The 6th Annual Biosimilars Conference will take place from March 2nd-4th, 2010 in Boston and will feature discussions on opportunities and challenges for biosimilars in global markets, strategies for biosimilar manufacturing processes, acceptance criteria for biosimilar immunogenicity, and commercializing biosimilars. Over two and a half days, the conference will include keynote speeches, panel discussions, and networking opportunities on topics such as regulatory approval pathways, clinical data requirements, intellectual property issues, and market penetration.
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 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.
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.
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.
The 6th Annual Biosimilars Conference will take place from March 2nd-4th, 2010 in Boston and will feature discussions on opportunities and challenges for biosimilars in global markets, strategies for biosimilar manufacturing processes, acceptance criteria for biosimilar immunogenicity, and commercializing biosimilars. Over two and a half days, the conference will include keynote speeches, panel discussions, and networking opportunities on topics such as regulatory approval pathways, clinical data requirements, intellectual property issues, and market penetration.
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 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.
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.
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.
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.
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 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
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.
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 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.
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.
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 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
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.
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 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.
1. This appears in the January 2010 edition: Gil BasheEVP, Health Practice DirectorMakovsky + Companygbashe@makovsky.com Convergence of the “watch-your-wallet” and “show-me” gatekeepers point the way to the essential 2010 product launch strategy—demonstrate clinical value before, during, and after launch. Emphasizing scientific innovation and ongoing clinical trial effort must be center stage in the new marketing communications environment. In a world of “What am I paying for?” science returns to the forefront as the cornerstone for successful brand positioning and extensions. Communication tools evolve (for instance, digital); however, in a spendthrift healthcare reform environment, marketers need to ramp up their efforts around amplifying innovation. The House bill includes a Wal-Mart-esque proposal for generics’
First-Free Fill,
eliminating co-pay costs the first time a patient switches from brand to generic. Who doesn’t like free? Marketers need to focus on physicians making prescribing decisions by communicating a strong clinical rationale for the brand. Physicians and PBM medical directors will advocate for brands showing clear clinical differences and addressing their patient needs. The ’90s gave consumers greater voice in health product decision making and DTC became the mascot of mega-brands. Today government agencies and pharmacy benefit managers hold product selection sway. The combination of code-bundling averaging reimbursement between brands and generics—already comprising 70% of medicines dispensed—cemented change in the branded marketing landscape. Not showing scientific difference is to fall into the trap set by legislatively mandated comparative effectiveness measures. Communications is about creating dialogue. Healthcare audiences are speaking with one another. Physicians will take prescribing cues from traditional and new decision makers—third-party guidelines, reimbursement agency recommendations, public comment (for example, analysts, investigators, and media) and company promotion. To neglect audiences influencing the national healthcare wallet is tantamount to opening a door to bad press, poor formulary position, and unenthusiastic health professionals and possible thumbs-down on the brand.