Pharmaceutical and life science companies and their chief regulator – the FDA – must find new ways to collaborate to meet 21st century demands.
Web Page: http://www.pwc.com/us/en/health-industries/health-research-institute/hri-pharma-life-sciences-fda.jhtml
Summary: Even in a time of high biopharma valuations, adopting an activist mentality adds rigor to capital allocation and strategic decision-making, improving not just returns to shareholders but long-term value creation. Therefore, biopharma management teams and boards of directors should proactively assess the “fitness” of their capital allocation strategies and their alignment with operational performance goals by taking an outsider’s view of the business even when times are good — and before a material stumble provides a compelling reason for an outsider to act. For more on this topic, go to http://www.ey.com/GL/en/Industries/Life-Sciences/EY-vital-signs-how-fit-is-your-capital-allocation-strategy.
MAPS2018 Keynote address on EY report: Life Sciences 4.0 – Securing value thr...EY
Summary: This keynote address presented by Pamela Spence, EY Global Life Sciences Leader (pspence2@uk.ey.com) at MAPS 2018 – the annual meeting for Medical Affairs Professional Society – discusses our latest life sciences report and the industry demands for a customer-focused, data driven approach to health care. We describe the accelerating pace of change as technological advances and the escalating expectations of payers, physicians and patient consumers are combining to disrupt the life sciences business model. Data and algorithms that maximize health outcomes based on individual needs and preferences are becoming the ultimate health care consumable. To create value now and in a future that we call Life Sciences 4.0, life sciences companies must build – or participate in – interoperable information systems that collect, combine and share data. For more on our report, Progressions 2018 – Life Sciences 4.0, please go to www.ey.com/progressions
On June 21st, PwC’s Health Research Institute (HRI) released its annual Medical Cost Trend: Behind the Numbers 2017 report. PwC’s HRI anticipates a 6.5% growth rate for 2017—the same as was projected for 2016. The report identifies the key inflators and deflators as well as historical context to better understand the medical cost trend for 2017. Increases in the trend due to utilization of convenient care access points and an uptick in behavioral healthcare benefits for employees are being offset by more aggressive strategies by pharmacy benefit
China Exit or Co-Investment Opportunities for German PE InvestorsL.E.K. Consulting
L.E.K.'s Karin von Kienlin recently presented at BVK on a study conducted by L.E.K. Munich and Shanghai. They wished to:
- Understand developments in Chinese equity investments in both the domestic China / pan-Asian market and cross-border investments between China and Germany / Europe
- Identify trends in likely future investment behavior and its drivers
- Defining success factors both for Chinese and German investors / corporates as to how to benefit from the potential opportunities of cross-border investments and cooperation
Learn more in the presentation here.
Since last year ended on such a strong note, many of us were optimistic about the prospects for Q1. Though not as strong as the fourth quarter of 2014, the first quarter of 2015 kicked off on a positive note, with 23 technology companies raising US$6.1billion* in proceeds from their IPOs. That’s the second highest first quarter proceeds in the past five years and impressive given the increased US market volatility and consistent with the high pre-IPO valuations we’ve seen recently. Granted, if you look at the year over year comparison, offerings were down 12% and proceeds declined 11%. And sequentially, the number of technology IPOs declined 32% while proceeds fell by 19%. Still, it’s a promising start for 2015. Learn more at www.pwc.com/globaltechipo
*Deal size greater than US$40 million
The Fourth Annual Global Mobility Study [hyperlink] by L.E.K. Consulting, Vision Mobility and CuriosityCX highlights that there is a much greater uptake of ride-hailing and other new mobility options in India and China than in mature western economies. With relatively low levels of car ownership and less developed public transport systems in these Asian countries, new mobility use is now comparable with and set to overtake traditional transport for a segment of the population.
Summary: Even in a time of high biopharma valuations, adopting an activist mentality adds rigor to capital allocation and strategic decision-making, improving not just returns to shareholders but long-term value creation. Therefore, biopharma management teams and boards of directors should proactively assess the “fitness” of their capital allocation strategies and their alignment with operational performance goals by taking an outsider’s view of the business even when times are good — and before a material stumble provides a compelling reason for an outsider to act. For more on this topic, go to http://www.ey.com/GL/en/Industries/Life-Sciences/EY-vital-signs-how-fit-is-your-capital-allocation-strategy.
MAPS2018 Keynote address on EY report: Life Sciences 4.0 – Securing value thr...EY
Summary: This keynote address presented by Pamela Spence, EY Global Life Sciences Leader (pspence2@uk.ey.com) at MAPS 2018 – the annual meeting for Medical Affairs Professional Society – discusses our latest life sciences report and the industry demands for a customer-focused, data driven approach to health care. We describe the accelerating pace of change as technological advances and the escalating expectations of payers, physicians and patient consumers are combining to disrupt the life sciences business model. Data and algorithms that maximize health outcomes based on individual needs and preferences are becoming the ultimate health care consumable. To create value now and in a future that we call Life Sciences 4.0, life sciences companies must build – or participate in – interoperable information systems that collect, combine and share data. For more on our report, Progressions 2018 – Life Sciences 4.0, please go to www.ey.com/progressions
On June 21st, PwC’s Health Research Institute (HRI) released its annual Medical Cost Trend: Behind the Numbers 2017 report. PwC’s HRI anticipates a 6.5% growth rate for 2017—the same as was projected for 2016. The report identifies the key inflators and deflators as well as historical context to better understand the medical cost trend for 2017. Increases in the trend due to utilization of convenient care access points and an uptick in behavioral healthcare benefits for employees are being offset by more aggressive strategies by pharmacy benefit
China Exit or Co-Investment Opportunities for German PE InvestorsL.E.K. Consulting
L.E.K.'s Karin von Kienlin recently presented at BVK on a study conducted by L.E.K. Munich and Shanghai. They wished to:
- Understand developments in Chinese equity investments in both the domestic China / pan-Asian market and cross-border investments between China and Germany / Europe
- Identify trends in likely future investment behavior and its drivers
- Defining success factors both for Chinese and German investors / corporates as to how to benefit from the potential opportunities of cross-border investments and cooperation
Learn more in the presentation here.
Since last year ended on such a strong note, many of us were optimistic about the prospects for Q1. Though not as strong as the fourth quarter of 2014, the first quarter of 2015 kicked off on a positive note, with 23 technology companies raising US$6.1billion* in proceeds from their IPOs. That’s the second highest first quarter proceeds in the past five years and impressive given the increased US market volatility and consistent with the high pre-IPO valuations we’ve seen recently. Granted, if you look at the year over year comparison, offerings were down 12% and proceeds declined 11%. And sequentially, the number of technology IPOs declined 32% while proceeds fell by 19%. Still, it’s a promising start for 2015. Learn more at www.pwc.com/globaltechipo
*Deal size greater than US$40 million
The Fourth Annual Global Mobility Study [hyperlink] by L.E.K. Consulting, Vision Mobility and CuriosityCX highlights that there is a much greater uptake of ride-hailing and other new mobility options in India and China than in mature western economies. With relatively low levels of car ownership and less developed public transport systems in these Asian countries, new mobility use is now comparable with and set to overtake traditional transport for a segment of the population.
Top 8 Insights From the 2018 Beauty, Health & Wellness SurveyL.E.K. Consulting
Think nutritional supplements and skincare are of interest only to consumers of a certain age? Think again. According to L.E.K. Consulting’s third installment of a biennial survey of the healthy living marketplace, this one focusing on nutrition and skincare, some 80% of health and wellness (H&W) consumers across generations — from millennials to baby boomers — are highly engaged with both categories.
The survey captured insights from more than 1,600 respondents, representing roughly 77% of the U.S. adult population who identify with H&W themes, and generated eight key insights across categories. Together these insights make clear that consumer interest in nutritional supplements and skincare often lasts a lifetime.
EY Price Point: global oil and gas market outlook, Q2 | April 2022EY
The theme for this quarter is rearrangement. The loss, or potential loss, of Russian oil and gas supplies is forcing producers, refiners and traders to rethink the flow of crude oil and refined products from the wellhead to the gas pump in light of sanctions, potential sanctions and the risk of reputational damage. Countries, companies and consumers will all be searching for ways to adapt, and the outcome of the race to bring alternatives to market could alter the global energy landscape for years to come.
It is likely crude oil and LNG prices will remain elevated for some time. The process of diverting Russian oil through countries unwilling to sanction it will take time and there is little indication OPEC members are willing (or able) to increase production to make up for the loss of Russian crude. Spare capacity sat at 3.7 mbpd at the end of 2021, just above where it was in January 2020. Currently, sanctioned Venezuelan and Iranian production (about 3 mbpd below their peak) could fill the gap, but political and commercial obstacles remain. At today’s prices, US shale production is attractive, but the fastest the industry has been able to grow is between 1mbpd and 2mbpd per year. The LNG infrastructure was already stretched before the war in Ukraine and there is little prosect of finding new supplies soon.
As the largest buyer of Russian energy, Europe will be the epicenter. There is a deeply embedded bias there in favor for renewable energy, and the current crisis is certain to result in an all-out effort to accelerate the build-out of wind and solar power. The capacity to add new green energy is limited though by the project pipeline and supply chains for solar panels and wind turbines, and it is likely that much of the shortfall will be made up with the new LNG infrastructure.
L.E.K. Consulting’s annual Media & Entertainment Study
was conducted between December 2018 and January
2019. We surveyed around 2,000 households on their
entertainment choices, preferences and viewing habits.
This Executive Insights analyzes key findings about
movie theater attendance and subscription services.
TMT Outlook 2017: A new wave of advances offer opportunities and challengesDeloitte United States
Important trends continue to shape the technology, media, and telecommunications (TMT) industry. What developments should you anticipate in 2017? https://subscriptions.deloitte.com/default.aspx?eventid=1323075
Apache Hadoop Summit 2016: The Future of Apache Hadoop an Enterprise Architec...PwC
Hadoop Summit is an industry-leading Hadoop community event for business leaders and technology experts (such as architects, data scientists and Hadoop developers) to learn about the technologies and business drivers transforming data. PwC is helping organizations unlock their data possibilities to make data-driven decisions.
18th Annual Global CEO Survey - Technology industry key findingsPwC
Tech CEOs are optimistic about the global economy and both near term and future revenue growth. They view strategic alliances, including partnering with competitors, as a primary means to grow their businesses. We invite you to explore the analysis and contact us to discuss how we can help your business capitalise on the new - but challenging - opportunities for growth. Learn more http://pwc.to/1DaolqY
Website: http://www.pwc.com/gx/en/ceo-survey/2015/industry/technology.jhtml
When, Where & How AI Will Boost Federal Workforce Productivityaccenture
Accenture developed an economic model to understand how AI will impact the U.S. federal workforce, through automation and augmentation. Learn more: https://accntu.re/3hsRG8O
Retailers who are proactive with their approach to consumer privacy and retail cyber security will create more meaningful data and consumer engagement.
The Diversity Imperative: 14th Annual Australian Chief Executive StudyPwC's Strategy&
This report provides insight into the 2013 Australian Chief Executive Study findings, compares the results to the global market and identifies trends. Our analysis looks at trends relating to performance and tenure; reasons for CEO turnover; and the number of insider appointments versus outsider appointments.
EY's European Banking Barometer – 2015 identifies the views of 226 senior European bankers across 11 markets regarding their views of the macro-economic outlook and the impact they think it will have on the banking industry in 2015.
For further information visit: www.ey.com/ebb
A.T. Kearney reached out to more than 2,000 executives, business leaders, and heads of strategy functions to discuss their thoughts on the state of strategy today. Our findings indicate that while most leaders continue to believe in strategy, the return on their strategy initiatives has largely eroded over the past decade. In fact, when asked what it takes to secure a prosperous future, more than 80 percent of executives consider agility as important or more important than strategy when it comes to securing a prosperous future. Fortunately, the findings also point to promising ways to reclaim strategy—including using future-focused tools and techniques and engaging the organization in strategy formulation.
Joining Forces: Interagency Collaboration and "Smart Power"Booz Allen Hamilton
Has U.S. defense, diplomacy and development adopted a “smart power” approach? In this follow-up to a 2010 report, the Government Business Council (GBC) evaluates progress towards increased interagency collaboration and how budget pressures may change foreign policy. Moderator is GBC's Associate Director of Research Erin Dian Dumbacher and Speakers include Booz Allen senior associate's Cheryl Steele and Jonathan Allen. Download the full report here: http://www.govexec.com/gbc/report/smart_power_2011/
Learn more about Smart Power: http://www.boozallen.com/smartpower
5 Opportunities in the Nutritional Supplements IndustryL.E.K. Consulting
According to the third installment of a biennial survey L.E.K. Consulting conducted on the healthy living marketplace, U.S. adult consumers spend, on average, a reported $635 on nutritional supplements each year: $433 on vitamins, minerals and herbal supplements (VMS), and $202 on sports nutrition products. And yet, within both categories, there is still room for further growth.
Indeed, when asked about their prior month’s purchases, just 55% of consumers who make H&W a priority said they bought VMS, and only 25% had purchased sports nutrition products. In other words, for retailers and brands there are some significant opportunities — and even a lurking threat — to be found.
A.T. Kearney Consolidation of the US Banking IndustryKearney
More and more banked consumers are migrating from small to large banks, flagging the accelerated consolidation of the retail banking industry in the years to come.
One in four customers is planning to either use branches less or stop visiting branches altogether after the COVID-19 crisis, according to new BCG retail banking consumer “pulse” survey.
Tech Adoption and Strategy for Innovation & Growthaccenture
Accenture presents the benefits of investing in technology at scale by discussing the importance of tech adoption and strategy through case studies. View more.
Top 8 Insights From the 2018 Beauty, Health & Wellness SurveyL.E.K. Consulting
Think nutritional supplements and skincare are of interest only to consumers of a certain age? Think again. According to L.E.K. Consulting’s third installment of a biennial survey of the healthy living marketplace, this one focusing on nutrition and skincare, some 80% of health and wellness (H&W) consumers across generations — from millennials to baby boomers — are highly engaged with both categories.
The survey captured insights from more than 1,600 respondents, representing roughly 77% of the U.S. adult population who identify with H&W themes, and generated eight key insights across categories. Together these insights make clear that consumer interest in nutritional supplements and skincare often lasts a lifetime.
EY Price Point: global oil and gas market outlook, Q2 | April 2022EY
The theme for this quarter is rearrangement. The loss, or potential loss, of Russian oil and gas supplies is forcing producers, refiners and traders to rethink the flow of crude oil and refined products from the wellhead to the gas pump in light of sanctions, potential sanctions and the risk of reputational damage. Countries, companies and consumers will all be searching for ways to adapt, and the outcome of the race to bring alternatives to market could alter the global energy landscape for years to come.
It is likely crude oil and LNG prices will remain elevated for some time. The process of diverting Russian oil through countries unwilling to sanction it will take time and there is little indication OPEC members are willing (or able) to increase production to make up for the loss of Russian crude. Spare capacity sat at 3.7 mbpd at the end of 2021, just above where it was in January 2020. Currently, sanctioned Venezuelan and Iranian production (about 3 mbpd below their peak) could fill the gap, but political and commercial obstacles remain. At today’s prices, US shale production is attractive, but the fastest the industry has been able to grow is between 1mbpd and 2mbpd per year. The LNG infrastructure was already stretched before the war in Ukraine and there is little prosect of finding new supplies soon.
As the largest buyer of Russian energy, Europe will be the epicenter. There is a deeply embedded bias there in favor for renewable energy, and the current crisis is certain to result in an all-out effort to accelerate the build-out of wind and solar power. The capacity to add new green energy is limited though by the project pipeline and supply chains for solar panels and wind turbines, and it is likely that much of the shortfall will be made up with the new LNG infrastructure.
L.E.K. Consulting’s annual Media & Entertainment Study
was conducted between December 2018 and January
2019. We surveyed around 2,000 households on their
entertainment choices, preferences and viewing habits.
This Executive Insights analyzes key findings about
movie theater attendance and subscription services.
TMT Outlook 2017: A new wave of advances offer opportunities and challengesDeloitte United States
Important trends continue to shape the technology, media, and telecommunications (TMT) industry. What developments should you anticipate in 2017? https://subscriptions.deloitte.com/default.aspx?eventid=1323075
Apache Hadoop Summit 2016: The Future of Apache Hadoop an Enterprise Architec...PwC
Hadoop Summit is an industry-leading Hadoop community event for business leaders and technology experts (such as architects, data scientists and Hadoop developers) to learn about the technologies and business drivers transforming data. PwC is helping organizations unlock their data possibilities to make data-driven decisions.
18th Annual Global CEO Survey - Technology industry key findingsPwC
Tech CEOs are optimistic about the global economy and both near term and future revenue growth. They view strategic alliances, including partnering with competitors, as a primary means to grow their businesses. We invite you to explore the analysis and contact us to discuss how we can help your business capitalise on the new - but challenging - opportunities for growth. Learn more http://pwc.to/1DaolqY
Website: http://www.pwc.com/gx/en/ceo-survey/2015/industry/technology.jhtml
When, Where & How AI Will Boost Federal Workforce Productivityaccenture
Accenture developed an economic model to understand how AI will impact the U.S. federal workforce, through automation and augmentation. Learn more: https://accntu.re/3hsRG8O
Retailers who are proactive with their approach to consumer privacy and retail cyber security will create more meaningful data and consumer engagement.
The Diversity Imperative: 14th Annual Australian Chief Executive StudyPwC's Strategy&
This report provides insight into the 2013 Australian Chief Executive Study findings, compares the results to the global market and identifies trends. Our analysis looks at trends relating to performance and tenure; reasons for CEO turnover; and the number of insider appointments versus outsider appointments.
EY's European Banking Barometer – 2015 identifies the views of 226 senior European bankers across 11 markets regarding their views of the macro-economic outlook and the impact they think it will have on the banking industry in 2015.
For further information visit: www.ey.com/ebb
A.T. Kearney reached out to more than 2,000 executives, business leaders, and heads of strategy functions to discuss their thoughts on the state of strategy today. Our findings indicate that while most leaders continue to believe in strategy, the return on their strategy initiatives has largely eroded over the past decade. In fact, when asked what it takes to secure a prosperous future, more than 80 percent of executives consider agility as important or more important than strategy when it comes to securing a prosperous future. Fortunately, the findings also point to promising ways to reclaim strategy—including using future-focused tools and techniques and engaging the organization in strategy formulation.
Joining Forces: Interagency Collaboration and "Smart Power"Booz Allen Hamilton
Has U.S. defense, diplomacy and development adopted a “smart power” approach? In this follow-up to a 2010 report, the Government Business Council (GBC) evaluates progress towards increased interagency collaboration and how budget pressures may change foreign policy. Moderator is GBC's Associate Director of Research Erin Dian Dumbacher and Speakers include Booz Allen senior associate's Cheryl Steele and Jonathan Allen. Download the full report here: http://www.govexec.com/gbc/report/smart_power_2011/
Learn more about Smart Power: http://www.boozallen.com/smartpower
5 Opportunities in the Nutritional Supplements IndustryL.E.K. Consulting
According to the third installment of a biennial survey L.E.K. Consulting conducted on the healthy living marketplace, U.S. adult consumers spend, on average, a reported $635 on nutritional supplements each year: $433 on vitamins, minerals and herbal supplements (VMS), and $202 on sports nutrition products. And yet, within both categories, there is still room for further growth.
Indeed, when asked about their prior month’s purchases, just 55% of consumers who make H&W a priority said they bought VMS, and only 25% had purchased sports nutrition products. In other words, for retailers and brands there are some significant opportunities — and even a lurking threat — to be found.
A.T. Kearney Consolidation of the US Banking IndustryKearney
More and more banked consumers are migrating from small to large banks, flagging the accelerated consolidation of the retail banking industry in the years to come.
One in four customers is planning to either use branches less or stop visiting branches altogether after the COVID-19 crisis, according to new BCG retail banking consumer “pulse” survey.
Tech Adoption and Strategy for Innovation & Growthaccenture
Accenture presents the benefits of investing in technology at scale by discussing the importance of tech adoption and strategy through case studies. View more.
The National Association of Pharmaceutical Manufacturers (NAPM) was established in 1977 as A Section 21 Trade Association which. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. The NAPM has a diverse membership comprising of 18 companies. Part of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
PwC’s Health Research Institute (HRI)
"People are accessing health information in new ways"
Telehealth users had employer-sponsored health plans, were middle-aged, and had chronic conditions
Health Services Tax Conference May 18-19, 2015, Presentations included: Mega Trends and the Impact on Healthcare, The Healthcare Industry: A View from Washington and The New Health Economy.
FDA Promotes Transparency, Collaboration for 2018Georgia_Bull
The Food and Drug Administration (FDA) prepares to shake up its traditional processes in the hopes of improving quality patient care and driving down the costs of drugs.
Presentation on current state of pharmaceutical drug research and ideas for change. It addresses how the pharmaceutical industry, NIH, Government, HealthCare Law, OIG, Public Health
Asian Hospital & Healthcare Management, the leading magazine in the healthcare industry empowers people providing the latest healthcare related issues, articles. Our latest issue provides the required information helpful to build healthier tomorrow. Check our Digital Magazine: https://goo.gl/4KfGjt
Real world data is no longer just for those trained in health economics and outcomes research — it can and will touch everyone in the pharma/healthcare space.
CBI asked industry's foremost RWD thought leaders a variety of questions to better understand how bio/pharmaceutical teams can collaborate and capture data in an aggregated form to continue to improve the value of products in development with real world, real-time data.
Real World Data - The New Currency in HealthcareJohn Reites
White paper published in June 2015 by CBI Life Sciences with interview insights from John Reites.
Real World Data (RWD) have become the bio/pharmaceutical industry’s treasure trove for information to inspire stakeholder decision-making. As an industry, professionals have increasingly been looking to RWD to not only assess the bene ts and risks of new medicines in clinical and real world settings, but also as a way to advise healthcare reimbursement decisions worldwide.
Similar to The FDA and industry: A recipe for collaborating in the New Health Economy (20)
This publication includes the deal activity in the insurance sector such as overall highlights, key announced transactions, and the outlook ahead. Read our full report to learn more.
Chain Reaction: How Blockchain Technology Might Transform Wholesale InsurancePwC
With the goal to identify where blockchain technologies have the greatest potential, this research report sponsored by PwC and conducted by Z/Yen, is based on 50+ interviews with brokers, insurers, reinsurers, regulators and trade bodies from across the global wholesale insurance market.
In depth: New financial instruments impairment modelPwC
On June 16, 2016, the FASB issued Accounting Standards Update 2016-13, Financial Instruments – Credit Losses (Topic 326) (the “ASU”). The ASU introduces a new model for recognizing credit losses on financial instruments based on an estimate of current expected credit losses. The new model will apply to: (1) loans, accounts receivable, trade receivables, and other financial assets measured at amortized cost, (2) loan commitments and certain other off-balance sheet credit exposures, (3) debt securities and other financial assets measured at fair value through other comprehensive income, and (4) beneficial interests in securitized financial assets.
Many internal audit departments are investing in data analytics, but are struggling to fully realize the anticipated benefits. By avoiding common pitfalls and implementing data analytics holistically throughout the department, stalled analytics programs can be restarted, or new programs more successfully implemented.
Stepping into the cockpit- Redefining finance's role in the digital agePwC
Insurance finance functions have been refining their
operating models to better align with business partner
demands, as well as adopting leading practices on how
to best utilize people, process and technology. The
challenge is that the business landscape is continuously
shifting and the pace of change is rapidly accelerating.
In spring 2016, PwC investigated the current state and
future direction of stress testing. We surveyed 55 insurers
operating in the US about their stress testing framework and
the specific stresses that they test. We also engaged in more
detailed dialogue with a number of insurers in the US and
globally, as well as with some North American insurance
regulators.
International Capital Standard (ICS) Background PwC
PwC US risk & capital management leader Henry Essert and PwC global insurance regulatory director Ed Barron
recently sat down to discuss the proposed International Capital Standards (ICS) for insurers. They addressed at
length what the ICS is and what it could mean to insurers. The following pages contain their thoughts on the
standard, as well as some background information on capital management and related issues in the
insurance industry.
Insurers are upgrading their technology to support more complex
products, lower operating costs, and get closer to their customers.
But they can do more harm than good when they make changes
that alienate their independent agents. We’ve identified five steps
that can help insurers engage agents early and create a
transition plan that meets agents’ needs—converting these
important stakeholders into enthusiastic advocates.
On February 25, 2016, the FASB issued the new standard, Leases (ASC 842). There are elements of the new standard that could impact almost all entities to some extent, although lessees will likely see the most significant changes. Lessees will need to recognize virtually all of their leases on the balance sheet, by recording a right-of-use asset and lease liability.
The IASB issued its new standard, IFRS 16, Leases, earlier this year. There are significant areas of divergence between guidance applicable under US GAAP and that required by IFRS.
On June 21st, PwC’s Health Research Institute (HRI) released its annual Medical Cost Trend: Behind the Numbers 2017 report. PwC’s HRI anticipates a 6.5% growth rate for 2017—the same as was projected for 2016. The report identifies the key inflators and deflators as well as historical context to better understand the medical cost trend for 2017. Increases in the trend due to utilization of convenient care access points and an uptick in behavioral healthcare benefits for employees are being offset by more aggressive strategies by pharmacy benefit
Putting digital technology and data to work for Tech CMO'sPwC
Tech Company CMOs are uniquely positioned to successfully leverage digital technologies and data to significantly impact business performance. At PwC, we're helping to change the goal of digital marketing from clicks and views to customer experiences designed to generate business performance. Explore how.
The insurance industry has remained much the same for more than 100 years, but over the past decade it has seen a number of exciting new innovations and new business models.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
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The FDA and industry: A recipe for collaborating in the New Health Economy
1. February 19, 2015
The FDA and industry: A
recipe for collaborating
in the New Health
Economy
2. PwC
About this report
As part of its Improving America’s
Health series, PwC has periodically
surveyed industry executives on their
relationship with the FDA.
In summer 2014, PwC’s Health
Research Institute and Biocom polled
100 senior executives on issues such
as regulations, the development of new
therapies, and patient engagement.
1000 adult consumers were also
surveyed about their views of the FDA,
the pharmaceutical/life sciences
industry and consumer access to
therapies.
Slide 2
The FDA and industry: A recipe for collaborating in the New Health Economy
3. PwC
Key findings
Slide 3
Executives say that the FDA has become a more
communicative and open partner
Executives understand that balancing innovation and risk
comes with tradeoffs
Industry attitudes are shifting when it comes to determinations
of value
Consumers want more engagement from both the FDA and
industry4
1
2
3
The FDA and industry: A recipe for collaborating in the New Health Economy
5. PwC
An evolving regulatory process
Slide 5
Source: 2014 HRI Pharmaceutical and Life Sciences Executive Survey
The FDA and industry: A recipe for collaborating in the New Health Economy
6. PwC
The FDA’s budget relies heavily on industry fees
Slide 6
Source: 2014 HRI Pharmaceutical and Life Sciences Executive Survey
The FDA and industry: A recipe for collaborating in the New Health Economy
7. PwC
The FDA’s standard review times have decreased
Slide 7
The FDA and industry: A recipe for collaborating in the New Health Economy
8. PwC
Priority reviews have also improved
Slide 8
The FDA and industry: A recipe for collaborating in the New Health Economy
9. PwC
The FDA has become a better communicator…
Steps taken by the FDA to improve working relationships with companies
Slide 9
Source: 2014 HRI Pharmaceutical and Life
Sciences Executive Survey
Better quality and more frequent communications with the FDA
helps executives anticipate the agency’s expectations and satisfy
regulatory requirements
The FDA and industry: A recipe for collaborating in the New Health Economy
10. PwC
But executives still question the value of user fees
Areas that executives believe have improved the most as a result of increased
PDUFA/MDUFA fees
Slide 10
Just 32% thought the fees they paid have resulted in shorter review
times and only 34% think the fees help accelerate innovation
Source: 2014 HRI Pharmaceutical and Life
Sciences Executive SurveyThe FDA and industry: A recipe for collaborating in the New Health Economy
11. PwC
Industry wants the FDA to prioritize innovation
Areas that executives believe have improved the most as a result of increased
PDUFA/MDUFA fees
Slide 11
Only 34% of executives
think user fees help
accelerate innovation
Source: 2014 HRI Pharmaceutical and Life
Sciences Executive Survey
User fees accelerate innovation
The FDA and industry: A recipe for collaborating in the New Health Economy
12. PwC
Experts say…
Slide 12
“Science is advancing so quickly, it’s difficult for
any single organization to stay on top
of everything. We need a system in the 21st
century that allows regulators to access the
scientific expertise they need, both internally
and externally, in a timely manner.”
- Stacy Holdsworth, senior advisor of US
regulatory policy and strategy at Eli Lilly &
Company
The FDA and industry: A recipe for collaborating in the New Health Economy
13. PwC
Experts say…
Slide 13
- Andrew von Eschenbach, former FDA
commissioner
“You have to recognize that the user fee program
is only addressing the review cycle and that’s
not the issue. Review is only one piece. You need
a much broader view. The issue is the process
from the very beginning of development to the
post market. And the FDA influences that entire
process.”
The FDA and industry: A recipe for collaborating in the New Health Economy
14. PwC
Experts say…
Slide 14
- Fred Hassan, former CEO of Schering-
Plough who now serves as a managing
director at Warburg Pincus
“The FDA needs to be part of the innovation
engine. I don’t think they currently see that as a
primary role”
The FDA and industry: A recipe for collaborating in the New Health Economy
15. PwC
Changes are already being implemented
Slide 15
Executives are less
familiar with new
programs
Familiarity with accelerated approval programs
The FDA and industry: A recipe for collaborating in the New Health Economy
Source: 2014 HRI Pharmaceutical and Life
Sciences Executive Survey
17. PwC
Case study: Breakthrough therapies
Slide 17
“I’m talking to the FDA every week about IMBRUVICA. My
experience with the FDA, as part of that process, has been
overwhelmingly positive. That doesn’t mean issues never
arise, but I’m happy because my expectation of the FDA is
that we can work through those issues and get them
resolved, before they become larger issues.”
The FDA and industry: A recipe for collaborating in the New Health Economy
18. PwC
Case study: Breakthrough therapies
Slide 18
“I’m talking to the FDA every week about IMBRUVICA. My
experience with the FDA, as part of that process, has been
overwhelmingly positive. That doesn’t mean issues never
arise, but I’m happy because my expectation of the FDA is
that we can work through those issues and get them
resolved, before they become larger issues.”
- Urte Gayko, senior vice president of global
regulatory affairs at Pharmacyclics on her
experience managing Imbruvica, a
breakthrough therapy drug
The FDA and industry: A recipe for collaborating in the New Health Economy
19. PwC
Case study: Breakthrough therapies
Slide 19
“It does seem to be changing the way the agency is doing
things. If this is a promising direction, we need to ask what
else needs to change along with it. The breakthrough
process is focused on drug review and approval but there
are other things that need to get done at the same time such
as review of good manufacturing processes.”
- Mark McClellan, former FDA commissioner
and current senior fellow and director of the
Health Care Innovation and Value Initiative
at the Brookings Institution
The FDA and industry: A recipe for collaborating in the New Health Economy
21. PwC
Consumers are willing to take on more risk
Slide 21
Respondents
overwhelmingly agreed that
patients with life-
threatening conditions
should be able to access
experimental therapies.
The FDA and industry: A recipe for collaborating in the New Health Economy
Source: 2014 HRI Pharmaceutical and Life
Sciences Consumer Survey
22. PwC
Executives support consumers’ desire for access
Slide 22
77% of executives agree that
consumers willing to assume
grater risks should have
access to experimental
therapies.
The FDA and industry: A recipe for collaborating in the New Health Economy
Source: 2014 HRI Pharmaceutical and Life
Sciences Executive Survey
23. PwC
But speedier access may require new thinking
Slide 23
“We’re looking at outcomes data and how it
should influence regulatory decisions.”
“Quickness to market is clearly a basic
principle. With that comes an even greater
need for post-market surveillance.”
- Stacy Holdsworth, senior advisor of US regulatory
policy and strategy at Eli Lilly & Company
- Ray Woosley, president emeritus of the Critical Path
Institute and founder of CredibleMeds – an
organization focused on safe medication use.
The FDA and industry: A recipe for collaborating in the New Health Economy
25. PwC
Experts say…
Slide 25
“We don’t want to squelch innovation, but tell
me what I'm getting for my healthcare costs.
Show me that these new technologies are
superior.”
- Scott Josephs, national medical officer at
Cigna Corp. at an Advanced Medical
Technology Association meeting on October
2014
The FDA and industry: A recipe for collaborating in the New Health Economy
26. PwC
Executives attitudes are shifting on value
Slide 26
The FDA and industry: A recipe for collaborating in the New Health Economy
27. PwC
Global experiences may shape industry views on
value
Slide 27
HRI’s survey
suggests
harmonization of
regulatory
requirements would
make it easier, and
faster, to bring a
new drug to market
worldwide.
Source: 2014 HRI Pharmaceutical and Life Sciences Executive Survey
The FDA and industry: A recipe for collaborating in the New Health Economy
28. PwC
Cost is not
considered
at all
Only if a
patient
asks
To a
lesser
degree
To some
degree
To a
significant
degree
Cost is a top consideration for prescribers
This matters to
consumers, who
rank a physician’s
recommendation as
the most important
factor that
influences their
treatment decisions,
followed by their
own out-of-pocket
costs.
1% 2% 5% 38% 54%
Is cost a factor when deciding whether or not to prescribe a drug?
The FDA and industry: A recipe for collaborating in the New Health Economy Source: 2014 HRI Clinician Survey
Slide 28
29. PwC
Cost-conscious consumers also seek value
Slide 29
% of Americans deciding not to purchase
medical services due to cost
Willingness to pay more for a
personalized medical product
The FDA and industry: A recipe for collaborating in the New Health Economy
Source: 2014 HRI Pharmaceutical and Life
Sciences Consumer Survey
31. PwC
Experts say…
Slide 31
“Today’s consumers make decisions in
conjunction with medical authority, not because
of a medical authority.”
- Ido Hadari, CEO of Treato, in an interview
with HRI
The FDA and industry: A recipe for collaborating in the New Health Economy
32. PwC
Experts say…
Slide 32
“Having a seat at the table is important, but how
do you make sure the patient perspective can be
turned into data points that can inform and
influence the review process? We’re talking
about quickly moving from a lofty goal of
making patients part of the system to a very
technical conversation about how to make it
happen.”
- Cecilia Arradaza, Executive Director of the
Milken Institute, which includes FasterCures -
an organization focused on speeding medical
innovation
The FDA and industry: A recipe for collaborating in the New Health Economy
33. PwC
Experts say…
Slide 33
“I’ve told industry that patients can contribute
to the conversation. That the patient voice is
important earlier in the process, such as how
clinical trials are designed.”
- Diane Dorman, vice president of public
policy for the National Organization for Rare
Disorders
The FDA and industry: A recipe for collaborating in the New Health Economy
34. PwC
Experts say…
Slide 34
“No patient community has ever done this and it
sets the stage for new partnerships with the
FDA.”
- Pat Furlong, founding president and CEO of
Parent Project Muscular Dystrophy,
explained how her group created the first
patient centered guidance document on
clinical trial design.
The FDA and industry: A recipe for collaborating in the New Health Economy
35. PwC
Case Study: Priority review vouchers
Innovative methods to promote research in rare
diseases
Slide 35
36. PwC
“The question isn’t how to get a drug approved.
The question is how you get a private company
to make the drug in the first place.”
Case study: Priority review vouchers
Slide 36
- Nancy Goodman, founder and executive
director of Kids V Cancer, a patient
organization that promotes pediatric cancer
research.
The FDA and industry: A recipe for collaborating in the New Health Economy
38. PwC
Future considerations
Slide 38
Prioritize consumer input
Demonstrate value to regulators and purchasers
Seek new alliances
Pursue new opportunities to minimize risk and accelerate access
Enrich the dialogue
The FDA and industry: A recipe for collaborating in the New Health Economy
39. PwC
Future considerations
Slide 39
Prioritize consumer input
Companies should seek out consumers’ views,
diligently incorporate their input at every stage and
share this information with the FDA.
The FDA and industry: A recipe for collaborating in the New Health Economy
40. PwC
Future considerations
Slide 40
Demonstrate value to regulators and purchasers
Manufacturers will need to demonstrate value over
existing therapies as both purchasers and consumers
look for products that meet their needs.
The FDA and industry: A recipe for collaborating in the New Health Economy
41. PwC
Future considerations
Slide 41
Seek new alliances
A greater reliance on public-private partnerships
could provide a forum for the exchange of ideas. For
instance, the Medical Device Innovation Consortium
coordinates efforts of industry and regulators to
develop new tools, methods and technologies.
The FDA and industry: A recipe for collaborating in the New Health Economy
42. PwC
Future considerations
Slide 42
Pursue new opportunities to minimize risk and
accelerate access
Pharmaceutical and life sciences companies should
partner with the FDA to facilitate early access to
experimental drugs for eligible patients with
articulated risks. Continued investment in new tools
and technology, such as biomarkers, may help
manufacturers and regulators assess risk more
accurately and quickly.
The FDA and industry: A recipe for collaborating in the New Health Economy
43. PwC
Future considerations
Slide 43
Enrich the dialogue
Communicate more often and effectively with the
FDA. Doing so will allow companies to build stronger
relationships with agency officials, including the
reviewers tracking their products. These interactions
can help companies understand the agency’s thinking
and compile stronger applications to avoid multiple
review rounds.
The FDA and industry: A recipe for collaborating in the New Health Economy
45. PwC
Contacts
Slide 45
The FDA and industry: A recipe for collaborating in the New Health Economy
Michael Mentesana
Principal, Pharmaceutical and Life Sciences
(646) 471-2268
michael.mentesana@us.pwc.com
Chandresh Harjivan
Principal, Pharmaceutical and Life Sciences
(202) 756-1710
chan.harjivan@us.pwc.com
Bobby Clark
Senior Manager, Health Research Institute
(202) 312-7947
robert.j.clark@us.pwc.com
46. Thank you
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