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.
National Genecular Institute (NGI) is establishing a large biobank called the BioTrust to advance research in personalized medicine. The BioTrust will collect and store biological samples like DNA, cells, tissue and blood, along with associated medical history data, to help researchers study complex diseases. NGI aims to collect over 15 million ethnically diverse samples to create one of the largest biological sample repositories in the world. By continuously updating the medical histories of donors, the BioTrust will provide researchers with a unique resource to study diseases and develop customized treatments tailored to individual genetics. NGI's biobank supports both its own research and drug development efforts as well as work by external scientists.
Drug Delivery Systems Americas (2011) PpPiyush Patel
The two-day Drug Delivery Systems Americas conference in Boston will focus on the latest scientific research, manufacturing, and commercial opportunities in drug delivery systems. Key topics will include drug formulations for small molecules, proteins, peptides, and biologics; delivery technologies such as controlled release, nanotechnology, and biologics targeting; commercialization aspects including partnering, outsourcing, and regulations; and case studies. Over 20 industry leaders from companies including Novartis, Pfizer, Genzyme, and Abbott will present on challenges and innovations in developing advanced drug delivery technologies. Attendees will gain insights on enhancing bioavailability, managing product lifecycles, and identifying strategic partnerships in the growing field of drug delivery.
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.
Will Biosimilars Be A Driver For InnovationAjaz Hussain
The Biosimilar debate touches upon several important reasons for innovation failure in a regulated environment – successful, scientific, resolution will be important for the entire sector.
Ws from innovation to commercialisation marcel van der sluisIventus
Presentation of dr. Marcel van der Sluis, Manager BD Drug Development Cluster at the Workshop 'From Innovation to Commercialisation' during the Dutch Life Sciences & Health Conference 2010
The document discusses using a tobacco-based manufacturing platform for rapidly and cost-effectively producing vaccines and therapeutics. It outlines the business model, which involves licensing the technology to larger biotech companies, and describes initial customer feedback indicating the flu vaccine market may be difficult to enter but the therapeutics market, such as for alpha-1 antitrypsin, could be more promising. Prototyping efforts involve further characterizing alpha-1 antitrypsin production in tobacco plants.
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.
Networks For Innovation Principal Attributes For Their Formation And Optimiza...Caspar Rijnbach v.
This document discusses frameworks for optimizing a company's innovation network architecture and composition. It presents five main business objectives for developing partner networks for technological collaboration: 1) Increase profitability 2) Shorten time to market 3) Enhance innovation capability 4) Create greater flexibility in R&D and 5) Expand market access. It also outlines the types of partners a company may seek out for different stages of research and development based on the required expertise, such as universities for pure science or manufacturers for advanced development. The goal is to define attributes that impact the formation and optimization of innovation networks based on network objectives and participant characteristics.
National Genecular Institute (NGI) is establishing a large biobank called the BioTrust to advance research in personalized medicine. The BioTrust will collect and store biological samples like DNA, cells, tissue and blood, along with associated medical history data, to help researchers study complex diseases. NGI aims to collect over 15 million ethnically diverse samples to create one of the largest biological sample repositories in the world. By continuously updating the medical histories of donors, the BioTrust will provide researchers with a unique resource to study diseases and develop customized treatments tailored to individual genetics. NGI's biobank supports both its own research and drug development efforts as well as work by external scientists.
Drug Delivery Systems Americas (2011) PpPiyush Patel
The two-day Drug Delivery Systems Americas conference in Boston will focus on the latest scientific research, manufacturing, and commercial opportunities in drug delivery systems. Key topics will include drug formulations for small molecules, proteins, peptides, and biologics; delivery technologies such as controlled release, nanotechnology, and biologics targeting; commercialization aspects including partnering, outsourcing, and regulations; and case studies. Over 20 industry leaders from companies including Novartis, Pfizer, Genzyme, and Abbott will present on challenges and innovations in developing advanced drug delivery technologies. Attendees will gain insights on enhancing bioavailability, managing product lifecycles, and identifying strategic partnerships in the growing field of drug delivery.
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.
Will Biosimilars Be A Driver For InnovationAjaz Hussain
The Biosimilar debate touches upon several important reasons for innovation failure in a regulated environment – successful, scientific, resolution will be important for the entire sector.
Ws from innovation to commercialisation marcel van der sluisIventus
Presentation of dr. Marcel van der Sluis, Manager BD Drug Development Cluster at the Workshop 'From Innovation to Commercialisation' during the Dutch Life Sciences & Health Conference 2010
The document discusses using a tobacco-based manufacturing platform for rapidly and cost-effectively producing vaccines and therapeutics. It outlines the business model, which involves licensing the technology to larger biotech companies, and describes initial customer feedback indicating the flu vaccine market may be difficult to enter but the therapeutics market, such as for alpha-1 antitrypsin, could be more promising. Prototyping efforts involve further characterizing alpha-1 antitrypsin production in tobacco plants.
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.
Networks For Innovation Principal Attributes For Their Formation And Optimiza...Caspar Rijnbach v.
This document discusses frameworks for optimizing a company's innovation network architecture and composition. It presents five main business objectives for developing partner networks for technological collaboration: 1) Increase profitability 2) Shorten time to market 3) Enhance innovation capability 4) Create greater flexibility in R&D and 5) Expand market access. It also outlines the types of partners a company may seek out for different stages of research and development based on the required expertise, such as universities for pure science or manufacturers for advanced development. The goal is to define attributes that impact the formation and optimization of innovation networks based on network objectives and participant characteristics.
The document discusses a manufacturing platform for producing therapeutics in tobacco plants. It summarizes meetings with experts on commercializing biotech platforms and understanding customers. Experts advised validating the platform by producing hard-to-make proteins, focusing on technical/manufacturing customers, and understanding regulatory issues. Customers cited interest in cost-effective production and combination vaccines. Next steps include further challenging the value proposition and better understanding commercialization and decision-making processes through additional expert meetings.
The MIT Consortium on Adventitious Agent Contamination in Biomanufacturing aims to identify best practices for preventing contamination of biomanufacturing processes. The Consortium will provide a collaborative environment for member companies to share experiences and develop solutions. Initial projects include collecting and analyzing industry virus contamination data in a confidential manner to determine risk factors and mitigation strategies. The goal is to advance practices for ensuring product safety and quality.
The document discusses Thermo Scientific's leadership in serving science through analytical instruments, equipment, reagents, software and services. It highlights the company's size and scale, unmatched capabilities, portfolio of leading brands, and mission to make the world healthier, cleaner and safer. Key strengths include global industry leadership, ability to continuously invest in growth opportunities through R&D, and an excellent track record of financial performance. New products are presented for applications such as sample preparation, analysis, and data interpretation.
This document summarizes an upcoming conference on pre-filled syringes in Europe. The two-day conference will feature presentations and discussions on pre-filled syringe formulations, filling and finishing processes, primary and secondary packaging developments, regulatory compliance, and patient safety approaches. It will also include two post-conference workshops on self-injection devices and safety issues within pre-filled syringes. Key industry leaders and experts will speak on topics such as biologics formulations, extractables and leachables, facility design strategies, and regulatory trends. The conference aims to explore challenges and solutions for pre-filled syringe development and commercialization.
Drug discovery process style 1 powerpoint presentation templatesSlideTeam.net
The document describes the drug discovery process from preclinical studies through clinical trials to approval. In preclinical studies, a research team is formed, objectives are set, and novel chemicals are synthesized and tested for efficacy and safety in test tubes and animals. Results are used to choose a drug candidate. In clinical trials, the drug is studied in Phase I-III trials with increasing numbers of patients to test safety, efficacy, and get regulatory approval. The company files an Investigational New Drug application and New Drug Application with the FDA.
The document discusses Affinity Therapeutics' technology platform for developing microparticle formulations that provide extended local release of antibiotics to prevent surgical site infections. The company was founded in 2010 and is developing formulations to be used with hernia mesh repairs initially, with the goal of licensing the technology to medical device companies. The company has received an NIH Phase I SBIR grant and is working to negotiate licensing and facility agreements with universities.
luxe research presentation at InnoCos Europe, ParisKGS Global
TARGETING EMERGING DELIVERY TECHNOLOGIES ACROSS THE VALUE CHAIN Delivery systems can differentiate products in a crowded market place. Learn how partnering with innovative start-ups can help keep your company ahead of the competition.
What are the innovative delivery technologies relevant to the cos- metics industry? Best practices for partnering in the delivery space with specific examples from the cosmetics industry
How delivery technology developers stack up against each other on the Lux Innovation Grid and how the grid can be used in partner selection process
Chananit Sintuu, Ph.D, Research Associate, Lux Research Inc
This document provides information about an upcoming conference on 4th Pre-Filled Syringes that will address challenges in developing efficacious pre-filled syringe products. The conference will take place from October 17-19, 2011 in London and will feature key speakers from companies such as AstraZeneca, Novartis, Bayer, and the UK Medicines and Healthcare products Regulatory Agency (MHRA). It will include topics such as manufacturing, formulation, quality, safety, and novel pre-filled syringe technologies. Attendees can gain insights on issues like ensuring drug identity, potency and sterility in pre-filled syringes.
This document provides an overview of biopharmaceutical manufacturing outsourcing to Asia. It discusses the complexities of biopharmaceutical production and why many companies outsource this work. It outlines key considerations for choosing a contract manufacturing organization (CMO) in Asia, including ensuring cGMP compliance, technical competence, intellectual property protection, and effective communication. The document briefly reviews the history of bioprocessing in Asia and provides examples of current CMOs in various Asian countries with relevant production capabilities.
Innovation and entrepreneurship in biotechnology an intl perspective - d. h...sanguru1977
This document provides an introduction to innovation and entrepreneurship in biotechnology. It defines innovation as new products, services, processes or ideas that are novel to an organization. Innovation can take various forms, including technological versus non-technological, and product versus process innovation. The document scopes the focus of the book, which is on entrepreneurship and innovation processes that are important for new biotechnology firms. It emphasizes the importance of innovation and entrepreneurship for competitiveness in the biotechnology industry.
AbbVie has acquired Stemcentrx. Learn more from the first outside investor and board member, Stuart Peterson: https://medium.com/artis-ventures/congratulations-stemcentrx-e65576762d28
Cell based assays presentation v3_03_2012Pete Shuster
Update presentation on "increasing returns in drug discovery by harnessing the power of cells". Includes images/data/pubs of differentiating human sensory and dopaminergic neurons from hNP1 neural progenitors + osteoblasts and chondrocytes from human mesenchymal stem cells. Our platforms are ideal for high throughput screening and other drug discovery processes.
How to Use Technology to Build a World Class Field Sales Organization Landslide Technologies
How do you as a field sales manager or salesperson reverse these trends?
Please join presenter Razi Imam, founder of Landslide Technologies, Inc. and guest speaker Russ Dworshak, Regional Sales Manager of Compressor Systems, Inc. as they talk about real-world ways to use technology to help your field sales organization sell, interact with buyers, and plan sales strategies more effieciently and effectively.
How to Crack the C-Suite Code in 2010: Secrets for Selling to the TopLandslide Technologies
Leaders at the highest corporate levels don’t always avoid sales pitches—in fact, research shows that executives welcome them- provided the salesperson approaches them in the right way.
What is the correct way to approach a senior-level sales pitch?
Please join presenter Dr. Steve Bistritz, co-author of Selling to the C-Suite and President of SellXL, as he brings to life over 10 years of research revealing what C-Suite leaders in 500 diverse companies and government bodies said about their relationships with professional salespeople. This ground breaking research has been presented to thousands of salespeople at the SellXL workshop and in other venues, and has been used by sales professionals around the world to help close top dollar deals.
This document discusses how biopharmaceutical companies are using social media platforms like YouTube, Twitter, Facebook, blogs and online communities to engage with patients and physicians. It provides examples of major companies' social media presences and strategies. It also outlines best practices for biopharma's use of social media, including listening, adapting, having response plans, and creating guidelines while offering value to users. A cautionary tale discusses a company that faced backlash over a drug price increase that was spread on social media.
Gene therapy involves inserting a normal gene to replace an abnormal gene that causes a genetic disease. It can replace or inactivate mutated genes, or introduce new genes to fight disease. Common applications include treating cystic fibrosis, hemophilia, cancer, and HIV. Viral vectors like retroviruses and adenoviruses are often used to deliver genes, but they can cause immune reactions. Non-viral methods like nanoparticles, electroporation, and ultrasound show promise for safer gene delivery. Overall, gene therapy holds potential for treating many currently incurable genetic disorders and diseases.
Global Biopharmaceutical Contract Manufacturing Market - Qualitative and Quan...Aiswariya Chidambaram
This presentation which highlights the key market and technology trends in the global biopharmaceutical contract manufacturing market was delivered as a lecture at the In-Focus Seminar session at CPhI Worldwide 2013 held at Frankfurt, Germany.
Silicon Valley Bank’s Trends in Healthcare Investments and Exits report analyzes the fundraising, investment, M&A and IPO activity of private, venture-backed biopharma, medical device and diagnostic/tools companies. Report author Jon Norris also gives his annual forecast of what’s likely to happen in 2016.
Information Management In Pharmaceutical IndustryFrank Wang
Pharmaceutical Industry Information Management Opportunities and Challenges in Research, Development, Clinical, Sales, Marketing, Managed Markets, Manufacturing, Supply Chain and Distribution
The document discusses a manufacturing platform for producing therapeutics in tobacco plants. It summarizes meetings with experts on commercializing biotech platforms and understanding customers. Experts advised validating the platform by producing hard-to-make proteins, focusing on technical/manufacturing customers, and understanding regulatory issues. Customers cited interest in cost-effective production and combination vaccines. Next steps include further challenging the value proposition and better understanding commercialization and decision-making processes through additional expert meetings.
The MIT Consortium on Adventitious Agent Contamination in Biomanufacturing aims to identify best practices for preventing contamination of biomanufacturing processes. The Consortium will provide a collaborative environment for member companies to share experiences and develop solutions. Initial projects include collecting and analyzing industry virus contamination data in a confidential manner to determine risk factors and mitigation strategies. The goal is to advance practices for ensuring product safety and quality.
The document discusses Thermo Scientific's leadership in serving science through analytical instruments, equipment, reagents, software and services. It highlights the company's size and scale, unmatched capabilities, portfolio of leading brands, and mission to make the world healthier, cleaner and safer. Key strengths include global industry leadership, ability to continuously invest in growth opportunities through R&D, and an excellent track record of financial performance. New products are presented for applications such as sample preparation, analysis, and data interpretation.
This document summarizes an upcoming conference on pre-filled syringes in Europe. The two-day conference will feature presentations and discussions on pre-filled syringe formulations, filling and finishing processes, primary and secondary packaging developments, regulatory compliance, and patient safety approaches. It will also include two post-conference workshops on self-injection devices and safety issues within pre-filled syringes. Key industry leaders and experts will speak on topics such as biologics formulations, extractables and leachables, facility design strategies, and regulatory trends. The conference aims to explore challenges and solutions for pre-filled syringe development and commercialization.
Drug discovery process style 1 powerpoint presentation templatesSlideTeam.net
The document describes the drug discovery process from preclinical studies through clinical trials to approval. In preclinical studies, a research team is formed, objectives are set, and novel chemicals are synthesized and tested for efficacy and safety in test tubes and animals. Results are used to choose a drug candidate. In clinical trials, the drug is studied in Phase I-III trials with increasing numbers of patients to test safety, efficacy, and get regulatory approval. The company files an Investigational New Drug application and New Drug Application with the FDA.
The document discusses Affinity Therapeutics' technology platform for developing microparticle formulations that provide extended local release of antibiotics to prevent surgical site infections. The company was founded in 2010 and is developing formulations to be used with hernia mesh repairs initially, with the goal of licensing the technology to medical device companies. The company has received an NIH Phase I SBIR grant and is working to negotiate licensing and facility agreements with universities.
luxe research presentation at InnoCos Europe, ParisKGS Global
TARGETING EMERGING DELIVERY TECHNOLOGIES ACROSS THE VALUE CHAIN Delivery systems can differentiate products in a crowded market place. Learn how partnering with innovative start-ups can help keep your company ahead of the competition.
What are the innovative delivery technologies relevant to the cos- metics industry? Best practices for partnering in the delivery space with specific examples from the cosmetics industry
How delivery technology developers stack up against each other on the Lux Innovation Grid and how the grid can be used in partner selection process
Chananit Sintuu, Ph.D, Research Associate, Lux Research Inc
This document provides information about an upcoming conference on 4th Pre-Filled Syringes that will address challenges in developing efficacious pre-filled syringe products. The conference will take place from October 17-19, 2011 in London and will feature key speakers from companies such as AstraZeneca, Novartis, Bayer, and the UK Medicines and Healthcare products Regulatory Agency (MHRA). It will include topics such as manufacturing, formulation, quality, safety, and novel pre-filled syringe technologies. Attendees can gain insights on issues like ensuring drug identity, potency and sterility in pre-filled syringes.
This document provides an overview of biopharmaceutical manufacturing outsourcing to Asia. It discusses the complexities of biopharmaceutical production and why many companies outsource this work. It outlines key considerations for choosing a contract manufacturing organization (CMO) in Asia, including ensuring cGMP compliance, technical competence, intellectual property protection, and effective communication. The document briefly reviews the history of bioprocessing in Asia and provides examples of current CMOs in various Asian countries with relevant production capabilities.
Innovation and entrepreneurship in biotechnology an intl perspective - d. h...sanguru1977
This document provides an introduction to innovation and entrepreneurship in biotechnology. It defines innovation as new products, services, processes or ideas that are novel to an organization. Innovation can take various forms, including technological versus non-technological, and product versus process innovation. The document scopes the focus of the book, which is on entrepreneurship and innovation processes that are important for new biotechnology firms. It emphasizes the importance of innovation and entrepreneurship for competitiveness in the biotechnology industry.
AbbVie has acquired Stemcentrx. Learn more from the first outside investor and board member, Stuart Peterson: https://medium.com/artis-ventures/congratulations-stemcentrx-e65576762d28
Cell based assays presentation v3_03_2012Pete Shuster
Update presentation on "increasing returns in drug discovery by harnessing the power of cells". Includes images/data/pubs of differentiating human sensory and dopaminergic neurons from hNP1 neural progenitors + osteoblasts and chondrocytes from human mesenchymal stem cells. Our platforms are ideal for high throughput screening and other drug discovery processes.
How to Use Technology to Build a World Class Field Sales Organization Landslide Technologies
How do you as a field sales manager or salesperson reverse these trends?
Please join presenter Razi Imam, founder of Landslide Technologies, Inc. and guest speaker Russ Dworshak, Regional Sales Manager of Compressor Systems, Inc. as they talk about real-world ways to use technology to help your field sales organization sell, interact with buyers, and plan sales strategies more effieciently and effectively.
How to Crack the C-Suite Code in 2010: Secrets for Selling to the TopLandslide Technologies
Leaders at the highest corporate levels don’t always avoid sales pitches—in fact, research shows that executives welcome them- provided the salesperson approaches them in the right way.
What is the correct way to approach a senior-level sales pitch?
Please join presenter Dr. Steve Bistritz, co-author of Selling to the C-Suite and President of SellXL, as he brings to life over 10 years of research revealing what C-Suite leaders in 500 diverse companies and government bodies said about their relationships with professional salespeople. This ground breaking research has been presented to thousands of salespeople at the SellXL workshop and in other venues, and has been used by sales professionals around the world to help close top dollar deals.
This document discusses how biopharmaceutical companies are using social media platforms like YouTube, Twitter, Facebook, blogs and online communities to engage with patients and physicians. It provides examples of major companies' social media presences and strategies. It also outlines best practices for biopharma's use of social media, including listening, adapting, having response plans, and creating guidelines while offering value to users. A cautionary tale discusses a company that faced backlash over a drug price increase that was spread on social media.
Gene therapy involves inserting a normal gene to replace an abnormal gene that causes a genetic disease. It can replace or inactivate mutated genes, or introduce new genes to fight disease. Common applications include treating cystic fibrosis, hemophilia, cancer, and HIV. Viral vectors like retroviruses and adenoviruses are often used to deliver genes, but they can cause immune reactions. Non-viral methods like nanoparticles, electroporation, and ultrasound show promise for safer gene delivery. Overall, gene therapy holds potential for treating many currently incurable genetic disorders and diseases.
Global Biopharmaceutical Contract Manufacturing Market - Qualitative and Quan...Aiswariya Chidambaram
This presentation which highlights the key market and technology trends in the global biopharmaceutical contract manufacturing market was delivered as a lecture at the In-Focus Seminar session at CPhI Worldwide 2013 held at Frankfurt, Germany.
Silicon Valley Bank’s Trends in Healthcare Investments and Exits report analyzes the fundraising, investment, M&A and IPO activity of private, venture-backed biopharma, medical device and diagnostic/tools companies. Report author Jon Norris also gives his annual forecast of what’s likely to happen in 2016.
Information Management In Pharmaceutical IndustryFrank Wang
Pharmaceutical Industry Information Management Opportunities and Challenges in Research, Development, Clinical, Sales, Marketing, Managed Markets, Manufacturing, Supply Chain and Distribution
The document discusses various business models in the life science industry. It describes models such as the fully integrated pharma company, virtually integrated pharma company, research model, platform model, no research development only model, re-indication/recovery model, combination drugs model, and drug delivery model. Each model is defined by its value proposition, value chain structure, and revenue generation approach. The document provides examples of companies that have utilized each business model.
Ersnt & Young Pharma 3.0 Business Model Zaki Sellam
Pharma companies are transforming their business models from Pharma 1.0 focused on blockbuster drugs, to Pharma 2.0 with diversified drug portfolios, and now to Pharma 3.0 centered around delivering healthy outcomes. This transformation is being driven by factors like healthcare reform, consumerism, and the need to prove value. Pharma 3.0 requires non-traditional collaborations across different industries in the healthy outcomes ecosystem, including providers, IT companies, social media platforms, and more, to achieve the goal of improving patient health.
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.
This document provides information about an upcoming conference on single-use bioreactors being held in London on November 1-2, 2012. The conference will feature speakers from pharmaceutical and biotech companies as well as equipment suppliers discussing topics such as using single-use bioreactors to increase flexibility, reduce costs and speed up research and development. Attendees will learn about case studies on scaling up production with disposable technology and accelerating cell culture development. The conference offers sponsorship and exhibition opportunities for companies to promote their services and products.
1) Companies must improve innovation management to remain competitive as globalization increases pressures and expectations for growth. Effective innovation is critical but many companies treat it as an unstructured process.
2) There is a lack of integration between the various tools and systems used for innovation, which leads to wasted resources as knowledge is scattered. Standard tools are not well-suited for scientific innovation data.
3) Companies need an enterprise approach to manage scientific experimentation and data to facilitate collaboration and learning from past work, in order to accelerate innovation and the commercialization process.
Thinking Beyond Compliance Medical Device WhitepaperJenna Dudevoir
This white paper is based on a research study with leading medical device companies - from startups to multibillion dollar enterprises - to explore how they are balancing new product development with compliance requirements.
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.
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.
This document announces the 11th Annual Biosimilars UK conference taking place October 29-31, 2012 in London. It will bring together major pharmaceutical companies, regulatory bodies, CROs, CMOs, and law firms to discuss strategies for competing in the complex biosimilars market. Key topics will include the latest regulatory guidelines, financial viability, patent strategies, approval pathways, legal issues, preclinical/clinical challenges, the roles of the US and European markets, pricing/reimbursement, and pharmacovigilance. The goal is to help participants maximize opportunities in this changing landscape. Major sponsors include Merck Millipore and United BioSource Corporation.
The document summarizes the 7th Annual Biosimilars conference to be held from October 5-7, 2010 in London. The conference will discuss strategies for developing biosimilars and biobetters, including overcoming regulatory barriers and gaining market access. Over the three days, speakers will address topics such as the competitive landscape in major markets, the impact of healthcare reform on global development, and developing long-acting biologics. Attendees will include those from pharmaceutical, biotechnology, and regulatory organizations seeking to maximize opportunities in this growing industry segment.
This document provides information about an upcoming biobanking conference to take place on March 10-11, 2011 in London. It lists key speakers from companies like AstraZeneca, Bayer, and Sanofi-Aventis who will discuss topics like sample storage, biomarker discovery, and stem cell banking. The document also notes the growing market for biobanking and its importance for medical research. Sponsoring companies and media partners promoting the conference are also listed.
This document provides an overview of open innovation. It begins with introducing the speakers and goals of discussing open innovation without hype, exploring key themes practically, and sharing case studies and exercises. The topics to be covered include definitions of open innovation, benefits for organizations, differences between large and small companies, the ideal open innovation ecosystem, and a collaboration exercise. Overall, the document aims to provide insights into open innovation from life science and IT sectors through mixing presentations and group activities.
Kandybin genova (2012) big pharma's uncertain futuredltofha
The article discusses how the business model of major drug companies is no longer sustainable due to upcoming patent expirations and increased competition. It is uncertain how the pharmaceutical industry will evolve in the future. To survive, drug companies will need to make strategic bets by diversifying into new areas that leverage their existing capabilities, but also develop new capabilities to succeed under different potential scenarios for the industry.
The document summarizes an upcoming conference on biobanking in the Americas from June 7-9, 2011 in Boston. It will bring together experts from biobanks, pharmaceutical companies, biotech firms, and regulatory agencies to discuss strategic approaches to biosample management and using biobanks to enable next-generation drug discovery and personalized medicine. Speakers will provide practical knowledge on new biobanking models, address ethical and legal challenges, and explore how to leverage biospecimen resources to support biomarker research. Attendees will learn best practices for biorepository management and implementation, applications of genome sequencing, and strategies for building biomarker discovery pipelines. The conference aims to facilitate networking and enable confident decision making through benchmarking against
This document discusses biotechnology R&D strategies and corporate strategy. It begins with an overview of the biopharmaceutical industry and challenges with early stage funding. The concept of strategy and purposes of a good strategy are then explained. Key elements of R&D performance strategies including architecture, processes, people and portfolio are covered. Case studies of innovation and biosimilar R&D strategies from companies like GSK, Wyeth and Novartis are summarized. The document concludes that different companies pursued different strategies based on their core hypotheses to address R&D productivity issues. Benchmarking capabilities is important for companies looking to enter the biosimilars market during the biologics patent cliff.
Managing innovation within firms-Chapter 4 (Paul Trott).pptxAartiPandey63
1. The document discusses the tension within organizations between the need for stability and efficiency versus the need for creativity and innovation. It notes that companies must balance these competing demands to be successful both today and in the future.
2. It explores the "innovation dilemma" where pursuing innovation too far can lead to failure, but pursuing it too little can also lead to company failure. Finding the right balance is difficult.
3. Several tools and factors that can help facilitate innovation within organizations are discussed, including having a growth orientation, accepting risks, cross-functional cooperation, and providing space for creativity. Formal structures, centralized decision-making, and size can impact innovation as well.
Pfizer Canada is exploring public-private partnerships and open innovation models to address gaps in drug innovation. These models include pre-competitive research partnerships and consortia involving multiple companies, universities, and research institutions. They aim to leverage diverse scientific capabilities and resources to make progress on understanding disease biology and developing new treatments. By sharing knowledge and resources in a pre-competitive space, these partnerships seek to accelerate innovation for the benefit of patients while also engaging industry, academia and government.
Integrity driven performance in the pharmaceutical industryOnly Medics
The foundation of any sustainable and profitable business model requires the trust of consumers, regulators, investors, and creditors. Relative to their counterparts in other sectors, however, pharmaceutical companies find themselves party to a more involved and demanding social contract. The public expects pharmaceutical companies to address social needs as well as earn a financial return.
The document is an invitation and agenda for the "Partnerships for Drug Delivery Conference" taking place April 26-28, 2010 in Philadelphia, PA. It outlines the schedule of sessions and presentations focused on drug delivery partnerships, licensing opportunities, and innovations. Key details include:
- Register by March 12, 2010 to receive up to $600 off registration fees.
- Sessions will discuss identifying partnership opportunities, addressing patent strategies, leveraging alliance management, FDA approval processes, and case studies.
- Presentations from major pharmaceutical companies like AstraZeneca, Merck, Pfizer, and Novo Nordisk.
- Networking opportunities with industry professionals from areas like business development, licensing, and regulatory affairs
This document discusses how the increased generation of data in pharmaceutical R&D has failed to improve productivity due to an inability to properly organize and apply knowledge. It describes how existing integration strategies store data in isolated "silos" that are difficult to access and compare. The author argues that new semantic technologies based on ontologies can better integrate knowledge across discovery, development, and other business areas to improve transparency, safety monitoring, and decision making.
Best Practices In Collaborative Innovation: How CPG Manufacturers & Retailers...Jenna Dudevoir
This white paper is based on a research study with thirty global consumer goods manufacturers, retailers, and brokers to better understand how manufacturers and retailers are working together to drive profitability and deliver innovative products.
This document discusses how ontologies can help manage knowledge in drug discovery. It notes that while companies invest heavily in data generation, they struggle to effectively harness this data. Ontologies provide a way to semantically represent knowledge from diverse sources and distribute it for applications. This allows knowledge to be more effectively applied to important tasks like decision making, data analysis, and text mining of literature. The document compares different ontology standards and notes their suitability for knowledge management versus computational reasoning. It concludes that ontologies can support applications in drug discovery by providing integrated access to knowledge from multiple sources.
Similar to Driving Innovation In Bio Pharma W Plm (20)
1. Driving Innovation
in BioPharma:
From Discovery to Delivery with
Product Lifecycle Management
Kalypso White Paper
by Scott Gibbard, Dr. Horst Groesser and Andrew Hunter
Normal
Reversed
2. Industry Challenges
The economic challenges faced by today’s biopharmaceutical industry
are well documented. Revenues are contracting due to patent expiries,
generics competition and pricing pressure from payers that are demanding
clearer demonstration of product value. By 2016, medicines that generated
sales of $133 billion in 2010 in the US will have lost patent protection.1
Innovative new products are scarce as R&D budgets chase increasingly
difficult scientific problems. For those products that successfully make it
through development, the regulatory approval bar is higher than ever.
By 2016, patent exclusivity Much of this is not recent news. Drug discovery,
development and commercialization have always been
expiries in one or more developed complex and risky. The vast majority of new product ideas
markets will impact 13 of the fail. Ideas that do make it out of the labs face an extremely
lengthy and expensive journey navigating a highly
top 20 selling medicines of 2010, regulated environment where the rules vary by country.
including Lipitor®, Plavix®, Advair The science is usually complicated and always unpredictable,
generating enormous amounts of data and experimental
Diskus®, Crestor® and Nexium®.2 results from both failed and successful programs.
And yet, many steps taken by companies over the last several years to
address these business challenges have only added to the complexity:
Figure 1:
Mergers and acquisitions Scientific partnering and collaborations,
Actions taken to
have made companies bigger often operationally complex,
address biopharma
and even more complex, have collided with the
business challenges carving already siloed culture of monolithic
functions into specialized research organizations
sub-functions. Rationalizing not accustomed to
differing processes, systems truly sharing their work.
and cultures has proven to
be difficult.
Expansion into Portfolio diversification
emerging markets into new therapeutic
has required areas or biologics (novel or
unfamiliar regulatory biosimilars) has required
environments to be companies to build new
learned and commercial scientific capabilities and
models to be modified develop a deep understanding
or rethought. of new technologies.
The biopharma industry’s ability to discover, develop and launch profitable
new products has been diminished by the pervasiveness of complexity.
In order to drive growth from innovation, companies must manage this
complexity within their product development and innovation processes.
1, 2 The Global Use of Medicines: Outlook Through 2016, July 2012,
IMS Institute for Healthcare Informatics
Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 2
3. Manage the Complexity of Innovation
Innovation is More Than Scientific Discovery
Innovation in biopharma is often understood as scientific breakthroughs in
basic research and discovery. While the discovery of new molecular entities
is the lifeline for biopharma companies, true innovation is not just about
the science – it also requires transforming those breakthrough discoveries
into marketable products and successfully launching them in highly
regulated markets.
In addition to developing new drug products, companies can be
innovative in many other ways. Product and service bundling, supply chain
restructuring, and information asset management are just a few examples
of areas with great innovation potential. While these forms of innovation
may not be viewed in the same light as launching a new product after
making a high-profile scientific breakthrough, they can accelerate product
commercialization, and ensure safe and compliant delivery once the
products are on the market. In fact, these other forms of innovation can fuel
scientific discovery by allowing quicker answers to “what-if” experiments,
ultimately leading to faster advancement of knowledge.
When operating in such a complex environment, there are three
fundamental capabilities that biopharma companies need to focus on
improving to maintain and enhance their innovation performance:
•• Visibility. Scientists with better visibility into one another’s work
improve the chances of “connecting the dots.” Better visibility
helps management set priorities and ensure resources are allocated
in line with those priorities. It can also smooth the transition
from research to manufacturing and commercialization.
•• Traceability. Better traceability improves the organization’s
ability to maintain compliance and address regulatory
inquiries. It also enables improved reuse of knowledge
assets by allowing product development teams to
retrace development decisions made in the past.
•• Collaboration. Drug development is a complex, cross-functional
endeavor. Increasingly, it involves partnering with researchers
from many different organizations. Better collaboration enables
a richer understanding of scientific challenges and more
innovative product solutions.
3 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
4. Improving visibility, traceability and collaboration can have a significant
impact on many important biopharma business processes, leading to better
product innovation. Figure 2 explores several examples:
Process Challenge Impact Solution
Regulatory submissions Complex cross-functional Delayed time to revenue; Improved global
and product launches coordination, with global premature launches with collaboration using one
product launches adding increased compliance risk longitudinal product
layers of complexity data history, created
by many functions in
multiple formats
Regulatory compliance Coordination of supply Product recalls, or Improved integration of
for marketed products chain and regulatory even worse, product tools for compliance and
functions working with withdrawals resulting change control based
different, non-integrated in loss of revenue on a single source of
systems and reputation product information
Handover from R&D Classic “throw over Organizational handoffs Improved visibility and
to manufacturing and the wall” knowledge and no accountability; collaboration between
product transfers from transfer often addressed knowledge loss; difficulty sending and receiving
one plant to another by carving out an manufacturing at scale organizations
organization to manage
the transition
Portfolio prioritization Often treated as a Delayed kills of failing Improved visibility
once-a-year event due to projects; resource and and collaboration that
the large effort required funding allocations enables important
to gather data get out of synch portfolio decisions to be
with priorities event-driven throughout
the year; timelier
re-allocation of
funding and resources
Product packaging Different packaging Delayed launches into Reduced compliance
and labeling (or even branding) and new markets; compliance risk through global
labeling in different risks with packaging or coordination of
markets, complicated label changes packaging and
by expansion into labeling processes
emerging markets
Figure 2: A management discipline called product lifecycle management (PLM) is an
Impact on biopharma effective approach to improving visibility, traceability and collaboration for
business processes
a wide range of business processes that create or use product information.
Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 4
5. Call to Action: Drive Innovation with
Product Lifecycle Management
What is PLM?
Product lifecycle management (PLM) has transformed how products
are developed and commercialized in several industries over the last two
decades. PLM is the process of managing the entire lifecycle of a product –
from its conception, through discovery, development, regulatory approval,
to launch, production and end-of-life. It is a technology-enabled discipline
that integrates the processes, data, people and enterprise information
systems comprising a company’s product development, introduction and
change control capabilities.
Adoption
Level
PLM High Low
Maturity
Aerospace, Process,
Defense, Medical Personal Care, BioPharma,
Automotive Industrial High Tech Device Household, CPG Nutraceutical Services
Established Industries Growth Industries Emerging Industries
PLM should not be confused with “lifecycle management” (LCM), a phrase Figure 3:
often used in biopharma to describe the practice of maximizing a product’s PLM adoption
across industries
lifetime value by defending/extending market share of approved products
through the pursuit of additional indications, new formulations and
expansion into new markets. PLM is a broader concept that defines how
product information is managed throughout the lifecycle of the product.
5 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
6. Portfolio
& Pipeline
Management
De
Strategic (Franchise and Therapy Area
Capabilities Strategies, Portfolio Balancing)
Collaboration S
Product
Portfolio Data
Internal
& External
Collaboration Manufacturing
& Supply Chain
Product An
Development
Product Record lo
Discovery & (Illustrative)
Packaging m
Product
Development Development
& Labeling dr
Capabilities & Tools
Suppliers
Quality & & Sourcing
Compliance Program
Data
PLM Platform ERP
Descriptive Product Data Transactional Data
Figure 4: Innovation in the biopharma industry is not going to get any easier,
Capabilities within or any less complex. Given the current challenges companies are facing,
the PLM platform
it is now time to adopt PLM principles in biopharma in order for companies
create an integrated
to succeed at developing and launching new products that deliver desired
set of capabilities
and Product Record in-market results.
The Product Record
At the core of PLM is the Product Record – a single version of the truth for
a product and all product-related data. It contains all of the information
necessary to design, develop, produce and modify the product.
The Product Record is based on a logical product data model that captures
comprehensively:
a. The physical entities that a product consists of
(materials, etc.)
b. The informational entities that are associated with
a product or its physical entities (regulatory data,
supplier information, material specifications, etc.)
c. The structural relationships between these
entities (product structure)
d. Attributes describing the physical and
informational entities of the product
Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 6
7. Figure 5 shows an illustrative example of
a basic, logical data model for a drug product. Finished Product
Packaging
Yet PLM goes beyond solely providing a Primary Packed
version-controlled source of product data for Delivery Device Packaging
nd Therapy Area all of the business functions. It incorporates Drug Product
rtfolio Balancing)
all processes that generate, modify or affect Specification Excipient
uct product data along the product lifecycle. Pharmaceutical
o Data Intermediate
Raw Ingredient
Manufacturing Drug Substance
& Supply PLM processes capture both structured data
Chain
An illustrative
Development documents. In biopharma, PLM links the
and Chemical
logical data Intermediate
Packaging“world of science” with the “transactional model for a
& Labeling drug product
world” of enterprise resource planning and Raw Ingredient
ers
ing manufacturing, by transforming and enhancing
scientific and experimental drug information
into descriptive drug product master data.
Figure 5:
PLM puts a company’s most valuable innovation
m ERP
asset – product data, from concept through
Drug product example
commercialization to end-of-life – at the center
of their innovation efforts.
ata Transactional Data
The product data that forms the backbone
of PLM represents all types of data collected
It is now time to adopt PLM
during the entire product lifecycle – including principles in biopharma in
early concept ideas, market research, business
cases, clinical trial results, description of
order for companies to succeed
key processes, phase gate reviews, clinical at developing and launching
strategies, and launch plans. Any data that
describes the product and its properties
new products that deliver
can be an element of the Product Record. desired in-market results.
Can PLM Work in BioPharma?
Significant benefits of PLM – such as faster product time to market,
and increased productivity in R&D and product/technical operations –
have been realized in industries such as aerospace, defense, automotive,
high technology, medical devices, food and beverage, and consumer
packaged goods. Although the biopharma industry may represent a unique
combination of risk, complex science and regulation, its uniqueness does
not prohibit it from achieving the same benefits from PLM.
7 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
8. While product development and commercialization in biopharma is certainly
distinctive, several significant dimensions of complexity are not entirely
exclusive to the industry, as explored in Figure 6:
Figure 6: The takeaway for biopharma companies: several industries share similar
Comparison of complexity complexity characteristics, and have successfully implemented PLM
across industries
solutions to address these challenges while reinvigorating their product
innovation efforts.
Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 8
9. Get Started
Six Tips for Starting the PLM Journey
Like most transformational changes, taking the first step with PLM can
be daunting. Fortunately, the nature of implementing PLM lends itself
to layering in capabilities as needed. Here are six tips for getting started:
1. Assess your current capabilities. Evaluate the maturity
of your current PLM capabilities related to strategy,
processes, data management and technical infrastructure.
Conduct interviews with a broad cross-section of the
organization to ensure accurate and balanced feedback.
2. Align on a vision. The insights gained from the current capabilities
assessment will provide the basis of your PLM vision. The vision
should crisply articulate your desired future state and support a
compelling case for change. The leadership team must align on and
believe in this vision, and be prepared to explain and support it.
3. Pick your leader…carefully. Like any major change, it matters
who the leader is for your PLM program. The leader should
be well respected and connected within your organization.
They must be a champion for change, and thus should deeply
understand and buy in to the promise of PLM to drive product
innovation. The leader should also have excellent communication
and influencing skills.
4. Develop a roadmap for a phased approach. Unlike other technology-
enabled transformation projects – ERP, for instance – PLM does not
need to be implemented with a disruptive “big bang” approach.
It can be implemented in phases – an approach that reduces risks,
breaks implementation into manageable “chunks” and minimizes
organizational impact. It also aids adoption by delivering a steady
stream of incremental value as the various capabilities are enabled.
5. Utilize rapid prototyping and iterative design. Use conference
room pilots, prototypes and sandbox environments from the
very beginning of the project to gather requirements as well as
to support organizational awareness. During implementation,
“go live” with basic functionalities, and add other functionalities
afterwards. Depending on the size and complexity of the
organization, a gradual roll-out by franchise, therapeutic area
(TA) or region might be the most suitable roll-out strategy.
6. Focus on quick wins. Upfront planning for PLM should be thoughtful
and holistic. Most of the benefits will come when product data
and processes from multiple business areas are implemented –
that’s when cross-functional collaboration and visibility really begin
to take hold. That said, select an early adopter area where you
expect to demonstrate immediate benefits – such as the Regulatory
Operations or Product Labeling group.
9 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
10. Summary: PLM Can Drive
Innovation in BioPharma
Growing complexity is changing the economics of drug development.
Many actions taken by the industry to date do not address the central issue
of driving innovation to produce more novel medicines to satisfy unmet
medical needs. Product innovation has never before been so imperative.
In this environment, biopharma executives must assess their innovation
capabilities by considering questions such as:
•• Are our current methods good enough to overcome
the growing complexity in our business?
•• How can we free up time to focus on real innovation?
•• Do we have a single source of truth for our product information?
•• Do we effectively learn as an organization from our
product development successes and failures?
PLM has transformed product innovation in other highly complex industries
over the last two decades, reducing time to market and improving product
development productivity as a result. The lessons learned from these
industries are relevant, and the biopharma industry must understand how
to apply them within their organizations. This includes recognizing that
their most valuable information assets – the product data – must be at the
center of their innovation efforts, not merely a by-product to be managed
by functional silos.
Adopting an entire lifecycle perspective to innovation will benefit the
measures that matter the most – truly innovative products that generate
real health benefits to patients and economic benefits to biopharma
companies. PLM processes and technologies can enable this kind of
real innovation.
Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 10
11. About the Authors
Scott Gibbard has over 20 years of experience in engineering,
product development, strategic planning, performance
management and change management in biopharma and other
science-driven industries. He holds an MBA from Cornell University,
a Master of Applied Science from the University of Toronto Institute
for Aerospace Studies (UTIAS) and a Bachelor of Applied Science in
Engineering Science from the University of Toronto.
scott.gibbard@kalypso.com
Dr. Horst Groesser has over 20 years of experience in product
lifecycle management (PLM) and supply chain management in the
biopharma, medical device, high technology and manufacturing
industries. He holds a PhD in Mechanical Engineering and a
Diploma in Industrial Engineering from the Technical University
of Darmstadt, Germany.
horst.groesser@kalypso.com
Andrew Hunter has over 25 years of experience in product
development, project management and change management in the
biopharma industry. He holds a Master of Business Administration
from INSEAD, a Master of Science from the University of Warwick
and a Bachelor of Science in Mechanical Engineering from
Imperial College.
andrew.hunter@kalypso.com
Contributors: aurens Broekhof, Senior Manager laurens.broekhof@kalypso.com
L
Sunny Sun, Senior Consultant sunny.sun@kalypso.com
11 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
12. About Kalypso
Kalypso is the world’s premier innovation consulting firm, helping clients improve performance
by delivering on the promise of innovation. Kalypso offers clients full service capabilities including
Business and Innovation Strategy, Front End of Innovation, Portfolio and Pipeline Management,
Development and New Product Introduction, Value Management, PLM Technology,
Leadership and Learning, and Intellectual Property Management. For more
information, visit http://kalypso.com. Follow @KalypsoLP on Twitter
and on Facebook at http://facebook.com/KalypsoLP.
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