When finding the fastest path between discovery and delivery, pharmaceutical companies are increasingly looking toward Contract Research Organizations (CRO s).
As the face of the industry changes, 2020 Pharma (Ph) sits down with two CRO experts to discuss these trends.
The CDDI approach provides drug development services through a virtual asset development model using an external team of experienced professionals. This allows clients to outsource drug development functions and access dedicated experts in a flexible manner. By using CDDI's virtual teams, clients can reduce costs and infrastructure while expediting development timelines.
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.
Aula 3. artigo durand (2000). forms of-incompetenceKarlla Costa
This document summarizes a case study of organizational incompetence in innovation at a large consumer goods company called Antinnova Inc. Interviews with managers revealed several issues: 1) there was no shared understanding of what innovation means, with differing views on process vs. product innovation; 2) the company's research center operated independently without clear priorities or deadlines set by management; 3) researchers looked down on engineers and marketing requirements and were disconnected from manufacturing; 4) while researchers distanced themselves from others, they still craved recognition within the organization. These findings suggest Antinnova lacked coordination and integration across functions needed for effective product development.
This paper explores biopharma industry challenges in product development and innovation, defines PLM for the industry and provides guidance on how to get started on the PLM journey.
Yuanzhen Zhong is seeking a new position and has over 25 years of experience in product formulation and development across various industries including pharmaceutical, cosmetic, beverage, and polymer. He has a PhD in Physical Chemistry of Polymers and has held positions at companies like MonoSol Rx, Hartz Mountain, PepsiCo, L'Oreal, and ISP where he successfully developed new products and delivery technologies. He is looking to continue making contributions to new product development.
Program - 3rd Annual Drug Delivery and Formulation Summit 2013, San DiegoMark Blendheim
This document provides an agenda for a pharmaceutical development program taking place from April 30th to May 1st 2013 in San Diego, USA. The agenda includes:
- Welcome addresses and presentations on overcoming the patent cliff and improving clinical trial timelines on day 1
- Interactive workshops on oral drug delivery techniques and first-in-human formulation strategies
- Presentations on academic-government partnerships in nanotechnology and biologics development
- Panel discussion on improving development relationships and reducing costs and risk
- Additional presentations and workshops on topics including biologics modeling and simulation, enhancing solubility through micronization, and process validation.
Moving with the Times for Better Drug Development: Interview with: Hasse Kromann, Head of Section R&D Partnership Management, Innovation & Research, LEO Pharma, a speaker at the marcus evans Discovery Summit 2013, on the importance of collaboration between the pharmaceutical industry and academia.
ICH Q9 provides guidance for quality risk management in the pharmaceutical industry. It encourages companies to implement quality by design from development through production to build quality into their processes and products. This helps reduce risks and allows for more efficient monitoring. While some companies fear changing processes may not be understood by FDA inspectors, proper documentation of scientific rationale is important. Strategies that mitigate multiple risks at once can help address areas of highest risk while supporting FDA compliance and inspection. ICH Q9 aims to foster both efficient operations and regulatory compliance in the competitive pharmaceutical industry.
The CDDI approach provides drug development services through a virtual asset development model using an external team of experienced professionals. This allows clients to outsource drug development functions and access dedicated experts in a flexible manner. By using CDDI's virtual teams, clients can reduce costs and infrastructure while expediting development timelines.
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.
Aula 3. artigo durand (2000). forms of-incompetenceKarlla Costa
This document summarizes a case study of organizational incompetence in innovation at a large consumer goods company called Antinnova Inc. Interviews with managers revealed several issues: 1) there was no shared understanding of what innovation means, with differing views on process vs. product innovation; 2) the company's research center operated independently without clear priorities or deadlines set by management; 3) researchers looked down on engineers and marketing requirements and were disconnected from manufacturing; 4) while researchers distanced themselves from others, they still craved recognition within the organization. These findings suggest Antinnova lacked coordination and integration across functions needed for effective product development.
This paper explores biopharma industry challenges in product development and innovation, defines PLM for the industry and provides guidance on how to get started on the PLM journey.
Yuanzhen Zhong is seeking a new position and has over 25 years of experience in product formulation and development across various industries including pharmaceutical, cosmetic, beverage, and polymer. He has a PhD in Physical Chemistry of Polymers and has held positions at companies like MonoSol Rx, Hartz Mountain, PepsiCo, L'Oreal, and ISP where he successfully developed new products and delivery technologies. He is looking to continue making contributions to new product development.
Program - 3rd Annual Drug Delivery and Formulation Summit 2013, San DiegoMark Blendheim
This document provides an agenda for a pharmaceutical development program taking place from April 30th to May 1st 2013 in San Diego, USA. The agenda includes:
- Welcome addresses and presentations on overcoming the patent cliff and improving clinical trial timelines on day 1
- Interactive workshops on oral drug delivery techniques and first-in-human formulation strategies
- Presentations on academic-government partnerships in nanotechnology and biologics development
- Panel discussion on improving development relationships and reducing costs and risk
- Additional presentations and workshops on topics including biologics modeling and simulation, enhancing solubility through micronization, and process validation.
Moving with the Times for Better Drug Development: Interview with: Hasse Kromann, Head of Section R&D Partnership Management, Innovation & Research, LEO Pharma, a speaker at the marcus evans Discovery Summit 2013, on the importance of collaboration between the pharmaceutical industry and academia.
ICH Q9 provides guidance for quality risk management in the pharmaceutical industry. It encourages companies to implement quality by design from development through production to build quality into their processes and products. This helps reduce risks and allows for more efficient monitoring. While some companies fear changing processes may not be understood by FDA inspectors, proper documentation of scientific rationale is important. Strategies that mitigate multiple risks at once can help address areas of highest risk while supporting FDA compliance and inspection. ICH Q9 aims to foster both efficient operations and regulatory compliance in the competitive pharmaceutical industry.
Cross Industry Collaboration: Creating the enablers for disruptive modelswimdecraene
Information technologies, mature markets, relentless demand for innovation, environmental concerns and the uncertain economy are combining to drive the emergence of new growth scenarios, which are spurring companies to fundamentally rethink their growth strategies.
The vision of an economy as a set of independent industries –each serving its own customers, with its own suppliers and its own innovation chain—is in many ways outmoded. New collaborations are emerging that stretch well beyond historical industrial boundaries, nurtured by mobility, payment systems, open information, energy management and infrastructure development. This new breed of cooperation is all about unlocking synergies and exploring fresh opportunities.
Although in recent years numerous factors have combined to encourage cross-collaboration among different industries, this trend has yet to gain any real traction. The main question is which enablers are missing to spur the development of new cross-industry ecosystems?
This document discusses opportunities and challenges for integrated contract research and manufacturing services (CRAMS) companies in India. As drugs worth $85 billion go off patent by 2020, it represents an opportunity for Indian generic drug companies and CRAMS industry. CRAMS companies can partner with innovator companies in drug development from conceptualization to commercialization. However, low drug success rates and stringent regulatory requirements pose challenges. The document analyzes strengths like qualified scientists, weaknesses like quality issues, opportunities like market growth, and threats like increasing regulatory standards facing integrated CRAMS companies in India.
Studied or thinking about studying chemistry and wondering where it might lead you? This presentation discusses some options you may not have thought of. Additionally, it looks at transferrable skills
Cross Industry Collaboration - How to Boost Innovation CapabilityEric Thunberg
This document summarizes a master's thesis that explores how firms use cross-industry collaboration to boost innovation capabilities. The thesis involved interviews with 17 respondents from 15 firms with experience in cross-industry collaboration. The results showed that firms collaborate across industries for different reasons, such as accessing new technologies, exploring new values, or gaining access to new markets. The conclusions indicate that Swedish firms can develop strategies to maximize the effects of cross-industry collaboration on innovation capabilities.
Eurand, a specialty pharmaceutical company, has hired Robert Becker as their new Chief Research Officer to oversee global research and development. Becker has nearly 25 years of experience in the pharmaceutical industry. As CRO, he will consolidate Eurand's core drug delivery technologies and identify new formulation approaches to advance the company's position in drug development partnerships and as an integrated pharmaceutical company. The new role aims to make R&D a greater contributor to Eurand's success and growth by leveraging their innovation in drug delivery to support their expanding proprietary product pipeline.
Alternative approaches to developing strategic partnerships in order to drive discovery and innovation and enhance pipelines.
http://www.globaldiscoverycollaborations.com
3M offers drug delivery technologies in inhalation and transdermal delivery. Their inhalation technologies include metered-dose inhalers which help treat respiratory diseases locally with fewer side effects than oral drugs. Their transdermal technologies expand the types of drugs that can be delivered through the skin. 3M helps pharmaceutical companies develop, manufacture, and bring new products to market through services like analytical work, regulatory assistance, and manufacturing various dosage forms from clinical to commercial scale.
EnRus is a translation agency based in Moscow that was founded in 1991. It specializes in translating technical documents in fields like computer science, law, finance, and medicine from European languages into Russian and other Slavic and Turkic languages. EnRus has translated books by notable authors and works with many corporate clients who praise EnRus' expertise, quality, and responsiveness. It employs a large network of highly qualified native language translators.
The document provides an overview of wireless data communications technologies including wide area cellular services, wireless LANs, and satellite integrated wireless services. It summarizes key aspects of these technologies such as cellular network principles, GSM network architecture, GPRS and EDGE integration, 3G UMTS standards, CDMA basics, Wi-Fi, Bluetooth, and issues with wireless LAN and 3G integration.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against developing mental illness and improve symptoms for those who already suffer from conditions like anxiety and depression.
El documento habla sobre la importancia de la privacidad y la seguridad en línea en la era digital. Explica que los usuarios deben tomar medidas para proteger su información personal de posibles amenazas cibernéticas como el robo de identidad y fraude. También enfatiza la necesidad de que las empresas mejoren la protección de los datos de los clientes.
Single node hardware design is shifting to a heterogeneous nature and many of today’s largest HPC systems are clusters that combine accelerators in heterogeneous compute device architectures. The need for new programming abstractions in the advancements to the Exascale era has been widely recognized and variants of the Partitioned Global Address Space (PGAS) programming model are discussed as a promising approach in this respect DASH is a C++ template library that provides distributed data structures with support for hierarchical locality in a PGAS programming model. Portable efficiency, an essential goal in the design of DASH, can only be achieved with programming abstractions of hardware locality that allow to optimize data structures and algorithms to the underlying system at compile- and run time. Established tools like LIKWID and hwloc provide reliable interfaces to query the hardware topology on node level but fail to construct a global representation of distributed locality domains and do not support accelerator architectures like Intel MIC. We present Locality Hierarchies, an abstraction of distributed, hierarchical locality represented as a modifiable data structure. The underlying model supports heterogeneous systems as first-class use case and introduces a well-defined concept of distance for arbitrary distributed hardware hierarchies. Using common range-based algorithms as motivating examples, we explain how our approach facilitates locality-aware load-balancing and process mapping on SuperMIC compute nodes.
DASH: A C++ PGAS Library for Distributed Data Structures and Parallel Algorit...Menlo Systems GmbH
DASH is a C++ PGAS library that provides distributed data structures and parallel algorithms. It offers a global address space without a custom compiler. DASH partitions data across multiple units through various distribution patterns. It supports distributed multidimensional arrays and efficient local and global access to data. DASH includes many parallel algorithms ported from STL and supports asynchronous communication. It aims to simplify programming distributed applications through its data-oriented approach.
A Multidimensional Distributed Array Abstraction for PGAS (HPCC'16)Menlo Systems GmbH
DASH is a C++ template library that offers distributed data structures and parallel algorithms for PGAS programming without a custom compiler. It provides a unified access to local and remote data through a global address space. DASH contains multidimensional distributed arrays, lists, maps and other containers, and growing set of parallel algorithms like fill, copy, reduce that also work on multidimensional ranges. It achieves portable efficiency through algorithms like SUMMA for matrix multiplication that leverage high performance libraries like Intel MKL. Benchmarks show DASH outperforms equivalent functions in ScaLAPACK, PLASMA and Intel MKL.
This document outlines a chapter on socialization from the Royal University of Phnom Penh. It discusses the process of socialization and how it occurs from a young age through childhood and into adulthood. Socialization involves learning the customs, attitudes and values of one's culture through both formal and informal education. It examines several theories of socialization, including how children develop a sense of self through interacting with others and imagining how they appear, as well as learning to take on social roles. Socialization is crucial for healthy development and occurs through interactions with family, teachers, and society.
The document summarizes two models of second language acquisition: the competition model and connectionist approaches. The competition model assumes language learning involves mapping between forms and functions. Connectionist approaches model mental phenomena as interconnected networks, focusing on strengthening associations between stimuli and responses through repeated exposure. Specifically, parallel distributed processing posits that language learning occurs through the simultaneous, parallel processing of multiple linguistic units in the brain, with connection strengths changing based on input frequency and feedback.
The document discusses Michael Long's interactional hypothesis, which is based on Stephen Krashen's input hypothesis. The interactional hypothesis proposes that negotiated interaction between learners and their interlocutors can qualitatively change the nature of the input, facilitating language acquisition. When communication breaks down, interlocutors provide modified input through repetition, confirmation checks, comprehension checks, and clarification requests to aid comprehension. While interaction can help comprehension, it is not solely responsible for acquisition and individual differences are also important factors. The interactional hypothesis perspective has limitations but provides insights applicable for language teaching.
Expressing and Exploiting Multi-Dimensional Locality in DASHMenlo Systems GmbH
DASH is a realization of the PGAS (partitioned global address space) programming model in the form of a C++ template library. It provides a multidimensional array abstraction which is typically used as an underlying container for stencil- and dense matrix operations.
Efficiency of operations on a distributed multi-dimensional array highly depends on the distribution of its elements to processes and the communication strategy used to propagate values between them. Locality can only be improved by employing an optimal distribution that is specific to the implementation of the algorithm, run-time parameters such as node topology, and numerous additional aspects. Application developers do not know these implications which also might change in future releases of DASH.
In the following, we identify fundamental properties of distribution patterns that are prevalent in existing HPC applications.
We describe a classification scheme of multi-dimensional distributions based on these properties and demonstrate how distribution patterns can be optimized for locality and communication avoidance automatically and, to a great extent, at compile time.
R&D presidents face the challenge of balancing both scientific and operational responsibilities. However, it is difficult for one person to effectively manage both roles. The document proposes appointing a Chief Operating Officer (COO) of R&D to allow the R&D president to focus solely on scientific matters while the COO handles operational issues like managing external partnerships, improving processes, and overseeing support functions. This division of roles has been successfully implemented in other industries and could help R&D organizations run more efficiently and improve performance.
Cross Industry Collaboration: Creating the enablers for disruptive modelswimdecraene
Information technologies, mature markets, relentless demand for innovation, environmental concerns and the uncertain economy are combining to drive the emergence of new growth scenarios, which are spurring companies to fundamentally rethink their growth strategies.
The vision of an economy as a set of independent industries –each serving its own customers, with its own suppliers and its own innovation chain—is in many ways outmoded. New collaborations are emerging that stretch well beyond historical industrial boundaries, nurtured by mobility, payment systems, open information, energy management and infrastructure development. This new breed of cooperation is all about unlocking synergies and exploring fresh opportunities.
Although in recent years numerous factors have combined to encourage cross-collaboration among different industries, this trend has yet to gain any real traction. The main question is which enablers are missing to spur the development of new cross-industry ecosystems?
This document discusses opportunities and challenges for integrated contract research and manufacturing services (CRAMS) companies in India. As drugs worth $85 billion go off patent by 2020, it represents an opportunity for Indian generic drug companies and CRAMS industry. CRAMS companies can partner with innovator companies in drug development from conceptualization to commercialization. However, low drug success rates and stringent regulatory requirements pose challenges. The document analyzes strengths like qualified scientists, weaknesses like quality issues, opportunities like market growth, and threats like increasing regulatory standards facing integrated CRAMS companies in India.
Studied or thinking about studying chemistry and wondering where it might lead you? This presentation discusses some options you may not have thought of. Additionally, it looks at transferrable skills
Cross Industry Collaboration - How to Boost Innovation CapabilityEric Thunberg
This document summarizes a master's thesis that explores how firms use cross-industry collaboration to boost innovation capabilities. The thesis involved interviews with 17 respondents from 15 firms with experience in cross-industry collaboration. The results showed that firms collaborate across industries for different reasons, such as accessing new technologies, exploring new values, or gaining access to new markets. The conclusions indicate that Swedish firms can develop strategies to maximize the effects of cross-industry collaboration on innovation capabilities.
Eurand, a specialty pharmaceutical company, has hired Robert Becker as their new Chief Research Officer to oversee global research and development. Becker has nearly 25 years of experience in the pharmaceutical industry. As CRO, he will consolidate Eurand's core drug delivery technologies and identify new formulation approaches to advance the company's position in drug development partnerships and as an integrated pharmaceutical company. The new role aims to make R&D a greater contributor to Eurand's success and growth by leveraging their innovation in drug delivery to support their expanding proprietary product pipeline.
Alternative approaches to developing strategic partnerships in order to drive discovery and innovation and enhance pipelines.
http://www.globaldiscoverycollaborations.com
3M offers drug delivery technologies in inhalation and transdermal delivery. Their inhalation technologies include metered-dose inhalers which help treat respiratory diseases locally with fewer side effects than oral drugs. Their transdermal technologies expand the types of drugs that can be delivered through the skin. 3M helps pharmaceutical companies develop, manufacture, and bring new products to market through services like analytical work, regulatory assistance, and manufacturing various dosage forms from clinical to commercial scale.
EnRus is a translation agency based in Moscow that was founded in 1991. It specializes in translating technical documents in fields like computer science, law, finance, and medicine from European languages into Russian and other Slavic and Turkic languages. EnRus has translated books by notable authors and works with many corporate clients who praise EnRus' expertise, quality, and responsiveness. It employs a large network of highly qualified native language translators.
The document provides an overview of wireless data communications technologies including wide area cellular services, wireless LANs, and satellite integrated wireless services. It summarizes key aspects of these technologies such as cellular network principles, GSM network architecture, GPRS and EDGE integration, 3G UMTS standards, CDMA basics, Wi-Fi, Bluetooth, and issues with wireless LAN and 3G integration.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against developing mental illness and improve symptoms for those who already suffer from conditions like anxiety and depression.
El documento habla sobre la importancia de la privacidad y la seguridad en línea en la era digital. Explica que los usuarios deben tomar medidas para proteger su información personal de posibles amenazas cibernéticas como el robo de identidad y fraude. También enfatiza la necesidad de que las empresas mejoren la protección de los datos de los clientes.
Single node hardware design is shifting to a heterogeneous nature and many of today’s largest HPC systems are clusters that combine accelerators in heterogeneous compute device architectures. The need for new programming abstractions in the advancements to the Exascale era has been widely recognized and variants of the Partitioned Global Address Space (PGAS) programming model are discussed as a promising approach in this respect DASH is a C++ template library that provides distributed data structures with support for hierarchical locality in a PGAS programming model. Portable efficiency, an essential goal in the design of DASH, can only be achieved with programming abstractions of hardware locality that allow to optimize data structures and algorithms to the underlying system at compile- and run time. Established tools like LIKWID and hwloc provide reliable interfaces to query the hardware topology on node level but fail to construct a global representation of distributed locality domains and do not support accelerator architectures like Intel MIC. We present Locality Hierarchies, an abstraction of distributed, hierarchical locality represented as a modifiable data structure. The underlying model supports heterogeneous systems as first-class use case and introduces a well-defined concept of distance for arbitrary distributed hardware hierarchies. Using common range-based algorithms as motivating examples, we explain how our approach facilitates locality-aware load-balancing and process mapping on SuperMIC compute nodes.
DASH: A C++ PGAS Library for Distributed Data Structures and Parallel Algorit...Menlo Systems GmbH
DASH is a C++ PGAS library that provides distributed data structures and parallel algorithms. It offers a global address space without a custom compiler. DASH partitions data across multiple units through various distribution patterns. It supports distributed multidimensional arrays and efficient local and global access to data. DASH includes many parallel algorithms ported from STL and supports asynchronous communication. It aims to simplify programming distributed applications through its data-oriented approach.
A Multidimensional Distributed Array Abstraction for PGAS (HPCC'16)Menlo Systems GmbH
DASH is a C++ template library that offers distributed data structures and parallel algorithms for PGAS programming without a custom compiler. It provides a unified access to local and remote data through a global address space. DASH contains multidimensional distributed arrays, lists, maps and other containers, and growing set of parallel algorithms like fill, copy, reduce that also work on multidimensional ranges. It achieves portable efficiency through algorithms like SUMMA for matrix multiplication that leverage high performance libraries like Intel MKL. Benchmarks show DASH outperforms equivalent functions in ScaLAPACK, PLASMA and Intel MKL.
This document outlines a chapter on socialization from the Royal University of Phnom Penh. It discusses the process of socialization and how it occurs from a young age through childhood and into adulthood. Socialization involves learning the customs, attitudes and values of one's culture through both formal and informal education. It examines several theories of socialization, including how children develop a sense of self through interacting with others and imagining how they appear, as well as learning to take on social roles. Socialization is crucial for healthy development and occurs through interactions with family, teachers, and society.
The document summarizes two models of second language acquisition: the competition model and connectionist approaches. The competition model assumes language learning involves mapping between forms and functions. Connectionist approaches model mental phenomena as interconnected networks, focusing on strengthening associations between stimuli and responses through repeated exposure. Specifically, parallel distributed processing posits that language learning occurs through the simultaneous, parallel processing of multiple linguistic units in the brain, with connection strengths changing based on input frequency and feedback.
The document discusses Michael Long's interactional hypothesis, which is based on Stephen Krashen's input hypothesis. The interactional hypothesis proposes that negotiated interaction between learners and their interlocutors can qualitatively change the nature of the input, facilitating language acquisition. When communication breaks down, interlocutors provide modified input through repetition, confirmation checks, comprehension checks, and clarification requests to aid comprehension. While interaction can help comprehension, it is not solely responsible for acquisition and individual differences are also important factors. The interactional hypothesis perspective has limitations but provides insights applicable for language teaching.
Expressing and Exploiting Multi-Dimensional Locality in DASHMenlo Systems GmbH
DASH is a realization of the PGAS (partitioned global address space) programming model in the form of a C++ template library. It provides a multidimensional array abstraction which is typically used as an underlying container for stencil- and dense matrix operations.
Efficiency of operations on a distributed multi-dimensional array highly depends on the distribution of its elements to processes and the communication strategy used to propagate values between them. Locality can only be improved by employing an optimal distribution that is specific to the implementation of the algorithm, run-time parameters such as node topology, and numerous additional aspects. Application developers do not know these implications which also might change in future releases of DASH.
In the following, we identify fundamental properties of distribution patterns that are prevalent in existing HPC applications.
We describe a classification scheme of multi-dimensional distributions based on these properties and demonstrate how distribution patterns can be optimized for locality and communication avoidance automatically and, to a great extent, at compile time.
R&D presidents face the challenge of balancing both scientific and operational responsibilities. However, it is difficult for one person to effectively manage both roles. The document proposes appointing a Chief Operating Officer (COO) of R&D to allow the R&D president to focus solely on scientific matters while the COO handles operational issues like managing external partnerships, improving processes, and overseeing support functions. This division of roles has been successfully implemented in other industries and could help R&D organizations run more efficiently and improve performance.
'Setting New Standards...one small company brings industry giants together'The Avoca Group
The Avoca Group brought together major pharmaceutical companies and contract research organizations to form the Avoca Quality Consortium in response to increasing FDA scrutiny of outsourced clinical trials. The Consortium aims to develop higher quality management standards for clinical trials through open collaboration. With 25 members so far, the Consortium seeks to establish global standards that improve patient safety and benefit the industry.
International Pharmaceutical Industry: Feasibility Is Not (Anymore) A Plain S...KCR
Investigational Sites
The sole term ‘feasibility’ has multiple definitions in a clinical environment, leading to certain bias with all stakeholders involved, including pharma companies (sponsors) and all types of contract research organizations (CROs). The most common perception is related to a never-ending argument between pharma outsourcing departments and CRO commercial groups, with sponsors expecting CROs to run a (non-defined) feasibility study prior to proposal submission and CROs undertaking a series of schematic actions to create an impression of fulfilled expectation.
Collaboration across the pharma enterpriseAmy Morgan
This paper examines key success factors for effective collaboration in the pharmaceutical industry. In an industry where speed to market is critical and where informed and timely decisions can have large financial implications, collaboration is a key factor to ensure value is delivered. Consequently, considerable investment is being made by pharmaceutical companies to enable project teams to work more effectively together across departmental, functional, company and geographic boundaries.
Optimization and management observations and ideas for clinical studiesrpochadt
This document outlines challenges facing clinical trials and proposes ideas to improve efficiency. It notes that clinical trials are increasingly time-consuming, expensive, and complex. Several ideas are presented to help address these issues, including making trials more adaptive, leveraging technology like cloud computing and mobile devices, improving data management systems, and learning from practices in other industries like Six Sigma. The document advocates bringing more of these types of ideas to clinical trials in order to help accelerate the process and better support researchers and patients.
This document provides an abstract and table of contents for a research paper that examines the impact of communication on mergers and acquisitions in the life sciences industry, using the Pfizer-Wyeth acquisition as a case study. The abstract outlines that the paper aims to understand how strategic communication can impact M&A business outcomes and reputation, and how it can emphasize clinical value. It also provides an overview of the paper's theoretical framework and methodology. The table of contents provides further detail on the structure and content of each chapter.
- CROs (Contract Research Organizations) are organizations contracted by pharmaceutical companies to conduct clinical trials and other drug development services. Outsourcing to CROs allows companies to reduce costs and accelerate drug development timelines without requiring large in-house capabilities.
- Key responsibilities of CROs include managing clinical sites and trials, conducting bioanalytical testing, and performing pharmacokinetic analyses. Proper qualification of CROs and ongoing communication are important for successful partnerships. Outsourcing can increase capacity and reduce development cycles for pharmaceutical sponsors.
This document discusses the benefits of using a process-driven clinical research organization (CRO) to manage clinical trials. It notes that clinical trials are increasingly complex and costly, creating challenges for drug developers. A process-driven CRO employs experts, proven processes, technologies and metrics to reduce risks, improve communication and ensure trials are completed efficiently and on schedule. The document provides an example of how one sponsor was able to cut patient enrollment time in half using a process-driven CRO. It outlines key criteria for evaluating CROs and highlights how INC Research meets these criteria through its Trusted Process methodology.
This document discusses the benefits of using a process-driven clinical research organization (CRO) partner to reduce risks and improve efficiencies in drug development. It outlines challenges such as longer trials, stricter safety standards, lack of transparency from CROs, and reluctance to change CROs. Process-driven CROs employ experts, proven processes, technologies and metrics to anticipate and mitigate risks, improve communication, and help sponsors meet milestones on time and on budget. Eight of the top ten pharmaceutical companies use INC Research, which provides therapeutic expertise, global reach, and metrics showing trials are completed ahead of schedule on average.
READ PROJECT CASE STUDY FIRSTResearch at least 2 organizations.docxmakdul
READ PROJECT CASE STUDY FIRST
Research at least 2 organizations that have had similar issues and successes as your project case study.
For this assignment, write a 1-2 page analysis of the change methods that were implemented to address the organization's problems. Compare and contrast to your chosen change model.
· Include an example of at least three similarities and three differences.
· Include a minimum of two peer-reviewed sources.
· Organizations will be utilized as references in your research paper.
Module 02 Project - Overview and Outline
Project - Part 1 - Project Overview
In a 1-page summary, give an overview of the Delta Pacific case study, listing at least three key takeaways of what you gleaned from the study. Share two separate contingency models that could be used to affect the organizational change and share which model you plan to use as your part of your change initiative.
Project - Part 2 - Outline (FOLLOW SAMPLE OUTLINE FORMAT BELOW)
Now it's time to create an outline of your paper. The outline should consist of the following:
· Introduction
· Overview
· Thesis
· Supporting Topics/Ideas (a minimum of three)
· Recommendations (a minimum of two)
· Conclusion
· References
For content this week, review the issues at Delta Pacific and select your change model. Determine which leadership style will be implemented through your change initiative. This observation should be noted within your project proposal.
Additionally, review your Myers-Briggs results (mine is listed below) and as an informed leader, determine whether you are the ideal leader for this change initiative. If you determine another candidate would be better suited, then describe the perfect characteristics of the preferred candidate.
My Myers-Briggs Results
Humanmetrics Jung Typology Test™
Your Type
ISFJ
Introvert(38%) Sensing(59%) Feeling(12%) Judging(12%)
· You have moderate preference of Introversion over Extraversion (38%)
· You have distinct preference of Sensing over Intuition (59%)
· You have slight preference of Feeling over Thinking (12%)
· You have slight preference of Judging over Perceiving (12%)
SAMPLE OUTLINE FORMAT TO FOLLOW IS BELOW
Thesis: The Solo practice has been on the forefront in the active improvement of quality of service for all its patients. The clinic has gained solid grounds in the realm of health care since it was founded as evidenced by the numerous inflows of patients who previously received treatment elsewhere. Our health practitioners have reported high levels of job satisfaction due to the serene working environment provided by the Solo practice.
I. Introduction
A. The project will be fully centered on discussing the Solo practice which was founded for the purpose of increasing customer involvement in conducting health care services. The clinic is inclined to operate as a patient-driven facility which offers patients an opportunity to propose ways of improving the services provided. This will increase the probability of ...
Lighting the Way - The Era of the ARO (European Pharmaceutical Contractor, Au...Cyrus Park
We are entering a new era of the ARO, one that challenges the current paradigm of clinical development and the numerous offerings of CROs. It will not be long before AROs play a more central role in pharmaceutical clinical development plans.
AROs, like Julius Clinical, have evolved over the years, giving rise to various definitions of what an ARO is and what it isn’t. In this opinion piece, published in the European Pharmaceutical Contractor (EPC) magazine, Cyrus Park highlights four common misperceptions about academic research organizations (AROs) and attempts to dispel some of the misconceptions from his own observations. The full article can be read here.
Intersting article written some time ago by Robert Hennessy, GLOBAL Practice Team Leader – Pharma/ Health Care/ Life Science, ( http://aims-international.net/global-teams/health-care/find-a-leader )before he joined AIMS International.
Treating job applicants well creates ambassadors for companies’
images and brands, even if they don’t get hired.
This document discusses project management challenges in pharmaceutical research and development. It aims to balance the costs of drug development with innovation. The R&D process is described involving discovery, preclinical, and clinical trial phases. R&D costs have significantly increased in recent decades due to factors like longer clinical trials. Measuring innovation based only on new drug approvals does not fully capture improvements to existing drugs. From a project management perspective, key challenges include scope management, time management, and resource management given the technical risks and long durations of drug development projects.
The document summarizes news from the clinical research industry, including:
1) MDS Pharma announcing plans to split its early-stage CRO division and sell it to Ricerca Biosciences and a private investment firm.
2) United BioSource Corporation opening its first office in Asia-Pacific, located in Tokyo, Japan.
3) Industry briefs on partnerships between CROs, new client contracts, financial results, and technology company performance.
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2. case studies
as cros go, charles river is one of the largest, with 9,000 employees worldwide and
over 60 facilities in 15 countries. We talk with two Charles River vice Presidents,
2
stephanie Wells and Nancy gillett, about the current trend of outsourcing by pharma-
ceutical and biotechnology companies
drug discovery
When finding the fastest path between discovery and delivery,
pharmaceutical companies are increasingly looking toward
contract research organizations (cros). As the face of the particularly the mid-development area around the
industry changes, 2020 Pharma (Ph) sits down with two regulatory required studies. They are no longer
CRO experts to discuss these trends. maintaining the expertise in specific areas where
they used to. For example: reproductive toxicology.
Ph: Are Contract Research Organizations of the cases, it’s a much deeper partnership. We’re That expertise is very specialized, requiring a strong
(CROs) in greater demand today than in past looking at taking on whole programs and we have historical control base and unique scientific exper-
years, and if so, why? a deeper expertise around the effects of particular tise. also, these studies typically are conducted late
sW: We are definitely seeing an increase in classes of molecules. it feels much more like an in the development process. so we’re seeing more
demand from our clients for outsourcing services, equal partnership than in previous years. it is also a companies choosing not to maintain that expertise
despite the fact that the overall pharmaceutical and more fun business model and gives us opportuni- internally and to rely instead on cros. That builds
biotech industry is somewhat depressed from a ties to evolve and integrate with our customers. efficiency into the process, because instead of
research and development (r&d) point of view. a fixed infrastructure with costs of both people
This is because there is a changing business model Ph: How can CROs affect the R&D process of and facilities that are doing these studies only
occurring out there: our clients are increasingly major pharmaceutical companies? occasionally, you’re getting into a situation where
looking to strengthen their pipeline while manag- sW: Historically, the larger companies have specific people are doing these studies routinely for
ing, or even decreasing their internal resource lacked agility — and connecting all of the multiple a variety of companies — making it more efficient
base and their capital expenditures. This means operating functions within the corporation has for everyone.
they’re focusing on defining core competencies always been a challenge. With the current move sW: increasingly, because of the need for effi-
and predominantly directing these to early pipeline toward reinventing the r&d process to acceler- ciency, the large corporations are looking for
development, compound qualification and so on. ate pipeline development and time-to-market, it’s standardization globally — although there is an
From the cros, these companies are there- causing a lot of internal tension in the companies, understanding that there are different regulatory
fore looking for operational efficiencies to stand- and there are clearly some political issues going on. standards. in many cases, these companies have
ardize procedures and processes; the facilitation of also, management direction seems less clear than it built their portfolios through acquisition of smaller
the drug development pathway; and expert advice was in the past, due to the speed of change. cros companies or licensing in compounds; they have
on study types and compound classes that can help can help by breaking down some of those internal lots of different processes and ways of doing things.
improve the design and implementation of the barriers that previously separated departments, We’re being seen as a way to help standardize some
study. consequentially, we’re seeing a change in functions and capability sets in the r&d process of this across their organization, and at least pro-
that relationship in many different dimensions, but within large corporations. We can facilitate that vide guidance about best- practice approaches.
the trend is definitely moving toward deeper part- process and replace parts of it as well. in the past, they’ve been able to deal with
nerships rather than supplier- vendor relationships, Ng: in previous years, major pharmaceutical the volatility of fluctuation in the pipeline and
and there is a lot more consultation and dialogue companies wanted complete control along every matching their workforce requirements with that.
between the two parties. step of the pipeline — from early discovery to However, the days of being able to have 20 percent
Ng: From my perspective, we definitely see that development to marketing. With the current extra capacity in any dimension is really over, given
change. i’ve been working in cros since 1994, challenges of identifying new therapeutics and the financial-performance requirements of many of
and it used to be just a vendor relationship with controlling cost, they’re finding that they need our clients. as a result, utilizing external resources
pharmaceutical companies. For instance, we’d get a to focus on their core competencies, which are helps balance the workload/workforce issues.
study and many times we wouldn’t know the nature more in the early stages of drug discovery and then
of the compound and so forth. during those years, again in the post-market stage of distribution, sales Ph: Do CROs specialize in new tools and tech-
cros were regarded as a ittle bit second-class in and marketing. We’re seeing them more willing nology to accelerate drug development? If so,
terms of the level of science. Now, in the majority to outsource, or relinquish control, in key areas, which ones are being focused on currently?
20/20 Pharma
3. case studies
Ng When i talk to new scientists in the cro models within oncology and inflammation. We’re development to get to approval of a product. We
business about safety assessment, i characterize us very pleased with our recent acquisition are particularly proud of the fact that we have
as being one step behind the cutting edge, so we’re of a company called Mir (Molecular imaging the Navigators, a group of individuals within the
3
not necessarily the group that would want to be research) that has expertise in imaging across company, who have previously worked at the Fda
drug discovery
using brand-new technologies that haven’t been a variety of different technologies working with and know what a reviewer is looking for in terms of
validated. We’re experts at taking technologies that laboratory animals. so we do see it continuing to safety and risk assessment for humans. They’re able
have been determined to be useful and using them be expanded in the early discovery arena, but also to actually sit down with these clients when design-
to advance the decision-making process, because imaging is going to increase in the field of pathol- ing the studies, discussing the particular compound
that’s what it’s really all about: How quickly can ogy, where it becomes an easy, quick way to share class and what the intended use is.
you decide if this compound is likely to make it to images across different geographies — both with The Fda has differing requirements in terms
being a drug or not? clients and with different sites. of the studies that are necessary, based on the in-
We want to be able to say, “This technology is sW: The example of acquiring Mir is a good tended use of the compound. For instance, expec-
one that’s being used by a number of key players way for us to demonstrate supporting research in tations will vary for a drug intended for children,
in drug discovery or drug development.” Then it’s the discovery space, along with developing dis- as opposed to that for a terminal cancer patient.
something that we can put in an offering to our ease-specific models. This is a great example of a often, it may be that some of the studies wouldn’t
clients. We can do it in a regulatory compliant man- complimentary technology that is really state- of- be appropriate in a particular animal model to
ner, which in many cases, as with something com- the-art in offering multiple modalities for in vivo determine if there’s an unknown toxicity. What our
ing out of academia, wouldn’t necessarily be done imaging. These services permit a lot of new types of people are able to do is design an efficient package
in that way. We certainly are always looking for new investigation, particularly in oncology and inflam- of studies. We will then also be able to sit down
tools and technologies to add to our offerings to mation studies. it is also a great example of a strate- with the client, discuss the intended program with
the client. We do get many opportunities to look gic add-on that enhances our portfolio but still very the Fda, and be a partner for them. it’s increasing-
at new tools, and many are very interesting and fun much focuses on supporting the drug development ly important to be able to provide the expertise in
from a science perspective — and i am a scientist process. That’s an area that perhaps we are unique regulatory strategic design, not only for the bigger
— but they don’t always change the decision point. in as a cro: We can add incremental value with companies who want to offload an entire program,
some new technologies, where cros do par- our portfolio of tools to help in the discovery but for the small companies that may have never
ticularly excel, are developed during the evolution phase — we can aid in identifying the right target taken a molecule down the development path.
of new, specific therapeutic classes. For example, compounds before more money is invested in later sW: The cro experience level is obviously built
there is a lot of work going on in stem cells, ribo- stages, and more expensive development activities. over time, and is something that can be shared with
nucleic acid interference and oligonucleotides. less- experienced companies or even in shaping
in many cases, we are the ones that do the initial Ph: With frequently reported FDA “crack- newer markets as a whole. With trends and ex-
efficacy and safety work, and we therefore end downs” in an often changing compliance land- pectations moving toward global standardization,
up being more knowledgeable about the classif- scape, how can CROs help navigate the world of this is especially important. We’re hearing that,
fects of specific therapeutic areas than individual FDA regulations? wherever a product or drug might come from, the
companies. That’s one place where growth of our Ng: cros do of course provide help to the global consumer is expecting the standards to be
knowledge and expertise accumulates more rap- major pharmaceutical companies, but many times the same. so setting standards high and implement-
idly than for companies individually. our work is coming from the smaller biotechnol- ing, albeit in a collaborative way, Western standards
transitioning to more innovative areas, imag- ogy companies, or the almost virtual companies in emerging markets is essential to ensure quality
ing technology will be very important in the future, with very few people, that don’t have the expertise processes and outcomes, particularly in an area as
and no one yet has fully grasped all of the ways in terms of regulatory requirements. They need sensitive and important as drug development. as
in which it can be applied, although there is cer- assistance in understanding what it takes to get a cro, we are highly focused on compliance and
tainly a lot of imaging that is being applied to early through the set of studies in order to proceed to the meeting regulatory goals; everything we do is in
discovery, particularly in some of the early efficacy first-dosing stage in humans, or the path of that domain.
stePHaNie Wells is senior vice President and chief Marketing officer at charles river. as cMo, Ms. Wells is charged with
developing and implementing a brand and marketing strategy that enhances the company’s ability to meet customers’ evolving needs.
Born in the uK, she has more than 25 years of international experience in the healthcare industry. this expertise, coupled with a clinical
biochemistry background, enables Ms. Wells to successfully spearhead initiatives that appeal to the global scientific community. Ms. Wells
holds the equivalent of a bachelor’s degree in Medical laboratory sciences and clinical chemistry from Paddington college, london,
england.
NaNcy gillett d.v.M, PH.d., is the corporate executive vice President and President, global Preclinical services at charles river.
she has more than 23 years of experience as an acvP board-certified pathologist and scientific manager. Her deep understanding of the
scientific community helps ensure that charles river provides a unique portfolio of products and services to help accelerates clients’ drug
development programs. dr. gillett received her d.v.M. degree from Washington state university and her Ph.d. degree from the univer-
sity of california, davis. in May 2006, dr. gillett received an Honorary doctor of science degree from Purdue university.
20/20 Pharma