HighPoint Blog

In this continuing blog series, we explore the adoption challenges of risk-based monitoring (RBM) of clinical trials. So far, we’ve addressed the risk assessment process and centralized monitoring of analytics. In our latest post, we explore the broader challenges of organizational change that research teams face when moving to RBM.

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Large pharma company facing a critical forecasting challenge

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In the life sciences industry, gross to net (GTN) is the management process at the heart of the pricing and contracting lifecycle. Within this process, manufacturers forecast demand and accrue for rebates, chargebacks, and any other adjustments to the price charged for a product’s sale.

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The shift to risk-based monitoring (RBM) is not without challenges for clinical research teams. In a previous blog, I outlined three key adoption challenges teams face. That blog also provides an in-depth review of the first challenge, risk assessment. In this blog, we focus on the challenge of establishing and performing the sophisticated statistical analyses which are critical to detecting...

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To begin, there should be two processes for integrating tendering and global price management that lead to a harmonized governance routine, as at the end of the tendering procurement process. It’s about governing the tender bid price.

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Co-authored by Olasile Abolade, Associate Consultant

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By now, there is strong consensus that Risk Based Monitoring (RBM) is an essential practice in clinical research. There are ample resources and supporting data on the benefits of a Risk-Based approach to monitoring, and we will not add to the chorus of voices promoting its adoption.

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Think of test management tools as the Swiss Army knife in the back of your pocket. Test management tools can be the one-stop resource for a multiple purpose benefit. There are thousands of test management tools available, however they all have a few benefits in common if used proficiently.

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Outcome-based contracting is definitely a buzzword in the life sciences industry. Over the past few years, many companies have tried to implement such contracting strategies. Nevertheless, after years of efforts, and even if the benefits are widely recognized, the reality is that only a few contracts have materialized. When looking at the last years’ numbers, these are not so promising.

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SETTING THE SCENE

This is it. Your Global Price Management and Tender Management tool has finally been deployed based on your global and local requirements. Your data is integrated from various sources ranging from enterprise resource planning (ERP) to finance to publicly available sources. Your users are trained; roles and responsibilities are clearly defined; processes outlined and...

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Co-authored by Mattias Berger, Associate, Shared Services

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Brief overview of 340B reimbursement

In 1992, the 340B drug discount program was passed as Section 340B of the Public Health Service Act. This program allows “covered entities”, hospitals and clinics which have enrolled in the program and demonstrated a minimum disproportionate share adjustment percentage, to receive discounted pricing when purchasing drugs from the manufacturer. 

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On July 18, 2018, the FDA published its guidance for biosimilars, “Labeling for Biosimilar Products.” This guidance provides an overview of the FDA’s recommendations for biosimilar labeling, so that prescribers can make informed decisions. The FDA states the intent of the guidance is to help manufacturers “develop draft labeling for proposed biosimilar products for submission in an application...

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In a world of frequent biopharma mergers and divestitures, the optimal size and structure for a pharma company’s contract operations department is a moving target. Whether you’re setting up a new department or adjusting an existing one, meeting these shifting expectations is a challenge. There is typically no single way to determine your company’s unique best fit – one that balances management...

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The pharmacovigilance (PV) team at a large, global biopharma company faced a challenging operational environment. Plagued with a host of disconnected systems, their day-to-day operation weighed them down with a stream of recurring inefficiencies, inaccuracies, and added oversight costs.

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Co-author: Yann Chappuis, Senior Associate Consultant

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In the patented drug manufacturing world, fixed manufacturing costs are not usually a key driver of profitability. Achieving the right price is typically a much greater driver of profit.

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In the life sciences industry, gross to net (GTN) is the management process at the heart of the pricing and contracting lifecycle. Within this process, manufacturers forecast demand and accrue for rebates, chargebacks, and any other adjustments to the price charged for a product’s sale.

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"RIM provides an integrated view of regulatory information."

"Affiliates and regions should play a key role in the system."

"RIM is the foundation of the future IDMP implementation."

The quotes listed above paraphrase some of the typical feedback we hear from clients about the role of regulatory information management (RIM). RIM is a key supporting structure for successful operation in today’s...

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At first glance, tendering and contracting may appear as two completely different procurement methodologies within the life sciences industry. The general understanding is that contracting predominates in the United States and Japan, whereas tendering (with some contracting opportunities) predominates in the rest of the world. While this presents a fairly accurate overview, on closer...

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In an ideal world, global market access functions would be totally aware of all prices – from list to net – in all countries. The ability to access net prices for any transaction in real time would ensure zero revenue leakage along the pricing waterfall. Sadly, for life sciences companies, this ideal doesn’t materialize in the real world. Very few life sciences companies enable their global...

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HighPoint is currently conducting a Gross to Net Benchmarking Survey. Early, initial results from the survey have yielded some useful insights into industry trends around the following GTN organizational size and structure questions:

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Co authored by Luca Morreale, Manager, Life Sciences EU 

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Let’s face it – traditional on-site monitoring is becoming obsolete. Given the complexity of today’s global, multi-site clinical trials landscape, traditional site monitoring can be an inefficient method to ensure patient safety.

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The industry is currently in a period of unprecedented transformation, driven by ongoing shifts in the regulatory sphere from document-driven to data-driven information management. This transition is certain to continue well into the next decade and poses a significant challenge to the industry, with profound impact on how we manage regulatory information going forward.

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What is an Early Access Program (EAP)?

Early access programs (EAPs) provide an alternative regulatory pathway for existing therapies and new medicines to more efficiently meet patient needs. Prior to market approval, promising new drugs can be made available outside of the clinical trial space to individuals with life threatening or chronic, debilitating diseases. Likewise, an existing...

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Part 1 of “Improving Project Outcomes through the use of Project or Program Management Office implementation”

At any one moment in time, across organizations of all sizes, there are multiple projects underway, each having one of the following goals:

  • Improve a process;
  • Launch a product;
  • Deliver critical, time-sensitive results; or
  • Implement a new technology.
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Is there a recipe for navigating the unique product launch challenges that Emerging Biotech organizations endure?

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It may be no surprise that during a sponsor audit, data management and source documentation rank among the top ten most common categories for critical inspection findings. According to a report on behalf of the European Medicines Agency (EMA), out of 398 GCP inspections over a 12-year period, a total of 5,685 findings were recorded; 532 of these findings were critical – 48 directly related to...

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Co authored by Javier Elkin, Senior Associate Consultant, Shared Services EU

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Co authors:

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Projected trends in population growth and size published by the U.S. Census Bureau indicate the U.S population is projected to increase by 98.1 million between 2014 and 2060. Over that same time span, the population aged 65 and over is expected to grow from 15 percent to 24 percent of the total population — an increase of 9 percent.  One can surmise from the statistics alone that a huge...

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Setting up a tender organization for life sciences can be a challenge. Not only do you need to deal with the way the tender governance is structured, on top of that, depending on your leadership, you may have to organize your company accordingly. As promised, this blog addresses another even more complex aspect of the organizational design, being “how the lifecycle of your portfolio impacts...

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A recurring issue observed when we conduct assessments of manufacturer “Gross to Net” operations is the apparent disconnect among multiple stakeholders on the role and responsibilities of the forecasting group. Similar to organizational and project charters, most disconnects can be resolved through the exercise of creating a forecasting charter.

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Commercial contracting within the pharmaceutical industry has undergone a dramatic transformation over the last decade. Payers have become more sophisticated and are applying additional pressure on manufacturers to “put their money where their mouth is.” But there is still a lot of confusion and misunderstanding about the different contract types, objectives, and associated risks. In this...

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Co-written by Gael Corbion, Manager EU, Master Data management

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Harmonization of the tendering process seems like a tremendous task. Local laws are so different from country to country, making you ask yourself, how can it be achieved? Also, what are the benefits of harmonization and how can a tendering organization accomplish it? This blog focuses on discussing these aspects.

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Latest revision of ICH guideline updates required data elements for transmission of Individual Case Safety Reports (ICSRs)

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With the recent pricing wars among pharmaceutical and biotech drug manufacturers, the U.S. government, and even the patient population, one thing is certain — it’s not stopping anytime soon. Manufacturers are being “asked” (read: strongly urged) to justify all product pricing to all parties impacted. That said, while some price adjustments are justified based on the costs of bringing a product...

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Risk-sharing agreements have emerged as a popular mechanism to balance increased payer focus on managing costs and the manufacturer’s need to gain market access for new products.  In Europe, variations of these agreements are common and in the U.S., they are gaining more prominence. However, a lot of confusion exists among payers and manufacturers on terminology. This article aims to clarify...

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