A global leader in real world health intelligence, Analytica Laser is powered by a renowned scientific team of 140+ senior experts across eight offices. Our consulting, research and data services are employed by the leading biopharma and public health innovators in over 20 countries. Every day, our work directly benefits millions of patients in advancing access to new therapies that are safer, more convenient and more affordable.
Twenty-first century technologies will create significant opportunities and challenges for all healthcare stakeholders. Pharmacovigilance (PV) too is in transition, with new sources of medical information and methods for its analysis that will transform today's largely reactive system into proactive benefit-risk management for all medication users.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
Twenty-first century technologies will create significant opportunities and challenges for all healthcare stakeholders. Pharmacovigilance (PV) too is in transition, with new sources of medical information and methods for its analysis that will transform today's largely reactive system into proactive benefit-risk management for all medication users.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
NLP (Natural Language Processing) shows a great deal of potential for many applications in the healthcare industry. This document shares 6 promising use cases for NLP to manage Epilepsy treatment effectively.
Learn how to leverage effective strategies for global drug development, including expedited regulatory pathways, personalized medicines and genomics. View the full presentation from PAREXEL Consulting experts.
Real-world patients have an average of 6 serious co-morbid conditions & take 10 medications
*Complicated patients are invariably excluded from clinical research studies, making it impossible to know what treatments work best
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
Patient confidentiality: Ethical and legal ramificationsArete-Zoe, LLC
Patient confidentiality is a complex ethical and legal area that is subject to detailed regulation in all developed countries. The general principles are shared across all jurisdictions.
Five Keys To Success In The New Patient EconomyRAPP
In the new Patient Economy, commonly used approaches are no longer effective for engaging patients – and more importantly, for delivering better patient outcomes.
RAPP NY hosted a webinar in June of 2016 that dives into five tips and tricks for optimizing success in the new patient economy. Learn tips and strategies for transforming your patient engagement model, along with the following:
• Why successful outcomes, not prescriptions, are the new measure of success
• What patients really want in the new Patient Economy
• Proven strategies for delivering superior patient experiences and outcomes
• Practical steps you can take to get started on your transformation
Virtual Workshop Innovative Approaches to Drug Safety 2019Arete-Zoe, LLC
The current practice of pharmacovigilance is fraught with challenges and limitations. Still, new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance. We offer you an opportunity to participate in a robust, informative, and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment
into automation and AI tools, the monetary value of safety information, patient privacy issues, and innovative approaches toward generating evidence.
New Disruptive Technology Helps CROs and Pharma Accelerate Oncology-Focused C...Rafael Casiano
As clinical trial outsourcing to CROs continues to increase, competition among CROs is becoming fierce, and sponsors are under pressure to do more with less. To respond, experienced CROs understand they must exploit every opportunity to gain a competitive edge. And, while technology can be a key differentiator, simply being “data-driven” is not enough to win studies. CROs must find consistent and predictable methods to accelerate clinical trial recruitment.
Existing pharmacovigilance post-market surveillance system is based on reporting of adverse drug reactions to national databases in real-time and post-marketing safety studies.
Quantitative evaluation of incidence, prevalence trends, and patterns of use from reporting data is problematic due to under-reporting and missing data on exposure. This is especially true if drugs are used off-label, in populations they were not intended for, or in combination with other medications.
While the case study below emphasizes post-market surveillance of marketed drugs, the same principles apply to other areas within clinical research and drug development, outcomes research, monitoring, and evaluation of the quality of provided care and pharmaco-economic applications.
Strand featured in CIO Review: Pharma and Life Science Special edition - July 2014
Strand Genomics Inc recognised by CIO Review as one among 20 most promising Tech solution providers to Pharma and Life science industry 2014
NLP (Natural Language Processing) shows a great deal of potential for many applications in the healthcare industry. This document shares 6 promising use cases for NLP to manage Epilepsy treatment effectively.
Learn how to leverage effective strategies for global drug development, including expedited regulatory pathways, personalized medicines and genomics. View the full presentation from PAREXEL Consulting experts.
Real-world patients have an average of 6 serious co-morbid conditions & take 10 medications
*Complicated patients are invariably excluded from clinical research studies, making it impossible to know what treatments work best
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
Patient confidentiality: Ethical and legal ramificationsArete-Zoe, LLC
Patient confidentiality is a complex ethical and legal area that is subject to detailed regulation in all developed countries. The general principles are shared across all jurisdictions.
Five Keys To Success In The New Patient EconomyRAPP
In the new Patient Economy, commonly used approaches are no longer effective for engaging patients – and more importantly, for delivering better patient outcomes.
RAPP NY hosted a webinar in June of 2016 that dives into five tips and tricks for optimizing success in the new patient economy. Learn tips and strategies for transforming your patient engagement model, along with the following:
• Why successful outcomes, not prescriptions, are the new measure of success
• What patients really want in the new Patient Economy
• Proven strategies for delivering superior patient experiences and outcomes
• Practical steps you can take to get started on your transformation
Virtual Workshop Innovative Approaches to Drug Safety 2019Arete-Zoe, LLC
The current practice of pharmacovigilance is fraught with challenges and limitations. Still, new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance. We offer you an opportunity to participate in a robust, informative, and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment
into automation and AI tools, the monetary value of safety information, patient privacy issues, and innovative approaches toward generating evidence.
New Disruptive Technology Helps CROs and Pharma Accelerate Oncology-Focused C...Rafael Casiano
As clinical trial outsourcing to CROs continues to increase, competition among CROs is becoming fierce, and sponsors are under pressure to do more with less. To respond, experienced CROs understand they must exploit every opportunity to gain a competitive edge. And, while technology can be a key differentiator, simply being “data-driven” is not enough to win studies. CROs must find consistent and predictable methods to accelerate clinical trial recruitment.
Existing pharmacovigilance post-market surveillance system is based on reporting of adverse drug reactions to national databases in real-time and post-marketing safety studies.
Quantitative evaluation of incidence, prevalence trends, and patterns of use from reporting data is problematic due to under-reporting and missing data on exposure. This is especially true if drugs are used off-label, in populations they were not intended for, or in combination with other medications.
While the case study below emphasizes post-market surveillance of marketed drugs, the same principles apply to other areas within clinical research and drug development, outcomes research, monitoring, and evaluation of the quality of provided care and pharmaco-economic applications.
Strand featured in CIO Review: Pharma and Life Science Special edition - July 2014
Strand Genomics Inc recognised by CIO Review as one among 20 most promising Tech solution providers to Pharma and Life science industry 2014
mHealth Israel_Future of Integrated Individualized Healthcare_Roche DiagnosticsLevi Shapiro
Presentation by Alexandra Eberhard, Sr. Director, Global Business Development, Roche Diagnostics on the "Future of Integrated Individualized Healthcare". Includes background about Roche Diagnostics and investments in innovation. Overview of Roche products and solutions with a portfolio covering the entire spectrum of diagnostics users. Emphasis on the triple aim of healthcare- The power of data and technology to enable the transformation from volume- to value-based healthcare. Interest in data for Pharma - drive more efficient R&D; DIA - develop novel patient care Dx solutions. Focus on the needs of labs, physicians & payers for better patient health. A suite of digital solutions that improve clinical & business outcomes. Suite of solutions to optimize the lab. Translating data into insights to achieve financial goals. A move from volume- to value-based care. New opportunities in the disease continuum- Holistic solutions approach. Expanding the focus towards earlier in the patient journey. Doing now what patients need next. Contact Alexandra Vallon-Eberhard, PhD MBA; Sr. Director Global Business Development; Diagnostics Lead for Innovation in Israel; Based in Basel, Switzerland; Email: alexandra.vallon_eberhard@roche.com
RiskAnalytica is a group of scientists that are dedicated to solving quantitative problems and supporting decision analysis in business, health care, markets and macroeconomic endeavours. Since 2001 we have earned a reputation for independence, integrity, and system insights that has made our brand of mathematical and systems analysis a leader in high-end, scientifically sound, quantitative decision support in Canada.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Global Engage is pleased to announce the 2018 Precision Medicine & Biomarkers Leaders Summit USA taking place on May 7-8th in Boston, MA. The event is part of our highly successful Drug Discovery Series which includes conferences on Biologics, Medicinal Chemistry, NASH, Pharmaceutical R&D IT and the Human Microbiome amongst others. It is also the sister meeting of the European Precision Medicine Summit which has run successfully since 2013.
Real world data is no longer just for those trained in health economics and outcomes research — it can and will touch everyone in the pharma/healthcare space.
CBI asked industry's foremost RWD thought leaders a variety of questions to better understand how bio/pharmaceutical teams can collaborate and capture data in an aggregated form to continue to improve the value of products in development with real world, real-time data.
Real World Data - The New Currency in HealthcareJohn Reites
White paper published in June 2015 by CBI Life Sciences with interview insights from John Reites.
Real World Data (RWD) have become the bio/pharmaceutical industry’s treasure trove for information to inspire stakeholder decision-making. As an industry, professionals have increasingly been looking to RWD to not only assess the bene ts and risks of new medicines in clinical and real world settings, but also as a way to advise healthcare reimbursement decisions worldwide.
Just to remind you that registrations for our 18th Pharmacovigilance 2019 event, which is taking place at The Pestana Chelsea Bridge Hotel in London, UK on 27-28th Feb are closing soon.For more details email to dinesh@virtueinsightsummits.com
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Accelerating Patient Care with Real World EvidenceCitiusTech
Life sciences and pharma companies are evolving their strategies to utilize Real World Data (RWD) to demonstrate value of pharmaceutical and medical device innovations. Technology advancements at the point of care and improvements in data collection strategies have led to a significant increase in the availability of RWD in healthcare
Real World Evidence (RWE) can provide actionable patient insights and accelerates time to market of new medical products in order to gain competitive advantage
With the emergence of wearable technologies, Internet of Things (IOT), Cognitive Computing, Genomics, Blockchain, etc., future RWE data sources will become more diverse and extensive. This document introduces the concept of Real World Evidence studies in healthcare, describes the various data sources for performing real world analytics and illustrates the role of RWE in better patient care. It then summarizes challenges faced while performing RWE analytics with respect to regulatory compliance, data accessibility and sharing, analysis reporting, costs etc.
Extended Real-World Data: The Life Science Industry’s Number One AssetHealth Catalyst
The life science industry has historically relied on sanitized clinical trials and commoditized data sources (largely claims) to inform its drug development process—an under-substantiated approach that didn’t reflect how a new drug would affect broader patient populations. In an effort to gain more accurate insight into the patient experience and bring drugs to market more efficiently and safely, the industry is now expanding into extended real-world data (RWD).
To access the needed breadth and depth of patient-centric data, life science companies must partner with a healthcare transformation company that has three key qualities:
A broad and deep data asset.
Extensive provider partnerships.
An outcomes-improvement engine to support the next generation of drug development.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
This expanding series attracts the leading authorities worldwide working in companion diagnostics, biomarkers, immuno-oncology, liquid biopsies, AI and other facets of precision medicine. It has been praised for its stimulating, interactive and engaging environment where it brings together a multi-disciplined community of researchers, leaders and innovators whose aim is to develop groundbreaking and impactful treatments for patients.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
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.
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/
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
The Impact of Meeting: How It Can Change Your Life
Real World Health Intelligence
1.
2. As a global research consultancy,
we are committed to providing the
highest level of scientific evidence
on the value of medicines and
health technologies
Analytica Laser studies and services currently
reach more than 20 countries
Our senior team unites more than 110 specialists
and consultants including 40 PhD/MD/PharmD
and 50 MSc/BSc
MAIN OFFICES
NEW YORK
MONTRÉAL
LONDON
PARIS
MADRID
MILAN
KRAKOW
BASEL/LÖRRACH
4. GLOBAL SERVICE LINES
REAL WORLD
DATA SOLUTIONS
DECISION ANALYTICS
+ MODELING
VALUE + ACCESS
CONSULTING
Burden of illness+
Outcomes research+
Quality of life+
Drug utilization+
Resource use+
Continuous benefit/risk+
PAES / PASS+
PGRx+ proprietary datasets
Electronic health data+
US healthcare databases+
Surveys+
+ Predictive modeling
+ Performance software
+ Bridging studies
+ Bayesian statistics
+ MTC / NMA
+ Disease modeling
+ Economic modeling
+ Enriched RCTs
+ Clinical trial analytics
Market access consulting+
Health economics+
Outcomes+ -based
agreements
Reimbursement+
submissions
Core HTA submissions+
Systematic reviews+
Global value dossiers+
Investment strategy+
MCDA+
5. REAL WORLD
DATA SOLUTIONS
Our real world data group offers solutions for every need, from
niche needs identification, justifying access, differentiating
value, quantifying an opportunity to demonstrating benefit/risk.
Analytica Laser’s proprietary PGRx Real World Datasets are a
unique source of real world data with a variety of applications.
Powered by the strongest epidemiology team in the industry,
we also offer multiple solutions for advanced observational
studies in risk and effectiveness research, as well as custom
outcomes research programs.
6. Our observational study experts, health economists
and PRO specialists join forces with operational
teams across Europe and North America to design
and conduct HEOR studies as well as Advanced
Pharmacoepidemiology research. Our work is
regularly published in the leading journals:
+ The Lancet
+ Value in Health
+ Amer J Epidemiology
+ Diabetes Care
+ Blood
+ Int J Medicine
+ Pharmacoepidemiology &
Drug Safety
+ Heart
+ Arthritis & Rheumatology
OUTCOMESRESEARCH&
PHARMACOEPIDEMIOLOGY
7. REAL WORLD DATA SOLUTIONS ACROSS
THE EVIDENCE CONTINUUM
Unmet need+
Treatment patterns+
Burden of illness+
Market sizing+
Cost minimization+
Cost offsets+
Cost effectiveness and+
budget impact analysis
+ Drug utilization studies
+ Relative effectiveness
+ Outcomes performance
+ PAES
Benefit/risk assessment+
Risk management+
Signal detection+
PASS+
+ Electronic health
records
+ Administrative
medical records
+ Chart reviews
+ Ad hoc surveys
+ Observational
studies
QUANTIFY
OPPORTUNITY
JUSTIFY ACCESS
MEASURE
PERFORMANCE
ENSURE SAFETY
8. ELECTRONIC DATABASES STUDIES
+ UK
+ France
+ Denmark
+ Germany
+ Italy
+ Spain
+ Israel
+ USA
+ Sweden
PGRx REAL WORLD DATASETS
MEDICAL INFORMATION + PATIENT VOICE
30+ epidemiologists, statisticians and data managers provide analysis and study
design services leveraging electronic healthcare databases available for various key
markets.
Available for license, Analytica Laser’s proprietary PGRx Real World Datasets offer a
unique opportunity for obtaining extremely high-quality data in real-time, combining
both medical information extracted from medical records and linkage to patients
questionnaires. Datasets are currently available for 12 therapeutic areas and more
than 20 disorders.
9. WHEN THE QUESTION IS…
…the quality of PGRx data makes a real difference
understanding patient needs…
PGRx data showed that the quality of life of patients with acute coronary syndrome varies greatly according to
risk factors and forms of the disease1, impacting drastically the burden of illness and the cost-effectiveness
assessment of the different interventions.
1Value in Health, 2015
ensuring safety…
PGRx data were used in multiple risk management plans. It generalised the methodology used in the famous
“fen-phen” study (IPPHS2) conducted by Lucien Abenhaim, which had uncovered the risk of these drugs and thus
prevented an epidemic of fatal disease in Europe and the US.
2New England J Medicine
expediting access…
With price negotiations at an impasse, PGRx was accepted by payers as offering the necessary confidence in
product value for a conditional pricing arrangement in the prevention of stroke by new anticoagulants. A similar
method was used for confirming the role of statins in the prevention cardiovascular disorders3.
3Int J Cardiology, 2014
10. Our scientific advice enjoys the attention of regulators, payers and HTA
bodies around the world. We are excited that our expertise has been
requested by various recent public-private initiatives
+ Improving methods for post-launch safety monitoring and real-time benefit risk
assessment
+ Member, Work Programme 2: Pharmacoepidemiology study designs framework
+ Leader, Work Programme 6: Methods validation in multiple data sources
+ Innovating RWE methods to inform clinical R&D decision-making, relative
effectiveness evaluation
+ Leader, Work Package 2: Leverage RCTs and Phase IIIb studies to decrease efficacy-to-
effectiveness gap
+ Organizing multi-centre,
independent, post-authorization
studies to strengthen the monitoring of
authorized medicines in Europe
+ Regular participant in ENCePP
Plenary Sessions and Scientific
Conventions
+ Principal investigator of 1 ENCePP-
registered collaborative study
+ Protocol reviewer of 1 ENCePP-
registered collaborative study
11. DECISION ANALYTICS
+ MODELING
Leveraging best-in-class capabilities in modeling, simulation,
mathematics and Bayesian statistics, Analytica Laser employs
advanced analytics frameworks and proprietary software to study
real world outcomes for drug value assessment.
Through the suite of proven methodologies, our team of experts
can leverage information available at any stage of development
and market access process. This informs strategic decisions for
drug evaluation and evidence generation.
12. Gaps in real world evidence have emerged
as a critical challenge across the product
lifecycle. Being able to explore a series of
highly complex scenarios in a timely
manner is more vital than ever
From early stage development to launch,
reimbursement, and outcomes performance
– we help you navigate the most difficult
trade-off decisions
We can draw on a global team of statisticians,
epidemiologists and analysts with expertise in
advanced predictive modeling and simulation
13. ANALYTICS AND MODELING SERVICES ACROSS THE PRODUCT LIFECYCLE
Analytica Laser has contributed to advance the methodological development in MTC and Bayesian meta-analysis
and in large IMI/EU funded research projects on benefit/risk characterization and communication.
PHASE
II
PHASE
III
REGISTRATION ACCESS EXPANSION
R&D
Drug positioning+
Optimal design and+
planning
Pipeline prioritization+
PRE-MARKETING
+ Launch strategy
+ Pragmatic trial design
+ Payer-relevant evidence
and value development
POST MARKETING
Risk sharing strategy+
Performance plan models+
Predicting comparative effectiveness+
Real world cost effectiveness models+
14. The interaction of risk factors with drug
efficacy is not what varies from one
population to another – it is the distribution
of these factors that does. This is why drug
effectiveness may be different from
country to country, or from one healthcare
system to another
PROF. LUCIEN ABENHAIM
Pioneer of Pharmacoepidemiology
Former Executive Board Member, World Health Organization
15. OUR PROVEN FRAMEWORK FOR “BRIDGING TO EFFECTIVENESS”
Coverage+
Medical Practices+
Screening Policies+
Patterns of use, dose,+
treatment duration
Past history of exposure+
Co+ -prescriptions
Adherence+
+ Age, gender, behaviors
+ Co-morbidities
+ Disease stage/severity
+ Other baseline risk factors
and genetics relevant to
disease/drug
HEALTH CARE SYSTEM
EFFICACY
EFFECTIVENESS
The team specializes in bridging efficacy to
effectiveness in terms of modeling:
+ Clinical trial to real-life populations
+ Proxy outcome to actual outcome
+ Country to country
+ One comparator to another
DRUG USE PATIENT POPULATION
16. REAL
WORLD
IMPACT
PATIENTS
EXPOSURE
SYSTEMS
USERS CHARACTERISTICS
Patients demographics, prognosis factors,+
treatment pattern history
USE
+ Prescription patterns,
decision rules to
switch or adjust dose
+ Patients adherence
and patterns of use HEALTHCARE SYSTEM FACTORS
Coverage+
Medical practices policies+
The industry’s first dynamic and
versatile tool dedicated to building
predictive models for effectiveness
We’re using our proprietary
technology HOPE to translate
clinical trial findings and population
health knowledge into expected
real world impact. Based on a
Bayesian dynamic modeling engine,
it allows for consideration of
dynamic exposure and influence
of risk factors in its predictions.
17. DEAL OR NO DEAL?
DECISION ANALYTICS FOR OUTCOMES-BASED CONTRACTING
Across all health systems, payers and reimbursement authorities are urging the adoption of
performance-based contracting. What if you’d be able to identify the sources and quantify the
impact of uncertainty around outcomes-based agreements?
Our proprietary HOPE technology enables us to:
Test highly complex scenarios to optimize your plan design and inform payer negotiations and contracting+
Understand what outcome, comparator and time horizon to select+
Define the best methods to measure performance and opt for the most appropriate payment models+
YOUR REAL WORLD
SETTING
CLINICAL TRIAL
EFFICACY
RELEVANT
DRIVERS OF
EFFECTIVENESS
HOPE
MODEL AND
SIMULATION
18. We are committed to removing the
uncertainties between clinical trial
efficacy and real world effectiveness so
that you can succeed with outcomes
predictions and payer engagements
DECISIONANALYTICS
+MODELING
Our global team draws on more
than a decade of experience
leveraging the industry’s most
advanced modeling frameworks for
performance-based agreements
19. VALUE + ACCESS
CONSULTING
Analytica Laser’s diverse teams provide a full range of strategic
market access services in an integrated model.
Our life sciences and medical device partners rely on our
strategic capabilities in real world evidence, advanced
simulation and unique payer insights.
We have completed hundreds of global value dossiers, helped
to secure approval and maintained coverage and
reimbursement through high-quality evidence of value and
impactful reimbursement submissions across all major markets.
20. Our market access consultants follow a structured
V+A analysis to measure what matters for your
product lifecycle management
Payer Research
Quantitative Pricing Research
HTA Strategy
Lifecycle Decision
Analytics
Health Economics
Real World Data
Generation & Analysis
MARKET
ACCESS
21. OUR COMPREHENSIVE APPROACH
In-depth and structured
review of available evidence
Build your product value
dossier based on what
matters to decision-makers
Align with payers’
evidentiary needs and
uncover evidence gaps
Optimize evidence
generation
Measure quantitatively and
qualitatively real world
benefit/risk
Measure real world value
through MCDA studies that
integrate evidence and
regional insights
Positioning and marketing
strategy
Bring the patient voice –
speak the language of
regulators, HTA organizations
and payers
Develop real-world data on
values and preferences
Gain insight on HCPs and
patient values and
preferences (MCDA driven
panels)
Collect rich insights and data
on regulator, HTAs and
payers (MCDA driven ad-
boards)
EVIDENCE
INTELLIGENCE
PRODUCT
INTELLIGENCE
CONTEXT
INTELLIGENCE
22. COVERING BOTH SCIENTIFIC
AND REAL WORLD PERSPECTIVES
Value Message
Development
Strategic Planning
for Optimal Access
Potential Value
Analysis
Scientific
Engagement
Pricing and Payer
Research
Economic models
for HTA
submission and
Regulatory
support
Profile testing,
positioning and
real-life models
Multi-criteria
Decision Analysis
(MCDA)
Consistency &
Continuity:
comprehensive
lifecycle support
Communications
(manuscripts,
presentations,
workshops,
trainings, mock
negotiation)
Core HTA
Submission
(GVD/Value
Dossier)
Reimbursement
Submissions
throughout the
world
23. ENABLING BREAKTHROUGH
INNOVATION FOR
TOMORROW’S CURES
Analytica Laser partners with early stage Biotech
to strategically optimize their market value in the
context of financing or partnering deals.
+ Full asset valuation
+ Target patient population selection
+ Clinical trial design
+ Competitive landscape
+ Pricing studies
+ Preparation and participation to investor and
partnering meetings
We’re leveraging a unique team of senior industry
executives and entrepreneurs, former HTA decision-
makers, scientists, and seasoned strategy consultants
to offer innovative expert advice.
24. EXECUTIVE LEADERSHIP
Lucien Abenhaim
PhD, MD, MSc
CHAIRMAN
London, UK
Fmr+ . Executive Board Member of the
World Health Organization
Honorary Prof. of Epidemiology, London+
School of Hygiene & Tropical Medicine
Roman Casciano
MSc
EVP & GM,
VALUE + ACCESS
New York, USA
+ Founder of Analytica International
+ 20 years’ experience in value assessment,
HEOR and market access strategy
Billy Amzal
PhD, X-Eng, MSc, MPA
EVP, DECISION ANALYTICS
London, UK & Paris, France
15+ + years’ experience in clinical program
design, modeling and analytics
Established and led model+ -based
development at Novartis
Lamiae Grimaldi
PhD, PharmD, MSc, MPH
EVP, EPIDEMIOLOGY AND
REAL WORLD DATA SOLUTIONS
Paris, France
+ 15+ years’ experience in clinical
pharmacology & pharmacoepidemiology
+ Co-founder of PGRx System
25. EXPERT MANAGEMENT TEAM
Sumeet Bakshi
MBBS, MMS, MBA
London, UK
VP, Real World Evidence Solutions+
17+ + years’ experience, fmr. Pfizer
and J&J
Patrizia Berto
PharmD, MBA
Milan, Italy
+ Sr. Global Consultant and
Managing VP, Italy
+ 30 years’ in biopharma with 20
years’ of HECON/ MA consulting
Matthew Brougham
MSc, DipHeathEcon
Montréal, Canada
Sr. Global Consultant+
Fmr+ . VP, CADTH (Canada) and Fmr. CEO,
PHARMAC (NZ)
20+ + years’ HTA/HEOR experience
Emmanuel Coeytaux
PhD, X-Eng
New York, USA
Managing VP, Strategy Consulting+
15+ + years’ experience, fmr. R&D Strategy
Director at Sanofi and BCG Principal
26. Jessica Jalbert
PhD
New York, USA
+ Director of Pharmacoepidemiology
+ Assistant Prof. of Healthcare Policy and
Research, Weill Cornell Medical College
Jenifer Ehreth
PhD
Paris, France
Sr. Global Consultant+
15+ + years’ experience in biopharma
and devices
+ University Prof. in Health Economics
Hélène Karcher
PhD, X-Eng
Basel, Switzerland
+ VP, Global Head of RW Modeling
+ Fmr. MIT academic and drug developer
(Novartis US/Europe)
Artak Khachatryan
PhD, MD
London, UK
+ Sr. Director, Pharmacoepidemiology
+ 10+ years’ experience as lead
epidemiologist in various international
studies
Hanane Khoury
PhD
Montréal, Canada
Assoc. Director, MCDA expert and Lead+
investigator for the EVIDEM collaboration
10+ + years’ experience in MCDA and
reimbursement dossier development
Marta Martinez
PharmD, MBA
Madrid, Spain
+ Director, Outcomes Research
+ 10+ years’ experience in CROs and industry
27. Dima Samaha
PharmD, MAS
London, UK
Sr. Director, Value & Access+
Fmr+ . Advisor on Innovation and External
Affairs at INESSS, Québec
Ulrich Neumann
MSc, MA, FRSA
New York, USA
Sr. Director, Commercial Development+
Business Consultant, Outcomes+ -based
Contracting
+ 15 years’ experience in marketing
Lee Stern
MSc
New York, USA
+ VP, Business Development
+ 15+ years’ experience in HEOR
Jacek Walczak
MD, Spec
Krakow, Poland
VP, Central and Eastern Europe+
15+ + years’ experience global market
access and systematic reviews
Elvira Müller
PhD, MPH
Lörrach, Germany
Managing VP, Germany+
15+ + years‘ experience in HTA and global
market access