HighPoint Blog

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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Biosimilars are on the agenda of several players in the pharmaceutical industry. Several companies’ new leg of growth seems to be the creation of a biosimilar franchise. The question is “How real are the opportunities in an ever growing competitive environment?"

In the next 5 years, Biosimilars could hit the market to compete with some key biologics cumulating sales of more than EUR40 billion....

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When we talk about open enrollment for January 1st activity, we tend to focus on the member-related situations that come during this time of new enrollments, disenrollments and benefit changes.   New benefit coverage requests will pour in and existing coverages will be modified, taxing your people and systems.  

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With the expansion of IDMP scope, we need to make sure we are tracking new and evolving requirements and guidelines for substances. Industrywide, that’s our next target.

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Getting your EDMS in place

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When open enrollment 2016 closed for the Health Insurance Marketplace, U.S. consumers made nearly 13 million plan selections in which they were either first-time enrollees or they adjusted their plans. Add Medicare and commercial plans to the mix and open enrollment 2017 will mean another expansion of healthcare coverage nationally, as well as a deluge of claims to process.

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The life sciences industry is evolving: the 2016 landscape looks nothing like 15 years ago. Change is inevitable and constant. It will be even more rapid in the 21st century.

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What do you do with legacy data and applications after you rollout your new electronic health records system?

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The game has changed

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In my travels across healthcare companies throughout the country, it’s evident that strategists, planners, and product owners are aggressively looking to break through the ice and begin thinking about how to leverage new digital technologies. But we should think further outside the box to envision new operational models, interactions, and services.

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Most project managers in the life sciences industry know that for a CRM implementation to be a true success, management buy-in and training must be top priorities. This is especially true for global CRM implementations where standardization of processes is even more important than the technology itself. However, without wide user adoption, the project is set for failure.

And to a fault in most...

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In today’s healthcare landscape, data grows continuously and at ever-increasing speeds, creating new challenges for a challenged industry.

There are clear and present drivers, not the least of which is the Affordable Care Act (ACA) adding 10 million plus patients to the healthcare ecosystem.  Imagine the data implications of those additional patients: new patient records, additional personal...

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Time to relax or time to do more work?

Q4 2018 may seem far, far away, but there is still lot to prepare for between now and then.

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There’s no time to spare when it comes to compliance. In this increasingly fast-paced market, companies must ensure that their operation is running efficiently in an effort to increase value. That said, automation helps to assess processes and verify that all potential issues and preventive actions are set in place to identify and fix events. This will ensure that companies are able to...

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As if being solely responsible for the company's medical innovation wasn't a big enough job, today's Life Sciences R&D professionals are hamstrung with inefficiencies and challenges such as collaborating with internal and external partners as well as centrally capturing, accessing, and integrating data for prospective decision making to name a few.

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