The document discusses developing new fluorine-based drugs for positron emission tomography (PET) imaging. It notes the short half-life of fluorine-18 requires rapid synthesis of imaging agents. The solution presented is a single-step fluorination method that can increase production yields 10-fold at the same cost. Feedback from medical professionals and radiopharmaceutical firms indicates a need and market for improved imaging agents that are more readily available and have fewer side effects.
ACCELERATE DATA: Traditional medicine and physicians cannot scale to deliver high-quality healthcare. New technologies and models of care are key enablers to drive better health outcomes at lower cost. The proof will be in the data, but traditional research and clinical testing yield painfully slow results. Medical knowledge comes from carefully accelerating Data -- traditionally pre-clinical and human experimental data -- either to prove or disprove whether new technologies, medicines, processes or incentives are actually superior. Today, researchers and patients can capture, aggregate and communicate new types of data, yielding faster insights and patient impact.
HACK HEALTHCARE: Medicine needs more Hackers -- clever engineers and designers to re-architect healthcare systems and invent new technologies. Some areas of healthcare are not hackable and must prove experiments down a traditional plodding path. However, health professionals and engineers can accelerate medical innovation across many diseases by applying techniques from high technology to healthcare. Borrowing philosophies from Silicon Valley and MIT for rapid product design, lean startup methodologies, workflow re-engineering, novel data collection, big data analysis, and info publishing can accelerate data generation.
Global Pharmaceuticals & Biotechnology IndustryGavin Pathross
This research service presents the CEO 360 Degree Perspective for the global pharmaceuticals and biotechnology industry in 2009. It is an amalgamation of research from more than 50 Pharmaceutical research services generated by Frost & Sullivan, customer research findings based on approximately 1,000 end-user interviews approximately 50,000 hours of analyst research, in the last 2 years. Global healthcare analysts from Frost & Sullivan have contributed their market knowledge to cover the most important issues that are relevant in the healthcare industry today. The report also includes research findings from econometric, advanced technology and several other business divisions of Frost & Sullivan.
Real-World Data Governance - Tools of Data Governance - Purchased and Develop...DATAVERSITY
The document discusses tools that can be used to enable and support data governance programs. It describes templates and tools that can be developed internally, such as an operating model to formalize roles and responsibilities, a common data matrix to record accountability for data, and templates for workflows and issue resolution. The webinar will focus on these types of internally developed tools that can help structure and add value to a company's data governance initiative.
BMC Holistic Health & Retail ClinicsLauren Peters
The document appears to be a pre-assignment for a service design course. It provides three potential topics or trends for the assignment:
1. The rise of religious "nones" and how this trend could impact traditional and organized religion.
2. The increasing reliance on technology and how "our heads are in the cloud." This could relate to issues around dependency on computers and technology failures.
3. The idea that "nature is over" and how humans now dominate nature, questioning the balance between nature and human-made environments.
The document asks the student to choose one of the three topics or trends for their assignment and provides example prompts for each relating to different industries and business models.
- The document discusses a web-based application that helps streamline the process of obtaining patient consent for sharing medical records between doctors.
- It aims to reduce the time required from over a week currently to just a few days by facilitating electronic consent forms and record transfers.
- The target customers are small medical practices, smaller EHR vendors, and insurance companies who want to cut costs from delays in medical care due to lengthy consent processes.
This document discusses evolving closed loop marketing (CLM) strategies for pharmaceutical companies. It explores how CLM aims to analyze physician feedback to refine marketing messages but faces challenges with technology changes, capturing qualitative data, and creating relevant content. The document outlines that CLM involves more than just tools and data collection, emphasizing the need to close multiple loops between sales/marketing, business processes/digital tools, and technology/sales representatives. It argues pharmaceutical companies must understand physician and sales representative experiences to develop effective digital solutions that facilitate meaningful conversations and gather useful feedback to optimize multichannel marketing strategies.
The document discusses creating an intelligent and cost-conscious shared services model. It outlines an approach to assess opportunities, formulate options, conduct feasibility analysis, and develop a low-cost model. Key aspects of the shared services vision discussed include centralized functional placement, process design, risk assessment, and organizational design/governance. Alternative shared services models like centralized, hybrid, and distributed are examined. Guiding principles for the shared services deployment include a balanced approach, strong business relationships, fact-driven decisions, and a staged implementation plan.
ACCELERATE DATA: Traditional medicine and physicians cannot scale to deliver high-quality healthcare. New technologies and models of care are key enablers to drive better health outcomes at lower cost. The proof will be in the data, but traditional research and clinical testing yield painfully slow results. Medical knowledge comes from carefully accelerating Data -- traditionally pre-clinical and human experimental data -- either to prove or disprove whether new technologies, medicines, processes or incentives are actually superior. Today, researchers and patients can capture, aggregate and communicate new types of data, yielding faster insights and patient impact.
HACK HEALTHCARE: Medicine needs more Hackers -- clever engineers and designers to re-architect healthcare systems and invent new technologies. Some areas of healthcare are not hackable and must prove experiments down a traditional plodding path. However, health professionals and engineers can accelerate medical innovation across many diseases by applying techniques from high technology to healthcare. Borrowing philosophies from Silicon Valley and MIT for rapid product design, lean startup methodologies, workflow re-engineering, novel data collection, big data analysis, and info publishing can accelerate data generation.
Global Pharmaceuticals & Biotechnology IndustryGavin Pathross
This research service presents the CEO 360 Degree Perspective for the global pharmaceuticals and biotechnology industry in 2009. It is an amalgamation of research from more than 50 Pharmaceutical research services generated by Frost & Sullivan, customer research findings based on approximately 1,000 end-user interviews approximately 50,000 hours of analyst research, in the last 2 years. Global healthcare analysts from Frost & Sullivan have contributed their market knowledge to cover the most important issues that are relevant in the healthcare industry today. The report also includes research findings from econometric, advanced technology and several other business divisions of Frost & Sullivan.
Real-World Data Governance - Tools of Data Governance - Purchased and Develop...DATAVERSITY
The document discusses tools that can be used to enable and support data governance programs. It describes templates and tools that can be developed internally, such as an operating model to formalize roles and responsibilities, a common data matrix to record accountability for data, and templates for workflows and issue resolution. The webinar will focus on these types of internally developed tools that can help structure and add value to a company's data governance initiative.
BMC Holistic Health & Retail ClinicsLauren Peters
The document appears to be a pre-assignment for a service design course. It provides three potential topics or trends for the assignment:
1. The rise of religious "nones" and how this trend could impact traditional and organized religion.
2. The increasing reliance on technology and how "our heads are in the cloud." This could relate to issues around dependency on computers and technology failures.
3. The idea that "nature is over" and how humans now dominate nature, questioning the balance between nature and human-made environments.
The document asks the student to choose one of the three topics or trends for their assignment and provides example prompts for each relating to different industries and business models.
- The document discusses a web-based application that helps streamline the process of obtaining patient consent for sharing medical records between doctors.
- It aims to reduce the time required from over a week currently to just a few days by facilitating electronic consent forms and record transfers.
- The target customers are small medical practices, smaller EHR vendors, and insurance companies who want to cut costs from delays in medical care due to lengthy consent processes.
This document discusses evolving closed loop marketing (CLM) strategies for pharmaceutical companies. It explores how CLM aims to analyze physician feedback to refine marketing messages but faces challenges with technology changes, capturing qualitative data, and creating relevant content. The document outlines that CLM involves more than just tools and data collection, emphasizing the need to close multiple loops between sales/marketing, business processes/digital tools, and technology/sales representatives. It argues pharmaceutical companies must understand physician and sales representative experiences to develop effective digital solutions that facilitate meaningful conversations and gather useful feedback to optimize multichannel marketing strategies.
The document discusses creating an intelligent and cost-conscious shared services model. It outlines an approach to assess opportunities, formulate options, conduct feasibility analysis, and develop a low-cost model. Key aspects of the shared services vision discussed include centralized functional placement, process design, risk assessment, and organizational design/governance. Alternative shared services models like centralized, hybrid, and distributed are examined. Guiding principles for the shared services deployment include a balanced approach, strong business relationships, fact-driven decisions, and a staged implementation plan.
This document provides an overview of the healthcare industry in Sri Lanka. It discusses how the industry is categorized globally and the professionals it employs. The presentation covers changes in the global healthcare industry and how they impact Sri Lanka. It performs a SWOT, PESTLE and marketing mix analysis of Sri Lanka's healthcare sector. Recommendations are provided on how the industry can address future challenges.
The document discusses the value of analytics in healthcare. It argues that healthcare organizations have large amounts of data from various sources like EMRs, finance systems, and other clinical and administrative systems. However, this data is often underutilized. The author proposes using a healthcare enterprise intelligence framework to extract, transform, and load this data into a centralized data warehouse where it can be integrated, standardized, and made available for analysis. This would allow healthcare leaders to better understand their operations and make more informed decisions using business intelligence tools like OLAP cubes, dashboards, and reports. The goal is to improve outcomes by personalizing care based on past patient data and evidence.
This document is a report on the Pakistan pharmaceutical industry from IQVIA for Q3 2022. Some key points:
- The total retail pharmaceutical market in Pakistan reached Rs. 678 billion with 15.29% growth in value from 2021 to 2022. However, the market shrank in US dollars.
- The top 10 corporations making over Rs. 1 billion accounted for 37.36% of the market share. The top corporation, Getz Pharma, had Rs. 204 billion in sales with 16.42% growth.
- 319 new products were launched in the last 12 months, with the top launches being trastuzumab and rituximab. All top 10 new launches were from domestic
Create a 'Customer 360' with Master Data Management for Financial ServicesPerficient, Inc.
This document summarizes Perficient's capabilities in providing master data management (MDM) solutions for financial services clients. Perficient has expertise in implementing MDM to create a unified customer view across systems and business units. Key benefits of MDM include improved customer experience, increased revenue opportunities, and reduced costs. The document also discusses current industry trends like social media, mobility, and big data that are driving greater need for MDM.
Evolution of the healthcare industry in India and the potential impact of the...Harshit Jain
2014 looks to be a positive but challenging year for the Indian health care sector; one in which many historic business models and operating processes will no longer suffice amid rising demand, continued cost pressures, lack of or inadequate care facilities, and rapidly evolving market conditions. India, likely will be dominated by the “Modi-care” –Health assurance for all.
Talking to your CEO about the Chief Data Officer Role Craig Milroy
The document discusses the role of the Chief Data Officer (CDO) and how to make the case for establishing this role to a company's CEO. It notes that data environments have become increasingly complex due to factors like regulatory demands, acquisitions, and the growth of digital technologies. The CDO role can help address business "pain points" with data and ensure the effective use of data as a strategic asset. An elevator pitch for the CDO should focus on improving customer insights, leveraging data for innovation, and managing regulatory demands that require better data governance. The document outlines how to define the CDO's mandate and proposes a model for the organizational structure and evolution of the Office of the CDO.
The document summarizes a team's final project presentation for a medical device startup called MammOptics. The team includes four members with engineering and business backgrounds working to develop a non-invasive, non-radiative breast cancer detection technology using optical spectroscopy. The presentation covers the initial technology and business model hypotheses, testing the value proposition with hospitals and doctors, and outlines the steps needed for product development, clinical trials, reimbursement, and company financing.
Volkswagen was embroiled in an emissions scandal where it was discovered the company installed software on over 10 million diesel vehicles worldwide to cheat emissions tests. The scandal resulted in billions in fines for Volkswagen, a major drop in sales, and the resignation of the CEO. In response, Volkswagen apologized, suspended engineers responsible, pledged to increase investment in electric vehicles and improve testing and transparency. The document recommends Volkswagen thoroughly test vehicles, implement stakeholder impact analysis for ethical decisions, and create a foundation to support green technology innovation.
Heath care projects need high level of investment, diverse set of stakeholders, and comply with rigorous federal and state regulations, and standards. In addition, project outcomes have direct impact on safety and well-being of patients. This speech focuses on challenges and opportunities in implementing Health care IT projects. Also discusses strategies to adopt agile methodologies in health care industry. Finally, highlights critical success factors in implementing Healthcare Projects successfully.
Learning Outcomes:
Understand characteristics of Healthcare projects
Learn challenges and opportunities in implementing Healthcare projects
Learn agile adoption strategies in Health IT
Learn and apply Critical Success Factors to improve project success
This document outlines 10 top trends in the healthcare industry for 2022 according to research by Capgemini. The trends include: 1) COVID-19 fast-tracking digital health and remote care delivery; 2) A focus on patient-centric, personalized care and shoppable healthcare experiences; 3) Adopting a whole-patient approach and understanding social determinants of health; 4) Using real-time healthcare data and IoMT to improve medical management; 5) Increased involvement of non-traditional players like BigTech firms; 6) Modernization efforts and cloud adoption in the industry; 7) Prioritizing pricing transparency and shoppable healthcare; 8) Increased focus on data privacy and security; 9) Margin pressures triggering
Drug discovery and development is a long and expensive process over time has notoriously bucked Moore's law that it now has its own law called Eroom's Law named after it (the opposite of Moore). It is estimated that the attrition rate of drug candidates is up to 96% and the average cost to develop a new drug has reached almost $2.5 billion in recent years. One of the major causes for the high attrition rate is drug safety, which accounts for 30% of drug failures. Even if a drug is approved in market, it could be withdrawn due to safety problems. Therefore, evaluating drug safety extensively as early as possible becomes all the more important to accelerate drug discovery and development. This talk provides a high-level overview of the current process of rational drug design that has been in place for many decades and covers some of the major areas where the application of AI, Deep learning and ML based techniques have had the most gains. Specifically, this talk covers a variety of drug safety related AI and ML based techniques currently in use which can generally divided into 3 main categories: 1. Classification 2. Regression 3. Read-across. The talk will also cover how by using a hierarchical classification methodology you can simplify the problem of assessing toxicity of any given chemical compound. We will also address recent progress of predictive models and techniques built for various toxicities. It will also cover some publicly available databases, tools and platforms available to easily leverage them. We will also compare and contrast various modeling techniques including deep learning techniques and their accuracy using recent research. Finally, the talk will also address some of the remaining challenges and limitations yet to be addressed in the area of drug safety assessment.
This document discusses the synergies between regulatory information management (RIM) and identification of medicinal products (IDMP). It argues that RIM and IDMP should be considered together, not separately, as IDMP expands on product data beyond what was traditionally included in RIM. The implementation of IDMP standards will converge various regulatory data initiatives and shape future regulatory submissions that will utilize structured IDMP data instead of documents. RIM systems will benefit from using the IDMP data model to standardize product information captured across systems and sources.
Introduction to Data Governance
Seminar hosted by Embarcadero technologies, where Christopher Bradley presented a session on Data Governance.
Drivers for Data Governance & Benefits
Data Governance Framework
Organization & Structures
Roles & responsibilities
Policies & Processes
Programme & Implementation
Reporting & Assurance
Development and Co-Commercialization for Emerging Biotech organizationsIndegene
This document provides an overview of Indegene's capabilities to support emerging biotech organizations across the product lifecycle from pre-launch to post-launch. It outlines Indegene's expertise in areas such as clinical development, regulatory affairs, medical affairs, safety, pricing and market access, marketing, and patient engagement. For each area, it summarizes the challenges faced by emerging biotechs, Indegene's relevant expertise and solutions, including proprietary technologies and platforms. The document emphasizes Indegene's flexible engagement models and ability to scale its capabilities as needed to meet commercialization outcomes for emerging biotech clients.
Hail: SCALING GENETIC DATA ANALYSIS WITH APACHE SPARK: Keynote by Cotton SeedSpark Summit
In 2001, it cost ~$100M to sequence a single human genome. In 2014, due to dramatic improvements in sequencing technology far outpacing Moore’s law, we entered the era of the $1,000 genome. At the same time, the power of genetics to impact medicine has become evident: for example, drugs with supporting genetic evidence have twice the clinical trial success rate. These factors have led to an explosion in the volume of genetic data, in the face of which existing analysis tools are breaking down.
Therefore, we began the open-source Hail project (https://hail.is) to be a scalable platform built on Apache Spark to enable the worldwide genetics community to build, share, and apply new tools. Hail is focused on variant-level (post-read) data; querying genetic data, annotations and sample data; and performing rare and common variant association analyses. Hail has already been used to analyze datasets with hundreds of thousands of exomes and tens of thousands of whole genomes.
We will give an overview of the goals of the Hail project and its architecture. The challenge of efficiently manipulating genetic data in Spark has led to several innovations that may have wider applicability, including an RDD-like abstraction for representing multidimensional data and an OrderedRDD abstraction for ordered data, (for example, data indexed by position in the genome). Finally, we will discuss Hail performance and future directions.
Master Data Management (MDM) has been one of the hot technology areas that are striving to solve the age old data quality and data management problems of the Master Data such as Customer, Product, Chart of Accounts (COA), etc. Of late given the ever increasing capabilities of Hardware, global single instances of packaged applications, mergers and acquisitions, it has become apparent that the data quality problems associated with Master data have been continue to worsen. It is in this context that the MDM solutions try to address the management of master data with robust data quality solutions. The Trading Community Architecture (TCA) framework is an Oracle's answer to solve the problem associated with managing the customer data. Of late the TCA has evolved much more into managing of Location data, Supplier data, Citizen Data, etc. The objective of this session is to provide the overview of Master Data Management (MDM) and Oracle's Trading Community Architecture (TCA) and how it can be used to model the customer data in an enterprise. This is an entry level session and any one with keen interest to learn what MDM and TCA can attend this session. Learn the basics of Master Data Management (MDM), MDM for Customer, and Oracle's Trading Community Architectue (TCA) Learn about the importance of MDM to an enterprise Take a brief look at the TCA's logical data model and the power/flexibility of model to solution cusotmer data
This document discusses key performance indicators (KPIs) for pharmaceutical sales forces. It provides examples of pre-launch and post-launch KPIs that can be used to track sales performance. Pre-launch KPIs include measures of physician awareness, market analysis, and regulatory approval progress. Post-launch KPIs include prescription sales, market share, message recall, customer perception, and incentives-related metrics. The document emphasizes that KPIs should provide a comprehensive picture of performance and be aligned with launch objectives.
A Reference Process Model for Master Data ManagementBoris Otto
This document presents an overview of a reference process model for master data management. It includes an introduction discussing business requirements for master data and challenges in managing master data quality. It also describes the research methodology used to develop an iterative reference process model. The results section provides an overview of the reference process model and discusses its evaluation through three case studies. The conclusion recognizes the model's contribution in explicating the design process for master data management organizations.
4 Best Practices for Analyzing Healthcare DataHealth Catalyst
Meaningful healthcare analytics today generally need data from multiple source systems to help address the triple aim cost, quality, and patient satisfaction. Once appropriate data has been captured, pulled into a single place, and tied together, then data analysis can begin. In this article I share 4 ways to enable your analyst including providing them with
1) a data warehouse
2) a sandbox
3) a set of discovery tools
4) the right kind of direction.
The document describes a technology that uses tobacco plants as biofactories to produce therapeutic proteins like alpha-1 antitrypsin (AAT) more cost effectively and at large scale. It summarizes the business model for producing recombinant AAT to treat AAT deficiency, a condition that currently requires expensive treatment via blood plasma-derived AAT. The technology aims to provide a more reliable and affordable supply of AAT to expand access and potentially new indications by leveraging tobacco plants' ability to act as scalable biomanufacturing platforms.
This document summarizes a business plan for developing hydrogen sensors for use in chlor-alkali plants. It outlines the founding team including the CEO and advisors from Carnegie Mellon University. It describes the major market opportunity in monitoring hydrogen levels in chlorine production plants and compares the innovation of real-time monitoring to current periodic monitoring. Finally, it lists next steps in product development, market testing, exploring partnerships, and understanding the economics between sensor suppliers and industrial plant customers.
This document provides an overview of the healthcare industry in Sri Lanka. It discusses how the industry is categorized globally and the professionals it employs. The presentation covers changes in the global healthcare industry and how they impact Sri Lanka. It performs a SWOT, PESTLE and marketing mix analysis of Sri Lanka's healthcare sector. Recommendations are provided on how the industry can address future challenges.
The document discusses the value of analytics in healthcare. It argues that healthcare organizations have large amounts of data from various sources like EMRs, finance systems, and other clinical and administrative systems. However, this data is often underutilized. The author proposes using a healthcare enterprise intelligence framework to extract, transform, and load this data into a centralized data warehouse where it can be integrated, standardized, and made available for analysis. This would allow healthcare leaders to better understand their operations and make more informed decisions using business intelligence tools like OLAP cubes, dashboards, and reports. The goal is to improve outcomes by personalizing care based on past patient data and evidence.
This document is a report on the Pakistan pharmaceutical industry from IQVIA for Q3 2022. Some key points:
- The total retail pharmaceutical market in Pakistan reached Rs. 678 billion with 15.29% growth in value from 2021 to 2022. However, the market shrank in US dollars.
- The top 10 corporations making over Rs. 1 billion accounted for 37.36% of the market share. The top corporation, Getz Pharma, had Rs. 204 billion in sales with 16.42% growth.
- 319 new products were launched in the last 12 months, with the top launches being trastuzumab and rituximab. All top 10 new launches were from domestic
Create a 'Customer 360' with Master Data Management for Financial ServicesPerficient, Inc.
This document summarizes Perficient's capabilities in providing master data management (MDM) solutions for financial services clients. Perficient has expertise in implementing MDM to create a unified customer view across systems and business units. Key benefits of MDM include improved customer experience, increased revenue opportunities, and reduced costs. The document also discusses current industry trends like social media, mobility, and big data that are driving greater need for MDM.
Evolution of the healthcare industry in India and the potential impact of the...Harshit Jain
2014 looks to be a positive but challenging year for the Indian health care sector; one in which many historic business models and operating processes will no longer suffice amid rising demand, continued cost pressures, lack of or inadequate care facilities, and rapidly evolving market conditions. India, likely will be dominated by the “Modi-care” –Health assurance for all.
Talking to your CEO about the Chief Data Officer Role Craig Milroy
The document discusses the role of the Chief Data Officer (CDO) and how to make the case for establishing this role to a company's CEO. It notes that data environments have become increasingly complex due to factors like regulatory demands, acquisitions, and the growth of digital technologies. The CDO role can help address business "pain points" with data and ensure the effective use of data as a strategic asset. An elevator pitch for the CDO should focus on improving customer insights, leveraging data for innovation, and managing regulatory demands that require better data governance. The document outlines how to define the CDO's mandate and proposes a model for the organizational structure and evolution of the Office of the CDO.
The document summarizes a team's final project presentation for a medical device startup called MammOptics. The team includes four members with engineering and business backgrounds working to develop a non-invasive, non-radiative breast cancer detection technology using optical spectroscopy. The presentation covers the initial technology and business model hypotheses, testing the value proposition with hospitals and doctors, and outlines the steps needed for product development, clinical trials, reimbursement, and company financing.
Volkswagen was embroiled in an emissions scandal where it was discovered the company installed software on over 10 million diesel vehicles worldwide to cheat emissions tests. The scandal resulted in billions in fines for Volkswagen, a major drop in sales, and the resignation of the CEO. In response, Volkswagen apologized, suspended engineers responsible, pledged to increase investment in electric vehicles and improve testing and transparency. The document recommends Volkswagen thoroughly test vehicles, implement stakeholder impact analysis for ethical decisions, and create a foundation to support green technology innovation.
Heath care projects need high level of investment, diverse set of stakeholders, and comply with rigorous federal and state regulations, and standards. In addition, project outcomes have direct impact on safety and well-being of patients. This speech focuses on challenges and opportunities in implementing Health care IT projects. Also discusses strategies to adopt agile methodologies in health care industry. Finally, highlights critical success factors in implementing Healthcare Projects successfully.
Learning Outcomes:
Understand characteristics of Healthcare projects
Learn challenges and opportunities in implementing Healthcare projects
Learn agile adoption strategies in Health IT
Learn and apply Critical Success Factors to improve project success
This document outlines 10 top trends in the healthcare industry for 2022 according to research by Capgemini. The trends include: 1) COVID-19 fast-tracking digital health and remote care delivery; 2) A focus on patient-centric, personalized care and shoppable healthcare experiences; 3) Adopting a whole-patient approach and understanding social determinants of health; 4) Using real-time healthcare data and IoMT to improve medical management; 5) Increased involvement of non-traditional players like BigTech firms; 6) Modernization efforts and cloud adoption in the industry; 7) Prioritizing pricing transparency and shoppable healthcare; 8) Increased focus on data privacy and security; 9) Margin pressures triggering
Drug discovery and development is a long and expensive process over time has notoriously bucked Moore's law that it now has its own law called Eroom's Law named after it (the opposite of Moore). It is estimated that the attrition rate of drug candidates is up to 96% and the average cost to develop a new drug has reached almost $2.5 billion in recent years. One of the major causes for the high attrition rate is drug safety, which accounts for 30% of drug failures. Even if a drug is approved in market, it could be withdrawn due to safety problems. Therefore, evaluating drug safety extensively as early as possible becomes all the more important to accelerate drug discovery and development. This talk provides a high-level overview of the current process of rational drug design that has been in place for many decades and covers some of the major areas where the application of AI, Deep learning and ML based techniques have had the most gains. Specifically, this talk covers a variety of drug safety related AI and ML based techniques currently in use which can generally divided into 3 main categories: 1. Classification 2. Regression 3. Read-across. The talk will also cover how by using a hierarchical classification methodology you can simplify the problem of assessing toxicity of any given chemical compound. We will also address recent progress of predictive models and techniques built for various toxicities. It will also cover some publicly available databases, tools and platforms available to easily leverage them. We will also compare and contrast various modeling techniques including deep learning techniques and their accuracy using recent research. Finally, the talk will also address some of the remaining challenges and limitations yet to be addressed in the area of drug safety assessment.
This document discusses the synergies between regulatory information management (RIM) and identification of medicinal products (IDMP). It argues that RIM and IDMP should be considered together, not separately, as IDMP expands on product data beyond what was traditionally included in RIM. The implementation of IDMP standards will converge various regulatory data initiatives and shape future regulatory submissions that will utilize structured IDMP data instead of documents. RIM systems will benefit from using the IDMP data model to standardize product information captured across systems and sources.
Introduction to Data Governance
Seminar hosted by Embarcadero technologies, where Christopher Bradley presented a session on Data Governance.
Drivers for Data Governance & Benefits
Data Governance Framework
Organization & Structures
Roles & responsibilities
Policies & Processes
Programme & Implementation
Reporting & Assurance
Development and Co-Commercialization for Emerging Biotech organizationsIndegene
This document provides an overview of Indegene's capabilities to support emerging biotech organizations across the product lifecycle from pre-launch to post-launch. It outlines Indegene's expertise in areas such as clinical development, regulatory affairs, medical affairs, safety, pricing and market access, marketing, and patient engagement. For each area, it summarizes the challenges faced by emerging biotechs, Indegene's relevant expertise and solutions, including proprietary technologies and platforms. The document emphasizes Indegene's flexible engagement models and ability to scale its capabilities as needed to meet commercialization outcomes for emerging biotech clients.
Hail: SCALING GENETIC DATA ANALYSIS WITH APACHE SPARK: Keynote by Cotton SeedSpark Summit
In 2001, it cost ~$100M to sequence a single human genome. In 2014, due to dramatic improvements in sequencing technology far outpacing Moore’s law, we entered the era of the $1,000 genome. At the same time, the power of genetics to impact medicine has become evident: for example, drugs with supporting genetic evidence have twice the clinical trial success rate. These factors have led to an explosion in the volume of genetic data, in the face of which existing analysis tools are breaking down.
Therefore, we began the open-source Hail project (https://hail.is) to be a scalable platform built on Apache Spark to enable the worldwide genetics community to build, share, and apply new tools. Hail is focused on variant-level (post-read) data; querying genetic data, annotations and sample data; and performing rare and common variant association analyses. Hail has already been used to analyze datasets with hundreds of thousands of exomes and tens of thousands of whole genomes.
We will give an overview of the goals of the Hail project and its architecture. The challenge of efficiently manipulating genetic data in Spark has led to several innovations that may have wider applicability, including an RDD-like abstraction for representing multidimensional data and an OrderedRDD abstraction for ordered data, (for example, data indexed by position in the genome). Finally, we will discuss Hail performance and future directions.
Master Data Management (MDM) has been one of the hot technology areas that are striving to solve the age old data quality and data management problems of the Master Data such as Customer, Product, Chart of Accounts (COA), etc. Of late given the ever increasing capabilities of Hardware, global single instances of packaged applications, mergers and acquisitions, it has become apparent that the data quality problems associated with Master data have been continue to worsen. It is in this context that the MDM solutions try to address the management of master data with robust data quality solutions. The Trading Community Architecture (TCA) framework is an Oracle's answer to solve the problem associated with managing the customer data. Of late the TCA has evolved much more into managing of Location data, Supplier data, Citizen Data, etc. The objective of this session is to provide the overview of Master Data Management (MDM) and Oracle's Trading Community Architecture (TCA) and how it can be used to model the customer data in an enterprise. This is an entry level session and any one with keen interest to learn what MDM and TCA can attend this session. Learn the basics of Master Data Management (MDM), MDM for Customer, and Oracle's Trading Community Architectue (TCA) Learn about the importance of MDM to an enterprise Take a brief look at the TCA's logical data model and the power/flexibility of model to solution cusotmer data
This document discusses key performance indicators (KPIs) for pharmaceutical sales forces. It provides examples of pre-launch and post-launch KPIs that can be used to track sales performance. Pre-launch KPIs include measures of physician awareness, market analysis, and regulatory approval progress. Post-launch KPIs include prescription sales, market share, message recall, customer perception, and incentives-related metrics. The document emphasizes that KPIs should provide a comprehensive picture of performance and be aligned with launch objectives.
A Reference Process Model for Master Data ManagementBoris Otto
This document presents an overview of a reference process model for master data management. It includes an introduction discussing business requirements for master data and challenges in managing master data quality. It also describes the research methodology used to develop an iterative reference process model. The results section provides an overview of the reference process model and discusses its evaluation through three case studies. The conclusion recognizes the model's contribution in explicating the design process for master data management organizations.
4 Best Practices for Analyzing Healthcare DataHealth Catalyst
Meaningful healthcare analytics today generally need data from multiple source systems to help address the triple aim cost, quality, and patient satisfaction. Once appropriate data has been captured, pulled into a single place, and tied together, then data analysis can begin. In this article I share 4 ways to enable your analyst including providing them with
1) a data warehouse
2) a sandbox
3) a set of discovery tools
4) the right kind of direction.
The document describes a technology that uses tobacco plants as biofactories to produce therapeutic proteins like alpha-1 antitrypsin (AAT) more cost effectively and at large scale. It summarizes the business model for producing recombinant AAT to treat AAT deficiency, a condition that currently requires expensive treatment via blood plasma-derived AAT. The technology aims to provide a more reliable and affordable supply of AAT to expand access and potentially new indications by leveraging tobacco plants' ability to act as scalable biomanufacturing platforms.
This document summarizes a business plan for developing hydrogen sensors for use in chlor-alkali plants. It outlines the founding team including the CEO and advisors from Carnegie Mellon University. It describes the major market opportunity in monitoring hydrogen levels in chlorine production plants and compares the innovation of real-time monitoring to current periodic monitoring. Finally, it lists next steps in product development, market testing, exploring partnerships, and understanding the economics between sensor suppliers and industrial plant customers.
The document discusses developing a new method for fluorinating compounds for positron emission tomography (PET) imaging using a single step. It notes the short half life of F-18 requires synthesis and injection within two hours. The solution presented is a single step fluorination process that could increase production 10-fold at the same cost and reduce side effects from unlabeled compounds. It then discusses engaging with various stakeholders in the radiopharmaceutical industry to develop the technology and business model.
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This document proposes a diagnostic platform that leverages existing personal glucose meters to provide direct readouts of target concentrations in patient samples. It suggests using this platform for therapeutic drug monitoring in clinical trials, medical diagnoses, and environmental detection. The initial target market was seen as diabetes patients who already own glucose meters and need HbA1c monitoring. However, immediate drug monitoring during clinical trials was identified as a better market that meets the value propositions of immediacy, low cost, multiple tests, and short development cycles. Partnerships with pharmaceutical companies are proposed, with GlucoSentient providing added value to meter manufacturers and the pharmaceutical companies being key customers and providing financial support.
\n\nThe document discusses developing photocatalysts called NanogridsTM to remove hydrocarbons from polluted water, particularly for treating wastewater from fracking. It notes an initial target market of $8 billion for environmental remediation. The team conducted customer discovery interviews and identified remediation of petroleum-based polluted water as the target market, and that distributing through partners makes more sense than direct sales. \n\n\n\n\nHuman: Thank you for the summary. Summarize the following document in 3 sentences or less:
[DOCUMENT]:
The meeting minutes from the company board meeting outlined the following:
- Revenues for Q1 were $500
\nIonExpress is developing an automated ion channel screening platform called IonExpress that is faster, cheaper, and easier to use than existing technologies. Their initial business model involves selling lower cost instrumentation and consumables targeted at academic, government, and small/medium pharma customers. Their goal is to develop a minimum viable 32 channel product and obtain early customers to demonstrate proof of concept and validate the market opportunity, which they estimate could be over $100 million annually.
Making a commercial success of new products and services dec 11Paul Fileman
An overview of the theory and practice of go to market planning for breaktrough products and services. Based on "Crossing the Chasm" by Geoffrey Moore with added elements around Value Proposition.
Osage University Partners has had a productive fall, completing seven new investments in 2021 and bringing their portfolio to 16 companies. Their sector diversification strategy provided stability during difficulties in the life science and cleantech sectors. They remain cautiously optimistic for 2012 despite expecting a modest year. Their most recent investments include companies developing clinical trial software, intravenous access systems, preterm birth diagnostics, and oncology therapies targeting protein degradation pathways.
This document discusses TexCone, a company that creates water repellent coatings to eliminate ice buildup. It summarizes their customer outreach efforts over multiple phases, targeting aviation manufacturers, experimental aircraft builders, and the antenna market. The document outlines their marketing strategy and discusses lessons learned from interacting with customers. It concludes that TexCone has potential as a viable business with more investment and work to increase production scale and obtain long-term reliability data.
Wintech Pharmachem Equipments Pvt. Ltd is a leading Indian manufacturer and exporter of pharmaceutical and chemical processing equipment established in 2001 in Thane, Maharashtra. It produces a wide range of equipment such as mixers, blenders, filters, dryers, and conveying machines. The company has over 11-25 employees, a turnover of up to $250,000, and exports to markets in Africa, Asia, the Middle East, and South America. It is headed by Vinod Bhojak and produces high-quality equipment for pharmaceutical and chemical industries.
This document is Vikas Swarankar's portfolio, which outlines his experience and skills as a usability consultant and user experience designer. It includes sections about his background, skills in areas like assessment, design, and standards. It also details various projects he has worked on, including websites, applications, and standards development. Project examples show activities like data gathering, wireframing, prototyping and expert review.
Profire Energy is a leading provider of burner management systems for the oil and gas industry. Their systems automate dangerous procedures to improve worker safety and meet EPA standards to protect the environment. They have two main products, the Profire 2100 and Profire 1100, which help oil and gas companies operate efficiently and save on costs. Profire has experienced strong revenue growth due to their expanding client base and presence in both the U.S. and Canada. They are well positioned for further growth as regulatory pressures increase safety and environmental standards in the oil and gas industry.
Our slides presented at the 34th annual meeting of the Molecular Biology Society of Japan.
Note that this version has been modified to publish under a CC-BY.
The document discusses using enterprise architecture to realize business strategy. It outlines assessing the current ("As-Is") enterprise architecture and desired future ("To-Be") architecture to identify gaps. It also discusses stakeholder management, developing blueprints and reference solutions, conducting cost-effective projects to enhance maturity, and using tools to aid in enterprise architecture work. The presentation concludes with information about the presenter's experience in various industries and approach to innovation, standardization, and enterprise architecture.
Similar to Ground Flour Pharma final NSF I-Corps presentation (15)
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Ground Flour Pharma final NSF I-Corps presentation
1. The Challenge: Synthesize and inject the drug within two hours.
(F-18 half-life = 110 min).
The Solution: Single step fluorination for PET imaging agents.
GFP does this better than anyone else.
PET is critical for the diagnosis and
treatment of cancer, neurological disease
(Parkinson’s, Alzheimer’s), and cardiac
disease. F-18 is the imaging isotope of
choice.
Spoke to: firms covering 60%-80% of the global radiopharmaceutical market,
15 clinical PET users, and 7 GMP PET manufacturers, 5 officials of state
economic development (>90 people total)
2. * 10X increase in production at same
cost
* Pure “carrier-free” product to
reduce side effects
* Robust manufacturing reliability
* Simplified regulatory approval
* Accelerate new agents to market
This is your brain on fluorine
* Global PET market estimated to
grow from $6.1 billion in 2010 to $9.8
billion in 2015
* GFP addresses the large unmet
clinical demand for imaging agents
I-Corps Final Presentation 12/14/11
3. *Kiel Neumann (Entrepreneurial lead)
* Graduate Student at UNL (PhD in May 2012)
* Thesis project developed technology used by GFP
*Stephen DiMagno PhD (PI)
* University of Nebraska Professor
* Expertise in the synthesis, physical properties, and
medicinal chemistry of fluorinated organic compounds
*Allan Green MD, PhD, JD (Mentor)
* Extensive experience in the pharmaceutical industry,
including the development and launch of imaging
products
* Currently teaches FDA Law at the Boston College Law
School
I-Corps Final Presentation 12/14/11
4. The Business Model Canvas - Initial
Technical Assistance
Nuclear Medicine and SOPs for precursors
(Image Atlas) Radiopharmacies
Radiology and drugs
Accessibility (RCY) FDA regulatory support
departments Recruit clinical sites
In vivo animal studies Purity Equipment producers
Develop regulatory Speed
plan for pre IND PET/SPECT Prescribing physicians
meeting Multiplatform Technical assistance
cGMP manufacturers ID cGMP CRO Sensitivity (nca) Radiologist who
Radiopharmacies Fund-raising Specific compounds perform studies
Pharmaceutical General Direct sales of precursor
IP
development methodology for
PoP data Drug developers
companies adding fluorine to Sales of packaged
lead compounds of precursor in cassettes
IP
interest
PoP data
Radiologists
Regulatory plan Cassette manufacturers
Understanding of
the regulatory
process
Sales of intermediates
Contract cGMP precursor manufacture
Salary, Rents
Technology license
Clinical trials
Product license (royalty)
I-Corps Final Presentation 12/14/11
5. • F-dopa iodonium intermediate
• F-dopamine iodonium intermediate Precursor Synthesis
Reagents
•ABX
•Eckert & Ziegler
GMP •GE MX module for TracerLab Precursor in Cassette
Cassette •Siemens Explora
Components
•TracerLab/ GE
•Eckert & Ziegler
•Siemens Explora Cassette (device)
GMP •Neoprobe
Compliant •Synthra
Synthesizer
•Siemens PETNet
•GE Amersham
•Cardinal Health
PET Drug •AAA
Finished product
Distributor •Iason
5
I-Corps Final Presentation 12/14/11
6. * Increase manufacturing yields by 10-fold without increase of
the cost of inputs
* Confirmed by European producer of F-18 DOPA. GFP technology
would increase their output 10x
* Cold unlabeled drug in current PET products produces side-
effects that limit clinical use
* Children’s Hospital confirms side-effects of F-18-dopamine are a
problem and would be solved by GFP technology
* Current manufacturing technology limits the clinical
availability of important PET agents
* Discussion with US hospital confirms important agent (F-18 DOPA)
not available due to low yield and unreliability of current
syntheses
I-Corps Final Presentation 12/14/11
7. * Companies with proposed proprietary PET agents need improved
manufacturing pathways for reliability and economic success
* Detailed discussion with two potential R & D partners (one large
pharma, one small pharma) confirm need
“Value is in the finished
Radiopharmaceutical
Distributors product”
•Siemens PETNet
•GE Amersham “Plug & Play”
•Cardinal Health
•AAA “We are definitely
•Iason interested IF you can
•Neoprobe
make it work on our
I-Corps Final Presentation 12/14/11 platform”
8. The Business Model Canvas - Pivot
Technical Assistance
Nuclear Medicine and SOPs for precursors
(Image Atlas)
Radiology and drugs Radiopharmacies
Accessibility (RCY) FDA regulatory support
departments Recruit clinical sites
In vivo animal studies Purity Equipment producers
Develop regulatory Speed
plan for pre IND PET/SPECT Prescribing physicians
cGMP manufacturers Multiplatform Technical assistance
meeting
Radiopharmacies Sensitivity (nca)
ID cGMP CRO Radiologist who
Fund-raising Specific compounds perform studies
General
Pharmaceutical IP methodology for Direct sales of precursor
development PoP data adding fluorine to Drug developers
companies lead compounds of Sales of packaged
IP interest precursor in cassettes
PoP data
Radiologists
Regulatory plan Cassette manufacturers
Understanding of
the regulatory
process
Sales of intermediates
Contract cGMP precursor manufacture
Salary, Rents
Technology license
Clinical trials
Product license (royalty)
I-Corps Final Presentation 12/14/11
9. UCSF
Memorial Sloan-Kettering
St. Jude Children’s Research Hospital
Stanford Medical Center
* Provide infrastructure for commercialization and clinical
trials
ABX
Albany Molecular
* Offer large-scale cGMP precursor production
* Met Biologics GMP production facility
TracerLab/ GE representatives at UNMC
Neptis
Eckert & Ziegler
Siemens Explora
* Offer GMP-compliant synthesizers
Neoprobe
Synthra I-Corps Final Presentation 12/14/11
10. Global PET Market ~ $6.3 billion
Serviceable available market ~ $1 billion
Initial Target Market (first 2
compounds) ~ $100 million
I-Corps Final Presentation 12/14/11
11. GFP F-18 DOPA
Parkinson’s Disease
SPECT DaTScan(GE) sales in Europe
~$100 M
-Current price - $2800/dose
-Medicare reimbursement - Current SPECT technology
$600/dose
Currently 1.5 million Americans
diagnosed with 60,000 new diagnoses
each year
Expected to rise with effective
imaging
PET imaging
GFP F-18 DOPA addresses this market
11
with a PET agent I-Corps Final Presentation 12/14/11
12. GFP F-18 Dopamine
• Neuroblastoma
• Childhood cancer with
prevalence comparable
to leukemia
• mIBG SPECT imaging now
used
• PET agent sought
• Carrier-free F-18 dopamine
synthesis shown by GFP
n
I-Corps Final Presentatio 12/14/11
13. GMP Finished
GMP
Precursor Drug
Finished
Cassette Finished
Product
Drug
Finished
Drug
$10’s/cassette $300 /cassette Product
Finished
Drug
Finished
Product
Drug Patients
Product
Drug
Finished
Product
Hospitals
Nominal Product
Drug
One time royalty Product
setup ($50) per
$140,000 cassette
$1700 per dose
~100 doses/cassette
13
I-Corps Final Presentation 12/14/11
14. The Final Business Model Canvas
SOPs for precursors
and drugs
Recruit clinical sites Accessibility (RCY)
In vivo animal studies Purity FDA regulatory support
Develop regulatory Speed
plan for pre IND PET/SPECT
meeting Multiplatform Technical assistance
Nuclear Medicine and Radiopharmacies
ID cGMP CRO Sensitivity (nca)
Radiology Specific compounds
departments Fund-raising
Equipment producers
cGMP manufacturers Intellectual Property
Sales of packaged
Radiopharmacies precursor in cassettes
PoP Data
Cassette manufacturers
FDA support
Licensing fees of precursor
Contract cGMP precursor manufacture
Salary, Rents
Clinical trials Product license (royalty)
I-Corps Final Presentation 12/14/11
15. * Limitations in current PET chemistry constrain the availability of
clinically important PET drugs
* Low manufacturing yields, unreliability of current procedures, and
manufacturing complexity are addressed by proprietary GFP
technology
* GFP technology addresses attractive markets
* GFP technology provides accessibility
* Proven synthesis of existing tracers with proven clinical use
* Improved manufacturing of third-party proprietary imaging agents
Submitted SBIR Phase 1 proposal
PI bought out of teaching commitment in spring
Rented space for GFP
Negotiated license agreement with UNL
Negotiating technology demonstrations
Met with State representatives for economic development