1) The document discusses challenges facing the clinical development process for pharmaceutical companies, including high costs, lengthy timelines, and increased regulation.
2) It proposes that implementing strategies like electronic data capture, data standardization, and centralized data management can help accelerate clinical development and lower costs.
3) The key is developing a holistic, long-term strategic framework for clinical information management that streamlines processes, integrates data, governs data standards, and supports strategic decision making.
Big Pharma is facing a crisis as many blockbuster drugs are going off-patent and the pipeline of new drugs is weak. R&D spending has doubled over the past decade but productivity has declined, with fewer new drugs approved despite higher costs. Alternative strategies such as mergers and acquisitions, in-licensing, and partnerships have had mixed results in addressing the pipeline problem. The document discusses challenges in drug development and strategies the pharmaceutical industry has used to boost R&D productivity.
The document discusses how clinical delivery alliances between biopharmaceutical sponsors and CROs can improve drug development performance. It notes that expiring drug patents, rising R&D costs, and more drug candidates are challenging traditional development models. Clinical delivery alliances create long-term, incentivized partnerships to increase quality while reducing costs and time to market compared to traditional project-based outsourcing. The benefits of clinical delivery alliances include lower costs through economies of scale, higher quality through a transparent and repeatable process, and faster development through dedicated resources and aligned incentives.
The document summarizes Weyerhaeuser Company's annual analyst meeting held on May 20, 2004 in New York City. It includes an agenda for the meeting and presentations on the company being positioned for success after achieving objectives of three acquisitions. It also discusses the company's financial philosophy and strategy, industry outlook, operating excellence initiatives, and vision for the future.
This document provides an overview of nanoparticle-based drug delivery technologies. It discusses how nanoparticles can help address challenges in traditional drug formulations by improving water solubility and targeting specificity. While only a few nanoparticle therapies have been FDA-approved so far, the author argues that these technologies are already impacting medicine and their impact will likely grow in the coming years. The document also reviews the drug development process and pressures facing pharmaceutical companies to improve success rates and reduce costs. Nanotechnology may help address these challenges through miniaturization, automation, high-throughput screening and other techniques.
This document summarizes Akihiko Matsumoto's minimalist music application for iPhone and iPod Touch called RjDj. It generates interactive, generative music using algorithmic composition based on Schenkerian analysis of minimal motifs. The app utilizes the iPhone's sensors and touchscreen for real-time control of musical parameters like progression, style, delay, tempo, transposition, and timbre. Matsumoto develops the algorithms in PureData and uploads scenes to the RjDj website to download and experience on an iPhone.
DSO2014: Vitale sportvereniging of open sportclub?Hans Slender
Presentatie Dag van het Sportonderzoek samen met Hiske Wiggers over de mate waarop sportverenigingen in Noord-Nederland vitaal zijn en open staan voor een maatschappelijke functie.
Big Pharma is facing a crisis as many blockbuster drugs are going off-patent and the pipeline of new drugs is weak. R&D spending has doubled over the past decade but productivity has declined, with fewer new drugs approved despite higher costs. Alternative strategies such as mergers and acquisitions, in-licensing, and partnerships have had mixed results in addressing the pipeline problem. The document discusses challenges in drug development and strategies the pharmaceutical industry has used to boost R&D productivity.
The document discusses how clinical delivery alliances between biopharmaceutical sponsors and CROs can improve drug development performance. It notes that expiring drug patents, rising R&D costs, and more drug candidates are challenging traditional development models. Clinical delivery alliances create long-term, incentivized partnerships to increase quality while reducing costs and time to market compared to traditional project-based outsourcing. The benefits of clinical delivery alliances include lower costs through economies of scale, higher quality through a transparent and repeatable process, and faster development through dedicated resources and aligned incentives.
The document summarizes Weyerhaeuser Company's annual analyst meeting held on May 20, 2004 in New York City. It includes an agenda for the meeting and presentations on the company being positioned for success after achieving objectives of three acquisitions. It also discusses the company's financial philosophy and strategy, industry outlook, operating excellence initiatives, and vision for the future.
This document provides an overview of nanoparticle-based drug delivery technologies. It discusses how nanoparticles can help address challenges in traditional drug formulations by improving water solubility and targeting specificity. While only a few nanoparticle therapies have been FDA-approved so far, the author argues that these technologies are already impacting medicine and their impact will likely grow in the coming years. The document also reviews the drug development process and pressures facing pharmaceutical companies to improve success rates and reduce costs. Nanotechnology may help address these challenges through miniaturization, automation, high-throughput screening and other techniques.
This document summarizes Akihiko Matsumoto's minimalist music application for iPhone and iPod Touch called RjDj. It generates interactive, generative music using algorithmic composition based on Schenkerian analysis of minimal motifs. The app utilizes the iPhone's sensors and touchscreen for real-time control of musical parameters like progression, style, delay, tempo, transposition, and timbre. Matsumoto develops the algorithms in PureData and uploads scenes to the RjDj website to download and experience on an iPhone.
DSO2014: Vitale sportvereniging of open sportclub?Hans Slender
Presentatie Dag van het Sportonderzoek samen met Hiske Wiggers over de mate waarop sportverenigingen in Noord-Nederland vitaal zijn en open staan voor een maatschappelijke functie.
Multiple Strategies and Technologies to Combat Counterfeit Drugsguest696d96
Counterfeit drugs pose a significant threat as they can harm patients and reduce pharmaceutical company profits. To combat this threat, a multi-level anti-counterfeiting strategy is needed that utilizes various technologies like RFID, ePedigrees, and security labeling. While no single solution is sufficient, a combination of approaches can better secure the drug supply chain, reduce counterfeits in the marketplace, and improve patient safety and brand protection.
Workshop gegeven bij symposia 'versterk je sportvereniging' van het Huis voor de Sport Groningen op 24 en 27 november 2013 over sociale media voor sportverenigingen.
50 stunning mobile statistics - trends in gadgets and mobilityAli Kafel
The transistor started the digital revolution. Probably most interesting is the impact in Mobility. Take a walk through the past, present and a glimpse into the future
Economic and social value of local sport eventsHans Slender
This document discusses a research program on the economic and social value of local sport events. It includes the following key points:
1. It describes a joint research program between Hanze University and a national community of practice called WESP that aims to standardize methods for evaluating the ex-ante and ex-post impacts of sport events.
2. Initial research has found economic impacts ranging from €1.3 million for smaller local events to over €20 million for larger international events hosted in the Netherlands.
3. The research agenda going forward includes feasibility studies, process evaluations, and impact studies of events, as well as a PhD project focusing on the long-term social legacies of local sport events.
NFV resiliency whitepaper - Ali Kafel, Stratus TechnologiesAli Kafel
This white paper makes the case for:
Why Resiliency Management Needs to be in the Software Infrastructure. It Covers:
- Fault Management and Resiliency Management
- Seamless Protection for Faster and Simpler Devl
- Multiple Levels of Availability
- Speed of Service Restoration & Redundancy Restoration
- State Management
- Higher Flexibility and Efficiency of Resiliency
- Demonstrating Carrier Grade Availability and Resiliency
Stratus Fault-Tolerant Cloud Infrastructure Software for NFV using OpenStackAli Kafel
This Webinar describes several ways of providing High Availability, Reliability and Resiliency in KVM and OpenStack for NFV. Plus a brief overview of Stratus' Software Defined Availability (SDA) - an elegant way of bringing transparent and seamless Resiliency to all VNFs without code changes
ETSI NFV#13 NFV resiliency presentation - ali kafel - stratusAli Kafel
This white paper makes the case for:
Why Resiliency Management Needs to be in the Software Infrastructure. It Covers:
- Fault Management and Resiliency Management
- Seamless Protection for Faster and Simpler Devl
- Multiple Levels of Availability
- Speed of Service Restoration & Redundancy Restoration
- State Management
- Demonstrating Carrier Grade Availability and Resiliency
Monitoring van het WK CP voetbal en de side-events om de maatschappelijke spin-off in kaart te brengen. Presentatie bij Dag van het Sportonderzoek in 2011.
1) Clinical drug development is a long and expensive process for pharmaceutical companies, with only a small percentage of drugs producing revenues that match or exceed costs.
2) Companies face challenges like increased generics, limited late-stage pipelines, and decreased profits, forcing them to find ways to reduce costs and increase efficiency.
3) The use of electronic data capture and clinical data management systems can help accelerate drug development by streamlining processes, reducing labor costs, and allowing for ongoing safety monitoring with up-to-date information.
Where Right Brain Meets Left: Translating for Medical and Pharmaceutical Mark...Erin Lyons
Medical and pharmaceutical marketing and promotional translation is a highly specialized discipline requiring scientific understanding and the agility and resourcefulness of a creative wordsmith. Translations must be accurate and intelligible, but they must also be engaging and work within the framework of an existing brand personality and advertising platform. Participants will be given an overview of advertising and promotional material (print, television, sales aids) and technical input (product monographs, patient brochures, production-related documents). Specific exercises and examples will explore interlinguistic wordplay, language-specific tone and voice, and production and regulatory constraints.
R&D leadership in crisis: rebuilding innovation through peopleRung Jaismut
Pharmaceutical R&D organizations are facing a leadership crisis as the billion dollar blockbuster drug model is questioned. Shareholders question the sustainability of this model and large pharmaceutical companies question their commitment to internal R&D. The document discusses challenges facing R&D leaders, including managing outsourcing, lack of autonomy over funds, and motivating scientists. It also notes a shortage of quality R&D talent and lack of support for career development. Sixty percent of executives surveyed would be interested in leaving R&D for commercial roles. The sustainability of increasing R&D budgets without corresponding increases in new drug approvals is also questioned.
This document provides an annual report from Quest Diagnostics for the year 2000. It discusses the company's core values of quality, integrity, innovation, accountability, collaboration and leadership. It summarizes the company's financial highlights for 2000 including record revenues of $3.4 billion and net income of $106.2 million, up significantly from 1999. It discusses the company's business strategy of being the undisputed leader in diagnostic testing and health care insights while achieving gold standard excellence in healthcare quality. It highlights examples of how the company is living its values through quality improvement initiatives, open communication with physicians, and new safety measures to protect patients and employees.
The CDA was founded in 2003 and spun out as an independent company in 2012. It has approximately 10 employees and works with experts worldwide. The CDA serves top pharmaceutical companies, biotechs, and organizations like the WHO. Its services include market forecasts, epidemiological research, disease burden modeling, and strategic and financial consulting. Recent projects include HCV epidemiology studies, biosimilars forecasts, a market access database, and presentations on global HCV burden and treatment.
The document is Boston Scientific's 2005 Annual Report. It discusses the company achieving $6.28 billion in revenue in 2005, a 12% increase over 2004, driven by market leadership in drug-eluting stents. It summarizes clinical trial results and new product approvals. It also notes the proposed acquisition of Guidant would make Boston Scientific a leader in cardiac rhythm management and expand its technology portfolio. The report discusses initiatives to address quality issues raised by the FDA and invest in growth areas like neuromodulation, drug-eluting stents, and peripheral interventions.
PositiveID is developing innovative molecular diagnostic technologies for biological testing and detection, including its Firefly Dx platform for rapid, point-of-need testing. Recent acquisitions of E-N-G, specializing in mobile labs, and Caregiver, an FDA-cleared thermometer, provide synergistic products and revenue. PositiveID reported $2.9 million in revenue for 2015 and $4.6 million for the first nine months of 2016, projecting $5-6 million for full-year 2016. Firefly Dx targets large molecular diagnostics markets and could begin commercial sales in 2017-2018 following field testing.
This document summarizes a presentation made by Quest Diagnostics at the Cowen and Company Health Care Conference on March 18, 2008. It outlines Quest Diagnostics' position as the leader in diagnostic testing in the US, its strategy to drive profitable growth through expanding its diagnostic scope and geographic reach, and its goals of being the undisputed world leader in diagnostic testing and services while profitably growing above industry rates. It also discusses leveraging assets and capabilities, reducing costs by $500 million, and focuses on margin expansion, earnings growth, and excellence in execution.
Translational data science at Merck involves combining data analytics and informatics across research and development to increase efficiency and success rates. Merck's data science team develops platforms and applies techniques like predictive modeling, data mining, and real-world evidence analysis to decrease costs and timelines for drug development while improving decision making. The goal is to enhance Merck's contributions in key therapeutic areas and increase the productivity of their drug pipeline.
Multiple Strategies and Technologies to Combat Counterfeit Drugsguest696d96
Counterfeit drugs pose a significant threat as they can harm patients and reduce pharmaceutical company profits. To combat this threat, a multi-level anti-counterfeiting strategy is needed that utilizes various technologies like RFID, ePedigrees, and security labeling. While no single solution is sufficient, a combination of approaches can better secure the drug supply chain, reduce counterfeits in the marketplace, and improve patient safety and brand protection.
Workshop gegeven bij symposia 'versterk je sportvereniging' van het Huis voor de Sport Groningen op 24 en 27 november 2013 over sociale media voor sportverenigingen.
50 stunning mobile statistics - trends in gadgets and mobilityAli Kafel
The transistor started the digital revolution. Probably most interesting is the impact in Mobility. Take a walk through the past, present and a glimpse into the future
Economic and social value of local sport eventsHans Slender
This document discusses a research program on the economic and social value of local sport events. It includes the following key points:
1. It describes a joint research program between Hanze University and a national community of practice called WESP that aims to standardize methods for evaluating the ex-ante and ex-post impacts of sport events.
2. Initial research has found economic impacts ranging from €1.3 million for smaller local events to over €20 million for larger international events hosted in the Netherlands.
3. The research agenda going forward includes feasibility studies, process evaluations, and impact studies of events, as well as a PhD project focusing on the long-term social legacies of local sport events.
NFV resiliency whitepaper - Ali Kafel, Stratus TechnologiesAli Kafel
This white paper makes the case for:
Why Resiliency Management Needs to be in the Software Infrastructure. It Covers:
- Fault Management and Resiliency Management
- Seamless Protection for Faster and Simpler Devl
- Multiple Levels of Availability
- Speed of Service Restoration & Redundancy Restoration
- State Management
- Higher Flexibility and Efficiency of Resiliency
- Demonstrating Carrier Grade Availability and Resiliency
Stratus Fault-Tolerant Cloud Infrastructure Software for NFV using OpenStackAli Kafel
This Webinar describes several ways of providing High Availability, Reliability and Resiliency in KVM and OpenStack for NFV. Plus a brief overview of Stratus' Software Defined Availability (SDA) - an elegant way of bringing transparent and seamless Resiliency to all VNFs without code changes
ETSI NFV#13 NFV resiliency presentation - ali kafel - stratusAli Kafel
This white paper makes the case for:
Why Resiliency Management Needs to be in the Software Infrastructure. It Covers:
- Fault Management and Resiliency Management
- Seamless Protection for Faster and Simpler Devl
- Multiple Levels of Availability
- Speed of Service Restoration & Redundancy Restoration
- State Management
- Demonstrating Carrier Grade Availability and Resiliency
Monitoring van het WK CP voetbal en de side-events om de maatschappelijke spin-off in kaart te brengen. Presentatie bij Dag van het Sportonderzoek in 2011.
1) Clinical drug development is a long and expensive process for pharmaceutical companies, with only a small percentage of drugs producing revenues that match or exceed costs.
2) Companies face challenges like increased generics, limited late-stage pipelines, and decreased profits, forcing them to find ways to reduce costs and increase efficiency.
3) The use of electronic data capture and clinical data management systems can help accelerate drug development by streamlining processes, reducing labor costs, and allowing for ongoing safety monitoring with up-to-date information.
Where Right Brain Meets Left: Translating for Medical and Pharmaceutical Mark...Erin Lyons
Medical and pharmaceutical marketing and promotional translation is a highly specialized discipline requiring scientific understanding and the agility and resourcefulness of a creative wordsmith. Translations must be accurate and intelligible, but they must also be engaging and work within the framework of an existing brand personality and advertising platform. Participants will be given an overview of advertising and promotional material (print, television, sales aids) and technical input (product monographs, patient brochures, production-related documents). Specific exercises and examples will explore interlinguistic wordplay, language-specific tone and voice, and production and regulatory constraints.
R&D leadership in crisis: rebuilding innovation through peopleRung Jaismut
Pharmaceutical R&D organizations are facing a leadership crisis as the billion dollar blockbuster drug model is questioned. Shareholders question the sustainability of this model and large pharmaceutical companies question their commitment to internal R&D. The document discusses challenges facing R&D leaders, including managing outsourcing, lack of autonomy over funds, and motivating scientists. It also notes a shortage of quality R&D talent and lack of support for career development. Sixty percent of executives surveyed would be interested in leaving R&D for commercial roles. The sustainability of increasing R&D budgets without corresponding increases in new drug approvals is also questioned.
This document provides an annual report from Quest Diagnostics for the year 2000. It discusses the company's core values of quality, integrity, innovation, accountability, collaboration and leadership. It summarizes the company's financial highlights for 2000 including record revenues of $3.4 billion and net income of $106.2 million, up significantly from 1999. It discusses the company's business strategy of being the undisputed leader in diagnostic testing and health care insights while achieving gold standard excellence in healthcare quality. It highlights examples of how the company is living its values through quality improvement initiatives, open communication with physicians, and new safety measures to protect patients and employees.
The CDA was founded in 2003 and spun out as an independent company in 2012. It has approximately 10 employees and works with experts worldwide. The CDA serves top pharmaceutical companies, biotechs, and organizations like the WHO. Its services include market forecasts, epidemiological research, disease burden modeling, and strategic and financial consulting. Recent projects include HCV epidemiology studies, biosimilars forecasts, a market access database, and presentations on global HCV burden and treatment.
The document is Boston Scientific's 2005 Annual Report. It discusses the company achieving $6.28 billion in revenue in 2005, a 12% increase over 2004, driven by market leadership in drug-eluting stents. It summarizes clinical trial results and new product approvals. It also notes the proposed acquisition of Guidant would make Boston Scientific a leader in cardiac rhythm management and expand its technology portfolio. The report discusses initiatives to address quality issues raised by the FDA and invest in growth areas like neuromodulation, drug-eluting stents, and peripheral interventions.
PositiveID is developing innovative molecular diagnostic technologies for biological testing and detection, including its Firefly Dx platform for rapid, point-of-need testing. Recent acquisitions of E-N-G, specializing in mobile labs, and Caregiver, an FDA-cleared thermometer, provide synergistic products and revenue. PositiveID reported $2.9 million in revenue for 2015 and $4.6 million for the first nine months of 2016, projecting $5-6 million for full-year 2016. Firefly Dx targets large molecular diagnostics markets and could begin commercial sales in 2017-2018 following field testing.
This document summarizes a presentation made by Quest Diagnostics at the Cowen and Company Health Care Conference on March 18, 2008. It outlines Quest Diagnostics' position as the leader in diagnostic testing in the US, its strategy to drive profitable growth through expanding its diagnostic scope and geographic reach, and its goals of being the undisputed world leader in diagnostic testing and services while profitably growing above industry rates. It also discusses leveraging assets and capabilities, reducing costs by $500 million, and focuses on margin expansion, earnings growth, and excellence in execution.
Translational data science at Merck involves combining data analytics and informatics across research and development to increase efficiency and success rates. Merck's data science team develops platforms and applies techniques like predictive modeling, data mining, and real-world evidence analysis to decrease costs and timelines for drug development while improving decision making. The goal is to enhance Merck's contributions in key therapeutic areas and increase the productivity of their drug pipeline.
johnson & johnson Q4 2008 Investor Relations Business Overview finance4
This document contains a safe harbor statement for Johnson & Johnson noting that the press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially. It also provides a list of specific risks and uncertainties the company faces and directs readers to further information in the company's annual report. The statement does not guarantee the company's financial performance but aims to fairly advise investors and analysts of known risks.
This document outlines a presentation on clinical research and development challenges and opportunities. It discusses the low productivity and increasing costs of R&D, potential loss of revenue from expiring patents, and reasons for low productivity such as target and trial design issues. It also covers trends like globalization of clinical trials to reduce costs and access large patient populations. Finally, it discusses the need for quality and qualified investigators to address the supply and demand imbalance.
Jeff Campbell, Executive Vice President and CFO of McKesson, presented at the Goldman Sachs Healthcare Conference on June 14, 2006. McKesson generated $88 billion in revenues in fiscal year 2006, with strong growth over the past six years. McKesson has leadership positions across pharmaceutical distribution, medical supplies, and healthcare IT. The company is well positioned for ongoing growth through leadership in growing areas of healthcare and long-term customer relationships.
The document is Boston Scientific's 2005 Annual Report. It discusses the company's strong financial performance in 2005, with total revenue reaching $6.28 billion, a 12% increase over 2004. It summarizes key accomplishments across its business units, including maintaining the leading market share for drug-eluting stents. It also addresses the FDA's letter regarding quality compliance systems and the company's response to comprehensively address issues. Looking ahead, the report discusses strategic priorities like accelerating base business growth and expanding drug-eluting stent market share.
The document is Boston Scientific's 2005 Annual Report. It discusses the company's strong financial performance in 2005, with total revenue reaching $6.28 billion, a 12% increase over 2004. It summarizes key accomplishments across its business units, including maintaining the leading market share for drug-eluting stents. It also addresses the FDA's letter regarding quality compliance systems and the company's response to comprehensively address issues. Looking ahead, it discusses strategic priorities like accelerating base business growth and expanding drug-eluting stent market share through new products.
The document is Boston Scientific's 2005 Annual Report. It discusses the company's strong financial performance in 2005, with total revenue reaching $6.28 billion, a 12% increase over 2004. It summarizes key accomplishments across its business units, including maintaining the leading market share for drug-eluting stents. It also addresses the FDA's letter regarding quality compliance systems and the company's response to comprehensively address issues. Looking ahead, the report discusses strategic priorities like accelerating base business growth and expanding drug-eluting stent market share.
The contract research organization (CRO) industry is a multi-billion dollar industry that is expected to grow substantially over the next five years. There are over 1,000 CROs globally, ranging in size from small firms to large publicly traded companies. The top five CROs capture over a third of total industry revenue, suggesting market consolidation. Growth in the industry is driven by increasing complexity and size of clinical trials, globalization of drug development, and pharmaceutical industry cost containment pressures that encourage further outsourcing of services.
A session by Susan P. Gibson, President & Founder, Vivolor Therapeutics, Inc. on the topic of 'Is Pharma Drug Pricing Being Disrupted?' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
This document summarizes a presentation made by Quest Diagnostics at the Cowen and Company Health Care Conference on March 18, 2008. It outlines Quest Diagnostics' position as the leader in diagnostic testing in the US, its strategy to drive profitable growth through expanding its diagnostic scope and geographic reach, and its goals of being the undisputed world leader in diagnostic testing and information services while profitably growing above industry rates. It also discusses leveraging assets and capabilities, reducing costs by $500 million, and focusing on margin expansion and earnings growth in 2008-2009.
Biomarkers are increasing the success rates of drug development and reducing costs by helping to identify failures earlier. They allow pharmaceutical companies to streamline clinical trials, make better decisions about drug candidates, and potentially develop personalized medicines to match patients with optimal treatments. While the initial costs of biomarker research and validation are high, biomarkers are expected to generate substantial savings over the long term through more efficient drug development and higher success rates.
As of my last knowledge update in September 2021, the list of the top Contract Research Organizations (CROs) can vary depending on factors such as revenue, services offered, therapeutic areas of expertise, and global presence. The following list includes some of the prominent CROs based on their reputation, scale, and contributions to the clinical research industry:
IQVIA (formerly QuintilesIMS):
IQVIA is one of the largest CROs in the world, offering a wide range of services including clinical development, real-world evidence solutions, commercialization services, and consulting. They have a vast global network and expertise across various therapeutic areas.
PPD (Pharmaceutical Product Development):
PPD is known for its comprehensive clinical trial services, laboratory services, and real-world evidence solutions. They have a strong global presence and experience in managing trials of varying complexity.
Covance:
Covance, a subsidiary of LabCorp, is known for its extensive portfolio of drug development services including clinical development, central laboratory services, and market access solutions. They have experience in a broad range of therapeutic areas.
Syneos Health:
Syneos Health offers integrated solutions across clinical development, commercialization, and real-world evidence. They focus on helping clients navigate the entire drug development journey.
ICON:
ICON provides a variety of clinical research services, including consulting, clinical trial execution, laboratory services, and outcomes research. They have expertise in a wide array of therapeutic areas.
Parexel:
Parexel offers services ranging from clinical research and regulatory consulting to market access and commercialization. They are known for their global reach and innovative approach to clinical trials.
WuXi AppTec:
WuXi AppTec is a global company that provides a wide range of R&D services, including preclinical and clinical development, manufacturing, and regulatory services.
Medpace:
Medpace is known for its focused and customized approach to clinical trial management, particularly in the area of complex and specialized studies.
Celerion:
Celerion specializes in early-stage clinical research, with a focus on providing solutions for both small and large molecules.
Charles River Laboratories:
While Charles River Laboratories primarily focuses on preclinical research, they also offer a range of early-stage clinical development services.
Similar to The ADD Effect In Clinical Development (20)
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
The Steadfast and Reliable Bull: Taurus Zodiac Signmy Pandit
Explore the steadfast and reliable nature of the Taurus Zodiac Sign. Discover the personality traits, key dates, and horoscope insights that define the determined and practical Taurus, and learn how their grounded nature makes them the anchor of the zodiac.
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Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
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Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
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The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
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The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
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1. THE ADD (ATTENTION DEFICIT DISORDER) EFFECT
IN CLINICAL DEVELOPMENT
Authors: Sanjeev Wadhwa and Sanjay Modi
• The Tufts Center for Establishing the Strategic Framework for Clinical
the Study of Drug
Development suggests
Information Management: A Holistic Look Through
that the R&D pipeline the Lens of a Future Operating Model
might be rebounding
as the leading U.S. Industry Trends
drug companies have Clinical development is a complex process for pharmaceutical companies
increased their clinical which bear a high cost to reap the final rewards of potentially billions of
trials numbers by dollars after FDA approval. The process can take up to 12 years and
greater than 50 requires a great deal of communication and coordination. Clinical data
percent has to be properly collected, managed and reviewed in order to obtain
full value of the results. The current industry is facing numerous
• Frost and Sullivan
challenges such as increased number of generics due to patent
estimates that the
expiration, limited late-stage pipeline drugs, lawsuits, payer influence and
global pharmaceutical
increased government regulation which lead to decreased profits. It
R&D outsourcing
needs to find ways to reduce costs in order to be more efficient.
market will grow to
$24.9 billion by 2007 • Total global spending on clinical development (Phases I-IV) is about
• The Tufts Center for 34 percent of total R&D costs
the Study of Drug • Only three out of every 10 marketed drugs produce revenues that
Development suggests match or exceed initial costs
that the R&D pipeline
might be rebounding
$3,000
as the leading U.S. $2,722
drug companies have
$2,500
increased their clinical
(Millions of 2000 Dollars)
trials numbers by
After-Tax Present Value
$2,000
greater than 50
percent $1,500
• Frost and Sullivan $1,015
estimates that the $1,000
global pharmaceutical $629
$433 A fter T ax R & D C o sts
R&D outsourcing $500
$235
$126
market will grow to $56 $30 $9 $0
$0
$24.9 billion by 2007 1 2 3 4 5 6 7 8 9 10
New Rx Drugs Introduced Between 1990 and 1994
Grouped by Decile According to Sales
Figure 1: Source: H. Gabrowski, J. Vernon, and J. DiMilasi, “Returns on Research
and Development for 1990s New Drug Introduction,” Pharmacoeconomics 20
(December 2002): suppl. 3, 11 – 29
| The ADD Effect in Clinical Development | 1
2. External Drivers
$U S (M illions)
New Data Types
$1,200 • ClinPharm, M&S, Genomics and Proteomics
Evolution of Industry Standards
$900 • Data Standardization
– XML, HL7 and RIM
$600
– Global Library Standards
– CRF templates
$300
– Medical versus FDA and ICH Analysis needs
$0 Strategy Partnering
1991 1997 1999 2003 2004 • Outsourcing
Source: Arcarya, 2006. Pharmalicensing • Data sharing
Figure 2: Escalating R&D Costs: Cost of Developing an NME • Data Aggregators
Regulatory and Ethical Requirements for Safety and
• Rising costs of NME development (2006) Post-Marketing
• The Tufts Center for the Study of Drug • Document submission
Development suggests that the R&D pipeline – CDISC versus Generic Data Model
might be rebounding as the leading U.S. drug
• Adverse event signal generation and coding
companies have increased their clinical trials
numbers by greater than 50 percent Federal Information Technology Impact
• Health Information Technology Impact
• Frost and Sullivan estimates that the global
pharmaceutical R&D outsourcing market will – Pay for Performance
grow to $24.9 billion by 2007 – Evidence Based Medicine
• The Tufts Center for the Study of Drug – E-Prescribing
Development suggests that the R&D pipeline – Electronic Health Records
might be rebounding as the leading U.S. drug
Long-term benefits of these drivers will lead to an
companies have increased their clinical trials
acceleration of the drug development process and a
numbers by greater than 50 percent
development of an integration framework to closely
• Frost and Sullivan estimates that the global monitor clinical data.
pharmaceutical R&D outsourcing market will
grow to $24.9 billion by 2007 Key Accelerators
Clinical Data Capture
Clinical Study Management Challenges EDC is evolving into a standard in the drug
Internal Drivers development process to electronically capture clinical
Streamlining Internal Processes data and support large trials. EDC techniques can
• Increase clinical development operating cause a 25 percent reduction in the effort compared
efficiencies to paper based trials along with reducing labor costs.
• Corporate mandate to decrease costs One advantage of EDC allows companies to make
• Need for retrospective and prospective metrics drug safety decisions during earlier stages of
development with current information. The
Massive Data Analytical Burden technology also incorporates lab data processing,
• Variant data capture techniques to move data performs multivariate checks across different CRFs
capture closer to the patient — EDC, CDMS, for proper data identification, and handles batch
e-Sourcing, etc. validation updates and adverse event coding needs.
• Data definition for internal and external use These capabilities permit on-line solutions with data
• Data transformation entry capability with various entry points and data
exchange with remote clinical trial sites.
Application Portfolio Diversity/Legacy
• Enhance business agility
• Increase application re-usability
| The ADD Effect in Clinical Development | 2
3. File NDA at FDA File NDA at FDA transformation and standardization process are
important factors, especially within a multi-user
Pre-clinical environment and for data sharing with external
Phase I Phase II Phase III FDA Phase IV
Testing partners.
Strategy Clinical Clinical Clinical Submission SAE Another key factor for accelerating clinical
Planning Data Data Data Preparation, Handling
• Clinical Capture Management Review Review and
development is data standardization so translation of
R&D Approval information is well defined. If this is not implemented,
• HIT
this could lead to variability downstream and result in
Involves applications and individuals from many groups errors in data analysis. CRF design and templates are
and demands a high-level of communication and coordination. essential to minimize different versions of the same
form increasing variability. A knowledge management
Figure 3: Clinical Study Management Value Chain system could be implemented to leverage previous
CRF templates resulting in fewer resources and
decreased time commitments to “reinvent the wheel.”
Industry experts estimate full implementation of EDC Data standards need to be driven by requestors such
in the next 12 to 24 months with lower barriers and as the FDA and the needs of the organization such as
more offerings. The larger pharmaceutical companies medical analysis by implementing a CDISC model for
have goals for implementation of EDC and to go 75 collecting, storing and processing the data from
to 80 percent paperless in the next 12 to 18 months the trials.
(Brooks, 2006).
CDISC.org recognizes the importance of data
Merck Capital Ventures and SAIC reports that standards for the submission and review process for
Novartis utilizes EDC in 60 percent of Phase I trials the FDA. It has worked with the FDA and Eli Lilly for
and almost 100 percent of Phase II and III trials. This an analysis of mock submissions in order to create a
has led to a reduction in contractors for data working prototype for the submission of electronic
management from 90 to 20. There is also a decrease data that meets the needs of the FDA reviewers. The
in the number of queries to four per 1,000 data end result will be faster review times by the FDA and
points versus 51 per 1000 when there were paper- a decrease in costs by companies. In addition it will
based trials. The costs associated with the new help regulatory agencies identify drug interactions.
system are dramatically lower. The cost per page
Proper analysis of the data is a key factor in Clinical
goes from $23 to $4.60 when shifting from paper to
Data Intelligence. An established data repository with
EDC. In addition, the time needed for database lock
proper maintenance supports large trials and data
went from 10 weeks to 4 days with EDC. The annual
processing. Standard information is utilized in
savings is in excess of $100 million (Roner, 2006).
downstream analysis and transformations in order
Another way EDC processes are evolving is with the to input additional data. The data can also be
introduction of e-sourcing. Data capture at the leveraged in modeling and simulation for bio-
patient’s bedside results in more accurate capturing statistical analysis. CDISC Compliant Repository is not
of patient information. Paper writing by the staff and only a submission repository but also a clinical data
then transcription is no longer necessary. This results management repository which can be further utilized
in less medical and prescription errors along with for additional analysis.
better medical care management by increasing
With multiple investigator sites, clinical trial
patient safety.
management consists of having the ability to also
Clinical Data Management manage and track these studies at the various
Once all the data is collected utilizing the latest locations. The clinical trial information should be
methods, it has to be properly managed in order to shared and recorded. Any additional administrative
create value in the process. With multiple and even information should be relayed to the users relatively
global locations, real-time technology should be quickly so delays will not occur in the development
implemented for capturing any changes at any given process. Therefore it should be feasible for global
time. The ability to merge data from different scheduling and coordination and protected with
databases and adapt to new versions are necessary security features to make it compliant with the
as well. Defining and streamlining the data current rules and regulations.
| The ADD Effect in Clinical Development | 3
4. Clinical Data Exploration/Review
The patient data review process allows the ability to
look at data across all the trials implemented by the
ie s e
company. This is enhanced by a strong graphical
nc ar
Care Providers
ge lthc
report feature to visually see a layered view of all
Pu
(Public Sector/
y A ea
patient data across the trial timeline. If there are
bl
or t H
Commercial)
ic
safety issues, then proper design implementation will
la t e n
He
gu m
al
result in safety signal detection when reviewing the
Re vern
th
Ag
data. An adverse drug event system can collect,
Patients
Go
en
assess and report this event. This system will be able
ci
es
to identify minor and major events to implement the Pharmaceutical/
Payors
proper steps. Medical Product
Manufacturers
With data standardization, there will be ability for
batch processing functionality resulting efficiency in
reviewing data for specific endpoints. The data Information Technology
should also be ready for submission to the FDA via
PDF and be 21CFR 11 compliant for proper quality Figure 4
controls. It should be easily searchable, be dynamic,
and have the ability to create, track and accept
responses from queries sent to the clinical manager
Strategic Framework for Clinical
for review. Proper EDC/CDM system implementation Information Management
can reduce Discrepancy Management as an issue to Due to the high costs of Research and Development,
make sure all necessary information has been entered companies must execute new strategies for efficient
so more accurate results are obtained from the data. clinical information management to drive operating
This also results in less time and costs when efficiency and meet future R&D and regulatory
reviewing the data. requirements. These new changes lead to a more
strategic framework for planning and decision making
The increase use of HIT enables the improvement of along with an emphasis on organizational change
quality, safety and cost-effectiveness of healthcare. It management. There needs to be a focus towards the
optimizes the clinical study design by allowing development of a vision and strategy which
researchers to analyze the clinical records of a emphasizes a strategic roadmap leading to a long-
population and evaluate protocol designs before term sustainable advantage.
engaging the resources and costs into a clinical
program. There will faster recruitment of patients as
the sponsor can access eligible patients directly. Culture
Controlled product launches will allow companies and
regulators to push the drug to market faster as trial Vision and Strategy
patients are monitored more effectively. The
adaptation of evidence-based medicine guidelines Governance
factors real-world outcomes and costs while health
Process
management models better gauge health risks and
diseases within the healthcare network. Also, Relationships
performance-based contracts can be tracked to tie
reimbursement to outcomes and cost of care. Finally, Organization/People/Skillsets
personal health records can allow patients to make
knowledgeable healthcare decisions, mange their Applications and Technology
health, and enroll in studies.
Finance
Location
Analysis Framework for Future Operating Model
Figure 5: Analysis Framework for Future Operating Model
| The ADD Effect in Clinical Development | 4
5. A commitment by management to develop and closer review of a “data concierge” type enterprise-
execute a holistic, top-down, process-oriented wide governance mechanism for management and
strategy is essential for success in the competitive enforcement of data standardization, delivery and
landscape. This will result in accelerating clinical drug handling will lead to a decrease in silo-ed operational
development while lowering research and modality. Functional silos have limited information
development costs and faster revenue generation. sharing and communication available to discuss any
business issues that overlap other departments. This
$U S (M illions)
view of decision-making results in a system which is
supported by diverse, inefficient and fragmented
metrics. The lack of cross-functional data
1000 C o st C u rve
requirements definition process does not allow
800
proper leveraging of good practices among its
600
affiliates and partners. This results in an inability to
400
support the changes necessary to address strategic
200 R e ve n u e C u rve influences and opportunities. An appropriate cross-
functional governance mechanism for strategic
I II III IV architecture framework development and
P h ases C ost C urv e C h a n g e maintenance should drive operational efficiency.
R ev e n u e C urve C h a n g e
Process
C h an g e s in R e ven u e an d C o st C u rve D u e to D ru g
D e ve lo p m en t A c c e leratio n Unclear process definitions and complex data loading
processes can lead to inefficiencies in the clinical
Figure 6: Changes in Revenue and Cost Curve Due to Drug development process. A global process alignment
Development Acceleration based on core competencies can lead to a focus on
process ownership rather than a system ownership.
Vision and Strategy This can define data flow processes to address the
One of the first stages of a strategic framework future needs of modeling and simulation, medical
involves the development of a top-down, process- analysis, and biostatistics data needs. New decision
centric vision and strategy which leads to a roadmap criteria can be incorporated on new trials
and a sustained movement towards a Plan, Build and implementing patient bedside EDC as part of a
Operate Model. This requires process-based scalable implementation plan. A technology
organizational alignment and change management. A evaluation and selection process is required to
migration toward architectural simplification and a manage introduction and retirement of applications.
data integration framework will streamline data In order to streamline the process, an initial step is to
processing and discrepancy management resulting in consolidate the application portfolio into a few
application consolidation. strategic applications and implement a generic,
A strategic plan is necessary for future data flexible data processor for external partner data
management in which the development of an overall transformation needs. Furthermore, quality checking
information management strategy will meet future of data in data loading processes is required to
needs, along with a three- to five-year roadmap will ensure lesser number of discrepancies downstream.
create an advantageous long-term strategy. Another Conducting an on-going analysis of the process for
key factor is the examination of the industry and data review should eliminate organizational, process
government initiatives to determine how these will and data repository redundancies. A continuous
affect the industry and the steps needed to remain evaluation of impact from strategic influencers,
competitive. leveraging new trends and examination of the entire
value chain for clinical data management will lead to
Governance an efficient processing system.
Companies lack an enterprise-wide governance
mechanism for the management and enforcement of Relationships
its initiatives. A necessary step is to determine an Expanding beyond an external partnership that is
appropriate cross-functional decision-making transactional in nature to one that is a strategic
authority for strategic roadmap approval, execution partnership can enhance the clinical information
and oversight. This involves incorporating management process. Key competencies can be
development towards a strategic architecture with enhanced by leveraging strategic partners. For
enterprise-wide data handling and standardization. A example, the lab data management process can be
| The ADD Effect in Clinical Development | 5
6. conducted with a lower number of central labs which Other initiatives such as EDC are supported by
deliver data in one format. A critical review of lab reallocation of existing workers. An examination of
partnerships and CRO contracts is essential in the data custodianship will lead to process ownership
process in order to get the data transformed into rather than system ownership. Finally, an evaluation is
usable data. necessary to evaluate core competencies to decide
which ones will be kept in-house. This assessment will
In addition, knowledge from other partners and
determine its culture and organizational readiness for
affiliates can be beneficial as a learning tool. Also,
strategic change.
there should be a determination whether it is
advantageous to promote an external vendor’s EDC Applications and Technology
product strategy and development. An external Another part of the operating framework is the
vendor’s strategy might not meet the strategic focus incorporation of data standardization utilizing new
of the company. Another benefit of relationships is applications and technology. All incoming data can
the alignment of internal capability building plans to be set to use XML and these standards can be
external opportunities by participating in external established depending on the analysis needs. There
industry and government initiatives (NAHIT). has to be an enforcement of global standards and
increased knowledge and utilization of CRF templates
CROs can decrease costs and increase savings which
which would alleviate the problem of CRF disparity
can be utilized for strategic initiatives by the
and non-standardization. The consolidation of several
company. Companies can concentrate their resources
functionality-aligned tools into fewer, enterprise-wide
toward core competencies to create a competitive
data review tools for data searching, discrepancy
advantage while outsourcing their non-core skills.
management, and patient data review would create
This can lead to dramatic cost savings along with
sharable and scalable solutions with less human
access to expertise-level staff leading to productivity
interface. A business process management layer
gains and process improvements. A recent study by
could decouple workflows from data storage and
Tufts Center for the Study of Drug Development
integration layers.
shows the increasing reliance on CROs by drug
companies. CROs offer an advantage to companies Implementation of role-based access to decision-
while providing new insight who do not have recent making information allows the designated users to
experience in a specific therapeutic area. They help look at all trial data and safety signaling. If there is
reduce R&D costs and utilize the rise in global ambiguity in documentation outlining end-to-end
capacity needs. The study states that companies that process/architectural relationships and impacts, there
extensively use CROs result in completing projects needs to be a development of technical
faster during study close-out period while realizing documentation writing guidelines.
comparable quality to companies that don’t rely on
Regarding database options, a single reference
CROs. Also, the FDA receives submissions more than
database is ideal which can also import converted
30 days earlier than the projected date than those
lab data from outsourced study data. This will allow
who have low CRO usage.
easier access to all clinical data in the system and
CROs are involved in 23,000 Phase I – IV trials. In provide standard information to end users for
2004, $5.5 billion of global R&D spending went to analysis. A review of in-house data models could lack
clinical CROs. CROs are becoming critical for cost the benefits that a standard CDISC would provide
savings for companies to focus on their core such as interoperability between its external partners.
competencies (Getz, 2006). An industry standard would allow easier data
management and integration needed for managing
Organization/People/Skillsets
data and satisfy needs for medical review and
A movement toward the Plan, Build and Operate
planning.
Model creates a new strategic “plan” function
(through reallocation of existing workers) supporting Furthermore, SaaS can allow users to access data in
a strategy toward development and management of real-time with low initial activation costs and
enterprise architecture. This will be a separate group resources that avoid the high costs of purchasing
and mandate with appropriate budgeting and hardware needed to set up an infrastructure needed
funding. Furthermore, there is management of for an application. The timeframe for implementing
organizational change through all enterprise-wide systems for clinical trials management is much
initiatives. Workers have clearly defined roles and smaller leading to faster access and analysis of data.
responsibilities while training and matching of skill set Furthermore, management of the system is pushed to
to applications. the vendor so companies can focus on the core skills.
| The ADD Effect in Clinical Development | 6
7. Finance Conclusion
The annual budget needs to be driven by a strategic The Research and Development process is a very
vision and not just break-even goals and be costly process with limited upside potential weighing
accounted for its data management practices. Multi- heavily on a FDA-approved drug. Strategic change
year budget planning that is conditional upon and organization of the Clinical Information
achieving strategic milestones is clearly understood Management capabilities can lead to operational
by workers and should have attainable goals and efficiencies and realized cost savings for
endpoints. In order to properly judge the economic Pharmaceutical companies. A Plan, Build and Operate
impact of a data transformation system, companies Model created, supported by process-based
can conduct financial impact assessments of the non- organizational alignment and change management, is
standard data models and measure the costs for a key driver to create a foundational framework for
maintaining a set of inefficient data management enabling future capabilities. This model will sustain a
processes and nonstandard data repositories. The long-term information management strategy and
end result could push a need for standardization due communications while permitting strategic enterprise
to the cost savings calculated from the assessment. planning and project prioritization. Furthermore, it
will create a cross-functional governance model for
Location
clinical data standardization, management and reuse
With the growing trend of firms located in different
functionality. This will enhance the existing resources
parts of the world, there is an issue of location-
and create additional value to reach long-term goals.
specific processes and tools which create
inefficiencies as there are separate instances of tools
utilized in each global location and the lack of global
consistency. There are also performance issues within
global locations due to architectural and application
limitations leading to global issues. One way to
alleviate this issue is to investigate and pilot other
database architectures and outline performance
Service Line Agreements to enhance investigator
satisfaction while ensuring less discrepancy
management by data managers.
| The ADD Effect in Clinical Development | 7
8. Abbreviations
21CFR 11 Title 21 Code of Federal Regulations
CDISC Clinical Data Interchange Standards
Consortium
CDM Clinical Data Management
CDMS Clinical Data Management System
CRF Case Report Form
EDC Electronic Data Capture
FDA Food and Drug Administration
HL7 Health Level Seven
ICH International Conference on
Harmonization
M&S Modeling and Simulation
NAHIT National Alliance for Health Information
Technology
NME New Molecular Entity
R&D Research and Development
RIM Reference Information Model
SAIC Science Applications International
Corporation
XML Extensible Markup Language
SaaS Software as a Service
| The ADD Effect in Clinical Development | 8
9. References Smith, Laura. 2006. The Six Sigma Cure. Quality
Acharya, Satish. 2006. The Productivity Tiger — Time Digest.
and Cost Benefits of Clinical Drug Development in http://www.qualitydigest.com/mar06/articles/01_artic
India. Pharmalicensing. le.shtml.
http://pharmalicensing.com/features/disp/1153412098 Whiting, Rick. 2004. Standards May Speed Approval
_44bfac02291f1. of New Drugs. InformationWeek.
Brolund, Greg. 2002. Food and Drug Administration. http://www.informationweek.com/story/showArticle.jh
Drug Approvals. tml?articleID=21700481.
http://www.adobe.com/showcase/casestudies/fda/cas Wirenga, Dale and Eaton, C Robert. 2004. Phases of
estudy.pdf. Product Development.
Brooks, Kristen. 2006. CRO Update- Growth, http://www.allp.com/drug_dev.htm..
Expansion, and New Opportunities. Zisson, Steve. 2006. Time to Embrace Paperless
http://www.contractpharma.com/articles/2006/05/cr Clinical Trials.
o-industry-update.php. http://64.233.187.104/search?q=cache:n4npTkuYzloJ:w
Getz, Ken. 2006. CROs Usage Associated With Faster ww.centerwatch.com/professional/cw_commentary.ht
Drug Development Speed At Comparable Quality, ml+EDC+drug&hl=en&gl=us&ct=clnk&cd=10.
According To Tufts Center For The Study Of Drug
Development. Tufts CSDD.
DiMasi, J. et al. 2002. Returns on Research and
Development for 1990s Drug Introductions.
Pharmoeconomics 20. Suppl. 3:11-29.
Numerof, Rita and Nightingale, Jack. 2005. Guest
Opinion: R&D Prioritization — Going Beyond Decision
Analysis.
http://www.eyeforpharma.com/search.asp?news=
47331.
Roner, Lisa (1). 2006. Guest Feature — Industry At a
Crossroads. Eyeforpharma.
http://www.eyeforpharma.com/search.asp?news=
51888 .
Roner, Lisa (2). 2006. Is Pharma R&D productivity
turning the corner? Eyeforpharma.
http://www.eyeforpharma.com/search.asp?news=
50963.
Roner, Lisa (3). 2006. R&D productivity in the pharma
industry is on the cusp of improving, says the Tufts
Center for the Study of Drug Development.
EyeforPharma.
http://www.eyeforpharma.com/search.asp?news=
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Roner, Lisa (4). 2006. Driving R&D Innovation and
Value With Technology. EyeforPharma.
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Roner, Lisa (5). 2006. Improving Drug Safety With IT.
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http://www.eyeforpharma.com/search.asp?news=
48215.
9
10. About CSC’s Life Sciences R&D Solutions Enterprise Technology Integration (ETI) — Our ETI
Our solutions span the entire range of drug Practice focuses on business systems strategy — we
development, from basic research at the cellular and align the business system strategy to business and
molecular levels to human clinical trials of potential organizational strategies to ensure that technology is
medicines that prevent and cure disease. CSC’s Life not implemented for the sake of technology; rather,
Sciences R&D solutions encompass: it serves the business strategy set for R&D. Our
solutions focus on:
Strategy and Process Innovation (SPI) — Our SPI
Practice links business and organizational strategies • Enterprise Content Management — We provide
for R&D to deliver process innovation that solutions that help collaborate, control and
dramatically increases throughput in clinical comply to 21 CFR Part 11 and global regulatory
development. Our proven solutions in this space bodies. Our expertise includes EDMS strategy,
include: migration, optimization, eBLA, eCTD, SPL, and
PIM. Our thought leadership in this space and
• Adaptive Clinical Trials — We provide consulting
our 14 years of expertise in this arena help our
and industry expertise to reduce dead time
clients achieve superior results
between phases. We effectively leverage
modeling and simulation to reduce number of • Clinical Research Data Management — For
patients in trials and help conduct in-silico trials, structured data, our team provides drug
where appropriate — resulting in cost take-out development data management solutions that
and shortened development cycles are ICH, HL7 and CDISC compliant. These
systems provide a better way to manage data
• Phase I Outsourcing — Through our division,
from labs, CROs, and imaging firms and enable
Dynport Vaccine Corp. (DVC), we provide clients
our clients to achieve significant efficiency and
the ability to outsource entire Phase I studies.
productivity improvements for the R&D
We provide the program management,
organization
quantitative measures to reduce time and costs,
and proven process that enables clients to
conduct more trials effectively. We currently For more information, visit
manage 11 such trials www.csc.com/lifesciences.
• In-Licensing — We implement strategies and CSC
cutting-edge solutions to help pharmaceuticals Life Sciences Practice
and biotechs take full advantage of in-licensing 1160 West Swedesford Road, Suite 200
to augment their pipelines. Our structured Berwyn, Pennsylvania 19312
solutions ensure that no licensing opportunity is Unites States
left unnoticed, and potential blockbuster
opportunities are not given away to competition
• Bioinformatics Partnership — With the rise of
commercial genomics, companies need to
differentiate themselves from competition by
efficiently managing biostatistics analytics and
bioinformatics. CSC’s Life Sciences Practice
serves as a strategic services partner to the
client and provides standards-driven
bioinformatics solutions both through our U.S.
and Indian operations and our strategic alliances
with key partners
• Anti-Counterfeiting Solutions — We leverage our
expertise in defense, consumer products, and
supply chain to deliver novel solutions for
solving the expensive and ever-increasing drug
counterfeiting issues. Our strategy and solutions
go beyond the traditional RFID-based solutions
and provide quantifiable ROI
| The ADD Effect in Clinical Development | 10
11. About the Authors
Sanjay Modi
CSC Life Sciences
+1.973.243.0023
smodi@csc.com
Sanjay Modi works in CSC Life Sciences R&D
Solutions and is based in New York City. He holds a
MBA from The University of Maryland and a
Bachelor’s of Arts degree in Biology from The
University of Delaware.
Sanjeev Wadhwa
CSC Life Sciences
+1.973.243.0023
swadhwa@csc.com
Sanjeev Wadhwa is a partner and senior strategy
expert within CSC Life Sciences R&D Solutions.
| The ADD Effect in Clinical Development | 11