approach such as low success rates. It then describes alternative approaches like considering transient binding drugs that interact weakly with multiple targets, leveraging natural products as drug leads, and exploring a multi-target drug discovery strategy to address complex diseases involving multiple molecular dysfunctions.
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The document discusses the process for approval of a new drug from development through marketing. It takes 10-15 years on average and costs over $2.6 billion to get a new drug approved. Key steps include:
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The document discusses the importance of biotechnology in drug discovery. It notes that biotechnology has produced over 200 new therapies targeting various diseases. Biotechnology companies are more entrepreneurial and nimble compared to traditional pharmaceutical companies. The document also provides details on the large and growing biotech market in India and worldwide. It describes several applications of biotechnology across various stages of the drug discovery process, including target identification and validation, assay development, high-throughput screening, biomarker analysis, and protein engineering.
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The drug development process involves lengthy preclinical and clinical testing that can take over 12 years and cost $350 million. It begins with drug discovery followed by preclinical studies to test the drug's toxicity, pharmacokinetics, and efficacy in animals. If successful, an IND application is submitted to the FDA to begin human clinical trials. Clinical trials involve 4 phases to test the drug's safety and efficacy in humans. If phase 3 is successful, an NDA is submitted for FDA review and potential approval to market the new drug. Post-approval monitoring continues to ensure safety.
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The document provides an overview of the drug discovery process. It discusses the various stages involved including target selection, lead discovery, medicinal chemistry, in vitro studies, in vivo studies, and clinical trials.
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Bioinformatics in drug discovery
INTRODUCTION
A PERFECT THERAPEUTIC DRUG
DRUG DISCOVERY- HISTORY
MODERN DRUG DISCOVERY
BIOINFORATICS IN DRUG DISCOVERY
DRUG DISCOVERY BASED ON BIOINFORMATIC TOOLS
BIOINFORMATICS IN COMPUTER-AIDED DRUG DISCOVERY
ECONOMICS OF DRUG DISCOVERY
CONCLUSION
REFERENCES
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Drug discovery and development is a long, expensive, and complex process averaging about 12 years and $500 million to bring a new prescription medication to market. Only 1 in 10,000 compounds eventually becomes an approved drug. The process involves discovery, preclinical research, clinical trials, and regulatory approval. Discovery aims to identify candidate drug molecules, while preclinical research studies their safety and efficacy in animal models before human testing. Clinical trials then evaluate new drugs with patients for safety and effectiveness over several phases before regulatory approval and marketing.
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A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
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Target selection involves identifying biological targets implicated in disease through methods like genomics, proteomics, and bioinformatics. Lead discovery focuses on identifying small molecule modulators through synthesis, combinatorial chemistry, assay development, and high-throughput screening. Medicinal chemistry optimizes leads through approaches such as library development, SAR studies, in silico screening, and chemical synthesis. In vitro and in vivo studies evaluate drug candidates prior to clinical trials in humans.
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Bioinformatics in drug discovery
INTRODUCTION
A PERFECT THERAPEUTIC DRUG
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BIOINFORATICS IN DRUG DISCOVERY
DRUG DISCOVERY BASED ON BIOINFORMATIC TOOLS
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The drug development process takes 10-15 years and costs over $800 million on average to develop a new drug. Only about 1 in 5,000-10,000 compounds tested make it to consumers, and only 3 of 10 drugs that reach the market earn back their R&D costs. The process involves extensive research, pre-clinical testing on animals, and clinical trials on humans in 3 phases before the FDA reviews the new drug application. If approved, large-scale manufacturing must be developed to produce the drug.
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Drug discovery and development is a long, expensive, and complex process that takes an average of 10-12 years and $800 million to $1.7 billion. It involves identifying candidate drugs through methods like molecular designing, screening, and serendipity. Only one in 5000 compounds makes it through preclinical and clinical testing to be approved. The process includes target selection and validation, lead discovery and optimization, and drug development to satisfy regulatory requirements before a new drug can be approved and marketed.
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The document summarizes the key events in the discovery and development of penicillin. Alexander Fleming first discovered penicillin in 1928 after noticing bacteria-killing properties of the Penicillium mold in one of his petri dishes. However, he was not able to purify or characterize penicillin at the time. In the 1940s, a team at Oxford led by Howard Florey and Ernst Chain managed to purify and mass produce penicillin, paving the way for clinical trials. The first successful human trials demonstrated penicillin's ability to cure bacterial infections. By the mid-1940s, large-scale production was established. Fleming, Florey and Chain received the 1945 Nobel Prize for their discoveries. Over time, resistance
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The document discusses the key stages in the drug discovery and development process including target selection, compound screening and hit optimization, selecting a drug candidate through further optimization of properties like absorption and metabolism, safety testing in animals and humans, proof of concept clinical trials in patients, large phase 3 clinical trials for registration and approval, and finally launch and life cycle management. It notes that the entire process from discovery to approval can take 12-16 years and cost over $1 billion.
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The drug development process involves several phases of clinical trials overseen by regulatory agencies. Drugs must first show safety in pre-clinical animal and lab testing before entering human trials. Clinical trials involve 3 phases - Phase I tests safety in small groups, Phase II assesses efficacy and optimal dosing in larger groups of patients, and Phase III confirms efficacy in even larger groups. If results are positive, the drug company submits a New Drug Application to the regulatory agency which can take 2-3 years to review before approving the drug for the market. Post-market studies in Phase IV further monitor long-term safety and efficacy. The entire process from discovery to market approval takes an average of 10-15 years and over $1 billion
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Drug development involves rigorous pre-clinical and clinical testing to prove a drug is safe and effective. Pre-clinical testing involves laboratory and animal studies. Clinical trials in humans have four phases, with each subsequent phase involving more subjects to further evaluate safety, efficacy, and optimal dosage. After Phase III trials demonstrate a drug's benefits outweigh its risks, a New Drug Application is submitted to regulators for review. If approved, Phase IV trials continue monitoring the drug's long-term safety profile after market approval. The entire process from discovery to market approval takes an average of 8-12 years and costs $800-900 million.
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The document provides an overview of the drug discovery and development process. It discusses the various stages involved, including target selection using genomics, proteomics and bioinformatics; lead discovery through synthesis, isolation and high-throughput screening; medicinal chemistry such as structure-activity relationships studies; in vitro and preclinical in vivo testing in animal models; and clinical trials in humans. The timeline for this process can span over 10-15 years from drug target identification to regulatory approval. Key techniques and approaches at each stage are also summarized.
BRAINco Biopharma company presentation
BRAINco Biopharma is part of the Progenika Group and develops personalized treatments for nervous system diseases. BRAINco has drug discovery programs for schizophrenia, major depression, and multiple sclerosis based on novel targets identified through proteomic and genomic studies. BRAINco also develops pharmacogenomic tools to improve drug safety and efficacy. The company utilizes an open innovation model and collaborates with research centers and CROs to advance its pipeline.
Natural products in drug discovery
Natural products are an important source for drug discovery. The drug discovery process involves several steps including target identification, validation, lead identification and optimization through screening compounds for activity against the target. Promising lead compounds then undergo preclinical testing in labs and animal models before progressing to human clinical trials. Computational tools also play an important role in drug design, such as identifying binding sites on target proteins and modeling molecular interactions to optimize lead compounds. Natural products, especially toxins from venom, continue to provide templates for rational drug design.
Sunday fillet lipinski
This document summarizes a keynote presentation on the state and future of drug discovery. The presentation discusses: 1) The "valley of death" between academic research and clinical development due to a lack of translational skills and partially flawed academic targets; 2) How genomics and high-throughput screening have set back drug discovery by prioritizing a reductionist approach; and 3) How phenotypic screening and considering biological networks may improve success rates over the traditional target-based approach. The keynote argues for improved target validation and considering the relationships between biological and chemical networks.
Drug discoverydevelopment2011
The document outlines the multi-step process of drug discovery and development. Key steps include:
1) Choosing a disease target and drug target. Common targets are diseases in developed countries.
2) Identifying a "lead compound" with some bioactivity against the target through screening natural products, synthetic libraries, or modifying existing drugs.
3) Optimizing the lead through structure-activity relationship studies and analog synthesis to improve potency and selectivity and identify the pharmacophore responsible for activity.
4) Testing analogs in animal and human clinical trials to determine toxicity, efficacy, and pharmacokinetics before patenting and commercialization. The process aims to continually improve drug properties while avoiding side effects.
Drug development and delivery system in BME
Drug delivery system introduction and its application in biomedical engineering
Drug discoverydevelopment
Drug discovery and development involves several basic steps: choosing a disease target and drug target, identifying a lead compound, optimizing the lead compound's structure through structure-activity relationships, determining toxicity and efficacy in animal models, and carrying out clinical trials in humans. Key parts of the process include identifying the pharmacophore of active compounds, improving pharmacokinetic properties like absorption and metabolism, ensuring safety through toxicity testing, and developing an efficient manufacturing process. Thalidomide highlights the importance of thorough safety testing, as its approval without adequate pregnancy testing led to severe birth defects in thousands of children.
Sunday (1) fillet
This document provides information about the 6th Drug Discovery for Neurodegeneration Conference held on February 12-14, 2012 in New York City. The conference aimed to provide an intensive course on translating research into drugs for neurodegenerative diseases. It was funded in part by the National Institute on Aging and had over 190 attendees from 20 countries. The scientific advisory committee included experts from various academic and research institutions. The goals of the meeting were to share knowledge on drug discovery principles and practices for neurodegenerative diseases and foster networking and collaboration. Neurodegenerative diseases pose major challenges for drug development but also opportunities to develop novel treatments.
Drug discovery, development and approches
In this slide we enlighten the Drug Discovery and Development with the different approaches of drug development like Pharmacological, Toxicological, Drug Characterization, IND Application and Dosage Form Approach.
The Translational Medicine
The document discusses using semantic web technologies to create a Translational Medicine Ontology and Knowledge Base (TMOKB) for integrating personalized medicine data. It describes how the TMOKB links terms from existing ontologies and data sources to answer questions about Alzheimer's disease genes, biomarkers, drug repurposing opportunities, and clinical trials. The TMOKB demonstrates how a high-level ontology can connect specialized domain ontologies and data to provide integrated answers across personalized medicine.
SLAS2013 Drug Repurposing SIG Meeting
Can target-based drug discovery be reconciled with phenotypic assays in the context of drug repurposing? One of the questions discussed at the SLAS Drug Repurposing SIG meeting at SLAS2013.
New drug development process
This document discusses the process of new drug development. It begins with basic research to understand disease pathways and identify potential drug targets. Promising compounds are identified through screening and optimized in preclinical testing, which evaluates safety and effectiveness in animals. If preclinical results are satisfactory, an Investigational New Drug Application is submitted to regulators to seek approval for clinical trials in humans. The drug development process is long and rigorous, aiming to bring safe and effective medications to market while meeting regulatory guidelines.
Preclinical trials
The document describes the process of pre-clinical trials for testing new drugs. It involves:
1) Identifying a drug target through basic research and applying that knowledge through applied research.
2) Developing a bioassay, usually using animal or cell models, to test the drug's safety and effectiveness.
3) Establishing the effective and toxic doses of the drug through screening in the bioassay system.
4) Filing for approval as an Investigational New Drug with the FDA if results show promise, allowing tests in human clinical trials. The goal of pre-clinical trials is to determine if a new drug or medical device is safe and effective before testing in humans using the scientific method.
Preclinical trials
The pre-clinical trial process involves testing new drugs on animal and cell bioassays before human testing to determine if they are safe and effective. It begins with basic research to identify a drug target related to a disease. Researchers then develop a bioassay and screen drug candidates to find ones that act on the target as intended without toxicity. Effective and toxic doses are established, and approval is sought from the FDA to begin clinical trials on humans by filing an Investigational New Drug application. The goal of pre-clinical trials is to apply findings from basic research on biochemical pathways and identify promising drug candidates ready for initial human testing.
Preclinical trials
The document describes the process of pre-clinical trials for testing new drugs. It involves:
1) Identifying a drug target based on basic research findings. Researchers determine targets associated with disease processes.
2) Developing a bioassay system like cell cultures or animal models to test the drug's safety and effectiveness.
3) Screening candidate drug compounds in the bioassay to determine if they interact safely and effectively with the target.
4) Establishing the effective and toxic dosage levels of any promising compounds before filing for approval to begin human clinical trials. The goal is to use the scientific method to evaluate drugs in living systems before testing in humans.
Pengantar Kimia Medisinal.pptx
Medicinal chemistry is the interdisciplinary field that combines chemistry and biology in the research and development of new pharmaceutical drugs. The goals of medicinal chemistry include discovering and designing biologically active compounds, determining their mode of action at the molecular level, and developing structure-activity relationship data to guide future drug design. Key aspects of medicinal chemistry include computer-aided drug design, drug synthesis and optimization, determining drug properties such as bioavailability and stability, and understanding the drug approval process. The ultimate goal is to develop safe and effective therapeutic agents to treat diseases.
Session 4 part 1
The document summarizes a session on designing drugs for central nervous system target classes. The session will include talks on:
1. Targeting protein-protein interactions, which is becoming more feasible as a drug strategy.
2. Challenges in targeting kinases for neurodegenerative diseases.
3. Considerations for druggability of G protein-coupled receptors and ion channels.
4. Unique challenges and lessons learned from developing biologics for difficult targets.
Opensourcepharma Dr Nibedita rath
Access to Research
Date 11-08-2018
Venue Conference HAll NIAS IISc campus
Conference and workshops for clinical practitioners to introduce them to modern tools and an alternative approach to modern scientific research.
Purpose
1. Build a network of physicians across the country
2 Train physicians to analyse clinical data and restructure it to make it compatible with research standards
3. Introduce modern tools to understand the mechanism of actions of medicine
4. Introduce artificial intelligence and machine learning to clinical practitioners to support decision-making processes
Access to Science
Clinical experience and traditional knowledge are important sources of data that affect decision making processes in modern healthcare systems. This data should be made accessible for scientific evaluation and validation to improve healthcare worldwide. The Open Source Pharma Foundation believes that clinical practitioners from various disciplines should have the right to access research so that they can help identify problems, contribute their scientific knowledge, and support the discovery ecosystem.
Background
The majority of medical practitioners working on the ground level with patients do not take part in open clinical research worldwide. However, the data collected and owned by them plays an important role in establishing better discovery pathways. Through this workshop, we seek to open opportunities to enhance health care systems around the world and to overcome the following challenges faced by medical practitioners.
1. Regulatory limitations
2. Academic limitations
3. Time constraints
4. Lack of access to modern tools
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Alp Drug discovery and development
- 1. THE QUEST FOR THE CURE
- 2. THE DRUG DISCOVERY CRISIS Are we running out of drugs??
- 3. HOW DO DRUGS WORK Most drugs (their active principle) are small molecules OMEPRAZOL DIAZEPAM IBUPROFEN PROZAC ATORVASTATIN
- 4. DRUGS OF ABUSE C o c a i n e Morphine Cannabinol (THC) Heroine (Bayer, 1874) The active principle is also a small molecule Addiction as a side effect makes them not useful
- 5. HOW DO DRUGS WORK Protein Drugs work by binding to specific proteins (enzymes) and modifying their activity The selectivity of a drug in provided by the 3D structure of the target protein Antibiotics and antivirals are drugs that inhibit bacterial and viral proteins, while leave ours untouched Besides the large number of drugs available, only 2% of the human proteins are known to targeted by the drugs
- 6. HOW NEW DRUGS ARE DISCOVERED In the past: • by identifying the active ingredient from traditional remedies (plant extracts…etc. ) • by serendipitous discovery (e.g. penicillin, benzodiazepines) Nowadays: • Large scale testing of chemical collections • Rational design
- 7. HOW NEW DRUGS ARE DISCOVERED Basic Science Screening thousand of compounds Target Development of an assay candidate for the desired activity Preclinical & clinical studies Rational design based on : • Structure of the target. • Modification of known drugs
- 8. STAGES IN THE DRUG DISCOVERY PROCESS Target selection Food and Drug Administration (FDA) in the United States (or comparable agency in other countries) The development of a new drug can take several decades and billion dollars invested Lombardino & Lowe. Nature Reviews Drug Discovery (2004) 3, 853-862
- 9. THE DRUG DISCOVERY CRISIS The future • The better understanding of human biology will offer new candidates to find drugs Are we running out of drugs?? (We must support basic research!!!) • New technologies for the rational design of drugs are in development. They will reduce costs and will provide new medicines. • There is little knowledge yet about how drugs interact. • Gene therapy methods will join the “small molecule” toolbox once their safety is assured.