Cellular Therapies Automation AusBio Oct 2008
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This document discusses the challenges of commercializing cellular therapies and how automation can help address those challenges. It outlines the innovation continuum from basic research to commercialization. Key challenges include meeting regulatory requirements, scaling production processes for higher volumes, and justifying the investment in automation. The document recommends taking a risk-driven design approach and developing cost models to help guide development priorities and investment scenarios. It emphasizes starting early with regulatory planning and positioning automation as enabling increased capacity and lower costs.
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Access 2-healthcare company introduction deck - english - may 2018
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Medical Device Reimbursement - Lean Startup Methodology
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Go forth and self organise -- building great teams 1st Conference Melbourne 2...
Go forth and self organise -- building great teams 1st Conference Melbourne 2...Edmund O'Shaughnessy
The document discusses self-organizing teams and provides guidance for building and sustaining them. It discusses how self-organizing teams choose how to accomplish their work rather than being directed by others. It also discusses the characteristics of self-organizing teams and how they are designed to optimize flexibility, creativity, and productivity. The document provides quotes from sources like the Scrum Guide emphasizing that teams should be self-organizing and not directed in how they complete their work. It also discusses what enables teams to self-organize, like having the appropriate skills, collective ownership, and control over their work methods.Go forth and self organise! | strategies & tactics for building great teams
The document discusses self-organizing teams and their characteristics according to agile principles. It provides several quotes from "The Scrum Guide" describing how Scrum development teams are intended to be self-organizing, choosing how to accomplish their work without being directed by others. The document also discusses what enables teams to self-organize, including having the right skills, collective ownership, control over work methods, and feedback on performance. Overall, the document focuses on the concept of self-organizing teams as an agile principle and what factors support teams in self-organizing effectively.
Advancing Agility Using Lean Coffee LAST Conference July 2016
Lean Coffee is a structured yet agenda-less meeting format where participants generate the agenda democratically. It follows steps where people float topic ideas, introduce their ideas briefly, vote on preferred topics, rank the top voted topics, discuss each topic in turn within a timebox, and record any notes from the discussions. The format aims to produce productive and directed conversations from an agenda created by the meeting participants themselves.
Psychological Safety Foundation of Effective Collaboration LAST Conference Ju...
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The document discusses psychological safety and its importance for effective team collaboration. It defines psychological safety as a sense of confidence to speak up without fear of punishment or rejection. When teams have high psychological safety, people feel comfortable being themselves and admitting mistakes. The document then lists some dysfunctions that occur when psychological safety is lacking, and provides techniques like roleplaying and brainstorming to help build psychological safety in teams.My Journey in Progressing an Agile Revolution 1st conference Feb 2016
The document summarizes a presentation given by Ed O'Shaughnessy on progressing an agile revolution. It discusses Ed's background as an agile coach and change agent. It then covers topics like who is adopting agile, making the switch to agile, forces that help and hinder change, and tips for bringing about the switch to agile. Key points emphasized include focusing on people, forming willing coalitions, creating safe environments, and always asking "the turtle" or those doing the work.
Go Forth and Self-organise, LAST Conference Melbourne 2017
The document discusses strategies for building self-organizing teams. It emphasizes that self-organizing teams choose how to accomplish their work rather than being directed by others. Key aspects that enable effective self-organization include an appropriate set of skills, collective ownership, control over work methods, feedback, and adapting to changes. The document also provides recommendations for improving team performance such as reflecting on frustrations, focusing on controllable factors, and using an agreement scale to facilitate decision making.
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Go forth and self organise -- building great teams 1st Conference Melbourne 2...
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Go forth and self organise! | strategies & tactics for building great teams
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My Journey in Progressing an Agile Revolution 1st conference Feb 2016
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Cell Therapy Expansion and Challenges in Autoimmune Disease
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.
Top 10 Best Ayurvedic Kidney Stone Syrups in India
we have mentioned the best 10 ayurvedic Kidney Stone Syrups. You can check all these products and choose the best one for yourself.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
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The Electrocardiogram - Physiologic Principles
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Role of Mukta Pishti in the Management of Hyperthyroidism
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Integrating Ayurveda into Parkinson’s Management: A Holistic Approach
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Artificial Intelligence Symposium (THAIS)
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In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...
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TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
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TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis is an increasing cause of morbidity among the elderly.
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Cellular Therapies Automation AusBio Oct 2008
- 1. Devices & Drugs – the new marriage Cellular Therapies: Enabling commercial viability through integrated automation Edmund O’Shaughnessy Manufacturing Innovation © 2008 Invetech Pty Ltd
- 2. Basic & Applied Research Business Creation Managing a going concern ‘From Science to Profits’ ‘From science project to profitable business’, © Richard G. Caro, 2004
- 3. ‘You can’t get there from here sir!’
- 4. ‘The Innovation Continuum’ ‘From science project to profitable business’, © Richard G. Caro, 2004 Basic research Directed research Product research Product development Market adoption Discovery Stage Business Creation Stage ?
- 5. ‘The Process is the Product’ http://www.fda.gov/cder/biologics/qa.htm
- 6. What regulatory requirements must I meet? How can I scale my process for volume production?
- 7. Fully automated clinical processing platform manipulating patient derived molecular materials in single- use devices
- 9. A Cost Model can help direct development priorities and generate investment scenarios Design concept estimates Patient volumes Process timings Market projections Scale-up timelines Capital Investment Scenarios Staffing levels Cost Of Tests Cost Of Goods Manual/Automation cross-over Breakeven points
- 10. Justifying Automation 0 50 100 200 400 800 1,600 3,200 5,000 7,000 10,000 Patients per year processed Costperpatient Manual Semi Automated Fully Automated
- 11. Capacity Planning Market prediction Planned capacity Cumul capital Schedule CapitalInvestment($'000) Devices/month
- 12. Start early with your regulatory requirements
- 14. Putting the pieces together
- 15. In Summary
- 17. Be a parrot! ‘What are the risks, what are we doing about them?’
- 18. The Regulator is not the enemy
- 19. Automation is your friend
- 20. Get the money!
- 21. People want you to succeed
- 22. Thank you for your attention Any questions? Edmund O’Shaughnessy Manufacturing Innovation Images used in this presentation from iStockphoto.com, not for reuse or resale