The pharmaceutical industry faces significant challenges in sustaining drug discovery and innovation due to factors such as patent expiries, regulatory hurdles, pricing pressures, and low clinical success rates. In response, companies are focusing resources on late-stage pipelines and reducing early-stage research. However, this threatens long-term sustainability. Creative collaboration between industry and academia, where resources and risks/rewards are shared, shows promise as a model to help secure ongoing innovation through drug discovery. AstraZeneca has formed a strategic alliance with Cancer Research Technology to jointly work on projects in cancer metabolism as an example of this collaborative approach.
Ezose Sciences Inc. is a relatively new biotech company located in New Jersey that focuses on glycomics and biomarker discovery. It has completed multiple collaborations and utilizes its GlycanMap technology. The pharmaceutical industry is facing pressures to control expenses as major drugs lose patent protection, while biomarkers, personalized medicine, and outsourced research and development represent growth opportunities. Glycomics is an underdeveloped field that could provide insights into disease, drug response and cellular processes.
The document discusses the Akron Biomedical Corridor, an initiative to develop Akron, Ohio into a hub for biomedical innovation. Key points:
1. The Corridor links the region's major hospitals and healthcare systems, the University of Akron, and the Austen Bioinnovation Institute to support biomedical technologies, products, services, and clinical trials.
2. Akron has strengths in polymers, biomaterials research, orthopedics, wound care, and pediatrics that it aims to leverage through the Corridor.
3. The goal is to attract, support and grow biomedical businesses to create jobs, economic growth, and redevelopment in Akron's urban core
The document provides data from a 2010 survey comparing various characteristics of established optometric practices versus new practices. Some key differences included that established practices were more likely to be sole proprietorships or S-corps while new practices favored partnerships or C-corps. Established practices also tended to be located in strip malls, medical buildings, or free-standing offices while new practices favored office buildings or enclosed shopping malls.
This document provides an overview of a life science seminar presented by Topotarget A/S executives. It includes a safe harbor statement noting forward-looking statements are based on management expectations and are subject to risks. The presentation summarizes Topotarget's focus on developing belinostat to treat cancer, its partnerships including with Spectrum Pharmaceuticals to develop belinostat in the US, and its strategy to continue establishing belinostat as an effective treatment for cancers like PTCL by analyzing late-stage study results and exploring ex-US commercial opportunities.
This document provides an overview of patenting small molecule therapeutics from target identification through clinical trials. It discusses why small molecule therapeutics are patented and provides details on patenting the target, assay, screening process, compounds identified, and formulations. The presentation covers patent eligibility, applications, and timelines. It also identifies potential patent pitfalls to avoid such as accidental disclosure or an incomplete provisional application.
The document summarizes Session III of a conference on pre-clinical proof-of-concept and development. It includes presentations on:
1. Edward Spack discussing the session overview and requirements for an Investigational New Drug (IND) application.
2. David Weiner presenting on what makes a clinical candidate, including factors like target selection, lead optimization, pre-clinical safety assessments, and estimating human starting doses.
3. Steve Perrin presenting on optimization and characterization of mouse models of neurodegeneration.
4. Barry Greenberg presenting on the value of biomarkers in preclinical development and translatable endpoints.
Medical drug discovery process powerpoint presentation slides.SlideTeam.net
The document describes the drug discovery process. It involves 10,000 to 20,000 candidate drugs being screened through high throughput screening and target validation. The leads then undergo optimization through combinatorial chemistry and structure-based drug design. Finally, the drug candidates proceed to ADMET studies, clinical trials, and FDA approval process with the goal of bringing one approved drug to market.
Medical drug discovery strategy powerpoint presentation slides.SlideTeam.net
The document describes the drug discovery process. It involves 10,000 to 20,000 candidate drugs being screened through high throughput screening and target validation. The leads then undergo optimization through combinatorial chemistry and structure-based drug design. Finally, the drug candidates proceed to ADMET studies, clinical trials, and FDA approval process with the goal of bringing one approved drug to market.
Ezose Sciences Inc. is a relatively new biotech company located in New Jersey that focuses on glycomics and biomarker discovery. It has completed multiple collaborations and utilizes its GlycanMap technology. The pharmaceutical industry is facing pressures to control expenses as major drugs lose patent protection, while biomarkers, personalized medicine, and outsourced research and development represent growth opportunities. Glycomics is an underdeveloped field that could provide insights into disease, drug response and cellular processes.
The document discusses the Akron Biomedical Corridor, an initiative to develop Akron, Ohio into a hub for biomedical innovation. Key points:
1. The Corridor links the region's major hospitals and healthcare systems, the University of Akron, and the Austen Bioinnovation Institute to support biomedical technologies, products, services, and clinical trials.
2. Akron has strengths in polymers, biomaterials research, orthopedics, wound care, and pediatrics that it aims to leverage through the Corridor.
3. The goal is to attract, support and grow biomedical businesses to create jobs, economic growth, and redevelopment in Akron's urban core
The document provides data from a 2010 survey comparing various characteristics of established optometric practices versus new practices. Some key differences included that established practices were more likely to be sole proprietorships or S-corps while new practices favored partnerships or C-corps. Established practices also tended to be located in strip malls, medical buildings, or free-standing offices while new practices favored office buildings or enclosed shopping malls.
This document provides an overview of a life science seminar presented by Topotarget A/S executives. It includes a safe harbor statement noting forward-looking statements are based on management expectations and are subject to risks. The presentation summarizes Topotarget's focus on developing belinostat to treat cancer, its partnerships including with Spectrum Pharmaceuticals to develop belinostat in the US, and its strategy to continue establishing belinostat as an effective treatment for cancers like PTCL by analyzing late-stage study results and exploring ex-US commercial opportunities.
This document provides an overview of patenting small molecule therapeutics from target identification through clinical trials. It discusses why small molecule therapeutics are patented and provides details on patenting the target, assay, screening process, compounds identified, and formulations. The presentation covers patent eligibility, applications, and timelines. It also identifies potential patent pitfalls to avoid such as accidental disclosure or an incomplete provisional application.
The document summarizes Session III of a conference on pre-clinical proof-of-concept and development. It includes presentations on:
1. Edward Spack discussing the session overview and requirements for an Investigational New Drug (IND) application.
2. David Weiner presenting on what makes a clinical candidate, including factors like target selection, lead optimization, pre-clinical safety assessments, and estimating human starting doses.
3. Steve Perrin presenting on optimization and characterization of mouse models of neurodegeneration.
4. Barry Greenberg presenting on the value of biomarkers in preclinical development and translatable endpoints.
Medical drug discovery process powerpoint presentation slides.SlideTeam.net
The document describes the drug discovery process. It involves 10,000 to 20,000 candidate drugs being screened through high throughput screening and target validation. The leads then undergo optimization through combinatorial chemistry and structure-based drug design. Finally, the drug candidates proceed to ADMET studies, clinical trials, and FDA approval process with the goal of bringing one approved drug to market.
Medical drug discovery strategy powerpoint presentation slides.SlideTeam.net
The document describes the drug discovery process. It involves 10,000 to 20,000 candidate drugs being screened through high throughput screening and target validation. The leads then undergo optimization through combinatorial chemistry and structure-based drug design. Finally, the drug candidates proceed to ADMET studies, clinical trials, and FDA approval process with the goal of bringing one approved drug to market.
El documento resume tres temas principales: 1) Que el volcán Chimborazo en Ecuador es el punto más alejado del centro de la Tierra, superando al Everest; 2) Que el Instituto de Astrofísica de Canarias es un referente internacional debido a la calidad del cielo en Canarias, permitiendo importantes observatorios; 3) Que los test de inteligencia miden una capacidad relacionada con el éxito pero se debate cuánto depende de factores biológicos o ambientales.
This document presents a research proposal to study the impact of employee turnover on the performance of Hoctief Construction Company Ltd. The research will use a mixed methods approach, collecting both quantitative and qualitative data. The literature review discusses conflicting views on whether turnover positively or negatively impacts performance. The research aims to determine the causes of turnover at Hoctief, measure its effects on performance, and identify ways to minimize turnover to increase performance. The methodology section evaluates the mixed methods approach and discusses its advantages for answering the research questions over a single methodology. Limitations are also acknowledged.
Industrial engineering education could be strengthened by incorporating systems thinking concepts, methodologies, and techniques. An industrial engineer who views an organization holistically as a system of interdependent components, and helps others do the same, has great potential to understand what drives organizational behavior and avoid sub-optimizing parts at the expense of the whole. Traditional IE tools combined with recognizing interdependencies allow insights beyond optimizing individual aspects in a way that adversely impacts others.
NK Instruments Pvt. Ltd. has BAUMER make Head Mounted Temperature Transmitters. These Temperature transmitters are available with 4 to 20 mA output or, RS 232 also.
This document discusses the future of shipbuilding and the driving forces necessitating changes, including:
1. Hard times in the shipbuilding industry and need to remove obstacles and reevaluate challenges.
2. New customer requirements around the environment, automation, and new markets.
3. Evolving industry trends like distributed work, replacing retiring workers, and increased automation.
4. Broad innovation enabled by technology advances and feedback relationships allowing more mature solutions.
The future of shipbuilding is predicted to involve infinite computing power, generative designs, virtual reality, digital twins, cyber-physical systems, automation, IoT, and 3D printing transforming engineering design, detail design, and manufacturing over the next 15 years.
EMN Plant Ltd is a plant hire, haulage, quarrying, and contracting business located in Shetland, Scotland that has been operating since 1972. The company owns a wide range of plant and equipment for hire including excavators, dump trucks, trailers, and more. EMN also operates a quarry that produces various aggregates and has a recycling facility. In addition to its core services, the company provides commercial garage services, civil engineering works, and is accredited to quality, health, and safety standards.
The student created a film trailer, poster, and magazine to promote their film. These media products both challenged and followed conventions of their respective genres. The trailer used techniques like switching between color and black-and-white footage to challenge conventions. The poster included glowing effects on the characters but lacked a slogan, challenging some conventions. Feedback was gathered from the target audience to evaluate the media products and campaign.
This thesis examines how China's pork industry has become a major source of pollution. It argues that restructuring pork production to prioritize economic efficiency has increased inequality and facilitated environmental degradation. The thesis analyzes this issue through the frameworks of environmentalism, neoliberal environmentalism, and political ecology. It concludes that viewing the connection between inequality and industrial pork production through the lens of political ecology provides the most convincing analysis.
The Asionic 400W is an ultrasonic domestic water meter that uses time-of-flight measurement of sound pulses to calculate water flow and volume without moving parts. It logs flow rate, volume, and other data for up to 10 years on an internal lithium battery powered electronics unit protected inside a vacuum chamber composite housing. The meter communicates wirelessly via M-Bus encryption and has alarms for battery, tampering, and flow conditions.
We have Block and Bleed type of Manifolds in SS 304 and SS316 construction.
These are normally used for Pressure Switches, Pressure Guages, Pressure Transmitters etc. to isolate the instrument from process and to vent out the blocked air in the process.
This deck explains how gift certificates can be sold and redeemed via the web store as well as Manager Panel for Hitachi Solutions Ecommerce. A mobile friendly feature, it used QR codes to make redemption easier.
An earthquake in Ecuador killed at least 272 people and injured over 2,500 others. The earthquake collapsed overpasses and buildings, leaving thousands to sleep outside or in temporary shelters. Rescuers searched through rubble for more victims from the 7.8 magnitude earthquake that struck 27 kilometers southeast of Muisne. Ecuador is at high risk for earthquakes because it is located on the Ring of Fire, so future natural disasters will continue to threaten the country.
This document discusses performance-based risk sharing arrangements (PBRSAs) between healthcare payers and manufacturers. It provides definitions and categories of PBRSAs, including non-outcomes based schemes, population-level schemes, and health outcomes-based schemes. Examples of implemented PBRSAs are described, such as the UK multiple sclerosis risk sharing scheme and the Australian Bosentan agreement. The literature on PBRSAs is summarized as having limited and mixed evidence on their success. Key considerations for the design, implementation, and evaluation of PBRSAs are discussed.
Drug Development Life Cycle - Costs and RevenueRobert Sturm
Presentation explains the Drug Development Process in terms of time/costs from initial research to final manufacturing. It presents strategies for increasing profits/decreasing costs, shows the impact of generics and details how Information Technology fits into this equation. It uses research from DiMasi and Grabowski to identify drug costs and product revenue.
The document discusses the process and costs associated with drug development. It notes that the average cost to develop a new drug is $350 million to $5.5 billion and the process takes 6.5-7 years from discovery to approval. Key barriers to drug development include high financial costs, lengthy timelines for clinical trials, and regulatory hurdles. Approaches to reduce costs and timelines include greater use of electronic health records, simplifying clinical trial protocols, and utilizing decentralized clinical trial models.
El documento resume tres temas principales: 1) Que el volcán Chimborazo en Ecuador es el punto más alejado del centro de la Tierra, superando al Everest; 2) Que el Instituto de Astrofísica de Canarias es un referente internacional debido a la calidad del cielo en Canarias, permitiendo importantes observatorios; 3) Que los test de inteligencia miden una capacidad relacionada con el éxito pero se debate cuánto depende de factores biológicos o ambientales.
This document presents a research proposal to study the impact of employee turnover on the performance of Hoctief Construction Company Ltd. The research will use a mixed methods approach, collecting both quantitative and qualitative data. The literature review discusses conflicting views on whether turnover positively or negatively impacts performance. The research aims to determine the causes of turnover at Hoctief, measure its effects on performance, and identify ways to minimize turnover to increase performance. The methodology section evaluates the mixed methods approach and discusses its advantages for answering the research questions over a single methodology. Limitations are also acknowledged.
Industrial engineering education could be strengthened by incorporating systems thinking concepts, methodologies, and techniques. An industrial engineer who views an organization holistically as a system of interdependent components, and helps others do the same, has great potential to understand what drives organizational behavior and avoid sub-optimizing parts at the expense of the whole. Traditional IE tools combined with recognizing interdependencies allow insights beyond optimizing individual aspects in a way that adversely impacts others.
NK Instruments Pvt. Ltd. has BAUMER make Head Mounted Temperature Transmitters. These Temperature transmitters are available with 4 to 20 mA output or, RS 232 also.
This document discusses the future of shipbuilding and the driving forces necessitating changes, including:
1. Hard times in the shipbuilding industry and need to remove obstacles and reevaluate challenges.
2. New customer requirements around the environment, automation, and new markets.
3. Evolving industry trends like distributed work, replacing retiring workers, and increased automation.
4. Broad innovation enabled by technology advances and feedback relationships allowing more mature solutions.
The future of shipbuilding is predicted to involve infinite computing power, generative designs, virtual reality, digital twins, cyber-physical systems, automation, IoT, and 3D printing transforming engineering design, detail design, and manufacturing over the next 15 years.
EMN Plant Ltd is a plant hire, haulage, quarrying, and contracting business located in Shetland, Scotland that has been operating since 1972. The company owns a wide range of plant and equipment for hire including excavators, dump trucks, trailers, and more. EMN also operates a quarry that produces various aggregates and has a recycling facility. In addition to its core services, the company provides commercial garage services, civil engineering works, and is accredited to quality, health, and safety standards.
The student created a film trailer, poster, and magazine to promote their film. These media products both challenged and followed conventions of their respective genres. The trailer used techniques like switching between color and black-and-white footage to challenge conventions. The poster included glowing effects on the characters but lacked a slogan, challenging some conventions. Feedback was gathered from the target audience to evaluate the media products and campaign.
This thesis examines how China's pork industry has become a major source of pollution. It argues that restructuring pork production to prioritize economic efficiency has increased inequality and facilitated environmental degradation. The thesis analyzes this issue through the frameworks of environmentalism, neoliberal environmentalism, and political ecology. It concludes that viewing the connection between inequality and industrial pork production through the lens of political ecology provides the most convincing analysis.
The Asionic 400W is an ultrasonic domestic water meter that uses time-of-flight measurement of sound pulses to calculate water flow and volume without moving parts. It logs flow rate, volume, and other data for up to 10 years on an internal lithium battery powered electronics unit protected inside a vacuum chamber composite housing. The meter communicates wirelessly via M-Bus encryption and has alarms for battery, tampering, and flow conditions.
We have Block and Bleed type of Manifolds in SS 304 and SS316 construction.
These are normally used for Pressure Switches, Pressure Guages, Pressure Transmitters etc. to isolate the instrument from process and to vent out the blocked air in the process.
This deck explains how gift certificates can be sold and redeemed via the web store as well as Manager Panel for Hitachi Solutions Ecommerce. A mobile friendly feature, it used QR codes to make redemption easier.
An earthquake in Ecuador killed at least 272 people and injured over 2,500 others. The earthquake collapsed overpasses and buildings, leaving thousands to sleep outside or in temporary shelters. Rescuers searched through rubble for more victims from the 7.8 magnitude earthquake that struck 27 kilometers southeast of Muisne. Ecuador is at high risk for earthquakes because it is located on the Ring of Fire, so future natural disasters will continue to threaten the country.
This document discusses performance-based risk sharing arrangements (PBRSAs) between healthcare payers and manufacturers. It provides definitions and categories of PBRSAs, including non-outcomes based schemes, population-level schemes, and health outcomes-based schemes. Examples of implemented PBRSAs are described, such as the UK multiple sclerosis risk sharing scheme and the Australian Bosentan agreement. The literature on PBRSAs is summarized as having limited and mixed evidence on their success. Key considerations for the design, implementation, and evaluation of PBRSAs are discussed.
Drug Development Life Cycle - Costs and RevenueRobert Sturm
Presentation explains the Drug Development Process in terms of time/costs from initial research to final manufacturing. It presents strategies for increasing profits/decreasing costs, shows the impact of generics and details how Information Technology fits into this equation. It uses research from DiMasi and Grabowski to identify drug costs and product revenue.
The document discusses the process and costs associated with drug development. It notes that the average cost to develop a new drug is $350 million to $5.5 billion and the process takes 6.5-7 years from discovery to approval. Key barriers to drug development include high financial costs, lengthy timelines for clinical trials, and regulatory hurdles. Approaches to reduce costs and timelines include greater use of electronic health records, simplifying clinical trial protocols, and utilizing decentralized clinical trial models.
DiagnoCure develops and commercializes more reliable cancer diagnostic tests to better support clinicians and patients in making decisions about clinical interventions. The global cancer diagnostics market is projected to double to $25.7 billion in 5 years, driven by trends like an aging population and increased adoption of molecular testing. DiagnoCure has two revenue-generating products and is developing additional clinically relevant oncology tests in its pipeline, including tests for prostate, colorectal, and lung cancers.
Regenerative Medicine Industry Outlook 2014Pete Shuster
The document summarizes the regenerative medicine field based on a report from the Alliance for Regenerative Medicine, including an overview of major industry players and subsectors, clinical trials and products in development, financial performance and investments in 2013, and insights from a panel discussion on key areas of focus. It analyzes trends in cell and gene therapies, areas attracting pharmaceutical investment, and challenges facing the commercialization of regenerative medicine technologies and therapies.
Computer-aided drug design (CADD) uses computational methods to simulate drug-receptor interactions and has reduced drug research duration by at least 5 years. CADD techniques rely on bioinformatics tools, databases, and applications. Quantitative structure-activity relationship (QSAR) modeling correlates compound structural properties with biological activities and has provided a basis for optimizing ligand molecules to improve activity. CADD approaches include structure-based modeling using protein-ligand docking and ligand-based modeling analyzing statistical relationships between ligand structural groups and biological effects.
Medical Imaging Seminar Company PresentationsSpace IDEAS Hub
Medical Imaging - Opportunities for Business Seminar
24/01/12
Short Company Presentations
14 companies took the opportunity to present a short sales pitch of their work and interests to the audience.
This document summarizes in vitro biology and drug discovery services offered by a contract research organization. It discusses computer-aided drug design, structure-based drug design, cheminformatics, virtual screening, and homology modeling services. It also describes medicinal chemistry, ADMET/pharmacokinetic services, and chemistry services including hit identification, lead optimization, and preclinical/clinical development. Resource estimates and funding models for various stages of drug discovery are provided. The document discusses moving projects from in vitro to in vivo testing and considerations for outsourcing various capabilities.
Totality of Evidence & Theraputic Equivalence 15 October 2016Ajaz Hussain
Put R back in R&D & recognize It is a “complex” product and process!
Invest smartly in analytics, mathematics & statistics, and large sample sizes; and in systems/integrative thinking and data integration
Get to know the RLD – multiple lots; open the door with large sample size
Build capability to justify measured RLD variability is relevant to development of the proposed generic/biosimilar
Exquisite regulatory communication strategy
This is not a ‘complicated process’ for which typical “good practices” will work seamlessly (e.g., typical project management approach); this is a complex process – with multiple interactions and “emergent properties”
Treat it as it is - a complex process and plan; anticipate and address “emergent issues” - in technical, regulatory and legal dimensions; at a certain point be prepared for stakeholder (payers, patient groups,..) communications
Alternative approaches to developing strategic partnerships in order to drive discovery and innovation and enhance pipelines.
http://www.globaldiscoverycollaborations.com
Personalized Medicine World Conference 2011 MedivoSundeep Bhan
This document summarizes a company called Medivo that provides personalized medicine solutions. Medivo leverages consumer empowerment trends, health IT, and genomic medicine to offer more tailored healthcare. It identifies issues with the current "one size fits all" model, such as high costs and low compliance. Medivo's platform integrates lab testing, physician networks, and analytics to close care gaps, target high-risk patients, and accelerate adoption of new tests. The company sees opportunities in addressing the $300 billion per year spent on unnecessary treatments. Its goal is to partner with various stakeholders like pharma, managed care organizations, and physicians to transition to more outcomes-based healthcare.
This document summarizes a presentation given by Dr. Robert Boorstein on drivers of change in the laboratory market. Five key trends are discussed: laboratory consolidation, growth of central laboratories vs point-of-care testing, new delivery models, new technologies, and increased competition across sectors. Laboratory consolidation is driven by cost reductions and allows for standardization but may shift market power from sellers to buyers. Point-of-care testing is growing rapidly but poses challenges to quality control. New national laboratory companies are emerging focused on unique branded products.
Transforming time for prostate cancer therapiesJames Hilbert
This document provides an overview of prostate cancer treatments and competitive landscape. Prostate cancer is the most commonly diagnosed cancer in men. Current standard of care includes local therapy for early stage, androgen deprivation therapy for advanced or recurrent disease, chemotherapy (e.g. Taxotere) for metastatic castration-resistant prostate cancer (mCRPC), and newer agents like Provenge, Zytiga, and Jevtana for mCRPC. The pipeline includes promising agents from Dendreon, Medivation, and OncoGenex that could change treatment paradigms and improve outcomes for mCRPC patients.
Oncology Global Strategic Marketing organizations face increasing challenges in a crowded oncology market. This study benchmarked the budget levels, service scope, and activities of GSM organizations from 17 pharmaceutical companies. Key findings include: 1) Large company GSM averages $805,231 per pipeline program and $6.2 million per marketed product. 2) Marketing and market intelligence account for over half of GSM budgets. 3) GSM most often leads in market intelligence activities across development phases. The study provides industry metrics for GSM budgeting and strategic planning.
Ocular Disorders-Insight Pharma ReportsDaniel Miller
Available to Insight Pharma Reports is Ocular Disorders: Rising Therapeutics, Technologies, and Devices Report. This report begins with outlining Age-related macular degeneration (both wet and dry) and delving into Anti-VEGF therapies in chapter 2. Further providing substantial weight to this report, several companies were interviewed on their approach to targeting wet and dry AMD, their strategies for seeking alternative therapeutic options, and the hardships they have encountered in their research and product execution.
This corporate presentation provides an overview of YM BioSciences' product pipeline and clinical trials for Q2 2012. Key points include:
1) YM's lead product CYT387, a JAK1/JAK2 inhibitor, showed positive interim efficacy and safety data in a Phase I/II trial for myelofibrosis at ASH 2011.
2) The Phase I/II trial for CYT387 in myelofibrosis is ongoing across multiple centers and has enrolled over 160 patients to date.
3) CYT387 is being evaluated in an advanced myelofibrosis patient population with high-risk disease features and transfusion dependence.
This document outlines a business plan for producing therapeutic proteins like vaccines and alpha-1 antitrypsin using tobacco plants. It discusses using tobacco's manufacturing capabilities to rapidly and cost-effectively produce proteins. Target markets include seasonal flu vaccines, pandemic flu vaccines, and alpha-1 antitrypsin for treating deficiencies. The plan involves outsourcing manufacturing activities and establishing partnerships with larger biotech companies and government organizations. Financial metrics like costs, pricing, and capital requirements are considered to evaluate feasibility and profitability.
Advanced Medical Isotope Corporation is developing RadioGel, a brachytherapy device, to treat cancers in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing. It is working towards FDA approval for human cancer indications like skin cancer. RadioGel consists of radioactive yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing revenue. It is led by an experienced management team and advises by world-class medical and scientific boards.
This document outlines a presentation on innovative strategies to accelerate drug development. It discusses Pfizer's locations in the UK and facilities for research, manufacturing, and commercial operations. Predictive science approaches using advanced data and technologies are described to enable accelerated development from molecule to medicine. Continuous manufacturing platforms and modular facilities are presented as ways to improve efficiency.
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
NAVIGATING THE HORIZONS OF TIME LAPSE EMBRYO MONITORING.pdfRahul Sen
Time-lapse embryo monitoring is an advanced imaging technique used in IVF to continuously observe embryo development. It captures high-resolution images at regular intervals, allowing embryologists to select the most viable embryos for transfer based on detailed growth patterns. This technology enhances embryo selection, potentially increasing pregnancy success rates.
5. The Perfect Storm for Pharma
REGULATORY
HURDLES
PRICING &
REIMBURSEMENT
PATENT
EXPIRIES
6. The Patent Cliff
Patent Expiring
Condition Company 2010 U.S. Sales
in 2011
Lipitor cholesterol Pfizer $5,329,000,000
Zyprexa antipsychotic Eli Lily $2,496,000,000
Johnson &
Levaquin antibiotics $1,312,000,000
Johnson
Johnson &
Concerta ADHD/ADD $929,000,000
Johnson
Protonix antacid Pfizer $690,000,000
7. Patent Expiring in
Condition Company 2010 U.S. Sales
2012
Bristol-Myers
Plavix anti-platelet Squibb / $6,154,000,000
Sanofi-Aventis
Seroquel antipsychotic AstraZeneca $3,747,000,000
Singulair asthma Merck $3,224,000,000
Actos type 2 diabetes Takeda $3,351,000,000
Enbrel arthritis Amgen $3,304,000,000
9. Health Technology Assessment Agency
reimbursement decisions
Disease Recommend Recommend Not recommended Total
Decision R* Decision Decisions
Cardiovascular 23 27 Decision
14 64
(36%) (42%) (22%) (100%)
Cancer 29 52 49 130
(22%) (40%) (38%) (100%)
Total decisions 52 79 63 194
(27%) (41%) (32%) (100%)
*R = Recommended decision with restriction to clinical classification or patient group.
Source – Health Economics Consortium, 2008
10. Impact on the pharmaceutical industry
AstraZeneca 2011 annual results
2011 2010 Actual CER
$m $m growth growth
Revenue 33,591 33,269 +1% -2%
Core Operating Profit 13,167 13,603 -3% -4%
Core EPS $7.28 $6.71 +9% +7%
Reported EPS $7.33 $5.60 +31% +29%
Full Year Dividend $2.80 $2.55
11. •Fewer successful product launches
•Negative growth
•Long term sustainability of pharma
operating model questioned
12. Pharma’s response
Cost constraints
Divert resources to filling and progressing late-
stage pipeline
Consequential reduction in resourcing of drug
discovery
13. Pharma’s challenge
How do we secure long-term sustainability through
innovative drug discovery?
15. Collaboration models
- the old and the new
• Pharma fully funds • Pharma and academia share
• Pharma retains all rights resources, risk and reward
• Pharma reaps all commercial • Payment for successful outcomes
benefit rather just for the work being done
• Significant success means
significant reward
• Hand-back rights to academic
partner if Pharma does not
prosecute
• Pharma contribution in kind such
as access to compound collection
16. AstraZeneca-Cancer Research Technology
Strategic Alliance in Cancer Metabolism
CRT show
selected
targets in
theme area Joint activities within a JMT managed portfolio of projects
with 50/50 resourcing (approx. 30 FTE in total)
Target Assay Early Lead
Validation Development HTS Hit-to-Lead Optimisation
Joint project
acceptance via
JMT. Project
Project passes
managed by JPT
to AZ but
monitored via
JMT until
enters AZ
Development
17. Deal terms – financial structure
• Access fee - in recognition of AstraZeneca gaining access to CR
UK’s network of scientific investigators in cancer metabolism
• Each party covers its own costs
• Success based milestone payments
- Each project start (start of screening)
- Each project that successfully delivers (adopted by AZ)
- Formal entry to AZ Development
- Clinical development milestones through to launch
• Royalty on product sales
18. AZ – MRCT AZ pursue – Research
Collaboration / licence
Model or
AZ & MRC pursue jointly Study /
licence
Research Collaboration
•AZ licence joint results
& MRC compound if
H2
Exercise Option 2
£20K Option Fee
£20K Option Fee
Exercise Option1
L
Selected required
Ch
MR
e
Target
m
C
i st
Sc
ree
ry
n
•AZ assigns
interest in joint
results
•MRC licence AZ
compound if
Reject Option 1
Reject Option 2 required
MRC
Rejected pursue
Target
•No further obligations to AZ
Hit from MRC CC •AZ assigns interest in joint
MRC can screen up to 5 Rejected Targets results
using the AZ CC – AZ retains Options
•AZ grants use of joint results /
1&2
Hit from AZ CC AZ compound to allow MRC
to perform H2L chemistry
•AZ retains Option 2