The document discusses risk assessment and management for new product planning in the pharmaceutical industry. It notes that [1] managing risk for new products is important given high development costs and failure rates, [2] forecasts often overestimate commercial potential which can lead to problems, and [3] using a target product profile and decision analysis can help capture development options and quantify risk.
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.
This document discusses outsourcing in clinical trials and how it can affect risk, cost, and outcomes. It examines different categories of risk in drug development like efficacy, safety, regulatory approval, and commercial assumptions. While outsourcing aims to reduce costs and access expertise, sponsors often report worse quality than in-house after several years. Specialized providers are important for data analysis but quality must be prioritized over price. Outsourcing can help manage workload flexibility but sponsors need to carefully model assumptions and scrutinize every step of the process.
How to Work Effectively with Research Teams in New Product PlanningAnthony Russell
Presented at the 3rd New Product Planning Summit. The presentation was designed to help professionals in New Product Planning to present a case for why commercial strategy input is needed early in the process of developing new therapeutics. The presentation also includes suggested approaches and tools to help with effective engagement with Research teams.
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/
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?
Decoding Phase II Clinical Trial Failuressubhabbasu
Clinical development is costly, with hundreds of millions of dollars spent to bring a drug to market. We identified the major reasons why Phase II clinical trials are terminated. Phase II serves as a major decision point, where a drug's effectiveness and safety are tested. However, our analysis of 444 clinical trials found Efficacy and Safety were reasons three and four, respectively, for trial terminations. Read to find out the top two reasons!
Specialty Medicine Revolution - Chris Bogan Keynote ((H2-2016)Chris Bogan
Chris Bogan, CEO of Best Practices, LLC, presented on launching new products and competing successfully in specialty care markets. The presentation discussed how the shift to specialty care has changed go-to-market strategies, requiring skills in areas like biologics, segmentation, outcomes research, and thought leader management. It also explained how specialty drug lifecycles are accelerating and compressing in challenging new ways, such as through fixed-dose combinations and multi-drug therapies that can create portfolio challenges for companies. The presentation provided insights into seven fronts where companies must evolve to keep pace with the changing specialty care environment.
PPDI is one of the top 10 clinical research organizations that provides drug development services. It has over 6,600 employees operating in 38 locations worldwide. PPDI generates most of its revenue from late-stage clinical trials. While it has strengths like operating efficiencies, it also faces weaknesses such as lack of diversification and high employee turnover. Opportunities include expanding into new areas like medical devices and proprietary drug development, while threats include increased competition and changes in the pharmaceutical industry.
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.
This document discusses outsourcing in clinical trials and how it can affect risk, cost, and outcomes. It examines different categories of risk in drug development like efficacy, safety, regulatory approval, and commercial assumptions. While outsourcing aims to reduce costs and access expertise, sponsors often report worse quality than in-house after several years. Specialized providers are important for data analysis but quality must be prioritized over price. Outsourcing can help manage workload flexibility but sponsors need to carefully model assumptions and scrutinize every step of the process.
How to Work Effectively with Research Teams in New Product PlanningAnthony Russell
Presented at the 3rd New Product Planning Summit. The presentation was designed to help professionals in New Product Planning to present a case for why commercial strategy input is needed early in the process of developing new therapeutics. The presentation also includes suggested approaches and tools to help with effective engagement with Research teams.
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/
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?
Decoding Phase II Clinical Trial Failuressubhabbasu
Clinical development is costly, with hundreds of millions of dollars spent to bring a drug to market. We identified the major reasons why Phase II clinical trials are terminated. Phase II serves as a major decision point, where a drug's effectiveness and safety are tested. However, our analysis of 444 clinical trials found Efficacy and Safety were reasons three and four, respectively, for trial terminations. Read to find out the top two reasons!
Specialty Medicine Revolution - Chris Bogan Keynote ((H2-2016)Chris Bogan
Chris Bogan, CEO of Best Practices, LLC, presented on launching new products and competing successfully in specialty care markets. The presentation discussed how the shift to specialty care has changed go-to-market strategies, requiring skills in areas like biologics, segmentation, outcomes research, and thought leader management. It also explained how specialty drug lifecycles are accelerating and compressing in challenging new ways, such as through fixed-dose combinations and multi-drug therapies that can create portfolio challenges for companies. The presentation provided insights into seven fronts where companies must evolve to keep pace with the changing specialty care environment.
PPDI is one of the top 10 clinical research organizations that provides drug development services. It has over 6,600 employees operating in 38 locations worldwide. PPDI generates most of its revenue from late-stage clinical trials. While it has strengths like operating efficiencies, it also faces weaknesses such as lack of diversification and high employee turnover. Opportunities include expanding into new areas like medical devices and proprietary drug development, while threats include increased competition and changes in the pharmaceutical industry.
This document is an investor presentation by PharmAust Limited that includes several disclaimers. It states that the presentation does not contain all information required by investors and should not be considered financial, tax, or legal advice. It also disclaims any representations or warranties regarding the accuracy of the information provided. The presentation is provided for investors to conduct their own independent research on the company. It also cautions that forward-looking statements in the presentation are based on assumptions that may not be realized.
1) Imugene is developing B-cell peptide cancer immunotherapy vaccines targeting the HER-2 receptor, which is the target of Roche's $6.4 billion breast cancer drug Herceptin.
2) Imugene has completed a Phase 1 clinical trial of its lead HER-Vaxx vaccine in HER-2 positive breast cancer patients, and plans to begin a Phase 1b/2 gastric cancer trial in early 2016.
3) HER-Vaxx induces polyclonal antibody responses against HER-2, unlike monoclonal antibodies, and has the potential to provide long-lasting immunity through immune memory activation.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
How to Create a Big Data Culture in PharmaChris Waller
A talk presented at the Big Data and Analytics conference in Boston on January 28, 2014. Emphasis on data and information sharing cultures in companies.
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The document discusses the potential role of mathematical modeling tools in improving regulatory communications on quality by design in the pharmaceutical industry. Specifically, it argues that chemometrics, pharmacometrics, and econometrics can provide objective ways to integrate scientific data across the product lifecycle in order to facilitate more risk-based regulatory decisions. Development reports that utilize chemometrics to predict critical quality attributes and verify predictions, along with explanations connecting these attributes to clinical outcomes, can give regulators a means to evaluate scientific understanding. Econometric modeling of manufacturing practices and their impact on product variability may allow facilities to be categorized by risk level. This integrated approach using multiple disciplines can help realize the goals of quality by design.
This document provides an overview of the SWOT analysis method. It defines SWOT as an acronym for strengths, weaknesses, opportunities, and threats. The method involves identifying internal strengths and weaknesses and external opportunities and threats and determining the strategic fit between an organization's internal capabilities and the external environment. The document outlines how to apply the SWOT method and provides an example of a completed SWOT analysis for Winnebago Industries.
This document discusses outsourcing in the pharmaceutical industry. It defines outsourcing as transferring portions of work to outside suppliers in order to reduce costs. The main types of outsourcing in pharma include research and development, clinical trials, manufacturing, packaging, and sales/marketing. The key drivers of outsourcing are focusing on core strengths, reducing costs, and decreasing time to market. While outsourcing provides advantages like cost reductions, it also presents risks such as loss of managerial control and internal talent. Overall, outsourcing allows pharma companies to exploit new drug technologies while solving problems, though successful management of vendor relationships is critical.
Physician e-sampling is an established tactic used by pharmaceutical companies to provide drug samples directly to physicians. The study found that while sales representatives remain the primary sampling channel, e-sampling is growing and accounts for about one-third of all sampling currently. Key drivers for implementing e-sampling programs are addressing shrinking sales forces and improving physician access. Most companies see e-sampling as positively contributing to their sales and marketing efforts, though only one in five strongly agree it greatly contributes. Innovation in e-sampling is focusing on supplemental approaches like tele-sampling and email/fax programs.
Physician e-sampling is an established marketing tactic used across many pharmaceutical companies and therapeutic areas to supplement diminished sales representative access to physicians. The key drivers for physician e-sampling programs are addressing issues like shrinking sales forces and restricted physician access. Most companies implement e-sampling programs to support increased sales, provide greater physician access, improve cost-effectiveness, and help build relationships. The number of monthly e-sampling requests varies significantly depending on the therapeutic areas and company sales structures.
The document discusses the evolution of medical science liaison (MSL) teams from the 1980s to present day. It describes how MSL teams initially focused on post-marketing activities but now also contribute value to clinical drug development processes like trial design and identification of new indications. The document provides examples of how MSL teams have helped pharmaceutical companies gain regulatory approval faster, lower development costs, and increase drug revenues.
Mtm9 white paper macro-environmental (steep) analysisIntelCollab.com
This document provides an overview of macro-environmental (STEEP) analysis, which examines the external social, technological, economic, environmental, and political factors that influence an organization. STEEP analysis involves scanning these macro-level factors to identify opportunities and threats in order to understand the overall context surrounding an industry. The results of STEEP analysis provide insights into how these external forces could impact a company. While useful for strategic planning, challenges in applying STEEP analysis include difficulties interpreting factors, inaccuracies in forecasts, short-term orientations, and lack of acceptance by management.
Translational data science at Merck involves combining data analytics and informatics across research and development to increase efficiency and success rates. Merck's data science team develops platforms and applies techniques like predictive modeling, data mining, and real-world evidence analysis to decrease costs and timelines for drug development while improving decision making. The goal is to enhance Merck's contributions in key therapeutic areas and increase the productivity of their drug pipeline.
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 speaker summarizes recent work analyzing trends in antibody-drug conjugate (ADC) clinical trials using a proprietary database. Some key findings include: (1) There are currently 59 ADCs in active clinical development. (2) In the last year alone, 15 new ADCs entered clinical trials with most targeting solid tumors. (3) There is increasing diversity in the payloads being tested, now over 11 distinct payloads in clinical trials. Continued analysis of drug performance and dosing strategies may help improve the therapeutic window for ADCs.
The document provides an overview of product life cycle (PLC) analysis, which describes how sales of a product evolve over time through four distinct stages: introduction, growth, maturity, and decline. It explains the characteristics and appropriate marketing strategies for each stage. For example, during introduction sales are low but advertising is high, while growth focuses on increasing sales and consumer loyalty. The document also cautions that PLC analysis has limitations and provides a case study analyzing the retail coffee industry through the PLC framework.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
The drug development process takes 10-15 years and costs over $800 million on average to develop a new drug. Only about 1 in 5,000-10,000 compounds tested make it to consumers, and only 3 of 10 drugs that reach the market earn back their R&D costs. The process involves extensive research, pre-clinical testing on animals, and clinical trials on humans in 3 phases before the FDA reviews the new drug application. If approved, large-scale manufacturing must be developed to produce the drug.
This document is an investor presentation by PharmAust Limited that includes several disclaimers. It states that the presentation does not contain all information required by investors and should not be considered financial, tax, or legal advice. It also disclaims any representations or warranties regarding the accuracy of the information provided. The presentation is provided for investors to conduct their own independent research on the company. It also cautions that forward-looking statements in the presentation are based on assumptions that may not be realized.
1) Imugene is developing B-cell peptide cancer immunotherapy vaccines targeting the HER-2 receptor, which is the target of Roche's $6.4 billion breast cancer drug Herceptin.
2) Imugene has completed a Phase 1 clinical trial of its lead HER-Vaxx vaccine in HER-2 positive breast cancer patients, and plans to begin a Phase 1b/2 gastric cancer trial in early 2016.
3) HER-Vaxx induces polyclonal antibody responses against HER-2, unlike monoclonal antibodies, and has the potential to provide long-lasting immunity through immune memory activation.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
How to Create a Big Data Culture in PharmaChris Waller
A talk presented at the Big Data and Analytics conference in Boston on January 28, 2014. Emphasis on data and information sharing cultures in companies.
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
Shedding Some Light on the Insights Lurking in the PMA DatabaseRevital (Tali) Hirsch
May 28, 2016 marked forty years of modern day federal authority over medical devices in the U.S. Not only is this period brief in and of itself, but it’s also shorter by half compared to the duration of federal authority over pharmaceuticals, which began with the Food, Drug and Cosmetics Act of 1938. In the past several years the FDA has been the target of much criticism with regards to the approval of high-risk medical devices. Some of that critique is likely merited, but it is important to keep in mind that the medical device arm of the FDA is a work-in-progress that has had considerably less time to invent itself in the larger context of history.
This paper compares and contrasts different stakeholders’ perspectives and takes a deeper dive into the data. In doing so, this paper outlines practical changes and enhancements to the PMA database that can be carried out in the immediate present to increase transparency between the FDA and Industry.
The deeper dive also identifies several potential avenues for follow-on research, including PMAs that do not reach a positive conclusion and PMAs that are sponsored by early-stage and/or inexperienced filers. Insights from such research may hold the key to longer-term regulatory process improvements within the existing framework to promote high-risk medical device innovation and shorten these devices’ time-to-market without compromising the higher standards of the domestic regulatory system or the safety of patients.
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The document discusses the potential role of mathematical modeling tools in improving regulatory communications on quality by design in the pharmaceutical industry. Specifically, it argues that chemometrics, pharmacometrics, and econometrics can provide objective ways to integrate scientific data across the product lifecycle in order to facilitate more risk-based regulatory decisions. Development reports that utilize chemometrics to predict critical quality attributes and verify predictions, along with explanations connecting these attributes to clinical outcomes, can give regulators a means to evaluate scientific understanding. Econometric modeling of manufacturing practices and their impact on product variability may allow facilities to be categorized by risk level. This integrated approach using multiple disciplines can help realize the goals of quality by design.
This document provides an overview of the SWOT analysis method. It defines SWOT as an acronym for strengths, weaknesses, opportunities, and threats. The method involves identifying internal strengths and weaknesses and external opportunities and threats and determining the strategic fit between an organization's internal capabilities and the external environment. The document outlines how to apply the SWOT method and provides an example of a completed SWOT analysis for Winnebago Industries.
This document discusses outsourcing in the pharmaceutical industry. It defines outsourcing as transferring portions of work to outside suppliers in order to reduce costs. The main types of outsourcing in pharma include research and development, clinical trials, manufacturing, packaging, and sales/marketing. The key drivers of outsourcing are focusing on core strengths, reducing costs, and decreasing time to market. While outsourcing provides advantages like cost reductions, it also presents risks such as loss of managerial control and internal talent. Overall, outsourcing allows pharma companies to exploit new drug technologies while solving problems, though successful management of vendor relationships is critical.
Physician e-sampling is an established tactic used by pharmaceutical companies to provide drug samples directly to physicians. The study found that while sales representatives remain the primary sampling channel, e-sampling is growing and accounts for about one-third of all sampling currently. Key drivers for implementing e-sampling programs are addressing shrinking sales forces and improving physician access. Most companies see e-sampling as positively contributing to their sales and marketing efforts, though only one in five strongly agree it greatly contributes. Innovation in e-sampling is focusing on supplemental approaches like tele-sampling and email/fax programs.
Physician e-sampling is an established marketing tactic used across many pharmaceutical companies and therapeutic areas to supplement diminished sales representative access to physicians. The key drivers for physician e-sampling programs are addressing issues like shrinking sales forces and restricted physician access. Most companies implement e-sampling programs to support increased sales, provide greater physician access, improve cost-effectiveness, and help build relationships. The number of monthly e-sampling requests varies significantly depending on the therapeutic areas and company sales structures.
The document discusses the evolution of medical science liaison (MSL) teams from the 1980s to present day. It describes how MSL teams initially focused on post-marketing activities but now also contribute value to clinical drug development processes like trial design and identification of new indications. The document provides examples of how MSL teams have helped pharmaceutical companies gain regulatory approval faster, lower development costs, and increase drug revenues.
Mtm9 white paper macro-environmental (steep) analysisIntelCollab.com
This document provides an overview of macro-environmental (STEEP) analysis, which examines the external social, technological, economic, environmental, and political factors that influence an organization. STEEP analysis involves scanning these macro-level factors to identify opportunities and threats in order to understand the overall context surrounding an industry. The results of STEEP analysis provide insights into how these external forces could impact a company. While useful for strategic planning, challenges in applying STEEP analysis include difficulties interpreting factors, inaccuracies in forecasts, short-term orientations, and lack of acceptance by management.
Translational data science at Merck involves combining data analytics and informatics across research and development to increase efficiency and success rates. Merck's data science team develops platforms and applies techniques like predictive modeling, data mining, and real-world evidence analysis to decrease costs and timelines for drug development while improving decision making. The goal is to enhance Merck's contributions in key therapeutic areas and increase the productivity of their drug pipeline.
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 speaker summarizes recent work analyzing trends in antibody-drug conjugate (ADC) clinical trials using a proprietary database. Some key findings include: (1) There are currently 59 ADCs in active clinical development. (2) In the last year alone, 15 new ADCs entered clinical trials with most targeting solid tumors. (3) There is increasing diversity in the payloads being tested, now over 11 distinct payloads in clinical trials. Continued analysis of drug performance and dosing strategies may help improve the therapeutic window for ADCs.
The document provides an overview of product life cycle (PLC) analysis, which describes how sales of a product evolve over time through four distinct stages: introduction, growth, maturity, and decline. It explains the characteristics and appropriate marketing strategies for each stage. For example, during introduction sales are low but advertising is high, while growth focuses on increasing sales and consumer loyalty. The document also cautions that PLC analysis has limitations and provides a case study analyzing the retail coffee industry through the PLC framework.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
The drug development process takes 10-15 years and costs over $800 million on average to develop a new drug. Only about 1 in 5,000-10,000 compounds tested make it to consumers, and only 3 of 10 drugs that reach the market earn back their R&D costs. The process involves extensive research, pre-clinical testing on animals, and clinical trials on humans in 3 phases before the FDA reviews the new drug application. If approved, large-scale manufacturing must be developed to produce the drug.
Leading Molecules to Market - An overview on licensingBananaIP Counsels
Leading Molecules to Market - An overview on licensing
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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.
Keynote by Michael Berman, Former President at Boston Scientific and Healthcare IT entrepreneur and innvestor, about US digital healthcare investment trends and opportunities for the mHealth Israel meetup community
How and When to Kill a Program in New Product PlanningAnthony Russell
Presented at the 4th New Product Planning Summit in Boston (Dec 2 -3 , 2019). Presentation covers why weak programs should be cut from pharmaceutical and biotech pipelines, what defines a "weak" program, and describes objective methods to evaluate programs to help prioritize assets.
This document summarizes the challenges facing the pharmaceutical research industry in India. It notes that while India has a large, low-cost workforce and regulatory framework to support pharmaceutical research, no new drug molecules have been developed domestically. The key challenges include high costs and failure rates in clinical trials, regulatory hurdles, concerns over side effects, and low productivity. Stakeholders across academia, industry and government must work together to strengthen education in interdisciplinary fields, promote intellectual property awareness, simplify regulations, and invest in research to help overcome these challenges and enable India to develop new drug molecules.
The document discusses the importance of early clinical recruitment planning for drug development programs. It notes that delays in recruitment can significantly increase costs and impact revenue opportunities due to later market entry. Early planning allows consideration of factors like disease characteristics, enrollment population size, competition, and protocol challenges that influence feasibility. Comprehensive recruitment programs costing 1-12% of delay costs can help avoid delays and ensure timely trial completion and drug approval.
Drug Development Life Cycle - Costs and RevenueRobert Sturm
Presentation explains the Drug Development Process in terms of time/costs from initial research to final manufacturing. It presents strategies for increasing profits/decreasing costs, shows the impact of generics and details how Information Technology fits into this equation. It uses research from DiMasi and Grabowski to identify drug costs and product revenue.
The document discusses bioprinting patents and intellectual property issues. It notes that while bioprinting techniques have been patented for years, the patenting of bioprinted tissues and organs is more limited as they lack expression, ornamental features, or source of origin. Utility patents provide the best protection for bioprinting innovation, though patents are difficult to obtain and enforce. Regulatory approval for bioprinted tissues is also expensive and time-consuming, providing little incentive for development without patent protection. The article examines patents covering the three phases of bioprinting and exceptions for experimental use.
Swaroop Vakkalanka provides an overview of starting a discovery-based R&D company in India. He discusses the background of pharmaceutical R&D globally and in India, opportunities for a business model, gaps that need to be addressed, the importance of licensing, and factors for success regarding infrastructure and operations. Key points include diminishing R&D productivity globally, India's progression from generics to biotech, gaps in India's capabilities, and the need for management experience, flexibility, financial support, and a focus on science in early-stage R&D.
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.
R&D Productivity and Costs in Today's Health Care Arena - Pat AudetTTC, llc
The document discusses challenges facing the pharmaceutical industry including increased healthcare costs, decreased R&D productivity, and more difficulty achieving blockbuster drugs. It also outlines strategies the industry is taking to address these challenges such as focusing on specialty and biologic drugs, reducing R&D costs through outsourcing and adaptive clinical trial designs, and pursuing mergers and acquisitions.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
What's In An Idea-Chanda-UofT Life Science CoachDebra A. Chanda
The document discusses challenges and opportunities in the medical innovation process. It notes that while regulatory approval and reimbursement processes can be slow, improvements are being made. Medical device innovation requires collaboration between physicians, engineers, and industry. The future includes more implanted diagnostics to better manage diseases and promote wellness. Overall, the field remains promising for new technologies despite barriers that can be further addressed.
The document discusses the Myelin Repair Foundation's (MRF) mission to accelerate the discovery of treatments for multiple sclerosis (MS) by establishing a new paradigm for medical research. It outlines some of the inefficiencies of the current academic research and drug discovery system. The MRF aims to coordinate disease-specific research, protect intellectual property, and transition promising targets to clinical candidates more efficiently through its Accelerated Research Collaboration model. It summarizes the MRF's research progress and plans over its first five years and outlines strategies to further translate its discoveries.
The document summarizes perspectives from a panel of finance directors on successful collaborations in the biopharmaceutical industry. The panel emphasizes clear communication, understanding partners' perspectives, resolving disputes internally, and adhering to collaboration agreements while considering real-world flexibility. It also provides examples of specific company collaborations and financial arrangements.
Investor presentation for Critical Outcome Technologies Inc. (TSX-V: COT; OTC: COTQF). This presentation provides the latest overview of the company's lead cancer drug, COTI-2, as well as other revenue opportunities being pursued by Critical Outcome Technologies.
Dyadic International is a global biotechnology company focused on improving and applying its proprietary C1 gene expression platform, a patented genetically modified strain of the fungus Myceliophthora thermophila, to address opportunities in human and animal health markets. The C1 platform can help bring biologic drugs to market faster, in greater volumes, and at lower cost than existing platforms like CHO cells. Dyadic pursues R&D collaborations and licensing arrangements to develop and manufacture biopharmaceuticals using the C1 platform.
The New Knowledge is the commercial opportunity. Integrating previous knowledge is all about integrating your assumptions.
“Future Experiments” is the future launch and commercialization of your drug
Better side effect profile might impact share, price, even treatment rate (think Hep C and Ribaviron/IFN)
Primary market research can be a real asset in quantifying impact of a drug’s improved side effect profile or efficacy