The document discusses drug delivery from the perspective of Wall Street. It notes that opportunities in drug delivery now lie in new molecular entities that can provide differentiated therapeutic profiles, rather than just reformulations. Valuing development programs considers factors like the targeted patient population, estimated pricing and discounts rates, and probability of success. While financing is challenging in the current market, options include partnering with pharmaceutical companies and royalty-based financing for later-stage programs. In conclusion, drug delivery is returning to solving complex problems through partnerships and platform technologies, but development costs are rising and investors have less risk tolerance.
This document discusses drug delivery from the perspective of Wall Street analysts and investors. It outlines where opportunities lie in drug delivery, how to value development programs, and options for financing development. The author notes Wall Street now views drug delivery as new molecular entities that can provide differentiated therapeutic profiles, rather than just reformulations. Opportunities exist in targeted and site-specific delivery technologies. Valuing programs requires estimating the patient population, pricing, discount rate, and probability of success. Financing options include public markets, though they are currently expensive; partnering for validation and development goals; and royalty-based deals for later-stage programs.
The document discusses drug delivery from the perspective of Wall Street analysts. It notes that opportunities in drug delivery now lie in new molecular entities that can provide differentiated therapeutic profiles through targeted or site-specific delivery technologies. While development costs are increasing, net present values of programs remain positive, especially when aided by royalty terms from pharmaceutical partners. Analysts are again looking for transformative delivery technologies but are less willing to fund development risks themselves. However, pharmaceutical companies remain willing to partner earlier in development to gain access to novel delivery technologies.
- Positive top-line results were reported from a Phase 3 trial of Zerenex in Japan comparing Zerenex to Sevelamer Hydrochloride. Zerenex showed non-inferiority to Sevelamer.
- Keryx's partner JT Torii plans to file a marketing application in Japan by March 31, 2013 based on the results.
- Keryx is conducting a Phase 3 trial of Zerenex in the US in 440 patients with end-stage renal disease that is expected to report results in the fourth quarter of 2012.
Dalradian corporate presentation july 25 2012 finalDalradianResource
This investor presentation by The European Explorer discusses the company's acquisition of approximately 1.7 million hectares of mineral rights over four greenstone belts and a historic silver mining camp in Norway. It notes that the presentation contains forward-looking statements regarding the acquisition, future performance, mineral resource estimates and other projections that are based on certain assumptions and involve known and unknown risks and uncertainties that could cause actual results to differ materially. The company disclaims any obligation to update forward-looking statements except as required by law.
Topaz Resources, Inc. (OTCBB: TOPZ) today announced that Grass Roots Research and Distribution, Inc. (www.grassrootsrd.com), the Investor Awareness Industry's Research Firm of Choice, has issued its 2nd Research Report with a Buy Recommendation on Topaz Resources.
Grass Roots' report stated: "Topaz is one of the most exciting junior oil and gas exploration and production companies. The Company is transforming itself from a start-up stage to a development stage oil and gas Company.
The document summarizes Oshkosh Corporation's earnings conference call for the second quarter of fiscal year 2008. Key highlights include sales increasing 6.7% to $1.8 billion and operating income rising 24.8% to $168.2 million. EPS grew 42.6% to $0.97. While access equipment and defense saw strong demand, commercial and fire & emergency faced challenging market conditions. The company maintained its fiscal year 2008 EPS estimate range of $4.15 to $4.35.
Intact Financial Corporation presented an investor presentation in March 2010. The presentation highlighted Intact as the dominant property and casualty insurer in Canada, with over $4 billion in direct premiums written. Intact has substantial size and scale advantages over its competitors due to its market share leadership positions in key provinces and a track record of successful acquisitions. The presentation also noted Intact's consistent outperformance of the P&C insurance industry over 10 years in areas like premium growth, combined ratio, and return on equity. Intact aims to continue its strong organic growth through its large broker network and by targeting the growing 50+ demographic market.
This document discusses drug delivery from the perspective of Wall Street analysts and investors. It outlines where opportunities lie in drug delivery, how to value development programs, and options for financing development. The author notes Wall Street now views drug delivery as new molecular entities that can provide differentiated therapeutic profiles, rather than just reformulations. Opportunities exist in targeted and site-specific delivery technologies. Valuing programs requires estimating the patient population, pricing, discount rate, and probability of success. Financing options include public markets, though they are currently expensive; partnering for validation and development goals; and royalty-based deals for later-stage programs.
The document discusses drug delivery from the perspective of Wall Street analysts. It notes that opportunities in drug delivery now lie in new molecular entities that can provide differentiated therapeutic profiles through targeted or site-specific delivery technologies. While development costs are increasing, net present values of programs remain positive, especially when aided by royalty terms from pharmaceutical partners. Analysts are again looking for transformative delivery technologies but are less willing to fund development risks themselves. However, pharmaceutical companies remain willing to partner earlier in development to gain access to novel delivery technologies.
- Positive top-line results were reported from a Phase 3 trial of Zerenex in Japan comparing Zerenex to Sevelamer Hydrochloride. Zerenex showed non-inferiority to Sevelamer.
- Keryx's partner JT Torii plans to file a marketing application in Japan by March 31, 2013 based on the results.
- Keryx is conducting a Phase 3 trial of Zerenex in the US in 440 patients with end-stage renal disease that is expected to report results in the fourth quarter of 2012.
Dalradian corporate presentation july 25 2012 finalDalradianResource
This investor presentation by The European Explorer discusses the company's acquisition of approximately 1.7 million hectares of mineral rights over four greenstone belts and a historic silver mining camp in Norway. It notes that the presentation contains forward-looking statements regarding the acquisition, future performance, mineral resource estimates and other projections that are based on certain assumptions and involve known and unknown risks and uncertainties that could cause actual results to differ materially. The company disclaims any obligation to update forward-looking statements except as required by law.
Topaz Resources, Inc. (OTCBB: TOPZ) today announced that Grass Roots Research and Distribution, Inc. (www.grassrootsrd.com), the Investor Awareness Industry's Research Firm of Choice, has issued its 2nd Research Report with a Buy Recommendation on Topaz Resources.
Grass Roots' report stated: "Topaz is one of the most exciting junior oil and gas exploration and production companies. The Company is transforming itself from a start-up stage to a development stage oil and gas Company.
The document summarizes Oshkosh Corporation's earnings conference call for the second quarter of fiscal year 2008. Key highlights include sales increasing 6.7% to $1.8 billion and operating income rising 24.8% to $168.2 million. EPS grew 42.6% to $0.97. While access equipment and defense saw strong demand, commercial and fire & emergency faced challenging market conditions. The company maintained its fiscal year 2008 EPS estimate range of $4.15 to $4.35.
Intact Financial Corporation presented an investor presentation in March 2010. The presentation highlighted Intact as the dominant property and casualty insurer in Canada, with over $4 billion in direct premiums written. Intact has substantial size and scale advantages over its competitors due to its market share leadership positions in key provinces and a track record of successful acquisitions. The presentation also noted Intact's consistent outperformance of the P&C insurance industry over 10 years in areas like premium growth, combined ratio, and return on equity. Intact aims to continue its strong organic growth through its large broker network and by targeting the growing 50+ demographic market.
Dover Corporation has reorganized into four new reporting segments - Industrial Products, Engineered Systems, Fluid Management, and Electronic Technologies - to better focus its portfolio and drive operational improvements. The reorganization is intended to increase synergies between similar businesses, expand executive opportunities, and improve clarity for investors. Dover expects the changes to its structure to enhance performance and increase operational earnings by 4-6% over the next two years through expanded synergies and best practices sharing.
Ideiasnet is a Brazilian business development company focused on long-term investments in IT. It has both private equity and venture capital arms. The private equity side focuses on larger investments in proven businesses for consolidation and growth. The venture capital side, Ideias Ventures, invests in early-stage companies with under R$10M in revenue to provide support for entrepreneurship. Ideiasnet aims to create synergies across its growing portfolio of IT companies.
The document summarizes Valeant Pharmaceuticals International's investor day agenda on June 21, 2012. The agenda included opening remarks by Mike Pearson, financial discussions by Howard Schiller, business overviews by Rajiv De Silva, and presentations on emerging markets and specialty pharmaceuticals. Guests in attendance included board members and senior leadership. The document also provided important information about forward-looking statements and non-GAAP financial measures.
The document discusses forward-looking statements made by the company regarding projected sales, profit margins, income, earnings per share, growth strategy, branding initiatives, innovation plans, and cost-savings initiatives. It notes that financial projections are based on assumptions and actual results could differ from projections. It also discusses non-GAAP financial measures included in the presentation. The document contains charts on the company's national footprint and segments, competitors' performance, distribution network, selling structure, and opportunities to standardize operations and use data to drive impact.
Pfizer at Citi Global Health Care Conferencefinance5
The document is a presentation from Pfizer's CFO at a healthcare conference in May 2008. It summarizes Pfizer's strategies to: 1) maximize revenues from existing, new, and diverse product sources; 2) establish a lower, more flexible cost base; and 3) innovate its business model. The presentation provides details on optimizing Pfizer's patent-protected portfolio, capitalizing on established products, growing in emerging markets, proven cost management track record, and 2008 financial guidance.
This document compares the brand strategies of Pepsi and Coke in India. It notes that Pepsi focuses more on being a youth and lifestyle brand, while Coke positions itself as more family-friendly. It also analyzes the companies' financial performance over 5 years, market share in India, and recommends strategies for Pepsi to increase sales in India by 10% such as CSR initiatives, festive offers, and price reductions.
This document outlines a presentation on clinical research and development challenges and opportunities. It discusses the low productivity and increasing costs of R&D, potential loss of revenue from expiring patents, and reasons for low productivity such as target and trial design issues. It also covers trends like globalization of clinical trials to reduce costs and access large patient populations. Finally, it discusses the need for quality and qualified investigators to address the supply and demand imbalance.
- The document discusses a biotechnology company, Omthera Pharmaceuticals, reporting positive results from a Phase 3 clinical trial of its lead drug Epanova for treating very high triglycerides.
- While Epanova lowered triglycerides and non-HDL cholesterol, Omthera did not disclose data on LDL cholesterol levels, which raised speculation that Epanova may increase LDL.
- This would be advantageous for the competing drug AMR101 from Amarin, which lowers triglycerides without raising LDL. In contrast, the krill oil-based drug CaPre from Neptune appears to lower triglycerides and LDL while raising HDL.
Annual update presented to members of the Investment Office by the officers of the club. I created this presentation in collaboration with my fellow officer and other club members.
Ezose Sciences Inc. is a relatively new biotech company located in New Jersey that focuses on glycomics and biomarker discovery. It has completed multiple collaborations and utilizes its GlycanMap technology. The pharmaceutical industry is facing pressures to control expenses as major drugs lose patent protection, while biomarkers, personalized medicine, and outsourced research and development represent growth opportunities. Glycomics is an underdeveloped field that could provide insights into disease, drug response and cellular processes.
ParentCo is considering whether to sell ApparelCo, acquire FashionCo, or maintain the status quo. Quantitative analysis was conducted including a SWOT analysis, Porter's Five Forces analysis, and valuation of the companies. Based on the analyses, ParentCo should sell a majority stake in ApparelCo, as it has weaknesses including few synergies with MediaCo and lower profit margins. Selling ApparelCo would allow ParentCo to divest a non-core asset.
The document discusses the need for marketing to demonstrate accountability by linking activities to brand value and firm value, outlines different perspectives and metrics used to measure branding effects, and explains how both traditional marketing funnel metrics and new online customer journey metrics can help predict sales performance across various product categories.
air products & chemicals 5 December 2007 Citi Basic Materialsfinance26
Paul Huck presented on Air Products' performance and outlook. Some key points:
1) Air Products has achieved four consecutive years of double-digit sales and earnings growth.
2) The company aims to continue delivering double-digit growth through large projects coming online, expansion in new geographies and markets, and cost reduction efforts.
3) Air Products is targeting 10-15% annual EPS growth and achieving returns well above its cost of capital through margin improvement and productivity initiatives.
From the clinic to the cfo adaptive trials and financial decision makingCytel USA
This document discusses how adaptive trial designs can be used to integrate clinical trial planning with financial decision making. It presents two case studies:
1) A biotech company used an adaptive design for a pivotal trial of an AML drug to reduce upfront costs and attract external investment. Interim results determined whether to increase the sample size. This improved the drug's risk/reward profile.
2) Hypothetical options for developing a niche oncology asset were evaluated. Scenarios including group sequential designs with interim analyses provided trade-offs between probability of success, time, cost, and expected value to discuss with management. Integrating financial metrics into adaptive trial design allows more flexible, "investable" research options.
Global Pharmaceutical and Biotechnology Outlook 2012mpadvisors
The document provides an outlook on the global biopharma industry in 2012, with a focus on large-cap pharma companies and the Japanese pharma market. It notes that large pharma companies will face significant patent cliff pressures totaling $134 billion from 2011-2016. Emerging markets may provide some growth but also face policy and economic pressures. The report's top picks for outperformance are Roche and GlaxoSmithKline, while Bristol-Myers Squibb is identified as a bottom pick. For the Japanese pharma market, the summary identifies drivers for increased generic uptake, innovation opportunities for major companies, and consolidation trends in the generics space.
TD Mergers & Acquisitions Competition 2015
We created a presentation on the potential bid structure and analysis of the transaction based on HBS case 9-210-040 "Roche's Acquisition of Genentech".
Team members:
Catherine Qian
Jenny Li
Terence Leung
Yu Cao
Engage Your Bottom Line: Understanding the Financial Implications of ICD-10 PYA, P.C.
ICD-10, the new, complex and expansive international healthcare coding system, goes into effect in less than two years. Denise and June shared with the audience of approximately 300 viewing the HIMSS telecast that organizations should now be engaged in staff training, budget and cash reserve preparation, and documentation improvement compliance efforts to meet the October. 1, 2013, deadline.
CMS estimates that ICD-10 conversion costs could total $640 million in 2013, but Denise and June offered real-world numbers for providers:
-Conversion costs alone for healthcare centers with more than 400 beds will range from $1.5 to $5 million
-100 to 400-bed hospitals will pay $500,000 to $1.5 million
-100- or fewer bed facilities can expect costs to range from $100,000 to $250,000
Denise and June also shared with HIMSS viewers that CMS and the American Health Information Management Association expect denial rates will increase 100 to 200 percent during the first two years of ICD-10 implementation. Claim error rates are expected to increase to 6 -10 percent from the current average rate of 3 percent.
Strategic Pricing - International CEO Forum 2011Pricing Insight
Strategic pricing - driving improved profitability and earnings growth. Presented by Ron Wood, Director of Pricing Insight at the International CEO Forum, 18th October 2011
The document provides an update on Fibrocell Science's commercial launch of LAVIV, its cell therapy product. Key points include:
- 30 dermatologists have been trained so far and 43 tissue samples submitted for processing.
- Fibrocell plans to train over 200 dermatologists by year's end.
- The company emphasized additional potential indications beyond the initial approval for nasolabial folds.
- Analysts maintain a "Market Outperform" rating and $3.50 price target, estimating $1 billion in annual sales by 2019.
The document appears to be a portfolio from Lawrence Samuels including details about his skills in corporate valuation, accounting, statistics, and additional tools. It includes a case study and analysis of Thumbs Up Corporation, a company that launched two projects to generate buzz about new products and establish a customer base. Samuels provides forecasts and analyses of Thumbs Up Corporation's sales, budgets, expansion projects, and marketing strategies.
This document summarizes a presentation on ensuring data quality in global clinical trials. It discusses deconstructing study protocols and plans to identify essential elements before initiating studies. Plans should be simplified and aligned across regions and partners. Study start-up is improved by engaging sites early and providing integrated training that simulates the trial process. An online community helps maintain relationships and information sharing with sites. The goal is to focus on critical data needs rather than planning excessively.
The document outlines key considerations for drug development including establishing a target product profile, clinical development plans, regulatory strategies, and clinical trial design. It emphasizes the importance of thorough planning including understanding regulatory requirements, involving key stakeholders, establishing development goals, and coordinating logistics to facilitate regulatory meetings and submissions. The overall process requires balancing factors like quality, time, and cost while aligning goals between stakeholders.
Dover Corporation has reorganized into four new reporting segments - Industrial Products, Engineered Systems, Fluid Management, and Electronic Technologies - to better focus its portfolio and drive operational improvements. The reorganization is intended to increase synergies between similar businesses, expand executive opportunities, and improve clarity for investors. Dover expects the changes to its structure to enhance performance and increase operational earnings by 4-6% over the next two years through expanded synergies and best practices sharing.
Ideiasnet is a Brazilian business development company focused on long-term investments in IT. It has both private equity and venture capital arms. The private equity side focuses on larger investments in proven businesses for consolidation and growth. The venture capital side, Ideias Ventures, invests in early-stage companies with under R$10M in revenue to provide support for entrepreneurship. Ideiasnet aims to create synergies across its growing portfolio of IT companies.
The document summarizes Valeant Pharmaceuticals International's investor day agenda on June 21, 2012. The agenda included opening remarks by Mike Pearson, financial discussions by Howard Schiller, business overviews by Rajiv De Silva, and presentations on emerging markets and specialty pharmaceuticals. Guests in attendance included board members and senior leadership. The document also provided important information about forward-looking statements and non-GAAP financial measures.
The document discusses forward-looking statements made by the company regarding projected sales, profit margins, income, earnings per share, growth strategy, branding initiatives, innovation plans, and cost-savings initiatives. It notes that financial projections are based on assumptions and actual results could differ from projections. It also discusses non-GAAP financial measures included in the presentation. The document contains charts on the company's national footprint and segments, competitors' performance, distribution network, selling structure, and opportunities to standardize operations and use data to drive impact.
Pfizer at Citi Global Health Care Conferencefinance5
The document is a presentation from Pfizer's CFO at a healthcare conference in May 2008. It summarizes Pfizer's strategies to: 1) maximize revenues from existing, new, and diverse product sources; 2) establish a lower, more flexible cost base; and 3) innovate its business model. The presentation provides details on optimizing Pfizer's patent-protected portfolio, capitalizing on established products, growing in emerging markets, proven cost management track record, and 2008 financial guidance.
This document compares the brand strategies of Pepsi and Coke in India. It notes that Pepsi focuses more on being a youth and lifestyle brand, while Coke positions itself as more family-friendly. It also analyzes the companies' financial performance over 5 years, market share in India, and recommends strategies for Pepsi to increase sales in India by 10% such as CSR initiatives, festive offers, and price reductions.
This document outlines a presentation on clinical research and development challenges and opportunities. It discusses the low productivity and increasing costs of R&D, potential loss of revenue from expiring patents, and reasons for low productivity such as target and trial design issues. It also covers trends like globalization of clinical trials to reduce costs and access large patient populations. Finally, it discusses the need for quality and qualified investigators to address the supply and demand imbalance.
- The document discusses a biotechnology company, Omthera Pharmaceuticals, reporting positive results from a Phase 3 clinical trial of its lead drug Epanova for treating very high triglycerides.
- While Epanova lowered triglycerides and non-HDL cholesterol, Omthera did not disclose data on LDL cholesterol levels, which raised speculation that Epanova may increase LDL.
- This would be advantageous for the competing drug AMR101 from Amarin, which lowers triglycerides without raising LDL. In contrast, the krill oil-based drug CaPre from Neptune appears to lower triglycerides and LDL while raising HDL.
Annual update presented to members of the Investment Office by the officers of the club. I created this presentation in collaboration with my fellow officer and other club members.
Ezose Sciences Inc. is a relatively new biotech company located in New Jersey that focuses on glycomics and biomarker discovery. It has completed multiple collaborations and utilizes its GlycanMap technology. The pharmaceutical industry is facing pressures to control expenses as major drugs lose patent protection, while biomarkers, personalized medicine, and outsourced research and development represent growth opportunities. Glycomics is an underdeveloped field that could provide insights into disease, drug response and cellular processes.
ParentCo is considering whether to sell ApparelCo, acquire FashionCo, or maintain the status quo. Quantitative analysis was conducted including a SWOT analysis, Porter's Five Forces analysis, and valuation of the companies. Based on the analyses, ParentCo should sell a majority stake in ApparelCo, as it has weaknesses including few synergies with MediaCo and lower profit margins. Selling ApparelCo would allow ParentCo to divest a non-core asset.
The document discusses the need for marketing to demonstrate accountability by linking activities to brand value and firm value, outlines different perspectives and metrics used to measure branding effects, and explains how both traditional marketing funnel metrics and new online customer journey metrics can help predict sales performance across various product categories.
air products & chemicals 5 December 2007 Citi Basic Materialsfinance26
Paul Huck presented on Air Products' performance and outlook. Some key points:
1) Air Products has achieved four consecutive years of double-digit sales and earnings growth.
2) The company aims to continue delivering double-digit growth through large projects coming online, expansion in new geographies and markets, and cost reduction efforts.
3) Air Products is targeting 10-15% annual EPS growth and achieving returns well above its cost of capital through margin improvement and productivity initiatives.
From the clinic to the cfo adaptive trials and financial decision makingCytel USA
This document discusses how adaptive trial designs can be used to integrate clinical trial planning with financial decision making. It presents two case studies:
1) A biotech company used an adaptive design for a pivotal trial of an AML drug to reduce upfront costs and attract external investment. Interim results determined whether to increase the sample size. This improved the drug's risk/reward profile.
2) Hypothetical options for developing a niche oncology asset were evaluated. Scenarios including group sequential designs with interim analyses provided trade-offs between probability of success, time, cost, and expected value to discuss with management. Integrating financial metrics into adaptive trial design allows more flexible, "investable" research options.
Global Pharmaceutical and Biotechnology Outlook 2012mpadvisors
The document provides an outlook on the global biopharma industry in 2012, with a focus on large-cap pharma companies and the Japanese pharma market. It notes that large pharma companies will face significant patent cliff pressures totaling $134 billion from 2011-2016. Emerging markets may provide some growth but also face policy and economic pressures. The report's top picks for outperformance are Roche and GlaxoSmithKline, while Bristol-Myers Squibb is identified as a bottom pick. For the Japanese pharma market, the summary identifies drivers for increased generic uptake, innovation opportunities for major companies, and consolidation trends in the generics space.
TD Mergers & Acquisitions Competition 2015
We created a presentation on the potential bid structure and analysis of the transaction based on HBS case 9-210-040 "Roche's Acquisition of Genentech".
Team members:
Catherine Qian
Jenny Li
Terence Leung
Yu Cao
Engage Your Bottom Line: Understanding the Financial Implications of ICD-10 PYA, P.C.
ICD-10, the new, complex and expansive international healthcare coding system, goes into effect in less than two years. Denise and June shared with the audience of approximately 300 viewing the HIMSS telecast that organizations should now be engaged in staff training, budget and cash reserve preparation, and documentation improvement compliance efforts to meet the October. 1, 2013, deadline.
CMS estimates that ICD-10 conversion costs could total $640 million in 2013, but Denise and June offered real-world numbers for providers:
-Conversion costs alone for healthcare centers with more than 400 beds will range from $1.5 to $5 million
-100 to 400-bed hospitals will pay $500,000 to $1.5 million
-100- or fewer bed facilities can expect costs to range from $100,000 to $250,000
Denise and June also shared with HIMSS viewers that CMS and the American Health Information Management Association expect denial rates will increase 100 to 200 percent during the first two years of ICD-10 implementation. Claim error rates are expected to increase to 6 -10 percent from the current average rate of 3 percent.
Strategic Pricing - International CEO Forum 2011Pricing Insight
Strategic pricing - driving improved profitability and earnings growth. Presented by Ron Wood, Director of Pricing Insight at the International CEO Forum, 18th October 2011
The document provides an update on Fibrocell Science's commercial launch of LAVIV, its cell therapy product. Key points include:
- 30 dermatologists have been trained so far and 43 tissue samples submitted for processing.
- Fibrocell plans to train over 200 dermatologists by year's end.
- The company emphasized additional potential indications beyond the initial approval for nasolabial folds.
- Analysts maintain a "Market Outperform" rating and $3.50 price target, estimating $1 billion in annual sales by 2019.
The document appears to be a portfolio from Lawrence Samuels including details about his skills in corporate valuation, accounting, statistics, and additional tools. It includes a case study and analysis of Thumbs Up Corporation, a company that launched two projects to generate buzz about new products and establish a customer base. Samuels provides forecasts and analyses of Thumbs Up Corporation's sales, budgets, expansion projects, and marketing strategies.
This document summarizes a presentation on ensuring data quality in global clinical trials. It discusses deconstructing study protocols and plans to identify essential elements before initiating studies. Plans should be simplified and aligned across regions and partners. Study start-up is improved by engaging sites early and providing integrated training that simulates the trial process. An online community helps maintain relationships and information sharing with sites. The goal is to focus on critical data needs rather than planning excessively.
The document outlines key considerations for drug development including establishing a target product profile, clinical development plans, regulatory strategies, and clinical trial design. It emphasizes the importance of thorough planning including understanding regulatory requirements, involving key stakeholders, establishing development goals, and coordinating logistics to facilitate regulatory meetings and submissions. The overall process requires balancing factors like quality, time, and cost while aligning goals between stakeholders.
The Biomarkers Consortium is a public-private partnership that qualifies biomarkers for applications in disease diagnosis, predicting treatment response, and improving clinical practice. It addresses a broad range of disease areas through collaborative projects involving industry, academics, and government. The Consortium generates pre-competitive data to inform regulatory decision-making and makes results openly available.
This document discusses challenges with patient recruitment for clinical trials and proposes a solution using electronic health records. It notes that clinical trial costs have risen significantly while few patients participate in research. The proposed solution involves matching clinical trial eligibility criteria to patient medical records and displaying potential trials to physicians within the electronic health record at the point of care. This has the potential to better inform patients and doctors about research opportunities tailored to each patient's individual health history.
Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services, with over 27,000 employees conducting business in more than 100 countries. Quintiles has helped develop or commercialize 100% of the top 50 best selling products or compounds from 2012. Quintiles provides integrated healthcare services across a product's entire lifecycle, from preclinical development to commercialization.
This document summarizes findings from surveys of sponsors and clinical research organizations (CROs) regarding quality in outsourced clinical trials. Key findings include: sponsors and CROs report moderate satisfaction with quality; cost pressures are a primary cause of quality issues; and proactive communication of quality expectations between sponsors and CROs is still lacking. Practices associated with higher quality and satisfaction include use of quality metrics and agreements. Risk-based approaches to monitoring and regional differences in quality were also discussed. Developing quality standards through collaboration between sponsors and CROs shows potential to improve outcomes.
This document proposes a new public-private partnership (PPP) model to validate novel drug targets through clinical proof-of-concept (POCM) studies more efficiently. It outlines the achievements and impact of the existing Structural Genomics Consortium (SGC) model of open access drug discovery. The new PPP would conduct precompetitive Phase II clinical trials on novel targets from academics and share all results and reagents openly to accelerate target validation and drug development while reducing waste. Regulators, patient groups, and funders have expressed interest in collaborating to design studies and leverage resources under this model.
Strategies for Developing & Commercializing Biobetters & BiosimilarsConferenceForum
Strategies for Developing & Commercializing Biobetters & Biosimilars a presentation by Phil Smith, PhD, Founder, PNPSmith Advisors, LLC at PODD Partnership Opportunites in Drug Delivery 2012, Boston, MA
The document discusses options for the design of a late-stage clinical trial evaluating three potential doses of a drug. It recommends a seamless two-stage adaptive design that begins with a four-arm dose-finding stage and selects the best dose at an interim analysis to continue to the second confirmatory stage. This reduces the required sample size compared to running separate trials or a single large four-arm trial. The design was approved by the FDA for a trial that successfully demonstrated efficacy of the selected dose.
Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the TalkConferenceForum
This document discusses the need for disruptive innovation in clinical research and drug development. It outlines 3 key challenges: 1) focusing only on incremental improvements rather than disruptive changes, 2) viewing research as a competitive rather than collaborative process, and 3) relying on closed rather than open systems of research. The document proposes moving to an open clinical intelligence network and experiment portfolio that uses crowd-sourcing, predictive analytics, and open data sharing to enable more efficient, collaborative research through disruptive approaches. By addressing these challenges, the pharmaceutical industry could overcome issues like rising costs and productivity declines threatening future revenues.
Changing Paradigms in Outsourcing, Liz StonerConferenceForum
The document discusses changing paradigms in biotech outsourcing from an investor's perspective. [1] Traditionally, biotech companies tightly controlled outsourcing with strong internal oversight, but new models favor capital efficiency through increased reliance on contract research organizations (CROs). [2] Venture capital investors seek innovative projects with medical and economic potential that CROs can help develop on a lean budget. [3] Successful models involve CROs providing expertise while core decisions remain internal, allowing companies to remain virtually organized with fractional staff.
The document discusses strategies for pharmaceutical pricing in the current healthcare environment. It outlines several market trends impacting price and positioning, including industry consolidation, risk-sharing contracts, biosimilars, and healthcare reform. The presentation also examines how to determine the perceived value of a product and considers factors like clinical benefits, unmet need, and cost-effectiveness studies. Finally, it discusses the complex pharmaceutical supply chain and how consolidation has impacted pricing negotiations.
The document discusses drug delivery from the perspective of Wall Street. It notes that opportunities in drug delivery now lie in new molecular entities that can provide differentiated therapeutic profiles, rather than just reformulations. Valuing development programs considers factors like the targeted patient population, estimated pricing and discounts rates, and probability of success. While financing is challenging in the current market, options include partnering with pharmaceutical companies and royalty-based financing for later-stage programs. In conclusion, drug delivery is returning to solving complex problems through partnerships and platform technologies, but development costs are rising.
The document discusses drug delivery from the perspective of Wall Street. It notes that opportunities in drug delivery now lie in new molecular entities that can provide differentiated therapeutic profiles, rather than just reformulations. Development costs are increasing and partnerships are relied on more. While drug delivery still has positive net present values, financing options are more limited and public markets are expensive. However, pharmaceutical companies are willing to finance novel delivery technologies in earlier stages of development.
This document outlines the key stages and decision points in developing a drug product from early research through commercialization. It discusses the critical drug product development deliverables, including clinical trial materials, regulatory documentation, and robust manufacturing technology. Several decision criteria are presented at key stages to evaluate progressing a product from discovery to clinical trials to registration and market launch. Finally, it stresses the importance of selecting a development partner with the appropriate technical capabilities and quality systems to help efficiently deliver a registered product.
The document provides information about Merck's partnership opportunities conference, including:
1) It discusses Merck's focus on partnerships, with about 64% of its 2010 revenue coming from alliance products and patents.
2) It provides key facts about Merck, such as its global operations, revenue, R&D spending, and pipeline of products in development.
3) It emphasizes Merck's large pipeline and willingness to partner on developing and commercializing drug delivery technologies.
The document discusses the relationship between corporate social responsibility (CSR), applied research ethics, and the clinical research enterprise. It summarizes views on renegotiating the social contract between industry and society to align private profits with public health interests using a triple bottom line approach of sustainability. The document also discusses how CSR principles of business ethics, sustainability, and governance can translate to clinical research by considering applied research ethics, feasibility of studies, and accountability.
Discover timeless style with the 2022 Vintage Roman Numerals Men's Ring. Crafted from premium stainless steel, this 6mm wide ring embodies elegance and durability. Perfect as a gift, it seamlessly blends classic Roman numeral detailing with modern sophistication, making it an ideal accessory for any occasion.
https://rb.gy/usj1a2
Best practices for project execution and deliveryCLIVE MINCHIN
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
Explore the fascinating world of the Gemini Zodiac Sign. Discover the unique personality traits, key dates, and horoscope insights of Gemini individuals. Learn how their sociable, communicative nature and boundless curiosity make them the dynamic explorers of the zodiac. Dive into the duality of the Gemini sign and understand their intellectual and adventurous spirit.
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...my Pandit
Dive into the steadfast world of the Taurus Zodiac Sign. Discover the grounded, stable, and logical nature of Taurus individuals, and explore their key personality traits, important dates, and horoscope insights. Learn how the determination and patience of the Taurus sign make them the rock-steady achievers and anchors of the zodiac.
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
3 Simple Steps To Buy Verified Payoneer Account In 2024SEOSMMEARTH
Buy Verified Payoneer Account: Quick and Secure Way to Receive Payments
Buy Verified Payoneer Account With 100% secure documents, [ USA, UK, CA ]. Are you looking for a reliable and safe way to receive payments online? Then you need buy verified Payoneer account ! Payoneer is a global payment platform that allows businesses and individuals to send and receive money in over 200 countries.
If You Want To More Information just Contact Now:
Skype: SEOSMMEARTH
Telegram: @seosmmearth
Gmail: seosmmearth@gmail.com
The Genesis of BriansClub.cm Famous Dark WEb PlatformSabaaSudozai
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
SATTA MATKA SATTA FAST RESULT KALYAN TOP MATKA RESULT KALYAN SATTA MATKA FAST RESULT MILAN RATAN RAJDHANI MAIN BAZAR MATKA FAST TIPS RESULT MATKA CHART JODI CHART PANEL CHART FREE FIX GAME SATTAMATKA ! MATKA MOBI SATTA 143 spboss.in TOP NO1 RESULT FULL RATE MATKA ONLINE GAME PLAY BY APP SPBOSS
NIMA2024 | De toegevoegde waarde van DEI en ESG in campagnes | Nathalie Lam |...BBPMedia1
Nathalie zal delen hoe DEI en ESG een fundamentele rol kunnen spelen in je merkstrategie en je de juiste aansluiting kan creëren met je doelgroep. Door middel van voorbeelden en simpele handvatten toont ze hoe dit in jouw organisatie toegepast kan worden.
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
Top 10 Free Accounting and Bookkeeping Apps for Small BusinessesYourLegal Accounting
Maintaining a proper record of your money is important for any business whether it is small or large. It helps you stay one step ahead in the financial race and be aware of your earnings and any tax obligations.
However, managing finances without an entire accounting staff can be challenging for small businesses.
Accounting apps can help with that! They resemble your private money manager.
They organize all of your transactions automatically as soon as you link them to your corporate bank account. Additionally, they are compatible with your phone, allowing you to monitor your finances from anywhere. Cool, right?
Thus, we’ll be looking at several fantastic accounting apps in this blog that will help you develop your business and save time.
Top 10 Free Accounting and Bookkeeping Apps for Small Businesses
Ian sanderson
1. An Analyst’s View: The Drug Delivery Opportunity
Ian Sanderson
Managing Director
Senior Research Analyst
Specialty Pharmaceuticals
1
2. An Analyst’s View: The Drug Delivery Opportunity
1. What defines drug delivery in the eyes of Wall Street?
2. Where do the opportunities lie in drug delivery?
– the Wall Street perspective
3. Valuing drug delivery development programs
4. Financing drug delivery development
2
3. Market perspectives – How we define drug delivery
Old: New:
Reformulation of an existing New molecular entities, with
compound – usually off- new PD profile
patent
Differentiating profiles for
Mostly oral controlled-release complex molecules
Out-licensed post POC - or Site-specific, targeted
earlier - in return for royalty delivery technologies
stream
Internally developed or
Once a life-cycle management partnered
strategy, now a generic
development requirement
NME risk and economics
3
5. Market perspectives – Where do the opportunities lie?
Evolving regulatory and reimbursement landscape
1. Gradual shift toward comparative effectiveness evaluation –
moves U.S. standards closer to E.U. standards
raises regulatory and reimbursement hurdles
raises differentiation standard for development partners
2. Biosimilar regulatory pathway creates opportunities
3. Development/commercial partners: new goals for drug delivery
fewer lifecycle extension programs
greater focus on changing/improving therapeutic profile
…driving shift toward NME/NCE development for drug delivery
5
6. Market perspectives – Where do the opportunities lie?
Business Models shifting back toward partnership model
EVOLUTION OF THE DRUG DELIVERY BUSINESS MODEL
1980's to early 1990's Mid-1990's to Mid-2000's 2008 to current
Broad technology platforms Companies built around products Technology platforms targeting
rather than technologies complex drug delivery issues
Development partnership, Internal product development Development partnership,
royalty-based model full integration ("FIPCO") royalty-based model
niche commercial capabilities
Standard equity financing Creative, off-balance sheet financing Creative, royalty-based financing
M&A Partner financing
M&A
ALZA, Elan, SkyePharma, etc. ALZA, Elan, Alkermes, Inhale, etc Nektar, ImmunoGen, Seattle Genetics,
etc.
6
7. Valuing drug delivery development programs
4 key valuation factors:
1. Targeted patient population and likely penetration
2. Estimated pricing
Incorporates therapeutic profile/differentiation
3. Discount rate
Incorporates cost of capital plus hurdle return rate
We assume positive NPV in our analyses
4. Probability of clinical/regulatory/market success
Usually a rough estimate based on what we know of clinical
trial design, FDA guidance, and medical need
7
8. Valuing drug delivery development programs
INTERNALLY-DEVELOPED PROGRAM
NPV ANALYSIS OF NKT R-1 0 2
2011E 2012E 2013E 2014E 2015E 2016P 2017P 2018P 2019P 2020P
Projected Sales $30 $120 $300 $400 $500 $600 $700
COGS $6 $14 $30 $40 $50 $60 $70
Estim ated R&D Spending $100 $150 $100 $65 $50 $45 $45 $40 $35 $30
Estim ated SG&A Spending $5 $20 $36 $60 $70 $80 $90 $100
Operating Ex penses $100 $150 $105 $91 $100 $135 $155 $170 $185 $200
Operating Incom e ($100) ($150) ($105) ($61) $20 $165 $245 $330 $415 $500
% Of Sales 16.3% 55.0% 61.3% 66.0% 69.2% 71.4%
Net Cash Flow ($100) ($150) ($105) ($61) $20 $165 $245 $330 $415 $500
Discount Rate 20%
Estim ated NPV $210
Sour ce: Com pany r epor t s and Cowen and Com pany, LLC est im at es
PARTNERED PROGRAM
NPV ANALYSIS OF EURX/ CEPH'S AM RIX
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 1 0
Projected Sales $6 $74 $114 $112 $115 $120 $130 $140
Royalties/ Mfg Fees to EURX $1 $13 $19 $19 $20 $20 $22 $24
COGS $0 $0 $0 $0 $0 $0 $0 $0
Estim ated R&D Spending $30 $25 $5 $3 $0 $0 $0 $0 $0 $0
Estim ated SG&A Spending $0 $0 $0 $0 $0 $0 $0 $0 $0
Operating Ex penses $30 $25 $5 $3 $0 $0 $0 $0 $0 $0
Operating Incom e ($30) ($25) ($4) $10 $19 $19 $20 $20 $22 $24
% Of Sales 17.0% 17.0% 17.0% 17.0% 17.0% 17.0%
Net Cash Flow ($30) ($25) ($4) $10 $19 $19 $20 $20 $22 $24
Discount Rate 10%
Estim ated NPV $48
Sour ce: Com pany r epor t s and Cowen and Com pany, LLC est im at es
8
9. Valuing drug delivery development programs
Changing Assumptions:
Revenues –
Longer development timelines (larger, longer pivotal trials)
Slower revenue ramps, due to managed care restrictions in U.S.
Higher year 4-8 sales estimates, due to global sales infrastructures
Costs –
Higher development costs (+20-40%, depending on the category)
Lower GPM in competitive U.S. markets and ROW markets
Lower relative promotional/marketing spending (as % of sales)
Terminal multiple:
Discount rate (cost of capital plus risk premium):
Probability of success:
9
10. Financing drug delivery development
Options more limited in volatile current market environment
Public market equity financing currently expensive
– if available at all
Debt/Convertible financing more available
– inflexible in a downside scenario
Pharma/Biotech partner financing
– important external validation to investors
– development goals aligned
– usually non-dilutive to equity investors
Royalty-based financing
– available for later-stage programs only
– lower capital costs than equity, less restrictive than debt
10
12. An Analyst’s View: The Drug Delivery Opportunity
Conclusions:
1. Drug Delivery returning to its routes of solving Tx problems
Platform technologies targeting more complex delivery problems
Development costs increasing – increased reliance on partnerships
NPV’s remain positive – aided by good royalty terms
2. Investors again looking for transformative delivery technologies
High unmet medical needs, strong pricing trends, little managed care
But…less willing to fund development risks and commercialization
3. …But Pharma companies willing to pay up for novel technologies
in earlier development stages
12
13. An Analyst’s View: The Drug Delivery Opportunity
Ian Sanderson
Managing Director
Senior Research Analyst
Specialty Pharmaceuticals
13