The Pharmaceutical Marketing Group

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Evaluation of Clinical Trial Costs and Barriers to Drug Development By Luca Dezzani Group Global Medical Director at Novartis Oncology

Source: https://www.linkedin.com/pulse/evaluation-clinical-trial-costs-barriers-drug-luca-dezzani-md/ The complete analysis of the costs and barriers to drug development in 2018. All the expenses to conduct clinical trials and the split by disease areas Clinical trials are a crucial part of the drug development process. Pharmaceutical companies conduct clinical trials to demonstrate safety and efficacy in order to gain approval from regulatory bodies. In recent times, the cost of clinical trials has increased and the time it takes to bring a drug to market is becoming longer. In 2003, the estimated cost of bringing a drug to market was US$802 million. The cost is no longer the same. In 2016, The Tuft Center for the Study of Drug Development estimated the cost of the same process at $2.6 bi...

Pharmacovigilance and Pharmacogenomics in the Digital Age: the EU General Data Protection Regulation (GDPR)

Pharmacogenomics: A Brief Introduction Pharmacogenomics is the study of the role of the genome in drug responses. That is, it identifies genetic loci associated with known drug responses on a population-level. Some of the current pharmacogenomic approaches used include multigene analysis and whole-genome single nucleotide polymorphism profiles. Subsequently, the genetic variants affecting an individual’s drug response can be assessed based on this information. Pharmacogenomics take into account both the pharmacokinetics and pharmacodynamics of a drug. Based on pharmacogenomic evidence, we now know that many differences in drug efficacy and toxicity are due to genetic polymorphisms. Understanding the effects of genetic variations can thus help improve drug efficacy. Moreover, it can help mi...

Real-world Data, Drug Access, and Digital

What are “Real-world Data”? “Real-world data” (RWD) refer to data collected in a real-life setting within a heterogeneous population. That is, not in a randomized controlled trial (RCT). In turn, analysis of these multi-source data provides real-world evidence (RWE) supporting the value of a product. This is especially important to confirm its long-term safety and efficacy outside of RCTs. Why We Need Real-world Data One needs to consider the inherent limitations of RCTs when interpreting the findings. Of note, selection bias is a limiting factor of most RCTs. Often, they only include patients within a specific age range, with limited comorbidities, and good performance status. This is obviously not representative of the real world. RWD can help identify subpopulations not included in RCTs...

Intellectual Property Protections for the Algorithms Used by the Healthcare Industry to Decode Big Data

Background As healthcare stakeholders begin to embrace real world evidence, along with many other forms of big data applications, there remains the issue of how to protect the underlying algorithms that derive meaning from this data. An algorithm is a very broad term that typically refers to the equations and/or a series of steps for a computer program that help organize and extract desired information. Protecting an algorithm from being stolen by a competitor or otherwise misappropriated requires enforceable legal remedies. Though algorithms are an absolute necessity when decoding big data, they do not fit well within most of the conventional intellectual property frameworks. For example, an algorithm is classified by courts as a mathematical equation, which, makes it nothing more than an...

Top 10 Pharmaceutical Companies 2018 – Cardiovascular by Luca Dezzani

The Complete List and Analysis of the Best Pharmaceutical Companies for Cardiovascular in 2017 The global cardiovascular therapeutics market in 2017 was estimated at USD 129 billion and projected to grow at CAGR of 2.3% to reach USD 141.38 billion by 2021. The top 10 cardiovascular drugs accounted for revenue of USD 11.55 billion in 2017. AstraZeneca/Shionogi /Chiesi, dominates the cardiovascular market, with its best-selling product, Crestor/Provisacor. Sources: SEC filings, companies websites, and annual reports. Luca Dezzani is a Novartis employee. All the views, analysis, and perspectives are fully independent and belongs to the author only. They do not represent the views or opinions of Novartis or any other company or organization. IgeaHub is a pharmaceutical blog created and curated...

The Role of Human-Centric Design Thinking in Healthcare

By Karin Bauer, VP Client Services, SGK Health Healthcare is an empathy-driven industry. But as healthcare consumers seek to become more empowered, changes in healthcare information gathering and sharing across systems have created a disconnect between the quantity of information available to empower care choices and the quality of care that patients receive. To win consumer confidence in this new healthcare information age, pharmaceutical companies, medical device manufacturers, healthcare enterprises and insurers must provide brand-centered relevance, based on insight into customer behaviors, perceptions and preferences. We recently interviewed 17 U.S. healthcare company representatives to gain their perspectives on the state of the industry, the objectives and challenges faced by market...

Special Access Programs: How to Successfully Implement in Pharma

Before a new product launches, many manufacturers need to decide if they are going to initiate a Special Access Program (SAP; also referred to as an Early Access Program [EAP] in the US or a Compassionate Use Program [CUP] or Named Patient Program [NPP] in the EU) for their brand while they are going through regulatory approval. The demand for SAPs has risen over the years due to the increased usage of social media outlets and the widespread online access to blogs and clinical trial websites. SAPs offer manufacturers an ethical, compliant, and controlled mechanism to offer patients, who have no other options, access to investigational drugs outside of clinical trials and before commercial launch. In addition, SAPs provide manufacturers with an excellent mechanism to give key opinion leader...

War games/competitive simulations overall framework

Besides the introduction we did, there was no unifying framework, so far we had seeing different models in an isolated way. Putting every framework in context is the purpose of this article. We believe that the best way to present this is by graphically depicting how the different models stack together in the following diagram: There are three levels of analysis on the above diagram: Strategic, where strategic moves are analyzed and decided, which includes using: Product introduction framework Strategic war games Tactical, where tactical moves are analyzed and decided, using tactical war games Post-experience analysis, where we analyze if everything went as expected and if not, what could be done to improve analysis. We did not talk about this part so far, however, it is extremely importan...

Tactical war games/competitive simulations to gain share

Tactical war games are generally used for strengthening detailing in product launches and to develop successful counter-messages to competitors that are gaining share. Definitions and main hypothesis: A tactical war game is a simulation of a typical sales visit to get a thorough knowledge and understanding of the competition’s sales approach to develop own alternatives to leapfrog the competition. The underlying main hypothesis is, as The Economist put it on its 05/31/2007 edition: “To know your enemy, you must become your enemy” Process: As in the case of strategic war games, running a war game does not begin with the dynamic itself, but earlier. The steps in strategic and tactical war games are the same, they only differ in their content and execution. The following steps are done before...

Unlearning Old Programming

Albert Einstein is widely credited with saying, “The definition of insanity is doing the same thing over and over again, but expecting different results.” While I do not view that choice as insane, I do see it as a common trap that most, if not all, in pharmaceutical sales seem to make. Here is how this usually plays out. Sales numbers for Drug X are not where they should be. To address this problem, Company A’s VP of Sales calls her Regional Directors, who email their District Managers, who tell their reps to increase their call frequency. Training reaches out to 3 vendors who all suggest an e-learning module. With a vendor’s help, training produces an e-module, and reps are told to complete it with a passing score of 90%. Marketing turns to their agency, which creates a product brochure ...

In Pharma…Without Digital, It’s not a Strategy

LIFE SCIENCES FORCES OF CHANGE New and often asymmetrical competition is reshaping the market. Disruption is the new normal, the pace of innovation is accelerating, and data more important than ever. Furthermore, we have entered the era of the Millennial healthcare providers (HCPs) & patients with technology-dependent expectations and empowerment regarding care treatment, research and sharing of information. Executives are asking tough questions about how to compete and succeed in this digital environment. They need to see a clear journey along with the crucial steps needed to realize true value from a digital strategy. THE DIGITAL TRENDS ARE CLEAR New digital technologies—such as e-health platforms, miniature diagnostics, the Internet of Health Things, and digital therapies—are forcin...

Off-Label Prescribing – A New Worry for the Pharmaceutical Industry

By Neil Grubert, market access specialist, analyst and author. EU Study on Off-Label Prescribing In recent years, the pharmaceutical industry has been concerned by the precedent set by the off-label use on purely economic grounds of Roche/Genentech/Chugai’s Avastin (bevacizumab) as a replacement for Roche/Novartis’s Lucentis (ranibizumab) in the management of wet age-related macular degeneration (AMD). The first part of this three-part article examined how the Italian and French authorities have vigorously promoted this practice, and assessed the implications of a potentially very significant new preliminary ruling from an advocate general of the Court of Justice of the European Union (CJEU).1 Part 2 considered how the authorities in Germany, Spain and the UK have taken divergent...