Blue Matter Blog

Alzheimer’s Disease: An In-Depth Look at a Formidable Foe
June 8, 2021

There is no shortage of disabling and deadly diseases in the world.  However, few match Alzheimer’s disease (AD) when it comes to sheer ability to cause fear and dread.  It’s not a rare disease.  In fact, it’s on the rise.  There is no cure (nor effective treatment yet) and it’s ultimately fatal.  And, most frightening, …

Beyond Linear Drug Development: Leveraging the Constellation Approach in Rare Diseases
June 7, 2021

We gratefully acknowledge the contributions of Alyssa Manz, Ph.D. and Quinn Civik for their work on the data analysis which supports this publication. Each rare disease (RD) only impacts a relatively small population, and given the clinical breadth of these conditions, new RD product development may feel like forging a completely new path towards a …

An Overview of Cross-Border Collaborations on Healthcare Technology Assessment, Pricing Negotiation, and Procurement
June 3, 2021

In our previous paper, we discussed several trends shaping the European market access landscape. Here, we explore recent cross border collaborations in more detail. While the recent COVID response highlighted many challenges, payers are making (slow) progress on a range of ongoing or planned initiatives: Small groups of countries conducting joint healthcare technology assessment (HTA) …

Recap:  Psychedelic Therapeutics and Drug Development Conference
May 25, 2021

Introduction Members of Blue Matter’s CNS team attended the Psychedelic Therapeutics & Drug Development Conference, a virtual event that took place May 4-6, 2021.  This event was particularly interesting to our team because we had just completed a white paper entitled “Taboo” Substances are Getting Another Look in CNS that explored the substances and companies …

American Academy of Neurology (AAN) 2021: Annual Meeting Recap
May 24, 2021

Introduction Members of our CNS team attended the American Academy of Neurology (AAN) virtual annual meeting, which took place April 17-22. As expected, it was an interesting and useful event, full of industry therapeutics updates, clinical research data, scientific sessions, and educational courses presented in a series of virtual panels, posters, and fireside chats.  It …

Key Themes from the 2021 Virtual World Orphan Drug Congress
May 3, 2021

Some of our Rare Disease team spent a day last week listening to patient experts and industry specialists in a series of virtual panels and fireside chats organized by the World Orphan Drug Congress. Amongst a wealth of interesting topics and a consistent focus on accelerating the delivery of rare disease (RD) therapies, a few …

Introducing our New Presentation Series on Access Evidence Generation
April 14, 2021

Generating Evidence to Support Market Access Great evidence planning is the foundation to successful market access. While good pricing and negotiation strategies at launch are essential, pharmaceutical companies can dramatically reduce the effort and risk required by having the “right” data that payers are seeking. In this case, “an ounce of prevention is really worth …

Five Trends to Watch in the European Market Access Environment
April 2, 2021

Every day, the sun rises and the sun sets. Here’s another thing that’s almost as dependable: national payers in Europe are facing increased pressures on their healthcare budgets. Payers want to provide access and fund innovative treatments to improve patient care, but they need to do so in the context of constrained budgets. However, the …

“Taboo” Substances Are Getting Another Look in CNS
March 22, 2021

Psychedelics and other traditionally taboo substances appear to be undergoing a bit of a “renaissance” in central nervous system (CNS) therapeutics these days.  These types of substances have a long and storied history all around the world.  Now, science is getting serious about exploring ways to use them to treat a range of diseases and …

Blue Matter Statement on Racial Equality and the Tragic Events This Week
March 18, 2021

At Blue Matter, we stand with the Asian American and Pacific Islander community and condemn all forms of hate, racial discrimination and violence.  We are deeply saddened by the horrific events that took place on Tuesday night near Atlanta, where the majority of those killed were Asian women.  The recent rise in racially motivated violence …

Novel Therapeutics in Oncology: What’s on the horizon, and what’s already here
March 11, 2021

2021 will be a big year for emerging oncology therapeutics, as we anticipate major late-stage clinical advancements for several new modalities either reaching their first regulatory decision (e.g., TILs, TCR-T, first solid tumor bispecific antibody) or making the leap from newly emerging into more established with new targets or indications beyond their initial approvals (e.g., …

Happy Women’s History Month!
March 3, 2021

Blue Matter wishes everyone a very happy Women’s History Month – this is an opportunity to discover, document, celebrate and respect women’s lives and achievements. At Blue Matter, we support an inclusive and intersectional feminist work environment where women have the freedom, recognition, and right to be their own powerful selves. We are observing Women’s …

Success in Rare Diseases, Part V: Working with Payers in the Rare Disease Ecosystem
March 1, 2021

Throughout this series, we’ve covered a wide range of areas that biopharma companies must address if they are to succeed in the rare disease (RD) ecosystem including clinical trial design, clinical trial implementation, and ongoing evidence generation.  In this installment, we cover the important topic of market access. To help drive commercial success, a therapy …

Oncology Outlook 2021: Scientific breakthroughs and competitive breakouts
February 24, 2021

2020 was a memorable year for some less-than-positive reasons, but even in the shadow of the COVID-19 pandemic there were numerous oncology advancements well worth celebrating. In addition to the specific research and clinical developments described below, there was also the recent announcement by the American Cancer Society that cancer death rates have continued to …

Go with the (Product) Flow: Establishing an Efficient and Effective Supply Chain in Europe
February 17, 2021

The most effective, groundbreaking, and revolutionary therapy in the world will not do much good if it can’t be effectively delivered to patients.  That fact should be highly self-evident.  However, establishing an effective supply chain is easier said than done and there are a lot of potential pitfalls, especially when dealing with the diverse and …

Why Blue Matter is Different from Other Consulting Firms
February 12, 2021

If you’re a consultant who’s looking for your next big career move—or if you’re thinking about a career in consulting—then you’re probably doing a lot of research about what it’s like to work at Consulting Firm A vs. Consulting Firm B, C, and so on.  We’d like to make that process a bit easier for …

Blue Matter Again Ranked as One of the 25 Best Consulting Firms to Work for in Europe; Ranked #1 in 5 Categories
January 19, 2021

Last week, we reported that Blue Matter was ranked as one of the Top 50 consulting firms to work for in North America (#19).  Today, Vault released its rankings for Europe.  We’re thrilled to announce that we were ranked #11 among the best firms to work for in Europe, improving our position over last year! …

Blue Matter Consulting - DNA Strand and Cancer Cell - Oncology Cell Therapy
2021 Outlook for Cell-Based Therapies in Oncology: CAR-T Expansion and Beyond
January 14, 2021

One year ago when we published an in-depth review of the cell-based immunotherapy landscape, no one could have predicted the global COVID-19 pandemic and its associated disruptions. But researchers, drug developers, regulatory agencies, clinicians, and patients all worked hard to ensure that the cell therapy field continued to advance and deliver promising new treatments in …

Blue Matter Ranked for 2nd Year as One of the 50 Best Consulting Firms to Work for in North America
January 13, 2021

For the second time, Blue Matter has earned a spot in the annual Vault Consulting 50 list!  We’re excited to be ranked as one of the 50 best consulting firms to work for in North America.  Among all consulting firms surveyed, Blue Matter ranked #19, up from the #30 position last year.  Among boutique firms, …

Central Nervous System Therapies: Outlook for 2021 & Beyond
January 5, 2021

So far in this series, we’ve spent a great deal of time looking backward.  In part 1, we discussed the “quiet revolution” that has been taking place in CNS over the past several years.  Interesting advances are being made in a range of CNS therapies while other areas, such as oncology, tend to get more …

Central Nervous System Therapies: A Look at Rising Investment Activity
December 15, 2020

In Part 1 of this series, we said that a “quiet revolution” has been taking place in central nervous system (CNS) therapies.  While much attention has been focused on the dramatic advancements in oncology, companies large and small have been focusing more resources on CNS research, and the pace of advancement is accelerating.  In that …

Success in Rare Diseases, Part IV: Successfully Implementing Clinical Programs in the Rare Disease Ecosystem
December 8, 2020

In the first three parts of our series, we introduced the rare disease (RD) ecosystem and its interconnected stakeholders. We also discussed the challenges and key considerations for RD clinical trial design – both (pre)registrational as well as ongoing evidence generation after the first approval. Here, we examine the practical considerations of successful clinical trial …

Central Nervous System Therapies: Where We’ve Been and the Road Ahead
November 16, 2020

“Life moves pretty fast. If you don’t stop and look around once in a while, you could miss it.” Some readers might recognize that as a memorable line from the ‘80’s classic movie, Ferris Bueller’s Day Off.  Those same readers might also ask what it has to do with central nervous system (CNS) therapies. In …

Diversity, Equity, and Inclusion: Core to Our “People First” Culture
October 30, 2020

If you’ve been reading the various articles in our “People First” series, you’ve no doubt learned that fostering an open, inclusive, and diverse environment is ingrained in our culture.  It’s one of our core values and we hold ourselves accountable by including it in our regular Values Survey, which you can learn more about here. …

Success in Rare Diseases, Part III: Continuous Evidence Generation in the Rare Disease Ecosystem
October 26, 2020

In Parts 1 and 2 of our series, we introduced the rare disease (RD) ecosystem as a uniquely interrelated set of stakeholders and discussed the key challenges and considerations for successful RD clinical trials. We focused on (pre)registrational clinical trial design, but of course regulatory approval does not mark the end of evidence generation. Here …

Success in Rare Diseases, Part II: Optimizing Clinical Trial Design for the Rare Disease Ecosystem
September 24, 2020

In Part 1 of our series we introduced the rare disease (RD) ecosystem, which is defined by a small patient population with often heartbreakingly high unmet need. Here, in Part 2 of our series, we will discuss in more detail the overarching design requirements and key considerations for RD clinical trials. The entrance of a …

Building a Better Team: Blue Matter Academy
September 22, 2020

A key part of building a People First Culture is making sure team members have the tools, training, and support they need to do their jobs.  But it doesn’t stop there.  At Blue Matter, People Development is essential to the success of our employees and our company.  We want to  help team members continually develop …

They’re In! – The Results of Our Latest Values Survey
September 1, 2020

In an earlier article, we introduced readers to our quarterly Values Survey.  Our “People First” culture is incredibly important to all of our team members, and we work hard to maintain and continuously improve it.  That means staying true to our core values, which are based on a deep-seated desire to foster a happy, productive …

Success in Rare Diseases, Part I: Understanding the Rare Disease Ecosystem
August 31, 2020

It’s a safe bet that anyone reading this article is familiar with the concept of an ecosystem. When we think of an ecosystem, we most often imagine how one exists in nature: a complex web of living organisms and non-living components (such as water, air, soil, rocks, and so on), all interacting with one another …

A Happy Team: Direct Result of a “People First” Culture
August 25, 2020

If you’ve been following along in this series of articles on Blue Matter’s People First culture, then you probably know by now that building a happy and motivated team is super important to us.  In fact, it’s in our core values.  After all, taking every reasonable step to ensure a happy team is the right …

Living Our “People First” Culture: The Blue Matter Values Survey
August 11, 2020

In a previous article, Emily Hua described our People First culture and why It’s so important to us.  Today, I want to add a little more to the story by telling you about our Values Survey. Lots of companies out there will talk about their values.  However, not many are willing to truly measure whether …

Our Foundation: A “People First” Culture
July 30, 2020

If you’ve followed our blog for any length of time, you’ve probably noticed that we like to create high-value content on some of the leading topics in the biopharma industry.  Today, I want to shift gears and write a bit about Blue Matter as a company and its culture. We’re growing rapidly, always engaging with …

Blue Matter “Breakfast Club” Meeting #5: Practical Implications of the COVID-19 Crisis for Biopharma
July 28, 2020

The Blue Matter Breakfast Club is an ongoing series of discussion forums (now virtual due to COVID-19), hosted by our team in Europe.  These forums are by invitation, bringing together leading executives from biopharma companies and other organizations to discuss critical business issues. The fifth Breakfast Club meeting took place on 8th July 2020.  The …

T Cell-Based Therapies in Oncology: Landscape Evolution After a Turbulent 1H2020
July 7, 2020

Six months ago, we published an in-depth review of the cell-based immunotherapy landscape, including forward-facing declarations of 2020 data releases, filings, etc. that would address key outstanding questions, namely: Six months later, despite the unprecedented and unanticipated impact of COVID-19 on corporate operations, clinical trial functions, and regulatory body decision-making, there have been multiple key …

And Now for Something Completely Different: Basketball in India
June 5, 2020

It may come as no surprise that most of the charitable work Blue Matter does is in some way related to healthcare. Our focus as a company is, after all, on the life sciences.  However, sometimes we like to put our consulting skills to use outside of the healthcare space, in areas that speak to …

Blue Matter Statement on Racial Equality
June 4, 2020

We are deeply outraged and shattered by the death of George Floyd, yet another death among too many horrific killings driven by racism and hatred.  We stand together with Black Americans and all those who are affected by systemic and learned racism. Our Blue Matter team—which is made up of talented people from more than …

Blue Matter “Breakfast Club” Meeting #4: A Conversation with Dr. Thomas Lönngren, Former Exec. Dir. of the EMA
May 20, 2020

The Blue Matter Breakfast Club is an ongoing series of two-hour breakfast forums, hosted by our team in Europe.  These forums are by invitation, bringing together thought leaders and executives from biopharma companies and other organizations to discuss critical business issues. The fourth Breakfast Club meeting was a virtual event on 13th May 2020.  The guest …

Continuing the Fight Against Lung Cancer with the GO2 Foundation for Lung Cancer
May 18, 2020

Last year, we wrote about our charitable work with a great non-profit organization, the Addario Lung Cancer Foundation (ALCF).  We’re proud to say that our work has continued with this organization.  However, things have changed over the past year, as the ALCF has merged with the Lung Cancer Alliance to form the GO2 Foundation for …

The Science Won’t Sell Itself
May 12, 2020

“Plans are worthless, but planning is everything.” That well-known quote comes from Dwight D. Eisenhower, 34th president of the United States and former Supreme Commander of the Allied Expeditionary Force in Europe.  It’s a pithy quote—though perhaps a little overstated—that highlights the critical importance of planning for any serious undertaking. For a biopharmaceutical company, the …

The Rarest of Them All: Why Neglected Rare Diseases Require a Very Different Mindset
April 1, 2020

Introduction In previous articles, we explored several important aspects of rare diseases (RDs).  First, we showed how different authorities define the term “rare disease” (or “orphan disease”).  We also established a spectrum of rarity, ranging from those diseases that are considered common—with well-established treatment paradigms—to those that are “hyper-orphan,” affecting perhaps a couple of people …

The COVID-19 Challenge: How Pharma Can Adapt and Succeed in the Face of an Uncertain Future
March 31, 2020

Current Scenario: Challenges, Opportunities, and Critical Success Factors The current situation regarding COVID-19 is alarming.  At the time of publication, infection and death rates are continuing to rise rapidly in the United States, Spain, Switzerland, and many other European countries. In other countries like China, Italy, and Germany the situation appears to be resolving, but …

How Rare Is Rare? Making Sense of Rare Disease Definitions, Nomenclature, and Patient Numbers
March 20, 2020

Many people working in and around the health care system and the biopharmaceutical industry use the terms “rare disease” and “orphan disease” on a fairly regular basis.  Obviously, they refer to any disease that’s uncommon, often with few treatment options (or no treatment options).  But what do these terms really mean? What’s the actual definition …

Location, Location, Location: Why You Need a Systematic Approach to Locating Your European HQ
March 17, 2020

Location, Location, Location:  Most regard that as the first rule of real estate.  Simply put, it refers to the fact that a home’s value can vary dramatically based solely on its location.  Nice neighborhood with good schools, low crime, and beautiful tree-lined streets? In a place like that, a home will command a much higher …

Cell-Based Therapies: Navigating Challenges Through 2020 and Beyond
March 10, 2020

In Part 1 of this series, we reviewed recent developments and upcoming milestones that are shaping the cell-based therapy landscape. Here in Part 2, we explore the various factors and challenges that will influence how each cell-based therapy—and the class as whole—will perform in the marketplace over the next few years. Some of these factors …

Europe’s Got Talent II: Deciding Who to Hire and When
March 3, 2020

When a non-EU-based biopharmaceutical company decides to establish a presence in Europe, there are seemingly countless items that need to be managed, ranging from the highly strategic to the mundane.  One of the most important items is building the European team.  In the previous article, we outlined five ways in which hiring and recruiting differ …

Europe’s Got Talent I: Five Ways Recruiting a Team in Europe Differs from the US
March 2, 2020

“Our people are our greatest asset.” That statement is a time-honored cliché in the business world.  However, clichés typically come about for a reason: They’re usually true.  No biopharmaceutical company can move into Europe without recruiting and hiring talent there.  Obviously, those are essential steps to building a local presence anywhere.  In this installment of …

How are Rare Diseases Different from Rare Oncology and Specialty Diseases and What are the Implications for Companies?
February 26, 2020

Rare vs. Specialty Diseases: Are They the Same? We’ve often been asked what the differences are between rare diseases and “specialty diseases” and/or rare cancers.  After all, these three types of disease share some similar characteristics.  For example, they’re often complex, require higher-cost and “higher touch” treatments, and a high degree of knowledge and specialization.  …

Show Me the Value: Understanding the Payer Landscape and Engaging with Payers in Europe
February 24, 2020

Basic and Essential For any biopharma company planning an initial move into Europe, there are myriad issues to address, as this series outlines.  One of the most important is ensuring that a company’s product(s) will be reimbursed by the various national payers that exist throughout European markets.  It’s a basic truth:  Payers are vital to …

Europe is Not a Country: Defining the launch sequence and market-specific strategies for a diverse Europe
February 19, 2020

Why a Europe-Tailored Strategy is Important When a biopharmaceutical company decides to enter the “European market,” it’s important to recognize that Europe is not really a single market.  Aside from having the European Medicines Agency (EMA) as common regulatory body, the European Union (EU) is actually a combination of 27 markets, each with a differentiated …

File and Don’t Forget: Securing Intellectual Property Protection and Completing Regulatory Filings
January 20, 2020

When entering European markets, a biopharma company must do a range of important things, many of which we will address throughout this series. In this installment, we cover two foundational elements of any European market entry that can set the commercial playing field for years to come.  They are 1.) Securing intellectual property (IP) protection …