Investigated the market for cardiovascular medical devices and clinical research organizations (CROs) to understand what roles play in the development and FDA approval process for therapeutics.
This presentation provides an overview of the company and its recent acquisition of Clarient. It summarizes that the acquisition is expected to more than double the company's revenue and more than triple its adjusted EBITDA in 2016. The company operates a fast-growing cancer genetics laboratory and sees significant opportunity in consolidating the dynamic and consolidating industry. The acquisition combines the companies' complementary assets and geographic footprints to create a leader in hematological and solid tumor cancer testing with synergies of $20-30 million annually.
- The company provides an overview presentation of its business operations as a fast growing cancer genetics laboratory.
- Key highlights include strategic client partnerships through its "tech-only" model, an industry-leading growth rate in revenue and test volume, and the most comprehensive cancer testing menu in the industry.
- The acquisition of Clarient is expected to more than double the company's revenue and more than triple adjusted EBITDA for 2016.
This presentation provides an overview of the company and its recent acquisition of Clarient. It summarizes that the acquisition is expected to more than double the company's revenue and more than triple its adjusted EBITDA in 2016. The company provides cancer genetic testing services and sees significant opportunity for growth and consolidation in the dynamic and expanding industry. The acquisition combines the companies' complementary assets and is expected to generate $20-30 million in annual synergies within 3-5 years.
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on being a leading cancer genetics testing provider, experience in consolidating the industry, a comprehensive testing menu, and strategic partnerships with pathologists and oncologists.
- Financial projections estimate the combined company will generate around $247 million in revenue and $35-40 million in adjusted EBITDA in 2016 following the acquisition.
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on cancer genetics testing, strategic partnerships with pathologists and oncologists, a comprehensive testing menu, and experienced management team.
- Financial projections estimate combined pro forma revenue of $242-252 million and adjusted EBITDA of $35-40 million in 2016 following the acquisition of Clarient. Synergies from the acquisition are expected to provide $20-30 million in annual cost savings.
This presentation provides an overview of a cancer genetics laboratory company. Key points include:
- The company has experienced strong and consistent revenue and test volume growth through strategic partnerships and an expanding test menu. An upcoming acquisition is expected to more than double revenue and more than triple adjusted EBITDA.
- The management team has extensive experience in large cap clinical laboratories.
- The company addresses a $5 billion clinical cancer testing market and has opportunities for further growth through innovation, such as liquid biopsy tests and partnerships with oncologists.
- Recent acquisitions and an expanding test menu have contributed to accelerating same store sales growth.
This presentation provides an overview of the company and its acquisition of Clarient. It summarizes that the acquisition will more than double the company's revenue and more than triple its adjusted EBITDA. The acquisition provides key benefits like synergies of $20-30 million annually within 3-5 years, a combined leadership in cancer testing, and expanded geographic coverage across the United States with field sales representatives.
This company presentation provides an overview of a cancer genetic testing services company. Key points include:
- The company has experienced strong and consistent growth in revenue and test volume over the past 10 years through both organic growth and acquisitions.
- It provides a broad menu of genetic and molecular testing services including next generation sequencing and is developing liquid biopsy tests.
- The company has an experienced management team with experience in large reference laboratories. It is focused on innovation, cost management, and expanding its commercial footprint.
- Financial results show increasing margins, productivity, and adjusted EBITDA despite lower average prices per test, demonstrating strong operating leverage as the business scales.
This presentation provides an overview of the company and its recent acquisition of Clarient. It summarizes that the acquisition is expected to more than double the company's revenue and more than triple its adjusted EBITDA in 2016. The company operates a fast-growing cancer genetics laboratory and sees significant opportunity in consolidating the dynamic and consolidating industry. The acquisition combines the companies' complementary assets and geographic footprints to create a leader in hematological and solid tumor cancer testing with synergies of $20-30 million annually.
- The company provides an overview presentation of its business operations as a fast growing cancer genetics laboratory.
- Key highlights include strategic client partnerships through its "tech-only" model, an industry-leading growth rate in revenue and test volume, and the most comprehensive cancer testing menu in the industry.
- The acquisition of Clarient is expected to more than double the company's revenue and more than triple adjusted EBITDA for 2016.
This presentation provides an overview of the company and its recent acquisition of Clarient. It summarizes that the acquisition is expected to more than double the company's revenue and more than triple its adjusted EBITDA in 2016. The company provides cancer genetic testing services and sees significant opportunity for growth and consolidation in the dynamic and expanding industry. The acquisition combines the companies' complementary assets and is expected to generate $20-30 million in annual synergies within 3-5 years.
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on being a leading cancer genetics testing provider, experience in consolidating the industry, a comprehensive testing menu, and strategic partnerships with pathologists and oncologists.
- Financial projections estimate the combined company will generate around $247 million in revenue and $35-40 million in adjusted EBITDA in 2016 following the acquisition.
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on cancer genetics testing, strategic partnerships with pathologists and oncologists, a comprehensive testing menu, and experienced management team.
- Financial projections estimate combined pro forma revenue of $242-252 million and adjusted EBITDA of $35-40 million in 2016 following the acquisition of Clarient. Synergies from the acquisition are expected to provide $20-30 million in annual cost savings.
This presentation provides an overview of a cancer genetics laboratory company. Key points include:
- The company has experienced strong and consistent revenue and test volume growth through strategic partnerships and an expanding test menu. An upcoming acquisition is expected to more than double revenue and more than triple adjusted EBITDA.
- The management team has extensive experience in large cap clinical laboratories.
- The company addresses a $5 billion clinical cancer testing market and has opportunities for further growth through innovation, such as liquid biopsy tests and partnerships with oncologists.
- Recent acquisitions and an expanding test menu have contributed to accelerating same store sales growth.
This presentation provides an overview of the company and its acquisition of Clarient. It summarizes that the acquisition will more than double the company's revenue and more than triple its adjusted EBITDA. The acquisition provides key benefits like synergies of $20-30 million annually within 3-5 years, a combined leadership in cancer testing, and expanded geographic coverage across the United States with field sales representatives.
This company presentation provides an overview of a cancer genetic testing services company. Key points include:
- The company has experienced strong and consistent growth in revenue and test volume over the past 10 years through both organic growth and acquisitions.
- It provides a broad menu of genetic and molecular testing services including next generation sequencing and is developing liquid biopsy tests.
- The company has an experienced management team with experience in large reference laboratories. It is focused on innovation, cost management, and expanding its commercial footprint.
- Financial results show increasing margins, productivity, and adjusted EBITDA despite lower average prices per test, demonstrating strong operating leverage as the business scales.
March 2017 Company Overview Presentation by NeoGenomics, (Nasdaq: NEO) a fast...Hawk Associates, Inc.
NeoGenomics, Inc. is a high-complexity CLIA-certified clinical laboratory and pharma services company that specializes in cancer genetics diagnostic testing, the fastest growing segment of the laboratory industry. The company's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology, and molecular genetics. Headquartered in Fort Myers, FL, NeoGenomics maintains a network of testing facilities across the US. NeoGenomics services the needs of pathologists, oncologists, urologists and other physician specialists, academic institutions, and the pharmaceutical industry.
The company’s acquisition of Clarient at the end of 2015 significantly transformed the company in terms of reach and capabilities. It more than doubled the size of the company overnight and puts the company on a strong path to achieve its vision of becoming the world’s leading cancer testing and information company.
The company has aggressively accelerated its pace of innovation adding new cancer tests. The company’s targeted tumor-specific multimodality NeoTYPE profiles, which combine molecular, FISH and IHC testing, are gaining acceptance by pathologists and clinicians. The new Liquid Biopsy NeoLAB family of tests now includes 16 different liquid biopsy test. Clarient’s expertise in PDL1 testing has further broadened the company’s cancer testing menu.
This presentation provides an overview of NeoGenomics' proposed acquisition of Clarient, which would more than double NeoGenomics' revenue. The strategic rationale is that the combined company would have greater scale and a more balanced oncology product portfolio, allowing it to be a lower-cost provider. It would also gain a larger clinical trials business and enhanced geographic coverage. Synergies of $20-30 million annually are projected from consolidating laboratories, purchasing, cross-selling and other areas. The acquisition supports NeoGenomics' strategy of using M&A to accelerate its vision of becoming a leading cancer testing and information company.
This document summarizes a report on cardiac toxicity. Cardiac toxicity, where drugs cause heart damage, has led to 28% of drug withdrawals over the last 30 years in the US. If cardiac toxicity is found during drug development or after launch, it can terminate development programs or require drugs to be withdrawn from the market. The report covers the physiology, pharmacology, clinical testing, regulation, and commercial implications of cardiac toxicity. It is intended to help understand, manage, and plan for the risks of cardiac toxicity.
NeoGenomics Company Overview 2014-09-12 includes the following sections:
-Forward-looking Statements
-Investment Highlights
-Experienced Management Team
-Company Overview
-Proven Track Record Of Consistent Growth
-U.S. Cancer Testing Market Size $10-12 Billion
-NeoGenomics' Cancer Testing Services
-Customer Targets
-Accelerating Pace of Innovation
-90+ New Assays Launched Since January 2012
-A Growing Commercial & Facility Footprint
-Acquisition of Path Logic
-Strategic Alliance
-2014 and 2015 Strategic Priorities
-Accelerating Cash Flow & Earnings
-Adjusted EBITDA Metrics
- And much more...
- NeoGenomics is acquiring Clarient, which should more than double NeoGenomics' revenue in 2016.
- The acquisition creates a leading cancer testing and information company with expanded geographic coverage and a more comprehensive product menu.
- Synergies of $20-30 million per year are expected from cost savings and cross-selling opportunities between the two companies.
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.
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
Specialized oncology reference laboratory providing the latest testing technologies, global/tech-only options, and interactive education to the pathology community
Offer the complete spectrum of diagnostic services through nationwide network of laboratories
Dedicated to providing superior service, faster turn-around times, and complete attention to the needs of our clients and their patients
The document provides an overview of the diagnostics market in Asia. It notes that the market is expected to grow at a CAGR of 8.5% between 2007-2008 due to factors such as increasing healthcare spending, aging populations, and demand for preventative healthcare tools. The largest regional markets are China, India, and Japan, though all markets are expected to see steady growth. The largest product segments are clinical chemistry, immuno-chemistry, and self-monitoring blood glucose devices.
The FOURIER trial investigated whether adding evolocumab to statin therapy reduces cardiovascular events. Over 27,000 patients with a history of cardiovascular disease were randomized to receive evolocumab or placebo injections in addition to statin therapy. The primary objective was to determine if evolocumab lowered the risk of major cardiovascular events such as heart attack, stroke, and cardiovascular death. Secondary objectives were to examine the long-term safety and tolerability of evolocumab and investigate the efficacy and safety of achieving very low LDL-cholesterol levels. Results from this outcomes trial could provide evidence on whether PCSK9 inhibition translates to clinical benefit for high-risk patients.
The document provides an overview of the Indian diagnostics market and options for players to enter the market. It notes that diagnostics is an important part of healthcare by enabling early detection and improved treatment. The global diagnostics market is projected to be $28.6 billion in 2005, driven largely by hospital testing. The Indian diagnostics market is estimated at Rs. 10 billion and is growing at 15% annually, led by clinical chemistry, hematology, immunoassays, and urinalysis testing. The market is served by private and public laboratories and hospitals. Major opportunities exist in clinical chemistry reagents, nephlometry, microbiology, and immunoassay products and services.
Cancer Genetics, Inc. (CGIX) is a cancer-focused diagnostics company that provides proprietary genomic tests for cancers like leukemia, lymphoma, and urogenital cancers. The company has a growing portfolio of 5 launched and 8 tests in development. CGIX aims to rapidly expand revenues through sales of its tests, partnerships, and an initiative to partner with community hospitals. The company also has partnerships with major cancer research centers to develop new tests and validate existing ones. CGIX operates in a growing molecular diagnostics market focused on oncology that is projected to reach $17.6 billion, as these types of tests improve cancer treatment.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
Annual State of Clinical Development CostsTTC, llc
The document summarizes key findings from a survey and presentation on annual clinical development costs. It discusses how:
1) Drug development costs are increasing while productivity is declining, putting pressure on the traditional development model.
2) Cost management strategies being used by companies include greater use of CROs, new geographic sites, and standard of care payments to reduce sponsor costs while increasing site payments.
3) Survey findings show CRO costs have risen significantly in recent years and continue to increase, while costs are lower in new geographic sites like Eastern Europe, Asia, and Latin America.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology.
Healthcare Contract Research Organization (CRO) MarketTom Clark
Global Healthcare Contract Research Organization (CRO) Market is expected to reach USD 51.3 billion by 2024 with CAGR of 6.5% over the future period as the scope and its applications are rising enormously across the globe.
This document provides an overview of the clinical pipeline for drugs treating venous thromboembolism (VTE). It highlights betrixaban, currently in Phase III development by Portola Pharmaceuticals, as a potential new oral anticoagulant for the extended treatment of VTE in acutely ill patients. If approved, betrixaban could become the standard of care for this niche patient group, facing minimal competition from other novel oral anticoagulants. Key advantages include its pharmacokinetic profile, safety, dosing regimen, and the development of andexanet alfa as a potential reversal agent, which may help address physician concerns over the lack of antidotes for this drug class.
New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period.
Point of care testing market and forecast to 2016 global analysisRenub Research
Renub Research (http://www.renub.com/report/point-of-care-testing-market-and-forecast-to-2016-global-analysis-88) has announced the addition of the "Point of Care Testing Market and Forecast to 2016: Global Analysis" report to its offering
Point of Care Testing Market and Forecast to 2016: Global Analysis - Market Overview
The concept of Point of Care Testing (POCT), also known as bedside, near-patient testing and decentralized testing, relates to tests that are conducted by clinical operators at the site of patient care where immediate medical action is taken on the results. The fact that point of care (POCT) represents a departure from conventional laboratory medicine has created new opportunities in the field of diagnostics industry. Technical advancements over recent years have helped point of care testing (POCT) to grow with double digit CAGR from 2009 to 2011 and evolve into a vital diagnostic tool. It is predicted that point of care testing market will be approximately US$ 25 Billion by 2016.
Blood glucose test controls a lion’s market share of around 70% for the year 2011 and it is expected to continue its dominance till 2016. Rest of all the others point of care tests market share covered in this report are in single digit. Infectious disease testing market is expected to double by 2016 from its market of 2011. As countries are making the healthcare more and more accessible to people, the demand for various point of care testing is keep on rising. The point of care testing market has become an established sector worldwide and will continue to provide vital contribution in in-vitro diagnostics industry.
This 83 page report contains 26 Figures and 12 Tables provides a comprehensive analysis of the emerging point of care tests market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers. Renub Research report entitled “Point of Care Testing Market and Forecast to 2016: Global Analysis” report also provides market landscape and market share information in the point of care testing market. The report brings together major merger & acquisition, distribution agreement, licensing deals information in point of care testing market. The report also entails major drivers and challenges of point of care testing market.
10 Point of Care Test Segments Covered in this Report
Blood Glucose Testing, Cardiac Marker Testing, Lipid Panel/Cholesterol Testing, Blood Coagulation Testing, Infectious Disease Testing, Urinalysis Testing, Drug of Abuse Testing, Fecal Occult Blood Testing, Pregnancy & Fertility Testing and Tumor Marker Testing
Contract research organization services (cr os) marketameliasimon0
Contract research organizations (CROs) provide support services and clinical trial management for pharmaceutical, biotech, medical device, and other healthcare companies. This document analyzes the global CRO market size and trends between 2019-2025. It finds that the market is growing due to increased outsourcing of research and development activities and rising clinical trial numbers. However, shortages of skilled professionals may restrain growth. The market is segmented by therapeutic area, services type, and end user, with oncology and pharmaceutical companies representing large segments.
Medical Device Contract Research Organization Marketsmyerke
This document provides an overview of a project examining the role of Clinical Research Organizations (CROs) in the medical device industry, with a focus on cardiovascular devices. It discusses the structure of the CRO industry and medical device market, top CROs and their cardiovascular capabilities, FDA regulations regarding offshore clinical trials, and trends in CRO/medical device partnerships and the use of CROs in post-approval testing. The objective is to help Santé Ventures decide whether to invest in or acquire a CRO company.
Jason A. Young, PhD of the UC San Diego AntiViral Research Center (AVRC) presents "Open Source Software Solutions for Clinical Research: Applications for HIV Research."
March 2017 Company Overview Presentation by NeoGenomics, (Nasdaq: NEO) a fast...Hawk Associates, Inc.
NeoGenomics, Inc. is a high-complexity CLIA-certified clinical laboratory and pharma services company that specializes in cancer genetics diagnostic testing, the fastest growing segment of the laboratory industry. The company's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology, and molecular genetics. Headquartered in Fort Myers, FL, NeoGenomics maintains a network of testing facilities across the US. NeoGenomics services the needs of pathologists, oncologists, urologists and other physician specialists, academic institutions, and the pharmaceutical industry.
The company’s acquisition of Clarient at the end of 2015 significantly transformed the company in terms of reach and capabilities. It more than doubled the size of the company overnight and puts the company on a strong path to achieve its vision of becoming the world’s leading cancer testing and information company.
The company has aggressively accelerated its pace of innovation adding new cancer tests. The company’s targeted tumor-specific multimodality NeoTYPE profiles, which combine molecular, FISH and IHC testing, are gaining acceptance by pathologists and clinicians. The new Liquid Biopsy NeoLAB family of tests now includes 16 different liquid biopsy test. Clarient’s expertise in PDL1 testing has further broadened the company’s cancer testing menu.
This presentation provides an overview of NeoGenomics' proposed acquisition of Clarient, which would more than double NeoGenomics' revenue. The strategic rationale is that the combined company would have greater scale and a more balanced oncology product portfolio, allowing it to be a lower-cost provider. It would also gain a larger clinical trials business and enhanced geographic coverage. Synergies of $20-30 million annually are projected from consolidating laboratories, purchasing, cross-selling and other areas. The acquisition supports NeoGenomics' strategy of using M&A to accelerate its vision of becoming a leading cancer testing and information company.
This document summarizes a report on cardiac toxicity. Cardiac toxicity, where drugs cause heart damage, has led to 28% of drug withdrawals over the last 30 years in the US. If cardiac toxicity is found during drug development or after launch, it can terminate development programs or require drugs to be withdrawn from the market. The report covers the physiology, pharmacology, clinical testing, regulation, and commercial implications of cardiac toxicity. It is intended to help understand, manage, and plan for the risks of cardiac toxicity.
NeoGenomics Company Overview 2014-09-12 includes the following sections:
-Forward-looking Statements
-Investment Highlights
-Experienced Management Team
-Company Overview
-Proven Track Record Of Consistent Growth
-U.S. Cancer Testing Market Size $10-12 Billion
-NeoGenomics' Cancer Testing Services
-Customer Targets
-Accelerating Pace of Innovation
-90+ New Assays Launched Since January 2012
-A Growing Commercial & Facility Footprint
-Acquisition of Path Logic
-Strategic Alliance
-2014 and 2015 Strategic Priorities
-Accelerating Cash Flow & Earnings
-Adjusted EBITDA Metrics
- And much more...
- NeoGenomics is acquiring Clarient, which should more than double NeoGenomics' revenue in 2016.
- The acquisition creates a leading cancer testing and information company with expanded geographic coverage and a more comprehensive product menu.
- Synergies of $20-30 million per year are expected from cost savings and cross-selling opportunities between the two companies.
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.
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
Specialized oncology reference laboratory providing the latest testing technologies, global/tech-only options, and interactive education to the pathology community
Offer the complete spectrum of diagnostic services through nationwide network of laboratories
Dedicated to providing superior service, faster turn-around times, and complete attention to the needs of our clients and their patients
The document provides an overview of the diagnostics market in Asia. It notes that the market is expected to grow at a CAGR of 8.5% between 2007-2008 due to factors such as increasing healthcare spending, aging populations, and demand for preventative healthcare tools. The largest regional markets are China, India, and Japan, though all markets are expected to see steady growth. The largest product segments are clinical chemistry, immuno-chemistry, and self-monitoring blood glucose devices.
The FOURIER trial investigated whether adding evolocumab to statin therapy reduces cardiovascular events. Over 27,000 patients with a history of cardiovascular disease were randomized to receive evolocumab or placebo injections in addition to statin therapy. The primary objective was to determine if evolocumab lowered the risk of major cardiovascular events such as heart attack, stroke, and cardiovascular death. Secondary objectives were to examine the long-term safety and tolerability of evolocumab and investigate the efficacy and safety of achieving very low LDL-cholesterol levels. Results from this outcomes trial could provide evidence on whether PCSK9 inhibition translates to clinical benefit for high-risk patients.
The document provides an overview of the Indian diagnostics market and options for players to enter the market. It notes that diagnostics is an important part of healthcare by enabling early detection and improved treatment. The global diagnostics market is projected to be $28.6 billion in 2005, driven largely by hospital testing. The Indian diagnostics market is estimated at Rs. 10 billion and is growing at 15% annually, led by clinical chemistry, hematology, immunoassays, and urinalysis testing. The market is served by private and public laboratories and hospitals. Major opportunities exist in clinical chemistry reagents, nephlometry, microbiology, and immunoassay products and services.
Cancer Genetics, Inc. (CGIX) is a cancer-focused diagnostics company that provides proprietary genomic tests for cancers like leukemia, lymphoma, and urogenital cancers. The company has a growing portfolio of 5 launched and 8 tests in development. CGIX aims to rapidly expand revenues through sales of its tests, partnerships, and an initiative to partner with community hospitals. The company also has partnerships with major cancer research centers to develop new tests and validate existing ones. CGIX operates in a growing molecular diagnostics market focused on oncology that is projected to reach $17.6 billion, as these types of tests improve cancer treatment.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
Annual State of Clinical Development CostsTTC, llc
The document summarizes key findings from a survey and presentation on annual clinical development costs. It discusses how:
1) Drug development costs are increasing while productivity is declining, putting pressure on the traditional development model.
2) Cost management strategies being used by companies include greater use of CROs, new geographic sites, and standard of care payments to reduce sponsor costs while increasing site payments.
3) Survey findings show CRO costs have risen significantly in recent years and continue to increase, while costs are lower in new geographic sites like Eastern Europe, Asia, and Latin America.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology.
Healthcare Contract Research Organization (CRO) MarketTom Clark
Global Healthcare Contract Research Organization (CRO) Market is expected to reach USD 51.3 billion by 2024 with CAGR of 6.5% over the future period as the scope and its applications are rising enormously across the globe.
This document provides an overview of the clinical pipeline for drugs treating venous thromboembolism (VTE). It highlights betrixaban, currently in Phase III development by Portola Pharmaceuticals, as a potential new oral anticoagulant for the extended treatment of VTE in acutely ill patients. If approved, betrixaban could become the standard of care for this niche patient group, facing minimal competition from other novel oral anticoagulants. Key advantages include its pharmacokinetic profile, safety, dosing regimen, and the development of andexanet alfa as a potential reversal agent, which may help address physician concerns over the lack of antidotes for this drug class.
New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period.
Point of care testing market and forecast to 2016 global analysisRenub Research
Renub Research (http://www.renub.com/report/point-of-care-testing-market-and-forecast-to-2016-global-analysis-88) has announced the addition of the "Point of Care Testing Market and Forecast to 2016: Global Analysis" report to its offering
Point of Care Testing Market and Forecast to 2016: Global Analysis - Market Overview
The concept of Point of Care Testing (POCT), also known as bedside, near-patient testing and decentralized testing, relates to tests that are conducted by clinical operators at the site of patient care where immediate medical action is taken on the results. The fact that point of care (POCT) represents a departure from conventional laboratory medicine has created new opportunities in the field of diagnostics industry. Technical advancements over recent years have helped point of care testing (POCT) to grow with double digit CAGR from 2009 to 2011 and evolve into a vital diagnostic tool. It is predicted that point of care testing market will be approximately US$ 25 Billion by 2016.
Blood glucose test controls a lion’s market share of around 70% for the year 2011 and it is expected to continue its dominance till 2016. Rest of all the others point of care tests market share covered in this report are in single digit. Infectious disease testing market is expected to double by 2016 from its market of 2011. As countries are making the healthcare more and more accessible to people, the demand for various point of care testing is keep on rising. The point of care testing market has become an established sector worldwide and will continue to provide vital contribution in in-vitro diagnostics industry.
This 83 page report contains 26 Figures and 12 Tables provides a comprehensive analysis of the emerging point of care tests market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers. Renub Research report entitled “Point of Care Testing Market and Forecast to 2016: Global Analysis” report also provides market landscape and market share information in the point of care testing market. The report brings together major merger & acquisition, distribution agreement, licensing deals information in point of care testing market. The report also entails major drivers and challenges of point of care testing market.
10 Point of Care Test Segments Covered in this Report
Blood Glucose Testing, Cardiac Marker Testing, Lipid Panel/Cholesterol Testing, Blood Coagulation Testing, Infectious Disease Testing, Urinalysis Testing, Drug of Abuse Testing, Fecal Occult Blood Testing, Pregnancy & Fertility Testing and Tumor Marker Testing
Contract research organization services (cr os) marketameliasimon0
Contract research organizations (CROs) provide support services and clinical trial management for pharmaceutical, biotech, medical device, and other healthcare companies. This document analyzes the global CRO market size and trends between 2019-2025. It finds that the market is growing due to increased outsourcing of research and development activities and rising clinical trial numbers. However, shortages of skilled professionals may restrain growth. The market is segmented by therapeutic area, services type, and end user, with oncology and pharmaceutical companies representing large segments.
Medical Device Contract Research Organization Marketsmyerke
This document provides an overview of a project examining the role of Clinical Research Organizations (CROs) in the medical device industry, with a focus on cardiovascular devices. It discusses the structure of the CRO industry and medical device market, top CROs and their cardiovascular capabilities, FDA regulations regarding offshore clinical trials, and trends in CRO/medical device partnerships and the use of CROs in post-approval testing. The objective is to help Santé Ventures decide whether to invest in or acquire a CRO company.
Jason A. Young, PhD of the UC San Diego AntiViral Research Center (AVRC) presents "Open Source Software Solutions for Clinical Research: Applications for HIV Research."
O documento descreve a história do fonógrafo, desde as primeiras tentativas de gravar e reproduzir sons até a sua invenção por Thomas Edison em 1877. Detalha os principais desenvolvimentos e inventores que contribuíram para o fonógrafo, como Leon Scott e Charles Cros, e descreve a importância da invenção de Edison.
Cros and other_outsourced_pharmaceutical_support_services_m_a_drivers_and_trendsAllu Sridhar Venkat
CROs (Contract Research Organizations) provide outsourced services to support pharmaceutical companies' research and development processes. This document discusses trends in the CRO industry, including drivers of mergers and acquisitions. It notes that the CRO market is expected to grow to over $30 billion by 2018 due to increasing biopharma R&D spending and the trend of outsourcing more services. Consolidation in the industry will likely continue, fueled by both strategic buyers seeking new capabilities and private equity firms. Specialized service providers in areas like patient recruitment and clinical technology remain a focus for larger CRO players.
Luis Braille, nacido ciego en 1809 en Francia, desarrolló el sistema de lectura y escritura en relieve que lleva su nombre a los 15 años. Dos siglos después, la tecnología permite que las personas ciegas o con problemas de visión puedan leer y escribir a través de equipos como impresoras y ordenadores Braille. El documento también describe brevemente los orígenes del sistema Braille y otras innovaciones tempranas para facilitar la lectura a personas ciegas.
O documento fornece um resumo histórico da fotografia desde os primórdios com a câmara escura até o desenvolvimento dos processos fotográficos em preto e branco e a popularização da fotografia digital. Aborda inventores como Niépce, Daguerre e Fox Talbot e processos como o daguerreótipo, calótipo e chapa úmida.
This document discusses medical monitoring, including what it is, what it is not, and the elements required to establish a claim for medical monitoring. It defines key terms like medical monitoring, diagnostic testing, and screening. Medical monitoring allows asymptomatic individuals exposed to hazardous substances to recover the costs of screening tests to check for diseases, even without present injury. However, most courts require the exposure to be significant and due to defendant's negligence. The exposure must also create an increased risk of a serious latent disease for which effective screening is available. The document also cautions that medical monitoring claims should not rely on precedent for recovering diagnostic or surveillance testing costs for injured plaintiffs.
O documento discute microbiologia aplicada aos alimentos. Aborda os principais microrganismos encontrados em diferentes alimentos como frutas, carnes e leite, e como eles podem causar deterioração ou ser usados na produção de alimentos fermentados. Também explica métodos de controle de microrganismos como refrigeração, calor, secagem, adição de solutos, acidificação e uso de aditivos. Por fim, lista doenças de origem microbiana que podem ser transmitidas por alimentos.
Louis Braille, um menino francês que ficou cego aos 3 anos de idade, desenvolveu um sistema de leitura e escrita para cegos usando combinações de pontos em relevo que podiam ser lidos pelo tato. Após muita pesquisa e experimentação, ele criou o alfabeto Braille com 6 pontos que permitiu que os cegos lessem livros e música de forma independente.
Louis Braille (1809-1852) was a blind French teacher who invented the Braille system for the blind. He lost his sight at age 3 after accidentally impaling his eye with an awl in his father's workshop. Despite being blind, Braille excelled in school and learned math and music. In 1821, he met Charles Barbier and they worked together to develop a tactile writing system using dots to represent letters. Braille's system used a 6 dot cell and was easier to learn and use than existing methods. Though initially rejected, Braille's system became widely adopted and is still used today to provide reading ability for the blind.
This document discusses the current management of cardiogenic shock. It defines cardiogenic shock and describes its causes, predictors of mortality, and pathophysiology. Treatment involves hemodynamic support, volume management, inotropic drugs, and early revascularization, which significantly reduces mortality. Mechanical circulatory support devices like IABP, Tandem Heart, Impella, and ECMO can further improve hemodynamics and outcomes when used as adjuncts to optimal medical therapy. Timing of revascularization is critical, with survival benefits seen for up to 48 hours after myocardial infarction onset. Special considerations are discussed for managing shock in the elderly, from mechanical causes, and with specific device therapies.
Os métodos de conservação de alimentos evoluíram ao longo da história humana, permitindo o desenvolvimento das civilizações. Inicialmente, homens pré-históricos usavam gelo, calor e fumaça para preservar a comida. Posteriormente, sal, vinagre, óleos e defumação foram empregados. Nos tempos modernos, pasteurização e liofilização tornaram-se técnicas eficientes de preservação baseadas nesses mesmos princípios antigos.
The European Communication Monitor 2016 surveyed 2,710 communication professionals across 43 European countries to understand current practices and future trends in strategic communication. The survey explored how communicators work with big data and algorithms, engage stakeholders, and develop skills. Key findings include: 1) While many see big data as important, few communication departments currently use big data analytics. 2) Communicators agree algorithms impact message spread but few adapt activities to algorithms. 3) Stakeholder engagement and coaching senior executives are seen as important but practices vary significantly across organizations and countries.
Braille is a tactile writing system used by blind and visually impaired people. It was developed in the 19th century and uses patterns of dots to represent letters and numbers. Louis Braille improved on a previous system to develop the 6-dot braille cell that is used today. Braille can be read through touch and allows blind people to read and write. It is produced using braille embossers or printers and comes in various formats including braille books, notes, and computer displays.
Canning has been a preservation process since ages. This presentation gives a brief description about the process and some of the problems related to it.
Computer monitors display visual output and have evolved from early text-based displays to modern LCD screens capable of showing millions of colors. Early monitors in the 1980s could only display text in a few colors but improved to color graphics. LCD monitors became popular in the 1990s and work by using a backlight and pixels to form images. Future monitor trends may include thinner OLED screens without backlights and 3D capable displays.
This document provides a summary of a comprehensive oncology intelligence report for 2013. The report contains over 800 pages divided into 6 sections with infographics and tables. It covers aspects of cancer drug development including companies, clinical trials, targets, indications and molecules in development. The report is designed to provide up-to-date intelligence on competition, collaboration patterns, emerging targets and research trends to help with strategic decision making. Each section analyzes the data through infographics and profiles of over 400 cancer-focused companies to explore research trends, development strategies and changes in the oncology landscape over time.
Joseph Dal Molin: Implementing VistA internationally: Myth-busting lessons fr...Nuffield Trust
In this slideshow Joseph Dal Molin, President of the E-cology Corporation and Chairman of WorldVistA, outlines Jordan’s health system and its approach to implementing VistA.
Joseph Dal Molin presented at the Nuffield Trust seminar: Sharing international experience: Is implementing the VA's electronic health record system an option for the NHS? in July 2012.
Global Uro-Gynecological Surgical Devices IndustryReportLinker.com
This report analyzes the worldwide markets for Uro-Gynecological Surgical Devices in US$ Million by the following segments: Urological Surgical Devices (Sling & Suspension Devices, & Other Urological Devices), and Gynecological Surgical Devices (Endometrial Ablation Devices, Endoscopes, Hysteroscope Systems, Fluid Management Systems, & Other Gynecological Devices). The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia'Pacific, and Rest of World. Annual estimates and forecasts are provided for each region for the period 2007 through 2015. Also, a six-year historic analysis is provided for these markets. The report profiles 66 companies including many key and niche players such as Gyrus ACMI Corporation, American Medical Systems Holdings Incorporated, Boston Scientific Corporation, C. R. Bard, Inc., Cook Urological Inc., CooperSurgical, Inc., Hologic Inc., Ethicon, Inc., Cytyc Corporation, Cytyc Surgical Products, Ethicon Inc., Karl Storz GmbH & Co. KG, MDMI Technologies, Inc., Medtronic, Inc., Olympus America Inc., Olympus Surgical & Industrial America, Inc., Richard Wolf GmbH, and Stryker Corporation. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
The document is Boston Scientific's 2005 Annual Report. It discusses the company achieving $6.28 billion in revenue in 2005, a 12% increase over 2004, driven by market leadership in drug-eluting stents. It summarizes clinical trial results and new product approvals. It also notes the proposed acquisition of Guidant would make Boston Scientific a leader in cardiac rhythm management and expand its technology portfolio. The report discusses initiatives to address quality issues raised by the FDA and invest in growth areas like neuromodulation, drug-eluting stents, and peripheral interventions.
Coronary Disease Global Clinical Trials Review, H1, 2012ReportLinker.com
Coronary Disease Global Clinical Trials Review, H1, 2012
Summary
GlobalData's clinical trial report, 'Coronary Disease Global Clinical Trials Review, H1, 2012" provides data on the Coronary Disease clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Coronary Disease. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Coronary Disease. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Cancer Diagnostics Reference Laboratory / NeoGenomics April 2014 investors company overview presentation. This presentation highlights the following:
--Fast growing cancer genetics lab servicing Oncologists, Pathologists and Hostpitals
--Strategic client partnerships created by "Tech-Only" model
--Dynamic, rapidly-growing and consolidating industry
Industry-leading revenue & test volume growth
--Strong productivity and operating leverage leading to accelerating cash flow and net income
--Strong Management Team with large cap lab experience
The document summarizes key happenings and trends from the 2014 AACC annual meeting and clinical lab expo in Chicago. Specifically:
- Point of care and infectious disease testing were highlighted areas with over 20% of exhibitors.
- Emerging "grassroots molecular" point of care systems were showcased, including systems from Cepheid, Quidel, Nanosphere, and others aiming to provide sample to result testing outside central labs.
- Animal diagnostics and emerging metabolomics offerings were other notable areas exhibited by some companies seeking new opportunities beyond traditional human diagnostics.
Insights into the Canadian eHealth Landscape - MaRS Future of MedicineMaRS Discovery District
In recognition of the need to develop a national digital health strategy and to co-ordinate activity across the country, the Conference of Deputy Ministers established Canada Health Infoway in 2001.
This lecture describes Infoway’s role and the progress that it and its jurisdictional partners have made over the last decade. It outlines the challenges to achieving our collective goal of using technology to improve the health of Canadians and describes key enablers that must be in place for us to be successful. It also contains the results of recent public opinion research conducted with Canadians and healthcare providers and outlines the priorities for moving forward and the opportunities for action.
Ibc cell therapy clinical development conference (arlington va september 10 ...Proteus Venture Partners
Gregory Bonfiglio presented on why cell therapy clinical trials often fail. The document discussed cell therapy market trends and ongoing clinical trials. It noted that the overall failure rate of FDA clinical trials is 84.7%, with failures occurring most often in phases II and III due to issues with efficacy, safety, and funding. Common reasons cell therapy trials fail include technology failures to demonstrate efficacy or safety, poor clinical trial design, lack of clinical operations experience, inadequate funding, and unresolved regulatory hurdles. The document examined case studies of failed cell therapy trials from Geron and Dendreon.
Regenerative Medicine Industry Outlook 2014Pete Shuster
The document summarizes the regenerative medicine field based on a report from the Alliance for Regenerative Medicine, including an overview of major industry players and subsectors, clinical trials and products in development, financial performance and investments in 2013, and insights from a panel discussion on key areas of focus. It analyzes trends in cell and gene therapies, areas attracting pharmaceutical investment, and challenges facing the commercialization of regenerative medicine technologies and therapies.
The document is Boston Scientific's 2005 Annual Report. It discusses the company's strong financial performance in 2005, with total revenue reaching $6.28 billion, a 12% increase over 2004. It summarizes key accomplishments across its business units, including maintaining the leading market share for drug-eluting stents. It also addresses the FDA's letter regarding quality compliance systems and the company's response to comprehensively address issues. Looking ahead, the report discusses strategic priorities like accelerating base business growth and expanding drug-eluting stent market share.
The document is Boston Scientific's 2005 Annual Report. It discusses the company's strong financial performance in 2005, with total revenue reaching $6.28 billion, a 12% increase over 2004. It summarizes key accomplishments across its business units, including maintaining the leading market share for drug-eluting stents. It also addresses the FDA's letter regarding quality compliance systems and the company's response to comprehensively address issues. Looking ahead, it discusses strategic priorities like accelerating base business growth and expanding drug-eluting stent market share through new products.
The document is Boston Scientific's 2005 Annual Report. It discusses the company's strong financial performance in 2005, with total revenue reaching $6.28 billion, a 12% increase over 2004. It summarizes key accomplishments across its business units, including maintaining the leading market share for drug-eluting stents. It also addresses the FDA's letter regarding quality compliance systems and the company's response to comprehensively address issues. Looking ahead, the report discusses strategic priorities like accelerating base business growth and expanding drug-eluting stent market share.
This document provides a summary of the Oncology Drug Report 2014, which is described as the world's largest active resource for decision making in oncology. Some key details include:
- It covers 931 active cancer drug developers across 33 countries, along with profiles of 2237 active drugs in development, 37 cancer indications under pipeline analysis, and 523 clinical and 360 preclinical and discovery companies.
- The report is organized across 6 sections and provides comprehensive intelligence on the global oncology drug development landscape, including clinical trials, targets, mechanisms of action, deals and partnerships for individual drugs and companies.
- It aims to help businesses, scientists, investors and clinicians make better decisions by bringing extensive data together in one place
HSIC is the largest distributor of healthcare products and services to office-based practitioners in North America and Europe. It has grown significantly since becoming a public company in 1995, with worldwide sales increasing from $616 million to $5.9 billion in 2007. HSIC services the dental, medical, and animal health markets through a broad product offering and value-added services. It has key strengths in sales and marketing expertise, centralized infrastructure, customer service, and practice management software. HSIC's strategies focus on expanding services to partner with customers and improve their efficiency, productivity, and profitability.
IDDI is a clinical data center founded in 1991 that provides eClinical and biostatistical services globally. Over the past 20 years, it has grown from a small company in France to operating internationally with offices in Europe and North America. IDDI has experience managing over 500 clinical trials involving over 50,000 patients across various therapeutic areas and trial phases. It works with over 75 pharmaceutical, biotechnology, academic, and medical device clients annually. IDDI's services include clinical trial design, data management, biostatistics, and regulatory support.
Prescient Therapeutics (PTX:ASX) is an ASX-listed biotechnology company focused on improving outcomes for cancer patients by developing personal medicines, using CAR-T and targeted therapy approaches.
Universal CAR-T therapies like OmniCAR have the potential to take personalised cancer treatment to the next level, by combining the cancer-killing capabilities of a T-cell with the control and pharmacology of a drug.
This document summarizes a presentation given by Dr. Robert Boorstein on drivers of change in the laboratory market. Five key trends are discussed: laboratory consolidation, growth of central laboratories vs point-of-care testing, new delivery models, new technologies, and increased competition across sectors. Laboratory consolidation is driven by cost reductions and allows for standardization but may shift market power from sellers to buyers. Point-of-care testing is growing rapidly but poses challenges to quality control. New national laboratory companies are emerging focused on unique branded products.
MaRS BioEntrepreneurship Series Event, June 12, 2007
Speaker: Wayne Schnarr, Senior VP, Life Sciences, The EquicomGroup
More information including a video: http://www.marsdd.com/bioent/june12
MDxHealth provides molecular diagnostic tests to improve diagnosis and treatment decisions for urological cancers like prostate and bladder cancer. Their lead product is ConfirmMDx, which helps determine if a repeat biopsy is needed after an initial negative biopsy result. They are also launching SelectMDx, a urine-based test to improve patient selection for initial biopsies. Looking forward, they plan to expand their product portfolio and commercial footprint in the US and EU to address unmet needs in urological cancer testing and help reduce unnecessary invasive procedures.
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
GASTROINTESTINAL INFECTIONS AND GASTRITIS
Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
NAVIGATING THE HORIZONS OF TIME LAPSE EMBRYO MONITORING.pdfRahul Sen
Time-lapse embryo monitoring is an advanced imaging technique used in IVF to continuously observe embryo development. It captures high-resolution images at regular intervals, allowing embryologists to select the most viable embryos for transfer based on detailed growth patterns. This technology enhances embryo selection, potentially increasing pregnancy success rates.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
“Psychiatry and the Humanities”: An Innovative Course at the University of Mo...Université de Montréal
“Psychiatry and the Humanities”: An Innovative Course at the University of Montreal Expanding the medical model to embrace the humanities. Link: https://www.psychiatrictimes.com/view/-psychiatry-and-the-humanities-an-innovative-course-at-the-university-of-montreal
How to Control Your Asthma Tips by gokuldas hospital.Gokuldas Hospital
Respiratory issues like asthma are the most sensitive issue that is affecting millions worldwide. It hampers the daily activities leaving the body tired and breathless.
The key to a good grip on asthma is proper knowledge and management strategies. Understanding the patient-specific symptoms and carving out an effective treatment likewise is the best way to keep asthma under control.
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Travel Clinic Cardiff: Health Advice for International Travelers
CROs & Medical Devices
1. CROs and Cardiovascular Devices
December 9, 2009
Prepared by Rachel Little, Stacee Millangue, Kathlyn Smyer, Cory Welch, & Kirk Yoshida
School of Information, University of Texas
Frost Bank Tower
401 Congress Ave, Suite 2950
Austin, Texas 78701
(512) 721-1200
www.santeventures.com
The information contained in this report is posted with permission.
2. PROJECT OVERVIEW
Objective
Focus on the role of Clinical Research Organizations (CROs) in the medical device industry to help Santé Ventures
decide whether or not to invest in or acquire a CRO company
Main Questions
• How is the CRO industry structured (key players, key sponsors, services, growth rates and trends)?
• Is there evidence of VC firms using CROs for their portfolio companies?
• Are there case studies that describe how a key sponsor used a CRO for medical device development?
• What is the FDA’s position on offshore clinical trials, including their view of offshore test populations as
representative of US populations?
Secondary Questions:
• What are the stages in the medical device development process and how do CROs help at each stage in the process?
• What are the service offerings that CROs provide and what are the pricing models?
• Are there metrics for sponsors to select CROs?
Other Deliverables:
• Provide a list of top CROs that either specialize or have known capabilities in the cardiovascular medical device area
• Provide a list of top VC firms that invest in medical devices
• Links to datasets for clinical trials and medical device submissions
2
Confidential & Trade Secret
3. OVERALL CRO MARKET
• Current estimated CRO market size: $10.91B (Frost & Sullivan)1 to $23.7B (Goldman Sachs)3
• Projected CRO market size: $22.87B (1) for 2015 to $33.7 for 2012 (3)
• Current growth rate (2009): 10% (1)
• 2008 growth rate: 14-15% (1)
• 1,100 CRO companies worldwide (1)
Pharmaceutical and Biotechnology Market: R&D Clinical Trial
Pipeline by Therapeutic Area (U.S.), 2009
Metabolic
5% Respiratory
Cardiovascular
3%
8%
Central Nervous
System Other
10% 37%
Other
Oncology
Infectious Diseases
Central Nervous System
Cardiovascular
Oncology
25% Metabolic
Respiratory
Infectious Diseases
11% Percentages rounded up
3
Confidential & Trade Secret
Sources: Frost & Sullivan(1,2)
4. TOP CARDIOVASCULAR CROS
Companies chosen from list compiled through searches in Cap IQ, Google, market research reports
• Narrowed down to medical device CRO’S
• Narrowed further to those with cardiovascular capabilities
• Researched for years of experience
• Checked for offices in Europe and Latin America
(CRO spreadsheets attached)
Top Players in CRO market who work on cardiovascular medical devices!
Year Latin American Revenue
CRO Europe Offices Company Website
Founded Offices ($b)
Quintiles 1990 Yes Yes 3 http://www.quintiles.com/
PPD 1985 Yes Yes 1.57 http://www.ppdi.com/
Covance 1987 Yes Yes 1.73 http://www.covance.com/
4
Confidential & Trade Secret
5. CARDIOVASCULAR CRO’S (continued)
Latin Latin
Year Europe Year Europe
CRO American Company Website CRO American Company Website
Founded Offices Founded Offices
Offices Offices
MDS Pharma Averion
1933 Yes Yes www.mdsps.com/
Svcs. International 2007 Yes No www.averionintl.com/
Corp.
Parexel 1983 Yes Yes www.parexel.com/
GRSworldwide 2007 Yes No http://www.grs-cro.com/
ParmaNet 1984 Yes Yes www.pharmanet.com/
Clinimetrics 1988 No No www.clinimetrics.com/
Factory CRO 1998 Yes Yes www.factory-cro.com/
Alquest 1993 No No www.alquest.com/
Clindatrix 2003 Yes Yes www.clindatrix.com/
MPI Research 1995 No No www.mpiresearch.com/
Charles River
1947 Yes No www.criver.com/
Labs Regulatory &
Clinical
MDCI 1980 Yes No www.mdci.com/ 1999 No No www.rcri-inc.com/
Research
Institute
Criterium 1991 Yes No www.criteriumusa.com/
CBSET, Inc. 2006 No No http://www.cbset.org/
ClinSys 1992 Yes No www.clinsys.com/
Symbios
2006 No No www.symbiosclinical.com/
Clinical, Inc.
Integrium 1998 Yes No www.integrium.com/
N/A
Innoventz (10+ yrs No No www.innoventz.com/
Cidal 2001 No Yes www.cidal.net/
exp.)
Venn Life
2006 Yes No www.vennlifesciences.com/
Sciences
5
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6. MEDICAL DEVICE MARKET
Types of Cardiovascular Devices
• Medical Device Market worth $250 billion in 2009 Cardiac Rhythm Management
• Growth rate 6%-8%
Cardiovascular Monitoring & Diagnostic
• Outsourcing has helped medical device manufacturers reduce product
development cost by 10% to 30% (MarketsandMarkets)1 Cardiovascular Prosthetic Device
Cardiovascular Surgery
• Orthopedics, neurology, cardiology, and cosmetics/aesthetics are the
fastest-growing medical device market segments in the United States Electrophysiology
• Industry produces approximately 100,000 individual products per year Interventional Cardiology
(Devicelink)2
Peripheral Vascular Devices
Top Cardiovascular Device Companies
!
(Global Data)3
by FDA submissions, 1976- present
Intermedics Inc.
Number of Documents
Cordis Corp.
St. Jude Medical Inc.
Medtronic Inc.
Boston Scientific Corp.
0 200 400 600 800 1000 1200 1400 1600 1800 2000
(Boliven)4!
6
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7. MEDICAL DEVICE INVESTMENTS
Top VC Firms
• Medical Device investments up 2002-2007 (Thomson)1
in Medical Device Field
• Medical Device investments fell 2008; increased in Q2 2009 (Dow Jones) 2
($100+ M in health care capital)
• VC firms investing in device companies (1,2, devicelink.com)
• Established medical device companies investing in start-ups Accuitive Medical Ventures
o Ex: Johnson & Johnson’s investment arm - JJDC group Golden Pine Ventures
• Evidence of CROs investing in medical devices, drugs, start-ups
o Ex: Quintiles takes cut in product revenues (4243B attached) Mayfield Fund
o Ex: Cato Research started investment arm Cato Bioventures4 MPM Capital
o Ex: PPD investing in Celtic Therapuetics (private equity firm)
Three Arch Partners
Versant Ventures
VC Investment in MedTech Sierra Ventures
Source: devicelink.com
MedTech Field Includes
• Nonimaging diagnostics
• Research and other equipment
• Imaging
• Therapeutic Devices
Source: Ernst & Young
Confidential & Trade Secret
Source: Ernst & Young, Capital IQ, Dow Jones VentureSource and Windhover
8. CRO & DEVICE SPONSOR PARTNERSHIPS
What to ask a CRO:
Pricing Models
• What are the capabilities and capacity of existing clinical personnel?
• What are the critical business factors Fixed
(e.g., time, money, headcount) for the organization? Great for small projects
• What are the long-term needs to support clinical development? Option for tight budgets
• Do they substantiate in-house capabilities?
What can be outsourced in conducting clinical trials? Billable Hours, by service
• SOP development Current standard for most CRO’s
• Site Protocol development Allows for some flexibility
• Monitoring / Project Management
• Data Management / Statistics
• Audits of internal and external of clinical processes, procedures and Sources: Clinpage: 1,2
personnel
(Source: Kate Giovino, OrganoGenesis Inc. )
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9. MEDICAL DEVICE TESTING PROCESS
Graphic Source
Major categories under which medical device testing fall aligned with the stages of product development:
1. Research and Development (2-3 years):
includes screening and qualification tests that chemically characterize raw materials or medical device components
2. Design and Validation (6-12 months):
or functionality testing, usually involves surgical studies that evaluate how well the device performs the intended
treatment
3. Biocompatibility (1-2 years):
testing uses both in vitro and in vivo models to ensure that the device or component material is biologically safe
for its intended use
4. Clinical Trials (1-2 years):
scientific studies are employed to evaluate a drug, device, or biologic on patients in the treatment, prevention, or
diagnosis of a disease or condition
5. Sterility Assurance & Microbiology (1-2 years):
sterilization validation, environmental monitoring, and packaging validation with shelf-life testing (Source)
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10. MEDICAL DEVICE POST-APPROVAL PROCESS
FDA charged to seek Device company Sites for trials are
“least burdensome may choose CRO determined by
means” to evaluate data, for post-market sponsor.
which necessitates post- testing.
market surveillance.
• Clarify CRO • Study tracking
responsibilities. website developed.
• When failure may • Concur on study • Sponsor legal team
result in health purpose and data and CRO negotiate
consequences. management. contract to facilitate
• When intended for study start-up.
• Reviews of
implantation for more milestones.
than one year.
• When life-supporting
devices will be used
outside facility.
(Source)!
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11. CLINICAL TRIALS
• 82,466 trials with locations in 170 countries
registered with FDA, 3/2000-12/1/2009
• 6,731 related to medical devices
• 3,480 outside U.S.
• 2,930 actively recruiting outside U.S.
• 1,945 trials related to cardiovascular
conditions and medical devices
975 conducted outside U.S.
(Source: ClinicalTrials.gov)
Percentages to whole number
Source: (Source: ClinicalTrials.gov)
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12. CRO/MEDICAL DEVICE TRENDS
CRO Industry Trends (Source)1
• "Undercurrent of interest" among private equity firms in acquiring CROs
• Possible emerging trend: Long-term partnering arrangements between CROs & recruiting firms
• Number of CROs has reached 1,100 despite continued consolidation (Source)2
Medical Device Trends (Depends on who you are talking to)
• FDA leadership on role of outsourcing: (Source)3
• Outsourcing requires more international collaboration on inspections, enforcement, and compliance policy issues.
Also, greater regulatory focus on supplier selection, qualification, and monitoring
• Market opportunity in fusion pumps – look at recalls
• Five new science platforms that apply to the medical device industry: nanotechnology, synthetic biology, tissue
engineering, stem cells, and robotics
• CRO Industry (Source: Linda Alexander, Alquest CEO)4
• Seeing a more cautious, rigorous approach from FDA, but not necessarily scientifically or medically sound
• Suggestions for sponsors - Take products abroad first
• With longer U.S approval process, companies should develop a strategy for selling their product abroad
• Revenue stream can help sustain the company and show VC market that they have a viable product
• Europe is best choice right now
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13. CRO/MEDICAL DEVICE TRENDS (continued)
Market Potential (Source)1
• The CRO medical device industry is smaller than pharmaceutical & biotech but growing
• Few blockbuster (>$1B sales) medical devices in the past but cardiovascular drug-eluting stents is game changer
• Anecdotal evidence shows firms moving into the medical device area
• Some CROs are differentiating themselves by concentrating on cardiovascular medical device testing
• Four fastest growing medical device segments are orthopedics, neurology, cardiology, and cosmetics/aesthetics
• Fueled by aging populations
• Barriers to growth - device recalls & device-related deaths (spiked in 2006 vs 2005)
Small to Medium CROs forming networks or alliances (Clinpage1, Clinpage2, Centerwatch)
• Smaller CROs provide better one-on-one service but do not have global presence
• Establish standard methodologies to expedite and improve operations
• Target sponsors based on specialties
• Allow smaller CROs to compete with larger companies
• Examples: Pharmaceutical Services Network and Agile Network
Expert Networks & Management Tools
• Beginning to see resources for connecting companies to CRO’s (example: GoBalto for pharma)
• Online business network for medical device industry and software reduce time & costs
o E-Zassi’s database and FDA regulation calculator
o M2S’s iMAP for collecting clinical trial images
• Management tools are often targeted to both sponsor and CRO’s for conducting trials (Example: StudyManager)
o Some CRO’s use multiple electronic data capture (EDC) vendors (Clinpage)
• Some CRO’s specialize in in-house management tools for EDC (Contractpharma)
o EDC allows smaller CRO’s to compete with larger ones
o EDC makes allows for easier management of global clinical trials
o Example: Clinipace 13
Confidential & Trade Secret
14. FDA POSITION ON OFFSHORE CLINICAL TRIALS OF MEDICAL DEVICES
• Permissible to conduct offshore clinical trials of medical devices.
• No FDA jurisdiction over foreign clinical trials, but FDA does set standards for data submitted in support of U.S.
marketing applications for medical devices (including Premarket Approvals (PMA) and Premarket Notifications(510
(k) ). (Source: FDA’s Total Product LifeCycle: What Clinical Data from Outside the U.S. Does FDA Accept?)
If a clinical trial is conducted overseas pursuant to an approved Investigational Device Exemption(IDE):
The trial must comply with U.S. FDA regulations (21 C.F.R. §814.15(a))
If a clinical trial is conducted overseas and no IDE is filed, the FDA will accept the study if it conforms with:
#
The 1983 version of the Declaration of Helsinki
(FDA regulations have not been updated to include the current version of the Declaration)
OR
The laws and regulations of the country in which the research was conducted (21 C.F.R. §814.15(b)).
• Clinical trials that use host country laws and regulations must state the difference between those laws and the
Declaration, and must explain why they offer greater protection to human subjects (21 C.F.R. § 814.15(b)).
• Foreign clinical data must be applicable to the U.S. population and U.S. medical practice, clinical investigators must
have recognized competence, and clinical data is subject to FDA inspection (on-site or through other means)
(21 C.F.R. §814.15(d)).
• IDEs place a higher regulatory burden on CROs. Further research is necessary to determine how often they are used
in foreign clinical trials.
Source: FDA Guidance – Acceptance of Foreign Clinical Studies. 14
Confidential & Trade Secret
15. BIOETHICAL ISSUES SURROUNDING CLINICAL TRIALS
1. Lack of foreign government regulation of CROs and human subject research activities.
2. Lack of strong international standards and legal remedies to protect patients in clinical trials.
3. Unethical or exploitative conduct by researchers (physician practices may be unacceptable by U.S. standards).
4. Lack of understanding by patients of purpose of clinical trials.
5. Participation in clinical trials may be the only way for individuals to access medical care.
6. Lack of patient consent (and inability of patients to give informed consent).
7. Risks to sponsors of working with CROs that are inexperienced in a particular market or that do not follow required
clinical trial standards.
8. Liability in U.S. courts under Alien Tort Statute (though risk appears to be fairly limited).
9. Liability under U.S. Foreign Corrupt Practices Act if U.S. sponsors or their CROs accept bribes from foreign
government officials.
10. Limited FDA oversight and inspections of overseas clinical trials.
11. Intellectual property theft, limited patent protections (especially in India and China), and trade secret issues with
employees who leave CROs to work for competitors.
Source: FDA Research Summary (Appendix).
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16. FDA: ARE OFFSHORE TEST POPULATIONS REPRESENTATIVE OF U.S.
POPULATIONS?
The FDA values diversity in clinical trial populations, but acknowledges that various issues that may exist in creating
comparable U.S. and foreign test populations. (See Drug Testing Goes Offshore).
Barriers to creating representative test populations: (See FDA Presentation - Total Product Lifecycle)
1. Demographic variables - race, gender, ethnicity and age.
2. Clinical variables - prevalence of smoking, obesity, and diabetes; compliance with medical regimen and follow-up;
education level of patients (e.g. ability to understand directions), and language/cultural differences.
3. Medication/device usage - economic factors in medication usage, legal/regulatory factors, and differing standards of
care.
4. Differing physician/medical practices - adherence to study protocol, varying regional practice guidelines, and
economic/legal considerations.
5. Availability of drugs/adjunct devices
Recommendations
1. Use statistical analysis to draw comparisons between foreign and U.S. populations (Id.).
2. Consult with the FDA on clinical protocol prior to conducting overseas clinical trials (Id.).
3. Create targeted enrollment programs based on geographic region and intended use of product (
New England Journal of Medicine).
4. Use bridging studies to link foreign and U.S. clinical data (Concept is discussed in
Guidance on Ethnic Factors in the Acceptance of Foreign Clinical Data and Questions and Answers, though this
guidance is specifically applicable to drug trials where the safety and efficacy of a drug is linked to ethnicity).
• Recommendations are very vague. This topic merits further research and may require discussions with actual CROs
to determine how they structure their clinical trials to address this issue.
16
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17. SOURCES
Slide 2: OVERALL CRO MARKET
• Frost & Sullivan: http://www.clinpage.com/article/frost_report_on_cros/C15
• Frost & Sullivan: http://www.reportbuyer.com/pharma_healthcare/therapeutic/u_s_cro_markets_key_therapeutic_areas.html
• Goldman Sachs: http://www.centerwatch.com/cwmonthly-complimentary/00x00x00x00_ThisMonthPDF.pdf
Slides 3-4: CARDIOVASCULAR CRO’S
• See company website links
• Attached CRO Spreadsheet: Appendices/MedicalDeviceCROs_and_Full_CRO_lists.xls
Slide 5: MEDICAL DEVICE MARKET
• MarketsandMarkets:
http://www.prnewswire.com/news-releases/service-outsourcing-opportunities-in-medical-device-market-worth-us2677-billion-by-2014-69837522.html
• Devicelink: http://www.devicelink.com/mddi/archive/09/08/017.html
• Global Data: http://www.researchandmarkets.com/reports/835265/united_states_cardiovascular_devices_market
• Source chart created with search aggregator Boliven.com from FDA data: http://www.boliven.com/medical_device_analytics?q=cardiovascular
Slide 6: MEDICAL DEVICE INVESTMENTS
• Thomson: http://www.morgenthaler.com/content/Ventures/Articles/Articles%20documents/Robin%20Bellas%20on%20investements%20taking%20off.pdf
• Dow Jones: http://mediligence.com/blog/2009/07/20/medical-devices-other-healthcare-driving-vc-investment/
• Devicelink VC list: http://www.devicelink.com/links/venture.html
• Johnson & Johnson investment arm: http://www.medicaldevicestoday.com/2009/10/pfizer-jj-see-promise-make-investment-in-cancer-device-company.html
• Quintiles SEC: Appendices/QUINTILESTRANSN424B3-20040330.pdf
• Cato Research: http://www.cato.com/
• Cato Bioventures: http://www.catobioventures.com/
• PPD investing: http://www.clinpage.com/article/ppd_divests_acquires/C15
• Ernst & Young Pulse on the Industry: http://www.ey.com/Publication/vwLUAssets/Pulse_of_the_industry_2009:medtech_review/$FILE/Pulse_Final.pdf
17
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18. SOURCES (continued)
Slide 7: MEDICAL DEVICE PARTNERSHIPS
• Kate Giovino presentation: http://www.massmedic.com/docs/kate07.ppt
• Clinpage article 1: http://www.clinpage.com/article/clinipace_data_visibility_manifesto/C15
• Clinpage article 2: http://www.clinpage.com/article/billable_hours_as_curse/C15
Slide 8: MEDICAL DEVICE TESTING PROCESS
• Expanding role of CRO (graphic): http://www.devicelink.com/mddi/archive/05/04/009.html
• Post-Approval Process article: http://www.circ.ahajournals.org/cgi/content/full/109/25/3068
Slide 9: POST-APPROVAL PROCESS
http://www.devicelink.com/mddi/archive/09/08/017.html
Slide 10: GLOBAL CLINICAL TRIALS
• Clinicaltrials.gov: http://clinicaltrials.gov/
• Clinicaltrials.gov medical device & cardiovascular map: http://clinicaltrials.gov/ct2/results/map?term=cardiovascular+medical+device
Slide 11: CRO/MEDICAL DEVICE TRENDS
• Frost & Sullivan: http://www.clinpage.com/article/frost_report_on_cros/C15
• Global Insights: http://www.globalbusinessinsights.com/content/rbcr0001m.pdf
• Devicelink: http://www.devicelink.com/mddi/archive/09/11/006.html
• Devicelink2: http://www.devicelink.com/mddi/archive/07/03/028.html
18
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19. SOURCES (continued)
Slide 12: CRO/MEDICAL DEVICE TRENDS (continued)
• http://www.devicelink.com/mddi/archive/09/08/017.html
• http://www.clinpage.com/article/cro_network_expands/C15
• http://www.clinpage.com/article/new_global_cro_network/C10
• http://www.centerwatch.com/news-resources/clinical-trials-today/headline-details.aspx?HeadlineID=209
• Pharmaceutical Services Network: http://www.psn-europe.com
• Agile Network: http://www.healthdec.com/page/agilenetwork
• GoBalto: https://www.gobalto.com/
• E-Zassi: http://www.e-zassi.com/Default.aspx
• FDA Regulation Calculator: http://www.ipmarketingadvisor.com/content/fdarc/
• iMAP: http://www.m2s.com/content/m2s-announces-new-clinical-trial-product-imas-medical-image-collect-and-hold-solution
• StudyManager: http://www.clinicalsoftware.net/Home.aspx
• Clinpage: http://www.clinpage.com/article/edc_firms_cro_strategies/C23
• Contractpharma: http://www.contractpharma.com/articles/2009/11/edc-focus-cros-edcs
• Clinipace: http://www.clinipace.com//Guidances/ucm129314.htm
Slide 13: FDA POSITION ON OFFSHORE CLINICAL TRIALS OF MEDICAL DEVICES
FDA’s Total Product Lifecycle: http://www.ilsi.org.il/data/7%20Rhodes%20What%20Clinical%20Data%20Does%20FDA%20Accept.pdf
IDE: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm
21 C.F.R. §814.15(a) (b) (d): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814&showFR=1
Declaration of Helsinki: http://www1.va.gov/oro/apps/compendium/Files/helsinki83.htm
Current Declaration of Helsinki: http://www.wma.net/en/30publications/10policies/b3/index.html
FDA Guidance – Acceptance of Foreign Clinical Studies: http://www.fda.gov/RegulatoryInformation/Guidances/ucm124932.htm
Slide 14: BIOETHICAL ISSUES
• FDA Research Sumamary (attached in Appendix): Appendices/FDA_Research_Summary.doc
Slide 15: FDA: ARE OFFSHORE TEST POPULATIONS REPRESENTATIVE OF U.S. POPULATIONS?
• Drug Testing Goes Offshore: http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm
• FDA Presentation - Total Product Lifecycle: http://www.ilsi.org.il/data/7%20Rhodes%20What%20Clinical%20Data%20Does%20FDA%20Accept.pdf
• New England Journal of Medicine: http://content.nejm.org/cgi/reprint/360/8/816.pdf
• Guidance on Ethnic Factors in the Acceptance of Foreign Clinical Data:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073117.pdf
• FDA Questions and Answers: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129314.htm 19
Confidential & Trade Secret