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.Read More
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.Read More
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...Read More
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.
Is there a recipe for navigating the unique product launch challenges that Emerging Biotech organizations endure?Read More
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...Read More
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...Read More
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...Read More
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.Read More
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...Read More
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.Read More
Latest revision of ICH guideline updates required data elements for transmission of Individual Case Safety Reports (ICSRs)Read More
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...Read More
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...Read More
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...Read More
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.Read More
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.Read More
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...Read More
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.Read More
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...Read More
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...Read More
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....Read More
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.Read More
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.Read More
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...Read More
Special thanks to co-writer Neelabh Saxena, Associate Director Pricing, Contracting, and Market Access.Read More
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,...Read More
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...Read More
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...Read More
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...Read More
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....Read More
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...Read More
With more than 30% of the pharmaceutical market now utilizing, a significant portion of the Life Sciences industry’s revenue is being subjected to tendering. It’s hard to think of a more imperative way to see, the time is now to adapt and master tendering. The tendering process can be divided into 5 essential phases: Awareness, Evaluation, Response, Fulfillment, and Tracking. All phases are...Read More
To successfully compete in the tender and contracting (T&C) market, Life Sciences companies require a strong and robust tender organization with a global-to-local tender strategy. This “Think Global, Act Local” strategy can be achieved by implementing a Global Tender Network with country Tender Champions where the whole organization partners with multiple, cross functional, corporate groups to...Read More