This document summarizes a presentation on creating an optimal commercial reimbursement landscape for pharmaceutical products. The presentation discusses the complexities of proving value to payers in light of healthcare reform uncertainties and a changing regulatory environment. It provides two case studies on companies that failed to consider reimbursement challenges and offers lessons on strategic planning to meet regulatory and reimbursement needs. The goal is developing a clinical and regulatory strategy that ensures reimbursement resonance with payers and reduces patient access barriers.
Life Sciences Implications of the U.S. Affordable Care ActCognizant
Life sciences companies will see substantial changes due to the upholding of the U.S. Affordable Care Act (ACA), and we offer a map of some of the forseeable developments for drug and device manufacturers, biotechnology innovators, and others. A primer on ACA impact on revenue opportunities, earnings pressures, pricing effectiveness, compliance and business models.
Life Sciences Implications of the U.S. Affordable Care ActCognizant
Life sciences companies will see substantial changes due to the upholding of the U.S. Affordable Care Act (ACA), and we offer a map of some of the forseeable developments for drug and device manufacturers, biotechnology innovators, and others. A primer on ACA impact on revenue opportunities, earnings pressures, pricing effectiveness, compliance and business models.
Great value propositions payer value deliveredCuro Consulting
Building a Payer value strategy is an incredibly complex process. We all look for the silver bullet: huge unmet need, great performance and an easy price target. In reality, most Market Access strategies are much more difficult. You may have significant unmet need and great performance but the economic challenges still need to be overcome…
What you'll learn:
• To achieve and manage successful MA strategies through a clear and pragmatic roadmap
• Insights into tools for MA management from flat files to web-based applications
• To deliver MA teams strategic aspirations
Powerpoint Slides used during Ernst and Young Singapore Business Case Competition 2011. Case study is on Keppel Offshore and Marine and the company\'s concerns to be the leading company in the shipbuilding and rig building industry.
This is the summary of a webinar I delivered in November 2012 on Health Outcomes Liaisons and their roles in supporting managed care busines and ACO business.
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
Five forces that will change healthcare marketingKaren Corrigan
In the healthcare industry, powerful demographic, economic, societal, technology and legislative forces are converging to change the underlying basis for competition. For health systems, new economic models, disruptive technologies and transformation of care delivery systems are front and center – challenging marketing executives to better understand and anticipate the impact of this change.
2013-01 Building a Framework for Sustainable ACO Enablementimagine.GO
Insurers and Providers must first agree on how to share risk. After that, begins the hard part. For ACOs to last, unlike managed care in the 90's, they will need a sustainable framework to achieve cost, quality, and patient experience.
Great value propositions payer value deliveredCuro Consulting
Building a Payer value strategy is an incredibly complex process. We all look for the silver bullet: huge unmet need, great performance and an easy price target. In reality, most Market Access strategies are much more difficult. You may have significant unmet need and great performance but the economic challenges still need to be overcome…
What you'll learn:
• To achieve and manage successful MA strategies through a clear and pragmatic roadmap
• Insights into tools for MA management from flat files to web-based applications
• To deliver MA teams strategic aspirations
Powerpoint Slides used during Ernst and Young Singapore Business Case Competition 2011. Case study is on Keppel Offshore and Marine and the company\'s concerns to be the leading company in the shipbuilding and rig building industry.
This is the summary of a webinar I delivered in November 2012 on Health Outcomes Liaisons and their roles in supporting managed care busines and ACO business.
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
Five forces that will change healthcare marketingKaren Corrigan
In the healthcare industry, powerful demographic, economic, societal, technology and legislative forces are converging to change the underlying basis for competition. For health systems, new economic models, disruptive technologies and transformation of care delivery systems are front and center – challenging marketing executives to better understand and anticipate the impact of this change.
2013-01 Building a Framework for Sustainable ACO Enablementimagine.GO
Insurers and Providers must first agree on how to share risk. After that, begins the hard part. For ACOs to last, unlike managed care in the 90's, they will need a sustainable framework to achieve cost, quality, and patient experience.
Health Economic and Reimbursement Implications for Emerging Pharmaceutical/ B...MaRS Discovery District
Speaker: Colin Vicente, MSc.
Managing Director
PIVINA Consulting
The biotechnology and pharmaceutical industry is confronting significant short-term and long-term challenges. One of which is the ever increasing financial pressures placed on them through governmental and provincial processes both in Canada and abroad. These pose quickly evolving challenges; however, the overriding issue remains the need for effective market access strategies to gain better and faster commercialization. This seminar focuses on health economic, reimbursement and pricing policies implemented by governments and discussion of best practices adopted by companies with a proven track record in gaining patient access to their products.
Find out more about this session at: http://www.marsdd.com/events/details.html?uuid=f1849c07-4dd1-4043-95d1-cbdbd2f720f6
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
an empirical approach for provider organizations transitioning during healthcare reform implementation, integrating clinical and financial historical experiences. The presentation, Challenge & Response -- delineates the discovery process within experiential databasesA
The Rise of Value-Based Contracting for Biopharmaceuticals and Medical Techno...Nathan White, CPC
ICON Access, Commercialisation & Outcomes (ACC) - November 2017 Pricing & Market Access Briefing
AUTHORS:
Michael Pace
Senior Principal, Pricing and Market Access
Guy Sherwin
Lead Consultant, EU Pricing and Market Access
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance...Nathan White, CPC
The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
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RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...PaulBryant58
This article provides a comprehensive guide on how to
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Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
As a business owner in Delaware, staying on top of your tax obligations is paramount, especially with the annual deadline for Delaware Franchise Tax looming on March 1. One such obligation is the annual Delaware Franchise Tax, which serves as a crucial requirement for maintaining your company’s legal standing within the state. While the prospect of handling tax matters may seem daunting, rest assured that the process can be straightforward with the right guidance. In this comprehensive guide, we’ll walk you through the steps of filing your Delaware Franchise Tax and provide insights to help you navigate the process effectively.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
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𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
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⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
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"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
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BIO Windhover Pharmaceutical Strategic Alliances Conference April 2011
1. Thinking Beyond The Clinical:
Creating An Optimal Commercial Reimbursement Landscape
Nathan White, CPC • Executive Director, Access and Reimbursement
BIO Windhover PSO • New York, NY • March 31, 2011
Connect. Engage. Simplify.
2. The journey to bring pharmaceutical products from
molecule to market is complex and filled with
The Journey unforeseen challenges.
inVentiv Health brings clarity to the intricate issues
facing the biotech and pharmaceutical industries and
provides the tools and talent necessary to succeed.
CONSULTING · CLINICAL · COMMERCIAL
3. 1. Background and Case Studies On
Reimbursement
Objectives
2. Discover How Proactive REMS Can Offset
Commercial Risk
3. Panel Discussion
4. The pharmaceutical industry is embarking on a perilous journey,
bracing itself for the perfect storm
What does the perfect storm look like?
UNCERTAINTIES OF HEALTHCARE REFORM
COMPLEXITY OF PROVING VALUE TO PAYERS
CHANGING REGULATORY LANDSCAPE
5. Increasing premiums and cost sharing
Medicare and Medicaid expansion Comparative Effectiveness Research
Access to affordable coverage Safety Doughnut hole rebates
Outcomes
Quality
Premium subsidies Insurance exchanges
6. Patient Protection and Affordable Care Act
Uncertainties with new Congress
Future legislative changes
Expansion of coverage
Cost Containment
Quality and outcomes
7. The Value Equation:
Safety + Efficacy + Comparative Cost/Clinical Effectiveness
Industry
AHRQ NIH
PCORI Payers Patients and providers
(CMS & Private)
Who’s Responsibility Is It?
10. Case Study: Company with no US commercialization experience
EU Diagnostic created strategic partnerships to manufacturer,
Company (Co. A) distribute and market a lab-based diagnostic.
• Co. A wanted to target usage by PCP’s without
approaching the AMA to alter UTI diagnostic guidelines
• Co. A wanted higher reimbursement than CMS would
clearly pay
• Co. A’s product was not clinically differentiated from
UTI diagnostics and would not receive approval for a
new HCPCS code or higher reimbursement rates
Co. A invested in a product that had no commercial value in the US due to
reimbursement issues and scrapped the project.
“Look Before You Leap” - Consider the commercial reimbursement
landscape before investing!
Results & Lessons Learned
11. Case Study: Company with some US commercialization experience
Mid-size Biotech launched a lyo-formulated SQ injectable biologic for a
(Co. B) chronic disease into a very crowded market.
• Co. B had label restricting administration by a HCP in a
market where most competitors were self-administered
• This caused payers to cover the product under the
medical benefit in most cases.
• Prescriber adoption was poor due to the hassles with
reimbursement when alternatives were easily accessible
with fewer access hurdles.
Co. B could have considered a pro-active REMS to negate concern with
patient education and altered the label pre-approval.
“Consider The Label” – nuances in the label can have drastic repercussions
on the future reimbursement scenario!
Results & Lessons Learned
12. The End Goal:
A clinical & regulatory
strategy that meets
regulatory approval
and ensures a label
that in turn resonates
with payers and
reduces patient and
provider access
barriers.
13.
14. Development & Commercialization. Not as simple as you think.
Strategic Direction and Planning
Access and
Product Positioning Distribution Strategy Recall Strategy Pricing and Contracting Contingency Planning
Reimbursement Strategy
Implementation and Execution
Account Management Field Sales and MSL
3PL Operations Patient Services
Operations Operations
Programs and Tools Development
Physician Materials and Patient Materials and Payer Materials and
Programs Programs Programs
Monitoring and Reporting
Safety Database/
Pharmacovigiliance REMs
Program
15. inVentiv Health can mobilize our teams of
experts to forge a clear path to your success.
Strategic Direction and Planning
Access and
Product Positioning Distribution Strategy Recall Strategy Pricing and Contracting Contingency Planning
Reimbursement Strategy
Implementation and Execution (Outsourced Ops)
Account Management MSL Operations Patient Services
3PL Operations
Operations
Programs and Tools Development
Physician Materials and Patient Materials and Payer Materials and
Programs Programs Programs
Monitoring and Reporting
Safety Database/
Pharmacovigiliance REMs
Program
18. Steve Bloom
Vice President
Business Development & Operations
Steve has more than 25 years of commercial experience in the pharmaceutical, biotechnology and
outcomes/reimbursement industries. Steven is currently responsible for a full array of business
development activities (identification & evaluation of opportunities, structuring and negotiating
transactions, out-licensing and alliance management). In addition, Mr Bloom is responsible for the
commercial assessment and planning for the late stage clinical pipeline of the company.
Prior to joining ZIOPHARM Oncology, Mr. Bloom served as Vice President of Business Development
at PHARMetrics (aquired by IMS in 2005) where he manged the business development team and the
early integration of the company into the IMS organization. Prior to joining PHARMetrics, Mr. Bloom
was Vice President of Business Operations at Inflexxion where he built the marketing, business
development and sales organization as the company expanded from 35 - 55 employees. Mr. Bloom
spent the early part of his career at Eli Lilly and Company, with management positions in marketing
(US Brand Leader PROZAC), corporate affairs, sales leadership and managed care.
19. Joff Masukawa
Vice President
Global Government Relations & Public Policy
Joff Masukawa established and leads global government relations and public policy for Shire, one of
the world’s leading biopharmaceutical companies. Shire markets products for attention deficit and
hyperactivity disorder, gastrointestinal and renal diseases, and rare genetic disorders, with a robust
pipeline of products under development.
Joff’s experience includes advocacy, communications, diagnostics, international government relations,
health policy, industry and trade association management, investor relations, lobbying, market access,
marketing, media, national accounts, orphan drugs, patient assistance programs, pricing, public affairs,
reimbursement, sales and sales management, specialty pharmaceuticals and strategic planning.
Joff began his career at Merck and subsequently worked for Gentiva, Visible Genetics and Genzyme
before joining Shire.
20. Shefali Shah, MBA
Senior Director
Managed Markets
Mrs. Shah has extensive experience from assisting small start ups with new product launch planning to
top biotech companies with environmental assessments, product launch strategies, patient services
strategies and product life cycle management. She has developed pricing and reimbursement
strategies for pre-launch ultra-orphan and specialty/biotech products based on extensive market
research for the US and EU markets.
She has worked extensively in Rare Diseases, Neurology and Oncology developing launch strategies
for the US and EU.
Prior to joining inVentiv, Shefali worked as a consultant in the Pharmaceutical and Biotech Industry at
top companies like Andersen Consulting and PricewaterhouseCoopers and as an employee of Wyeth.
21. Jeff Fetterman, MBA
President
Jeff Fetterman is President of ParagonRx, a company specializing in REMS (Risk Evaluation and
Mitigation Strategies) and benefit-risk management for pharmaceutical, biotech and medical device
industries. As co-author of two pharmaceutical risk management books and consultant for
numerous risk management programs, he is helping to pioneer this field in our industry. Having led
the pre-startup safety assessment of the only nuclear reactor to be renovated following deactivation,
Jeff is familiar with the cross-industry implications of risk management techniques.
In previous work, he co-founded Empower Health, a business that integrated tools and services to
improve clinical health outcomes of people with chronic illness. Jeff has extensive pharmaceutical
industry experience, having led marketing, medical education, strategic planning, and business
development organizations at DuPont Pharmaceuticals and DuPont Consumer Health.
The end goal of Patient Access Solutions is to provide a faster and more streamlined experience for patients and providers while collecting and analyzing useful data to power our client’s brand value propositions.
The heart of Patient Access Solutions, formerly known as The Franklin Group, is a leader in the design and management of customized reimbursement and patient assistance contact center programs. While our award-winning contact center takes over two million calls and manages hundreds of thousands of reimbursement cases each year, we treat each patient and provider as if they were our only priority.
Each team member brings diverse perspectives and experience, yielding undiscovered insights.Drawing upon these insights, inVentiv develops and deploys innovative and fully integrated programs designed to grow your brand and enhance your customer relationships. We then mobilize our teams of experts to forge a clear path to success.