The document discusses the Grifols Procleix Panther System, the latest innovation in blood donor screening from Grifols. It is a fully automated system that uses nucleic acid testing (NAT) to screen blood donations, allowing for early detection of viruses like HIV, HCV, and HBV. The primary target market is blood banks that screen at least 800 donations per month. The Panther System provides sensitive, specific results faster than competitive systems, improving blood safety.
March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the Pan...BerkeleyPoCDx
Development of the PanDx Integrated Diagnostic Platform
Wallace White
Director, Point-of-Care Diagnostics
Stratos Product Development
UC Berkeley, March 5, 2015
After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it.
Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI
Bioanalytical Capabilities -- Thought-Leading Science Armed with the Latest T...Covance
Helping your drug development program succeed is what we do. Keeping your timeline on track requires scientific expertise, operational experience and up-to-date knowledge of the regulatory environment. Whether you need preclinical or clinical bioanalysis, local support or global capabilities, Covance is the partner that you can trust to help deliver on your bioanalytical timelines every day, every time.
Ethocle Reports has published its latest Market Research Report on Transcatheter Heart Valves - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Neurological Diagnostic Equipment - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Ventricular Assist Devices. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the Pan...BerkeleyPoCDx
Development of the PanDx Integrated Diagnostic Platform
Wallace White
Director, Point-of-Care Diagnostics
Stratos Product Development
UC Berkeley, March 5, 2015
After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it.
Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI
Bioanalytical Capabilities -- Thought-Leading Science Armed with the Latest T...Covance
Helping your drug development program succeed is what we do. Keeping your timeline on track requires scientific expertise, operational experience and up-to-date knowledge of the regulatory environment. Whether you need preclinical or clinical bioanalysis, local support or global capabilities, Covance is the partner that you can trust to help deliver on your bioanalytical timelines every day, every time.
Ethocle Reports has published its latest Market Research Report on Transcatheter Heart Valves - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Neurological Diagnostic Equipment - Medical Devices Pipeline Assessment, 2016. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
Ethocle Reports has published its latest Market Research Report on Ventricular Assist Devices. Formulate significant competitor information, analysis, and insights to improve R&D strategies. Browse market data tables and figures.
The international community is at a cross-roads, keep allowing counterfeit medicinal drugs, or create legislation that prevents that from happening in the future. The legislation has been created, so how will you ensure compliance?
Brand protection traceability through serializationShari Popovich
Counterfeit drugs is a global issue. Not isolated to certain countries or geographies.
The global economy demands a comprehensive and more robust supply chain to protect brands and their associated assets.
Brand owners and manufacturers face many challenges including the potential opportunity for counterfeit products to land in their supply chain.
Global regulatory bodies, governments, and pharmaceutical companies believe serialization is a required step to combat growing concern.
Serialization allows the unique identification of products and the ability to track these products through the supply chain.
A comprehensive system is required to identify and track products from manufacturer to consumer.
Profit Model Improvement and Innovation: How Businesses Really Make Money and...Rod King, Ph.D.
“Profit is the oxygen of a business.”
How would you classify your profit model? How would you improve or innovate on it?
If you are asking the above questions, you are thinking about Profit Model Innovation (PMI). The current focus is on business model innovation. However, for established businesses the Profit Model poses the greatest risk to the existence of the business.
This presentation presents an industry-based classification system for profit models. The Profit Model Classification System (PMCS) can be used to visually organize and classify profit models in the past, present, and future. The PMCS would save you considerable time and energy when formulating, testing, and managing prototypes of profit models.
Clustered regularly interspaced short palindromic repeats (CRISPR) represent a foundational technology that has enjoyed widespread adoption over the last two years and is one of the most exciting developments affecting the life science market. Researchers are pursuing a wide variety of applications ranging from agricultural bioengineering to therapeutic development. Numerous life science suppliers are racing to meet the growing demand for products based on the CRISPR/Cas9 system.
This report will focus on the following product categories:
- Design tools
- Plasmids and vectors
- Cas9 nucleases and guide RNAs
- Delivery systems
The Market for CRISPR/Cas9 Genome Editing
Products:
- Estimate market size, share and growth by region, industry segment and product category
- Understand the drivers of brand loyalty and compare brand performance
- Measure customer satisfaction with CRISPR/Cas9 products
- Highlight the strengths and weaknesses of competitors and their customers’ likelihood-to-switch
Mannitol is a versatile and widely used substance with various applications in the pharmaceutical, food, and chemical industries. It is produced commercially through the hydrogenation of fructose or glucose, resulting in a white, crystalline powder with a sweet taste.
The report provides a complete roadmap for setting up a sanitizer manufacturing plant. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
Integra gen s.a (alint) product pipeline analysis, 2014 updateAmbikabasa
Summary IntegraGen S.A (IntegraGen) is a biotechnology service provider. The company provides clinical genomic services to academic researchers and life sciences companies. It offers services such as DNA extraction, management samples, study design, strategy, selection markers, tagging, biostatistics analysis, and bioinformatics analysis of sequence data. IntegraGen provides sequencing and genotyping of DNA and RNA. The company offers services in the fields of pharmacogenetics, cytogenetics, epigenetics, and agriculture. It serves patients, clinicians and researchers. IntegraGen partners with illumia, Fluidigm, DNA genotek and Agitent Certified companies.
http://www.researchmoz.us/integragen-sa-alint-product-pipeline-analysis-2014-update-report.html
Medical equipment manufacturing business plan exampleupmetrics.co
If you are planning to start a new manufacturing business, the first thing you will need is a business plan. Use our Lanzor - medical equipment manufacturing business plan example created using upmetrics business plan software to start writing your business plan in no time.
Before you start writing your business plan for your new medical equipment manufacturing business, spend as much time as you can reading through some examples of manufacturing business plans. Reading some sample business plans will give you a good idea of what you’re aiming for and also it will show you the different sections that different entrepreneurs include and the language they use to write about themselves and their business plans.
We have created this medical equipment manufacturing business plan example for you to get a good idea about how a perfect manufacturing business plan should look like and what details you will need to include in your stunning business plan.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
The international community is at a cross-roads, keep allowing counterfeit medicinal drugs, or create legislation that prevents that from happening in the future. The legislation has been created, so how will you ensure compliance?
Brand protection traceability through serializationShari Popovich
Counterfeit drugs is a global issue. Not isolated to certain countries or geographies.
The global economy demands a comprehensive and more robust supply chain to protect brands and their associated assets.
Brand owners and manufacturers face many challenges including the potential opportunity for counterfeit products to land in their supply chain.
Global regulatory bodies, governments, and pharmaceutical companies believe serialization is a required step to combat growing concern.
Serialization allows the unique identification of products and the ability to track these products through the supply chain.
A comprehensive system is required to identify and track products from manufacturer to consumer.
Profit Model Improvement and Innovation: How Businesses Really Make Money and...Rod King, Ph.D.
“Profit is the oxygen of a business.”
How would you classify your profit model? How would you improve or innovate on it?
If you are asking the above questions, you are thinking about Profit Model Innovation (PMI). The current focus is on business model innovation. However, for established businesses the Profit Model poses the greatest risk to the existence of the business.
This presentation presents an industry-based classification system for profit models. The Profit Model Classification System (PMCS) can be used to visually organize and classify profit models in the past, present, and future. The PMCS would save you considerable time and energy when formulating, testing, and managing prototypes of profit models.
Clustered regularly interspaced short palindromic repeats (CRISPR) represent a foundational technology that has enjoyed widespread adoption over the last two years and is one of the most exciting developments affecting the life science market. Researchers are pursuing a wide variety of applications ranging from agricultural bioengineering to therapeutic development. Numerous life science suppliers are racing to meet the growing demand for products based on the CRISPR/Cas9 system.
This report will focus on the following product categories:
- Design tools
- Plasmids and vectors
- Cas9 nucleases and guide RNAs
- Delivery systems
The Market for CRISPR/Cas9 Genome Editing
Products:
- Estimate market size, share and growth by region, industry segment and product category
- Understand the drivers of brand loyalty and compare brand performance
- Measure customer satisfaction with CRISPR/Cas9 products
- Highlight the strengths and weaknesses of competitors and their customers’ likelihood-to-switch
Mannitol is a versatile and widely used substance with various applications in the pharmaceutical, food, and chemical industries. It is produced commercially through the hydrogenation of fructose or glucose, resulting in a white, crystalline powder with a sweet taste.
The report provides a complete roadmap for setting up a sanitizer manufacturing plant. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
Integra gen s.a (alint) product pipeline analysis, 2014 updateAmbikabasa
Summary IntegraGen S.A (IntegraGen) is a biotechnology service provider. The company provides clinical genomic services to academic researchers and life sciences companies. It offers services such as DNA extraction, management samples, study design, strategy, selection markers, tagging, biostatistics analysis, and bioinformatics analysis of sequence data. IntegraGen provides sequencing and genotyping of DNA and RNA. The company offers services in the fields of pharmacogenetics, cytogenetics, epigenetics, and agriculture. It serves patients, clinicians and researchers. IntegraGen partners with illumia, Fluidigm, DNA genotek and Agitent Certified companies.
http://www.researchmoz.us/integragen-sa-alint-product-pipeline-analysis-2014-update-report.html
Medical equipment manufacturing business plan exampleupmetrics.co
If you are planning to start a new manufacturing business, the first thing you will need is a business plan. Use our Lanzor - medical equipment manufacturing business plan example created using upmetrics business plan software to start writing your business plan in no time.
Before you start writing your business plan for your new medical equipment manufacturing business, spend as much time as you can reading through some examples of manufacturing business plans. Reading some sample business plans will give you a good idea of what you’re aiming for and also it will show you the different sections that different entrepreneurs include and the language they use to write about themselves and their business plans.
We have created this medical equipment manufacturing business plan example for you to get a good idea about how a perfect manufacturing business plan should look like and what details you will need to include in your stunning business plan.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
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CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Contact ME {89011**83002} Haridwar ℂall Girls By Full Service Call Girl In Ha...
MarkMan v84 Group 4 - PTM and USP
1. Grifols Procleix Panther System
Latest Innovation in Blood Donor Screening
#GoingMolecular #SaferBloodisBetter
AGSB MarkMan v84 Group 3
Alves, Padua, Salvador, Santos
2. linkedin.com/in/josealvesjrmd21fpsgs | linkedin.com/in/acenerpadua | linkedin.com/in/sarah-santos-ped | linkedin.com/in/rjosalvador 2
Dr. Jose Alves
General Surgeon
Batangas Healthcare Specialist
Medical Center
Ace Padua
Business Development and
Private Sector Engagement
Specialist - FHI 360
Dr. Sarah Santos
General Pediatrician
Rizal Medical Center
Missions Hospital
Ryan Salvador
Senior Health Program Officer
Department of Health
Marketing Management v84 Group 3
3. linkedin.com/in/josealvesjrmd21fpsgs | linkedin.com/in/acenerpadua | linkedin.com/in/sarah-santos-ped | linkedin.com/in/rjosalvador 3
1940
1818 1990 1999
First Successful
Patient Blood
Transfusion
1971 1985
History of Blood Transfusion and Safety
First National
Blood Collection
Program
HbSAg Testing and
Standardization of
Practices
Reference: https://givingblood.org/about-blood/history-of-blood-banking.aspx
First AIDS Blood-
Screening Test
First Hepatitis C
Donor Blood
Screening
First NAT Testing
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What, Why and How?
Outcome (Z)
4
Position Grifols Panther System
as the choice of our Primary
Target Market
Presenting to the PTM of Grifols
Panther System its, USP and
competitive positioning
To provide safer blood products
for transfusion to patients
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#GoingMolecular
▷ What is Grifols Procleix Panther System?
▷ Who is the PTM of this system?
▷ Why does a Blood Bank need this system?
▷ How can we help Blood Bank solve his problem?
▷ What are Blood Bank’s choices?
▷ What are the USPs of his choices?
▷ Let’s recap
5
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▷ Blood Bank
○ Stand-alone blood banks
○ Tertiary Hospitals
○ Regional Hospitals
Who is the primary target market (PTM)?
7
○ Census of blood product screened
■ At least 800 screened blood units / month
○ Space Capacity of 85 sqm
○ Buying capacity of 1.2 Mio/month
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Why does a Blood Bank need this system?
8
▷ To detect certain pathogens from the
donated blood products before they
are transfused to a patient
▷ To prevent transfusion-transmitted
infections (TTIs) brought about by
transfused blood products
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What parameters will Blood Bank use to
decide?
12
▷ FDA approved
▷ Highly sensitive and specific
▷ Detects HBV, HCV, HIV in blood products
▷ Provide patient confidence in blood product received
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Difference in Testing Modality
Nucleic Acid Testing
13
▷ Technique used to directly
detect a particular nucleic acid
sequence present in a sample
Immunoassay
▷ Measures the presence or
concentration of an analyte
in a solution by using an
antibody or an antigen as a
biorecognition agent
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Grifols Workflow
Thaw calibrators at room temperature;
remove reagents from refrigerator and
freezer and prepare in reagent
preparation incubator (RPI)
Start Procleix Panther; load
consumables
as needed; manage lower bay as
needed
Rack samples
Load assay reagents and sample
racks
as needed . Testing starts
automatically.
Review results on Procleix Panther
• Discriminatory results on same
platform
• No deconvolution required as results
obtained in IDT
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Roche Workflow Equilibrate reagents to
room temperature
Start Hamilton pipettor and pooling and data
management workstations
Uncap controls and load specimens, consumables, and
controls into Hamilton
Load reagent cassettes into AmpliPrep
Prepare sample processing unit (SPU)
Load SPU racks, K-tubes, and K-tip racks into AmpliPrep
if required
Create orders using AmpliLINK software at workstation
Cap S-tubes; transfer SK24 racks with
S-tubes containing specimens from
Hamilton to AmpliPrep
Check AmpliLINK software; press start
Docking station transfers K-tubes via
K-carrier from AmpliPrep to TaqMan®
Results automatically exported by AmpliLINK software;
review results on data management workstation
• If using MPX 1.0, separate
discriminatory platform and assay required; reactive
specimens require extra deconvolution steps in IDT
• Without docking station, manual
transfer required between AmpliPrep
and TaqMan; TaqMan starts
automatically
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Releases first reportable result in
3.5 hours, then 5 results every
5 minutes
• 275 results in 8 hours
• 500 results in 12 hours
Results are released as a batch
test
First sample and last sample will
have the same time for release
Requires 8 hours for availability
of results
Turnaround Time
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Grifols’ USP for a niche PTM
▷ FDA approved, Highly sensitive and specific
▷ Detect TTIs - HBV, HCV, HIV
▷ Reduces the window period for TTI detection
▷ Prevents morbidity and mortality
▷ Increases confidence in accepting blood products for
transfusion
▷ Detects SARS-CoV 2
▷ Screens plasma donors for Covid treatment
32. Grifols Procleix Panther System
#SaferBloodisBetter
AGSB MarkMan v84 Group 3
Alves, Padua, Salvador, Santos
Editor's Notes
Census blood product screening
= at least 800 screened blood units/month
= at least 800 blood bags transfused/month
Required Space Capacity = 85 sqm
Buying capacity = 1.2M/month for 1,000 tests/kit
Census blood product screening
= at least 800 screened blood units/month
= at least 800 blood bags transfused/month
Required Space Capacity = 85 sqm
Buying capacity = 1.2M/month for 1,000 tests/kit