This document discusses SpectraScience's optical biopsy technology platform and commercialization plans. The technology uses light to provide faster, non-invasive cancer detection compared to physical biopsies. Clinical studies show the technology exceeds accuracy criteria for detecting colon cancer. The company plans to commercialize the technology first in Europe, where distribution agreements are in place, to take advantage of single-payer healthcare systems and proven cost savings. Future indications for bladder, esophageal, and other cancers are also discussed.
ICH-E2A: Safety Reporting in Clinical Trials in Australia
Dr. Ananda Kondepati, M.D. and
Dr. Shalini Pasumarthi, M.D.
Research Program Director:
Pr. Peivand Pirouzi
Objective
Safer Healthcare Now!, a program of the Canadian Patient Safety Institute, invites you to participate in the Canadian VTE Audit, designed to establish a national perspective of VTE thromboprophylaxis rates and raise awareness of appropriate VTE prophylaxis.
VTE is one of the most common and preventable complications of hospitalization and is a Required Organizational Practice (ROP) of Accreditation Canada.
By participating in the national audit day you will be a part of a movement aimed at preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) in hospital patients.
Watch the recording: http://bit.ly/1wfinCE
Critical Care Research: Connection to PracticeAllina Health
1) The document discusses a critical care research program at Abbott Northwestern Hospital with the goals of conducting studies to improve patient outcomes, enhance quality of care, and reduce costs.
2) The program involves intensivists, hospitalists, and other clinical specialties conducting studies and presenting findings to improve practice.
3) Several ongoing studies are summarized that examine issues like postoperative monitoring, pulmonary ultrasound scoring, infection risks, and outcomes after procedures.
Purpose of the Call:
Review the results of the National VTE audit
Discuss lessons learned from the audit – strengths and areas for improvement
Gather ideas for future steps for implementation of VTE prophylaxis
SVMPharma Real World Evidence – Why NHS must embrace Real World DataSVMPharma Limited
SVMPharma Real World Evidence (RWE) – In this paper, we look at how to navigate the difficult balance between financial sustainability
and optimal performance the NHS needs to be more proactive in the collection and
analysis of Real World Data (RWD) and exploit the multiple opportunities for
commissioning RWD analysis at a local and national level . For more resources on RWE visit us at www.svmpharma.com
This document outlines a real-world knowledge translation approach used in Alberta, Canada to facilitate evidence-informed decision making about robot-assisted surgery (RAS). It describes establishing committees to guide the re-evaluation of RAS, identifying current RAS procedures and gaps in evidence, developing strategies for data collection and a training/credentialing process, commissioning an economic analysis, and engaging patients. The overall goal is to ensure RAS technologies are implemented responsibly based on accurate local data and with oversight of costs, outcomes, and impacts on the health system and population health needs.
Biostatistics in development of Medical Devices By T. Mudde - Clinquest (Qser...qserveconference2013
The document discusses guidelines and considerations for clinical investigations of medical devices, focusing on the role of biostatistics in evaluating safety and effectiveness. It outlines statistical aspects that should be addressed in a clinical investigation plan and protocol, including study objectives, design, analyses, and handling of issues like missing data and sample size calculations. Interactive aspects between biostatisticians and sponsors are also covered, such as balancing precision and bias in study design and choice of endpoints.
Presentation by David Farber, FDA Life Science Partner at King & Spalding, about US Reimbursement.
I. Introduction
• II. FDA Approval vs. Reimbursement
• a. Different Standards
b. Clinical Evidence Needed
• III. The Three Keys to Reimbursement
A. Coverage
B. Coding
C. Payment
• IV. What’s New for 2019
• V. Reimbursement for MedTech AI Solutions
• VI. Tips for Successful Reimbursement
ICH-E2A: Safety Reporting in Clinical Trials in Australia
Dr. Ananda Kondepati, M.D. and
Dr. Shalini Pasumarthi, M.D.
Research Program Director:
Pr. Peivand Pirouzi
Objective
Safer Healthcare Now!, a program of the Canadian Patient Safety Institute, invites you to participate in the Canadian VTE Audit, designed to establish a national perspective of VTE thromboprophylaxis rates and raise awareness of appropriate VTE prophylaxis.
VTE is one of the most common and preventable complications of hospitalization and is a Required Organizational Practice (ROP) of Accreditation Canada.
By participating in the national audit day you will be a part of a movement aimed at preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) in hospital patients.
Watch the recording: http://bit.ly/1wfinCE
Critical Care Research: Connection to PracticeAllina Health
1) The document discusses a critical care research program at Abbott Northwestern Hospital with the goals of conducting studies to improve patient outcomes, enhance quality of care, and reduce costs.
2) The program involves intensivists, hospitalists, and other clinical specialties conducting studies and presenting findings to improve practice.
3) Several ongoing studies are summarized that examine issues like postoperative monitoring, pulmonary ultrasound scoring, infection risks, and outcomes after procedures.
Purpose of the Call:
Review the results of the National VTE audit
Discuss lessons learned from the audit – strengths and areas for improvement
Gather ideas for future steps for implementation of VTE prophylaxis
SVMPharma Real World Evidence – Why NHS must embrace Real World DataSVMPharma Limited
SVMPharma Real World Evidence (RWE) – In this paper, we look at how to navigate the difficult balance between financial sustainability
and optimal performance the NHS needs to be more proactive in the collection and
analysis of Real World Data (RWD) and exploit the multiple opportunities for
commissioning RWD analysis at a local and national level . For more resources on RWE visit us at www.svmpharma.com
This document outlines a real-world knowledge translation approach used in Alberta, Canada to facilitate evidence-informed decision making about robot-assisted surgery (RAS). It describes establishing committees to guide the re-evaluation of RAS, identifying current RAS procedures and gaps in evidence, developing strategies for data collection and a training/credentialing process, commissioning an economic analysis, and engaging patients. The overall goal is to ensure RAS technologies are implemented responsibly based on accurate local data and with oversight of costs, outcomes, and impacts on the health system and population health needs.
Biostatistics in development of Medical Devices By T. Mudde - Clinquest (Qser...qserveconference2013
The document discusses guidelines and considerations for clinical investigations of medical devices, focusing on the role of biostatistics in evaluating safety and effectiveness. It outlines statistical aspects that should be addressed in a clinical investigation plan and protocol, including study objectives, design, analyses, and handling of issues like missing data and sample size calculations. Interactive aspects between biostatisticians and sponsors are also covered, such as balancing precision and bias in study design and choice of endpoints.
Presentation by David Farber, FDA Life Science Partner at King & Spalding, about US Reimbursement.
I. Introduction
• II. FDA Approval vs. Reimbursement
• a. Different Standards
b. Clinical Evidence Needed
• III. The Three Keys to Reimbursement
A. Coverage
B. Coding
C. Payment
• IV. What’s New for 2019
• V. Reimbursement for MedTech AI Solutions
• VI. Tips for Successful Reimbursement
This document discusses Medtronic's strategy to address global healthcare needs by developing new therapies and technologies, expanding access through globalization, and optimizing costs and efficiencies. Medtronic aims to become a healthcare solutions provider by improving clinical outcomes, expanding access to care, and translating the clinical value of its products into economic benefits. The document provides examples of Medtronic technologies like its Integrity and Resolute Integrity drug-eluting stents and the Symplicity renal denervation system. It also outlines Medtronic's portfolio and programs to facilitate adoption of transradial access procedures.
The document provides an introduction to the Surgical Site Infection (SSI) Audit Tool. It describes the objectives of the tool which are to retrospectively review patient charts and measure processes to help drive continuous improvement in preventing SSIs. The tool measures adherence to best practices across pre-operative, peri-operative, and post-operative periods using a series of yes/no questions. Hospitals are encouraged to begin using the tool to collect monthly SSI data and track their progress towards reduction goals. Support is available from Central Measurement Team and SSI experts to help sites implement and utilize the audit tool.
Optical coherence tomography (OCT) is a significant financial investment for any practice. This eBook focuses on the financial aspect of acquiring an OCT, and answers questions like: How much is an OCT system? How is a practice going to pay for it? And how does the OCT system generate revenue?
With the help of Dr. Kerksick, these important questions will be addressed.
Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
The document discusses liquid biopsies and next generation cancer molecular diagnostics. It summarizes that OncoCyte Corporation is focused on developing diagnostic tests for early cancer detection using liquid biopsies, with an initial focus on tests for lung cancer. Key points include that lung cancer diagnostics represents a large market opportunity and that OncoCyte's preliminary lung cancer diagnostic test shows strong performance in clinical trials with high sensitivity and specificity. The test has the potential to reduce risky follow-up procedures for patients and provide significant healthcare cost savings.
Critical Illness definitions are at risk of being affected by advances and developments in medicine. The CoC Medical Underwriting and Claims Consulting is continuously monitoring these changes. Expected developments and their possible impact are summarized in this Q&A article.
This document analyzes the rate of normal vs abnormal findings from trauma CT scans performed at AAH over a 4 month period. The study found that 55% of scans were on men under 35, while 8% were on women under 35 and 6.5% were on children. The high percentage of normal findings raises concerns about unnecessary radiation exposure. The document recommends developing trauma CT guidelines to help determine appropriate cases and reduce avoidable scans by 20-40%. It also suggests exploring alternatives like Statscan machines to reduce initial radiation doses.
SMi Group's Adaptive Designs in Clinical Trials conferenceDale Butler
This document summarizes an upcoming conference on adaptive designs in clinical trials taking place from April 20-21, 2015 in London. The conference will focus on topics such as Bayesian adaptive designs, subgroup selection in clinical trials, integrating real-world patient data into adaptive trials, and designing biomarker-driven multi-arm multi-stage cancer trials. Speakers will discuss challenges with adaptive designs and their use in different therapeutic areas like neurodegenerative diseases. Participants can also register for optional half-day workshops on April 22nd focusing on Bayesian clinical trial designs and navigating international regulatory landscapes for adaptive trials.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
This document discusses current and future innovation in the pharmaceutical industry from the perspective of Merck Research Laboratories. It outlines Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. Statistics are provided on Merck's 2018 clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams. Considerations for clinical trial planning, site selection, and protocol design are examined. Pembrolizumab clinical development across many tumor types is reviewed, as are challenges developing a treatment for all genotypes of Hepatitis C.
A global leader in real world health intelligence, Analytica Laser is powered by a renowned scientific team of 140+ senior experts across eight offices. Our consulting, research and data services are employed by the leading biopharma and public health innovators in over 20 countries. Every day, our work directly benefits millions of patients in advancing access to new therapies that are safer, more convenient and more affordable.
Health technology assessment (HTA) is familiar as technique for gauging the value of specific medical technologies or approaches to care. As Adrian Towse points out, however, HTA has a much broader, ‘macro’ role in contributing to the efficiency of health care systems and supporting universal health coverage. This is particularly crucial in the face of increasing demands and limited budgets.
This 10-minute lecture gives a step-by-step instruction on medical device definition. It covers the basic definition of a medical device, its key attributes, and intended purpose. A brief insight is provided into in vitro diagnostic medical devices. At the end of this lecture, the student will be able to differentiate a medical device from pharmaceutical and biological healthcare products. The student will also be able to decide whether a particular healthcare product comes under the definition of a medical device.
http://semoegy.com
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Ophthalmic Innovation 2016 - "A View From The NEI"Healthegy
The National Eye Institute (NEI) funds vision research through its $707 million annual budget. Its Audacious Goal Initiative aims to regenerate neurons in the eye and visual system by focusing on photoreceptor loss, ganglion cell injury, and optic nerve regeneration. The NEI supports translational research through grants such as the NEI Translational Research Program and Small Business Grants. It also conducts intramural research including stem cell therapy and gene therapy clinical trials. The NEI commits $50 million annually to support large clinical trials through organizations like the Diabetic Retinopathy Clinical Research Network. It also trains students and clinicians in vision research through fellowship programs.
The document is a presentation from Quest Diagnostics given at the UBS 2007 Global Life Sciences Conference. It summarizes that Quest Diagnostics is a leader in diagnostic testing and information technology solutions, touching over 150 million patient lives in 2006. It provides an overview of the company's network, services, growth opportunities around cancer diagnostics, personalized medicine, and near-patient testing, and approach to driving profitable growth.
Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
This webinar presentation discusses operationalizing advanced therapy clinical trials using lessons learned from past experiences. The webinar covers regulatory considerations, operational challenges, and case studies. Regulatory agencies require strategic engagement, assessment of regulatory readiness, and oversight of country requirements. Investigative sites face additional committee reviews and license applications. Manufacturing complex cell and gene therapies poses challenges around process transfer, scaling, and product availability. Aligning supply chain readiness, site capabilities, and an investigational product tracking process is key to avoiding delays. Developing a global strategy requires addressing requirements for manufacturing, stability data, labeling, and supply logistics early.
Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
This investor presentation summarizes Oncolytics Biotech's clinical development plan for REOLYSIN, a viral immunotherapy for cancer. It discusses three pathways: 1) chemotherapy combinations, which are the basis for the first registration pathway in pancreatic cancer. Survival data from several phase 2 studies is expected in 2017. 2) Immunotherapy combinations, including an ongoing study of REOLYSIN with pembrolizumab. 3) Targeted agent/IMiD combinations, such as a collaboration using REOLYSIN with pomalidomide in multiple myeloma. The presentation outlines the mechanism of action of REOLYSIN and how combinations can enhance innate and adaptive immune responses against cancer.
NeoGenomics provides cancer genetic testing services to oncologists, pathologists, and hospitals. It has experienced strong and consistent growth in revenue and tests performed annually through expanding its test menu, increasing sales force productivity, and gaining market share. The company aims to continue its growth by launching new tests, pursuing partnerships and acquisitions, and capitalizing on the large and growing market for cancer genetic testing fueled by an aging population and advancements in targeted therapies.
- NeoGenomics is a pure-play cancer genetics testing company that has experienced fast revenue and test volume growth through expanding its test menu and increasing sales force productivity. Its "tech-only" business model focuses on partnerships with oncologists and hospitals to provide genetic testing services.
- The company has consistently grown its annual revenue and tests performed historically through new test innovations, a growing sales force, and greater productivity. It is targeting further market share gains and operating leverage to accelerate cash flow and earnings growth.
This document discusses Medtronic's strategy to address global healthcare needs by developing new therapies and technologies, expanding access through globalization, and optimizing costs and efficiencies. Medtronic aims to become a healthcare solutions provider by improving clinical outcomes, expanding access to care, and translating the clinical value of its products into economic benefits. The document provides examples of Medtronic technologies like its Integrity and Resolute Integrity drug-eluting stents and the Symplicity renal denervation system. It also outlines Medtronic's portfolio and programs to facilitate adoption of transradial access procedures.
The document provides an introduction to the Surgical Site Infection (SSI) Audit Tool. It describes the objectives of the tool which are to retrospectively review patient charts and measure processes to help drive continuous improvement in preventing SSIs. The tool measures adherence to best practices across pre-operative, peri-operative, and post-operative periods using a series of yes/no questions. Hospitals are encouraged to begin using the tool to collect monthly SSI data and track their progress towards reduction goals. Support is available from Central Measurement Team and SSI experts to help sites implement and utilize the audit tool.
Optical coherence tomography (OCT) is a significant financial investment for any practice. This eBook focuses on the financial aspect of acquiring an OCT, and answers questions like: How much is an OCT system? How is a practice going to pay for it? And how does the OCT system generate revenue?
With the help of Dr. Kerksick, these important questions will be addressed.
Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
The document discusses liquid biopsies and next generation cancer molecular diagnostics. It summarizes that OncoCyte Corporation is focused on developing diagnostic tests for early cancer detection using liquid biopsies, with an initial focus on tests for lung cancer. Key points include that lung cancer diagnostics represents a large market opportunity and that OncoCyte's preliminary lung cancer diagnostic test shows strong performance in clinical trials with high sensitivity and specificity. The test has the potential to reduce risky follow-up procedures for patients and provide significant healthcare cost savings.
Critical Illness definitions are at risk of being affected by advances and developments in medicine. The CoC Medical Underwriting and Claims Consulting is continuously monitoring these changes. Expected developments and their possible impact are summarized in this Q&A article.
This document analyzes the rate of normal vs abnormal findings from trauma CT scans performed at AAH over a 4 month period. The study found that 55% of scans were on men under 35, while 8% were on women under 35 and 6.5% were on children. The high percentage of normal findings raises concerns about unnecessary radiation exposure. The document recommends developing trauma CT guidelines to help determine appropriate cases and reduce avoidable scans by 20-40%. It also suggests exploring alternatives like Statscan machines to reduce initial radiation doses.
SMi Group's Adaptive Designs in Clinical Trials conferenceDale Butler
This document summarizes an upcoming conference on adaptive designs in clinical trials taking place from April 20-21, 2015 in London. The conference will focus on topics such as Bayesian adaptive designs, subgroup selection in clinical trials, integrating real-world patient data into adaptive trials, and designing biomarker-driven multi-arm multi-stage cancer trials. Speakers will discuss challenges with adaptive designs and their use in different therapeutic areas like neurodegenerative diseases. Participants can also register for optional half-day workshops on April 22nd focusing on Bayesian clinical trial designs and navigating international regulatory landscapes for adaptive trials.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
This document discusses current and future innovation in the pharmaceutical industry from the perspective of Merck Research Laboratories. It outlines Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. Statistics are provided on Merck's 2018 clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams. Considerations for clinical trial planning, site selection, and protocol design are examined. Pembrolizumab clinical development across many tumor types is reviewed, as are challenges developing a treatment for all genotypes of Hepatitis C.
A global leader in real world health intelligence, Analytica Laser is powered by a renowned scientific team of 140+ senior experts across eight offices. Our consulting, research and data services are employed by the leading biopharma and public health innovators in over 20 countries. Every day, our work directly benefits millions of patients in advancing access to new therapies that are safer, more convenient and more affordable.
Health technology assessment (HTA) is familiar as technique for gauging the value of specific medical technologies or approaches to care. As Adrian Towse points out, however, HTA has a much broader, ‘macro’ role in contributing to the efficiency of health care systems and supporting universal health coverage. This is particularly crucial in the face of increasing demands and limited budgets.
This 10-minute lecture gives a step-by-step instruction on medical device definition. It covers the basic definition of a medical device, its key attributes, and intended purpose. A brief insight is provided into in vitro diagnostic medical devices. At the end of this lecture, the student will be able to differentiate a medical device from pharmaceutical and biological healthcare products. The student will also be able to decide whether a particular healthcare product comes under the definition of a medical device.
http://semoegy.com
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Ophthalmic Innovation 2016 - "A View From The NEI"Healthegy
The National Eye Institute (NEI) funds vision research through its $707 million annual budget. Its Audacious Goal Initiative aims to regenerate neurons in the eye and visual system by focusing on photoreceptor loss, ganglion cell injury, and optic nerve regeneration. The NEI supports translational research through grants such as the NEI Translational Research Program and Small Business Grants. It also conducts intramural research including stem cell therapy and gene therapy clinical trials. The NEI commits $50 million annually to support large clinical trials through organizations like the Diabetic Retinopathy Clinical Research Network. It also trains students and clinicians in vision research through fellowship programs.
The document is a presentation from Quest Diagnostics given at the UBS 2007 Global Life Sciences Conference. It summarizes that Quest Diagnostics is a leader in diagnostic testing and information technology solutions, touching over 150 million patient lives in 2006. It provides an overview of the company's network, services, growth opportunities around cancer diagnostics, personalized medicine, and near-patient testing, and approach to driving profitable growth.
Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
This webinar presentation discusses operationalizing advanced therapy clinical trials using lessons learned from past experiences. The webinar covers regulatory considerations, operational challenges, and case studies. Regulatory agencies require strategic engagement, assessment of regulatory readiness, and oversight of country requirements. Investigative sites face additional committee reviews and license applications. Manufacturing complex cell and gene therapies poses challenges around process transfer, scaling, and product availability. Aligning supply chain readiness, site capabilities, and an investigational product tracking process is key to avoiding delays. Developing a global strategy requires addressing requirements for manufacturing, stability data, labeling, and supply logistics early.
Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
This investor presentation summarizes Oncolytics Biotech's clinical development plan for REOLYSIN, a viral immunotherapy for cancer. It discusses three pathways: 1) chemotherapy combinations, which are the basis for the first registration pathway in pancreatic cancer. Survival data from several phase 2 studies is expected in 2017. 2) Immunotherapy combinations, including an ongoing study of REOLYSIN with pembrolizumab. 3) Targeted agent/IMiD combinations, such as a collaboration using REOLYSIN with pomalidomide in multiple myeloma. The presentation outlines the mechanism of action of REOLYSIN and how combinations can enhance innate and adaptive immune responses against cancer.
NeoGenomics provides cancer genetic testing services to oncologists, pathologists, and hospitals. It has experienced strong and consistent growth in revenue and tests performed annually through expanding its test menu, increasing sales force productivity, and gaining market share. The company aims to continue its growth by launching new tests, pursuing partnerships and acquisitions, and capitalizing on the large and growing market for cancer genetic testing fueled by an aging population and advancements in targeted therapies.
- NeoGenomics is a pure-play cancer genetics testing company that has experienced fast revenue and test volume growth through expanding its test menu and increasing sales force productivity. Its "tech-only" business model focuses on partnerships with oncologists and hospitals to provide genetic testing services.
- The company has consistently grown its annual revenue and tests performed historically through new test innovations, a growing sales force, and greater productivity. It is targeting further market share gains and operating leverage to accelerate cash flow and earnings growth.
This presentation provides an overview of NeoGenomics, a cancer genetic testing company. Key points include:
- NeoGenomics has experienced consistent historical growth in the number of cancer tests performed and annual revenue.
- The company focuses on fast-growing cancer genetics testing and has strategic partnerships with oncologists and hospitals.
- Management aims to continue expanding the test menu and achieving operating leverage to accelerate cash flow and earnings.
The presentation provides an overview of NeoGenomics, a cancer genetic testing company. It highlights the company's consistent historical growth in tests performed and revenue. The management team has significant experience in large cap clinical laboratories. The company aims to continue expanding its test menu and market share through new product development and partnerships within the fast-growing cancer genetic testing industry.
This presentation provides an overview of NeoGenomics, a cancer genetics testing company. Key points include:
- NeoGenomics has experienced strong and consistent growth in revenue and test volume historically through strategic partnerships and an expanding test menu.
- The company focuses on fast turnaround times and exceptional client service to drive continued growth.
- Management aims to increase market share and profitability through expanding sales coverage, new test offerings like next generation sequencing, and potential M&A opportunities.
- NeoGenomics seeks to capitalize on favorable industry trends like an aging population, rise of personalized medicine, and consolidation in the cancer diagnostics field.
Making Value-Based Healthcare in Cataract a Reality Insights from VBHCAT Pr...Alexandre Lourenço
Alexandre Lourenço's keynote on "Making Value-Based Healthcare in Cataract a Reality - Insights from VBHCAT Project in Portugal", at the 44th World Hospital Congress organized by the International Hospital Federation, in November 8th 2021.
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.
Bernie Harrison - Australian Council Healthcare StandardsInforma Australia
The document discusses using targets to improve healthcare performance and patient safety. It notes that while modern medicine is advanced, healthcare systems still fail to meet their full potential due to issues like clinical practice variation and preventable medical errors. Targets have been implemented, like the 4-hour rule for emergency department wait times, but focusing only on targets can incentivize the wrong behaviors. True reliability and safety require a culture that learns from failures and embraces continuous improvement. High-reliability organizations exemplify principles like preoccupation with failure and deference to expertise. The goal should be zero preventable harm through reliable processes of care.
SpectraScience's WavSTAT® Optical Biopsy System uses light-based fluorescence spectroscopy to diagnose cancer in the colon during colonoscopy procedures. It is currently in late-stage European clinical trials and poised to commence sales in Europe initially targeting colorectal cancer screening. Studies have found the technology could increase colonoscopy's ability to correctly identify non-cancerous tissue to around 96%. Crystal Research Associates published a 48-page report analyzing SpectraScience and its WavSTAT technology, market opportunities in colorectal cancer screening, competitive advantages, growth strategies and leadership team.
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.
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
- 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.
This investor presentation by Cancer Genetics, Inc provides an overview of the company and its proprietary genomic testing programs. CGI has locations in the US, India, and China serving biopharma, clinical, and research clients. It has launched 7 proprietary diagnostic products focused on hematologic and urogenital cancers, and is working to validate additional next generation sequencing panels. CGI's tests provide information to aid in diagnosis, prognosis, and therapeutic decision making for cancers like CLL, cervical cancer, and kidney cancer. The company is collaborating with academic centers to further develop and validate its genomic tests.
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
Challenges and improvements in diagnostic services across seven day services NHS Improving Quality
Prof Erika Denton, National Clinical Director for Diagnostics. Slides from Erika's presentation at the 7 Day services events in West Midlands 11th June and East Midlands 12th June, 2014.
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.
The Top 5 Ancillary Services For Urology PracticesClark Love
The document discusses potential ancillary services for urology practices to increase revenue. It identifies the top 5 services as: 1) lithotripsy, 2) CT/ultrasound equipment, 3) ambulatory surgery centers, 4) pathology labs, and 5) clinical labs. The document provides details on each service, noting benefits like facilitating comprehensive patient care, diversifying income streams, and offsetting losses from decreased reimbursement. It also discusses factors to consider when adding ancillary services like compliance, reimbursement rates, developing a financial model to determine feasibility, and properly marketing new services.
This presentation provides an overview of the company, which provides cancer genetic testing services. It highlights the company's fast growth, experienced management team, expanding product and service offerings including next generation sequencing and liquid biopsy tests. The company has achieved significant reductions in costs per test through economies of scale and innovation. Financial metrics show accelerating revenue, earnings, and cash flow in recent years through both organic growth and acquisition.
Similar to SCIE Investor Presentation January 2017 (20)
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This presentation contains statements of a forward-looking nature which
represent our management's beliefs and assumptions concerning future
events. When used in this presentation, the words “believe,” “expect,” and
similar expressions are intended to identify forward-looking statements,
including statements regarding revenue, distribution agreements and
potential partnerships. Forward-looking statements involve risks,
uncertainties and assumptions, and are based on information currently
available to us. Actual results may differ materially from those expressed in
the forward-looking statements due to many factors, including, without
limitation, those disclosed under “Item 1A. Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2015 and our
quarterly reports on Form 10-Q. We undertake no obligation to update any
forward-looking statements to reflect events or circumstances that may
arise after the date of this presentation.
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♦ Patented platform technologies using light to provide faster, more
accurate, less costly non-invasive detection and diagnosis of
cancerous tissue
– Replaces physical biopsies with optical biopsies when differentiating
between normal and cancerous tissue
– Only “true” optical biopsy
– Procedure can be performed by nurses
– In vivo, in real time, approximately 1 second
♦ First indication ready for immediate sales in Europe and Middle East
♦ Second indication ready for clinical evaluation
♦ Product exceeds medical society’s accuracy criteria
♦ Technology & Development Risk behind us
♦ Sales, Marketing and Manufacturing Execution
♦ Management team with extensive turnaround and commercial
experience
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Team Background
Michael Oliver
President & CEO
♦ 30 years of experience in the medical device field spanning management, sales
and marketing
♦ Expertise in commercial operations and product management
♦ Four previous successful turnaround / restarts at Prescription Health Services,
Diatek, Inc., New Image Industries, and “A” Company Orthodontics
♦ MBA, George Washington University; BS, United States Naval Academy
Lowell Giffhorn
Chief Financial
Officer
♦ More than 25 years of senior management experience spanning finance,
operations, strategic planning and turnaround situations
♦ Former CFO of Patriot Scientific & Sym-Tek Systems, Inc.
♦ Raised more than $30MM in public equity
♦ MBA, National University; BS in Accounting, University of Illinois
Hughes
Wielemans
Director,
European Sales
♦ More than 25 years experience in medical device sales and marketing
♦ Experience with direct sales and distributor models
♦ Previous companies: US Surgical, Tyco Healthcare, Covidien
♦ Fluent in English, French, Dutch and German
♦ Economic Sciences Degree from ICHEC, Brussels, and Vierick-Leuven Ghent
Business School
♦ Board with more than 150 years of medical device experience
♦ Internationally renowned Medical Advisors
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♦ The largest patent portfolio for “optical methods for
identifying cancer and its precursors” provides a
substantial barrier to entry
♦ 38 utility and 7 design patents in US and
approximately 28 active European and Canadian
counterparts
– Optical biopsy apparatus (forceps)
– Scanning technologies (detection)
– Analysis and analytics
– Calibration, alignment, normalizing, etc.
♦ Continue to broaden product offerings through
licensing and acquisition
– Recent IP license from Duke University
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Platform Technology Adaptable to a Wide Spectrum of Cancers
Annual Procedures US ($Cost*)
Esophagus
1,600,000 ($4.0B)
Colon
8,900,000 ($17B)
Bladder
660,000 ($1.1B)
Oral Cavity
884,000 ($0.9B)
Lung
220,000 ($0.38B)
Stomach
294,000 ($0.6B)
Cervix
1,320,000 ($1.32B)
- Areas of Interest
• US, annual endoscopy monitoring cost
• and Duke (under UCSF support)
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Lower GI
Colon
Upper GI
Barrett’s
Lower GI
IBD
Urology
Bladder
US & EU Cases/year1 12.2 M 3.9 M 5.4 M 1.2M
Revenue/Case2 $162.00 $550.00 $ 650.00 $1,045.00
Total Addressable
Market (per annum)
$ 2.0 Billion $ 2.15 Billion $3.5 Billion $1.25 Billion
First Revenue 2017 2018 2019 2018
1Statistics from National Cancer Institute data base
2Company Estimates
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♦ Reduce total cost of colorectal cancer screening
♦ 80% of physical biopsies removed during screening are normal tissue
♦ Pathology savings alone in US for those unnecessary “normal tissue”
biopsies is more than $1 Billion per year**
♦ UK Savings approximately £ 60,000,000 annually
♦ WavSTAT Optical Biopsy System is a valuable tool in realizing savings
Endoscopist* Add WavSTAT*
Sensitivity 56.2% 96.9%
False Negative 43.8% 3.1%
Economic Considerations
WavSTAT Reduces False Negatives
* AMC, Netherlands, 2012
** Kessler WR, Imperiale TF, Klein RW, Wielage RC, Rex DK. A
quantitative assessment of the risks and cost savings of
forgoing histologic examination of diminutive polyps.
Endoscopy. 2011 Aug;43(8):683-91.
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♦ Growth in screening as population ages
♦ New modalities (DNA, MRI) for preliminary screening
bring more people to colonoscopy
♦ If benign: Diagnose and Ignore
♦ If malignant: Resect and Discard
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♦ American Society for Gastrointestinal Endoscopy (ASGE)
– Preservation and Incorporation of Valuable endoscopic Innovation
(PIVI)
– Real-Time Endoscopic Assessment of Histology of Diminutive
Colorectal Polyps (2011)
– “…reduce costs and improve patient safety compared to current
paradigm.”
– “…therapeutic threshold that must be met for a technology or device
to become considered appropriate for incorporation into clinical
practice.”
– 90% or greater Negative Predictive Value (NPV)
– “The ASGE encourages and supports the appropriate use of
technologies that meet its established PIVI thresholds.”
♦ WavSTAT NPV is 96% overall, 98% in recto-sigmoid
colon*
Dr. Noor Mohammed, presentation at UEGW, October 2016
Dr. Noor Mohammed, presentation to BSG, June 2016
*Dr. Timo Rath, et. al., Endoscopy, April 2016
*Dr. Timo Rath, presentation at UEGW, October 2015
*Pr. Helmut Neumann, presentation at DDW, May 2015
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♦ Multi-Center, Prospective Marketing Evaluation
– 8 sites, 7 nations, 800+ patient specimens
– Italy, Germany, France, Sweden, Denmark, Belgium, UK
– Leading authorities in each country
– Early results promising
♦ Replicate results of 96-98% NPV
♦ Capture economic savings at each site
♦ Submit to approval authorities in each country
♦ Coverage determination
♦ Accepted as “Standard of Care”
♦ Completed data collection Q4 2016
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♦ Nothing new for the clinician to learn
– Designed as a tool to assist
– Procedure does not change
♦ Compatible with existing endoscopes
– Uses working channel of flexible endoscopes
♦ Business Model (Razor/Blade)
– Recurring revenue stream from disposables
– Mobile console leased at nominal charge
– Hospital customers familiar with this model
Output = 1 second
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♦ Definitive, instant
diagnosis
♦ Non-subjective, no
interpretation
♦ Significantly
reduces costs of
follow-on
procedures
Results
Laser Induced Fluorescence (“LIF”) Technology
Optical fiber transmits
laser light via endoscope
to tissue
Auto-fluorescence collected
by fiber and returned to optical
detector within console for
analysis
OUTPUT
(one second)
}
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SpectraScience
WavSTAT
Mauna Kea
Technologies
Olympus
Medical
Fujinon
Procedure Type Endoscope Based Probe Based Endoscope
Based
Endoscope
Based
Technology Laser Induced
Fluorescence
Confocal
Microscopy
Narrow Band
Imaging
Confocal
Endomicroscopy
Costs $0 capital cost
~$175 per
procedure
$125K capital cost
$400+ per
procedure
$125-150K
capital
cost
$125-150K
capital
cost
Results Suspect/Not
Suspect
Objective
Interpretive
Subjective
Interpretive
Subjective
Interpretive
Subjective
Lengthens
Procedure?
No Yes Yes Yes
Interval/Specime
n
One Second Three to Ten
Minutes
Three to Ten
Minutes
Three to Ten
Minutes
NPV 96-98% 95% 82% 84%
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• Increased by 600% since 1975!
• Fastest growing cancer type, with 96% mortality
• Barrett’s esophagus is a precursor to esophageal
cancer:
• U.S. prevalence of 3M+
• 0.3M-0.5M new cases annually
• Predicated on GERD (~40M in U.S.)
• 1.6M+ endoscopy screenings annually US
• Early detection and treatment can result in 90%
cure!
Relevant Statistics
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3M+ US Barrett’s patients are screened
every 6 months to 2 years
Standard of Care: Random Biopsy Oncoscope: Guided Biopsy
$
$
$
$
$
$
$
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Kelloff, et al. Nature Vol 7, 508 – 518 (2007)
9 to 13 years
Delivers smarter, targeted biopsies,
requiring fewer of them
Diagnostic Area of
Existing Technologies
Narrow Band Imaging
Fluorescence
Ultrasound
Pill-Cam
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Feature SpectraScience NinePoint Mauna Kea
Compatible with current
procedure – –
Full tissue depth –
Real-time – –
Automated analysis – –
Dysplasia detection High Limited Manual
Cost $ $$$ $$$
Which is
easiest for
clinician to
interpret &
act upon?
SpectraScience NinePoint Mauna
Kea
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♦ Market first to EU, then to U.S. managed care
– Germany, UK and France, Middle East
– Distribution agreements in place
– EU markets are single-payer
– Economic savings already determined by NIHR in UK
– Approximately £ 60M annually
– Germany private pay physicians incentivized to use WavSTAT
♦ Europe-based Director of Business Dev.
– Direct sales organization in Germany, UK, France
– Distribution elsewhere
– Discussions regarding China, Korea, Japan
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√ Distribution agreements across Europe and Middle East
√ Products address large, growing and increasingly cost-
conscious markets
√ Exceed the technology adoption hurdle 96-98% NPV
√ No Technology or Development Risk
√ Proven technology that is faster, more accurate and less
costly
√ Faster for clinician; Answer in 1 second
√ Safer for the patient; Fewer biopsies & polypectomies
√ Less expensive for payers
√ Platform ensures multiple products to drive growth and
diversify distribution
√ Robust portfolio of Intellectual Property
√ Management team with extensive experience
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♦ Complementary to current endoscopic
standard of care
♦ Can be used wherever endoscopes are used
for diagnosis
♦ Targets biochemical properties of tissue
Laser Induced Fluorescence (“LIF”)
Lower GI (Colon)
Scattering Spectroscopy (“SS”)
Upper GI (Barrett’s Esophagus)
♦ Complementary to current endoscopic
standard of care
♦ Can be used wherever endoscopes are used
for diagnosis
♦ Targets physical properties of tissue
♦ Best technology or combination for optimal clinical result
♦ Multiple potential partners
♦ Multiple distinct channels
♦ Multiple markets
Multi-modal Future