HighPoint Blog

As discussed in a previous post, a tendering dedicated resource is a must and it represents the first step in building a successful tendering organization. But plenty of questions will remain unanswered, even before you tackle the governance of your tendering business. However, a tendering organization will begin to be defined through the creation of a dedicated resource, as well as by...

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Special thanks to co-author Joe Cabe, Manager, Pricing, Contracting & Market Access. 

It’s common to lump the medical device and pharmaceutical industries together. Both are essential to the healthcare industry and have similar business models. However, when we examine each, we uncover vast differences between the two markets.

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In the life sciences industry, there are no clear best practices or standard frameworks on how to establish a measurement plan for an end-to-end CRM implementation. A CRM roadmap strategy is challenging and the specificities of pharmaceuticals, with R&D being such an important piece of the business model, make it even more difficult.

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Are your practices for handling TMFs compliant with the new GCP requirements from ICH E6 (R2) coming into effect June 14?

Background for ICH E6 (R2)

The ICH GCP E6 regulation was introduced in 1996 when clinical trials were largely run on paper. Since then, the following trends have significantly increased:

• the scale, complexity, and cost of clinical trials • the degree of outsourcing for... Read More

Companies contemplating moving their unstructured data to the cloud are often concerned with the security of the platform and the cloud provider: managing cyber-risk to protect digital assets. Contrary to those concerns, the evidence shows the data centers and security processes of cloud providers are, in fact, far more hardened than any corporate data center. Greatly eliminating this security...

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Market Access is becoming more and more challenging. This is irrespective of drug classes and new technologies. Payers are applying the same scrutiny on orphan drugs as on drugs for primary care. This is driven by increased budget constraints in healthcare systems and the heterogeneity of reimbursement systems worldwide.

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Special thanks to co-writer Heenal Patel, Manager Pricing & Contracting. 

In United States' managed care contract administration, price protection is a strategy frequently used on executed contracts.

In simple terms, price protection calculates a ceiling price, safeguarding a price point as price increases occur. As drug prices rise, a rebate is issued for anything above the maximum price...

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Are “traditional” product launch strategies falling short of delivering desired results as it relates to your specialty drugs? Are product launch strategies including the full spectrum of “market conditions” that could impact the successful positioning of products at global and local levels? What are those “market conditions” impacting product launch? Should they be analyzed and incorporated...

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In previous installments, we tackled two challenges to success with eDetailing in the life sciences. The first challenge is getting teams in the field to adopt the new tools and adapt their interactions with customers. The second challenge is how to generate content that is engaging to customers and sales reps alike. However, just overcoming these challenges do not guarantee success....

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Are you or your colleagues facing never-ending issues when being audited or inspected? It might be time to start putting your (clinical) house in order.

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Market access functions in life sciences are always evolving. Disrupted by the increasing share of Biosimilars, companies are reorganizing themselves. In this environment, market access departments are absolutely required and given increased responsibilities — all driven by external and internal factors.

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Preparation is key to pass your Good Clinical Practice (GCP) inspection. You need to prepare well in advance and certainly not shortly before.

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Now that the first performance period for MACRA — the U.S. Medicare Access and CHIP Reauthorization Act of 2015 — is underway, it is vital that healthcare providers identify and implement strategies to ensure value-based reimbursement (VBR) success. MACRA, which expands and reforms quality-based Medicare clinician payments, has the potential based on program incentives to either increase or...

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Innovation and competition are constantly influencing commercial drug decisions worldwide in the life sciences industry. This is evident by years of record drug approvals by the FDA and EMA, followed by a sharp decline in new therapies in 2016.  Additional factors affecting commercial decisions include the advent of Biosimilars, the passage of the U.S. Affordable Care Act and recent proposed...

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Special thanks to co-writer Neelabh Saxena, Associate Director Pricing, Contracting, and Market Access. 

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Nowadays, it’s a well-known fact that tender management is essential across most markets. Thus, as part of your tender management strategy, you must setup a network of tender champions or a global tender network. However to address the specifics of tendering across various markets and diverse portfolios, a tender management organization needs to be built.

Within any life science organization,...

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Tenders set the stage in the new procurement landscape

The importance of tenders is rising. Tendering has become a new, standard method of entry into the procurement game in most European countries, and even across Asia, Middle East and Latin America. This competitive form of procurement procedure by national, regional or local tender authority is often heavily regulated by law.

The most...

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The goal of a public company and the fiduciary responsibility of company executives is to maximize shareholder value. In simple terms, maximize profit, which drives long-term shareholder value. Pharmaceutical companies are no exceptions.

However, when commercial strategy is scrutinized, an interesting trend emerges. Let us assume that an executive goal is to maximize profit over the life of...

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One of the major work streams of a contract management repository initial implementation involves the processing of your existing contracts. These existing contracts will often be referred to as your backfile, or legacy contracts. How you decide to handle them will have a considerable bearing on both the duration and cost of your implementation.

Why is backfile important? Many experts feel...

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Tendering has become a global trend and one of the most frequently used procurement methodologies outside the U.S. Presently, at least a quarter of pharmaceutical sales are made through some form of tendering. But tender processes are complex and far from standardized across countries, making it highly difficult to understand and manage. In addition, it’s a constantly evolving framework with...

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Contributors to this compilation include HighPoint experts John Wollman, Ted Marsh, Jim Slubowski, and Chris McShanag.

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This blog was co-authored by: Antonio Pesqueira, Manager Life Sciences; Antonio Pregueiro, VP Life Sciences Commercial Excellence EU; and Sara Carvalho, Senior Associate Consultant. A special thanks to all of them for their input on this piece. 

Digitalization is spreading at a remarkable pace. But in the life sciences, leveraging digital alternatives to enrich customer engagement has a long...

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Feedback on the passing of the 21st Century Cures Act in early December 2016 has generally been encouraging, with many industry experts weighing in on the positive impacts of the act and the need to continually advance new healthcare technologies.

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In 2016, the U.S. Food and Drug Administration (FDA) published draft guidance on “Data Integrity and Compliance” with respect to Current Good Manufacturing Practice (CGMP). This Guidance was published in response to a recent string of violations. In 2016 alone, FDA CGMP Warning Letters increased from 41 (in 2013) to 102. That’s a 148% increase in warning letters served.

 More than 45% of the...

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Since 2010, European Union (EU) Pharmacovigilance legislation is subject to regular and further enhancements because of EudraVigilance (EV), particularly the collection, management, and analysis of suspected adverse reaction reports. This includes the implementation and use of new ISO Individual Case Safety Report (ICSR)/ICH E2B(R3) standards, which deliver better data structures including...

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Hopefully not lost among all the headlines on the future of U.S. healthcare, an important collaboration was announced at the end of 2016, the launching of a new group that is committed to improving mobile healthcare applications.

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On January 30, 2017, the OMB website officially designated the 340 B Omnibus Guidance as withdrawn. Manufacturers should continue to follow historical guidance in place until the new administration provides further clarity.

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As part of the actions linked to a single market strategy, eForm aims at facilitating the management of data in the European procurement process. This new European legislation would apply to Life Science tenders as well. The increased importance of tendering  . The updates will potentially impact all the different types of tender existing within the European Framework. To fill some of the gaps...

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The dawn of a new healthcare landscape is upon us. But what exactly it may look like when the dust of the new Trump Administration settles is anyone’s guess.

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While components of the Affordable Care Act (ACA) are expected to come under significant scrutiny from the Trump Administration and Congress, the ongoing “retailization” of healthcare will accelerate regardless of the dustups over Obamacare.

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In a number of our previous blogs we discussed R&D data obstacles, looked at industry problems, and presented a use case for vendor management where data governance and consolidation can improve efficiency and decision making. Now we’ll continue this story with real world experience and advice.

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Co-authored by Aubrey Elmore, Senior Consultant PCMA

By the year 2025, the government-sponsored share of health spending is projected to increase and account for 47% of national health care expenditures, indicating a majority of Americans will receive pharmaceutical benefits through a publically funded program, such as Medicaid, Medicare, The Veterans Health Administration (VA) or Public...

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We use information largely for a few key things – we use it to drive our processes, we use it to measure performance, we use it to envision the future, and we use it to show compliance. As Healthcare continues to transform and demand accurate measurement of performance, data engines are being fired up to supply information and analytics to answer the call.

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Leaders who achieve their vison have thought through how to optimize their people, their processes and their technology.  Workday delivers a modern interface with easy to use click icons, making the application one of the highest rated applications on the market today.[1]  The enterprise software implementation, however, is not without it’s pitfalls.  Often, leaders delegate implementing their...

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“Medical products should meet standards of quality, safety and efficacy. The quality of medical products is, however, a major public health concern to the World Health organization and its Member States... The illegitimate manufacture, distribution, widespread availability and indiscriminate use of substandard/spurious/falsely labelled/falsified/counterfeit medical products have serious...

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There are a few reasons why eDetailing was a natural evolution of pharma promotion. Every healthcare professional, and particularly specialist physicians, report a reduction in availability or willingness to receive visits from pharmaceutical reps. In fact a 2016 survey showed that only 11% of HCPs preferred to be contacted in person.

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Medicare Access and CHIP Reauthorization Act (MACRA) final rule has been released, changing the playing field by repealing the long-delayed Medicare Part B Sustainable Growth Rate (SGR) reimbursement formula and replacing it with a new Quality Payment Program (QPP).

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It’s been nearly a month since Donald Trump won the election to become the next President of the United States. In those four weeks, industry experts and healthcare executives have been projecting and planning on what the win means given President-Elect Trump ran on a platform to repeal PPACA and transform Medicare. The overall tenor of the election was a demand for change and eliminating the...

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For any Managed Care rebating organization, formulary confirmation can mark a massive drain on resources, or simply an overlooked area of financial leakage. There is a wide range of solutions that companies use to work through the logistics and process necessary to adjudicate formulary-based rebates. The process of formulary adjudication is without a doubt the most varied area of managed care...

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