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-
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.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
Presentation providing an overview of the recent milestones and next steps for getting Critical Outcome's p53-dependent cancer treatment, COTI-2, into clinical trials. This presentation was first given by Dr. Wayne Danter at Critical Outcome Technologies' annual shareholders meeting on October 21, 2014.
Critical Outcome Technologies Inc. is listed on the Toronto Venture Exchange under the trading symbol COT.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
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.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
Presentation providing an overview of the recent milestones and next steps for getting Critical Outcome's p53-dependent cancer treatment, COTI-2, into clinical trials. This presentation was first given by Dr. Wayne Danter at Critical Outcome Technologies' annual shareholders meeting on October 21, 2014.
Critical Outcome Technologies Inc. is listed on the Toronto Venture Exchange under the trading symbol COT.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
Sutro Biopharma is conducting a Phase 1 clinical trial of STRO-002, an antibody-drug conjugate (ADC) targeting folate receptor alpha (FolRα), in patients with advanced platinum-resistant or refractory epithelial ovarian cancer, fallopian tube or primary peritoneal cancers. Interim data from the trial will be presented at the AACR virtual conference on April 27th. STRO-002 was designed using Sutro's proprietary protein engineering platform, XpressCF, to have improved stability and a widened therapeutic index compared to other FolRα-targeting ADCs. Preclinical studies demonstrated STRO-002's enhanced potency and specificity versus benchmarks. The trial will evaluate
NPS Pharmaceuticals is a global biopharmaceutical company focused on developing therapies for rare diseases. It has recently launched Gattex/Revestive (teduglutide) for the treatment of adult Short Bowel Syndrome in the US and EU. It is also developing Natpara (recombinant human parathyroid hormone 1-84) as a potential first approved replacement therapy for hypoparathyroidism, with a BLA submission planned for the US in the second half of 2013. The company has a proven track record of successfully developing and launching orphan drugs and is focused on executing its Gattex launch and advancing its pipeline to become a leading global orphan specialty drug company.
The document provides an overview of industry and FDA liaisons. It discusses the FDA's mission to protect public health through regulations and inspections. The FDA is divided into centers focused on drugs, biologics, devices, food, and other areas. Industry can communicate with the FDA through inquiries, meetings, and Freedom of Information Act requests. Effective planning and understanding FDA processes are important for interactions between industry and the regulatory agency.
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 Rheumatoid Arthritis and 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.
The document discusses industry and FDA liaisons. It describes the FDA's mission to protect public health by regulating food, drugs, and other products. The FDA has 9,000 employees who monitor over $1 trillion worth of products annually. The FDA ensures product safety through inspections, legal sanctions for noncompliance, and scientific review. Industry can communicate with the FDA through various divisions and meetings to facilitate product development and approval processes.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET) as a potential third line therapy. Phase 1 and 2 clinical trials showed that GALE-401 maintains platelet lowering effects while reducing peak plasma concentrations and adverse events compared to immediate release anagrelide. The company plans to initiate a Phase 3 trial in Q2 2017 to further evaluate GALE-401 in ET patients who are intolerant or refractory to first and second line therapies such as hydroxyurea and anagrelide.
Sorrento Therapeutics is developing several immuno-oncology programs including CD38 CAR-T and CD38 antibody-drug conjugates (ADCs) for the treatment of multiple myeloma. Sorrento has an industry-leading CD38 CAR-T program and most advanced CD38 CAR-T in development with planned IND filing in 1H18. Sorrento also has a CD38 ADC program showing efficacy in preclinical models at low doses against multiple myeloma, including in daratumumab-resistant tumors. Sorrento has cGMP manufacturing facilities and an experienced clinical team to support the clinical development of these programs.
The document summarizes the 2016 annual meeting of stockholders held on July 14, 2016. It includes a forward-looking statement noting risks and uncertainties in projections. The development pipeline outlines several investigational products in various phases of clinical trials for breast cancer, gastric cancer, gynecological cancers, and hematological conditions. An overview of the current status of NeuVax clinical trials in breast cancer is provided, along with collaborations. Summaries are also given for GALE-301 and GALE-401 clinical programs, corporate details, leadership, and motivation.
Cytori Therapeutics provides a cell therapy for the treatment of scleroderma using cells derived from a patient's own adipose tissue. Their lead indication is for the treatment of hand dysfunction in scleroderma patients. A pilot clinical trial in France showed improvements in hand function, Raynaud's symptoms, and pain out to 24 months with a single administration of the therapy. Cytori is preparing for commercial launch in the EU in 2016 and anticipates FDA approval in the US in 2018.
This document provides guidance on quality risk management for the pharmaceutical industry. It outlines principles of quality risk management including responsibilities, risk assessment, risk control, risk communication, and risk review. The goal is to offer a systematic approach to quality risk management that supports existing quality practices and regulations. Quality risk management can help pharmaceutical companies and regulators make more effective risk-based decisions regarding drug quality across the product lifecycle. It is intended to complement, not replace, current regulatory requirements and quality systems.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
GALE-401 is a controlled release formulation of anagrelide targeting patients who are intolerant to immediate release anagrelide, the current standard of care for third line treatment of essential thrombocythemia. Phase 1 and 2 clinical trials demonstrated GALE-401's improved pharmacokinetic profile with lower Cmax and longer half-life, maintaining platelet lowering effects while showing better tolerability. A Phase 3 trial is planned to initiate in Q2 2017. NeuVax is an immunotherapy targeting HER2-expressing cancers by eliciting a CD8+ T-cell immune response. Current clinical trials are investigating NeuVax in combination with trastuzumab for the treatment of HER2 1+/2+ breast cancer
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
Presentation to San Diego Regulatory Affairs Network (SDRAN) February 12, 2015 meeting 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
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
PDUFA has had a significant role in modern drug review at FDA. Before PDUFA, FDA's review process was understaffed, unpredictable and slow. FDA lacked sufficient staff to perform timely reviews or develop procedures and standards to make the process more rigorous, consistent, and predictable. FDA lacked the funds to provide computers to all FDA reviewers.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
VeriTeQ provides proprietary healthcare solutions including implantable radio frequency microchip technology cleared by the FDA. The document discusses VeriTeQ's unique value in enabling compliance with an FDA Final Rule requiring medical devices to carry a direct part marking through automatic identification and data capture technology. It also summarizes VeriTeQ's product portfolio in medical device identification, bio-sensing technologies, target markets, and financial projections showing significant revenue growth potential over the next five years.
This document provides a summary of statements made in a presentation by VeriTeQ Corporation. It includes forward-looking statements about VeriTeQ's proposed name change, reverse stock split, commercialization activities, market opportunities, strategy, competition, FDA regulation, and partnership opportunities. The document cautions that VeriTeQ's actual results could differ from these statements due to various risks and uncertainties. It also provides background on VeriTeQ, including its acquisition of intellectual property for implantable RFID technology in healthcare. The document summarizes VeriTeQ's business areas in medical device UDI compliance and biosensing technologies for radiation dosimetry.
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.
Sutro Biopharma is conducting a Phase 1 clinical trial of STRO-002, an antibody-drug conjugate (ADC) targeting folate receptor alpha (FolRα), in patients with advanced platinum-resistant or refractory epithelial ovarian cancer, fallopian tube or primary peritoneal cancers. Interim data from the trial will be presented at the AACR virtual conference on April 27th. STRO-002 was designed using Sutro's proprietary protein engineering platform, XpressCF, to have improved stability and a widened therapeutic index compared to other FolRα-targeting ADCs. Preclinical studies demonstrated STRO-002's enhanced potency and specificity versus benchmarks. The trial will evaluate
NPS Pharmaceuticals is a global biopharmaceutical company focused on developing therapies for rare diseases. It has recently launched Gattex/Revestive (teduglutide) for the treatment of adult Short Bowel Syndrome in the US and EU. It is also developing Natpara (recombinant human parathyroid hormone 1-84) as a potential first approved replacement therapy for hypoparathyroidism, with a BLA submission planned for the US in the second half of 2013. The company has a proven track record of successfully developing and launching orphan drugs and is focused on executing its Gattex launch and advancing its pipeline to become a leading global orphan specialty drug company.
The document provides an overview of industry and FDA liaisons. It discusses the FDA's mission to protect public health through regulations and inspections. The FDA is divided into centers focused on drugs, biologics, devices, food, and other areas. Industry can communicate with the FDA through inquiries, meetings, and Freedom of Information Act requests. Effective planning and understanding FDA processes are important for interactions between industry and the regulatory agency.
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 Rheumatoid Arthritis and 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.
The document discusses industry and FDA liaisons. It describes the FDA's mission to protect public health by regulating food, drugs, and other products. The FDA has 9,000 employees who monitor over $1 trillion worth of products annually. The FDA ensures product safety through inspections, legal sanctions for noncompliance, and scientific review. Industry can communicate with the FDA through various divisions and meetings to facilitate product development and approval processes.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET) as a potential third line therapy. Phase 1 and 2 clinical trials showed that GALE-401 maintains platelet lowering effects while reducing peak plasma concentrations and adverse events compared to immediate release anagrelide. The company plans to initiate a Phase 3 trial in Q2 2017 to further evaluate GALE-401 in ET patients who are intolerant or refractory to first and second line therapies such as hydroxyurea and anagrelide.
Sorrento Therapeutics is developing several immuno-oncology programs including CD38 CAR-T and CD38 antibody-drug conjugates (ADCs) for the treatment of multiple myeloma. Sorrento has an industry-leading CD38 CAR-T program and most advanced CD38 CAR-T in development with planned IND filing in 1H18. Sorrento also has a CD38 ADC program showing efficacy in preclinical models at low doses against multiple myeloma, including in daratumumab-resistant tumors. Sorrento has cGMP manufacturing facilities and an experienced clinical team to support the clinical development of these programs.
The document summarizes the 2016 annual meeting of stockholders held on July 14, 2016. It includes a forward-looking statement noting risks and uncertainties in projections. The development pipeline outlines several investigational products in various phases of clinical trials for breast cancer, gastric cancer, gynecological cancers, and hematological conditions. An overview of the current status of NeuVax clinical trials in breast cancer is provided, along with collaborations. Summaries are also given for GALE-301 and GALE-401 clinical programs, corporate details, leadership, and motivation.
Cytori Therapeutics provides a cell therapy for the treatment of scleroderma using cells derived from a patient's own adipose tissue. Their lead indication is for the treatment of hand dysfunction in scleroderma patients. A pilot clinical trial in France showed improvements in hand function, Raynaud's symptoms, and pain out to 24 months with a single administration of the therapy. Cytori is preparing for commercial launch in the EU in 2016 and anticipates FDA approval in the US in 2018.
This document provides guidance on quality risk management for the pharmaceutical industry. It outlines principles of quality risk management including responsibilities, risk assessment, risk control, risk communication, and risk review. The goal is to offer a systematic approach to quality risk management that supports existing quality practices and regulations. Quality risk management can help pharmaceutical companies and regulators make more effective risk-based decisions regarding drug quality across the product lifecycle. It is intended to complement, not replace, current regulatory requirements and quality systems.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
GALE-401 is a controlled release formulation of anagrelide targeting patients who are intolerant to immediate release anagrelide, the current standard of care for third line treatment of essential thrombocythemia. Phase 1 and 2 clinical trials demonstrated GALE-401's improved pharmacokinetic profile with lower Cmax and longer half-life, maintaining platelet lowering effects while showing better tolerability. A Phase 3 trial is planned to initiate in Q2 2017. NeuVax is an immunotherapy targeting HER2-expressing cancers by eliciting a CD8+ T-cell immune response. Current clinical trials are investigating NeuVax in combination with trastuzumab for the treatment of HER2 1+/2+ breast cancer
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
Presentation to San Diego Regulatory Affairs Network (SDRAN) February 12, 2015 meeting 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
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
PDUFA has had a significant role in modern drug review at FDA. Before PDUFA, FDA's review process was understaffed, unpredictable and slow. FDA lacked sufficient staff to perform timely reviews or develop procedures and standards to make the process more rigorous, consistent, and predictable. FDA lacked the funds to provide computers to all FDA reviewers.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
VeriTeQ provides proprietary healthcare solutions including implantable radio frequency microchip technology cleared by the FDA. The document discusses VeriTeQ's unique value in enabling compliance with an FDA Final Rule requiring medical devices to carry a direct part marking through automatic identification and data capture technology. It also summarizes VeriTeQ's product portfolio in medical device identification, bio-sensing technologies, target markets, and financial projections showing significant revenue growth potential over the next five years.
This document provides a summary of statements made in a presentation by VeriTeQ Corporation. It includes forward-looking statements about VeriTeQ's proposed name change, reverse stock split, commercialization activities, market opportunities, strategy, competition, FDA regulation, and partnership opportunities. The document cautions that VeriTeQ's actual results could differ from these statements due to various risks and uncertainties. It also provides background on VeriTeQ, including its acquisition of intellectual property for implantable RFID technology in healthcare. The document summarizes VeriTeQ's business areas in medical device UDI compliance and biosensing technologies for radiation dosimetry.
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.
- DecisionPoint Systems is an enterprise mobility solutions provider that has experienced rapid growth, with revenues increasing from $58 million in 2011 to over $71 million in 2012.
- The company provides end-to-end mobile solutions across several vertical markets, including field workforce automation, retail systems, and warehouse distribution.
- DecisionPoint's growth strategy focuses on increasing higher margin software and professional services revenue, penetrating new verticals, leveraging partners, and pursuing acquisitions.
This document provides an overview of Energy Fuels Inc., which is America's premier uranium producer. Energy Fuels aims to become the dominant uranium producer in the US and a mid-tier global producer. It currently has the largest uranium production platform in the US, with production facilities located in Arizona, Utah, Colorado, and Wyoming. The document discusses Energy Fuels' strategy of maintaining prudent production levels in the current weak price environment but positioning itself for growth as uranium prices are expected to rebound with increasing global nuclear energy demand.
Envision Solar International is a company that designs, markets, and deploys solar energy products for parking structures. Their products include the Solar Tree structure that shades multiple parking spaces, the Solar Tree Socket that shades a single space, and the EV ARC transportable solar-powered electric vehicle charger. The company aims to leverage these products to access the large markets for solar-shaded parking and electric vehicle charging. They see opportunities to scale production efficiently and achieve significant operating leverage as markets and sales grow over the next few years. The management team has experience in renewable energy, infrastructure deployment, and public companies.
CUI Global presented an overview of its business and recent acquisition of Orbital Gas Systems. CUI provides enabling technologies to industries including energy, healthcare, and networking. It has a dynamic base business and is pursuing disruptive innovations like gas measurement devices. The acquisition of Orbital, a natural gas solutions provider, creates strategic synergies and a combined solution to address gas quality measurement. Management believes the combined company is well positioned for growth with opportunities in the large natural gas market.
AV Therapeutics is developing Capridine, a patented drug that shows promise for treating prostate cancer. Preclinical studies found Capridine to be effective against taxane-resistant prostate cancer with minimal toxicity. The company plans to manufacture and formulate Capridine under GMP and conduct toxicology studies to file an IND and begin phase I/II clinical trials. AV Therapeutics is led by a team of renowned oncologists and scientists from top institutions and has scientific and medical advisors supporting its work developing Capridine as a new targeted therapy for prostate cancer.
This document provides an overview of Actinium Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing targeted radiotherapies for cancer. It discusses Actinium's proprietary alpha particle immunotherapy platform technology, clinical pipeline including lead drug Iomab-B, intellectual property protection, and financial details. The document contains disclaimer language stating that it does not constitute an offer to buy or sell securities and no reliance should be placed on the information provided.
Thinspace is a global provider of application delivery, desktop virtualization, and cloud client technology solutions that enable secure application and desktop delivery to any device over any network. The company has 28 staff across offices in the US, UK, India, and Canada. Thinspace develops solutions for customers of all sizes and pursues routes to market through distribution, hosting, and independent software vendors. Its competitors include Citrix but it aims to provide more competitive pricing with reduced time to market and costs through its technology solutions.
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.
Energy Fuels is a uranium mining and milling company with operations in the United States. It owns the only operating conventional uranium mill in the US and has a large portfolio of uranium projects. The company is pursuing a strategy of low-cost production while conserving capital in the current weak uranium market. It aims to grow production significantly if uranium prices strengthen in the future.
NanoViricides is developing nanomedicine-based drugs to treat various viral diseases like influenza, HIV, hepatitis C, and Ebola. The company has 9 drug candidates in development that have shown safety and efficacy in animal studies. NanoViricides' first drug to enter human trials will be FluCide for influenza, which completely protected animals against lethal viral exposure without toxicity.
Energy Fuels Inc. is a leading American uranium producer focused on conventional uranium production in the United States. It operates the White Mesa Mill, the only conventional uranium mill operating in the U.S., which produced 1.2 million pounds of U3O8 in 2013. Energy Fuels aims to increase production to over 6 million pounds annually by restarting idled mines and developing new projects as uranium market conditions improve. The company has existing sales contracts with major utilities and seeks to become the dominant uranium producer in the U.S. and a mid-tier global producer.
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.
GlyEco is an innovative green chemistry company that recycles glycol using a patented process. It transforms hazardous waste glycol into profitable recycled glycol products. The company has acquired several existing glycol recyclers and plans to integrate them and expand globally. Glycol recycling is an emerging industry with significant growth potential as GlyEco can process all five major types of waste glycol streams to produce high quality recycled glycol.
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.
The Coin Tree is a cloud-based platform that provides storage, insurance, and payment processing for bitcoin, leveraging advanced security. It aims to serve the growing virtual currency community by solving issues around accessibility, security, liquidity, and adoption of bitcoin.
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
American Noble Gas is an oil and gas exploration, development, and production company with a history of operations in Texas, Kansas, Oklahoma, and the Rocky Mountain region of the US. The Company is currently exploring and developing natural gas, helium, and other noble gases and brine minerals contained in the Hugoton Gas Field, a prolific natural gas and helium gas field spanning the states of Kansas, Oklahoma, and Texas, through a 40% participation in a farmout agreement that covers drilling and completion of up to 50 wells. American Noble Gas also owns 60.7143% of GMDOC, LLC, LLC which acquired certain oil and gas leases covering approximately 10,000 acres located in Southern Kansas near the Oklahoma border. The GMDOC leases currently produce approximately 100 barrels of oil and 1.2 million cubic feet of natural gas per day on a gross basis. The Company also owns mineral rights to approximately 11,000 acres in the Otis/Albert Field located on the Kansas Central Uplift.
Unicycive Therapeutics (UNCY) is a developer of residential communities in Northern Baja California with projects are targeted at buyers and investors of primary, vacation, and/or retirement homes. The Company’s projects in Northern Baja – a popular tourism and retirement destination – are strategically located within driving distance of Southern California and are supported by the region’s attractive demographics, large pent-up demand, and persistent housing shortages. With a goal of delivering sustainable and socially responsible solutions, the Company leverages advanced property and construction technologies to provide a seamless and efficient platform that enhances the customer sales experience. A newly added mortgage division, providing previously unattainable financing options to US buyers, is expected to drive accelerate sales growth across UNCY’s projects.
Reata Pharmaceuticals: Creating New Opportunities for PatientsJon Le Culpepper
Bardoxolone methyl consistently increased eGFR in clinical trials involving over 2,800 patients with CKD. In a Phase 2 trial in 30 patients with Alport syndrome, bardoxolone treatment resulted in significant time-dependent increases in eGFR from baseline, with a mean increase of 13.4 mL/min/1.73 m2 by week 12. Nearly all patients experienced increases in eGFR, and over 70% improved their CKD stage by week 12 with no worsening. eGFR increases occurred across subgroups defined by baseline eGFR level, proteinuria level, gender, and age, with no serious safety issues observed.
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.
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.
- Sanofi's CEO Olivier Brandicourt presented at a healthcare conference on September 14, 2018.
- He discussed Sanofi's continued progress on its strategic transformation including acquiring new assets, driving simplification through restructuring, reshaping its portfolio, and executing new product launches.
- Brandicourt highlighted several potentially significant drug approvals and trial results for new drugs and indications expected over the next 12 months that could further advance Sanofi's growth.
- He concluded that while Sanofi saw impacts from recent drug losses of exclusivity in the first half of 2018, performance was otherwise in line with expectations and several factors position Sanofi for a new growth phase in the second half of
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.
The document discusses strategies for successful global drug development. It focuses on navigating FDA accelerated approval programs, new frontiers in personalized medicine, and evolving regulatory paradigms for digital health. The presentation provides an overview of key FDA expedited programs like fast track designation and breakthrough therapy designation. It also examines how regulators are adapting approaches to personalized medicine and digital health technologies.
Bellus Health Corporate Presentation May 2016BellusHealth
- The document is a corporate presentation for Bellus Health Inc. discussing their rare disease drug pipeline and lead product candidate KIACTA for AA amyloidosis.
- KIACTA has shown positive results in a Phase 2/3 trial, significantly reducing kidney function decline. A Phase 3 confirmatory study has completed enrollment with results expected in Q2 2016.
- If successful, KIACTA has the potential for regulatory approval and commercialization through a partnership, providing funding to advance Bellus' pipeline of rare disease programs.
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.
Bellus Health Corporate Presentation June 2016BellusHealth
- The document is a corporate presentation for Bellus Health Inc. discussing their rare disease drug pipeline and lead product candidate KIACTA for AA amyloidosis.
- KIACTA showed positive results in a Phase 2/3 trial, reducing risk of worsening kidney events. A Phase 3 confirmatory study has completed enrollment with results expected in Q2 2016.
- If successful, KIACTA has the potential for regulatory approval and commercialization through a partnership, as Bellus' partner Auven Therapeutics is funding the entire development program.
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.
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.
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
- The document presents information on Praluent (alirocumab), the first PCSK9 inhibitor therapy approved in the US for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.
- Praluent demonstrated robust and durable LDL-C reduction of over 52 weeks in clinical trials in patients on maximally tolerated statin therapy, with 57-83% of patients achieving sufficient LDL-C reduction with the 75 mg starting dose.
- The Committee for Medicinal Products for Human Use adopted a positive opinion for Praluent in Europe, and approval is expected in late September 2015. The OD
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 provides an overview of Cancer Genetics, Inc. It discusses the company's focus on empowering personalized cancer treatment through molecular diagnostics. The summary highlights Cancer Genetics' proprietary diagnostic products for various cancers, partnerships with biopharma companies, growth in revenue and testing volume in 2013, and pipeline of diagnostic tests in development. It also outlines the company's business model and strategy to commercialize its products to target markets globally.
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.
“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."
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 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.
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.
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.
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) .
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
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.
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.
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.
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.
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.
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
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.
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International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
2024 HIPAA Compliance Training Guide to the Compliance OfficersConference Panel
Join us for a comprehensive 90-minute lesson designed specifically for Compliance Officers and Practice/Business Managers. This 2024 HIPAA Training session will guide you through the critical steps needed to ensure your practice is fully prepared for upcoming audits. Key updates and significant changes under the Omnibus Rule will be covered, along with the latest applicable updates for 2024.
Key Areas Covered:
Texting and Email Communication: Understand the compliance requirements for electronic communication.
Encryption Standards: Learn what is necessary and what is overhyped.
Medical Messaging and Voice Data: Ensure secure handling of sensitive information.
IT Risk Factors: Identify and mitigate risks related to your IT infrastructure.
Why Attend:
Expert Instructor: Brian Tuttle, with over 20 years in Health IT and Compliance Consulting, brings invaluable experience and knowledge, including insights from over 1000 risk assessments and direct dealings with Office of Civil Rights HIPAA auditors.
Actionable Insights: Receive practical advice on preparing for audits and avoiding common mistakes.
Clarity on Compliance: Clear up misconceptions and understand the reality of HIPAA regulations.
Ensure your compliance strategy is up-to-date and effective. Enroll now and be prepared for the 2024 HIPAA audits.
Enroll Now to secure your spot in this crucial training session and ensure your HIPAA compliance is robust and audit-ready.
https://conferencepanel.com/conference/hipaa-training-for-the-compliance-officer-2024-updates
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
Letter to MREC - application to conduct studyAzreen Aj
Application to conduct study on research title 'Awareness and knowledge of oral cancer and precancer among dental outpatient in Klinik Pergigian Merlimau, Melaka'
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
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R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.