- PTC Therapeutics announced two drug discovery deals worth up to $1.9 billion, including a $12 million upfront payment from Roche and an undisclosed option exercise by Celgene. Both deals center around PTC's GEMS technology platform.
- The Roche deal is worth up to $1.9 billion in milestones and royalties and involves finding molecules for 4 CNS targets. The Celgene deal involves an oncology target but financial terms were not disclosed.
- PTC's GEMS platform identifies small molecules that regulate post-transcriptional control mechanisms to increase or decrease protein production from difficult targets.
Golden Helix’s SNP & Variation Suite (SVS) has been used by researchers around the world to do trait analysis and association testing on large cohorts of samples in both humans and other species. As Next-Generation Sequencing of whole genomes becomes more affordable, large cohorts of Whole Genome Sequencing (WGS) samples are available to search for additional trait association signals that were not found in array-based testing. In fact, recent papers have shown that WGS analysis using advanced GREML (Genomic Relatedness Restricted Maximum Likelihood) techniques is able to outperform micro-array based GWAS methods in the analysis of complex traits and proportion of the trait heritability explained.
Our latest update release of SVS has expanded the exiting maximum likelihood and GRM methods to support these new techniques. We have also enhanced various other association testing and prediction methodologies. This webcast showcases:
- Newly supported analysis workflow for whole genome variants using LD binning and enhanced GBLUP analysis
- Enhanced gender correction using REML
- Additional capabilities for genomic prediction and phenotype prediction
We are continually improving our products based on our customer’s feedback. We hope you enjoy this recording highlighting the exciting new features and select enhancements we have made.
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
A User’s Perspective: ACMG Guidelines for CNVs in VSClinicalGolden Helix
Our last webcast introduced the newest features of VarSeq that will be included in our upcoming release. After a serious developmental effort, we are excited to announce one of these being the integration of ACMG Guidelines for CNVs!
VarSeq is not only the tertiary environment to filter through your imported SNVs and indels from any VCF file, but also includes robust and proven capabilities of CNV detection and clinical variant interpretation. With our upcoming release, users will be able to leverage an automated CNV ACMG classification filter that is paired with the CNV evaluation in the VSClinical interpretation hub. This webcast will expose attendees to literature reinforcing the quality of our CNV caller, as well as showing examples of CNV analysis to demonstrate how this tool can streamline the analysis process. In this webcast, we will cover:
Describing the new CNV guidelines and how Golden Helix tackles their complexity
Assessing CNV impact on Gene and Gene Dosage
Cited literature referencing the accuracy of VarSeq’s CNV calling
Product demonstrations of VSClinical’s CNV interpretation/classification and final report functionalities
Manually traversing the guidelines and classification process is fundamentally complex with multiple criteria considerations, collecting any necessary caveats, and bulk literature review just to name a few. It is our goal to simplify and streamline this process without losing user-control of final results or overlooking any crucial criteria components necessary for final classification. We hope you will join us to see how this is accomplished as we explore the ACMG CNV Guidelines within VSClinical from the user’s perspective!
This document provides information about a 5-day project management training seminar taking place from June 22-26, 2009 in Washington DC. The training will provide 35 PDUs and 30 CPE credits. Participants will learn project management methodology based on the PMBOK and will gain skills in defining and planning projects, tracking projects, defining goals and requirements, managing scope, and closing projects. The training will cover topics such as project initiation, organization, estimation, scheduling, risk management, team development, reporting, and closeout. It provides an agenda and descriptions for each day of the training.
This two-day training seminar teaches project leadership skills, including how to effectively lead project teams, manage project change, improve communication and decision-making, and increase work productivity. Attendees will learn tools and techniques for managing their projects and teams through interactive sessions covering motivation, leadership styles, delegation, and risk management. The course is suitable for project managers, program managers, PMO managers, and others seeking to develop their leadership abilities.
This two-day training on employee engagement will teach participants how to understand what drives employee engagement, discover causes of employee motivation and procrastination, and use social media to foster collaboration. The training will provide tools and best practices for listening to employees, providing feedback, and engaging a multi-generational workforce. Participants will learn how employee disengagement impacts productivity and costs organizations. They will earn up to 12 CPE credits for attending.
This document provides information about the Corporate Performance Management Training Forum 2010, which will take place from January 20-22, 2010 in Arlington, VA. The forum will provide up to 18 CPE credits and feature step-by-step training on building strategy maps, balanced scorecards, and initiative maps. Participants will learn best practices for performance measurement, reporting, and communication to improve organizational results. Sessions will include hands-on exercises using real examples. The training is intended for strategic planners, directors, analysts, and other professionals seeking to implement performance management frameworks.
This document provides information about the Budgeting & Forecasting Masters 2009 conference to be held September 28-30, 2009 in Philadelphia, PA. The conference will focus on improving budgeting and forecasting techniques and will provide up to 15 CPE credits. Sessions over the two day conference will address topics such as developing accurate forecasts with imperfect data, driver-based budgeting, risk reduction in forecasting, and streamlining organizational forecasting processes. Optional workshops on September 30 will focus on transitioning to rolling forecasts and modeling key business drivers. The conference will be held at the Radisson Plaza-Warwick Hotel in Philadelphia.
Golden Helix’s SNP & Variation Suite (SVS) has been used by researchers around the world to do trait analysis and association testing on large cohorts of samples in both humans and other species. As Next-Generation Sequencing of whole genomes becomes more affordable, large cohorts of Whole Genome Sequencing (WGS) samples are available to search for additional trait association signals that were not found in array-based testing. In fact, recent papers have shown that WGS analysis using advanced GREML (Genomic Relatedness Restricted Maximum Likelihood) techniques is able to outperform micro-array based GWAS methods in the analysis of complex traits and proportion of the trait heritability explained.
Our latest update release of SVS has expanded the exiting maximum likelihood and GRM methods to support these new techniques. We have also enhanced various other association testing and prediction methodologies. This webcast showcases:
- Newly supported analysis workflow for whole genome variants using LD binning and enhanced GBLUP analysis
- Enhanced gender correction using REML
- Additional capabilities for genomic prediction and phenotype prediction
We are continually improving our products based on our customer’s feedback. We hope you enjoy this recording highlighting the exciting new features and select enhancements we have made.
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
A User’s Perspective: ACMG Guidelines for CNVs in VSClinicalGolden Helix
Our last webcast introduced the newest features of VarSeq that will be included in our upcoming release. After a serious developmental effort, we are excited to announce one of these being the integration of ACMG Guidelines for CNVs!
VarSeq is not only the tertiary environment to filter through your imported SNVs and indels from any VCF file, but also includes robust and proven capabilities of CNV detection and clinical variant interpretation. With our upcoming release, users will be able to leverage an automated CNV ACMG classification filter that is paired with the CNV evaluation in the VSClinical interpretation hub. This webcast will expose attendees to literature reinforcing the quality of our CNV caller, as well as showing examples of CNV analysis to demonstrate how this tool can streamline the analysis process. In this webcast, we will cover:
Describing the new CNV guidelines and how Golden Helix tackles their complexity
Assessing CNV impact on Gene and Gene Dosage
Cited literature referencing the accuracy of VarSeq’s CNV calling
Product demonstrations of VSClinical’s CNV interpretation/classification and final report functionalities
Manually traversing the guidelines and classification process is fundamentally complex with multiple criteria considerations, collecting any necessary caveats, and bulk literature review just to name a few. It is our goal to simplify and streamline this process without losing user-control of final results or overlooking any crucial criteria components necessary for final classification. We hope you will join us to see how this is accomplished as we explore the ACMG CNV Guidelines within VSClinical from the user’s perspective!
This document provides information about a 5-day project management training seminar taking place from June 22-26, 2009 in Washington DC. The training will provide 35 PDUs and 30 CPE credits. Participants will learn project management methodology based on the PMBOK and will gain skills in defining and planning projects, tracking projects, defining goals and requirements, managing scope, and closing projects. The training will cover topics such as project initiation, organization, estimation, scheduling, risk management, team development, reporting, and closeout. It provides an agenda and descriptions for each day of the training.
This two-day training seminar teaches project leadership skills, including how to effectively lead project teams, manage project change, improve communication and decision-making, and increase work productivity. Attendees will learn tools and techniques for managing their projects and teams through interactive sessions covering motivation, leadership styles, delegation, and risk management. The course is suitable for project managers, program managers, PMO managers, and others seeking to develop their leadership abilities.
This two-day training on employee engagement will teach participants how to understand what drives employee engagement, discover causes of employee motivation and procrastination, and use social media to foster collaboration. The training will provide tools and best practices for listening to employees, providing feedback, and engaging a multi-generational workforce. Participants will learn how employee disengagement impacts productivity and costs organizations. They will earn up to 12 CPE credits for attending.
This document provides information about the Corporate Performance Management Training Forum 2010, which will take place from January 20-22, 2010 in Arlington, VA. The forum will provide up to 18 CPE credits and feature step-by-step training on building strategy maps, balanced scorecards, and initiative maps. Participants will learn best practices for performance measurement, reporting, and communication to improve organizational results. Sessions will include hands-on exercises using real examples. The training is intended for strategic planners, directors, analysts, and other professionals seeking to implement performance management frameworks.
This document provides information about the Budgeting & Forecasting Masters 2009 conference to be held September 28-30, 2009 in Philadelphia, PA. The conference will focus on improving budgeting and forecasting techniques and will provide up to 15 CPE credits. Sessions over the two day conference will address topics such as developing accurate forecasts with imperfect data, driver-based budgeting, risk reduction in forecasting, and streamlining organizational forecasting processes. Optional workshops on September 30 will focus on transitioning to rolling forecasts and modeling key business drivers. The conference will be held at the Radisson Plaza-Warwick Hotel in Philadelphia.
The synthetic cell created by J. Craig Venter Institute researchers represents an important milestone, though the cell is not truly synthetic from scratch. While synthesizing the Mycoplasma mycoides genome was successful, the researchers encountered challenges in booting up the synthetic genome in a host cell. The creation of synthetic life raises philosophical and ethical issues and shows that life can be explained mechanistically. Additionally, Santhera Pharmaceutical's drug idebenone failed a second pivotal trial for Friedreich's ataxia, causing its stock price to plunge.
This document provides a summary of recent news in the biotech industry. It discusses several studies and clinical trial results, including the successful creation of a bacterial cell controlled by a synthetic genome and Santhera Pharmaceutical's failure in a Phase III trial for idebenone to treat Friedreich's ataxia. It also reports on financing news, such as NeuroTherapeutics Pharma raising $43 million for epilepsy and pain drug development. In addition, it notes commentary from NIH Director Francis Collins on the importance of continued funding for NIH and organizations like the Cystic Fibrosis Foundation to derisk drug development.
Celldex reported that its phase III ACT IV trial of Rintega for glioblastoma was stopped early after a recommendation from the data safety monitoring board. The control arm performed just as well as the Rintega arm, with a median overall survival of 20.4 months for Rintega patients and 21.1 months for control patients. Celldex shares fell over 50% on the news. Company executives said they are analyzing the data to understand why the control arm performed so well but currently have no explanation. Celldex has five other active programs and sufficient cash to fund operations through 2017. Its next program to report data is varlilumab, an anti-CD27 antibody.
NanoViricides is developing nanomedicine-based drugs to treat various viral diseases like influenza, HIV, hepatitis C, and Ebola. The company has 9 drug candidates in development that have shown safety and efficacy in animal studies. NanoViricides' first drug to enter human trials will be FluCide for influenza, which completely protected animals against lethal viral exposure without toxicity.
Lensar's laser system has been cleared by the FDA for performing arcuate incisions during cataract surgery. With this clearance, Lensar's laser system can now perform corneal and arcuate incisions as well as lens fragmentation and anterior capsulotomy procedures. The clearance expands the capabilities of Lensar's laser system and strengthens its position as a provider of advanced laser technology for cataract surgery. Lensar expects the new indication to drive adoption of its system by both new and existing customers.
This document summarizes the challenges of rapidly developing a vaccine for SARS-CoV-2 (Covid-19) during a pandemic. It discusses how previous epidemics like H1N1, Ebola, and Zika showed that vaccines often weren't available before the epidemics ended. New platforms like DNA, RNA, and recombinant protein vaccines may speed development but regulatory review and large-scale manufacturing are challenges. The pandemic requires overlapping and parallel development phases with high financial risk. Coordinated global efforts are needed to fund manufacturing at scale and establish a fair global allocation system for any successful vaccines.
The document discusses the challenges of bringing recombinant DNA products to market. It notes that many companies fail to bring products to Phase 3 clinical trials due to lack of efficacy or unintended side effects. Successfully moving a product from Phase 3 to regulatory approval takes an average of 5-6 years. Additionally, increasing production capacity for monoclonal antibodies takes an estimated 5 years and $300-500 million. There is concern the industry will be overwhelmed if even a fraction of antibody products in development succeed due to limited manufacturing capabilities.
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...MilliporeSigma
This document discusses an integrated approach to ensuring viral vector and gene therapy commercial readiness. It covers four main topics: 1) the current state and future perspectives of viral vectors, 2) scalability and reproducibility in viral vector manufacturing, 3) testing and quality considerations, and 4) regulatory approval and commercial readiness. The current demand for clinical and commercial doses of viral vectors is increasing. Ensuring scalable, reproducible manufacturing processes and comprehensive testing and quality measures is critical for regulatory approval and commercialization.
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...Merck Life Sciences
Come learn more about our integrated approach to ensure viral vector and gene therapy commercial readiness. We will discuss topics relating to process development for viral vector manufacturing, biosafety testing and commercial readiness.
Significant progress has been made for the use of viral vectors for gene therapy. Promising clinical trial results as well as recent FDA approval for CAR-T cell therapy to treat certain children and young adults with B-cell lymphoblastic leukemia have signaled advancements in the field. This marks a historic action, providing opportunities for new viral vector technologies to transform medicine and the way patients are treated and even cured. The need for process development for viral vector manufacturing to improve yield to meet patient demand, biosafety testing for product characterization, potency and safety and commercial readiness to accelerate therapy to-market are critically important. Here, we emphasis an integrated approach that allows our customers solutions to ensure viral vector and gene therapy commercial readiness to meet the growing market need.
In this webinar, you will learn:
● Process development advances for production scale-up of viral vectors for gene therapy
● Methods specific for viral gene therapy product characterization, purity, potency, safety and release testing
● Commercial readiness through our US and UK Centers of Excellence for viral product manufacturing
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
1. Plant-based production of pharmaceuticals is a disruptive technology that could challenge traditional mammalian production methods. Over 400 biotech proteins are currently in development, mostly produced in microbial or animal systems.
2. Plants have been investigated as an alternative production platform since the 1980s and offer rapid, low-cost scalable production without the risks of using animal pathogens.
3. The first licensed human vaccine may combine plant and insect cell approaches for a cancer therapeutic, demonstrating the potential of plant-made pharmaceuticals.
This document outlines the progress of a startup developing a technology to authenticate biologic drugs. It includes:
1) Background on the founders and advisors, with relevant experience in industry and academia.
2) An overview of the company's progress in validating the market need, securing partners, and developing prototypes to test their solution.
3) Details on funding received to date from grants and equity investors to support their work developing assays and devices to quantify biologics.
This document appears to be notes from a biotech startup working on drug authentication. It outlines the founders and advisors, progress made in validating customers and markets overseas, developing minimum viable products for different use cases, forming new partnerships, and progress towards an investment ready prototype. The startup has received several grants and is working to develop their prototype and secure further funding.
The document discusses a $35 million contract awarded by the U.S. Department of Health and Human Services to Protein Sciences Corporation to develop an influenza vaccine using a gene-based technique. The technique aims to shorten vaccine production time compared to conventional egg-based methods. However, some express concern over the company's financial difficulties and history of vaccine development errors. Critics argue the contract could enable further dissemination of deadly pathogens beyond influenza under the guise of vaccine development.
Necessity of COVID-19 vaccination in previously infected individualsMattisHallsteinVolla
This study examined the incidence of COVID-19 among 52,238 employees in an American healthcare system over 5 months. The study found:
1) The cumulative incidence of COVID-19 remained almost zero among those previously infected who remained unvaccinated, those previously infected who were vaccinated, and those not previously infected who were vaccinated.
2) In contrast, there was a steady increase in cumulative incidence among those not previously infected who remained unvaccinated.
3) Not one of the 1,359 previously infected subjects who remained unvaccinated had COVID-19 over the duration of the study.
The results suggest individuals who have had COVID-19 are unlikely to benefit from vaccination, and vaccines
In this section of the coronavirus pandemic series, we discuss the current capacity of local healthcare systems and the need for effective treatment options as well as the pathogenesis of the coronavirus. Current treatment options include RNA, monoclonal antibodies (mAb), antibodies, convalescent plasma, and others. Critical stage implications such as cytokine storm and the need for immunomodulatory agents would also be discussed. Therapeutic pathways would are also compared.
This document discusses developing a new antiviral drug to treat COVID-19. It notes that current treatments are not fully effective and an oral drug is needed that can cure early infections. The company, AntiRNA, plans to develop drugs that interfere with viral RNA methylation, an approach they have previously used successfully against other viruses. Their proposed approach involves first synthesizing and testing prototype drugs in vitro and in vivo in Phase 1, then synthesizing derivatives and testing them in Phase 2. If successful, the potential market could be in billions annually given the lack of existing treatments. The company founders have extensive experience in antiviral drug development.
Can Canadian Vaccine Research Survive the Challenges of Globalization?pcirnkt
1) Globalization of the vaccine industry has led major vaccine companies to conduct fewer clinical trials in Canada, threatening the stability of academic vaccine research centers.
2) A network of experienced vaccine trial centers in Canada could help attract more industry-sponsored studies and demonstrate value through world-class immunology research.
3) Program evaluation and research on vaccine effectiveness, safety, and value is increasingly important but underfunded in Canada; greater investment could distinguish Canada's research and improve immunization programs.
This investor presentation by Medicago provides an overview of their focus on developing influenza vaccines using a plant-based vaccine production platform called Proficia. Their platform uses virus-like particles (VLPs) produced in plants to develop vaccines, which they believe can produce large quantities of pandemic influenza vaccines much faster than egg-based methods. Medicago aims to initiate clinical trials for their pandemic influenza vaccine candidate and leverage those results to accelerate development of a seasonal influenza vaccine, while also exploring VLP opportunities for other diseases beyond influenza.
Gennaro D'Urso: PharmaDAO - The future of MedicineEdunomica
Gennaro D'Urso: PharmaDAO - The future of Medicine
DAO Camp 2022
Website: https://daocamp.org
Youtube: https://www.youtube.com/channel/UCeHtPZ_ZLZ-nHFMUCXY81RQ
FB: https://www.facebook.com/DAO-Camp-102442798988862/
This document is an image file without any text content. Therefore, I am unable to provide a meaningful summary in 3 sentences or less based on the information given. The document appears to be an image but I cannot determine the subject or essential details of the image from the file itself.
The document discusses five common workplace legal pitfalls and provides strategies to avoid them. It addresses issues related to employee classification, health and safety litigation, equal employment opportunity laws, social media use, and limiting supervisor liability. For each pitfall, it provides tips such as carefully auditing employee classifications, establishing clear expectations and accountability, asking consistency questions during EEO investigations, defining appropriate social media use policies, and conducting harassment training for supervisors.
The synthetic cell created by J. Craig Venter Institute researchers represents an important milestone, though the cell is not truly synthetic from scratch. While synthesizing the Mycoplasma mycoides genome was successful, the researchers encountered challenges in booting up the synthetic genome in a host cell. The creation of synthetic life raises philosophical and ethical issues and shows that life can be explained mechanistically. Additionally, Santhera Pharmaceutical's drug idebenone failed a second pivotal trial for Friedreich's ataxia, causing its stock price to plunge.
This document provides a summary of recent news in the biotech industry. It discusses several studies and clinical trial results, including the successful creation of a bacterial cell controlled by a synthetic genome and Santhera Pharmaceutical's failure in a Phase III trial for idebenone to treat Friedreich's ataxia. It also reports on financing news, such as NeuroTherapeutics Pharma raising $43 million for epilepsy and pain drug development. In addition, it notes commentary from NIH Director Francis Collins on the importance of continued funding for NIH and organizations like the Cystic Fibrosis Foundation to derisk drug development.
Celldex reported that its phase III ACT IV trial of Rintega for glioblastoma was stopped early after a recommendation from the data safety monitoring board. The control arm performed just as well as the Rintega arm, with a median overall survival of 20.4 months for Rintega patients and 21.1 months for control patients. Celldex shares fell over 50% on the news. Company executives said they are analyzing the data to understand why the control arm performed so well but currently have no explanation. Celldex has five other active programs and sufficient cash to fund operations through 2017. Its next program to report data is varlilumab, an anti-CD27 antibody.
NanoViricides is developing nanomedicine-based drugs to treat various viral diseases like influenza, HIV, hepatitis C, and Ebola. The company has 9 drug candidates in development that have shown safety and efficacy in animal studies. NanoViricides' first drug to enter human trials will be FluCide for influenza, which completely protected animals against lethal viral exposure without toxicity.
Lensar's laser system has been cleared by the FDA for performing arcuate incisions during cataract surgery. With this clearance, Lensar's laser system can now perform corneal and arcuate incisions as well as lens fragmentation and anterior capsulotomy procedures. The clearance expands the capabilities of Lensar's laser system and strengthens its position as a provider of advanced laser technology for cataract surgery. Lensar expects the new indication to drive adoption of its system by both new and existing customers.
This document summarizes the challenges of rapidly developing a vaccine for SARS-CoV-2 (Covid-19) during a pandemic. It discusses how previous epidemics like H1N1, Ebola, and Zika showed that vaccines often weren't available before the epidemics ended. New platforms like DNA, RNA, and recombinant protein vaccines may speed development but regulatory review and large-scale manufacturing are challenges. The pandemic requires overlapping and parallel development phases with high financial risk. Coordinated global efforts are needed to fund manufacturing at scale and establish a fair global allocation system for any successful vaccines.
The document discusses the challenges of bringing recombinant DNA products to market. It notes that many companies fail to bring products to Phase 3 clinical trials due to lack of efficacy or unintended side effects. Successfully moving a product from Phase 3 to regulatory approval takes an average of 5-6 years. Additionally, increasing production capacity for monoclonal antibodies takes an estimated 5 years and $300-500 million. There is concern the industry will be overwhelmed if even a fraction of antibody products in development succeed due to limited manufacturing capabilities.
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...MilliporeSigma
This document discusses an integrated approach to ensuring viral vector and gene therapy commercial readiness. It covers four main topics: 1) the current state and future perspectives of viral vectors, 2) scalability and reproducibility in viral vector manufacturing, 3) testing and quality considerations, and 4) regulatory approval and commercial readiness. The current demand for clinical and commercial doses of viral vectors is increasing. Ensuring scalable, reproducible manufacturing processes and comprehensive testing and quality measures is critical for regulatory approval and commercialization.
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...Merck Life Sciences
Come learn more about our integrated approach to ensure viral vector and gene therapy commercial readiness. We will discuss topics relating to process development for viral vector manufacturing, biosafety testing and commercial readiness.
Significant progress has been made for the use of viral vectors for gene therapy. Promising clinical trial results as well as recent FDA approval for CAR-T cell therapy to treat certain children and young adults with B-cell lymphoblastic leukemia have signaled advancements in the field. This marks a historic action, providing opportunities for new viral vector technologies to transform medicine and the way patients are treated and even cured. The need for process development for viral vector manufacturing to improve yield to meet patient demand, biosafety testing for product characterization, potency and safety and commercial readiness to accelerate therapy to-market are critically important. Here, we emphasis an integrated approach that allows our customers solutions to ensure viral vector and gene therapy commercial readiness to meet the growing market need.
In this webinar, you will learn:
● Process development advances for production scale-up of viral vectors for gene therapy
● Methods specific for viral gene therapy product characterization, purity, potency, safety and release testing
● Commercial readiness through our US and UK Centers of Excellence for viral product manufacturing
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
1. Plant-based production of pharmaceuticals is a disruptive technology that could challenge traditional mammalian production methods. Over 400 biotech proteins are currently in development, mostly produced in microbial or animal systems.
2. Plants have been investigated as an alternative production platform since the 1980s and offer rapid, low-cost scalable production without the risks of using animal pathogens.
3. The first licensed human vaccine may combine plant and insect cell approaches for a cancer therapeutic, demonstrating the potential of plant-made pharmaceuticals.
This document outlines the progress of a startup developing a technology to authenticate biologic drugs. It includes:
1) Background on the founders and advisors, with relevant experience in industry and academia.
2) An overview of the company's progress in validating the market need, securing partners, and developing prototypes to test their solution.
3) Details on funding received to date from grants and equity investors to support their work developing assays and devices to quantify biologics.
This document appears to be notes from a biotech startup working on drug authentication. It outlines the founders and advisors, progress made in validating customers and markets overseas, developing minimum viable products for different use cases, forming new partnerships, and progress towards an investment ready prototype. The startup has received several grants and is working to develop their prototype and secure further funding.
The document discusses a $35 million contract awarded by the U.S. Department of Health and Human Services to Protein Sciences Corporation to develop an influenza vaccine using a gene-based technique. The technique aims to shorten vaccine production time compared to conventional egg-based methods. However, some express concern over the company's financial difficulties and history of vaccine development errors. Critics argue the contract could enable further dissemination of deadly pathogens beyond influenza under the guise of vaccine development.
Necessity of COVID-19 vaccination in previously infected individualsMattisHallsteinVolla
This study examined the incidence of COVID-19 among 52,238 employees in an American healthcare system over 5 months. The study found:
1) The cumulative incidence of COVID-19 remained almost zero among those previously infected who remained unvaccinated, those previously infected who were vaccinated, and those not previously infected who were vaccinated.
2) In contrast, there was a steady increase in cumulative incidence among those not previously infected who remained unvaccinated.
3) Not one of the 1,359 previously infected subjects who remained unvaccinated had COVID-19 over the duration of the study.
The results suggest individuals who have had COVID-19 are unlikely to benefit from vaccination, and vaccines
In this section of the coronavirus pandemic series, we discuss the current capacity of local healthcare systems and the need for effective treatment options as well as the pathogenesis of the coronavirus. Current treatment options include RNA, monoclonal antibodies (mAb), antibodies, convalescent plasma, and others. Critical stage implications such as cytokine storm and the need for immunomodulatory agents would also be discussed. Therapeutic pathways would are also compared.
This document discusses developing a new antiviral drug to treat COVID-19. It notes that current treatments are not fully effective and an oral drug is needed that can cure early infections. The company, AntiRNA, plans to develop drugs that interfere with viral RNA methylation, an approach they have previously used successfully against other viruses. Their proposed approach involves first synthesizing and testing prototype drugs in vitro and in vivo in Phase 1, then synthesizing derivatives and testing them in Phase 2. If successful, the potential market could be in billions annually given the lack of existing treatments. The company founders have extensive experience in antiviral drug development.
Can Canadian Vaccine Research Survive the Challenges of Globalization?pcirnkt
1) Globalization of the vaccine industry has led major vaccine companies to conduct fewer clinical trials in Canada, threatening the stability of academic vaccine research centers.
2) A network of experienced vaccine trial centers in Canada could help attract more industry-sponsored studies and demonstrate value through world-class immunology research.
3) Program evaluation and research on vaccine effectiveness, safety, and value is increasingly important but underfunded in Canada; greater investment could distinguish Canada's research and improve immunization programs.
This investor presentation by Medicago provides an overview of their focus on developing influenza vaccines using a plant-based vaccine production platform called Proficia. Their platform uses virus-like particles (VLPs) produced in plants to develop vaccines, which they believe can produce large quantities of pandemic influenza vaccines much faster than egg-based methods. Medicago aims to initiate clinical trials for their pandemic influenza vaccine candidate and leverage those results to accelerate development of a seasonal influenza vaccine, while also exploring VLP opportunities for other diseases beyond influenza.
Gennaro D'Urso: PharmaDAO - The future of MedicineEdunomica
Gennaro D'Urso: PharmaDAO - The future of Medicine
DAO Camp 2022
Website: https://daocamp.org
Youtube: https://www.youtube.com/channel/UCeHtPZ_ZLZ-nHFMUCXY81RQ
FB: https://www.facebook.com/DAO-Camp-102442798988862/
This document is an image file without any text content. Therefore, I am unable to provide a meaningful summary in 3 sentences or less based on the information given. The document appears to be an image but I cannot determine the subject or essential details of the image from the file itself.
The document discusses five common workplace legal pitfalls and provides strategies to avoid them. It addresses issues related to employee classification, health and safety litigation, equal employment opportunity laws, social media use, and limiting supervisor liability. For each pitfall, it provides tips such as carefully auditing employee classifications, establishing clear expectations and accountability, asking consistency questions during EEO investigations, defining appropriate social media use policies, and conducting harassment training for supervisors.
This document provides information about a two-day conference on applying Lean Six Sigma methodology to improve IT processes and drive business results. The conference will provide an overview of Lean Six Sigma and the DMAIC process, techniques for selecting and managing Six Sigma projects in IT, and case studies on implementing Six Sigma in IT departments. Sessions will also address change management, integrating Six Sigma with ITIL, and migrating from waterfall to lean development models. Attendees can earn up to 18 CPE credits. The conference will be held in Arlington, VA on September 29-30, 2010.
The document discusses a Lean Six Sigma conference for IT professionals to be held from September 27-30, 2010. The conference will provide 18 CPE credits and optional yellow belt certification. Attendees will learn how to apply Lean Six Sigma methodology to improve IT processes and drive business results. They will gain tools to continuously improve work through problem solving. The yellow belt track on September 27-28 will cover Lean Six Sigma concepts and techniques to define, measure, analyze, improve and control processes.
This 3-day course provides comprehensive exam preparation for the Project Management Professional (PMP)® certification exam. Participants will learn the essential terminology, tools, and techniques to navigate the five process groups and nine knowledge areas of the PMBOK® Guide. The course covers key topics like scope, time, cost, quality and risk management, and communication skills. Participants receive a complimentary copy of the PMBOK® Guide and take practice questions and a full-length mock exam to prepare for the real PMP® exam.
The document discusses a Lean Six Sigma conference for IT professionals to be held from September 27-30, 2010. The conference will provide 18 CPE credits and optional yellow belt certification. Attendees will learn how to apply Lean Six Sigma methodology to improve IT processes and drive business results. They will gain tools to continuously improve work through problem solving. The yellow belt track on September 27-28 will cover Lean Six Sigma concepts and techniques to define, measure, analyze, improve and control processes.
This document provides information about a two-day conference on applying Lean Six Sigma methodology to improve IT processes and functions. The conference will provide an overview of Lean Six Sigma and the DMAIC process, discuss specific case studies, and offer a pre-conference certification option. Sessions will address topics such as change management, process transformation, and integrating Six Sigma with other frameworks like ITIL. Attendees will learn techniques for enhancing the quality, efficiency and results of their IT operations through Lean Six Sigma.
This document provides information about a 3-day training course on preparing for the Project Management Professional (PMP) certification exam. The course will cover the key concepts and processes needed to understand the PMP exam, provide sample questions and a practice exam, and help attendees create a personalized study plan. It will be held in Arlington, VA in October 2010. Attendees will learn about the latest PMBOK guide, tips for passing the exam, and how to apply and prepare to take the PMP exam.
This document provides an agenda for a three-day training on implementing a balanced scorecard for government. The training will cover developing a strategy map, identifying key performance measures, building balanced scorecards, setting targets, and creating strategic initiative maps. Attendees will learn best practices for rolling out a balanced scorecard and creating a strategy-focused organization through presentations, exercises and case studies.
This 3-day training event provides government employees with the skills to implement a balanced scorecard performance management system. Attendees will learn how to create strategy maps, develop performance measures, link individual performance plans, and build organizational strategies. The training will cover building scorecards, setting targets, prioritizing initiatives, and communicating results. Attendees can earn 18 continuing education credits, and the training is offered at the Performance Institute in Arlington, VA from October 18-20, 2010.
The document announces an environmental performance summit to be held from June 28-30, 2010 in Arlington, VA. The summit will focus on measuring and improving environmental performance in government through workshops on developing quality performance measures, performance-based budgeting, and selecting the right performance measures for environmental programs. Featured speakers will discuss renewable energy contributions to environmental sustainability and innovations for utilizing performance measures. Attendees include environmental managers, specialists, researchers, and sustainability coordinators.
The document describes a Lean Six Sigma Yellow Belt certification course that will teach participants to apply Six Sigma tools and the DMAIC process to solve organizational challenges and improve processes. The 2-day course will cover Six Sigma concepts and methods, process mapping, project management, and tools for defining problems, measuring performance, analyzing causes of defects, improving processes, and controlling gains. Attendees will learn techniques to support continuous improvement through team problem solving and complete a work-related project.
The document announces an upcoming training event on auditing and evaluating government program performance held from September 27-30, 2010 in Arlington, VA. The event features two interactive courses on performance auditing and program evaluation. Performance auditing focuses on achieving maximum impact through relevant program measures and improving program objectives. Program evaluation teaches how to determine if a program is accomplishing its intended outcomes and how to build an evaluation system. Attendees will learn how to use performance information to drive decision making and capture accurate data to prove government programs are achieving their goals.
The document announces an upcoming training event on auditing and evaluating government program performance held from September 27-30, 2010 in Arlington, VA. The event features two interactive courses on performance auditing and program evaluation, with the goal of helping participants use performance information to drive decision making and prove that government programs are achieving intended outcomes. The performance auditing course will cover creating successful auditing strategies, developing relevant program measures, and learning how to improve program objectives. The program evaluation course will teach how to determine if a program is accomplishing its goals and how to build an evaluation system within an organization.
The document describes two interactive courses on performance auditing and program evaluation taking place from September 27-30, 2010 in Arlington, VA. The performance auditing course will focus on creating strategies to improve performance auditing and developing relevant program measures. The program evaluation course will teach how to determine if a program is achieving its intended outcomes and how to build an evaluation system. The courses will provide techniques for using performance data to drive decision making, assessing risks and vulnerabilities, developing audit objectives, and selecting appropriate data collection and analysis methods. Attendees include government auditors, inspectors general, program managers, and other professionals.
The document discusses a Lean Six Sigma conference for IT professionals to be held from September 27-30, 2010. The conference will provide 18 CPE credits and optional yellow belt certification. Attendees will learn how to apply Lean Six Sigma methodology to improve IT processes and drive business results. They will gain tools to continuously improve work through problem solving. The yellow belt track on September 27-28 will cover Lean Six Sigma concepts and techniques to define, measure, analyze, improve and control processes.
This document provides information about a two-day conference on applying Lean Six Sigma methodology to improve IT processes and functions. The conference will provide an overview of Lean Six Sigma and the DMAIC process, discuss specific case studies, and offer a pre-conference certification option. Sessions will address topics such as change management, process transformation, innovation, and combining Six Sigma with the ITIL framework. Attendees include IT professionals seeking to enhance quality, efficiency and results. CPE credits are offered.
This document provides an agenda and information for the "Budgeting and Forecasting Conference 2010" event being held from September 13-15, 2010 in San Diego, CA. The agenda outlines keynote speeches and sessions on each day that will discuss implementing tools for budgeting and forecasting, utilizing balanced scorecard techniques, developing rolling forecasts, and identifying key business drivers to improve forecasts. A post-conference workshop on September 15th will focus on modeling and forecasting key business drivers. The document provides information on registration, CPE credits, hotel accommodations, and pricing for the conference and workshop.
The document provides information about a conference on implementing balanced scorecards effectively that will take place from August 23-25, 2010 in Washington DC. The conference will include workshops on the first day covering balanced scorecard fundamentals and using business intelligence to enable strategy-aligned scorecards. Day two will focus on developing key measures and cascading scorecards throughout an organization. Speakers will provide guidance on topics such as change management, strategy mapping, monitoring performance, and motivating employees. Attendees include CEOs, CFOs, and other executives seeking to transform strategy into action using balanced scorecards.
This document provides information about a 5-day training seminar on project management titled "Project Management for Results". The seminar will be held from October 4-8, 2010 in Arlington, VA and offers 35 PDUs and 30 CPE credits. Over the 5 days, participants will learn about project initiation, planning, execution, closing, tracking projects, using earned value management tools, understanding the project life cycle, developing estimates and schedules, and more. The seminar is aimed at project managers, program managers, procurement managers, IT specialists, and others involved in project management. Attending the seminar will help professionals bring projects from initiation to execution, develop performance measurements, understand factors for improving troubled projects, and prepare
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Introduction
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Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
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