The document discusses how clinical delivery alliances between biopharmaceutical sponsors and CROs can improve drug development performance. It notes that expiring drug patents, rising R&D costs, and more drug candidates are challenging traditional development models. Clinical delivery alliances create long-term, incentivized partnerships to increase quality while reducing costs and time to market compared to traditional project-based outsourcing. The benefits of clinical delivery alliances include lower costs through economies of scale, higher quality through a transparent and repeatable process, and faster development through dedicated resources and aligned incentives.
Big Pharma is facing a crisis as many blockbuster drugs are going off-patent and the pipeline of new drugs is weak. R&D spending has doubled over the past decade but productivity has declined, with fewer new drugs approved despite higher costs. Alternative strategies such as mergers and acquisitions, in-licensing, and partnerships have had mixed results in addressing the pipeline problem. The document discusses challenges in drug development and strategies the pharmaceutical industry has used to boost R&D productivity.
The pharmaceutical industry is facing challenges developing new drugs due to limited knowledge of biology and chemistry. There are only about 500 validated drug targets and 9,500 known chemical compounds. The industry has relied on developing oral small-molecule drugs but is running out of viable targets and compounds. To succeed in the future, companies will need to accelerate target validation, invest more in new areas like genomics and proteomics, broaden their portfolios, and increase collaboration with external partners to gain expertise in areas like biologics development.
This document analyzes biopharmaceutical company Macrogenics and recommends selling its stock. Key points include:
- Macrogenics focuses on developmental oncology which has low success rates and faces competition from biosimilars.
- Its lead drug margetuximab faces uncertainty due to expected biosimilar competition for breast cancer treatments.
- Macrogenics will need to continue dilutive equity offerings to fund clinical programs and manufacturing expansions.
- The company's platforms are speculative without FDA approvals demonstrating safety and efficacy.
- Macrogenics is overvalued and does not align with the investor's value strategy due to binary risks and clinical uncertainty.
This document summarizes research examining factors that impact the valuation of biotechnology firms. It finds that advancement of drugs through clinical trials is associated with increased firm value, while drug failures are associated with decreased value. Surprisingly, partnerships and alliances do not seem to result in better performance than independent firms. The presence of medical doctors on boards of directors is associated with higher valuation metrics. Small cap biotech firms seem less likely to get drug approvals, possibly because promising small firms are acquired. Higher approval rates are seen for AIDS/cancer drugs and when financiers make up more of the board.
This document provides an overview of nanoparticle-based drug delivery technologies. It discusses how nanoparticles can help address challenges in traditional drug formulations by improving water solubility and targeting specificity. While only a few nanoparticle therapies have been FDA-approved so far, the author argues that these technologies are already impacting medicine and their impact will likely grow in the coming years. The document also reviews the drug development process and pressures facing pharmaceutical companies to improve success rates and reduce costs. Nanotechnology may help address these challenges through miniaturization, automation, high-throughput screening and other techniques.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
Biomarkers are increasing the success rates of drug development and reducing costs by helping to identify failures earlier. They allow pharmaceutical companies to streamline clinical trials, make better decisions about drug candidates, and potentially develop personalized medicines to match patients with optimal treatments. While the initial costs of biomarker research and validation are high, biomarkers are expected to generate substantial savings over the long term through more efficient drug development and higher success rates.
Big Pharma is facing a crisis as many blockbuster drugs are going off-patent and the pipeline of new drugs is weak. R&D spending has doubled over the past decade but productivity has declined, with fewer new drugs approved despite higher costs. Alternative strategies such as mergers and acquisitions, in-licensing, and partnerships have had mixed results in addressing the pipeline problem. The document discusses challenges in drug development and strategies the pharmaceutical industry has used to boost R&D productivity.
The pharmaceutical industry is facing challenges developing new drugs due to limited knowledge of biology and chemistry. There are only about 500 validated drug targets and 9,500 known chemical compounds. The industry has relied on developing oral small-molecule drugs but is running out of viable targets and compounds. To succeed in the future, companies will need to accelerate target validation, invest more in new areas like genomics and proteomics, broaden their portfolios, and increase collaboration with external partners to gain expertise in areas like biologics development.
This document analyzes biopharmaceutical company Macrogenics and recommends selling its stock. Key points include:
- Macrogenics focuses on developmental oncology which has low success rates and faces competition from biosimilars.
- Its lead drug margetuximab faces uncertainty due to expected biosimilar competition for breast cancer treatments.
- Macrogenics will need to continue dilutive equity offerings to fund clinical programs and manufacturing expansions.
- The company's platforms are speculative without FDA approvals demonstrating safety and efficacy.
- Macrogenics is overvalued and does not align with the investor's value strategy due to binary risks and clinical uncertainty.
This document summarizes research examining factors that impact the valuation of biotechnology firms. It finds that advancement of drugs through clinical trials is associated with increased firm value, while drug failures are associated with decreased value. Surprisingly, partnerships and alliances do not seem to result in better performance than independent firms. The presence of medical doctors on boards of directors is associated with higher valuation metrics. Small cap biotech firms seem less likely to get drug approvals, possibly because promising small firms are acquired. Higher approval rates are seen for AIDS/cancer drugs and when financiers make up more of the board.
This document provides an overview of nanoparticle-based drug delivery technologies. It discusses how nanoparticles can help address challenges in traditional drug formulations by improving water solubility and targeting specificity. While only a few nanoparticle therapies have been FDA-approved so far, the author argues that these technologies are already impacting medicine and their impact will likely grow in the coming years. The document also reviews the drug development process and pressures facing pharmaceutical companies to improve success rates and reduce costs. Nanotechnology may help address these challenges through miniaturization, automation, high-throughput screening and other techniques.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
Biomarkers are increasing the success rates of drug development and reducing costs by helping to identify failures earlier. They allow pharmaceutical companies to streamline clinical trials, make better decisions about drug candidates, and potentially develop personalized medicines to match patients with optimal treatments. While the initial costs of biomarker research and validation are high, biomarkers are expected to generate substantial savings over the long term through more efficient drug development and higher success rates.
Global Pharmaceutical Contract Manufacturing Resource Pack 2011Veronica Araujo
This document provides an overview of the global pharmaceutical contract manufacturing industry. It discusses key reasons why pharmaceutical companies outsource manufacturing, including lack of internal capacity, expertise, and the potential for cost savings. The most commonly outsourced areas of production are finished medicines. Emerging markets like India, China, and others offer lower costs and are attractive outsourcing destinations. However, outsourcing also presents challenges such as language/cultural barriers, meeting regulatory/quality requirements, and managing distant relationships. Overall, cost savings remain the top motivation for the 60% of pharmaceutical and biopharmaceutical manufacturing that is outsourced globally.
This document analyzes and dispels five common myths about the drug delivery industry. It argues that drug delivery has delivered many new products, the market is growing not declining, the business model can be sustainable, product line extensions using drug delivery approaches are effective strategies, and drug delivery companies offer diverse technologies, not just similar controlled release solutions. The drug delivery industry plays a key role in addressing challenges in pharma by developing improved treatment options.
This research service provides an in-depth analysis of the global pharmaceutical contract manufacturing market with particular focus on the finished dose formulations such as solid, liquid and semi-solid, and injectable dose formulations. Segment analysis, trends and revenue forecast for the global, U.S. and European regions have been provided in detail. Strategic recommendations for the success of market participants have also been discussed.
Momenta Pharmaceuticals is a biotechnology company focused on developing generic versions of complex drugs and biosimilars. It has one approved product, a generic version of Lovenox, and received approval for a generic version of Copaxone in 2015. The company partners with larger drug manufacturers for commercialization who obtain marketing approval. Momenta earns revenue through profit sharing, royalties, licensing fees, and research services. It has a pipeline of 10 drug candidates and sees its partnership with MIT and proprietary sequencing technology as competitive advantages. Historically the company has experienced fluctuating revenues and losses as it funds research and development but maintains liquidity through investments in market securities.
ICON is a contract research organization that provides outsourcing services to pharmaceutical, biotechnology, and medical device companies. ICON has expanded into foreign markets through acquisitions of AptivSolutions and Niphix, which position it for growth in Asia and Europe. ICON has also partnered with IBM to utilize IBM's Watson HealthCloud for data storage and analytics, giving ICON a competitive advantage over other CROs. ICON offers a full scope of clinical trial services, from drug development through FDA approval, attracting large pharmaceutical clients.
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
The document discusses several common myths about high-throughput screening (HTS) in drug discovery. It argues that HTS has been unfairly blamed for declining productivity in the pharmaceutical industry. The summary addresses three key points:
1) HTS data is of high quality due to rigorous quality control methods used in HTS laboratories.
2) While HTS is more expensive and time-consuming than other methods, the incremental increases are relatively small, around 10-20% more than alternatives.
3) There are successful examples of drugs discovered through HTS that eventually received FDA approval, despite the long timelines of the drug discovery process, showing that HTS can produce results.
This comprehensive presentation examines the most important incentives and disincentives for innovation in the pharmaceutical and biotech industries, discussing their effect on decisions about R&D direction/targets.
This document provides a business plan for a new pharmaceutical company called NEWTech Advant. The plan includes a situation analysis of the pharmaceutical market, noting trends like an aging population and increased regulation. It outlines NEWTech Advant's goals of improving existing drugs and discovering new ones. The marketing strategy discusses targeting physicians and patients aged 45+, and increasing market share through advertising. Financial objectives include achieving profitability in three years. The plan also analyzes strengths, weaknesses, opportunities and threats for the new company.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
The contract research organization (CRO) industry is a multi-billion dollar industry that is expected to grow substantially over the next five years. There are over 1,000 CROs globally, ranging in size from small firms to large publicly traded companies. The top five CROs capture over a third of total industry revenue, suggesting market consolidation. Growth in the industry is driven by increasing complexity and size of clinical trials, globalization of drug development, and pharmaceutical industry cost containment pressures that encourage further outsourcing of services.
This document provides a summary of the Oncology Drug Report 2014, which is described as the world's largest active resource for decision making in oncology. Some key details include:
- It covers 931 active cancer drug developers across 33 countries, along with profiles of 2237 active drugs in development, 37 cancer indications under pipeline analysis, and 523 clinical and 360 preclinical and discovery companies.
- The report is organized across 6 sections and provides comprehensive intelligence on the global oncology drug development landscape, including clinical trials, targets, mechanisms of action, deals and partnerships for individual drugs and companies.
- It aims to help businesses, scientists, investors and clinicians make better decisions by bringing extensive data together in one place
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
Fulgent Genetics - Biotech - Total return >200%Rogelio Rea
Fulgent Genetics is a genetic testing company with a market capitalization of $60.7 million. It has more than $40 million in cash and insider ownership of approximately 60% by the founder and CEO. The company provides genetic testing and sequencing at low costs using proprietary technology. It focuses on selling to hospitals and medical institutions, with approximately 86% of test billings being paid. The genetic testing market is growing significantly and Fulgent aims to become a leading provider through expanding its test menu, customer base, and global presence while maintaining low costs.
BioEntrepreneurship: Intellectual Property: What Do Investors Look For?MaRS Discovery District
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
This session presentation is available in audio format here: http://www.marsdd.com/bioent/dec4
The document summarizes findings from interviews with 23 primary sources and 7 secondary sources regarding Teva Pharmaceutical Industries Ltd.'s ability to overcome increasing competition and the impending patent cliff for its top-selling drug Copaxone. Most sources believed Teva's growth initiatives would help, but strategic acquisitions would be key to success. Sources viewed Teva as a strong, innovative leader but said maintaining Copaxone patients and generic sales would be challenges without new blockbuster products or deals. While Teva's generic pipeline and sales were seen as promising, uncertainty remained around fending off competitors and retaining its share of the Copaxone market.
Disseminate Clinical Data Early to Support Payer Coverage DecisionsTodd Berner MD
This document summarizes Todd Berner's presentation on early dissemination of clinical data to support payer coverage decisions. The presentation discusses comparative effectiveness research standards and how cost, comparators, and ambiguous results should be handled. It also addresses tailoring drug development to patient heterogeneity and biomarkers. Developing an open dialogue with payers throughout drug development is emphasized to demonstrate clinical and economic value. Field teams can establish relationships, disseminate outcomes data, and conduct research to support products. The goal is for clinical programs to demonstrate value through meaningful endpoints and real-world evidence.
QPS is a contract research organization that specializes in developing close relationships with clients based on trust and mutual respect. They offer flexible and nimble clinical work to improve outsourced work quality and reduce oversight needs. Their biosimilar drug development expertise can help clients advance their biosimilar portfolios in a timely manner for the benefit of patients worldwide.
The U.S. Biopharmaceutical Industry (2014): Perspectives on Future Growth and...PhRMA
The capability to innovate is fast becoming the most important determinant of economic growth and a nation’s ability to compete and prosper in the 21st century global knowledge-based economy.
The innovative biopharmaceutical industry stands out among high-value knowledge-based industries, including aerospace, automotive, and semiconductors, as a driver for future U.S. economic growth. Aging populations throughout the world and rising purchasing power for medical advances among emerging economies are expected to drive increased demand for prescription medicines in the coming years, providing opportunities to increase production and exports.
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
Predictive Analytics for Competitive Advantagevishwavijayps
This document discusses how Dr. Reddy's Laboratories uses predictive analytics to gain a competitive advantage. It describes two case studies: (1) using marketing mix modeling to optimize promotional strategies based on historical data, and (2) developing pricing and reimbursement strategies using claims data to understand patient costs and behaviors. It acknowledges challenges integrating diverse data sources for predictive modeling. Modern technologies like automated data integration and machine learning are proposed to enable real-time predictive modeling and recommendations.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Global Pharmaceutical Contract Manufacturing Resource Pack 2011Veronica Araujo
This document provides an overview of the global pharmaceutical contract manufacturing industry. It discusses key reasons why pharmaceutical companies outsource manufacturing, including lack of internal capacity, expertise, and the potential for cost savings. The most commonly outsourced areas of production are finished medicines. Emerging markets like India, China, and others offer lower costs and are attractive outsourcing destinations. However, outsourcing also presents challenges such as language/cultural barriers, meeting regulatory/quality requirements, and managing distant relationships. Overall, cost savings remain the top motivation for the 60% of pharmaceutical and biopharmaceutical manufacturing that is outsourced globally.
This document analyzes and dispels five common myths about the drug delivery industry. It argues that drug delivery has delivered many new products, the market is growing not declining, the business model can be sustainable, product line extensions using drug delivery approaches are effective strategies, and drug delivery companies offer diverse technologies, not just similar controlled release solutions. The drug delivery industry plays a key role in addressing challenges in pharma by developing improved treatment options.
This research service provides an in-depth analysis of the global pharmaceutical contract manufacturing market with particular focus on the finished dose formulations such as solid, liquid and semi-solid, and injectable dose formulations. Segment analysis, trends and revenue forecast for the global, U.S. and European regions have been provided in detail. Strategic recommendations for the success of market participants have also been discussed.
Momenta Pharmaceuticals is a biotechnology company focused on developing generic versions of complex drugs and biosimilars. It has one approved product, a generic version of Lovenox, and received approval for a generic version of Copaxone in 2015. The company partners with larger drug manufacturers for commercialization who obtain marketing approval. Momenta earns revenue through profit sharing, royalties, licensing fees, and research services. It has a pipeline of 10 drug candidates and sees its partnership with MIT and proprietary sequencing technology as competitive advantages. Historically the company has experienced fluctuating revenues and losses as it funds research and development but maintains liquidity through investments in market securities.
ICON is a contract research organization that provides outsourcing services to pharmaceutical, biotechnology, and medical device companies. ICON has expanded into foreign markets through acquisitions of AptivSolutions and Niphix, which position it for growth in Asia and Europe. ICON has also partnered with IBM to utilize IBM's Watson HealthCloud for data storage and analytics, giving ICON a competitive advantage over other CROs. ICON offers a full scope of clinical trial services, from drug development through FDA approval, attracting large pharmaceutical clients.
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
The document discusses several common myths about high-throughput screening (HTS) in drug discovery. It argues that HTS has been unfairly blamed for declining productivity in the pharmaceutical industry. The summary addresses three key points:
1) HTS data is of high quality due to rigorous quality control methods used in HTS laboratories.
2) While HTS is more expensive and time-consuming than other methods, the incremental increases are relatively small, around 10-20% more than alternatives.
3) There are successful examples of drugs discovered through HTS that eventually received FDA approval, despite the long timelines of the drug discovery process, showing that HTS can produce results.
This comprehensive presentation examines the most important incentives and disincentives for innovation in the pharmaceutical and biotech industries, discussing their effect on decisions about R&D direction/targets.
This document provides a business plan for a new pharmaceutical company called NEWTech Advant. The plan includes a situation analysis of the pharmaceutical market, noting trends like an aging population and increased regulation. It outlines NEWTech Advant's goals of improving existing drugs and discovering new ones. The marketing strategy discusses targeting physicians and patients aged 45+, and increasing market share through advertising. Financial objectives include achieving profitability in three years. The plan also analyzes strengths, weaknesses, opportunities and threats for the new company.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
The contract research organization (CRO) industry is a multi-billion dollar industry that is expected to grow substantially over the next five years. There are over 1,000 CROs globally, ranging in size from small firms to large publicly traded companies. The top five CROs capture over a third of total industry revenue, suggesting market consolidation. Growth in the industry is driven by increasing complexity and size of clinical trials, globalization of drug development, and pharmaceutical industry cost containment pressures that encourage further outsourcing of services.
This document provides a summary of the Oncology Drug Report 2014, which is described as the world's largest active resource for decision making in oncology. Some key details include:
- It covers 931 active cancer drug developers across 33 countries, along with profiles of 2237 active drugs in development, 37 cancer indications under pipeline analysis, and 523 clinical and 360 preclinical and discovery companies.
- The report is organized across 6 sections and provides comprehensive intelligence on the global oncology drug development landscape, including clinical trials, targets, mechanisms of action, deals and partnerships for individual drugs and companies.
- It aims to help businesses, scientists, investors and clinicians make better decisions by bringing extensive data together in one place
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
Fulgent Genetics - Biotech - Total return >200%Rogelio Rea
Fulgent Genetics is a genetic testing company with a market capitalization of $60.7 million. It has more than $40 million in cash and insider ownership of approximately 60% by the founder and CEO. The company provides genetic testing and sequencing at low costs using proprietary technology. It focuses on selling to hospitals and medical institutions, with approximately 86% of test billings being paid. The genetic testing market is growing significantly and Fulgent aims to become a leading provider through expanding its test menu, customer base, and global presence while maintaining low costs.
BioEntrepreneurship: Intellectual Property: What Do Investors Look For?MaRS Discovery District
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
This session presentation is available in audio format here: http://www.marsdd.com/bioent/dec4
The document summarizes findings from interviews with 23 primary sources and 7 secondary sources regarding Teva Pharmaceutical Industries Ltd.'s ability to overcome increasing competition and the impending patent cliff for its top-selling drug Copaxone. Most sources believed Teva's growth initiatives would help, but strategic acquisitions would be key to success. Sources viewed Teva as a strong, innovative leader but said maintaining Copaxone patients and generic sales would be challenges without new blockbuster products or deals. While Teva's generic pipeline and sales were seen as promising, uncertainty remained around fending off competitors and retaining its share of the Copaxone market.
Disseminate Clinical Data Early to Support Payer Coverage DecisionsTodd Berner MD
This document summarizes Todd Berner's presentation on early dissemination of clinical data to support payer coverage decisions. The presentation discusses comparative effectiveness research standards and how cost, comparators, and ambiguous results should be handled. It also addresses tailoring drug development to patient heterogeneity and biomarkers. Developing an open dialogue with payers throughout drug development is emphasized to demonstrate clinical and economic value. Field teams can establish relationships, disseminate outcomes data, and conduct research to support products. The goal is for clinical programs to demonstrate value through meaningful endpoints and real-world evidence.
QPS is a contract research organization that specializes in developing close relationships with clients based on trust and mutual respect. They offer flexible and nimble clinical work to improve outsourced work quality and reduce oversight needs. Their biosimilar drug development expertise can help clients advance their biosimilar portfolios in a timely manner for the benefit of patients worldwide.
The U.S. Biopharmaceutical Industry (2014): Perspectives on Future Growth and...PhRMA
The capability to innovate is fast becoming the most important determinant of economic growth and a nation’s ability to compete and prosper in the 21st century global knowledge-based economy.
The innovative biopharmaceutical industry stands out among high-value knowledge-based industries, including aerospace, automotive, and semiconductors, as a driver for future U.S. economic growth. Aging populations throughout the world and rising purchasing power for medical advances among emerging economies are expected to drive increased demand for prescription medicines in the coming years, providing opportunities to increase production and exports.
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
Predictive Analytics for Competitive Advantagevishwavijayps
This document discusses how Dr. Reddy's Laboratories uses predictive analytics to gain a competitive advantage. It describes two case studies: (1) using marketing mix modeling to optimize promotional strategies based on historical data, and (2) developing pricing and reimbursement strategies using claims data to understand patient costs and behaviors. It acknowledges challenges integrating diverse data sources for predictive modeling. Modern technologies like automated data integration and machine learning are proposed to enable real-time predictive modeling and recommendations.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Dr. Reddy's Laboratories is an Indian pharmaceutical company founded in 1984 and headquartered in Hyderabad, India. It produces active pharmaceutical ingredients, finished dosages, and biologics. Dr. Reddy's controls its entire supply chain to offer high quality, affordable medicines while maintaining quality at every stage. It has 20,000 employees worldwide and facilities in India, the US, UK, and Mexico. Dr. Reddy's goals include becoming a global, integrated mid-sized pharmaceutical company through diversifying into generics and specialty medicines across emerging markets.
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
DRL was once a leading Indian pharmaceutical company but has recently faced several crises and setbacks. It rose rapidly in the 1980s and 1990s through new product launches and acquisitions. However, the acquisition of Betapharm led to major losses and quality issues emerged in other facilities. Litigation in key markets like the US and Mexico hurt revenues. Fatal accidents at plants damaged the company's reputation. To recover, DRL must resolve legal issues, improve quality control, give more focus to the domestic market, and ensure transparency.
Dr. Reddy's Laboratories is a major Indian pharmaceutical company founded in 1984 and headquartered in Hyderabad. It has over 190 medications and 60 active pharmaceutical ingredients. The company has a global workforce of over 20,000 employees and a commercial presence in 26 countries. Dr. Reddy's Laboratories aims to bring new medicines to India at affordable prices. It has several subsidiaries and joint ventures around the world. The company produces generic medicines, APIs, differentiated formulations, and biosimilars. Its major competitors include Sun Pharma, Lupin, Aurobindo Pharma, and Cipla.
Drug discovery process style 5 powerpoint presentation templatesSlideTeam.net
The document describes the key stages in the drug discovery process, including cellular and genetic target identification, compound synthesis and isolation, high-throughput screening, lead optimization, preclinical testing in animal models and in vitro/in vivo studies, and clinical trials in humans. The flow diagram shows the iterative process moving from early research to identify biological targets through compound development and testing, culminating in clinical evaluation and potential approval of new therapeutics.
The document discusses herbal and drug design technology. It covers the process of drug discovery including target identification, lead identification, lead optimization, preclinical and clinical testing. It also discusses sources of lead compounds including natural products, observed drug side effects, and in silico computer-assisted drug design. Advances in molecular biology, genomics, high throughput screening and computer-aided drug design have revolutionized the field. Herbal drug design involves a multidisciplinary approach combining botanical, phytochemical and biological techniques to discover drugs from plants.
The document discusses the basics of clinical research and clinical trials. It covers the key steps in drug discovery and development including target selection, validation, drug selection, optimization, pre-clinical and clinical testing. Clinical trials are systematic investigations in human subjects to evaluate safety and efficacy of new drugs, and are done in 4 phases. It takes approximately 10-12 years and $800 million to bring a new drug to market. Regulations, stakeholders, essential documents, and infrastructure requirements for clinical trials are also outlined.
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
The document discusses the key stages in the drug discovery and development process including target selection, compound screening and hit optimization, selecting a drug candidate through further optimization of properties like absorption and metabolism, safety testing in animals and humans, proof of concept clinical trials in patients, large phase 3 clinical trials for registration and approval, and finally launch and life cycle management. It notes that the entire process from discovery to approval can take 12-16 years and cost over $1 billion.
The drug development process involves several phases of clinical trials overseen by regulatory agencies. Drugs must first show safety in pre-clinical animal and lab testing before entering human trials. Clinical trials involve 3 phases - Phase I tests safety in small groups, Phase II assesses efficacy and optimal dosing in larger groups of patients, and Phase III confirms efficacy in even larger groups. If results are positive, the drug company submits a New Drug Application to the regulatory agency which can take 2-3 years to review before approving the drug for the market. Post-market studies in Phase IV further monitor long-term safety and efficacy. The entire process from discovery to market approval takes an average of 10-15 years and over $1 billion
The document provides biographies of three executives from Reimbursement Intelligence: Rhonda Greenapple, Julie Schachter, and Maxim Miller. It then summarizes an article about challenges faced by the pharmaceutical industry during product development and strategies to optimize commercial opportunities. The summary identifies four critical steps in product development covered in the article: proof of concept, opportunity identification, pre-launch planning, and post-launch/life cycle management. It emphasizes the importance of understanding reimbursement and health outcomes at each step to maximize access and commercial success of new products.
This document discusses the rise of contract research organizations (CROs) that conduct clinical trials and other services on behalf of pharmaceutical companies. It notes that CROs have grown dramatically since the 1980s as drug companies increasingly outsource research to cut costs. While CROs claim to provide independent research, some experts argue they still face conflicts of interest since they rely on industry funding. The document also examines how CROs are expanding globally and investing in new technologies to increase their service capacity and distinguish themselves from competitors in a growing market.
Strategies for becoming_a_preferred_providerTruong Pham
This document summarizes a roundtable discussion with representatives from several contract manufacturing organizations on the trend of pharmaceutical companies consolidating their supplier base to work with fewer preferred providers.
The representatives observed that pharmaceutical companies are pursuing this approach to gain efficiencies from managing fewer relationships and to foster more strategic partnerships. Larger pharmaceutical companies are primarily driving this trend. When a contract manufacturer becomes a preferred provider, the relationship changes to involve more transparency, commitment to long term planning, and integration between the companies. The key factors for a contract manufacturer to become a preferred provider include having a strong track record of delivery, a customer-centric approach, and transparency to build trust in the relationship.
Biotech revolution changed the pharmaceutical industry, triggering a wave of risky collaborations between rivals. Based on the research findings, we answer the question why cooperation in the field of immuno-oncology is a better strategy for Pfizer and Merck KGaA, which aim to achieve competitive advantage quickly and with minimum effort. Combining their assets and core expertise companies realize benefits of greater size and variety in the conduct of research, development and commercializing of their new breakthrough therapy for cancer treatment.
Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?
Generic drug companies are relying heavily on qualified contract research organizations (CROs) to accelerate their development processes and be first to market after patents expire on branded drugs. CROs provide expertise across development areas like preclinical research, clinical trials management, bioequivalence studies, analytical testing, and ANDA submissions that help generics meet tight deadlines. Successfully demonstrating bioequivalence through bioavailability and dissolution studies is key for regulatory approval and requires CROs with strong laboratory capabilities and experience navigating regulatory requirements.
This document provides an overview of nanoparticle-based drug delivery technologies. It discusses how nanoparticles can help address challenges in traditional drug formulations by improving water solubility and targeting specificity. While only a few nanoparticle therapies have been FDA-approved so far, the author argues that these technologies are already impacting medicine and their impact will likely accelerate in coming years. The document also reviews the drug development process and pressures facing pharmaceutical companies to improve success rates and reduce costs. Nanotechnology may help address these challenges through miniaturization, automation, high-throughput screening and other techniques.
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 analyzes and dispels five common myths about the drug delivery industry. It argues that far from being a declining sector, drug delivery has delivered steady product approvals over the past decade and continues to be an important source of new products. It also contends that the drug delivery market is growing, drug delivery business models can be sustainable, product line extensions using drug delivery technologies are effective strategies, and drug delivery companies offer diverse technologies, not just similar controlled release solutions.
The document discusses the process and costs associated with drug development. It notes that the average cost to develop a new drug is $350 million to $5.5 billion and the process takes 6.5-7 years from discovery to approval. Key barriers to drug development include high financial costs, lengthy timelines for clinical trials, and regulatory hurdles. Approaches to reduce costs and timelines include greater use of electronic health records, simplifying clinical trial protocols, and utilizing decentralized clinical trial models.
Merck has developed a revolutionary scientific modeling platform to support all aspects of drug discovery and development. This platform, called the Virtual Pipeline, was created over 10 years in collaboration with regulators. It has allowed Merck to fully simulate drug lifecycles, power strategic decision making like portfolio acquisitions, and is projected to reduce timelines by 40% and costs by 50%. The platform aggregates both internal and external data, builds models and simulations, and provides best practice workflows to researchers.
Building a Culture of Model-driven Drug Discovery at MerckChris Waller
Merck has developed a revolutionary scientific modeling platform to support all aspects of drug discovery and development. This platform, called the Virtual Pipeline, was created over 10 years in collaboration with regulators. It has allowed Merck to fully simulate drug lifecycles, power strategic decision making like portfolio acquisitions, and is projected to reduce timelines by 40% and costs by 50%. The platform aggregates both internal and external data, builds models and simulations, and provides best practice workflows to researchers.
The pharmaceutical industry is facing many challenges in research and development including increased costs, higher hurdles for drug approval, and loss of blockbuster drugs to generics. As a result, the traditional model of large pharmaceutical companies conducting all research and development in-house has changed. The industry now involves a complex network of large companies, startups, contract research organizations, academic labs, and other partners. Opportunities still exist for students in the sciences but lie in more specialized areas such as clinical operations, business development, and roles outside of traditional drug discovery that apply scientific skills and knowledge. Emerging areas of focus include biotechnology, biomarkers, cancer immunotherapy, and bioelectronics.
The Innovation Gap in Pharmaceutical Drug Discovery and New Models for R&D Su...Michael Hu
Whitepaper exploring the root causes behind Pharma Industry's widening Innovation Gap and discusses several R&D innovation models for addressing the productivity conundrum.
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
R&D leadership in crisis: rebuilding innovation through peopleRung Jaismut
Pharmaceutical R&D organizations are facing a leadership crisis as the billion dollar blockbuster drug model is questioned. Shareholders question the sustainability of this model and large pharmaceutical companies question their commitment to internal R&D. The document discusses challenges facing R&D leaders, including managing outsourcing, lack of autonomy over funds, and motivating scientists. It also notes a shortage of quality R&D talent and lack of support for career development. Sixty percent of executives surveyed would be interested in leaving R&D for commercial roles. The sustainability of increasing R&D budgets without corresponding increases in new drug approvals is also questioned.
This document provides an overview of the science and business of drug discovery and development. It discusses the histories of large pharmaceutical companies and biotech startups. The current business landscape is defined by mergers and acquisitions as companies strive for efficiency. The scientific landscape is constrained by a limited number of known drug targets. Future trends may include increased collaboration between industry and academia to improve productivity and develop pre-competitive standards.
The pharmaceutical industry is shifting away from the traditional blockbuster drug model towards new business models. Long term strategies include adopting an integrated model that bundles drugs, healthcare services, and medical devices. Companies are also focusing on personalized drugs, disease management, and partnerships with biotech firms. Short term strategies involve semi-blockbuster portfolios, pre- and post-patent competition, and network-based research models relying more on outsourcing.
1. A New Approach to Outsourced
Drug Development:
How Sponsor-CRO Clinical Delivery Alliances
Improve Performance
Therapeutic Foresight. Trusted Results.
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