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The document discusses developing new radiotracers for positron emission tomography (PET) imaging through efficient fluorination synthesis methods. It identifies initial target indications as pediatric neuroblastoma and Parkinson's disease. The business model would involve developing specific imaging agents, conducting clinical trials, and marketing the tracers and synthesis methods to radiopharmacies and imaging equipment companies.
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This document summarizes Advanced Cell Technology's work translating stem cell research into commercial products. It discusses ACT's focus on retinal pigment epithelium (RPE), hemangioblast, and dermal programs. It outlines ACT's progress establishing Good Manufacturing Practice facilities and protocols for producing cells for clinical trials. Key milestones for 2006 include completing a GMP facility, beginning GMP cell production, and expanding technology platforms. Goals for 2007 include raising capital, filing an IND for RPE therapy, and advancing preclinical work for hemangioblast and dermal programs.
The Case Of Incyte Genomics
1) Incyte Genomics pursued an ambitious business model and patent strategy in the late 1990s and early 2000s that involved sequencing the human genome, patenting gene sequences, and selling subscriptions to genomic databases and licensing the patents.
2) A key part of the strategy was filing over 2,000 patent applications covering about 11,000 human gene sequences to generate licensing revenues, but this strategy faced challenges from the US Patent Office's utility requirement.
3) In 2004, Incyte abandoned its original business model and patent strategy after the US Patent Office rejected many of its patent applications for lack of demonstrating utility and specific and substantial real world use for the gene sequences.
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Bringing NGS Testing In-House
Is insourcing NGS testing worth it?
Dartmouth-Hitchcock has experienced nearly 40% savings by bringing NGS testing in-house. A recent AMP study using non-small cell lung cancer as an example cites $2.7 million in anticipated savings.
In-house NGS testing is the foundation of any modern precision medicine program. It can have a profound effect on patient care. And, as these examples show, a strong business case can be made.
How have Dartmouth-Hitchcock and other progressive institutions been so successful despite myriad challenges?
Join us for a webinar on May 31st at 12pm ET as Eric Loo, MD (Dartmouth-Hitchcock) and Rakesh Nagarajan, MD, PhD (PierianDx) explore answers to this question and more.
In this webinar you will learn:
How recent precision medicine trends are driving strong market growth for clinical NGS and other complex molecular testing.
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Challenges your institution is likely to face by insourcing.
Blueprints for overcoming these challenges, including reimbursement.
Ethical Issues Surrounding Patenting of Human Genes and the Development of Ne...
This document discusses the ethical issues surrounding patenting human genes and how it affects scientific research and medical practice. While companies argue patents fuel research, evidence shows patents can slow research by requiring licensing fees and risk of infringement penalties. Patents on genes linked to diseases have limited further research identifying new mutations and made diagnosis only available through the patent holder. Surveys found many researchers limited projects or discontinued research due to patent risks. Withdrawing gene patents, like the Supreme Court did for BRCA1/2, can benefit research, innovation, healthcare costs and patients.
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Breast Cancer – Patents
Executive Summary
Introduction
Breast cancer is a malignancy that effects women across the world and is most prevalent among various types of cancers. Patents are jurisdiction specific exclusive rights that are sought by innovators across various technological fields.
breast-cancer-ribbon
However, patent rights become questionable and debatable when these are sought in respect of pharmaceutical drugs, medical devices, surgical techniques, diagnostic tests, personalized medicines and research tools related to healthcare. Across Western jurisdictions, patents have been sought for artificial plant varieties (hybrid plants, genetically modified plants etc.), animal species created with human intervention (Harvard Oncomouse, Dolly the Sheep etc.), and methods of human treatment. Due to the presence of numerous patents in the field of healthcare, it imminently results in the requirement of large number of licenses to access patented technology, which subsequently leads to increased cost of treatment because of accumulation of royalties (royalty stacking) to be paid to the patent holders. Therefore, in developing countries like India, it becomes highly controversial as to whether to grant such patents to protect Intellectual Property Rights (IPR) or to focus on affordable healthcare by rejecting such patents.
Strategy, Scope and Focus
With a view to discuss implications of patents specifically related to breast cancer, we have researched and analyzed the breast cancer patent landscape in India and US, in light of latest legal developments, with special focus on Trastuzumab (a medicine which treats a form of breast cancer) and US Supreme Court judgement to overturn Myriad Genetics’ patents on the “breast cancer genes - BRCA1 and BRCA2”.
Breast Cancer and Patents
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As it is well known that patent protection is granted for a limited period of 20 years, wherein the patent holder holds exclusive rights for exploitation of the patented invention. Generally, patents are aimed at encouraging innovations by providing incentives to the patent holders by offering them recognition for their creativity.
Biotechnology Patents
In the field of biotechnology and healthcare, the cost of reparation is crucial, as the research in these fields is highly expensive. The financial investments can only be paid off if the companies can protect results by exclusive rights (patents) and gain the competitive advantage.
Gene Therapy Patents
Historically, there has been a close relation between gene therapy, patents and scientific advancements. Large pharmaceutical companies have invested huge amount of capital in patenting genes, either on their own or by acquiring small biotech companies. For example, Swiss pharmaceutical company Sandoz (subsidiary of Novartis) acquired Genetic Therapy Inc. of Gaithersburg, Md. In 1995, for about $295 million. At that point of time, Genetic Therapy held e
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The document summarizes an FDA presentation on the regulation of cellular, tissue, and gene therapies. It provides an overview of the FDA organization relevant to these therapies. It discusses premarket review pathways, recent guidance documents, current activities around stem cells, gene therapy, and tissue safety, and international engagement efforts towards regulatory harmonization.
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This document discusses direct-to-consumer genetic testing, including its purposes and benefits, current examples, and privacy concerns. It also covers genetic sequencing techniques, pharmacogenomics, and predictions for the future of personalized medicine, including increasing market size and regulatory guidelines.
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This document summarizes Advanced Cell Technology's work translating stem cell research into commercial products. It discusses ACT's focus on retinal pigment epithelium (RPE), hemangioblast, and dermal programs. It outlines ACT's progress establishing Good Manufacturing Practice facilities and protocols for producing cells for clinical trials. Key milestones for 2006 include completing a GMP facility, beginning GMP cell production, and expanding technology platforms. Goals for 2007 include raising capital, filing an IND for RPE therapy, and advancing preclinical work for hemangioblast and dermal programs.
The Case Of Incyte Genomics
1) Incyte Genomics pursued an ambitious business model and patent strategy in the late 1990s and early 2000s that involved sequencing the human genome, patenting gene sequences, and selling subscriptions to genomic databases and licensing the patents.
2) A key part of the strategy was filing over 2,000 patent applications covering about 11,000 human gene sequences to generate licensing revenues, but this strategy faced challenges from the US Patent Office's utility requirement.
3) In 2004, Incyte abandoned its original business model and patent strategy after the US Patent Office rejected many of its patent applications for lack of demonstrating utility and specific and substantial real world use for the gene sequences.
Global radiopharmaceuticals market insight
“Global Radiopharmaceuticals Market Insight” Report Highlights
Global Radio Pharmaceuticals Market Overview by Region
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Radiopharmaceuticals Market Regulation for US, Europe & Canada
Radioisotopes Used in Radiopharmaceuticals
Radiopharmaceutical Clinical Pipeline Insight
Profile of 87 Radiopharmaceuticals Drugs in Clinical Phase
Bringing NGS Testing In-House
Is insourcing NGS testing worth it?
Dartmouth-Hitchcock has experienced nearly 40% savings by bringing NGS testing in-house. A recent AMP study using non-small cell lung cancer as an example cites $2.7 million in anticipated savings.
In-house NGS testing is the foundation of any modern precision medicine program. It can have a profound effect on patient care. And, as these examples show, a strong business case can be made.
How have Dartmouth-Hitchcock and other progressive institutions been so successful despite myriad challenges?
Join us for a webinar on May 31st at 12pm ET as Eric Loo, MD (Dartmouth-Hitchcock) and Rakesh Nagarajan, MD, PhD (PierianDx) explore answers to this question and more.
In this webinar you will learn:
How recent precision medicine trends are driving strong market growth for clinical NGS and other complex molecular testing.
How to make a strong business case for in-house NGS testing.
Challenges your institution is likely to face by insourcing.
Blueprints for overcoming these challenges, including reimbursement.
Ethical Issues Surrounding Patenting of Human Genes and the Development of Ne...
This document discusses the ethical issues surrounding patenting human genes and how it affects scientific research and medical practice. While companies argue patents fuel research, evidence shows patents can slow research by requiring licensing fees and risk of infringement penalties. Patents on genes linked to diseases have limited further research identifying new mutations and made diagnosis only available through the patent holder. Surveys found many researchers limited projects or discontinued research due to patent risks. Withdrawing gene patents, like the Supreme Court did for BRCA1/2, can benefit research, innovation, healthcare costs and patients.
Breast Cancer Patents Research - Myriad Genetics in US | Trastuzumab in India...
Breast Cancer – Patents
Executive Summary
Introduction
Breast cancer is a malignancy that effects women across the world and is most prevalent among various types of cancers. Patents are jurisdiction specific exclusive rights that are sought by innovators across various technological fields.
breast-cancer-ribbon
However, patent rights become questionable and debatable when these are sought in respect of pharmaceutical drugs, medical devices, surgical techniques, diagnostic tests, personalized medicines and research tools related to healthcare. Across Western jurisdictions, patents have been sought for artificial plant varieties (hybrid plants, genetically modified plants etc.), animal species created with human intervention (Harvard Oncomouse, Dolly the Sheep etc.), and methods of human treatment. Due to the presence of numerous patents in the field of healthcare, it imminently results in the requirement of large number of licenses to access patented technology, which subsequently leads to increased cost of treatment because of accumulation of royalties (royalty stacking) to be paid to the patent holders. Therefore, in developing countries like India, it becomes highly controversial as to whether to grant such patents to protect Intellectual Property Rights (IPR) or to focus on affordable healthcare by rejecting such patents.
Strategy, Scope and Focus
With a view to discuss implications of patents specifically related to breast cancer, we have researched and analyzed the breast cancer patent landscape in India and US, in light of latest legal developments, with special focus on Trastuzumab (a medicine which treats a form of breast cancer) and US Supreme Court judgement to overturn Myriad Genetics’ patents on the “breast cancer genes - BRCA1 and BRCA2”.
Breast Cancer and Patents
Basics of Patent Rights
As it is well known that patent protection is granted for a limited period of 20 years, wherein the patent holder holds exclusive rights for exploitation of the patented invention. Generally, patents are aimed at encouraging innovations by providing incentives to the patent holders by offering them recognition for their creativity.
Biotechnology Patents
In the field of biotechnology and healthcare, the cost of reparation is crucial, as the research in these fields is highly expensive. The financial investments can only be paid off if the companies can protect results by exclusive rights (patents) and gain the competitive advantage.
Gene Therapy Patents
Historically, there has been a close relation between gene therapy, patents and scientific advancements. Large pharmaceutical companies have invested huge amount of capital in patenting genes, either on their own or by acquiring small biotech companies. For example, Swiss pharmaceutical company Sandoz (subsidiary of Novartis) acquired Genetic Therapy Inc. of Gaithersburg, Md. In 1995, for about $295 million. At that point of time, Genetic Therapy held e
Fda phacilitate2010final
The document summarizes an FDA presentation on the regulation of cellular, tissue, and gene therapies. It provides an overview of the FDA organization relevant to these therapies. It discusses premarket review pathways, recent guidance documents, current activities around stem cells, gene therapy, and tissue safety, and international engagement efforts towards regulatory harmonization.
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This document discusses direct-to-consumer genetic testing, including its purposes and benefits, current examples, and privacy concerns. It also covers genetic sequencing techniques, pharmacogenomics, and predictions for the future of personalized medicine, including increasing market size and regulatory guidelines.
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If you are a clinical lab looking to build or accelerate your NGS testing capability where do you start? The components of success can be overwhelming - planning, assay design, validation, clinical lab workflow, informatics, and interpretation.
During this one-hour webinar, BG Jones, SVP of Business Development for PierianDx, who has 23 years of experience in healthcare IT and genomics technology, will demonstrate how to pull it all together using "Actionable Intelligence" - a combination of machine learning and human expertise to achieve clinically actionable insights.
Ownership Rights Patents For Derivatives Of The Human Body
This document discusses several court cases and issues around patents for derivatives of the human body and ownership rights over genetic material and biological samples. It summarizes key cases such as Moore v. Regents of the University of California and Washington University v. Catalona that established donors do not have property rights over excised tissue or genetic information derived from samples. The document recommends strict donor consent rules and maintaining donor ownership over genetic material to address imbalances in current laws and policies.
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Ownership Rights:: Patents for Derivatives of the Human Body
This document discusses several court cases related to ownership rights over genetic material and the implications of commercializing genetic research. It summarizes key issues such as donors maintaining ownership interest in genetic material and informed consent. It recommends strict donor consent regulations, exempting non-profit research from licensing fees, and genetic privacy laws giving donors control over their genetic data and samples.
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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.
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This document discusses next generation sequencing (NGS) data and implications for data stewardship. It notes that NGS allows measuring the full-length transcriptome, including alternatively spliced transcripts specific to samples. This alters gene models and highlights the need to capture gene models and context in data commons for future reuse. The document also recommends that more metadata be captured about samples, experiments, and instruments to provide context and aid in data processing. It emphasizes making data FAIR (findable, accessible, interoperable, and reusable) according to W3C standards to improve data stewardship and enable both human and machine use of data.
Patentable Subject Matter” nurture or neglect innovation? A case study based ...
Dara Ajay (Cheers Interactive, India)
Patentable Subject matter, list out the controversial inventions ineligible for patent registration. These inventions are related to genetic modification, software patents and business methods etc. which have been debated on national, international levels at various conventions. Currently, there are multiple patent litigation reported under patentable subject matter and are prosecuted with different perspectives. However, these inventions despite meeting the criteria are still been prosecuted based on patentable subject matter. The presentation would discuss some of the famous case studies in the area of genetic modification both at level of inventions and discovery. Further, more emphasis is focused toward the recent patent case on gene discovery of Myriad Patent litigations. There by address the critical question whether “patentable subject matter” is actually satisfying the current upcoming technologies assessment or acting as an impediment for future innovations. In other words, dose patentable subject matter stifle the growth of latest upcoming technologies which could emerge as future breakthrough innovations!
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Stem cell research faces challenges due to numerous existing and pending patents covering related technologies. A patent pool is proposed to consolidate these patents into a single license to streamline access for researchers and developers. A patent pool would integrate complementary patents and reduce costs by avoiding multiple licensing agreements. However, any patent pool must be carefully designed to avoid anti-competitive behaviors like restricting innovation. If properly structured, a stem cell patent pool could enable continued progress while respecting patent holders' rights.
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This presentation summarizes the business of Advanced Cell Technology (ACT), including their therapeutic stem cell programs. ACT has stem cell lines that do not require embryo destruction awaiting FDA approval for clinical trials to treat macular degeneration. Their myoblast program has received FDA clearance for a Phase II clinical trial to treat heart disease. ACT also has preclinical programs in retinal pigment epithelium cells and hemangioblasts, and they utilize a single blastomere technique to derive stem cells without embryo harm.
Personalized Medicine: Genetic Diagnostics Technologies
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
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The US Court of Appeals for the Federal Circuit issued a decision regarding the utility requirement for patents of expressed sequence tags (ESTs). The court affirmed the Patent and Trademark Office's rejection of a patent application for ESTs from corn plants. The majority found that the ESTs lacked a specific, substantial utility as required, as the application disclosed no information about the corresponding genes' structure or function. The court determined the disclosed potential uses for the ESTs, such as gene markers, were too generic and did not demonstrate real-world utility for the particular claimed ESTs. The decision confirmed that the utility standard under US patent law requires disclosure of a specific, practical benefit to satisfy the usefulness requirement.
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- Advanced Cell Technology (ACT) is a biotechnology company focused on developing stem cell therapy programs including retinal pigment epithelium cells for age-related macular degeneration, myoblast cells for heart disease, and hemangioblast cells for blood and circulatory disorders.
- ACT has a proprietary single blastomere technology that can generate embryonic stem cell lines without destroying embryos using preimplantation genetic diagnosis.
- ACT has several stem cell therapy programs in clinical trials or preclinical research stages and collaborates with major research institutions. It also has a robust stem cell patent portfolio and facilities for manufacturing.
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In addition to filing and prosecuting patent and trademark applications worldwide for their Israeli clients, JMB Davis Ben-David files and prosecutes patent and trademark applications for clients the world over, both in the Israeli and US Patent and Trademark Offices.
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When performing variant analysis on whole exome or large gene panels, clinicians must sort through thousands of variants to determine which variants are most likely to be associated with the patient’s phenotypes. To assist with this process, we have implemented the PhoRank algorithm, which incorporates phenotypic associations to highlight the most relevant genes with potentially damaging variants. PhoRank 1.0 supports researchers leveraging all possible gene-disease associations by traversing multiple gene and pathway ontologies. Recent papers have demonstrated new techniques that have improved ranking performance in a clinical context. We have incorporated these new strategies into PhoRank 2.0: providing better ranking and improved computational performance for most clinically diagnostic and testing scenarios. Join us in this webinar as we cover:
Utility of gene ranking in genetic testing
Scenarios that warrant the use of PhoRank 2.0
New ranking strategies provided by recent papers
Benchmarks of PhoRank 2.0 on published datasets
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2016 ngs health_lecture
Genomic medicine is being applied clinically through sequencing technologies that have reduced costs and increased knowledge. Primary applications include diagnosing rare genetic disorders, cancer treatment guidance, and infectious disease monitoring. However, continued innovation depends on lowering costs, expanding knowledge of genetic variation and gene function through large population studies, and developing new technologies.
Organ-i World Transplant Congress Soild Organ Rejection Test (k-SORT)
SORT
Solid Organ Rejection Test is a gene based biomarker panel that evaluates the gene expression profile of RNA isolated from peripheral blood leukocytes. SORT is intended for diagnosis and subsequent monitoring of renal transplant recipients who have a high probability of early cellular or humoral acute rejection at the time of testing. SORT should be utilized in conjunction with standard clinical assessment.
The renal transplant community is heavily reliant on serum creatinine levels as a trigger to diagnose acute rejection. However, serum creatinine is a late indicator of renal injury and exhibits high variability and high false positivity. These inadequacies lead to delayed diagnosis and irreversible renal damage.
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SORT is intended to be utilized in conjunction with standard clinical assessment.
In the US for 0.5 Million patients with Renal Failure, transplant is the treatment of choice, but due to a critical shortage of organs, there are 85,000 patients on the waitlist of 2.5 years. Only 21,000 receive kidney transplants annually. This costs Medicare $6.3 Billion. The absence of accurate, non-invasive monitoring tests is an unmet need reflected in the high attrition rates. Organ-I is commercializing, ‘SORT’ (Solid Organ Rejection Test) first predictive, accurate, non-invasive test available to patients, averting the need for unnecessary biopsies and saving upwards of $750M.
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This document summarizes TexCone, a laser micro textured surface coating for anti-icing applications. It discusses production and testing of the coating, potential customers in aviation and other industries, and next steps which include scheduling more customer calls and obtaining icing tunnel test data to share with interested companies like Boeing and Cessna. Recent customer calls showed strong interest from Boeing and Cessna contingent on receiving convincing durability and performance data from icing tunnel tests.
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MammOptics is developing an optical spectroscopy device to screen for breast cancer that can detect abnormalities earlier than mammography with less radiation and cost. The US breast cancer screening market is projected to be $600 million for equipment and $1.2 billion for use in 2015. MammOptics' non-invasive technology could replace mammography due to being radiation-free, cheaper, and able to detect cancer at earlier stages. The company aims to gain FDA approval and drive adoption through pioneering doctors to generate continuous revenue in the large but underpenetrated breast cancer screening market.
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If you are a clinical lab looking to build or accelerate your NGS testing capability where do you start? The components of success can be overwhelming - planning, assay design, validation, clinical lab workflow, informatics, and interpretation.
During this one-hour webinar, BG Jones, SVP of Business Development for PierianDx, who has 23 years of experience in healthcare IT and genomics technology, will demonstrate how to pull it all together using "Actionable Intelligence" - a combination of machine learning and human expertise to achieve clinically actionable insights.
Ownership Rights Patents For Derivatives Of The Human Body
This document discusses several court cases and issues around patents for derivatives of the human body and ownership rights over genetic material and biological samples. It summarizes key cases such as Moore v. Regents of the University of California and Washington University v. Catalona that established donors do not have property rights over excised tissue or genetic information derived from samples. The document recommends strict donor consent rules and maintaining donor ownership over genetic material to address imbalances in current laws and policies.
Organ Specific Proteomics
Organ Specific Proteomics as Presented by Paul Kearney, PhD; CSO, Integrated Diagnostics at the 2010 Personalized Health Care National Conference at Ohio State.
Ownership Rights:: Patents for Derivatives of the Human Body
This document discusses several court cases related to ownership rights over genetic material and the implications of commercializing genetic research. It summarizes key issues such as donors maintaining ownership interest in genetic material and informed consent. It recommends strict donor consent regulations, exempting non-profit research from licensing fees, and genetic privacy laws giving donors control over their genetic data and samples.
Survival guide to stem cell research and therapies
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.
Jax bio dataworldcongress.ngs.20181128finalwithoutbu
This document discusses next generation sequencing (NGS) data and implications for data stewardship. It notes that NGS allows measuring the full-length transcriptome, including alternatively spliced transcripts specific to samples. This alters gene models and highlights the need to capture gene models and context in data commons for future reuse. The document also recommends that more metadata be captured about samples, experiments, and instruments to provide context and aid in data processing. It emphasizes making data FAIR (findable, accessible, interoperable, and reusable) according to W3C standards to improve data stewardship and enable both human and machine use of data.
Patentable Subject Matter” nurture or neglect innovation? A case study based ...
Dara Ajay (Cheers Interactive, India)
Patentable Subject matter, list out the controversial inventions ineligible for patent registration. These inventions are related to genetic modification, software patents and business methods etc. which have been debated on national, international levels at various conventions. Currently, there are multiple patent litigation reported under patentable subject matter and are prosecuted with different perspectives. However, these inventions despite meeting the criteria are still been prosecuted based on patentable subject matter. The presentation would discuss some of the famous case studies in the area of genetic modification both at level of inventions and discovery. Further, more emphasis is focused toward the recent patent case on gene discovery of Myriad Patent litigations. There by address the critical question whether “patentable subject matter” is actually satisfying the current upcoming technologies assessment or acting as an impediment for future innovations. In other words, dose patentable subject matter stifle the growth of latest upcoming technologies which could emerge as future breakthrough innovations!
SKGF_Advisory_Stem Cells-Patent Pools to the Rescue_2005
Stem cell research faces challenges due to numerous existing and pending patents covering related technologies. A patent pool is proposed to consolidate these patents into a single license to streamline access for researchers and developers. A patent pool would integrate complementary patents and reduce costs by avoiding multiple licensing agreements. However, any patent pool must be carefully designed to avoid anti-competitive behaviors like restricting innovation. If properly structured, a stem cell patent pool could enable continued progress while respecting patent holders' rights.
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This presentation summarizes the business of Advanced Cell Technology (ACT), including their therapeutic stem cell programs. ACT has stem cell lines that do not require embryo destruction awaiting FDA approval for clinical trials to treat macular degeneration. Their myoblast program has received FDA clearance for a Phase II clinical trial to treat heart disease. ACT also has preclinical programs in retinal pigment epithelium cells and hemangioblasts, and they utilize a single blastomere technique to derive stem cells without embryo harm.
Personalized Medicine: Genetic Diagnostics Technologies
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
Utility must be specific, practical
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- Advanced Cell Technology (ACT) is a biotechnology company focused on developing stem cell therapy programs including retinal pigment epithelium cells for age-related macular degeneration, myoblast cells for heart disease, and hemangioblast cells for blood and circulatory disorders.
- ACT has a proprietary single blastomere technology that can generate embryonic stem cell lines without destroying embryos using preimplantation genetic diagnosis.
- ACT has several stem cell therapy programs in clinical trials or preclinical research stages and collaborates with major research institutions. It also has a robust stem cell patent portfolio and facilities for manufacturing.
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When performing variant analysis on whole exome or large gene panels, clinicians must sort through thousands of variants to determine which variants are most likely to be associated with the patient’s phenotypes. To assist with this process, we have implemented the PhoRank algorithm, which incorporates phenotypic associations to highlight the most relevant genes with potentially damaging variants. PhoRank 1.0 supports researchers leveraging all possible gene-disease associations by traversing multiple gene and pathway ontologies. Recent papers have demonstrated new techniques that have improved ranking performance in a clinical context. We have incorporated these new strategies into PhoRank 2.0: providing better ranking and improved computational performance for most clinically diagnostic and testing scenarios. Join us in this webinar as we cover:
Utility of gene ranking in genetic testing
Scenarios that warrant the use of PhoRank 2.0
New ranking strategies provided by recent papers
Benchmarks of PhoRank 2.0 on published datasets
Golden Helix provides a comprehensive solution for NGS testing labs to perform best practice guidelines such as ACMG and AMP. Our gene ranking methods provide a vital role in scaling tests to large gene panels and exomes. Please join us as we review the testing workflow and how this significant update to our gene ranking algorithm fits into the testing workflow.
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Genomic medicine is being applied clinically through sequencing technologies that have reduced costs and increased knowledge. Primary applications include diagnosing rare genetic disorders, cancer treatment guidance, and infectious disease monitoring. However, continued innovation depends on lowering costs, expanding knowledge of genetic variation and gene function through large population studies, and developing new technologies.
Organ-i World Transplant Congress Soild Organ Rejection Test (k-SORT)
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The renal transplant community is heavily reliant on serum creatinine levels as a trigger to diagnose acute rejection. However, serum creatinine is a late indicator of renal injury and exhibits high variability and high false positivity. These inadequacies lead to delayed diagnosis and irreversible renal damage.
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Team Aurora - 2021 Technology, Innovation & Great Power Competition
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Team Conflicted Capital Team - 2021 Technology, Innovation & Great Power Comp...
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