This presentation provides an overview of Galectin Therapeutics' clinical development programs and strategy. Key points include:
1) Galectin Therapeutics is developing carbohydrate-based drugs that bind to galectin proteins to treat diseases where galectins are important, including liver fibrosis, cancer, and others.
2) For liver fibrosis, the lead drug GR-MD-02 is in a Phase 1 trial in NASH patients with advanced fibrosis. Phase 2 plans target NASH patients with advanced fibrosis.
3) For cancer, the strategy is to enhance immunotherapy by inhibiting galectins. A Phase 2a trial is ongoing combining GM-CT-01 with a melanoma vaccine. Preclinical
This document discusses expedited drug development and review pathways at the FDA, including Subpart E and Subpart H. Subpart E allows for an expedited approval based on early consultation and compressed clinical trials for drugs treating serious diseases lacking alternatives. Subpart H, called accelerated approval, allows for earlier approval based on surrogate endpoints, with required post-approval studies and restrictions until clinical benefit is verified. Both aim to get drugs to patients faster while maintaining safety standards.
This document summarizes a presentation on clinical practice tools for identifying potential medication-related problems in the elderly. The presentation discusses several tools including the Beers List, Medication Appropriateness Index, IPET, Zhan-AHRQ, Medication Regimen Appropriateness Index, STOPP/START, IMAP, and NCQA-HEDIS. It provides definitions of related terms and describes each tool, how it was developed, its strengths and limitations. The presentation aims to help clinicians incorporate these tools into practice to improve medication management for elderly patients.
The document summarizes the 2015 update of the American Geriatrics Society Beers Criteria, which provides a list of potentially inappropriate medications that should generally be avoided in older adults. Key points:
- The updated criteria include revisions to existing medications to avoid as well as new sections on medications requiring dose adjustments for kidney function and drug-drug interactions.
- A 13-member expert panel reviewed evidence and reached consensus on the criteria using a systematic, evidence-based process.
- The criteria are intended to improve medication safety for older adults by providing guidance to medical professionals, consumers, and health systems.
Clinical Pharmacology: Leveraging Science to Provide AccessE. Dennis Bashaw
1) The document discusses the paradigm shift in biomarker development from a "learn and confirm" model to an "identify, confirm, refine, and learn" model to continuously learn from clinical trials.
2) It outlines policies used by the FDA to incentivize orphan drug development, including expedited programs, marketing exclusivity, and fee reductions. International collaboration is important for developing policies tailored to individual countries.
3) Successful partnerships between the FDA, NIH, patient groups, and industry have helped advance rare disease drug development, including through biospecimen repositories and training programs.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
Here are three scenarios that could result in overpayments subject to
limitation on recoupment under Section 935:
1. A hospital is paid for an inpatient admission under Medicare Part A. Upon a post-
payment review, the MAC determines the admission was not medically necessary
and issues a written demand letter for repayment of the claim. This would be
subject to 935 limitations.
2. A home health agency receives a Request for Anticipated Payment (RAP) and
provides services to a Medicare beneficiary. Upon filing the final claim, the MAC
determines the beneficiary was not homebound and denies the claim. A written
demand is issued.
Transalational Sciences and Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This document discusses challenges and solutions for developing orphan drugs and implementing precision medicine programs. It notes that orphan drug development faces resource constraints as trials require more patients than rare diseases have. However, using clinical pharmacology tools allows learning from small populations by incorporating biomarkers, modeling, and innovative designs. The future of drug development lies in going beyond traditional trials to involve patients more and continually learn from individual experiences. Quantitative tools during all stages of development can extract maximum knowledge from minimal data to improve understanding, approval chances, and labeling.
The Survivor community can learn more about the state of the art in new tests available in cancer centres, which pinpoint specific types of tumours that will respond best to treatments.
This document discusses expedited drug development and review pathways at the FDA, including Subpart E and Subpart H. Subpart E allows for an expedited approval based on early consultation and compressed clinical trials for drugs treating serious diseases lacking alternatives. Subpart H, called accelerated approval, allows for earlier approval based on surrogate endpoints, with required post-approval studies and restrictions until clinical benefit is verified. Both aim to get drugs to patients faster while maintaining safety standards.
This document summarizes a presentation on clinical practice tools for identifying potential medication-related problems in the elderly. The presentation discusses several tools including the Beers List, Medication Appropriateness Index, IPET, Zhan-AHRQ, Medication Regimen Appropriateness Index, STOPP/START, IMAP, and NCQA-HEDIS. It provides definitions of related terms and describes each tool, how it was developed, its strengths and limitations. The presentation aims to help clinicians incorporate these tools into practice to improve medication management for elderly patients.
The document summarizes the 2015 update of the American Geriatrics Society Beers Criteria, which provides a list of potentially inappropriate medications that should generally be avoided in older adults. Key points:
- The updated criteria include revisions to existing medications to avoid as well as new sections on medications requiring dose adjustments for kidney function and drug-drug interactions.
- A 13-member expert panel reviewed evidence and reached consensus on the criteria using a systematic, evidence-based process.
- The criteria are intended to improve medication safety for older adults by providing guidance to medical professionals, consumers, and health systems.
Clinical Pharmacology: Leveraging Science to Provide AccessE. Dennis Bashaw
1) The document discusses the paradigm shift in biomarker development from a "learn and confirm" model to an "identify, confirm, refine, and learn" model to continuously learn from clinical trials.
2) It outlines policies used by the FDA to incentivize orphan drug development, including expedited programs, marketing exclusivity, and fee reductions. International collaboration is important for developing policies tailored to individual countries.
3) Successful partnerships between the FDA, NIH, patient groups, and industry have helped advance rare disease drug development, including through biospecimen repositories and training programs.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
Here are three scenarios that could result in overpayments subject to
limitation on recoupment under Section 935:
1. A hospital is paid for an inpatient admission under Medicare Part A. Upon a post-
payment review, the MAC determines the admission was not medically necessary
and issues a written demand letter for repayment of the claim. This would be
subject to 935 limitations.
2. A home health agency receives a Request for Anticipated Payment (RAP) and
provides services to a Medicare beneficiary. Upon filing the final claim, the MAC
determines the beneficiary was not homebound and denies the claim. A written
demand is issued.
Transalational Sciences and Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This document discusses challenges and solutions for developing orphan drugs and implementing precision medicine programs. It notes that orphan drug development faces resource constraints as trials require more patients than rare diseases have. However, using clinical pharmacology tools allows learning from small populations by incorporating biomarkers, modeling, and innovative designs. The future of drug development lies in going beyond traditional trials to involve patients more and continually learn from individual experiences. Quantitative tools during all stages of development can extract maximum knowledge from minimal data to improve understanding, approval chances, and labeling.
The Survivor community can learn more about the state of the art in new tests available in cancer centres, which pinpoint specific types of tumours that will respond best to treatments.
The document summarizes the 2019 update of the American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. An expert panel reviewed evidence published since the 2015 update and determined whether new criteria should be added or existing criteria removed or modified. The panel retained the five types of criteria from the 2015 update and incorporated new evidence. The goal is to improve care for older adults by reducing exposure to medications with unfavorable benefit-harm balances or safer alternatives.
Getting the most out of your scpp practice review l. postnikoffPASaskatchewan
The document provides information about practice reviews conducted by the Saskatchewan College of Pharmacy Professionals (SCPP). The goals of the reviews are to assess compliance with standards of practice, provide information on safe medication practices, communicate priorities and policies, provide support to pharmacists, and assess compliance with regulations. Pharmacies complete a self-assessment prior to the review visit. The review evaluates pharmacists' documentation of patient information, assessment of medication therapy, patient education, prescribing practices when applicable, advanced scope of practice such as injections, and effective use of pharmacy personnel.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
The document outlines the steps taken to implement a comprehensive transition of care program for patients with acute venous thromboembolic events (VTE) who present to the emergency department. The program allows for appropriately selected patients to be safely discharged directly from the ED to outpatient care with oral anticoagulation therapy. Key elements of the program include developing standardized order sets, patient education materials, and discharge processes, as well as establishing patient tracking and follow up. An evaluation of outcomes after one year found no patients experienced VTE-related readmissions or complications, and patient satisfaction with the program was high.
The Future of pharmacogenomics applications in Alberta Community PharmaciesDalia A. Hamdy
The document discusses current efforts in Alberta, Canada to implement pharmacogenomic (PGx) testing in community pharmacies. A few pharmacies started offering PGx testing services in 2016. A 2018 study found that while patients are open to PGx testing, pharmacists lack confidence in counseling on genetic results and PGx education is needed in pharmacy curricula. Alberta regulatory and educational organizations are working to increase PGx implementation and awareness among pharmacists and patients. A 2020-2021 study will expand PGx services to rural areas and assess clinical outcomes to support wider adoption across Alberta pharmacies.
Balancing post-market monitoring with pre-market requirementsTGA Australia
Dr Jane Cook discusses balancing pre-market requirements with post-market monitoring of new drugs. International trends show increased demand for early access to promising new therapies and different regulatory approaches between Europe and the US. This includes adaptive licensing in Europe and breakthrough therapy designation in the US. Ensuring benefits are realized requires effective post-market monitoring as initial trials may overstate benefits or overlook safety issues. Opportunities exist to learn from other regulators and focus on the drug lifecycle to confirm benefits, inform patients of limitations, and withdraw products if risks outweigh benefits.
This document summarizes the roles and services provided by pharmacists in the UK healthcare system. It outlines essential services like dispensing medications and providing advice for self-care that all pharmacies must offer. It also describes advanced and locally commissioned services pharmacists can provide, such as managing prescriptions, reviewing medications, and screening for conditions. The document discusses how pharmacists aim to optimize medication use, support independent living, and promote public health. It notes payment incentives for pharmacists, like the Quality and Outcomes Framework, to improve care for conditions like diabetes, hypertension, and mental health issues.
Causality Assessment of Adverse Drug Reactions: An overviewDrSahilKumar
Causality assessment is important for determining if an adverse drug reaction is caused by a medication. Several scales exist to assess causality, including the WHO-UMC scale and Naranjo scale. The WHO-UMC scale categorizes causality as certain, probable, possible, unlikely, unclassified or unassessable based on factors like dechallenge/rechallenge outcomes, alternative causes, and temporal relationship. Accurately assessing causality prevents unnecessary drug withdrawals but also identifies true safety issues. Exercises are provided to help learn causality assessment.
This document summarizes a proposed Patient Blood Management (PBM) program at St. Elsewhere Hospital. It identifies issues with current transfusion practices and policies across three pilot areas: post-partum haemorrhage, pre-operative optimization of haemoglobin levels, and deployment of intraoperative cell salvage. The program proposes applying ISO 9001 quality management standards to establish a PBM quality system and governance structure to standardize practices, reduce unnecessary transfusions, and improve outcomes. Key elements include developing a PBM committee, validating all clinical policies, establishing responsibilities and trainings, and deploying alternatives to transfusion like intraoperative cell salvage. The flexibility of ISO 9001 makes it suitable to implement across complex healthcare organizations
The regulation of complementary medicinesTGA Australia
The Therapeutic Goods Administration (TGA) regulates complementary medicines in Australia using a risk-based, two-tiered system. Lower risk listed medicines can be marketed with minimal pre-market evaluation, while higher risk registered medicines require pre-market assessment of quality, safety and efficacy. The TGA oversees post-market monitoring and compliance reviews to ensure that medicines meet regulatory requirements. Guidance materials provide information on evidence requirements and the different pathways for listed and registered complementary medicines.
This document discusses using real world data from healthcare databases to support adaptive biomedical innovation. It outlines four key principles - meaningful, valid, expedited, and transparent evidence (MVET) - that are necessary to generate evidence from healthcare databases that is fit for decision making. Meaningful evidence requires using relevant and high quality data sources to answer the research question. Evidence should be generated and shared in a transparent manner while protecting patient privacy. Following MVET principles can help produce rigorous evidence from real world data to support faster access to new medications through adaptive pathways, while maintaining evidentiary standards.
Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, a...OARSI
The document discusses considerations for developing medical products to treat osteoarthritis (OA) using structural endpoints. It notes that while modifying disease pathophysiology and changing the natural course of OA is desirable, there are challenges to reliably assessing a product's ability to alter disease progression. Specifically, there is a lack of standard definitions for progression and validated endpoints. Additionally, the relationship between structural changes and symptoms/function is variable. The document advises that substantial evidence would be needed to accept a structural endpoint for accelerated approval and reliably predict clinical benefits like reduced pain and increased function. The ultimate goal is to avoid joint failure and replacement while preserving function and relieving pain.
Breakthrough Therapy Designation- Spring 2014 Reg. IntelligenceCharles Kemmerer
Breakthrough Therapy Designation is a process created by the FDA to expedite the development and review of drugs for serious conditions. It requires preliminary clinical evidence that the drug may demonstrate substantial improvement over existing therapies. This allows drugs to be submitted for approval based on smaller trials. Benefits of designation include intensive FDA guidance, involvement of senior managers, and potentially reaching the market 3 years faster than standard approval. However, the designation may be removed if later trials do not confirm preliminary results. As of September 2013, 40 drugs had received this designation from the FDA.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
This webinar covered oral chemotherapy options for colorectal cancer. The speaker discussed commonly used intravenous drugs as well as the two FDA-approved oral options: capecitabine and regorafenib. Capecitabine is an oral prodrug of 5-FU that is used as an alternative to intravenous 5-FU for stages II-IV disease. Regorafenib is used for metastatic colorectal cancer that has progressed on all standard therapies. The talk outlined how the drugs work, their administration schedules, common side effects, and factors to consider when determining if oral chemotherapy is appropriate. It emphasized that oral chemotherapy still requires vigilance regarding side effects and medication adherence.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
Presentation to the Joint Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference on May 6, 2016, in Irvine, CA, with a focus on the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
This document discusses the detection and monitoring of adverse drug reactions (ADRs). It outlines that ADRs are detected through pre-marketing studies such as acute toxicity and specific animal tests as well as clinical trials. Post-marketing surveillance also plays an important role in ADR detection through spontaneous reporting systems and epidemiological methods. In hospitals, healthcare professionals can detect ADRs by closely monitoring high-risk patients and collecting detailed patient data to assess causality and severity of suspected ADRs.
Quality assurance of clinical pharmacy servicesvarshawadnere
This document discusses quality assurance in clinical pharmacy services. It defines quality assurance as ensuring quality of practice and outcomes. The main objectives are to ensure appropriate patient care, monitor medicine needs, and evaluate service standards. Key quality assurance services discussed include patient counseling, adverse drug reporting, and drug information. The document outlines methods for assessing these services, including performance appraisal, peer review, and clinical audit. It also evaluates patient counseling and quality assurance in drug information services.
Pharmaceutical care concepts - clinical pharmacy ShaistaSumayya
This document summarizes the concept of pharmaceutical care as presented by Shaista Sumayya, a 4th year PharmD student. It defines pharmaceutical care as the direct provision of medication-related care to improve patient outcomes. The pharmacist's role involves identifying and resolving drug-related problems by designing treatment plans, monitoring outcomes, and preventing potential issues. Key aspects of pharmaceutical care include collecting patient data, evaluating treatment alternatives, individualizing drug regimens, and documenting provided care. The overall goal is to cure diseases, reduce symptoms, and improve a patient's quality of life through optimized medication management.
Lattice Inc. is a communications technology company that provides services to correctional facilities. It has experienced 400% growth from 2009 to 2012 with a 90% CAGR. It provides cloud-based services that give smaller facilities access to technology traditionally only available to larger facilities. The correctional technology market is over $5 billion annually and growing as the prison population increases 3% per year. While large national competitors focus on larger facilities, Lattice aims to capture market share in smaller facilities by providing better technology and services. Lattice is also expanding internationally where the market is less developed and its technology gives it an advantage over incumbent telecom providers.
The document provides an overview of Aspen Group, Inc., a publicly traded online university. It discusses Aspen's business model, competitive advantages, and financial projections. Key points include:
- Aspen focuses on graduate degree programs like MBAs and MSNs, which have higher completion rates and salaries than undergraduate programs.
- Their low tuition rates and in-house student acquisition model help keep costs down compared to competitors.
- Projections estimate growing student enrollment from 2,300 in 2013 to 5,000 in 2015, with revenues increasing from over $4 million to over $11 million in that period.
- Aspen expects to break even on an adjusted EBITDA basis around 2,500 students and achieve
The document summarizes the 2019 update of the American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. An expert panel reviewed evidence published since the 2015 update and determined whether new criteria should be added or existing criteria removed or modified. The panel retained the five types of criteria from the 2015 update and incorporated new evidence. The goal is to improve care for older adults by reducing exposure to medications with unfavorable benefit-harm balances or safer alternatives.
Getting the most out of your scpp practice review l. postnikoffPASaskatchewan
The document provides information about practice reviews conducted by the Saskatchewan College of Pharmacy Professionals (SCPP). The goals of the reviews are to assess compliance with standards of practice, provide information on safe medication practices, communicate priorities and policies, provide support to pharmacists, and assess compliance with regulations. Pharmacies complete a self-assessment prior to the review visit. The review evaluates pharmacists' documentation of patient information, assessment of medication therapy, patient education, prescribing practices when applicable, advanced scope of practice such as injections, and effective use of pharmacy personnel.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
The document outlines the steps taken to implement a comprehensive transition of care program for patients with acute venous thromboembolic events (VTE) who present to the emergency department. The program allows for appropriately selected patients to be safely discharged directly from the ED to outpatient care with oral anticoagulation therapy. Key elements of the program include developing standardized order sets, patient education materials, and discharge processes, as well as establishing patient tracking and follow up. An evaluation of outcomes after one year found no patients experienced VTE-related readmissions or complications, and patient satisfaction with the program was high.
The Future of pharmacogenomics applications in Alberta Community PharmaciesDalia A. Hamdy
The document discusses current efforts in Alberta, Canada to implement pharmacogenomic (PGx) testing in community pharmacies. A few pharmacies started offering PGx testing services in 2016. A 2018 study found that while patients are open to PGx testing, pharmacists lack confidence in counseling on genetic results and PGx education is needed in pharmacy curricula. Alberta regulatory and educational organizations are working to increase PGx implementation and awareness among pharmacists and patients. A 2020-2021 study will expand PGx services to rural areas and assess clinical outcomes to support wider adoption across Alberta pharmacies.
Balancing post-market monitoring with pre-market requirementsTGA Australia
Dr Jane Cook discusses balancing pre-market requirements with post-market monitoring of new drugs. International trends show increased demand for early access to promising new therapies and different regulatory approaches between Europe and the US. This includes adaptive licensing in Europe and breakthrough therapy designation in the US. Ensuring benefits are realized requires effective post-market monitoring as initial trials may overstate benefits or overlook safety issues. Opportunities exist to learn from other regulators and focus on the drug lifecycle to confirm benefits, inform patients of limitations, and withdraw products if risks outweigh benefits.
This document summarizes the roles and services provided by pharmacists in the UK healthcare system. It outlines essential services like dispensing medications and providing advice for self-care that all pharmacies must offer. It also describes advanced and locally commissioned services pharmacists can provide, such as managing prescriptions, reviewing medications, and screening for conditions. The document discusses how pharmacists aim to optimize medication use, support independent living, and promote public health. It notes payment incentives for pharmacists, like the Quality and Outcomes Framework, to improve care for conditions like diabetes, hypertension, and mental health issues.
Causality Assessment of Adverse Drug Reactions: An overviewDrSahilKumar
Causality assessment is important for determining if an adverse drug reaction is caused by a medication. Several scales exist to assess causality, including the WHO-UMC scale and Naranjo scale. The WHO-UMC scale categorizes causality as certain, probable, possible, unlikely, unclassified or unassessable based on factors like dechallenge/rechallenge outcomes, alternative causes, and temporal relationship. Accurately assessing causality prevents unnecessary drug withdrawals but also identifies true safety issues. Exercises are provided to help learn causality assessment.
This document summarizes a proposed Patient Blood Management (PBM) program at St. Elsewhere Hospital. It identifies issues with current transfusion practices and policies across three pilot areas: post-partum haemorrhage, pre-operative optimization of haemoglobin levels, and deployment of intraoperative cell salvage. The program proposes applying ISO 9001 quality management standards to establish a PBM quality system and governance structure to standardize practices, reduce unnecessary transfusions, and improve outcomes. Key elements include developing a PBM committee, validating all clinical policies, establishing responsibilities and trainings, and deploying alternatives to transfusion like intraoperative cell salvage. The flexibility of ISO 9001 makes it suitable to implement across complex healthcare organizations
The regulation of complementary medicinesTGA Australia
The Therapeutic Goods Administration (TGA) regulates complementary medicines in Australia using a risk-based, two-tiered system. Lower risk listed medicines can be marketed with minimal pre-market evaluation, while higher risk registered medicines require pre-market assessment of quality, safety and efficacy. The TGA oversees post-market monitoring and compliance reviews to ensure that medicines meet regulatory requirements. Guidance materials provide information on evidence requirements and the different pathways for listed and registered complementary medicines.
This document discusses using real world data from healthcare databases to support adaptive biomedical innovation. It outlines four key principles - meaningful, valid, expedited, and transparent evidence (MVET) - that are necessary to generate evidence from healthcare databases that is fit for decision making. Meaningful evidence requires using relevant and high quality data sources to answer the research question. Evidence should be generated and shared in a transparent manner while protecting patient privacy. Following MVET principles can help produce rigorous evidence from real world data to support faster access to new medications through adaptive pathways, while maintaining evidentiary standards.
Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, a...OARSI
The document discusses considerations for developing medical products to treat osteoarthritis (OA) using structural endpoints. It notes that while modifying disease pathophysiology and changing the natural course of OA is desirable, there are challenges to reliably assessing a product's ability to alter disease progression. Specifically, there is a lack of standard definitions for progression and validated endpoints. Additionally, the relationship between structural changes and symptoms/function is variable. The document advises that substantial evidence would be needed to accept a structural endpoint for accelerated approval and reliably predict clinical benefits like reduced pain and increased function. The ultimate goal is to avoid joint failure and replacement while preserving function and relieving pain.
Breakthrough Therapy Designation- Spring 2014 Reg. IntelligenceCharles Kemmerer
Breakthrough Therapy Designation is a process created by the FDA to expedite the development and review of drugs for serious conditions. It requires preliminary clinical evidence that the drug may demonstrate substantial improvement over existing therapies. This allows drugs to be submitted for approval based on smaller trials. Benefits of designation include intensive FDA guidance, involvement of senior managers, and potentially reaching the market 3 years faster than standard approval. However, the designation may be removed if later trials do not confirm preliminary results. As of September 2013, 40 drugs had received this designation from the FDA.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
This webinar covered oral chemotherapy options for colorectal cancer. The speaker discussed commonly used intravenous drugs as well as the two FDA-approved oral options: capecitabine and regorafenib. Capecitabine is an oral prodrug of 5-FU that is used as an alternative to intravenous 5-FU for stages II-IV disease. Regorafenib is used for metastatic colorectal cancer that has progressed on all standard therapies. The talk outlined how the drugs work, their administration schedules, common side effects, and factors to consider when determining if oral chemotherapy is appropriate. It emphasized that oral chemotherapy still requires vigilance regarding side effects and medication adherence.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
Presentation to the Joint Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference on May 6, 2016, in Irvine, CA, with a focus on the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
This document discusses the detection and monitoring of adverse drug reactions (ADRs). It outlines that ADRs are detected through pre-marketing studies such as acute toxicity and specific animal tests as well as clinical trials. Post-marketing surveillance also plays an important role in ADR detection through spontaneous reporting systems and epidemiological methods. In hospitals, healthcare professionals can detect ADRs by closely monitoring high-risk patients and collecting detailed patient data to assess causality and severity of suspected ADRs.
Quality assurance of clinical pharmacy servicesvarshawadnere
This document discusses quality assurance in clinical pharmacy services. It defines quality assurance as ensuring quality of practice and outcomes. The main objectives are to ensure appropriate patient care, monitor medicine needs, and evaluate service standards. Key quality assurance services discussed include patient counseling, adverse drug reporting, and drug information. The document outlines methods for assessing these services, including performance appraisal, peer review, and clinical audit. It also evaluates patient counseling and quality assurance in drug information services.
Pharmaceutical care concepts - clinical pharmacy ShaistaSumayya
This document summarizes the concept of pharmaceutical care as presented by Shaista Sumayya, a 4th year PharmD student. It defines pharmaceutical care as the direct provision of medication-related care to improve patient outcomes. The pharmacist's role involves identifying and resolving drug-related problems by designing treatment plans, monitoring outcomes, and preventing potential issues. Key aspects of pharmaceutical care include collecting patient data, evaluating treatment alternatives, individualizing drug regimens, and documenting provided care. The overall goal is to cure diseases, reduce symptoms, and improve a patient's quality of life through optimized medication management.
Lattice Inc. is a communications technology company that provides services to correctional facilities. It has experienced 400% growth from 2009 to 2012 with a 90% CAGR. It provides cloud-based services that give smaller facilities access to technology traditionally only available to larger facilities. The correctional technology market is over $5 billion annually and growing as the prison population increases 3% per year. While large national competitors focus on larger facilities, Lattice aims to capture market share in smaller facilities by providing better technology and services. Lattice is also expanding internationally where the market is less developed and its technology gives it an advantage over incumbent telecom providers.
The document provides an overview of Aspen Group, Inc., a publicly traded online university. It discusses Aspen's business model, competitive advantages, and financial projections. Key points include:
- Aspen focuses on graduate degree programs like MBAs and MSNs, which have higher completion rates and salaries than undergraduate programs.
- Their low tuition rates and in-house student acquisition model help keep costs down compared to competitors.
- Projections estimate growing student enrollment from 2,300 in 2013 to 5,000 in 2015, with revenues increasing from over $4 million to over $11 million in that period.
- Aspen expects to break even on an adjusted EBITDA basis around 2,500 students and achieve
GlyEco is a green chemistry company that uses its patented GlyEco Technology to recycle hazardous waste glycol from various industries into virgin-quality glycol. It operates 7 processing centers across the US to recycle over 700 million gallons of waste glycol produced annually. The recycled glycol meets the highest purity specifications and is sold at prices comparable to refinery-grade glycol. GlyEco aims to expand its market share domestically and internationally by partnering with other waste collectors and acquiring other recycling companies.
This document provides an overview of Quadrant 4 System Corporation and its business. It summarizes the company's products and services which focus on social, mobile, analytics and cloud technologies. Key points include that Q4 expects over $50 million in revenue in 2014 through organic growth of existing products like its retail and healthcare platforms. It is focused on capitalizing on digital disruptions across industries through its technology stack and growth strategy of expanding customer base, products and strategic acquisitions.
Direct Insite (“DIRI”) provides cloud-based, ERP-agnostic solutions that automate Accounts Payable (AP) and Accounts Receivable (AR) invoice processes for Global 3000 companies. Their solutions include invoice validation, order matching, consolidation, dispute handling and e-payment processing. DIRI helps clients eliminate manual processes and costs associated with doing everything on paper. By migrating from paper to electronic, DIRI can reduce transactions costs 50-70% and reduce time by 80%. Current clients include Siemens, HP, IBM, Saint-Gobain, Shell Oil, and Hyatt with a Global vendor network of 350,000+ suppliers.
Ron Najafi, Chairman and CEO of NovaBay Pharmaceuticals, provided an update to shareholders at their annual meeting. NovaBay is developing new anti-infective products to address the growing crisis of antibiotic resistance. Their lead product candidates include auriclosene, which has shown effectiveness against bacteria, viruses, and fungi in clinical trials for conditions like conjunctivitis and impetigo, without inducing resistance. NovaBay also markets NeutroPhase, a pure hypochlorous acid solution for wound care. They anticipate results from multiple global phase 2 clinical trials in 2013 and have established partnerships to commercialize their products in key markets.
Quadrant 4 Systems Corporation is a leading provider in of health exchange platforms, innovative software products and proprietary SMAC (social media, mobility, analytics and cloud computing) solutions to enterprise clients in Retail and Manufacturing, Media and Publishing, Financial Services and Health Care sectors.
This document provides an overview of Actinium Pharmaceuticals, Inc. and summarizes their proprietary alpha particle immunotherapy technology and product pipeline. Key points include:
1) Actinium has a pipeline of targeted radiotherapy candidates using alpha emitters to treat various blood cancers. Their lead candidate, Iomab-B, is being developed for conditioning blood cancer patients prior to bone marrow transplant.
2) Iomab-B has shown promising results in clinical trials, successfully preparing older refractory AML patients for transplant who otherwise would not be eligible. Actinium has FDA agreement to advance Iomab-B into a Phase III registration trial.
3) Actinium has a proprietary technology
Richfield Oil & Gas Company (OTCQX: ROIL) is an independent exploration and production company headquartered in Salt Lake City, Utah. The Company’s current oil production flows from wells in fields located in Kansas and Wyoming. In addition to several thousand acres in Kansas, Richfield also owns strategically-located exploratory leases in central Utah on trend to major oil discoveries.
The document is a presentation by Energy Fuels Inc., America's premier uranium producer, discussing its corporate overview and proposed acquisition of Strathmore Minerals. It summarizes that Energy Fuels is the only conventional uranium producer in the US, with plans to become the dominant producer in the US and a mid-tier global producer. It currently produces around 1.2 million pounds annually from its Arizona mines, but sees potential to increase production to 3.5 million pounds annually from 8 mines across 4 Western states if uranium prices strengthen. The proposed acquisition of Strathmore enhances its future production profile and valuation.
Texas Rare Earth Resources is a mining company focused on exploring and developing rare earths from its 950 acre Round Top lease in Texas. An independent study estimated over 1 billion metric tonnes of rare earth elements at the Round Top site. The management team includes CEO Daniel Gorski, who has decades of experience in mining projects in Latin America and Texas, and Director Anthony Marchese, a senior vice president of an investment firm focusing on companies where officers acquire their own stock.
StationDigital is a digital media and ecommerce platform that allows users to stream or access any media and purchase digital and physical goods from any device. It has grown rapidly since its public beta launch in 2013, achieving over 1.3 million mobile users. The presentation outlines StationDigital's mission and growth strategy, competitive advantages over other media companies, and large market opportunity in digital media and ecommerce. It argues that StationDigital is well positioned for continued growth and market share capture.
This document provides an overview of AV Therapeutics, a biotechnology company developing safer and more effective chemotherapeutic agents. Their lead drug candidate, Capridine-β, shows promise for treating prostate cancer. It has demonstrated efficacy against hormone-responsive and non-responsive prostate cancer xenografts in mice, with limited side effects. Capridine-β is a patented anticancer drug that kills prostate cancer cells preferentially over other cell types and has been shown to be more potent than other drugs like taxanes. AV Therapeutics aims to develop Capridine-β as an effective drug-based therapy for prostate cancer with a better safety profile than existing options.
Lattice Inc. provides technology services to correctional facilities and has experienced 700% revenue growth from 2009 to 2013. It offers a suite of cloud-based services that provide secure communications and information technology to smaller facilities. Some of its products and services include video visitation, email, music downloads, and an integrated jail management software solution. While it faces competition from larger national service providers, Lattice has a technology advantage in serving smaller facilities. It sees opportunities for continued growth in both the US market and expanding internationally.
- GlyEco is an innovative green chemistry company that recycles glycol using a breakthrough, patent-pending technology.
- The technology transforms hazardous waste glycol into Type 1 quality recycled glycol that can be sold at the same price as refinery grade product.
- GlyEco is aggressively acquiring existing glycol recycling companies to expand capacity and integrate the new technology to better serve customer needs.
American Water provides water and wastewater services to approximately 14 million people in 16 states, has a market capitalization of $8.6 billion, and seeks to continue growing its regulated water business through capital investments and acquisitions while also expanding its complementary market-based business lines. The company has delivered strong total shareholder returns since its 2008 IPO and maintains a transparent dividend policy aimed at increasing its dividend in line with normalized earnings per share growth.
StarStream Entertainment aims to be a theatrical motion picture production and financing company focused on producing edgy, high quality films with strong casts and lean budgets. It mitigates risk through fiscal precision by financing projects once they are fully developed and ready to produce, offering investors a quicker return. Recent successful films include Lee Daniels' The Butler, Life of Crime, and Life After Beth.
“The Coin Tree is a cloud-based storage, insurance, and payment processing platform for bitcoin that leverages cutting edge transactional security to serve the ever expanding virtual currency community."
Profire Energy is an oilfield technology company that specializes in burner management systems (BMS). A BMS automates the monitoring and control of burner flames, improving safety and efficiency for oil and gas companies. Profire has experienced strong revenue growth in recent years and expects revenues to increase 5% in 2013 to $16.7 million and 34% in 2014 to $22.5 million, driven by continued adoption of BMS in the United States and Canada. The company is profitable with no long-term debt and forecasts net income to grow 200% in 2014 to $4.2 million.
This document summarizes a corporate presentation for Galectin Therapeutics. It provides an overview of the company and its clinical-stage drug candidates that target galectin proteins to treat fibrotic diseases and cancer. Key points include:
- Galectin Therapeutics is developing inhibitors of galectin-3 to treat conditions like liver fibrosis and cancer.
- Their lead candidate, GR-MD-02, is in a Phase 1 clinical trial for liver fibrosis associated with NASH. Results from the first cohort showed declines in fibrosis biomarkers, suggesting regression of fibrosis.
- The presentation reviews the large unmet medical need in treating liver fibrosis and NASH, the development program for GR-MD-
Galectin Therapeutics is developing novel drug compounds that inhibit galectin proteins to treat fibrotic diseases and cancer. Their lead drug candidate, GR-MD-02, is currently in clinical trials for liver fibrosis associated with non-alcoholic steatohepatitis (NASH) and metastatic melanoma. NASH affects an estimated 6 million people in the US with advanced liver fibrosis, representing a major unmet medical need. Data from animal and early human studies suggest that GR-MD-02 can reduce liver inflammation and fibrosis. Galectin Therapeutics is focused on developing GR-MD-02 for the indication of NASH with advanced liver fibrosis.
This document provides an overview of Galectin Therapeutics, a clinical stage biopharmaceutical company targeting fibrotic diseases and cancer. It summarizes the company's focus on developing galectin inhibitors, proteins that are important in fibrosis and cancer. Specifically, it outlines Galectin's development program for non-alcoholic steatohepatitis (NASH), a fatty liver disease, including preclinical evidence, current Phase 1 clinical trial testing safety and pharmacokinetics, and plans for a Phase 2 trial to evaluate efficacy in reducing liver fibrosis.
Galectin Therapeutics is a clinical stage biopharmaceutical company developing novel carbohydrate-based compounds that inhibit galectin proteins to treat fibrotic diseases and cancer. The company currently has two compounds in clinical trials:
1) GR-MD-02 is in a Phase 1 clinical trial for the treatment of NASH (non-alcoholic steatohepatitis) with advanced liver fibrosis. Preclinical studies showed GR-MD-02 improved fat, liver cell death, inflammation and fibrosis in mouse models of fatty liver disease.
2) GM-CT-01 is being studied in combination with a peptide vaccine for advanced melanoma in a Phase 2a clinical trial to enhance the ability of the immune
- The document presents information on Galectin Therapeutics, a biotechnology company developing treatments for fibrosis and cancer.
- Their lead drug candidate, GR-MD-02, is a complex carbohydrate that binds to galectin-3 protein and shows efficacy in preclinical models of fibrosis and cancer immunotherapy.
- A Phase 1 clinical trial in NASH patients with advanced fibrosis showed GR-MD-02 was safe and well tolerated, achieved targeted drug levels, and significantly reduced serum markers and liver stiffness, indicating potential therapeutic benefit.
GR-MD-02 is being studied in clinical trials for the treatment of fibrosis and cancer. A Phase 1 trial in NASH patients found GR-MD-02 to be safe and well tolerated. Upcoming Phase 2 trials will evaluate the efficacy of GR-MD-02 in reducing liver fibrosis in NASH patients, as assessed by non-invasive imaging methods. A positive trial could support further development of GR-MD-02 for the treatment of advanced liver fibrosis.
On July 7, 2014, the Green Park Collaborative (GPC) of the Center for Medical Technology Policy (CMTP) and the Institute for Clinical and Economic Review (ICER) co-hosted a web conference to explore the evidence needed to demonstrate the effectiveness and value of new drugs to treat chronic hepatitis C (HCV) infection. Representatives from various stakeholder groups, including payers, patients, pharmaceutical industry, health technology assessment organizations, and regulatory bodies, presented and discussed this issue with a particular focus on:
1. The evidence generated for regulatory approval;
2. The evidence preferences of post-approval decision makers; and
3. Strategies to efficiently generate the additional evidence.
Each of the invited speakers gave a brief presentation followed by a question and answer session at the end of the presentations. Audience members had an opportunity to submit questions through a chat feature. The conference was moderated by Dr. Sean Tunis, Founder
and CEO of CMTP. More than 200 participants, including a variety of subject matter experts and stakeholder representatives, attended the web conference.
Video and webinar summary available here: http://www.cmtpnet.org/featured-projects/green-park-collaborative/gpc-usa-meetings/webinars/hepatitis-c-drugs-evidence-to-demonstrate-effectiveness-value
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
This document discusses Canada's regulatory framework for orphan drugs and opportunities to improve pan-Canadian access to treatments for rare diseases. It outlines the need for a life-cycle approach and managed access programs to balance innovation, effectiveness, risk, and access given uncertainties surrounding orphan drugs. Such programs have proven effective internationally and in some Canadian jurisdictions. The document calls on health ministers to implement a pan-Canadian managed access program now to ensure timely, equitable access for rare disease patients.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Impact of innovative therapies on regulation of therapeutic goods - John Sker...TGA Australia
The nature of medicines and medical technologies has changed significantly with the rise of biologics, personalized medicine, and combination products, requiring therapeutic goods regulation to evolve; emerging areas like adaptive licensing, real-world data, and regulatory science will be important for facilitating patient access to innovative therapies while managing risks; regulatory agencies also face challenges in evaluating new technologies quickly and supporting small companies developing novel products.
Impact of Real world data in Pharmacovigilance and Regulatory Decision MakingClinosolIndia
Real-world data (RWD) has emerged as a transformative force in the field of pharmacovigilance, significantly influencing regulatory decision-making processes. Unlike data generated in controlled clinical trials, RWD reflects the everyday clinical experiences and outcomes of patients in real-world settings. The impact of integrating RWD into pharmacovigilance and regulatory decision-making is multifaceted and has profound implications for patient safety, drug development, and healthcare policymaking
This presentation contains an overview of the scientific and business update provided by management during Critical Outcome Technologies' 2017 Annual General and Special Meeting of Shareholders on December 20, 2017.
This document discusses the importance and benefits of pharmacogenetic testing for physicians and their patients. It notes that pharmacogenetic testing can help physicians determine the right drug, dose, and timing for each individual patient to reduce adverse drug reactions and improve outcomes. Not utilizing this testing could open physicians up to legal liability issues. The document provides several case studies demonstrating how pharmacogenetic testing could have helped identify the right treatment for patients and avoided negative health consequences or legal risks for physicians. It also addresses the ease of testing, billing, and reimbursement to make the case for integrating pharmacogenetics into medical practice.
This document discusses personalized medicine (PM), which aims to provide customized treatment and care based on a patient's genetic profile. PM considers how genetic variations affect an individual's response to medications and susceptibility to diseases. The document outlines key benefits of PM, such as improved medication selection and safer dosing to minimize adverse reactions. It also discusses some current genetic tests used in PM, such as tests for enzymes involved in drug metabolism. Overall, the document presents PM as a promising approach that may enable more effective, targeted treatment tailored to individual patients.
This document discusses Phase IV clinical trials, which are post-marketing studies conducted after a drug has been approved. Phase IV trials have several objectives, including assessing long-term risks and benefits of drug use in real-world populations. They can be mandated by regulatory authorities or initiated independently. Regulatory-mandated studies evaluate things like drug interactions, new formulations, or safety in special populations. Independent studies may utilize randomized controlled trial designs to compare drugs or surveillance methods to monitor drug use. Sample sizes are typically larger than Phase III trials to detect rare side effects.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
Big North Graphite : Presenting at Global Online CEO Conference Small Stocks...RedChip Companies, Inc.
This document provides an overview of Big North Graphite Corp., a mining company exploring graphite opportunities in Mexico and Canada. It summarizes the management team's experience, the capital structure including shares outstanding and warrants, and key investment highlights. Specifically, it notes Big North is currently selling amorphous graphite in Mexico and aims to restart near-term flake graphite production at its recently acquired El Tejon Flake Graphite Mine and Mill in Oaxaca, Mexico, which was previously operational until 2002. A cautionary note also indicates forward-looking statements may materially differ from expectations.
StarStream Entertainment is a theatrical motion picture production and financing company focused on producing and financing edgy, high quality motion pictures with strong cast and lean budgets for a commercial audience.
StarStream Entertainment is a theatrical motion picture production and financing company focused on producing and financing edgy, high quality motion pictures with strong cast and lean budgets for a commercial audience.
Cancer Genetics provides personalized cancer treatment through molecular diagnostic testing. They have launched 6 proprietary diagnostic products targeting hematological and urogenital cancers. Their tests help determine cancer type and prognosis, guiding treatment selection. Recent acquisitions expand their capabilities and access to new markets in India. Their business model provides clinical testing services to oncologists and biopharma partnerships to support drug development.
- Bitcoin Shop is one of the first publicly traded companies focused on the virtual currency ecosystem. It operates an ecommerce platform that accepts bitcoin and other cryptocurrencies as payment.
- The company is developing its BTCS 2.0 platform to expand its product offerings and vendor base. It aims to build a virtual currency ecosystem through ecommerce.
- Bitcoin Shop has a experienced management team with expertise in capital markets, technology, and the virtual currency industry. It plans to grow its customer base and monetize through additional service offerings.
InterCloud Systems provides cloud-centric solutions and services to enterprises and service providers. Their two main business focus areas are Software Defined Enterprise and Cloud to Cloud Mobility. They help customers modernize infrastructure, develop cloud strategies, and deliver cloud-centric IT visions aligned to business value. InterCloud partners with major cloud platform and solution providers like VMware, OpenStack, and CloudStack.
This presentation provides an overview of SANUWAVE Health Inc., a regenerative medicine company developing non-invasive biological response activation devices. SANUWAVE's lead product, dermaPACE, is in a Phase III FDA trial for treating diabetic foot ulcers and has the potential for approval in 2015 pending positive results. DermaPACE offers a lower-cost, non-invasive alternative to existing wound therapies. If approved, dermaPACE could address the large diabetic foot ulcer market and be expanded to other applications. SANUWAVE completed a $9.3 million capital raise to fund the dermaPACE trial and has 38 patents covering its shockwave technology platform.
Genius Brands International is a company focused on providing children's entertainment content with purpose for toddlers to tweens. It was created through the merger of A Squared Entertainment and Genius Brands. The document discusses Genius Brands' plans to grow its portfolio of animated properties like Baby Genius, Warren Buffett's Secret Millionaires Club, and new shows in partnership with Stan Lee and Martha Stewart. It aims to distribute this content across television, online, mobile and through a new streaming service, while supporting the content through consumer products licensing. The management team, including Andy and Amy Heyward, have decades of experience in the children's entertainment industry.
DRONE Aviation Corp (DRNE) was formed in April 2014 to penetrate the rapidly growing Unmanned Aerial Systems (UAS) business in U.S. and abroad for government and commercial customers.
DRNE’s mission is to aggressively penetrate the expanding Drone market with our unique Tethered Drones, which are currently being fielded to the U.S. Department of Defense and State and Local municipalities.
DRNE owns and operates Florida-based Lighter Than Air Systems Corp (LTAS), a developer and supplier of unique and specialized aerial solutions to the U.S. Government, State municipalities, and commercial entities.
InterCloud Systems Incorporated is a single - source provider of end - to - end IT technology and telecom solutions to the ent erprise, service provider, and g overnment markets through “Cloud Platforms” and professional services. “Cloud Comput ing”, is defined as the use of computing resources (compute, NTK, Storage) that are delivered as a managed service over a network. InterCloud offers its service provider custo mers the ability to utilize “cloud” solutions inside their existing network footp rint as well as in a “white label environment” so it can offer a suite of cloud products under their own brand, delivered over the broadband services it presently sell s . ICLD’s cloud services include infrastructure as a service (IaaS), platform as a servi ce (PaaS), and software as a service (SaaS) .
The nuclear energy industry has lain stagnant for over 30 years and has suffered from missteps and perception issues.
Lightbridge is here to innovate and change the conversation. About: Lightbridge is a U.S. nuclear energy company based in McLean, Virginia with operations in Abu Dhabi, Moscow and London. The Company develops proprietary, proliferation resistant, next generation nuclear fuel technologies for current and future nuclear reactor systems. The Company also provides comprehensive advisory services for established and emerging nuclear programs based on a philosophy of transparency, non-proliferation, safety and operational excellence. Lightbridge's breakthrough fuel technology is establishing new global standards for safe and clean nuclear power and leading the way to a sustainable energy future. Lightbridge consultants provide integrated strategic advice and expertise across a range of disciplines including regulatory affairs, nuclear reactor procurement and deployment, reactor and fuel technology and international relations. The Company leverages those broad and integrated capabilities by offering its services to commercial entities and governments with a need to establish or expand nuclear industry capabilities and infrastructure.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
Exeo Entertainment, Inc. is a manufacturing company concentrating on developing innovative products that fill a clearly defined need in today’s interactive entertainment industry. Featured products include the Zaaz™ smart TV keyboards, Patented Psyko Krypton™ 5.1 gaming headphones, Krankz Bluetooth music headphones, an Android® based portable gaming system, and the Extreme Gamer® -the world’s first multi–disc game changer.
Lattice Incorporated (“Lattice” or the “Company”), founded in 1973, provides secure communications and information technology, specializing in deploying advanced technology and services to create innovative, cost - effective solutions for the Company’s global customers. The Company provides both wholesale and direct services to correctional facilities and their service providers in the U.S., Canada and Europe. Expansion of Lattice’s direct and wholesale services, including increased techno logy equipment and software sales to wholesale customers, is expected to drive revenue growth and increased margins in the quarters ahead
Energy Fuels is the nation's leading conventional uranium producer, supplying approximately 25% of the uranium produced in the U.S. (based on FY-2013 deliveries). The Company also has the capability to be a significant producer of vanadium. Energy Fuels owns and operates the White Mesa Mill, which is the only conventional uranium mill currently operating in the U.S. The mill is capable of processing 2,000 tons per day of uranium ore and producing up to 8 million lbs. of U3O8 per year (depending on ore grade).
This document provides a safe harbor statement and background information on VeriTeQ Corporation. It discusses forward-looking statements and risks associated with investment. It then provides an overview of the company, including its founding, acquisitions, regulatory clearances, and financing activities. Key areas of focus for the company are discussed, including medical device UDI/identification and biosensing/radiation dosimetry technologies. Leadership and intellectual property are also summarized.
Opexa Therapeutics is developing Tcelna, a precision immunotherapy for the treatment of multiple sclerosis (MS). Tcelna consists of attenuated antigen-specific T-cell clones that are designed to program the immune system to target pathogenic myelin reactive T-cells (MRTC) that cause damage in MS. Opexa has completed enrollment in a Phase IIb clinical trial of Tcelna in secondary progressive MS (SPMS) and expects top-line data in mid-2016. The company has an option agreement with Merck for the development and commercialization of Tcelna in MS that could provide up to $220 million in payments if certain development and sales milestones are achieved.
The document discusses forward-looking statements and risks related to Akers Biosciences, Inc. It summarizes the company's management team, products, platform technologies, markets, growth strategy, and financial performance. Akers develops rapid diagnostic tests for conditions like heparin allergy, cholesterol, ketones, alcohol, and infectious diseases. It aims to expand sales, marketing, and product launches to drive revenue growth.
This document summarizes a corporate presentation for Giggles N' Hugs, a family restaurant chain. It outlines the company's history and growth plans, including opening 3 current locations that are profitable. The company aims to expand nationwide with support from major mall operators. Risk factors are also disclosed relating to execution of expansion plans and regulatory issues. Financial information shows increasing revenues from 2011 to 2013. The presentation promotes the company's family-friendly concept and organic menu as filling an unmet market need.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...my Pandit
Dive into the steadfast world of the Taurus Zodiac Sign. Discover the grounded, stable, and logical nature of Taurus individuals, and explore their key personality traits, important dates, and horoscope insights. Learn how the determination and patience of the Taurus sign make them the rock-steady achievers and anchors of the zodiac.
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The Most Inspiring Entrepreneurs to Follow in 2024.pdfthesiliconleaders
In a world where the potential of youth innovation remains vastly untouched, there emerges a guiding light in the form of Norm Goldstein, the Founder and CEO of EduNetwork Partners. His dedication to this cause has earned him recognition as a Congressional Leadership Award recipient.
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
The Genesis of BriansClub.cm Famous Dark WEb PlatformSabaaSudozai
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This PowerPoint compilation offers a comprehensive overview of 20 leading innovation management frameworks and methodologies, selected for their broad applicability across various industries and organizational contexts. These frameworks are valuable resources for a wide range of users, including business professionals, educators, and consultants.
Each framework is presented with visually engaging diagrams and templates, ensuring the content is both informative and appealing. While this compilation is thorough, please note that the slides are intended as supplementary resources and may not be sufficient for standalone instructional purposes.
This compilation is ideal for anyone looking to enhance their understanding of innovation management and drive meaningful change within their organization. Whether you aim to improve product development processes, enhance customer experiences, or drive digital transformation, these frameworks offer valuable insights and tools to help you achieve your goals.
INCLUDED FRAMEWORKS/MODELS:
1. Stanford’s Design Thinking
2. IDEO’s Human-Centered Design
3. Strategyzer’s Business Model Innovation
4. Lean Startup Methodology
5. Agile Innovation Framework
6. Doblin’s Ten Types of Innovation
7. McKinsey’s Three Horizons of Growth
8. Customer Journey Map
9. Christensen’s Disruptive Innovation Theory
10. Blue Ocean Strategy
11. Strategyn’s Jobs-To-Be-Done (JTBD) Framework with Job Map
12. Design Sprint Framework
13. The Double Diamond
14. Lean Six Sigma DMAIC
15. TRIZ Problem-Solving Framework
16. Edward de Bono’s Six Thinking Hats
17. Stage-Gate Model
18. Toyota’s Six Steps of Kaizen
19. Microsoft’s Digital Transformation Framework
20. Design for Six Sigma (DFSS)
To download this presentation, visit:
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