Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
Complementary Tests and Companion Diagnostics in OncologyDr. Sima Salahshor
1) Companion diagnostics are tests that are essential for the safe and effective use of a corresponding drug or therapeutic product. Complementary diagnostics provide additional information that may predict treatment response but are not required for determining treatment.
2) Companion diagnostic tests identify biomarkers that indicate whether a patient is likely or unlikely to respond to a targeted drug. For example, the KRAS companion diagnostic predicts response to cetuximab for colorectal cancer.
3) The global cancer diagnostic market, including companion diagnostics, is large and growing as healthcare shifts toward personalized medicine approaches.
Personalised Medicine in the EU— Evolving Landscape and New HTA ConsiderationsOffice of Health Economics
The document discusses precision medicine and health technology assessment (HTA) of complementary diagnostics in Europe. It notes that precision medicine is moving from single biomarker tests to complex multi-parameter disease management, but markets have struggled to adopt even simple biomarkers. A new paper published by Epemed identifies additional elements of value for complementary diagnostics beyond traditional HTA considerations like life years gained and cost savings. These include reducing uncertainty, value of hope, and option value of future treatments. The paper recommends changing evidentiary requirements for HTA to consider broader clinical utility and value-based pricing approaches that account for all elements of value.
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Presentation delivered by Johan Luthman, Vice President, Neuroscience Clinical Development, Eisai Pharmaceuticals at the marcus evans Evolution Summit Fall 2015 in Las Vegas
Seventh Annual Next Generation Dx SummitJaime Hodges
The Next Generation Dx Summit (www.nextgenerationdx.com), entering its seventh year, brings together more than 800 diagnostics professionals from across the world, providing comprehensive programming and valuable networking opportunities. Spanning from clinical diagnostics to business strategy, this year’s expanded program encompasses predictive cancer biomarkers, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, cell-free DNA, commercialization, cancer immunotherapy, and reimbursement. With widespread coverage of all the most relevant diagnostics topics, the Next Generation Dx Summit promises to be a must-attend event to hear the latest announcements and developments in this rapidly evolving field.
The Business of Genomic Testing by James CrawfordKnome_Inc
This document summarizes the key findings from a survey of 13 early adopter institutions that have implemented next-generation genomic sequencing (NGS) technologies. The survey identified common drivers for adoption including demands from clinical colleagues, anticipated efficiency gains, and acquiring institutional expertise. It also explored barriers such as lack of informatics expertise and high costs. Respondents provided lessons learned such as NGS being more complicated than expected and the importance of multidisciplinary teams. Common measures of successful outcomes included growth in test volumes and expansion of testing menus. The document concludes with recommendations for professional organizations like the College of American Pathologists, including providing educational programs and testing standards.
The Survivor community can learn more about the state of the art in new tests available in cancer centres, which pinpoint specific types of tumours that will respond best to treatments.
Complementary Tests and Companion Diagnostics in OncologyDr. Sima Salahshor
1) Companion diagnostics are tests that are essential for the safe and effective use of a corresponding drug or therapeutic product. Complementary diagnostics provide additional information that may predict treatment response but are not required for determining treatment.
2) Companion diagnostic tests identify biomarkers that indicate whether a patient is likely or unlikely to respond to a targeted drug. For example, the KRAS companion diagnostic predicts response to cetuximab for colorectal cancer.
3) The global cancer diagnostic market, including companion diagnostics, is large and growing as healthcare shifts toward personalized medicine approaches.
Personalised Medicine in the EU— Evolving Landscape and New HTA ConsiderationsOffice of Health Economics
The document discusses precision medicine and health technology assessment (HTA) of complementary diagnostics in Europe. It notes that precision medicine is moving from single biomarker tests to complex multi-parameter disease management, but markets have struggled to adopt even simple biomarkers. A new paper published by Epemed identifies additional elements of value for complementary diagnostics beyond traditional HTA considerations like life years gained and cost savings. These include reducing uncertainty, value of hope, and option value of future treatments. The paper recommends changing evidentiary requirements for HTA to consider broader clinical utility and value-based pricing approaches that account for all elements of value.
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Presentation delivered by Johan Luthman, Vice President, Neuroscience Clinical Development, Eisai Pharmaceuticals at the marcus evans Evolution Summit Fall 2015 in Las Vegas
Seventh Annual Next Generation Dx SummitJaime Hodges
The Next Generation Dx Summit (www.nextgenerationdx.com), entering its seventh year, brings together more than 800 diagnostics professionals from across the world, providing comprehensive programming and valuable networking opportunities. Spanning from clinical diagnostics to business strategy, this year’s expanded program encompasses predictive cancer biomarkers, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, cell-free DNA, commercialization, cancer immunotherapy, and reimbursement. With widespread coverage of all the most relevant diagnostics topics, the Next Generation Dx Summit promises to be a must-attend event to hear the latest announcements and developments in this rapidly evolving field.
The Business of Genomic Testing by James CrawfordKnome_Inc
This document summarizes the key findings from a survey of 13 early adopter institutions that have implemented next-generation genomic sequencing (NGS) technologies. The survey identified common drivers for adoption including demands from clinical colleagues, anticipated efficiency gains, and acquiring institutional expertise. It also explored barriers such as lack of informatics expertise and high costs. Respondents provided lessons learned such as NGS being more complicated than expected and the importance of multidisciplinary teams. Common measures of successful outcomes included growth in test volumes and expansion of testing menus. The document concludes with recommendations for professional organizations like the College of American Pathologists, including providing educational programs and testing standards.
The Survivor community can learn more about the state of the art in new tests available in cancer centres, which pinpoint specific types of tumours that will respond best to treatments.
DeciBio Perspectives on Pain Points, Unmet Needs, and Disruption in Precision...Andrew Aijian
We conducted interviews with precision medicine KOLs to create a map of the precision medicine stakeholder landscape and identify and understand the unmet needs and pain points within precision medicine, as well as areas and scenarios of potential disruption.
Next Generation Companion Diagnostics; Adoption, Drivers, and Moderators of N...Andrew Aijian
Analysis and synthesis of a pulse survey conducted across >140 oncologists, pathologists, and lab directors regarding current adoption and trends associated with emerging oncology biomarkers and companion diagnostics (CDx), with an emphasis on next-generation sequencing (NGS)-based CDx.
Survival guide to stem cell research and therapiesArete-Zoe, LLC
Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.
Potential: The first section explains how stem cells are currently used in research, drug testing, and therapy, and how they have to be manipulated before transfer to make any treatments possible.
Classification: Origin and ability of stem cells to differentiate into different cell types determine how different types of stem cells are typically used.
Clinical Research: In this section, we will introduce the two most important registries of clinical trials: NIH registry ClinicalTrials gov and WHO International Clinical Trials Registry Platform. A project is part of this section to give students the opportunity to get hands-on experience with collecting and collating relevant information from registries and libraries, and interpretation of the findings. Real-time interactive sessions are included to allow students to ask questions and offer additional guidance.
Patient Demand: In this section, we briefly introduce challenges relating to marketing claims, objective outcome measures, advertising strategies, and patient autonomy.
Regulatory and Legal Framework: Stem cell therapies are regulated differently in various countries around the world. In this section, we will focus on regulations that govern stem cell research and therapies in the U.S. and in the European Union. Policies on stem cell research are driven by ethical concerns relating to research that utilizes human embryos. China recently announced new ethical guidelines and new rules for its stem cell clinics, regulating both trials and treatments.
Professional Societies: The last section explains the role of professional societies in stem cell research and therapies.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Update on the Adoption and Utilization of Emerging Precision Medicine Biomark...Andrew Aijian
In this 2nd wave of our precision oncology pulse survey, we explore how recent clinical, commercial, and regulatory events have impacted the adoption of emerging precision oncology biomarkers and diagnostic tools. We also examine the key technological trends likely to impact the landscape in the near-mid term.
2015 10-06 Building Bridges Biomarker symposium FIMM Helsinki, Alain van GoolAlain van Gool
A unique honour and opportunity to give a 1.5 hour lecture to young biomarker scientists to introduce biomarkers and their importance in translational medicine and personalized healthcare.
Next-Generation Immuno-Oncology Biomarkers: Insights for Developing Companion...Andrew Aijian
At DeciBio Consulting, we track the immuno-oncology (I/O) biomarker and technology landscape closely. Our analysis of biomarkers from ~1,000 immuno-oncology clinical trials and discussions with oncologists, pathologists, and KOLs reveals some key insights for diagnostic manufacturers to consider to address the I/O market.
- Telemonitoring for heart failure patients has been shown to reduce mortality rates by up to 36% and decrease hospitalization rates in studies such as TEN-HMS and the Cochrane review.
- The Hull model of telemonitoring in the UK involves a comprehensive system of care including home monitoring devices, community kiosks, and support from nurses and specialist clinics to closely manage heart failure patients.
- Further research and investment in telemonitoring technologies could help shift care from crisis management to proactive health maintenance and empowering patients to better self-manage their condition.
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.
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
The document 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.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
Introducing Drugs & Trials for Cancer DiagnosticsGolden Helix
When interpreting a variant using the AMP/ASCO guidelines for somatic variant interpretation, clinicians must determine whether the variant can be considered a biomarker that affects clinical care by predicting sensitivity, resistance, or toxicity to a specific therapy. Such a determination requires the investigation of multiple evidence sources, including clinical trials, FDA approved therapies and peer-reviewed studies. Unfortunately, strong evidence linking specific genetic biomarkers to FDA-approved therapies only exists for a small number of cancers. Thus, most variants require an exploration of clinical practice guidelines, peer-reviewed literature, and large-scale cancer mutation databases to effectively assess the clinical significance of a given mutation.
This webcast explores this new incorporation of Drugs & Trials Annotations in VSClinical's AMP Workflow covering:
Identification of relevant clinical evidence for drug sensitivity and resistance based on patient biomarkers and tumor type
Review of clinical trial information including inclusion criteria, trial status, and contact information
Management of citations associated with relevant, targeted therapies
Evaluation of a biomarkers clinical evidence tier based on available evidence for drug sensitivity and resistance
The document discusses efforts by the National Institutes of Health (NIH) and Food and Drug Administration (FDA) to advance personalized medicine through several initiatives:
1. Developing a more integrated pathway to connect target identification by researchers to drug approval to help fill the void of insufficient private sector interest in most new targets.
2. The TRND program will help accelerate development of drugs for rare and neglected diseases by funding preclinical development.
3. The FDA is developing standards to incorporate genetic information into drug and device development and using biomarkers to evaluate therapies through its Critical Path Initiative.
Viral Challenge Studies: An Innovative Way to Speed Up Vaccine Development; A...SGS
In order to effectively fight influenza, the development of new, higher performing and universal vaccines is essential. However, clinical development is a lengthy and very expensive process, making it difficult for researchers to design vaccines for rapidly mutating viruses such as influenza. Assessing efficacy of a new influenza vaccine as early as possible in the development, to make a first selection and an early ‘go – no go’ decision, is key. Viral Challenge studies are an important tool to aid in the swift development of effective influenza vaccines particularly for potential pandemics like the avian influenza (bird flu).
jlme article final on NGS coverage n reimb issues w pat deverkaJennifer Dreyfus
The document discusses the challenges of obtaining coverage and reimbursement for clinical next generation sequencing (NGS) from both public and private health payers. It outlines the evidentiary standards payers use to evaluate new diagnostic tests, including requirements for analytic validity, clinical validity, and clinical utility. However, establishing these standards is difficult for NGS given limitations in analytical validation methods, lack of proficiency testing, and the technology's rapid advancement. Additionally, while regulatory approval for market entry requires less evidence than reimbursement decisions, demand for NGS often outpaces evidence development. The document argues more collaboration is needed between developers and payers to strengthen evidence standards and facilitate clinical integration of NGS.
Big Data and Analytic Strategy for Clinical ResearchBBCR Consulting
This document discusses how big data and analytics can help simplify clinical research and make trials more cost-effective. It begins by providing context on how Henry Ford revolutionized car manufacturing using specialized machinery and standardized processes. Similarly, big data is creating a radical shift in how research is conducted by enabling the analysis of large and complex datasets. The rest of the document outlines opportunities in areas like personalized medicine, challenges like dealing with diverse and fast-changing data, and how innovation in clinical research design can help address these challenges to develop more targeted treatments.
AV Therapeutics is developing new cancer therapeutics including Capridine, a patented drug that has shown specific activity against prostate cancer in preclinical studies. Capridine addresses an unmet need as it has limited side effects and bone toxicity compared to existing treatments. AV Therapeutics plans to submit an IND application to begin Phase I/II clinical trials for Capridine based on its promising preclinical results showing potency against prostate cancer cells and taxane resistant cell lines with no toxicity to bone marrow cells. The company has a strong management team and scientific advisory board from top institutions to advance its pipeline of safer and more effective cancer treatments.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Covance provides customized clinical trial solutions and services for oncology drug development. Their services include utilizing patient lab data to assess trial feasibility and identify eligible patients, scientific consultation in precision medicine areas, and selecting investigator sites with the right patients and experience. Covance aims to help clients accelerate development timelines, improve the probability of success, and deliver trials on budget.
Robert Parson has over 15 years of experience in leadership roles in the healthcare industry. He has a proven track record of guiding medical products from concept to commercialization and ensuring quality and regulatory compliance. Parson has expertise in areas such as strategic planning, regulatory affairs, clinical research, and pharmacoeconomics. He holds advanced degrees from the University of California San Diego, Rochester Institute of Technology, and Purdue University.
DeciBio Perspectives on Pain Points, Unmet Needs, and Disruption in Precision...Andrew Aijian
We conducted interviews with precision medicine KOLs to create a map of the precision medicine stakeholder landscape and identify and understand the unmet needs and pain points within precision medicine, as well as areas and scenarios of potential disruption.
Next Generation Companion Diagnostics; Adoption, Drivers, and Moderators of N...Andrew Aijian
Analysis and synthesis of a pulse survey conducted across >140 oncologists, pathologists, and lab directors regarding current adoption and trends associated with emerging oncology biomarkers and companion diagnostics (CDx), with an emphasis on next-generation sequencing (NGS)-based CDx.
Survival guide to stem cell research and therapiesArete-Zoe, LLC
Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.
Potential: The first section explains how stem cells are currently used in research, drug testing, and therapy, and how they have to be manipulated before transfer to make any treatments possible.
Classification: Origin and ability of stem cells to differentiate into different cell types determine how different types of stem cells are typically used.
Clinical Research: In this section, we will introduce the two most important registries of clinical trials: NIH registry ClinicalTrials gov and WHO International Clinical Trials Registry Platform. A project is part of this section to give students the opportunity to get hands-on experience with collecting and collating relevant information from registries and libraries, and interpretation of the findings. Real-time interactive sessions are included to allow students to ask questions and offer additional guidance.
Patient Demand: In this section, we briefly introduce challenges relating to marketing claims, objective outcome measures, advertising strategies, and patient autonomy.
Regulatory and Legal Framework: Stem cell therapies are regulated differently in various countries around the world. In this section, we will focus on regulations that govern stem cell research and therapies in the U.S. and in the European Union. Policies on stem cell research are driven by ethical concerns relating to research that utilizes human embryos. China recently announced new ethical guidelines and new rules for its stem cell clinics, regulating both trials and treatments.
Professional Societies: The last section explains the role of professional societies in stem cell research and therapies.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Update on the Adoption and Utilization of Emerging Precision Medicine Biomark...Andrew Aijian
In this 2nd wave of our precision oncology pulse survey, we explore how recent clinical, commercial, and regulatory events have impacted the adoption of emerging precision oncology biomarkers and diagnostic tools. We also examine the key technological trends likely to impact the landscape in the near-mid term.
2015 10-06 Building Bridges Biomarker symposium FIMM Helsinki, Alain van GoolAlain van Gool
A unique honour and opportunity to give a 1.5 hour lecture to young biomarker scientists to introduce biomarkers and their importance in translational medicine and personalized healthcare.
Next-Generation Immuno-Oncology Biomarkers: Insights for Developing Companion...Andrew Aijian
At DeciBio Consulting, we track the immuno-oncology (I/O) biomarker and technology landscape closely. Our analysis of biomarkers from ~1,000 immuno-oncology clinical trials and discussions with oncologists, pathologists, and KOLs reveals some key insights for diagnostic manufacturers to consider to address the I/O market.
- Telemonitoring for heart failure patients has been shown to reduce mortality rates by up to 36% and decrease hospitalization rates in studies such as TEN-HMS and the Cochrane review.
- The Hull model of telemonitoring in the UK involves a comprehensive system of care including home monitoring devices, community kiosks, and support from nurses and specialist clinics to closely manage heart failure patients.
- Further research and investment in telemonitoring technologies could help shift care from crisis management to proactive health maintenance and empowering patients to better self-manage their condition.
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.
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
The document 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.
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
Introducing Drugs & Trials for Cancer DiagnosticsGolden Helix
When interpreting a variant using the AMP/ASCO guidelines for somatic variant interpretation, clinicians must determine whether the variant can be considered a biomarker that affects clinical care by predicting sensitivity, resistance, or toxicity to a specific therapy. Such a determination requires the investigation of multiple evidence sources, including clinical trials, FDA approved therapies and peer-reviewed studies. Unfortunately, strong evidence linking specific genetic biomarkers to FDA-approved therapies only exists for a small number of cancers. Thus, most variants require an exploration of clinical practice guidelines, peer-reviewed literature, and large-scale cancer mutation databases to effectively assess the clinical significance of a given mutation.
This webcast explores this new incorporation of Drugs & Trials Annotations in VSClinical's AMP Workflow covering:
Identification of relevant clinical evidence for drug sensitivity and resistance based on patient biomarkers and tumor type
Review of clinical trial information including inclusion criteria, trial status, and contact information
Management of citations associated with relevant, targeted therapies
Evaluation of a biomarkers clinical evidence tier based on available evidence for drug sensitivity and resistance
The document discusses efforts by the National Institutes of Health (NIH) and Food and Drug Administration (FDA) to advance personalized medicine through several initiatives:
1. Developing a more integrated pathway to connect target identification by researchers to drug approval to help fill the void of insufficient private sector interest in most new targets.
2. The TRND program will help accelerate development of drugs for rare and neglected diseases by funding preclinical development.
3. The FDA is developing standards to incorporate genetic information into drug and device development and using biomarkers to evaluate therapies through its Critical Path Initiative.
Viral Challenge Studies: An Innovative Way to Speed Up Vaccine Development; A...SGS
In order to effectively fight influenza, the development of new, higher performing and universal vaccines is essential. However, clinical development is a lengthy and very expensive process, making it difficult for researchers to design vaccines for rapidly mutating viruses such as influenza. Assessing efficacy of a new influenza vaccine as early as possible in the development, to make a first selection and an early ‘go – no go’ decision, is key. Viral Challenge studies are an important tool to aid in the swift development of effective influenza vaccines particularly for potential pandemics like the avian influenza (bird flu).
jlme article final on NGS coverage n reimb issues w pat deverkaJennifer Dreyfus
The document discusses the challenges of obtaining coverage and reimbursement for clinical next generation sequencing (NGS) from both public and private health payers. It outlines the evidentiary standards payers use to evaluate new diagnostic tests, including requirements for analytic validity, clinical validity, and clinical utility. However, establishing these standards is difficult for NGS given limitations in analytical validation methods, lack of proficiency testing, and the technology's rapid advancement. Additionally, while regulatory approval for market entry requires less evidence than reimbursement decisions, demand for NGS often outpaces evidence development. The document argues more collaboration is needed between developers and payers to strengthen evidence standards and facilitate clinical integration of NGS.
Big Data and Analytic Strategy for Clinical ResearchBBCR Consulting
This document discusses how big data and analytics can help simplify clinical research and make trials more cost-effective. It begins by providing context on how Henry Ford revolutionized car manufacturing using specialized machinery and standardized processes. Similarly, big data is creating a radical shift in how research is conducted by enabling the analysis of large and complex datasets. The rest of the document outlines opportunities in areas like personalized medicine, challenges like dealing with diverse and fast-changing data, and how innovation in clinical research design can help address these challenges to develop more targeted treatments.
AV Therapeutics is developing new cancer therapeutics including Capridine, a patented drug that has shown specific activity against prostate cancer in preclinical studies. Capridine addresses an unmet need as it has limited side effects and bone toxicity compared to existing treatments. AV Therapeutics plans to submit an IND application to begin Phase I/II clinical trials for Capridine based on its promising preclinical results showing potency against prostate cancer cells and taxane resistant cell lines with no toxicity to bone marrow cells. The company has a strong management team and scientific advisory board from top institutions to advance its pipeline of safer and more effective cancer treatments.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Covance provides customized clinical trial solutions and services for oncology drug development. Their services include utilizing patient lab data to assess trial feasibility and identify eligible patients, scientific consultation in precision medicine areas, and selecting investigator sites with the right patients and experience. Covance aims to help clients accelerate development timelines, improve the probability of success, and deliver trials on budget.
Robert Parson has over 15 years of experience in leadership roles in the healthcare industry. He has a proven track record of guiding medical products from concept to commercialization and ensuring quality and regulatory compliance. Parson has expertise in areas such as strategic planning, regulatory affairs, clinical research, and pharmacoeconomics. He holds advanced degrees from the University of California San Diego, Rochester Institute of Technology, and Purdue University.
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.
Theranos presented to investors with the goal of becoming the standard for improving drug therapies. Its initial market is phase IV clinical trials, using a product platform of cartridges, readers, and informatics services. Founded in 2003 with 50 employees, Theranos aims to generate $120-300M in revenue over 1.5 years through deals with pharmaceutical companies. The company's system allows for simultaneous quantitative measurement of drugs and biomarkers from small blood samples, returning results comparable to gold standards within 30 minutes. Theranos' value proposition is improving drug labels and safety by enabling real-time pharmacokinetic and pharmacodynamic monitoring during trials and treatment.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
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.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Global Engage is pleased to announce the 2018 Precision Medicine & Biomarkers Leaders Summit USA taking place on May 7-8th in Boston, MA. The event is part of our highly successful Drug Discovery Series which includes conferences on Biologics, Medicinal Chemistry, NASH, Pharmaceutical R&D IT and the Human Microbiome amongst others. It is also the sister meeting of the European Precision Medicine Summit which has run successfully since 2013.
The Pistoia Alliance is examining the challenges of the Faster Safe Companion Diagnostics (CDx) by Aligning Discovery & Clinical Data in the Regulatory Domain.
The slides discuss whether the data standards used in the research environment be aligned better with the data standards used in the regulated environment? If so, the time and cost of the development of NGS-based CDx could be reduced.
The document discusses opportunities and challenges for personalized medicines and sickle cell disease treatments. It provides an overview of current limited treatment options for sickle cell disease and highlights several new treatment options currently under development or approval, including Novartis' crizanlizumab, Global Blood Therapeutics' voxelotor, and gene therapies. It notes obstacles to access like high drug costs, long review processes, Canada's drug pricing system, and the small market size. The presentation calls on stakeholders to work together to improve access and education.
HealthBIO 2021_PerkinElmer, leading with innovation - from COVID success into...Business Turku
This document provides an overview of PerkinElmer, a company focused on diagnostics, life sciences, food, and applied markets. It discusses their mission of innovating for a healthier world, with over 80 years of innovations including a COVID-19 PCR kit launched in 2020. The company's diagnostics segment focuses on reproductive health, immunoassays, and applied genomics. PerkinElmer has global capabilities across molecular diagnostics, imaging, automation, and more. It is pursuing growth in areas like single-cell analysis, therapeutics, digital solutions, and decentralized testing. The company's strategy focuses on detection, decentralization, and digitization to drive profitable growth.
- Discover new methods for managing clinical next-gen data with insights from Pfizer, Boston Children’s Hospital and AstraZeneca
- Uncover and critique the latest technologies out there for you to use in clinical trials. Mayo Clinic, Merck and Harvard Medical School let you into their trade secrets
- Hear the genomics strategies that Roche, Millennium and Regeneron are using for discovery and validation of clinically actionable biomarkers
-Bristol-Myers Squibb, Takeda and Partners Healthcare the role that NGS can play when implementing an effective strategy in the lab to speed up CDx development
- Learn how to integrate molecular details into medical decision making, with fresh data from Washington University School of Medicine and Genzyme
Testing times for clinical trials - Perscetives on personalised health careMats Sundgren
Clinical trials face increasing challenges like longer timelines and higher costs due to outdated regulations from the 1970s. Modernizing the clinical trials process could help address these issues through approaches like increased data sharing and reuse of electronic health records. The EHR4CR project aims to develop new business models for pharmaceutical companies to collaborate and reuse hospital patient data from electronic health records to help accelerate patient recruitment and reduce trial timelines. This emphasizes moving towards more personalized, data-driven trials with the right targeted patients through closer collaboration between pharmaceutical companies and healthcare organizations.
Solving the operational challenges of oncology clinical trialsRoberto Lara
This executive briefing explores new strategies for solving your oncology clinical operations challenges. It also features valuable insights into how you can enrich your site selection, speed up your start-up times and maximize patient recruitment opportunities here in North America.
Bridging The Valley Of Death A Tale Of Two Culturesrwmalonemd
This document discusses the challenges of transitioning biotechnology discoveries from research to commercial products, known as crossing the "valley of death". It notes that on average only 1 in 4 to 1 in 5 biotechnology products in development achieve approval due to fundamental differences between the cultures of research and product development. Bridging this gap requires addressing regulatory, capital, and project management challenges throughout the product development process. The future of biotechnology will rely on rigorous project planning, outsourcing, earlier consideration of development pathways, and continual engagement between research and development teams.
Vivos Inc. presented a new brachytherapy tool called RadioGel for treating cancers in humans and animals. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel vehicle. It is designed to deliver a high radiation dose directly to tumors while minimizing damage to healthy tissue. The company expects to generate near-term revenue from veterinary applications and international licensing as it pursues FDA approval for multiple human cancer indications starting with skin cancer. Vivos has strong leadership and advisors in place and an intellectual property protected platform technology to become an important new tool for cancer treatment.
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...MaRS Discovery District
Speaker Dr. Annemarie Moseley, CEO of Aggregate Therapeutics (Palo Alto) explores how drug-device combination products are altering the medical practice from development to regulation to treatment.
Part of the MaRS Emerging Technologies Event Series. More information on the series can be found here:
http://www.marsdd.com/emergingtech/
Joint San Diego Chapters CLMA AACC / May 16 2010 Mtg Robert Parsonbpstat
With closer scrutiny by public and private payers of laboratory tests and their importance to medicine, evidence for their appropriate use often is limited and their cost effectiveness too often misunderstood.
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2. 2
Cellgen is developing a bio-fluid based molecular diagnostic that
will serve as a cancer therapeutic guidance platform capable of
pushing companion diagnostic testing from reference labs into
clinics
Headquartered in Irvine, CA with an RD lab in San Diego
Technology exclusively licensed from UC San Diego
Founded in October of 2012
Technology transfer completed in June 2015
Lean organization with 2 full-time and 2 part-time employees
Overview
3. 3
Management Team Key Advisors
Lavance Northington, MBA
Chief Executive Officer
Has successfully led several start-ups; Most
recently served as Founding President of
Soberlink
John Radak, CPA MBA
Financial Strategic Advisor
Former VP of Finance Accounting of Life
Technologies; Former CFO of Quidel; Current CFO
of ArborGen
Gary Gust
Technology Officer
Previously held senior positions at Johnson
Johnson and GenMark Diagnostics; Taken more
than a dozen devices through FDA approval
Robert Thompson
Strategic Advisor
Former CEO of e-Screen (sold to Alere); Current
CEO of Emerge Diagnostics
Yuhwa Lo, Ph.D.
Cellgen Technology Inventor
Professor of electrical and computer engineering
at University of California, San Diego; Director of
Nano3 and Calit2; Transferred over 15 different
technologies out of his lab
Sylvia Norman, Ph.D.
Scientific Officer
Previously held senior positions at Gen-Probe and
DermTech
Alex Khalessi. M.D.
Medical Advisor
Director of Endovascular Neurosurgery at
University of California, San Diego
4. 4
Investment Opportunity
$775k investment to date
»» 2009-13: $550K of non-dilutive
grants in conjunction with UCSD
»» 9/2012: $100k ($2M pre-money)
»» 5/2013: $175k ($2M pre-money)
»» 5/2015: $500k ($3.8M pre-money)
Capital Efficient
»» Successfully transferred
technology from UCSD
»» Opened its RD lab in San Diego
»» Developed its LDT workflow
and commenced discovery
on its POCT platform
Use of proceeds
»» Certify CLIA lab and gain CAP
accreditation
»» Develop an alpha prototype of its
clinical EVAP platform
»» Hire additional technical
commercial professionals
»» Provide 12 months of runway until
its Series A round
(planned for 2Q 2017)
$775K
Cellgen is raising a $1M follow-on seed round with
»» a $10M pre-money valuation based on discounted cash flow and comparable company analyses (See MedDx Industry
Sector Analysis); and
»» a capital efficient business leveraging proven biology to lower overall investment risk
5. 5
Valuation Drivers
Cellgen embodies several of the prevailing trends currently impacting
clinical diagnostics
»» Multiple product roadmap
»» Strategic appeal for acquisition
»» Recognition that companion diagnostics are an essential element of personalized medicine
»» Companion diagnostics are key to sustainable cost containment
»» Migration of diagnostics to the point-of-care
Large strategics are following these trends closely as
evidenced in their corporate development initiatives
(acquisitions, partnering etc.)
6. 6
Significant Value Creation
$450M $450M$203M $308M$275M
Main Driver:
Novel POCT
MDx Platform
Main Driver:
Novel MDx
Platform
Main Driver:
Novel Digital
PCR Platform
Main Driver:
Novel Protein
Research Tool
Main Driver:
Novel MDx
Platform
Targets capable of hitting key inflection points (technology
validation FDA approval) will continue to receive much
attention and premium valuations from potential acquirers with
the potential to create immense value for shareholders
7. 7
What Does Cellgen Sell?
Cellgen is developing a biofluid based, molecular diagnostic
platform that uses disposable cartridges to determine if a
patients genetic profile is a match for a particular cancer
therapeutic
8. 8
What Makes Cellgen Different: Novel EVAP Technology
Clearly Disruptive
Based on patent-pending evaporating droplet
technology
»» Amplification-free
»» Target flexibility: DNA including cfDNA, RNA
including exosomal miRNA proteins
»» Quantitative, digital results in less than 5 hours
»» Target enrichment up to 500X
»» On-chip hybridization and detection
Great promise for near-patient testing
Tecnolology System Cost Sample Type Technology Strengths Test Run Time Test Location Reimbursement
Cellgen Liquid
Biopsy CDx
$15K-$20K Bio Fluids
Evaporation/
Hybridization
Speed, Cost, Ease
of Use, Desktop
Footprint
4-5 hours Clinic Physician
Traditional Liquid
Biopsy CDx
$75K-$100K Bio Fluids PCR/ NGS
No Need for
Tissue Biopsy
7-10 days Reference Lab Reference Lab
Tissue Biopsy CDx $75K-$100K Tissue
PCR/ NGS/ FISH/
IHC
Industry “Gold
Standard”
Universally
Accepted
7-10 days Reference Lab Reference Lab
AMPLIFICATION
9. 9
Cellgen’s Patent Pending Process
Pipetting DNA mixed with
buffer onto black silicone
chip with super-hydrophobic
surface and hydrophilic
micro islands
Sample Pipetting
11. 11
Manual Workflow: Re-Suspension
Dipping in hybridization solution, creating homogenous nano-droplets throughout
the entire chip
Dip in hybridization solution to enrich
target up to 1 million times
12. 12
Manual Workflow: Oil Immersion
Immerse the chip
into the oil to
create a controlled
hybridization
chamber for the
self-assembled
droplets
Oil
Oil
15. 15
Manual Workflow: Observation Under Microscope
Wafer Chip
Washing allows for the detection of individual binding events of each target DNA
marker
16. 16
Manual Workflow: DNA Molecules Under the Microscope
Q-dot emission from target DNA (green) and non-specific binding or imperfect
wash (red) in high DNA copy number (left) and low DNA copy number (right).
The target DNA is the number of green spots subtracted from the number of
red spots.
17. 17
The Problem: Current Therapies Fail Most Patients
“HEALTH CARE TODAY IS IN CRISIS AS IT IS EXPENSIVE, REACTIVE,
INEFFICIENT, AND FOCUSED LARGELY ON ONE-SIZE-FITS-ALL
TREATMENTS FOR EVENTS OF LATE STAGE DISEASE.”
—Ralph Snyderman, M.D., Chancellor Emeritus, Duke University
IMPRECISION MEDICINE
Abilify
aripiprazole
(Schizophrenia)
Advair Diskus
fluticasone propionate
(Asthma)
Nexium
esomeprazole
(Heartburn)
Enbrel
etanercept
(Psoriasis)
Humira
adalimumab
(Arthritis)
Remicade
infliximab
(Crohn’s disease)
Crestor
rosuvastatin
(High cholesterol)
Copaxone
glatiramer acetate
(Multiple sclerosis)
Cymbalta
duloxetine
(Depression)
Neulasta
pegfilgrastim
(Neurtopenia)
For every person they do help (blue), the ten highest-grossing drugs in the
United States fail to help most patients (red). Successfully helped Unsuccessfully helped
$350BEstimated Healthcare
Spend Wasted in 2011
Over
18. 18
The Solution: Personalized Medicine
The right person, the right drug at the right time
Medicine Today
Reactive
Population-based
One-size-fits-all model of care
Personalized Medicine
Predictive
Preventive
Patient-centric model of care
Patients with unknown
disease sub-group
Unlikely to Respond
or Adverse Reaction
Likely to Respond
A
B
On Time,
Everytime
Genetic Match
19. 19
Key Statistics
42 percent of all drugs in the pipeline have a companion diagnostic
Oncology leads the way with 73 percent of the pipeline represented by personalized therapies
Biopharmaceutical companies nearly doubled their RD investment in personalized medicines over the
past five years, and expect to increase their investment by an additional one-third in the next five years
Biopharmaceutical researchers forecast a 69 percent increase in the number of personalized medicines
in development over the next five years.
Personalized Medicine: At Its Tipping Point
Personalized Medicine is Transforming Cancer Care
73% of Cancer medicines
in the pipline have
the potential to be
personalized medicines
Biopharmaceutical companies focusing on personalized medicine has resulted in several recent approvals and a
growing number of new medicines in the pipeline
“ONCOLOGY IS ON FIRE WITH
[PERSONALIZED MEDICINE], WITH
TREATMENT SELECTIONS BASED
ON INDIVIDUAL MOLECULAR
CHARACTERISTICS. THIS IS ALSO
HAPPENING WITH CHRONIC
INFECTIOUS DISEASES, AND GENETIC
DISEASES ARE NOT FAR BEHIND”
—Janet Woodcock, Director
Center for Drug Evaluation and Research,
U.S. Food and Drug Administration
20. 20
Personalized Medicine: Stakeholders Perfectly Aligned
Rx Company Benefits
Accelerated FDA approvals
Faster therapeutic adoption
Decreased development costs
Accelerated clinical trials cost
Longer product life cycles
Patient Benefits
Better outcomes
Reduced trial and error prescribing
Avoid adverse drug reactions
Avoid over toxicity
“IN ORDER FOR ANY OF OUR DRUGS TO MOVE INTO CLINICAL DEVELOPMENT, THERE MUST
BE A BIOMARKER PLAN … TO DETERMINE WHICH BIOMARKERS CAN BE USED IN CLINICAL
DEVELOPMENT TO AID IN DECISION MAKING OR TO HELP IN PATIENT SELECTION”
—Nancy Simonian, MD
Chief Medical Officer, Millenium Pharmaceuticals
Physician Benefits
Assay reimbursement
New revenue center
Reduced lab sendouts
Faster clinical decisions
Payer Benefits
Fewer unsubstantiated payouts
Meaningful use initiatives meet
Substantial financial savings
Less over-prescribing of drugs
21. 21
Companion Diagnostics are the Key to Personalized Medicine
“IN MOST CIRCUMSTANCES, IF USE OF AN IN VITRO COMPANION DIAGNOSTIC DEVICE IS ESSENTIAL FOR THE
SAFE AND EFFECTIVE USE OF A THERAPEUTIC PRODUCT, THE IVD COMPANION DIAGNOSTIC DEVICE AND
THERAPEUTIC PRODUCT SHOULD BE APPROVED OR CLEARED CONTEMPORANEOUSLY BY FDA FOR THE USE
INDICATED IN THE THERAPEUTIC PRODUCT LABELING”
—FDA
CDx
Companion diagnostics enable personalized medicine by
analyzing a patient’s DNA to determine if their genetics are a
match for a given drug
22. 22
Current Companion Diagnostics Landscape
Current CDx tests are specialized kits which run on
complex technology platforms and are focused on a
specific target type (DNA, RNA, Proteins)
Consequently, all CDx testing is currently performed
away from patients in reference and specialty labs
preventing patients and clinicians from quickly
receiving valuable information
Even when a companion diagnostic is unequivocally required in drug labeling, not all doctors order testing for a variety of
reasons, including lengthy turnaround times for results and difficulty getting a tumor sample.
— GenomeWeb - February 2016
Current: 1-2 Weeks Average Turnaround Times
23. 23
Cellgen Diagnostics: Changing the Companion Diagnostics Landscape
Physicians and patients
receive vital information
rapidly to avoid wasting
precious time
Cellgen: CDx Performed in the Clinic, Results in Hours
Greatly improve patient outcomes by eliminating delays in
therapy selection, improving turnaround time from days to
hours
Creates a significant new revenue opportunity
for physicians
Drives increased commercial adoption of therapeutics,
particularly those from smaller Rx companies
Incorporates machine learning to dynamically improve
prediction of therapeutic response
Cellgen’s EVAP platform will be capable of performing near-patient CDx assays, while at the same time sharing real time
data, across various clinical settings to enhance clinic decisions
24. 24
Cellgen Diagnostics: Intelligent Therapeutic Guidance Platform
Cellgen’s companion diagnostics platform will provide 2 outputs:
A Yes or No answer for a patient/drug genetic match decision
If yes, a predictive therapeutic outcome value
»» Cellgen will quantify a signature of miRNA expression levels and place those expression levels into a set of machine
learning algorithms that will classify the patients likely response to the given medicine. With every new patient, the
deep learning algorithms more specifically predict the therapeutic outcome of each patient.
Enhancing clinical decisions with machine learning
25. 25
Companion Diagnostics Success
Zelboraf (Vemurafenib)
Therapy for patients with metastatic
melanoma
Targets BRAF V600E mutation which exists in
50-60% of melanomas
In 2006, Plexxikon and Roche Molecular began
collaborating on development of a companion
diagnostic
Therapy and companion diagnostic approved in
2011, just 4 months after FDA submission and
only 5 years after the initial IND filing
Xalkori (Crizotinib)
Therapy for patients with non-small-cell lung
cancer
Targets ALK gene rearrangements which occur in
3-5% of patients
In 2009, Pfizer and Abbott Molecular began
collaborating on development of a companion
diagnostic
Therapy and companion diagnostic approved in
2011, just 5 months after FDA submission and only
1 year after being granted fast track designation by
FDA
Industry-leading Pharma Companies Are Embracing CDx
26. 26
An Immense Opportunity
Key Drivers
Advanced technologies increasing the adoption of companion diagnostics
Encouragement/requirements by regulatory bodies for companion diagnostics
Increasing costs of traditional drug discovery
Obvious benefits of companion diagnostics to all stakeholders
The global companion diagnostics market is expected to grow
at a 22.7% CAGR reaching $8.7 billion by 2019 Source: MarketsandMarkets
$8.7B
In 2019
~$4B
Now
“Companion Similar” Market Strategy
Target (or duplicate) established EGFR-related companion diagnostic tests which is
already a significant market opportunity
De-risk venture by removing lengthy and expensive biology clinical trials
Simply validate proven EGFR Biomarkers on Cellgen platform
27. 27
Cellgen Killer App: EGFR-related Cancer Companion Diagnostics
EGFR is a gene mutation that is used as a therapeutic
response indicator for various cancers, particularly
lung cancer
Epidermal Growth Factor Receptors (EGFR) mutations
are a common target of MANY drugs across various
cancer types, making EGFR the “killer” first piece of
content for Cellgen’s novel EVAP platform
Focusing on existing EGFR-related CDx tests addresses
a signifcant slice of the $8.7B projected CDx testing
market
Cellgen is in the process of developing and validating a
menu of EGFR CDx tests to launch commercial LDTs
Clear visibility to a robust menu of companion diagnostics content
Lung
Head
Neck
Immuno Therapy
(Future)
Colon
Pancreatic
Thyroid
Breast
Other
28. 28
A Winning Combination
Near-Patient
Capabilities
Yes None None None
Size Small Medium Large Large
Scope of Services Full Full Full Full
One Stop Shop Yes Yes Yes Yes
IVD/LDT IVD LDT LDT LDT
Preferred Sample Type Biofluids Biofluids Tissue Tissue
Target Flexibility
Many (DNA, RNA, Protein,
Exosomes)
Limited by technology
systems adopted
Limited Limited
Test Turnaround Time 5 hours 7-10 days 7-10 days 7-10 days
Cellgen combines the best characteristics of a leading CDx partner with a
proprietary POCT platform empowering clinician preference and increased
drug throughput
29. 29
The Path Forward
Cellgen will follow a well established path to successfully
comercialize its groundbreaking EVAP Clinical CDx platform
Phase 1
(1-12 months):
Develop prototype
open CLIA lab
Phase 2
(12-24 months):
Partner of choice for
pharma and research
labs
Phase 3
(24-36 months):
Generate revenue
from trials and
research as LDTs
Phase 4
(month 36):
Begin FDA approval
process
30. 30
Strong Ongoing Collaborations Validate Our Solution
Plan to use of Cellgen’s EVAP
technology to validate assays
related to
Protein Detection
Bacterial Detection
Using Cellgen’s EVAP
technology to validate assays
across a diverse set of
infectious disease targets
Bio terror
Infectious disease
Livestock
Agricultural
Veterinary
Food safety
Environmental
Promising discussions
regarding miRNA
applications of Cellgen’s
EVAP technology
Lung cancer
Breast cancer
Colon cancer
Glioblastoma
Lymphoma leukemia
31. 31
Market Applications: Beyond Human Healthcare
Although Cellgen is focused on cancer markets, potential acquirers will be
attracted to its combination of full automation and diverse target detection
capabilities (DNAs, RNAs Proteins) perfectly suited for large and growing
markets outside of healthcare
A key component to
delivering the many
promises of personalized
medicine. Key indications
include: depression, asthma,
cystic fibrosis, HIV.
Allows for in-field testing
of various agricultural and
animal products
Rapid, on-site testing for
various harmful biological
and environmental agents
A simple system to power a broad
array of life science research
Healthcare Biothreat
Environmental
Food Safety
Agriculture
Basic Research