The document discusses current challenges and future trends in clinical development from the perspective of a CRO. It notes that the global CRO market is large but fragmented, and outlines pressures on the pharmaceutical industry like high R&D costs, patent expirations, and regulatory demands. The text also examines trends towards more global, efficient trials using new technologies and less traditional geographies to address these challenges. It argues that collaboration between industry, regulators and CROs will be key to transforming clinical research processes to increase competitiveness and innovation.
Edifecs CJR: don't fumble with your bundle ssEdifecs Inc
Comprehensive Care for Joint Replacement (CJR) opens the door to opportunity for improved joint replacement patient care delivery. With full accountability for both cost and quality for the joint replacement episode, hospitals must share critical data in near real time to align and coordinate the full continuum of post-acute providers. The top complexities Jay Sultan addressed include:
The top complexities Jay Sultan addressed include:
Considerations for entering into contracts with your orthopedic surgeons and other collaborating episode providers
Episode bundle administration and monitoring; gain sharing administration
Real-time data acquisition from collaborating providers
Analytics and reporting, focused care delivery management, and preparation for CMS audits
Whatever burning issues and questions are on your mind
Edifecs CJR: don't fumble with your bundle ssEdifecs Inc
Comprehensive Care for Joint Replacement (CJR) opens the door to opportunity for improved joint replacement patient care delivery. With full accountability for both cost and quality for the joint replacement episode, hospitals must share critical data in near real time to align and coordinate the full continuum of post-acute providers. The top complexities Jay Sultan addressed include:
The top complexities Jay Sultan addressed include:
Considerations for entering into contracts with your orthopedic surgeons and other collaborating episode providers
Episode bundle administration and monitoring; gain sharing administration
Real-time data acquisition from collaborating providers
Analytics and reporting, focused care delivery management, and preparation for CMS audits
Whatever burning issues and questions are on your mind
In a C-Suite Resources presentation, Chairman Emeritus Don Wegmiller provided INTEGRATED with knowledge and insight into the state of the provider sector of healthcare today. Topics covered include new structures, reforms impacting providers, and provider challenges.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
Mercer Capital's Value Focus: Medical Device Manufacturers | Q4 2015 | Five T...Mercer Capital
Mercer Capital provides medical device manufacturers, related start-up enterprises, and private equity funds with valuation services, including purchase price allocation, 409a compliance, goodwill impairment testing, and other transaction and valuation advisory services.
Trends in Global Medical Device OEM Strategies and Issues for the Medical Dev...Tony Freeman
Presented at the February, 2013 mdmX Conference, Manning Advisors' Tony Freeman reviews issues facing the largest medical device manufacturers and implications for their supply chain.
Optimize the Role of Medical Affairs in Health Economics & Outcomes Research ...Best Practices
The Medical Affairs function plays an important role in health outcomes (HO) information exchange between bio-pharmaceutical organizations and key external stakeholders.
Development of robust health outcomes capabilities within Medical Affairs function requires an increase in the function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data as per stakeholders’ needs, and building real world data capabilities to generate and utilize health outcomes information.
This benchmarking research from Best Practices, LLC is designed to assist companies focused on oncology therapies find better ways to develop effective health outcomes groups. It provides current data and best practices from Medical Affairs leaders with an oncology focus at leading bio-pharmaceutical companies.
Download Full Report: http://bit.ly/2e3sl9Q
2016 trends in global medical device strategy and issues for the supply chainTony Freeman
In its 2016 annual review of the global medical device supply chain Manning Advisors identifies two core trends driving both OEM and supplier strategy. The first trend, consolidation, has paused to allow integration of large acquisitions made in the last three years. The second trend, changing products to compete in a fee-for-value rather than fee-for-service reimbursement environment, drives new technologies and capabilities. These trends continue to redistribute favored firms in medical devices.
How much does it cost to launch and commercialize a companion diagnostic test?Diaceutics Group
We ask four senior executives to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. View the infographic to see what they came up with.
We defined low end as a follow on diagnostic product where a similar test exists in the market and a high end test which is a new biomarker (needing to establish novel clinical utility), or a new platform likely to be in oncology, a chronic disease like rheumatoid arthritis or a range of infectious markers requiring panel performance.
Source http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.ryk5zoEa.dpuf
HCG, Best Cancer Care Hospital in india. Cancer Treatment, CyberKnife Surgery, Oncology Symptoms, Cancerous Tumors,Breast Cancer Treatment, chemotherapy, Radiation oncology, Medical Oncology, Surgical Oncology.
An overview of some of our best work in Medical Affairs. Reports are available individually or as bundles. All of our Excellence Services come with a membership to our Best Practice Database. Contact me for details.
EuroBioForum 2013 - Day 2 | Rachael RitchieEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# REGIONAL PERSPECTIVES #
Genome British Colombia, Canada:
Regional Perspectives on Personalized Medicine in British Columbia, Canada
Dr Rachael Ritchie
Director Business Development Genome British Colombia
=======================================
http://www.eurobioforum.eu
Advanced health technologies and their budgetary implications - Valérie Paris...OECD Governance
This presentation was made by Valérie Paris, OECD Secretariat, at the 6th meeting of the joint OECD DELSA-GOV network on fiscal sustainability of health systems held in Paris, on 18-19 September 2017
In a C-Suite Resources presentation, Chairman Emeritus Don Wegmiller provided INTEGRATED with knowledge and insight into the state of the provider sector of healthcare today. Topics covered include new structures, reforms impacting providers, and provider challenges.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
Mercer Capital's Value Focus: Medical Device Manufacturers | Q4 2015 | Five T...Mercer Capital
Mercer Capital provides medical device manufacturers, related start-up enterprises, and private equity funds with valuation services, including purchase price allocation, 409a compliance, goodwill impairment testing, and other transaction and valuation advisory services.
Trends in Global Medical Device OEM Strategies and Issues for the Medical Dev...Tony Freeman
Presented at the February, 2013 mdmX Conference, Manning Advisors' Tony Freeman reviews issues facing the largest medical device manufacturers and implications for their supply chain.
Optimize the Role of Medical Affairs in Health Economics & Outcomes Research ...Best Practices
The Medical Affairs function plays an important role in health outcomes (HO) information exchange between bio-pharmaceutical organizations and key external stakeholders.
Development of robust health outcomes capabilities within Medical Affairs function requires an increase in the function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data as per stakeholders’ needs, and building real world data capabilities to generate and utilize health outcomes information.
This benchmarking research from Best Practices, LLC is designed to assist companies focused on oncology therapies find better ways to develop effective health outcomes groups. It provides current data and best practices from Medical Affairs leaders with an oncology focus at leading bio-pharmaceutical companies.
Download Full Report: http://bit.ly/2e3sl9Q
2016 trends in global medical device strategy and issues for the supply chainTony Freeman
In its 2016 annual review of the global medical device supply chain Manning Advisors identifies two core trends driving both OEM and supplier strategy. The first trend, consolidation, has paused to allow integration of large acquisitions made in the last three years. The second trend, changing products to compete in a fee-for-value rather than fee-for-service reimbursement environment, drives new technologies and capabilities. These trends continue to redistribute favored firms in medical devices.
How much does it cost to launch and commercialize a companion diagnostic test?Diaceutics Group
We ask four senior executives to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. View the infographic to see what they came up with.
We defined low end as a follow on diagnostic product where a similar test exists in the market and a high end test which is a new biomarker (needing to establish novel clinical utility), or a new platform likely to be in oncology, a chronic disease like rheumatoid arthritis or a range of infectious markers requiring panel performance.
Source http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.ryk5zoEa.dpuf
HCG, Best Cancer Care Hospital in india. Cancer Treatment, CyberKnife Surgery, Oncology Symptoms, Cancerous Tumors,Breast Cancer Treatment, chemotherapy, Radiation oncology, Medical Oncology, Surgical Oncology.
An overview of some of our best work in Medical Affairs. Reports are available individually or as bundles. All of our Excellence Services come with a membership to our Best Practice Database. Contact me for details.
EuroBioForum 2013 - Day 2 | Rachael RitchieEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# REGIONAL PERSPECTIVES #
Genome British Colombia, Canada:
Regional Perspectives on Personalized Medicine in British Columbia, Canada
Dr Rachael Ritchie
Director Business Development Genome British Colombia
=======================================
http://www.eurobioforum.eu
Advanced health technologies and their budgetary implications - Valérie Paris...OECD Governance
This presentation was made by Valérie Paris, OECD Secretariat, at the 6th meeting of the joint OECD DELSA-GOV network on fiscal sustainability of health systems held in Paris, on 18-19 September 2017
Advanced health technologies and budgetary implications -- Valerie Paris, OECDOECD Governance
This presentation was made by Valérie Paris, OECD Secretariat, at the 6th Meeting of the Joint OECD DELSA-GOV Network on Fiscal Sustainability of Health Systems, held at the OECD Conference Centre, Paris, on 18-19 September 2017
Analysis of drivers that cause restricted access to funding for smaller biotech companies.
A detailed reviewed of the steps
venture capitalists and companies are
taking — models such as fail-fast R&D, asset-centric funding and more.
Proposal of a model that
could radically change R&D by taking a
much more holistic approach to drug
development, sharing information to
learn in real time across the cycle of care
and fundamentally changing how risk
and reward are allocated.
Historically, the medical device industry has been highly attractive and relatively stable. As a consequence, established players have been able to compete successfully across the device spectrum, applying common business models and processes without much need for differentiation.
The future, however, is very different as disruptive change is underway. Companies will need to look at new segments and offer end-to-end solutions to secure additional revenue and maintain their profit margins.
John Babitt, Partner, Life Sciences, Transaction Advisory Services, Ernst & Young LLP, presented at MEDTECH 2014 on The State of Change: A Look at the Evolving Healthcare Landscape and the Effect on Life Science Organizations Today and Tomorrow.
New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period.
AI in medicine revolutionizes healthcare through precision diagnostics, personalized treatments, and predictive analytics, enhancing patient outcomes, bridging gaps in access, and fostering innovation and collaboration for a healthier future.
DeciBio Perspectives on Pain Points, Unmet Needs, and Disruption in Precision...Andrew Aijian
We conducted interviews with precision medicine KOLs to create a map of the precision medicine stakeholder landscape and identify and understand the unmet needs and pain points within precision medicine, as well as areas and scenarios of potential disruption.
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.
Similar to Future Challenges of Clinical Development; a View from the CRO - Hani Zaki (20)
Future Challenges of Clinical Development; a View from the CRO - Hani Zaki
1. 12 January 2011 Hani Zaki, MPH, MBA Senior Vice President, Late Phase Services PRA International Future Challenges of Clinical Development: A View from the CRO
2.
3. Clinical Trials By The Numbers 100,838 trials registered on ClinTrial.gov as of January 3, 2011 40,998 trials are Pharma based 10,192 are “enrolling” 8,824 Interventional 4,633 Safety Outcome 20,982 are US based
23. Some Trends and Needs Trends Needs Significant decrease in NME approvals (revenue) at 40x the expense Development efficiencies Increasing cost of late phase (II, III, IV) development New processes, technology & Innovation Global trials with increasing needs in CEE, Asia, MENA, Africa Global resources, training, standardization Fierce competition for study patients Medical informatics and utilization of emerging new data resources Pharma and Biotech relaying on outsourcing to re-structure expense from fixed to variable CROs leading change in processes, logistics, metrics, delivery and quality
25. Challenge: New Efficiencies Lead Innovation Lead Efficiency Lead Delivery Metrics Lead Quality Metrics Active Approach: Suppliers Setting New Standards Balanced Collaboration Global Bio-Pharmaceutical Industry Discovery Innovation Licensing Supply competitiveness, savings, flexibility, global reach, insight ….
26. Clinical Trial Costs Is this the most efficient process? Can we do better to reduce burden? Are we building effective partnerships?
27. Challenge: Technology & Innovation Must be a joint effort between industry, suppliers and regulators Break from 1970’s thinking and processes and re-draw the mechanics of conducting clinical research based on today’s realities, resources and capabilities
30. Challenge: Broader Geographies Accelerating the rate of enrollment in clinical trials toward reduced costs and quicker results Finding the right patients and navigating narrow inclusion and exclusion criteria Greater competition for patients and the need for larger sample sizes to detect slight differences Ethical considerations Regulatory Oversight
32. Challenge: Access to Patients Vast cultural differences on healthcare “privacy.” Nordic countries have a tradition of health registries. Every citizen is provided with an identifier from birth and enrolled into registries to elucidate epidemiological trends. Data are used for public health research and improvement of medical care. Can we guarantee healthcare privacy as we break new ground to accelerate research? Can we generalize across countries?
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Editor's Notes
Cannot speak about future challenges without a solid understanding of where we are today, and the market forces that will effects us into the future
I like to first set the stage of where we are today and talk about the drivers, market dynamics and trends Then I’ll talk about what I see as some future challanges
Size (1) Consider the clinical development space today Here is a picture Over 100,000 trials registered in CT.Gov ~ 40% are Pharma based; the others are Gov institutions, academia, hospitals, research institutes, and individual researchers 20K of the Pharma 40K are US based 10K of the 40K are now open for enrollment 8K of the 10K are “Interventional” 50% of the interventional studies have some safety-outcome component So, let’s focus on the Pharma segment. How is this work being done?
Economic Drivers (1) Pharma traditionally has acted as innovator/discoverer, formulator, developer, manufacturer, and marketer This model began to slowly change beginning in the 1970’s. At every step post-innovation you can now effectively outsource your needs. From initial pre-clinical testing, to first-in-man, to development, to manufacturing, to marketing and to selling. We’ve come a long way in the past 30 years. The frustration is that we also stood still in many aspects for the past 30 years. And in focusing on clinical development, we are still one of the few industries in the world that still manage to use “NCR paper” on occasion. (Ask what NCR paper is). And although we outsource more than ever in our industry, the standards, process, logistics, efficiencies, and quality metrics are held more or les by the folks that outsource – this is not the norm in other industries The constant that we’ve seen is a palpable shift in where resources reside; and as Pharma outsourcing increases so does the shift in professional resources What does this shift look like? Take a look at the next graph …
Size (2)
Economic Drivers (2)
Economic Drivers (3) If you have ANY doubt about the relationship that I just described take a look at this graph – the clinical research stock index. We established that Pharma development activity and needs have shaped the CRO industry and will continue to shape the CRO industry in the future. Therefore it makes sense to consider what forces are now effecting the global Pharma space since these market pressures will likely shape future Pharmaceutical demands
Market Dynamics (1)
Market Dynamics (2) One of the biggest challenges facing the drug industry today is the cost of development We are spending 40 times more today for an equal level of productivity This is a picture of an industry in a tail spin
Market Dynamics (3)
Market Dynamics (4)
Market Dynamics (5) Now that we’ve established the drivers of the CRO business let’s look at some of the market dynamics that are now effecting the space, and will continue to do so into the future Recent article in the Wall Street Journal indicating some relief in sight for some industries following adjustments in their businesses as well as positive accumulation of cash But look closely at the Pharma industry
Trends (1) The global economy, shrinking pipelines, lower NME approvals, pricing pressures, and loss of patents has effected development and Pharma’s ability to support development. This is reflected in the number of study starts with a trend beginning in 2008