This document summarizes a seminar on 3D printing of pharmaceuticals. 3D printing, also called additive manufacturing, is the process of making 3D objects from a digital file by laying down successive layers of material. There are several methods of 3D printing including selective laser sintering (SLS), fused deposition modeling (FDM), and stereolithography (SLA). 3D printing offers advantages like reduced costs, customization, and increased productivity through constant prototyping. However, it also faces challenges like high costs, limited materials, and slow printing speeds. The seminar discusses the various applications, growth, and challenges of 3D printing in the pharmaceutical industry.
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
This document provides an overview of the key departments and functions within the pharmaceutical industry. It describes the roles of production, quality control, quality assurance, engineering, regulatory affairs, and clinical research organizations. It also outlines the responsibilities of key personnel like heads of production and quality control, as well as the qualified person. The document emphasizes that effective quality management systems are important for product realization, process control, and continual improvement.
This document discusses the role and importance of regulatory affairs professionals in the pharmaceutical industry. It notes that regulatory affairs professionals ensure companies comply with relevant laws and regulations, advise on regulatory strategies and requirements, and facilitate the approval and marketing of drugs by communicating with regulatory agencies. Their work is important for developing innovative products and accelerating time to market while ensuring safety, efficacy and compliance.
Commercialization and problems with case studies in Industrial PharmacyArchana Mandava
This document discusses technology transfer and commercialization. It notes that commercialization involves identifying potential research for commercial exploitation through licensing agreements, joint ventures or spin-outs. The process involves multi-disciplinary teams and protection of intellectual property through patents, trademarks or copyrights. Key aspects of commercialization include sustaining innovations over time through a staged process that involves stakeholders. Common problems include weak intellectual property and ideas, which can be addressed through targeted funding and training commercialization managers.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
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.
This document summarizes a seminar on 3D printing of pharmaceuticals. 3D printing, also called additive manufacturing, is the process of making 3D objects from a digital file by laying down successive layers of material. There are several methods of 3D printing including selective laser sintering (SLS), fused deposition modeling (FDM), and stereolithography (SLA). 3D printing offers advantages like reduced costs, customization, and increased productivity through constant prototyping. However, it also faces challenges like high costs, limited materials, and slow printing speeds. The seminar discusses the various applications, growth, and challenges of 3D printing in the pharmaceutical industry.
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
This document provides an overview of the key departments and functions within the pharmaceutical industry. It describes the roles of production, quality control, quality assurance, engineering, regulatory affairs, and clinical research organizations. It also outlines the responsibilities of key personnel like heads of production and quality control, as well as the qualified person. The document emphasizes that effective quality management systems are important for product realization, process control, and continual improvement.
This document discusses the role and importance of regulatory affairs professionals in the pharmaceutical industry. It notes that regulatory affairs professionals ensure companies comply with relevant laws and regulations, advise on regulatory strategies and requirements, and facilitate the approval and marketing of drugs by communicating with regulatory agencies. Their work is important for developing innovative products and accelerating time to market while ensuring safety, efficacy and compliance.
Commercialization and problems with case studies in Industrial PharmacyArchana Mandava
This document discusses technology transfer and commercialization. It notes that commercialization involves identifying potential research for commercial exploitation through licensing agreements, joint ventures or spin-outs. The process involves multi-disciplinary teams and protection of intellectual property through patents, trademarks or copyrights. Key aspects of commercialization include sustaining innovations over time through a staged process that involves stakeholders. Common problems include weak intellectual property and ideas, which can be addressed through targeted funding and training commercialization managers.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
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.
- Generic drugs are comparable to brand name drugs in dosage, quality, and intended use but are cheaper. They contain the same active ingredients as original formulations.
- The generic drug development process involves concept development, system-level design, detail design, testing and refinement, production ramp-up, and product launch. It aims to develop affordable drugs that balance public health needs.
- Generic drugs are available after patents or marketing rights expire on brand name drugs. They maintain quality at affordable prices for critical diseases.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
The document discusses the generic drug development process and the Hatch-Waxman Act. It defines generic drugs as being identical to brand name drugs in active ingredients, dosage form, quality and therapeutic effects. The generic drug approval process involves submitting an Abbreviated New Drug Application to the FDA that demonstrates bioequivalence to the brand name drug. The Hatch-Waxman Act established the modern system of generic drug regulation, providing incentives for generic drugs to gain FDA approval and compensating brand name drugs for patent time lost during regulatory review.
Disruptive innovation in the pharmaceutical industrySung Yoon Bae
The document discusses the results of a study on the impact of COVID-19 lockdowns on air pollution. Researchers analyzed satellite data from NASA and the European Space Agency and found that nitrogen dioxide levels decreased significantly during lockdown periods in major cities across the world as traffic and industrial activities reduced. Overall, the temporary improvements in air quality during widespread lockdowns highlight the human-caused nature of poor air quality but also show how collective changes in behavior can positively impact the environment.
This document discusses the new quality paradigm in pharmaceuticals which emphasizes building quality in from the beginning through a systematic quality by design (QbD) approach. It outlines the key elements of QbD including establishing a quality target product profile, identifying critical quality attributes, understanding material attributes and process parameters that impact critical quality attributes through risk assessment, developing a design space, and implementing a control strategy. The new paradigm focuses on science-based approaches, quality risk management, robust quality systems, and an integrated approach across the product lifecycle between industry and regulators.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Regulatory affairs professionals act as the interface between the pharmaceutical industry and drug regulatory authorities. Their main goals are to protect human health, ensure drug safety and quality, and ensure accurate product information. Key roles include liaising with regulatory agencies, preparing regulatory submissions, and advising on regulatory requirements and guidelines. An investigational new drug (IND) application is filed with regulatory agencies to legally test an experimental drug in humans after preclinical testing. A new drug application (NDA) is filed to obtain approval to market a new drug, while an abbreviated new drug application (ANDA) is filed for generic drug approval based on demonstrating bioequivalence to an existing drug. Drug master files and active substance master files provide confidential manufacturing
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Technology transfer (tt) agencies in Indiakavita bahmani
The document discusses various agencies involved in technology transfer in India. It provides details on 6 key agencies:
1) APCTD - A UN agency that promotes technology transfer between countries in Asia and the Pacific.
2) NRDC - India's premier organization for commercializing technologies from universities and research institutions. It has licensed over 4,500 technologies.
3) TIFAC - Set up under the Department of Science and Technology to identify and implement technology projects to further goals of developing India.
4) BCIL - A public company set up to support biotechnology transfer, consulting, funding and training. It assists with commercializing academic technologies.
5) TBSE - Provides funding and consulting for small businesses
Bioavailability and bioequivalence studies are essential to ensure uniform quality, efficacy, and safety of pharmaceutical products. Bioavailability measures the rate and amount of drug that reaches systemic circulation, while bioequivalence demonstrates that generic and brand name products have comparable rates and extents of absorption. Well-designed pharmacokinetic studies are commonly used to assess bioequivalence by comparing AUC and Cmax of test and reference products. Factors like dosage form, solubility, transit time and metabolism can influence bioavailability, so studies may be necessary after manufacturing changes or for different routes of administration. Guidelines regulate bioequivalence testing to allow approval of lower-cost generic drugs while maintaining therapeutic equivalence.
This document provides a summary of a presentation on generic drugs. It discusses the definition of generic drugs, the generic drug development and approval process, provisions of the Hatch-Waxman Act, and relevant sections of the Code of Federal Regulations. The summary highlights that a generic drug must be equivalent to the branded version in ingredients, dosage, safety and efficacy. It also outlines the steps in generic drug approval via an Abbreviated New Drug Application, including requirements for bioequivalence testing and patent certifications. Additionally, it notes provisions established by the Hatch-Waxman Act related to patent term extensions and patent challenges involved in the generic approval pathway.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
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.
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
The ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) brings together regulatory authorities and pharmaceutical industry representatives from Europe, Japan and the US to discuss scientific and technical issues around ensuring safety, quality and efficacy of medicines. The objectives of ICH include increasing international harmonization of technical requirements and developing pharmaceuticals in an efficient manner while promoting public health. ICH guidelines cover quality, safety, efficacy and multidisciplinary topics with the goal of international harmonization.
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
This document discusses the role of information technology in pharmacy. It begins by defining information technology and pharmacy informatics. It explains that IT systems automate manual work in the pharmaceutical industry and aid in efficiency, accuracy, and decision making through various software programs. The document highlights the importance of IT in providing time savings, reducing costs, aiding research, and preventing medication errors. It then explores several technologies including 3D printing, which can be used to create customized drug doses; nanotechnology for targeted drug delivery and detection of medication adherence; and mHealth sensors in smartphones and devices that can remotely monitor patients for clinical research studies.
This presentation contains an introduction to emerging healthcare Technologies. These emerging technologies include Data Analytics, AI, Blockchain, Telehealth, virtual reality, cloud computing, and IOT. The concept of Nanorobots as future medicine is also included in this presentation.
- Generic drugs are comparable to brand name drugs in dosage, quality, and intended use but are cheaper. They contain the same active ingredients as original formulations.
- The generic drug development process involves concept development, system-level design, detail design, testing and refinement, production ramp-up, and product launch. It aims to develop affordable drugs that balance public health needs.
- Generic drugs are available after patents or marketing rights expire on brand name drugs. They maintain quality at affordable prices for critical diseases.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
The document discusses the generic drug development process and the Hatch-Waxman Act. It defines generic drugs as being identical to brand name drugs in active ingredients, dosage form, quality and therapeutic effects. The generic drug approval process involves submitting an Abbreviated New Drug Application to the FDA that demonstrates bioequivalence to the brand name drug. The Hatch-Waxman Act established the modern system of generic drug regulation, providing incentives for generic drugs to gain FDA approval and compensating brand name drugs for patent time lost during regulatory review.
Disruptive innovation in the pharmaceutical industrySung Yoon Bae
The document discusses the results of a study on the impact of COVID-19 lockdowns on air pollution. Researchers analyzed satellite data from NASA and the European Space Agency and found that nitrogen dioxide levels decreased significantly during lockdown periods in major cities across the world as traffic and industrial activities reduced. Overall, the temporary improvements in air quality during widespread lockdowns highlight the human-caused nature of poor air quality but also show how collective changes in behavior can positively impact the environment.
This document discusses the new quality paradigm in pharmaceuticals which emphasizes building quality in from the beginning through a systematic quality by design (QbD) approach. It outlines the key elements of QbD including establishing a quality target product profile, identifying critical quality attributes, understanding material attributes and process parameters that impact critical quality attributes through risk assessment, developing a design space, and implementing a control strategy. The new paradigm focuses on science-based approaches, quality risk management, robust quality systems, and an integrated approach across the product lifecycle between industry and regulators.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Regulatory affairs professionals act as the interface between the pharmaceutical industry and drug regulatory authorities. Their main goals are to protect human health, ensure drug safety and quality, and ensure accurate product information. Key roles include liaising with regulatory agencies, preparing regulatory submissions, and advising on regulatory requirements and guidelines. An investigational new drug (IND) application is filed with regulatory agencies to legally test an experimental drug in humans after preclinical testing. A new drug application (NDA) is filed to obtain approval to market a new drug, while an abbreviated new drug application (ANDA) is filed for generic drug approval based on demonstrating bioequivalence to an existing drug. Drug master files and active substance master files provide confidential manufacturing
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Technology transfer (tt) agencies in Indiakavita bahmani
The document discusses various agencies involved in technology transfer in India. It provides details on 6 key agencies:
1) APCTD - A UN agency that promotes technology transfer between countries in Asia and the Pacific.
2) NRDC - India's premier organization for commercializing technologies from universities and research institutions. It has licensed over 4,500 technologies.
3) TIFAC - Set up under the Department of Science and Technology to identify and implement technology projects to further goals of developing India.
4) BCIL - A public company set up to support biotechnology transfer, consulting, funding and training. It assists with commercializing academic technologies.
5) TBSE - Provides funding and consulting for small businesses
Bioavailability and bioequivalence studies are essential to ensure uniform quality, efficacy, and safety of pharmaceutical products. Bioavailability measures the rate and amount of drug that reaches systemic circulation, while bioequivalence demonstrates that generic and brand name products have comparable rates and extents of absorption. Well-designed pharmacokinetic studies are commonly used to assess bioequivalence by comparing AUC and Cmax of test and reference products. Factors like dosage form, solubility, transit time and metabolism can influence bioavailability, so studies may be necessary after manufacturing changes or for different routes of administration. Guidelines regulate bioequivalence testing to allow approval of lower-cost generic drugs while maintaining therapeutic equivalence.
This document provides a summary of a presentation on generic drugs. It discusses the definition of generic drugs, the generic drug development and approval process, provisions of the Hatch-Waxman Act, and relevant sections of the Code of Federal Regulations. The summary highlights that a generic drug must be equivalent to the branded version in ingredients, dosage, safety and efficacy. It also outlines the steps in generic drug approval via an Abbreviated New Drug Application, including requirements for bioequivalence testing and patent certifications. Additionally, it notes provisions established by the Hatch-Waxman Act related to patent term extensions and patent challenges involved in the generic approval pathway.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
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.
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
The ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) brings together regulatory authorities and pharmaceutical industry representatives from Europe, Japan and the US to discuss scientific and technical issues around ensuring safety, quality and efficacy of medicines. The objectives of ICH include increasing international harmonization of technical requirements and developing pharmaceuticals in an efficient manner while promoting public health. ICH guidelines cover quality, safety, efficacy and multidisciplinary topics with the goal of international harmonization.
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
This document discusses the role of information technology in pharmacy. It begins by defining information technology and pharmacy informatics. It explains that IT systems automate manual work in the pharmaceutical industry and aid in efficiency, accuracy, and decision making through various software programs. The document highlights the importance of IT in providing time savings, reducing costs, aiding research, and preventing medication errors. It then explores several technologies including 3D printing, which can be used to create customized drug doses; nanotechnology for targeted drug delivery and detection of medication adherence; and mHealth sensors in smartphones and devices that can remotely monitor patients for clinical research studies.
This presentation contains an introduction to emerging healthcare Technologies. These emerging technologies include Data Analytics, AI, Blockchain, Telehealth, virtual reality, cloud computing, and IOT. The concept of Nanorobots as future medicine is also included in this presentation.
This document discusses artificial intelligence and its applications in the pharmaceutical industry. It begins with definitions of artificial intelligence and its goal of simulating human logic and reasoning. It then describes several applications of AI in pharmaceuticals, including disease identification, personalized treatment, drug discovery/manufacturing, clinical trial research, radiology/radiotherapy, and electronic health records. Challenges and the future of AI are also mentioned. In conclusion, the author states that AI has great potential to guide humanity if developed responsibly.
In medical technologies, the potential of mRNA is thought to extend beyond the realm of vaccinations. Since mRNA can code for almost any protein, the same basic technique could theoretically pave the way for the creation of an enormous number of therapeutic interventions, each of which would work in much the same way as medicine.
This document discusses the importance and various applications of artificial intelligence in the pharmaceutical industry. It begins with an introduction from Dr. Ruchi Tiwari on the uses of AI in R&D, drug development, diagnosis, disease prevention, epidemic prediction, remote monitoring, manufacturing, and marketing. The rest of the document provides more details on each of these areas, including examples of companies using AI for drug discovery, clinical trials, adherence monitoring, and data analysis. It also discusses challenges to AI adoption in pharma such as unfamiliarity, lack of infrastructure, and unstructured data formats. The overall message is that AI has great potential to improve efficiency and outcomes across the pharmaceutical industry.
Artificial intelligence has great potential applications in public health by analyzing large health datasets to provide insights on disease determinants and shape public health policies. AI technologies like machine learning, computer vision, and deep learning can be used for epidemic prediction, disease screening, diagnostics, telemedicine, and drug discovery by analyzing medical records, images, genetic data, and more. However, AI in public health is still in its early stages and faces challenges regarding data quality, transparency, bias, regulatory issues, and replacing human jobs. Principles for ethical AI development include prioritizing human well-being, transparency, accountability, and non-discrimination. Overall, AI shows promise to transform public health when developed collaboratively with human experts.
This startup develops a wearable vitals monitor currently in clinical tests for continuously monitoring blood pressure. Originally designed to be worn behind the ear, the tool now resembles other smart watches and this shift is to encourage consumer-friendly, self-management. A number of studies have already been conducted at Massachusetts General Hospital and it is now scaling up for FDA clearance.
The document discusses various topics around mind control and brain implants including:
1) The potential for "smart pill" technology using microchips embedded in medications to track consumption and ensure compliance, but also privacy and health concerns.
2) Research on brain-computer interfaces that has progressed to allow direct communication with the brain, but raises ethical issues around consent and potential abuse.
3) Hypothetical future applications and implications of direct brain interfaces including memory enhancement, mood control implants, and autonomous control implants, but also risks of addiction or loss of control.
How AstraZeneca is Applying AI, Imaging & Data Analytics (AI-Driven Drug Deve...Nick Brown
Keynote AI Presentation given at AI-Driven Drug Development Summit Europe on 26th April 2023 in London. Overview around how AstraZeneca has been developing AI in the past 5+ years. Predominantly focused on R&D and how we are developing digital solutions & AI for right safety and right dose. AI examples include machine learning for safety assessment, augmenting digital pathology for image quantification & segmentation, understanding more about our drugs through advanced imaging modalities and first steps in applying AI for right dose - immunogenicity, adverse events and tolerability.
This document discusses the use of artificial intelligence in the pharmaceutical industry. It covers how AI can be applied across various areas like drug discovery, clinical trials, manufacturing, and healthcare. Some key benefits mentioned are reducing drug development time and costs, improving success rates of clinical trials, and optimizing manufacturing processes. Challenges to adoption like data and skills gaps are also summarized.
Poc activity group 1 (1)(Artificial intelligence in pharmaceutical indsutry)sakshibagul1
Artificial intelligence in the pharmaceutical industry has the potential to help speed up drug discovery and development processes. AI tools are being used for tasks like analyzing large datasets to predict new drug targets and compounds for further investigation. Companies are also exploring applications of AI like using machine learning algorithms to better detect cancerous tissues for radiation therapy planning. While AI shows promise for aiding decision making and reducing costs and human error, challenges remain around the lack of emotion in AI and need for more expertise to advance these technologies safely.
Artificial intelligence can be used in many areas of the pharmaceutical industry. It can help identify diseases, personalize treatment, assist with drug discovery and manufacturing, improve clinical trials, and aid radiology and radiotherapy. Some challenges remain around fully replicating human intelligence and creativity. However, AI is being applied successfully in areas like analyzing medical images and optimizing drug development processes. Many major pharmaceutical companies are investing in partnerships to further apply AI.
The document discusses various advances in medical technology in the 21st century, including 4D ultrasound that provides more detailed moving images of fetuses; microfluidic chips that can quickly diagnose the flu; non-invasive methods for detecting diabetes; brain-computer interfaces; ingestible camera pills; smart capsules equipped with tools and sensors; engineered bacteria that prevent tooth decay; artificial lymph nodes; sensors for monitoring asthma and detecting oral cancer from saliva; biological pacemakers; prosthetics that provide feedback to the user; smart contact lenses that monitor eye pressure; speech restoration devices; and absorbable heart stents. The technologies presented help with diagnoses, treatment, and quality of life.
Machine learning in health data analytics and pharmacovigilanceRevathi Boyina
Machine learning and data analytics can help improve pharmacovigilance in several ways:
1) Machine learning algorithms can automatically extract adverse drug reactions from biomedical literature and FDA drug labels, helping pharmacovigilance teams more efficiently identify all potential ADRs.
2) Large healthcare datasets and sophisticated algorithms can help pharmaceutical companies with drug discovery, clinical trials, personalized treatment, and epidemic outbreak prediction.
3) Advances in machine learning are reshaping healthcare and have the potential to cut clinical trial costs, improve quality, speed up trials, and facilitate tasks like reviewing literature, recruiting patients, and making diagnoses.
Powering the Future of Healthcare in Asia - ETPL "IOT FOR HEALTH" PROGRAM | T...Julien de Salaberry
Presentation on the importance and impact of IoT Healthcare / Healthtech on the delivery of healthcare in Asia to the ETPL "IOT FOR HEALTH" PROGRAM cohort
#healthtechasia
5 Best Companies in Digital Pathology Market, March 2023insightscare
TissueGnostics GmbH provides streamlined solutions for both biomedical imaging and image analysis through its tissue cytometers. Founded by Dr. Rupert Ecker based on his experience in microscopy during his PhD, TissueGnostics aims to advance research on cells and tissues through precision automation. The company develops its own software and works with partners to provide open platforms like TissueFAXS and COLUBRIS Tissue Cytometer with AI. Through collaborative projects, TissueGnostics continues innovating to address diverse questions in tissue cytometry while maintaining high standards for research and clinical applications.
IBM Watson, Google Health, SyncThink, and Aprecia are emerging healthcare technology companies developing applications of artificial intelligence, virtual reality, and 3D printing. IBM Watson uses natural language processing to match cancer patients to clinical trials. Google Health developed an AI algorithm to detect diabetic retinopathy from retinal scans. SyncThink uses virtual reality eye-tracking to identify brain impairment from concussions. Aprecia 3D prints personalized drugs with customized dosages and release mechanisms. These companies are poised for growth in the next five years as their technologies improve healthcare delivery and outcomes.
This will make the readers to uderstand the topics... WHAT IS ARTIFICIAL INTELLIGENCE AND HOW THIS INTELLECTUAL MACHINE USAGE ENHANCES THE PROCESS OF DRUG DISCOVERY AND ITS DEVOLOPMENT..
Similar to Innovations in pharmaceutical industry (20)
Flanton-D is a new vitamin D syrup being launched by Aishwaraya Gupta and team. It contains 400 IU of vitamin D per drop in 25 ml bottles, priced at Rs. 45. The presentation outlined Flanton-D's marketing strategy, including targeting pediatricians and general physicians. Sales of 4 million units and Rs. 1.32 crore in profit are expected in the first year by capturing 1% market share. Promotional strategies like samples and visual aids will be used to promote the brand.
Business communication, intercultural communication, uae-united arab emirates, information for reference, cross cultural information, meetings . attire, code of conduct.
Biotechnology in capsule form. Plant biotechnology . Industry related information. Latest info. Different aspects of plant biotechnology. Cell biology. industrial biotechnology.
Business proposal writing , technical writing, cost estimation, new age tech training. How to write a business proposal?
Basic contents in a technical writing. Simple template for reference.
Human resource management in pharma sectorBHARATH G
The document discusses challenges faced by HR managers in the pharmaceutical industry. It outlines several challenges: 1) a need for skilled employees in areas like clinical research and R&D due to expanding R&D activities and new subsidiaries, 2) the importance of drafting comprehensive HR policies and compliance training to ensure legal compliance, and 3) retaining top talent and addressing skill deficiencies, leadership crises, and workplace stress. The document also provides examples of HR issues faced by specific pharmaceutical companies and suggests possible solutions like outsourcing HR functions, implementing new incentive programs, and adopting employee-focused HR models.
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Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
2. INNOVATION
o Defined as the idea which must be replicable at an economic cost and must
satisfy specific need.
o Involves applications of information, imagination and initiative in deriving
greater or different values from resources.
o It includes all processes by which new idea generated and converted into useful
products.
3. 3D PRINTING
What is 3D Printing of Drugs?
Three-dimensional (3D) printing of drugs uses computer-aided designs to
manufacture individualized pharmaceutical drug products.
The USFDA approved an epilepsy medicine called spritam introduced by Aprecia
pharmaceutical company.
TECHNOLOGY:-
o Inkjet based fabrication
o Direct-write
o ZipDose®
o Thermal Inkjet printing
o Stereolithography (SLA)
o Fused deposit modeling (FDM).
5. What is the Purpose of 3D Printing of Pharmaceuticals?
o To develop medications with controlled release of drugs & fixed-dose
combinations.
o 3D bio-printed human models, tissues or organs are being used in oncology therapy
to develop newer anti-cancer drugs. Use of these models would help formulate
anti-cancer drugs quickly.
Advantages:-
o Small batches can be manufactured
o Hospitals could manufacture small batches on-demand, eliminating the need to
maintain an extensive inventory of generic formulations
o There is no need to provide extended shelf life for a product
6. mHealth Sensors
o mHealth sensors are used in the practice of medicine supported by mobile
devices.
o Can be monitored with the health and physiological data without visiting
doctor.
o Patient-compliance is more.
o World’s first Virtual Care Center– Mercy Virtual Center
8. Organ-on-chip Technology
o Emulate developed organ-on-chip technology, which has created a new living
system that emulates a human biology.
o It has been done to understand the diseases, medicines, and food affect the
human health.
o The main motive to develop this technology is to provide more predictive and
useful measures of safety and efficacy of new drug or drug combination and
also to reduce use of animals and humans in testing.
o Company has developed working models on liver, lung, intestine and brain.
9. o Translucent polymer chip models, about the size of a AA battery, could provide
drug candidate safety data with greater speed and accuracy.
o On 11 April 2017 FDA Signs Collaborative Agreement with Emulate, to Use
Organs-on-Chips Technology as a Toxicology Testing Platform for
Understanding How Products Affect Human Health and Safety.
o In human chip, we simply recreate the environment required for the particular
organ.
11. MALACIDINS
o New class of antibiotic discovered in Rockefeller University, New York
o Used DNA information that encodes production of antibiotic in daptomycin
o Active against multidrug – resistant pathogens, Staphylococcus aureus (MRSA) skin
infections
13. TruMedicine
Drug and pill packet tracking app
o Pattern Image Recognition
Tru Medicines uses advanced Image Edge Neural Network processing to
identify Billions of registered pill images. Method protected by U.S. and
International Patents.
o FDA Guidance
2011 Oct FDA guidance recommends the use
of colored excipients for identification and
prevention of counterfeiting.
o High Speed Cameras
To verify quality of pills and capsules in 2,500 production lines. 360
degree photos 2,000/min., 100%inspection, images uploaded to cloud
databases
14. o Opioid Treatment Tracking
Compliance with drug treatment programs can monitor hundreds of
patients at a fraction of the cost of traditional 30 day in-service treatment
programs. Stops Relapse
o Deep pill open Source API
TruMedicines open source API interface allows 3rd party developers to
integrate image recognition into hardware; Pill Packaging, Smart Pill
dispensers, etc.
15. Track billons of
pills or pill packets
instantly using GPS
It helps
to recalls
product
within
24 hr
Combine
power of
machine
learning image
recognition