This document summarizes a conference on biosimilars and follow-on biologics taking place September 14-15, 2009. The conference will provide insight on the political, safety, regulatory, and strategic implications of pending biosimilars legislation. Speakers will include representatives from the offices of Henry Waxman and Anna Eshoo, the FDA, FTC, biopharmaceutical companies, and other organizations. Topics will include analyses of pending bills, the comparative safety of biologics and biosimilars, antitrust provisions, and regulatory mechanisms and considerations for a biosimilars pathway. Attendees will gain timely and relevant information to advise their companies on issues and next steps regarding biosimil
CBI\'S 4TH ANNUAL SUMMIT ON BIOSIMILARS AND FOLLOW-ON BIOLOGICSgbashe
Register by January 22, 2010 and receive $400 off the registration fee for CBIs 4th Summit on Biosimilars and Follow-On Biologics being held March 18-19, 2010 in Washington DC. The conference will provide updates on the developing biosimilars framework in the US and EU, evaluate how to design clinical programs and assess similarity, and understand perspectives from payers, providers, and legislators. Hospira will present on lessons learned from their EU biosimilar experiences to provide insight for successful biosimilar development and launches.
This document provides information about a biosimilars summit to be held March 30-31, 2011. It summarizes:
1) The summit will focus on leveraging the regulatory, legal and clinical realities of the Biologics Price Competition and Innovation Act to achieve maximum commercial value for follow-on biologics.
2) Attendees can choose from two pre-conference workshops on March 30th focusing on reimbursement landscapes for biosimilars or keys for commercial success in ex-US biosimilar markets.
3) The main conference on March 30-31st will feature panels on navigating patent disputes for biosimilars, FTC perspectives on market competition, and how innovative
The Future of BioSimilars, BioGenerics, Follow-On Biologics – A Rose by Any O...Michael Swit
The document discusses the future of biosimilars and how they differ from traditional generics. It notes that biosimilars are unlikely to achieve therapeutic equivalence due to structural complexity, making substitution and an abbreviated approval pathway difficult. Biosimilars will likely require clinical efficacy and safety trials like innovator drugs. Price discounts for biosimilars will likely be smaller than for generics, reducing incentives for utilization. Reimbursement and marketing will also present challenges without substitution. Overall, biosimilars represent a new business model compared to traditional generics.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
This document discusses healthcare reform and the implications for community behavioral health organizations as employers. It provides an overview of the current state of employer-sponsored healthcare coverage and how provisions in the Affordable Care Act will impact employers. Key provisions that will affect employers beginning in 2014 include requiring plans to cover those seeking coverage regardless of pre-existing conditions, eliminating annual limits on coverage, and assessing penalties on employers not offering affordable coverage. The document outlines various insurance market, coverage, and employer requirements that will be implemented between 2010 and 2018 as a result of healthcare reform.
This document discusses implications of the Affordable Care Act for community behavioral health organizations as employers. It provides an agenda that will cover the current status of employer-provided health insurance, relevant provisions in the ACA, the impact on employers, retiree benefits, and opportunities and threats. Introductory polls ask about organization size, offering retiree insurance, and considering dropping insurance benefits. The presentation is by Avalere Health experts Bonnie Washington and Eric Hammelman.
CBI\'S 4TH ANNUAL SUMMIT ON BIOSIMILARS AND FOLLOW-ON BIOLOGICSgbashe
Register by January 22, 2010 and receive $400 off the registration fee for CBIs 4th Summit on Biosimilars and Follow-On Biologics being held March 18-19, 2010 in Washington DC. The conference will provide updates on the developing biosimilars framework in the US and EU, evaluate how to design clinical programs and assess similarity, and understand perspectives from payers, providers, and legislators. Hospira will present on lessons learned from their EU biosimilar experiences to provide insight for successful biosimilar development and launches.
This document provides information about a biosimilars summit to be held March 30-31, 2011. It summarizes:
1) The summit will focus on leveraging the regulatory, legal and clinical realities of the Biologics Price Competition and Innovation Act to achieve maximum commercial value for follow-on biologics.
2) Attendees can choose from two pre-conference workshops on March 30th focusing on reimbursement landscapes for biosimilars or keys for commercial success in ex-US biosimilar markets.
3) The main conference on March 30-31st will feature panels on navigating patent disputes for biosimilars, FTC perspectives on market competition, and how innovative
The Future of BioSimilars, BioGenerics, Follow-On Biologics – A Rose by Any O...Michael Swit
The document discusses the future of biosimilars and how they differ from traditional generics. It notes that biosimilars are unlikely to achieve therapeutic equivalence due to structural complexity, making substitution and an abbreviated approval pathway difficult. Biosimilars will likely require clinical efficacy and safety trials like innovator drugs. Price discounts for biosimilars will likely be smaller than for generics, reducing incentives for utilization. Reimbursement and marketing will also present challenges without substitution. Overall, biosimilars represent a new business model compared to traditional generics.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
This document discusses healthcare reform and the implications for community behavioral health organizations as employers. It provides an overview of the current state of employer-sponsored healthcare coverage and how provisions in the Affordable Care Act will impact employers. Key provisions that will affect employers beginning in 2014 include requiring plans to cover those seeking coverage regardless of pre-existing conditions, eliminating annual limits on coverage, and assessing penalties on employers not offering affordable coverage. The document outlines various insurance market, coverage, and employer requirements that will be implemented between 2010 and 2018 as a result of healthcare reform.
This document discusses implications of the Affordable Care Act for community behavioral health organizations as employers. It provides an agenda that will cover the current status of employer-provided health insurance, relevant provisions in the ACA, the impact on employers, retiree benefits, and opportunities and threats. Introductory polls ask about organization size, offering retiree insurance, and considering dropping insurance benefits. The presentation is by Avalere Health experts Bonnie Washington and Eric Hammelman.
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
This document provides an agenda for the "2nd Biosimilars & Biobetters USA" conference happening on November 16-17, 2015 in Iselin, New Jersey. The conference will focus on the evolving regulatory landscape and commercialization of biosimilars, and will include presentations and panels on topics such as the FDA approval process, the European experience with biosimilars, and determining interchangeability. It lists speakers from companies such as Sandoz, Merck Serono, Dr. Reddy's Laboratories, and the FDA. Workshops on November 18th will focus on regulatory updates and the development and commercial needs for biosimilars globally.
Feisal Nanji --- Article - Journal Of Health Care Compliance; Sept. 2010Feisal Nanji
The article draws a parallel between the BP oil spill disaster and information security compliance in the healthcare industry. It argues that most healthcare organizations have an immature approach to information security that puts patient privacy and safety at risk. Specifically, it notes that in many organizations the chief information officer, whose role is to ensure smooth IT operations, is also responsible for information security compliance. The article maintains that this creates a conflict of interest that prioritizes operations over integrity monitoring. It calls on healthcare compliance professionals to separate information security oversight from IT operations to avoid potential disasters from security failures.
The Application Integrity Policy (AIP): A Little History.Michael Swit
This document summarizes the FDA's Application Integrity Policy (AIP), which was established in 1991 in response to fraud in generic drug applications. The AIP allows the FDA to defer review of any application where they have questions about the reliability of the data, until those questions are resolved. Companies that fall under the AIP must cooperate with investigators, identify wrongdoers, conduct an internal review, and submit a corrective action plan signed by the CEO to address procedures and controls to prevent future issues. Few companies have survived being placed on the AIP, as it often coincides with criminal prosecution and civil litigation that can damage a company.
Diem Nguyen, regional president of North America for Global Established Pharmaceuticals at Goldman Sachs, presented at a biosimilars conference on April 2, 2015. The presentation discussed the attractive growth opportunity for biosimilars, with the market expected to reach $20 billion by 2020. It noted biosimilars have the potential to expand access to important medicines while providing savings to healthcare systems. However, biosimilars are complex to produce and require significant expertise in manufacturing. Pfizer believes policies should be based on science and physicians should have the ability to choose the treatment that is best for their patients. Pfizer is well positioned in the biosimilars space due to its capabilities and experience developing
Maximize your Share of the Multi-Billion Dollar Biosimilars MarketDyan Cornacchio
Experts are estimating the global biosimilars market to be worth more than $11 billion by 2021- now is the time to learn best practices and strategies to maximize your position in this robust market.
Whether you are on the innovator or biosimilar side, ACI’s 8th Annual Summit on Biosimilars (https://goo.gl/4mtUUF) will help you develop and protect your biologics portfolio as our stellar faculty of experts discuss these featured topics:
• Policy and Politics of Biosimilars under the New Administration
• Untangling the Inner Workings of IPRs for Biosimilars
• Shall we Dance: Mastering the “Steps” of the BPCIA while Avoiding Common Pitfalls
View Agenda - https://goo.gl/454z9D
Don’t miss your chance to grab a piece of this exponentially growing market and register today! Mention Registration Code: B00-658-LNK17 when registering!
pharmacogenomics, current regulatory efforts to ensure and promote innovationscomplianceonline123
It covers the new and expected regulations and their effects on use of pharmacogenomics in industry. PharmacoGenomics Data, genetic tests and Biomarkers, FDA guidances and federal initiatives, EMEA, Clinical Genomics data standards will explore medicine landscape.
Michael Swit presented at the RAPS Annual Conference in San Jose on October 25, 2010. He discussed the history of biologics regulation and the new pathway for biosimilars established by the Biologics Price Competition and Innovation Act of 2009. The new pathway allows for an abbreviated approval process for biosimilars but gives FDA flexibility in implementation. Biosimilars must show similarity to the reference product through analytical, animal, and clinical studies but may not need to repeat all studies. Interchangeability requires additional evidence and is not required for approval. FDA is seeking input on guidance and other implementation issues.
Drug Safety: Perspectives on Industry's Duties in the Post-Vioxx Age.Michael Swit
Presentation to the Food & Drug Law Institute (FDLI) on Drug Safety with commentary on what are the emerging duties that industry may have to undertake in order to stay ahead of safety issues and avoid related products liability exposure.
Creative Solutions to Launching & Funding Early Stage Bioscience Compani...Boltonhillconsulting
Speakers who will present at this TCM/Bio Breakfast event organized by Bolton Hill Consulting and co-hosted by GBC & GBTC and sponsored by Arcion Therapeutics, Martek, VWR, and the University of Maryland BioPark.
UMB BioPark Life Sciences Conference Center First Floor 801 West Baltimore St Baltimore, MD 21201
4/16/09 7:30-10:30 am
In today’s economic environment, more so than at any other time, it is imperative for emerging and early-stage companies to be able to identify and access both traditional and non-traditional sources of capital. What are some of the creative funding strategies that Maryland-based entrepreneurs have successfully used to keep their products and projects moving through development?
Hear from our panel of funding specialists representing foundations, angel investment groups, venture capital firms, and the State government as they describe their programs and the resources available to help fledgling businesses. In addition, a group of well-respected local bioscience entrepreneurs will share their first-hand experiences in overcoming the challenges posed by today’s financial crisis.
Join us for an informative and interactive discussion. Our speakers include:
Paul Silber, Ph.D. (moderator)
Director, Evergreen Capital
Former CEO, InVitro Technologies
Delegate Dan Morhaim, M.D.
Deputy Majority Leader
Maryland House of Delegates
Margaret A. Anderson
Chief Operating Officer
FasterCures
Youseph Yazdi, Ph.D.
Corporate Director, Corporate Office of Science and Technology
Johnson and Johnson
Registration link: https://techcouncilmd.com/events/register.php
Wellpoint is the largest health insurance provider nationally with over 34 million members. Through strategic acquisitions, Wellpoint has expanded its market presence and now operates Blue Cross Blue Shield plans in 14 states. Wellpoint aims to continue growing by targeting the uninsured, elderly, and large national employer accounts. Its strategy also includes wellness initiatives like investments in luxury health resorts to promote preventative healthcare and keep membership healthy.
Oregon Legislative Assembly It started on Friday Mar 6, 2.docxhopeaustin33688
Oregon Legislative Assembly
It started on Friday Mar 6, 2015 when we decided to attend the 78th Oregon Legislative Committee about Health Care. We read the entire agendas before we attended it, and they were really interested topics that not only we will use it in the assignment, but it can help and benefit us in our real life if they were applied. The committee was meeting in Oregon Capitol Hall, room HR E. The Committees members consisted of Chair REP. Greenlick, Mitch, VICE-CHAIR REP Nosse, VICE CHAIR REP Hayden , REP Keny-Guyer, REP Weidner, REP Lively, REP Kennemer, REP Buehler, and REP Clem. Committee Administration. Sandy Thiele-Cirka and Committee assistant Mania Daniel.
They started with the work session HB 2234 which Requires Oregon Health Authority and insurers offering policies or certificates of health insurance that reimburse costs of physician services to create billing codes or alternative mechanism to enable community assessment center to bill for child abuse medical assessment and related services.
It started with a testimony from Gene Wisenhouse, and what said was that they testified on this before, and we still looking for compromise and fix solution how actually we build or going to pay this, and he supports dash 4 a lot of effort by lobbyist and representatives in the health authority and providers. So the action on this was Do Pass recommendation as Amended and Be Printed Engrossed. All the committee members voted I on it.
Then they moved to HB 2825 which Carried Over from 3/4/15 Agenda: Requires Oregon Health Authority to seek out and apply for funding for, and appropriates moneys from General Fund to pay for, crisis intervention services and residential care for individuals with mental illness.
The action on this was Do Pass recommendation as Amended and that be referred to the committee reference. All the committee members voted I on it.
After that they moved work session HB 2541 to Wednesday, and move to HB 2560 which Carried Over from 3/4/15 Agenda: Requires health benefit plan to cover cost of colonoscopy for insured who is 50 years of age or older and who has positive fecal immunochemical test result.
So the action on this was Do Pass recommendation as Amended and Be Printed Engrossed. All the committee members voted I on it.
Then they moved to work session HB 2307 which Prohibits mental health care professionals and social health professionals from providing any service to person under 18 years of age for purpose of attempting to change person's sexual orientation or gender identity. It was moved to Monday because, REP Lively, REP Kennemer think there are a lot of questions out there for them, and they still chasing them down. After the work sessions part, the committee jumped to the public hearing session and they started with REP Keny-Guyer who Carried HB 2930 which Requires hospital to adopt rules granting admitting privileges to licensed, certified nurse midwife nurse practitioner saying that she has.
How To Write Movie, Music, And Video Game ReviewsLori Gilbert
The document discusses the steps to request and complete an assignment writing request through the HelpWriting.net platform, including registering an account, completing an order form with instructions and deadline, and choosing a bid from qualified writers to complete the assignment. It notes the bidding system used and assurances of original, high-quality content with the option of free revisions. The summary highlights the main process outlined in the document for requesting and receiving assistance with assignment writing.
Maurice Mayrides discusses the importance of the patient voice in regulating biosimilars. He summarizes the value of biosimilars from different stakeholder perspectives including patients, clinicians, industry, and governments. While biosimilars offer potential cost savings and innovation, patients will only feel comfortable with interchangeability if regulations are sophisticated and harmonized internationally. Regulations must ensure safety, efficacy, and quality to gain patient trust especially in emerging markets and lower-resource countries. Continued advocacy is needed to refine regulations and gather real-world evidence to demonstrate biosimilar interchangeability. The ultimate goal is ensuring patients can access effective treatments.
The document discusses Risk Evaluation and Mitigation Strategies (REMS), which were introduced by the FDA Amendments Act of 2007. REMS allow the FDA to require risk management plans from drug manufacturers to ensure that a drug's benefits outweigh its risks. The document outlines the various elements that can be required in a REMS, including medication guides, communication plans, and elements to assure safe use like restricted distribution and registries. It also discusses factors the FDA considers in determining whether a REMS is needed and the experience with the first drugs approved with a REMS.
Pharma R&D in a Value-based Healthcare Systemnenglezos
This document discusses the challenges of drug development over the past 100 years of diabetes management:
- In the late 19th/early 20th century, diabetes was uniformly fatal but clinical observations helped uncover its links to the pancreas and carbohydrate metabolism. Insulin's discovery in 1921 revolutionized treatment but was initially accompanied by dangerous side effects.
- Advances since include longer-acting insulin forms and emphasis on daily regimens. However, allergic reactions and hypoglycemia remained issues. Pregnancy outcomes also improved.
- The author questions if early innovations like insulin could have survived in today's regulatory and litigation environments given initial safety issues, and if companies could withstand financial pressures from adverse events. Strict modern standards
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
This document provides an agenda for the "2nd Biosimilars & Biobetters USA" conference happening on November 16-17, 2015 in Iselin, New Jersey. The conference will focus on the evolving regulatory landscape and commercialization of biosimilars, and will include presentations and panels on topics such as the FDA approval process, the European experience with biosimilars, and determining interchangeability. It lists speakers from companies such as Sandoz, Merck Serono, Dr. Reddy's Laboratories, and the FDA. Workshops on November 18th will focus on regulatory updates and the development and commercial needs for biosimilars globally.
Feisal Nanji --- Article - Journal Of Health Care Compliance; Sept. 2010Feisal Nanji
The article draws a parallel between the BP oil spill disaster and information security compliance in the healthcare industry. It argues that most healthcare organizations have an immature approach to information security that puts patient privacy and safety at risk. Specifically, it notes that in many organizations the chief information officer, whose role is to ensure smooth IT operations, is also responsible for information security compliance. The article maintains that this creates a conflict of interest that prioritizes operations over integrity monitoring. It calls on healthcare compliance professionals to separate information security oversight from IT operations to avoid potential disasters from security failures.
The Application Integrity Policy (AIP): A Little History.Michael Swit
This document summarizes the FDA's Application Integrity Policy (AIP), which was established in 1991 in response to fraud in generic drug applications. The AIP allows the FDA to defer review of any application where they have questions about the reliability of the data, until those questions are resolved. Companies that fall under the AIP must cooperate with investigators, identify wrongdoers, conduct an internal review, and submit a corrective action plan signed by the CEO to address procedures and controls to prevent future issues. Few companies have survived being placed on the AIP, as it often coincides with criminal prosecution and civil litigation that can damage a company.
Diem Nguyen, regional president of North America for Global Established Pharmaceuticals at Goldman Sachs, presented at a biosimilars conference on April 2, 2015. The presentation discussed the attractive growth opportunity for biosimilars, with the market expected to reach $20 billion by 2020. It noted biosimilars have the potential to expand access to important medicines while providing savings to healthcare systems. However, biosimilars are complex to produce and require significant expertise in manufacturing. Pfizer believes policies should be based on science and physicians should have the ability to choose the treatment that is best for their patients. Pfizer is well positioned in the biosimilars space due to its capabilities and experience developing
Maximize your Share of the Multi-Billion Dollar Biosimilars MarketDyan Cornacchio
Experts are estimating the global biosimilars market to be worth more than $11 billion by 2021- now is the time to learn best practices and strategies to maximize your position in this robust market.
Whether you are on the innovator or biosimilar side, ACI’s 8th Annual Summit on Biosimilars (https://goo.gl/4mtUUF) will help you develop and protect your biologics portfolio as our stellar faculty of experts discuss these featured topics:
• Policy and Politics of Biosimilars under the New Administration
• Untangling the Inner Workings of IPRs for Biosimilars
• Shall we Dance: Mastering the “Steps” of the BPCIA while Avoiding Common Pitfalls
View Agenda - https://goo.gl/454z9D
Don’t miss your chance to grab a piece of this exponentially growing market and register today! Mention Registration Code: B00-658-LNK17 when registering!
pharmacogenomics, current regulatory efforts to ensure and promote innovationscomplianceonline123
It covers the new and expected regulations and their effects on use of pharmacogenomics in industry. PharmacoGenomics Data, genetic tests and Biomarkers, FDA guidances and federal initiatives, EMEA, Clinical Genomics data standards will explore medicine landscape.
Michael Swit presented at the RAPS Annual Conference in San Jose on October 25, 2010. He discussed the history of biologics regulation and the new pathway for biosimilars established by the Biologics Price Competition and Innovation Act of 2009. The new pathway allows for an abbreviated approval process for biosimilars but gives FDA flexibility in implementation. Biosimilars must show similarity to the reference product through analytical, animal, and clinical studies but may not need to repeat all studies. Interchangeability requires additional evidence and is not required for approval. FDA is seeking input on guidance and other implementation issues.
Drug Safety: Perspectives on Industry's Duties in the Post-Vioxx Age.Michael Swit
Presentation to the Food & Drug Law Institute (FDLI) on Drug Safety with commentary on what are the emerging duties that industry may have to undertake in order to stay ahead of safety issues and avoid related products liability exposure.
Creative Solutions to Launching & Funding Early Stage Bioscience Compani...Boltonhillconsulting
Speakers who will present at this TCM/Bio Breakfast event organized by Bolton Hill Consulting and co-hosted by GBC & GBTC and sponsored by Arcion Therapeutics, Martek, VWR, and the University of Maryland BioPark.
UMB BioPark Life Sciences Conference Center First Floor 801 West Baltimore St Baltimore, MD 21201
4/16/09 7:30-10:30 am
In today’s economic environment, more so than at any other time, it is imperative for emerging and early-stage companies to be able to identify and access both traditional and non-traditional sources of capital. What are some of the creative funding strategies that Maryland-based entrepreneurs have successfully used to keep their products and projects moving through development?
Hear from our panel of funding specialists representing foundations, angel investment groups, venture capital firms, and the State government as they describe their programs and the resources available to help fledgling businesses. In addition, a group of well-respected local bioscience entrepreneurs will share their first-hand experiences in overcoming the challenges posed by today’s financial crisis.
Join us for an informative and interactive discussion. Our speakers include:
Paul Silber, Ph.D. (moderator)
Director, Evergreen Capital
Former CEO, InVitro Technologies
Delegate Dan Morhaim, M.D.
Deputy Majority Leader
Maryland House of Delegates
Margaret A. Anderson
Chief Operating Officer
FasterCures
Youseph Yazdi, Ph.D.
Corporate Director, Corporate Office of Science and Technology
Johnson and Johnson
Registration link: https://techcouncilmd.com/events/register.php
Wellpoint is the largest health insurance provider nationally with over 34 million members. Through strategic acquisitions, Wellpoint has expanded its market presence and now operates Blue Cross Blue Shield plans in 14 states. Wellpoint aims to continue growing by targeting the uninsured, elderly, and large national employer accounts. Its strategy also includes wellness initiatives like investments in luxury health resorts to promote preventative healthcare and keep membership healthy.
Oregon Legislative Assembly It started on Friday Mar 6, 2.docxhopeaustin33688
Oregon Legislative Assembly
It started on Friday Mar 6, 2015 when we decided to attend the 78th Oregon Legislative Committee about Health Care. We read the entire agendas before we attended it, and they were really interested topics that not only we will use it in the assignment, but it can help and benefit us in our real life if they were applied. The committee was meeting in Oregon Capitol Hall, room HR E. The Committees members consisted of Chair REP. Greenlick, Mitch, VICE-CHAIR REP Nosse, VICE CHAIR REP Hayden , REP Keny-Guyer, REP Weidner, REP Lively, REP Kennemer, REP Buehler, and REP Clem. Committee Administration. Sandy Thiele-Cirka and Committee assistant Mania Daniel.
They started with the work session HB 2234 which Requires Oregon Health Authority and insurers offering policies or certificates of health insurance that reimburse costs of physician services to create billing codes or alternative mechanism to enable community assessment center to bill for child abuse medical assessment and related services.
It started with a testimony from Gene Wisenhouse, and what said was that they testified on this before, and we still looking for compromise and fix solution how actually we build or going to pay this, and he supports dash 4 a lot of effort by lobbyist and representatives in the health authority and providers. So the action on this was Do Pass recommendation as Amended and Be Printed Engrossed. All the committee members voted I on it.
Then they moved to HB 2825 which Carried Over from 3/4/15 Agenda: Requires Oregon Health Authority to seek out and apply for funding for, and appropriates moneys from General Fund to pay for, crisis intervention services and residential care for individuals with mental illness.
The action on this was Do Pass recommendation as Amended and that be referred to the committee reference. All the committee members voted I on it.
After that they moved work session HB 2541 to Wednesday, and move to HB 2560 which Carried Over from 3/4/15 Agenda: Requires health benefit plan to cover cost of colonoscopy for insured who is 50 years of age or older and who has positive fecal immunochemical test result.
So the action on this was Do Pass recommendation as Amended and Be Printed Engrossed. All the committee members voted I on it.
Then they moved to work session HB 2307 which Prohibits mental health care professionals and social health professionals from providing any service to person under 18 years of age for purpose of attempting to change person's sexual orientation or gender identity. It was moved to Monday because, REP Lively, REP Kennemer think there are a lot of questions out there for them, and they still chasing them down. After the work sessions part, the committee jumped to the public hearing session and they started with REP Keny-Guyer who Carried HB 2930 which Requires hospital to adopt rules granting admitting privileges to licensed, certified nurse midwife nurse practitioner saying that she has.
How To Write Movie, Music, And Video Game ReviewsLori Gilbert
The document discusses the steps to request and complete an assignment writing request through the HelpWriting.net platform, including registering an account, completing an order form with instructions and deadline, and choosing a bid from qualified writers to complete the assignment. It notes the bidding system used and assurances of original, high-quality content with the option of free revisions. The summary highlights the main process outlined in the document for requesting and receiving assistance with assignment writing.
Maurice Mayrides discusses the importance of the patient voice in regulating biosimilars. He summarizes the value of biosimilars from different stakeholder perspectives including patients, clinicians, industry, and governments. While biosimilars offer potential cost savings and innovation, patients will only feel comfortable with interchangeability if regulations are sophisticated and harmonized internationally. Regulations must ensure safety, efficacy, and quality to gain patient trust especially in emerging markets and lower-resource countries. Continued advocacy is needed to refine regulations and gather real-world evidence to demonstrate biosimilar interchangeability. The ultimate goal is ensuring patients can access effective treatments.
The document discusses Risk Evaluation and Mitigation Strategies (REMS), which were introduced by the FDA Amendments Act of 2007. REMS allow the FDA to require risk management plans from drug manufacturers to ensure that a drug's benefits outweigh its risks. The document outlines the various elements that can be required in a REMS, including medication guides, communication plans, and elements to assure safe use like restricted distribution and registries. It also discusses factors the FDA considers in determining whether a REMS is needed and the experience with the first drugs approved with a REMS.
Pharma R&D in a Value-based Healthcare Systemnenglezos
This document discusses the challenges of drug development over the past 100 years of diabetes management:
- In the late 19th/early 20th century, diabetes was uniformly fatal but clinical observations helped uncover its links to the pancreas and carbohydrate metabolism. Insulin's discovery in 1921 revolutionized treatment but was initially accompanied by dangerous side effects.
- Advances since include longer-acting insulin forms and emphasis on daily regimens. However, allergic reactions and hypoglycemia remained issues. Pregnancy outcomes also improved.
- The author questions if early innovations like insulin could have survived in today's regulatory and litigation environments given initial safety issues, and if companies could withstand financial pressures from adverse events. Strict modern standards
The document discusses challenges in raising capital for biotech companies due to a tight venture capital market as a result of the global financial crisis. Experts note that while venture funding is still available, investors prefer lower risk, shorter term projects. As a result, biotech companies are increasingly looking to alternative sources of funding such as alliance deals, grants, and strategic partnerships. While the venture capital environment remains difficult, some experts believe conditions are slowly improving and funding will continue to be available for innovative life science projects.
1) Maintaining US leadership in medical innovation requires consistent application of policies that incentivize innovation, such as tax breaks for research and strong intellectual property protections.
2) Collaboration between government, private industry, and academia can speed up the discovery process and maximize potential by bringing together diverse expertise and resources.
3) The pharmaceutical industry has a responsibility to safely develop and validate new treatments while also taking risks to pursue new cures, but government policies must continue fostering an environment where innovation can thrive.
The pharmaceutical industry is facing significant changes driven by healthcare reform, increased regulation, and declining drug pipelines. Traditional commercial strategies are no longer effective. The nichebuster commercial model focuses on following disease pathways to target smaller patient populations. While companies have tried strategies like mergers, salesforce reductions, and new management, these have not led to long-term success. The industry must fundamentally change its commercial approach. The nichebuster model requires coordinating R&D, markets, and business models. It also demands realigning marketing, sales, and other functions to focus on outcomes rather than just products. This paradigm shift will be challenging but necessary for pharmaceutical companies to adapt to the new market realities.
This document is the editor's letter from PharmaVOICE magazine discussing the growing importance of comparative effectiveness research (CER). Key points:
1) CER was a major topic at recent healthcare conferences and will be the focus of an upcoming summit, reflecting its increasing impact on all healthcare stakeholders.
2) CER will provide physicians with treatment choice data, patients with information to set expectations, and payers with evidence for coverage decisions. Pharmaceutical companies will need to change their business models to focus on niche populations.
3) The need to prove comparative effectiveness will influence drug discovery and development, with companies less likely to pursue treatments for common diseases without significant benefits over existing options.
PharmaVoice - Letter From the Editor - September 2010gbashe
This document is the editor's letter from PharmaVOICE magazine discussing the growing importance of comparative effectiveness research (CER). Key points:
1) CER was a major topic at recent healthcare conferences and will be the focus of an upcoming summit, reflecting its increasing impact on all healthcare stakeholders.
2) CER will provide physicians with treatment choice data, patients with information to set expectations, and payers with evidence for coverage decisions. Pharmaceutical companies will need to change their business models to focus on niche patient populations.
3) The need to prove comparative effectiveness will influence drug discovery and development, with companies less likely to pursue treatments for common diseases without substantial benefits over existing options.
This article discusses legislation aimed at banning "pay-for-delay" deals between brand-name and generic drug companies. Such deals involve brand-name firms paying generics to delay entering the market, in exchange for settling patent litigation. Supporters argue this delays lower-cost generics and costs consumers billions annually, while opponents warn it could reduce drug innovation by increasing litigation costs. The legislation was not included in the final healthcare reform bill but sponsors plan to continue pursuing its passage.
Research: Are You Asking the Right Questions?gbashe
This newsletter article discusses the importance and various roles of research in public relations. It identifies four main types of research: 1) Foundational research which examines underlying psychology, sociology and other relevant fields, 2) Best practices and benchmarking studies which analyze trends in PR and other industries, 3) Initial or formative research which identifies knowledge gaps and informs objectives, and 4) Measurement and evaluation which assesses program results and identifies areas for improvement. The article provides examples of companies effectively integrating different types of research into their PR strategies and programs.
1. Social media is changing how health information is shared, as people can now discuss topics on platforms like Twitter.
2. The FDA has not provided clear guidance for pharmaceutical companies on social media use, but holds meetings to get public input on developing guidelines.
3. Some key challenges for healthcare companies engaging on social media include adverse event reporting and maintaining fair balance in discussions.
This document summarizes the market reaction to clinical trial results from three biotech companies - Poniard Pharmaceuticals, Arena Pharmaceuticals, and Anadys Pharmaceuticals. It discusses how the companies' stocks dropped significantly despite data that met primary endpoints or showed safety and efficacy. The document suggests the wider market often fails to understand clinical data and is driven more by risk aversion than scientific understanding. It attributes overreactions in part to shallow reporting and quick analyses that prioritize speed over comprehension.
This document discusses how various stakeholders in the healthcare industry, such as patients, payers, journalists, physicians, and investors all have opinions that can influence new health products. It notes that payers influence analysts, reporters influence physicians, and patient concerns can derail products. The document promotes the services of Makovsky, a public relations firm that can help connect healthcare brands with these important stakeholders by making science accessible, empathizing with patient needs, and addressing economic realities from a public relations or health policy perspective.
This 3-day conference in Boston will discuss challenges and innovations in the biosimilars market. Key speakers will address regulatory issues, manufacturing processes, clinical assessments, commercialization, and pricing of biosimilars. The US biosimilar market is expected to generate $1.95 billion annually by 2014 if a regulatory pathway is implemented in 2013. The conference will provide networking opportunities for leaders in the biosimilar field.
This document summarizes a conference on biosimilars and follow-on biologics taking place September 14-15, 2009. The conference will provide insight on the political, safety, regulatory, and strategic implications of pending biosimilars legislation. Speakers will include representatives from the offices of Henry Waxman and Anna Eshoo, the FDA, FTC, biopharmaceutical companies, and other organizations. Topics will include analyses of current bills, the expected approval pathway and implications for industry, patient safety and regulatory issues, antitrust provisions, and the commercial landscape for biosimilars.
The document discusses pharmaceutical companies entering social media and online patient communities. It notes opportunities for non-branded disease awareness campaigns and collaborating with patient advocacy groups. Examples are given of companies like GSK, J&J, and Pfizer creating educational video and online content to engage patients without being overtly promotional. Special focus is given to engaging micro-patient communities for rare diseases through foundations and online support groups.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
1. Register by July 17, 2009 and Receive $400 Off of Your Registration Fee!
C B I ’ s 3 r d S u m m i t o n
Biosimilars and
CLE Credits
Available
Pending Approval
Follow-On Biologics
Providing Timely and Relevant Insight on Political, Safety,
Regulatory and Strategic Implications of Pending Legislation
September 14-15, 2009 • Gaylord National • National Harbor, MD
Conference Legisl ative and R egul atory Addresses
Co-Chairs: The Pathway for the Biosimilars Act
Juliana Reed, Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation
Vice President Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc.
Government Affairs,
Hospira, Inc. Promoting Innovation and Access to Life-Saving Medicines Act
Gil Bashe, Ann M. Witt, Health Counsel, Office of Henry Waxman, U.S. House of Representatives
Executive Vice President,
Makovsky + Company Analyze Patient Safety Concerns and Biologic/Biosimilar Comparability
Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins,
Additional Office of Biotechnology Products, CDER, U.S. Food and Drug Administration
Faculty from:
Assess Antitrust Concerns and the Competitive Impact of Biosimilars
BIO Suzanne Drennon, Counsel for Intellectual Property, Bureau of Competition,
GlaxoSmithKline Federal Trade Commission
Glenmark Generics
Hogan & Hartson LLP Featur ed Sessions
Hospira, Inc.
HPS Group LLC Healthcare Policy and Payment Perspective —
MedImmune Reimbursement Payment System and Benefit Design Implications
NORD James Langley, Vice President Reimbursement, Accredo Health Group
NPS Pharmaceuticals
Analyze the Commercial and
Pfizer Inc
Economic Implications of Biosimilars Legislation
Sandoz
sanofi-aventis Biotech Market Analysis –
Vinson & Elkins LLP Mark Schoenebaum, M.D., Biotechnology Analyst, Deutsche Bank
Wyeth Biosimilars Market Analysis –
R.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader, Deloitte LLP
Organized By: Visit Us Outstanding
on the Web at Support
www.cbinet.com Provided by:
2. Dear Colleague,
For the last three years it has been said that this is the year that an approval pathway for biosimilars will be created.
With two competing bills in the House and one before the Senate, combined with the Obama administration
allocating budget funding, this year that prediction might actually be right. What great news this is for the slowing
pharma industry as biologics continue to outperform the global pharma market with premium prices and specialty
therapies that cannot be treated with conventional drugs. Biosimilar market entry carries high hopes for those
willing to take the risk, and it is becoming clear that many are.
For several years now, the bio/pharmaceutical industries have been debating the policy of this pathway, along with
many other political and government organizations. For much of this time, the data on which these arguments were
founded was dubious at best, but since the U.S. has found itself trailing other countries in creating this pathway,
more data is becoming available in terms of costs, pricing and market effects.
So although the actual market effects of an approval pathway for biosimilars in the U.S. will never truly be known
until they’ve happened, as an industry, we have enough collective information now on which to base our individual
company decisions and start taking our next steps – no matter if a company’s steps are to enter the biosimilars
market or to protect their innovative biologic from a lower priced alternative. Because the fact is, an approval
pathway is going to be created. And whether it occurs sooner or later, don’t you think you should be ready?
All of these considerations were in play in developing CBI’s 3rd Summit on Biosimilars and Follow-On Biologics,
taking place September 14-15, 2009 at the Gaylord National, National Harbor, MD. Through our esteemed and
diverse faculty, this meeting gathers the collective information from many facets of industry to share with the
delegates over two days of keynote presentations, panel discussions and case studies. Key policy makers,
regulators, analysts, healthcare organizations and bio/pharma companies are on hand to share their timely, relevant
and practical insights so that delegates can best advise their companies on next steps – and more importantly, start
taking them.
As conference Co-Chairperson, I invite you to join us in September for this critical juncture in the evolution of
healthcare and the bio/pharma industry. I will be sharing the stage with an impressive group of representatives
from the Office of Henry Waxman, FDA, FTC, BIO, MedImmune, Pfizer, Sandoz, GSK, NORD, Deloitte, Deutsche
Bank, Genzyme, Genentech, Accredo Health and many more.
I look forward to meeting you this September!
Sincerely,
Juliana Reed
Juliana Reed
Vice President, Government Affairs
Hospira, Inc.
P.S. Don’t miss Accredo Health’s presentation on understanding the reimbursement and benefit implications for
biosimilars – it provides perspective from PBMs, CMS and Commercial Insurers!
3. • Understand how and why this bill differs from the
MaIN CONFereNCe 2007 Waxman bill (H.R. 1038)
• Discuss key components to the legislation and their
Day One — Monday, September 14, 2009 intended outcomes
8:00 Main Conference Registration and Ann M. Witt, Health Counsel, Office of Henry Waxman,
Continental Breakfast U.S. House of Representatives
9:00 Co-Chairs’ Opening Remarks 10:45 Networking and
Juliana Reed, Vice President Government Affairs, Hospira, Inc. Refreshment Break Hosted by:
Ms. Reed has overall responsibility for the Government Relations function
which includes the oversight of global government relations and public policy
initiatives for the corporation. As the first U.S. based company to launch a
biosimilar product in Europe, Retacrit® (epoetin zeta), Hospira — the world POLIC Y Pa NeL
leader in generic injectables — has the scientific expertise and manufacturing 11:15 Explore the Political Principles, Expectations and
capabilities to bring biogenerics to market in the United States. Ms. Reed Implications of Pending Biosimilars Legislation
has also held positions in health policy and reimbursement, both at Hospira
and Baxter Healthcare. In addition, Ms. Reed has extensive experience The 2009 versions of biosimilars legislation are currently
in U.S. healthcare, where she has worked as a hospital administrator and being debated among many parties with vested interests.
clinician. Ms. Reed holds a BS degree from Marquette University and While almost everyone can agree that it is time for a
a Master’s Degree from DePaul University. She is a licensed Physical regulatory pathway to approve biosimilars or biogenerics,
Therapist and Nursing Home Administrator in the State of Illinois. there is not yet a consensus of how to achieve this.
Gil Bashe, Executive Vice President, Makovsky + Company This, coupled with the enormity of potential implications
As executive vice president at Makovsky + Co., Mr. Bashe is counselor to resulting from this pathway, has industry keeping a close
pharmaceutical, biotechnology, medical-device manufacturers and patient- eye on biosimilars policy. This panel discusses the pending
advocacy groups. He has advised clients on follow-on-biologic (FOB) policies legislation, the principles in which they are based, the
and reimbursement, first in Europe and now in the United States. Through force behind enactment on the Hill and expectations for
the years, Mr. Bashe has left his mark on health-product access. At the implementation. The potential implications of pending
onset of the CMS Part D program, he helped change a Medicare drug benefit
– ensuring continued reimbursement for a leading heart-disease medication. legislation are also explored.
Mr. Bashe was CEO of CommonHealth, a WPP Group company, having • What is the public positioning of pending legislation?
served as vice-chairman for strategic planning. At sister-company Hill and • What timelines for enactment and implementation
Knowlton, he was worldwide Health Practice director overseeing policy, are most likely?
provider and product communications. In the frontlines of ensuring patients
retain access to care; Mr. Bashe served as paratrooper commander and • What are the potential implications for industry?
combat medic. He is an American Heart Association (AHA) New York * patient safety
past chair, and AHA regional affiliate board member. Mr. Bashe is co- * FDA’s resources
editor of Branding Health Services: Defining Yourself in the Marketplace * healthcare
and a member of the American Pharmacists Association, National Lipid
Association and the Society for Nuclear Medicine. * ability to manufacture biotech drugs
* ability to manufacture biosimilars
Policy Update and analysis Moderator: Steven Grossman, President, HPS Group LLC
Panelists: Ann M. Witt, Health Counsel, Office of Henry Waxman,
U.S. House of Representatives
L eGISL at I v e a DDr eSSeS
Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc.
9:15 Pathway for the Biosimilars Act
Elizabeth Seifert, Director Public Policy, GlaxoSmithKline
On March 17, 2009, Representatives Anna G. Eshoo,
Inslee and Barton introduced a bill that would create an Kent Jancarik, Director Federal Policy, Pfizer Inc
abbreviated pathway for the FDA to approve biosimilars. Diane Edquist Dorman, Vice President, Public Policy,
Eshoo’s bill differs significantly than the Waxman bill on National Organization for Rare Disorders (NORD)
several issues such as naming, clinical trials and exclusivity.
This address discusses Eshoo’s proposed legislation and the 12:15 Luncheon
intended outcomes of its provisions.
• Compare the 2009 bill to the 2008 version evaluate the regulatory Challenges
• Discuss key provisions of the bill, what they are and and expectations for Biosimilars
what they mean for industry
Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation
Heidi Wagner, Senior Director, Government Affairs, Genentech, Inc. 1:30 Analyze Patient Safety Concerns and
Biologic/Biosimilar Comparability
10:00 Promoting Innovation and Access to Life-Saving
Medicines Act The foundation of the biosimilars debate is focused on
patient safety — whether biosimilars can achieve acceptable
On March 11, 2009, House Energy and Commerce
levels of safety, including immunogenicity, and what level
Chairman Henry Waxman and Representatives Pallone,
Deal and Emerson introduced their version of bill that would of clinical data is needed to ensure an acceptable risk.
give the FDA the authority to approve generic versions of This address evaluates the factors of biologic comparability
FDa and provides an assessment of available data in relation to
biotech drugs. This address discusses this bill and how it address
differs from Waxman’s bill that was introduced to the 2007 patient safety.
Congress, as well as key points that set it apart from other • Explore the criteria used to evaluate comparability
pending legislation. of biologics
4. “the conference gave me a good view of what important
issues should be investigated for impact on my company.”
— Previous Attendee, Eric A. Utt, Ph.D., Specialty Market Access, Pfizer Inc
• Assess available data supporting and opposing review antitrust Provisions
predictions on safety and immunogenicity and Lessons Learned from
Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry,
Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, Hatch-Waxman
U.S. Food and Drug Administration
Dr. Shacter received her Ph.D. in Biochemistry from Johns Hopkins
University in 1982, carried out basic research on cell regulation and cancer 4:00 Assess Antitrust Concerns and the Competitive
at the National Institutes of Health for twelve years, and then joined the Impact of Biosimilars
FDA in 1994. Dr. Shacter oversees the review of INDs and BLAs for The unintended competition and antitrust issues that
novel therapeutic proteins covering a wide range of clinical indications, stemmed from Hatch-Waxman are a source of concern
including cancer, hematopoiesis, tissue repair, hemostasis, inflammatory
diseases and bioterrorism. Dr. Shacter is engaged in establishing CDER among industry and government when considering the
policy regarding product manufacture and characterization and performs structure of an abbreviated approval pathway for biosimilars.
inspections of biotechnology manufacturing facilities. Dr. Shacter speaks The desire to avoid pharma Hatch-Waxman-like issues in
frequently at national and international meetings on a wide range of the biotech market prompted the FTC to take a proactive
topics related to the development and licensure of therapeutic proteins. role in evaluating and shaping this impact by encouraging
She is an Agency expert on scientific issues associated with evaluation of stakeholders to consider unintended consequences before
follow-on biologics. Dr. Shacter also runs an active laboratory research hand. This address discusses these potential unintended
FtC
program to support the scientific review of therapeutic proteins. Her address anticompetitive consequences and how they are addresses
laboratory research focuses on studying the cytotoxic mechanisms of
cancer chemotherapy drugs and understanding how elements of the immune in pending legislation, as well as the antitrust provisions and
system, such as oxidants and activated phagocytes, influence killing and what they could mean for industry.
clearance of dying cells. Her research expertise in the area of protein • Methods of patent disputes and resolution
oxidation is applied regularly to the review of protein therapeutics. • Settlements and reverse payments
• Authorized generics
r eGUL atOrY Pa NeL • Exclusivity
2:15 Regulatory Mechanisms, Considerations and • Forfeiture and other “parking” mechanisms
Implications of Biosimilar Policy Suzanne Drennon, Counsel for Intellectual Property,
The proposed regulatory pathways for the approval of Bureau of Competition, Federal Trade Commission
biosimilars greatly vary on the mechanisms by which Ms. Drennon focuses on antitrust and intellectual property policy and
approval takes place. The mechanisms, in addition to being
enforcement. Prior to joining the FTC, Ms. Drennon was an antitrust and
heavily debated, also bring up many questions and concerns
about our regulatory system in general, like whether or not intellectual property litigator in Los Angeles. She received her A.B. in
we are equipped to handle this change in our current state mathematics from Bryn Mawr College and her J.D. from the University of
and what is the potential fall out of legislation. This panel Minnesota Law School where she was Managing Editor of the Minnesota
discusses these issues in-depth from multiple perspectives. Law Review.
• What should the clinical data requirements be
for immunogenicity? 4:45 Close of Day One
• What should the clinical data requirements be
for interchangeability?
• How descriptive or flexible will the legislation be?
• How much authority will the FDA have to
make decisions?
4:45-5:45 Networking,
• How would the regulatory mechanisms for a
pathway be established? Wine & Cheese Reception
* universal model or class systems? Join colleagues and friends in a relaxed setting.
• What should the naming requirements be
for biosimilars? photo by: Photolink / Getty Images
• What are the potential regulatory implications for
biologics currently on the market? Day Two — Tuesday, September 15, 2009
Moderator: Steven Grossman, President, HPS Group LLC
Panelists: Ross Lobell, Senior Director — Regulatory Affairs, MedImmune 7:30 Continental Breakfast
Brian E. Harvey, M.D., Ph.D., Vice President, Regulatory Policy,
sanofi-aventis 8:00 Co-Chairs’ Review of Day One
Philip Katz, Partner, Hogan & Hartson LLP
Juliana Reed, Vice President Government Affairs, Hospira, Inc.
3:30 Networking and Refreshment Break Gil Bashe, Executive Vice President, Makovsky + Company
5. to register Call toll Free 800-817-8601 (339-298-2100 outside the U.S.)
or Fax 781-939-2490. register on our website at www.cbinet.com
Identify the Commercial, economic and 10:30 Networking and
Str ategic Implications of Biosimilars Refreshment Break Hosted by:
Analyze the Biotech and Biosimilars Markets Understand the reimbursement and
The commercial and economic implications of biosimilars Benefit Implications for Biosimilars
legislation are largely debated by industry, but remain fundamental
to the business decisions of both biotech and biosimilar 11:00 Healthcare Policy and Payment Perspective —
manufacturers and their key stakeholders. The following sessions Reimbursement Payment System and
provide an in-depth analysis of biotech and biosimilars markets Benefit Design Implications
with top economic, commercial, risk and strategic considerations. This session evaluates likely government and commercial
insurer payment/reimbursement policy strategies for
8:15 Biotech Market Analysis biosimilars. The discussion focuses on three key areas
• Understand the top biotech therapeutic areas and including, 1) The PBM perspective — How will PBM’s view
patient population demographics biosimilars and what drug utilization management models
• Evaluate the EU system and experience to date might they consider? What are the major concerns/issues
• Analyze biotech pricing performance and impacting these models? 2) The Government Payor Policy
market share — Key issues around CMS payment policy, both based on
• Assess the commercial impact of biosimilars legislation current systems/tools and potential emerging legislative
• Forecast the long term effects of an abbreviated implications; and 3) Commercial Insurers — Potential
pathway on the risk-sensitive biotech industry strategies to be utilized by commercial insurers including
benefit category and payment systems considerations.
Mark Schoenebaum, M.D., Biotechnology Analyst,
Deutsche Bank • Review/discuss the major Reimbursement System
categories impacting biosimilar adoption
9:00 Biosimilars Market Analysis • Evaluate the conflicting perspectives driving the
• Review key factors affecting biosimilar market different major reimbursing entities — PBM’s,
creation and entry Government Payors and Commercial Insurers and
• Examine lessons learned from the EU discuss current and likely tools they may use
• Discuss key considerations that will impact • Linking likely Payment System strategies with key
biosimilar adoption clinical/patient safety considerations
• Identify the commercial opportunities for biosimilars James Langley, Vice President, Reimbursement, Accredo Health Group
R.T. (Terry) Hisey, Vice Chairman and U.S. Life Sciences Leader,
Deloitte LLP
examine Patent Dispute Mechanisms,
9:45 Biosimilars versus Biobetters — IP Issues and Litigation Concerns
A Side-By-Side Strategic Analysis
Since the actual cost savings for biosimilars is still unknown, 11:45 Analyze the Methods of Patent Dispute and
some of industry has been looking at a different “follow-on” Resolution in Pending Legislation
biologic opportunity in biobetters. Biobetters are considered The methods of patent dispute and resolution in pending
biologics that are similar to the original product but better biosimilars legislation differ substantially from those
in some way i.e. less side effects, reduced dosing schedule, set forth in Hatch-Waxman and are a key component
better delivery system, higher absorption rate, multiple of the biosimilars debate. This session analyzes the
Case indications, etc. Biobetters may be considered traditional methods outlined in pending legislation to provide a better
analyses “Fast Follower” therapeutics where the strategy is to launch
understanding of what the mechanisms are and how they
into established categories with a “best-in-class” brand impact patent dispute strategies, while incorporating lessons
profile. The evolving regulatory landscape will determine learned from Hatch-Waxman and what they tell us for
if Biobetters will face greater scrutiny or benefit from a biologic patent disputes.
streamlined development program. This session compares
the opportunities and challenges to consider when deciding • Methods for filing disputes
biosimilars or biobetters. • Timelines for notification and response —
• Traditional Biobetters — Recent case studies Potential areas to delay or speed up litigation
• Capture market share through price or • Which comes first — Approval or litigation?
therapeutic benefits? • Are there penalties involved?
• Are improvements in delivery sufficient to • Will settlements and authorized generics be allowed
accelerate adoption ? or encouraged?
• Is a novel indication a requirement for regulatory Sean Ryder, Director of Intellectual Property, Glenmark Generics
and commercial success? David Fox, Partner, Hogan & Hartson LLP
Robert Ward, Vice President, Corporate Development,
NPS Pharmaceuticals 12:30 Luncheon
6. 1:45 Current and Future IP Challenges for Biogenerics
Players — A Global Perspective Here are Just a Few of the Organizations
As the U.S. finds itself trailing other countries in creating a that have Benefitted from
pathway to approve biogenerics, a global (and strategic) approach
to patent issues is warranted. In this session, we knock down attending CBI’s Previous Summits
the domestic “silo” approach to biogenerics patent issues as we on Biosimilars and Follow-On Biologics:
consider the following issues from a global perspective:
• The differences between pharma and biopharma AARP * Abbott Diabetes Care Inc * Abbott Laboratories * Accredo Health Group
patent landscapes Inc * Allergan * American Ent Institute for Public Policy Research * American
• Strategic implications of the patent landscape differences Pharmacists Association * AmerisourceBergen Specialty Group * Amgen
• Current and future patent challenges for global Amylin Pharmaceuticals Inc * ASCP * Axinn Veltrop & Harkrider LLP * Ballard
biogenerics players Spahr Andrews & Ingersoll LLP * Barr Pharmaceuticals Inc * Baxter Health
• “Patently obvious” lessons learned from biogeneric Care * Bayer Healthcare LLC * Bexton Dickinson * Bi Pharma GmbH & Co KG
launches to date BIO * Biogen Idec * Biolex Therapeutics Inc * BioMarin Pharmaceuticals
Naomi Pearce, IP Director & Counsel Lawyer & Patent Attorney, Hospira, Inc. Biotechnology Industry Organization * Biotechnology Information Institute
Boehringer Ingelheim GmbH * Brigham & Woman Hospital * Brinks Hofer Gilson
2:30 A Change in the Patent Litigation Dynamic — & Lione * Bristol-Myers Squibb Co * Centocor * Congressman Waymans Office
Will “Big Pharma” Become “Big Generic?” DataMonitor * DDN * DDN Obergfel LLC * Department of Business & Econ De
Traditionally (with some exceptions), patent litigation under Duane Morris LLP * Eisai * Eli Lilly & Co * EMD Serono Inc * Engel &
Hatch-Waxman has been thought of as a dispute between
P a “big pharma” and “small generic” company, but early Novitt LLP * Enzon * Express Scripts Inc * Federal Trade Commission
Finston Consulting * Foley Hoag LLP * Food & Drug Administration
a observations of the biosimilars big pharma companies have
different picture. A number of
market is painting a much
Forest Laboratories * Genentech Inc * Genzyme * Gibraltar Associates llc
GlaxoSmithKline * Glycofi Inc * GlycoFi Merck and Co Inc * Health Results
N already shown interest in entering the follow-on market and Group * Healthpoint * Hoffmann-La Roche Inc * HPS Group LLC * Hyman
more are popping up all the time. So what does “big generic”
Phelps & McNamara PC * ImClone Systems Inc * Insmed Corp * Johnson &
e pharma mean to “small biotech” companies in the court room?
How will this change in dynamic affect the biologics industry? Johnson * Kardiatech Inc * Loyola University Medical Center * Makovsky & Co
L The pharma industry? Only time will tell, but this panel of McDermott Will & Emery LLP * MedImmune Inc * Merck & Co Inc * Momenta
experts attempts to shed light on the future of patent litigation. Mylan Pharmaceuticals Inc * National Economic Research Associates Inc
• Analyze the Hatch-Waxman IP and patent landscape NERA Economic Consulting * Novartis * Novo Nordisk Pharmaceuticals
• Evaluate how the size of a company and litigation Nucleonics Inc * Pfizer * Pharmaceutical Executive Magazine * Pharmaceutical
resources impacts litigation Strategic Initiatives * Pink Sheet * Plasma Protein Therapeutics
• Understand the role of risk assessment in patent Association Procer & Gamble * Questcor Pharmaceuticals * sanofi -aventis
disputes and how this may differ from a change in Shire Human Genetic Therapies Inc * Taro Pharmaceuticals USA Inc
the dynamic Technology Catalysts International * Teva Neuroscience * Teva Pharma AG
• Consider how biosimilars legislation could change the Teva Pharmaceuticals Europe BV * The Henry L Stimson Center
patent litigation dynamic across industry Thomas Jefferson University * Thomson Reuters * Vinson & Elkins LLP
Moderator: Constance S. Huttner, Partner, Vinson & Elkins LLP VirSci Corp * Watson Pharmaceuticals Inc * West Pharmaceutical Services
Panelists: Naomi Pearce, IP Director & Counsel Lawyer & Patent Attorney,
Widener University * Zuckerman Spaeder LLP * Zymo Genetics Corp
Hospira, Inc.
Hans Sauer, Ph.D., Associate General Counsel, BIO
Mark Bowditch, Patent Attorney, Sandoz
Geoffrey Levitt, Vice President, Chief Regulatory Counsel, Wyeth
3:30 Close of Conference Previous attendee representation
In recognition of Our Sponsors:
CBI Research, Inc’s corporate sponsors represent select companies that share
a common mission: business advancement through thought leadership, strategic
interaction and innovation. The companies represented below are proud contributors
on this program and have carefully selected messaging, branding or positioning
statements to encourage the evaluation and investigation of quality products and/or 33% 22%
Regulatory
services available. We applaud these companies as well as others that wish to join the Attorney/Counsel
conference, as important members of this event’s delegation.
12
%
22%
Policy
11
Government
Affairs
%
Patents
If you are interested in sponsorship or exhibit opportunities, please call Alexa Moore
at 339-298-2107, fax 781-939-2694 or email alexa.moore@cbinet.com
7. Register by July 17, 2009 and Receive $400 Off of Your Registration Fee!
C B I ’ s 3 r d S u m m i t o n — Top Reasons to Attend —
Biosimilars and
• Key policy updates from the
Office of Henry Waxman, U.S. House
of Representatives, Genzyme, NORD,
Follow-On Biologics
Genentech, GlaxoSmithKline and Pfizer
• Biotech and biosimilar market analyses by
Deutsche Bank and Deloitte LLP
Providing Timely and Relevant Insight on Political, Safety, • Healthcare policy and payment perspective
by Accredo Health Group
Regulatory and Strategic Implications of Pending Legislation • Patient safety concerns addressed by the
U.S. Food and Drug Administration
September 14-15, 2009 • Antitrust and competition insights by the
Gaylord National • National Harbor, MD Federal Trade Commission
CD-rom Compendiums CBI Research, Inc. PRSRT STD
600 Unicorn Park Drive • Woburn, MA 01801 U.S. Postage
If you are unable to attend the conference or
you would like extra copies for your colleagues, PAID
you can order your conference CD-Rom today. Gallery
Don’t miss out on the valuable information
presented by industry leaders exclusively at this
event. The CD-Rom is available for only $198 and
includes the conference agenda, presentations and
speaker biographies. Simply fill out the order form 853209
and the CD-Rom will be shipped to you
photo by: Keith Brofsky / Getty Images
2 weeks after the conference occurs.
• Registration Fee: Standard Advantage Pricing
2-Day Conference $2095 $1,695
Advantage Pricing — Register by July 17, 2009 and SAVE $400.
Fee includes continental breakfast, lunch, wine and cheese reception, refreshments
and CD-Rom Compendium. Please make checks (in U.S. funds drawn on a U.S. bank) registration Card DO NOT REMOVE MAILING LABEL. PLEASE RETURN ENTIRE FORM. PC09070
payable to CBI Research, Inc. (No personal checks accepted.) Advantage Pricing
may not be combined with other discount offers, special category rates or promotions. Yes! Please register me for CBI’s 3rd Summit on Biosimilars and Follow-On Biologics
Discounts only apply to standard rates.
• Team Discount: I am registering for ADVANTAGE PRICING
Your organization may send 1 executive free for every 3 delegates registered.
All registrations must be made at the same time to qualify.
We would like to take advantage of the TEAM DISCOUNT (see left for details).
• Discount Accommodations & Travel: I cannot attend. Please send me a Conference CD-Rom Compendium.
Contact CBI’s official travel service Travel Concepts for all of your travel needs. Register 3
In order to receive CBI’s special discounted hotel rate, you must call Do you have any special needs? ________________________________________________ Get 1 FREE
Travel Concepts at 800-640-8082 (508-879-8600 outside the U.S.) or
email reservations@travelconcept.com by September 1, 2009. Travel Concepts KEY CODE (appears above mailing address): ___________________________________
can also negotiate low group airfares and car rentals. Mention that you are attending
CBI’s 3rd Summit on Biosimilars and Follow-On Biologics to qualify for hotel and 1. NAME POSITION
travel discounts. All travel arrangements subject to availability.
2. NAME POSITION
• Venue:
Gaylord National CAll TRAVEl COnCEPTS 3. NAME POSITION
201 Waterfront Street TOdAy AT 800-640-8082
National Harbor, MD 20745 4. NAME POSITION
Negotiated rates only available through Travel Concepts
free
COMPANY DIVISION
• Substitution & Cancellation:
Your registration may be transferred to a member of your organization up to ADDRESS
24 hours in advance of the conference. Cancellations received in writing on or before
September 1, 2009 will be refunded, less a $195 administrative charge. No refunds CITY STATE/COUNTRY ZIP/POSTAL CODE
will be made after this date; however, the registration fee less the $195 administrative
TELEPHONE FAx E-MAIL
charge can be credited to another CBI conference if you register within 30 days from
the date of this conference. In case of conference cancellation, AUTHORIZED SIGNATURE
CBI’s liability is limited to refund of the conference registration fee only.
CBI reserves the right to alter this program without prior notice.
Please Note: Speakers and agenda are subject to change without notice.
Payment Options: Payment in full is required to process registration. Please call with any payment questions.
In the event of a speaker cancellation, every effort to find a suitable replacement will Enclosed is a check for payment in full (No personal checks accepted) Please
be made. The opinions of the conference faculty do not necessarily reflect those of the
companies they represent or The Center for Business Intelligence. MC/Visa: photocopy
this form for
additional
• Satisfaction Guaranteed: Amex: delegates.
CBI stands behind the quality of its conferences. If you are not satisfied with the
quality of the conference, a credit will be awarded towards a comparable NAME (AS APPEARS ON CARD) ExP. DATE
CBI conference of your choice. Please contact 800-817-8601 for further information.
CARDHOLDER SIGNATURE
Advanced preparation for CBI conferences is not required.
WeBSiTe Phone fAX e-MAil MAil
5 Easy Ways www.cbinet.com 800-817-8601 781-939-2490 cbireg@cbinet.com Registration Dept.
339-298-2100 Please include all information CBI Research, Inc.
to REgistER outside the U.S. requested on registration card. 600 Unicorn Park Drive
Woburn, MA 01801