Recent client and publishing successes
Keys to Mitigating Risk in Adaptive Trials
Phase III trials are the big, expensive ones that come right before a drug is submitted to a regulatory agency for approval. Phase III trials cost about $20 million, so you can see why the fact that about 50% of them fail is a big problem. Sy Pretorius, Chief Scientific Officer of PAREXEL, a leading international pharmaceutical consulting firm, believes that high rate of failure is due to traditional rigid trial designs. He argues that adaptive designs that enable trials to change as new data is collected can reduce failures (or lead to faster trial terminations), thereby saving companies a whole lot of time and money. We helped Pretorius publish his article about how to run adaptive trials (which are more complex than traditional ones) safely and effectively in Life Science Leader, here.
New Drug Submission Rules: A How-To
The FDA has mandated that by May 2017 all new drug applications must be submitted electronically in a format called eCTD. For drug developers to comply, they will need new tools, workflows, and publishing strategies. PAREXEL is a leading international drug consulting firm, and the Bloom Group helped PAREXEL Director Steven Dowdley and Senior Director Chet Shemanski place their article, “Accelerating Submissions With a Six-Point eCTD Strategy,” in the online journal of the Regulatory Affairs Professionals Society (RAPS), here.
How to De-Risk Complex Molecule Formulation
If formulation problems surface late in the process of turning active pharmaceutical ingredients (APIs) into beneficial drugs, developers may have to change their API production processes, and, in the worst cases, redo Phase I and Phase II trials Anil Kane, Global Head of Formulation Sciences at Patheon, a leader in contract drug manufacturing, explains how developers can anticipate formulation problems in an article we helped him publish in BioProcess Online, here.
The Perils of Underpricing New Products
Simon-Kucher & Partners is a $200 million+ management consulting firm specializing in marketing, sales and pricing strategies. In 2015, the Bonn, Germany-based firm asked us to turn its expertise and client experiences on product innovation into a book. After finding an agent (who secured a publisher, John Wiley & Sons Inc.) and helping the authors, Madhavan Ramanujam (an SKP partner) and Georg Tacke (co-CEO), capture their ideas in a manuscript, Bloom Group then worked with SKP in 2016 to market the book (Monetizing Innovation: How Smart Companies Design the Product Around the Price) through two Harvard Business Review articles. This, the second HBR article (“Your New Hit Product Might Be Underpriced”), ran in the publication’s May 24, 2016 online edition. You can read that article here.
Innovation Lessons from Porsche and Fiat Chrysler
This was the first of two Harvard Business Review articles that Bloom Group helped Simon-Kucher & Partners' Madhavan Ramanujam and Georg Tacke prepare and secure to help publicize their book Monetizing Innovation.
In this article (titled “In Product Development, Let Your Customers Define Perfection”), the authors compare new-car launches from Porsche (the Cayenne SUV in the early 2000s) and Fiat Chrysler’s Dodge Dart about 10 years later. The Cayenne became a huge hit that propelled Porsche, and the Dart became a poor sales performer that soon will be discontinued. The article ran in the May 9, 2016 online edition of HBR. You can read it here.
In 2015, Bloom Group helped the Simon-Kucher consultants convert their ideas into a manuscript, as well as secure an agent for the book (Leah Spiro of Riverside Creative Management), who sold it to a top-tier publisher (John Wiley & Sons).
Simon-Kucher is a $200 million+ management consulting firm that is widely considered to be the world's leading consulting firm in pricing strategy.
Simon Kutcher & Partners (SKP) is a global management consulting firm. Bloomberg Business Week called it “the world leader in giving advice to companies on how to price their products.” As a frightening percentage of excellent new products and services either fail to gain traction in the market, or produce an inadequate return on investment, companies can use that advice. SKP believes that good innovations fail when companies leave the pricing discussion to the end of the development process, and advises that innovation should begin with solid research on what prospective customers want, and their willingness to pay for the value they (not the company) perceive is being offered.
In the summer of 2015, SKP board member and partner Madhavan Ramanujam, and co-CEO Georg Tacke, engaged the Bloom Group to help them conceptualize, outline, and write a book about how companies can improve the chances that their new products or services will succeed by determining a price for their products – and finding out if customers are willing to pay it – before pouring time and money into R&D, manufacturing, marketing, and sales. Monetizing Innovation: How Smart Companies Design the Product Around the Price was published by Wiley in May 2016, and is rated 5 stars out of a possible 5 on Amazon.
Speeding Drugs to Market
The FDA has created several new pathways that can shorten the time it takes for needed new medicines to receive regulatory approval. These pathways certainly benefit patients that need these medicines by getting them to market more quickly, and they also can benefit drug developers by providing a more rapid return on investment. However, meeting new FDA requirements can be a complicated and tricky business. PAREXEL is a leading international drug consulting firm, and the Bloom Group helped PAREXEL Vice President Barry Farrimond, Network for Excellence in Health Innovation President Jonathan Fleming, and PAREXEL expert Mark Mathieu place their article “FDA’s Accelerated Pathways Are the New Normal” in DIA, the publication of the Drug Information Association, here.
The National Football League and Its Attackers
Hudson Institute Senior Fellow Hank Cardello weighs in on the latest round between the NFL and the growing number of activists who are attacking its stand on concussions. In his latest Forbes.com post, Cardello suggests that the NFL should recognize those who are railing against it as an important market segment, not as a parariah. You can read Hank's article, his 19th Forbes.com post since 2012, here.
Waste-Not Want-Not Formulation and Process Design
Developers must make important decisions about product formulation and process design to move a drug from preclinical through Phase II trials as quickly as possible. Over-engineering a Phase I or Phase II drug that ultimately fails in the clinic wastes resources. But neglecting sound science during early stages can result in a promising product that may not have a scalable or commercially manufacturing process. That’s can be an even a bigger waste. Anil Kane, Global Head of Formulation Sciences at Patheon, a leader in contract drug manufacturing, explains how to strike the right balance in an article we helped him publish on PharmTech.com, here.
Asian Supply Chain Mysteries
An Oregon woman opens a box of Halloween decorations she bought at her local K-Mart and out falls a note pleading for help, written by a man in a Chinese prison camp. How does this happen? According to FTI Consulting Forensic & Litigation Consulting Senior Director Greg Hallahan, Western companies that outsource manufacturing to Asia do a pretty good job vetting their suppliers, but not such a good job checking to see if their suppliers are subcontracting the work out. We helped Hallahan repurpose his article in FTI Journal, for Thomson Reuters News and for Supply & Demand Chain Executive.
Solving for Solubility
Solubility is a key issue when formulating drugs for manufacture, and the proportion of new drugs that are hard to dissolve has been increasing. There are lots of formulation technologies available to drug manufacturers to address solubility, but it’s not always easy to know which one is best for a new drug. We helped the scientists at Patheon, a global contract manufacturing firm, publish their guide to technologies and strategies for developers in Drug Development & Delivery, here.
Fighting Pharma Demand Forecast Fails
Given the long road drugs must travel to get to market, developers have to predict demand, and line up production capacity, years before a new product launches. If they guess too low, they won’t have enough to meet demand (causing reputational damage and the loss of potential revenue). If they guess too high, they’re stuck with product they can’t sell. And because forecasts are always off, James Mullen, CEO of Patheon, a global contract manufacturing firm, has a solution: flexible and scalable manufacturing capabilities. We helped Mullen publish his solution in Life Science Leader, here.
Taking Coke and Its Attackers to Task
Coca-Cola Co. has made lots of headlines in the summer and fall of 2015, not all of them good. The company was criticized for not disclosing its investments in health organizations and health research initiatives. In his latest post for Forbes.com (“Shame Is a Losing Strategy for Both Coke And Its Attackers”), our client Hank Cardello (head of the Obesity Solutions initiative at the Washington, D.C., think-tank the Hudson Institute) discusses the criticism lobbied against Coke, and why the beverage giant’s new transparency about who it funds is good but not good enough. You can read his article (published in September) here.
Fighting Bribery and Fraud in Emerging Markets
Matías Mora Simoes is a Senior Managing Director in the FTI Consulting Forensic and Litigation Consulting practice and is the head of the FTI Consulting Panama and FTI Consulting Mexico offices. We helped him place his article, “What Companies Do Right (and Wrong) Fighting Bribery and Fraud in Emerging Markets,” based on FTI Consulting research, in Corporate Compliance Insights. You can read the article, here.
Avoiding Risk in Emerging Markets: A Study
The Bloom Group helped FTI Consulting, an international business advisory firm, conduct a quantitative and qualitative survey of global business leaders to discover how leading companies successfully mitigated the many risks of doing business in emerging markets, and what laggard companies were doing wrong. We then helped FTI Consulting’s senior leaders publish the survey’s findings, and many articles derived from them, in several executive journals, including the online edition of The Harvard Business Review, Risk Management Monitor, Corporate Compliance Insights, and CFO.com.
Mighty Midsized Companies
We recently worked with Rob Sher, a coach to CEOs of midsize companies, to craft his book, Mighty Midsized Companies: How Leaders Overcome the 7 Silent Growth Killers, and promote it in a series of high-profile blogs on HBR.com.
The book scores 5/5 on amazon from 70 reviews and made the Washington Post best seller list.
If you'd like to discuss a book project, please give us a call.
Big Food's Collaboration Lessons for Congress
Our client Hank Cardello of the Hudson Institute writes in his latest guest commentator post for Forbes.com about what Washington could learn from the food industry on how to work with anti-industry activitists. Through a number of initiatives, the food industry and many of its critics have found common ground in the fight against obesity and for healthier food. You can read Hank's article here.
The How and Why of Telemedicine
Telemedicine is on the rise. Patient and physician acceptance is growing quickly, the benefits are clear, but there are barriers – social and regulatory – that remain to be surmounted. FTI Consulting Forensic & Litigation Consulting practice Senior Managing Director Wayne Gibson, and FTI Consulting Health Solutions Managing Director Jeffrey Bessette wrote “The How and Why of Telemedicine” to answer questions that many have about this new, promising way of delivering healthcare, and the Bloom Group helped them place it in Health Management Technology. You can read the article here.
Oil and Gas Industry Gets Social Media Wrong
Steve Everley is a Senior Director at FTI Consulting, advising clients in a broad range of industries, including coal, refining and LNG exports. Everley published an article in FTI Journal, “Drilling for a Social Media Strategy,” here, about how social media, which can target small groups and communicate with them in an intimate manner, is a better communication channel for the oil and gas industry than the national marketing efforts it has heretofore focused upon. The industry has left social media to its activist opponents. It can do so no longer.
In December, we helped Everley publish a version of his FTI Journal article in industry publication OGI, here.
Taking Business School Research Out of the Ivory Tower
Most business school research is, well, academic – not at all relevant to the needs of companies. You’d think colleges would want to make their research relevant to business since that’s where most of their students look for work.
At least, that’s the opinion of two business school professors – James Wetherbe of TexasTech University and Jon Eckhardt of the University of Wisconsin-Madison. In this Harvard Business Review article (published Dec. 24), they explain why this is so and what schools can do about it. You can read that article here.
This is the 11th article we’ve helped our clients publish in the Harvard Business Review in just the last two years.
Restaurants and the Obesity Epidemic
In his latest Forbes.com guest commentary, Hudson Institute consultant Hank Cardello takes the U.S. restaurant industy to task. The industry’s shortcoming? Failing to regard the nation’s obesity epidemic seriously enough, as both a social problem and an economic opportunity.
The article (“Restaurants Should Be Doing More to Fight Obesity – for Their Own Good”) ran on Dec. 22 in Forbes.com’s Leadership section. You can read it here. We helped Cardello with the piece, as well as 15 other Forbes.com articles in the last two years.
Why the Oil and Gas Industry Can’t Ignore Social Media
Steve Everley is a Senior Director at FTI Consulting, advising clients in a broad range of industries, including coal, refining, and LNG exports. Everley published an article in FTI Journal, “Drilling for a Social Media Strategy,” here, pointing out how social media, with its ability to identify small groups and communicate with them in a powerfully intimate manner, is becoming increasingly important when it comes to granting licenses for drilling and fracking. The oil and gas industry has always focused its communication efforts nationally, but fracking is a local matter, and must be addressed locally.
In October, we helped Everley publish a version of his FTI Journal article in industry publication OGM, here.
Life Sciences And Taxes
Barbara Ryan is a Managing Director in healthcare capital markets and strategic communications at FTI Consulting. Last year, the global life sciences market had more M&As than ever before. Much of this action was driven by a desire to expand into new markets, and a lot was about decreasing tax liabilities through the now-infamous tactic of corporate inversion. In May, Ryan led a panel in a discussion of the life science boom, published in FTI Journal, here, and in September the Bloom Group helped her publish an article in Life Science Leader, here, about “the elephant” in the life science room.
A New Way to Pay
Mark Fish is a Managing Director at FTI Consulting, in the Health Solutions practice, and he has spent 24 years in the healthcare industry. But in the last four – since the passage of the 2010 Affordable Care Act, commonly known as Obamacare – Fish has seen a tectonic shift in the healthcare landscape. In May 2014, Mark wrote an article for FTI Journal, “A Road Map for Healthcare Convergence,” detailing how providers need to remake themselves to change successfully from the traditional fee-for-service paradigm, in which reimbursement tracks to the quantity of services delivered, to a pay-for-value model in which having the capabilities to improve patient outcomes – and track that improvement – is critical. In September 2014, we helped Fish publish a version of his FTI Journal article in McKnight’s, here.
The Big Heat
Barbara Ryan is a Managing Director in the Healthcare Capital Markets and Strategic Communications practices at FTI Consulting. Ryan, who also has years of experience as a Wall Street sell-side research analyst covering the biopharmaceutical industry, recently moderated a panel discussion with several other life sciences and investment experts on the boom in life science mergers and acquisitions, as well as the issues and challenges confronting pharmaceutical companies both large and small as they attempt to compete in a complex global market. That discussion, in edited version, ran in the June issue of FTI Journal here.
Ryan turned the meat of that wide-ranging conversation into an incisive article, “The Big Heat: What Lies Behind the Mergers, Acquisitions, and Consolidations in the Life Sciences,” which the Bloom Group helped her publish in July in Outsourced Pharma, here.
Don't Tolerate Intolerable Leaders
In Robert Sher's seventh Harvard Business Review blog post this spring on the seven silent growth killers of midsized companies, he tells the stories of firms that put up with dysfunctional executives too long and later regretted it. You can read that post here.
Catch-22 in Asian eDiscovery
Richard Kershaw is a Managing Director and leader in the Technology practice of FTI Consulting. In June 2014, the Bloom Group helped Kershaw publish an article in FTI Journal here, identifying the problem U.S. and European companies face when they try to collect information in Asia to comply with requests from their home regulators. Because of the complex data privacy laws in many Asian countries that control what information can be collected and where it can be moved, if foreign companies produce the information their home regulators are asking for they may face fines and criminal prosecution in Asia. If they don’t, their own regulators will come down on them hard. In other words, they’re damned if they do and damned if they don’t.
Based in Hong Kong, Kershaw, an expert in data forensic strategies, suggests that in this age of cloud computing – in which information may be stored here, there, or someplace else – Western companies must be alert not only to the privacy rules in the Asian countries in which they operate but to the whereabouts and character of the data that may be of interest to regulators.
Shortly after the FTI Journal article appeared, the Wall Street Journal published a commentary in its “Morning Risk Report” here focusing on the problem Kershaw identified, quoting him extensively.
Balanced Healthcare Transformation
Phillip Polakoff, M.D, is a Senior Managing Director and Chief Medical Executive in the Health Solutions practice of FTI Consulting. Dr. Polakoff’s healthcare career spans thirty-five years and he currently helps clients (both providers and payers) design and implement value-based reimbursement initiatives, construct clinical integration organizations, facilitate physician-hospital alignment and structure population health management programs. Early in 2013 we worked with Dr. Polakoff to write an article on the ongoing and substantial transformation in U.S. healthcare for FTI’s management journal here. The article lays out not only what is happening, but also articulates strategies for every healthcare player to follow.
Early this year we helped Dr. Polakoff produce a variation on his article for the Asian market which was published by Asian Hospital and Healthcare Management here.
Avoiding the Judgment Day
This is Robert Sher's sixth in his seven-part series of blog posts on Harvard Business Review's online edition, HBR.org. The series focuses on the growth issues that are unique to (or accentuated in) midsized firms -- companies with revenue between $10 million and $1 billion.
In this post, Sher discusses the uncomfortable issue of running out of cash, and how to avoid it. You can read his article here.
A Refreshing Approach to Fighting Obesity
Hank Cardello's 16th Forbes.com article since the fall of 2012 shines the light on a collaboration of the food industry, White House and public health experts in getting Americans to drink more water. The early returns on that campaign are impressive, as you can read here.
How Operational Meltdowns Can Melt Down Midsized Companies
This is the fifth in Robert Sher's seven-part blog series in Harvard Business Review's online edition. HBR posted this article on April 25, and like the previous four posts, it too generated numerous comments (55 as of this typing).
How M&A Can Kill the Midsized Firm
This is the fourth in a seven-part Harvard Business Review blog series by Robert Sher, an executive coach of midsized company leaders, and the head of CEO to CEO. The article, "How Midsized Companies Can Avoid Fatal Acquistions," ran April 22 and can be found here, along with more than 60 comments that have come in since.
Why Midsized Firms Must Cautiously Roll the Dice
In Robert Sher's third of his seven-part blog series in Harvard Business Review, he explains how midsized companies can foolishly roll the dice, as well as how to avoid doing so. You can read that April 18 post here, as well as the 70+ comments that rolled in less than two months afterwards.
Hard and Necessary: End-of-Life Discussions
Studies have shown that people who have advance end-of-life planning discussions with their physicians spend less time receiving painful, unwanted, expensive, and ultimately futile treatments under the cold, blinking lights of Intensive Care Units. Instead, they get to spend that time with their loved ones. Unfortunately, these discussions happen all too infrequently as physicians are not trained to conduct them and families are often unfamiliar with the process. In this article that the Bloom Group helped FTI Consulting Senior Managing Director/Health Solutions Kerry Shannon place in McKnight's Long Term Care News, Shannon argues that long-term care facilities need to make sure these conversations take place, and she explains how. You can read the article here.
Stop Tinkering with the Strategy
Robert Sher's second HBR article on the growth killers of midsize businesses appeared April 4. As with his first post, many people have weighed in.
You can read that article and the 80+ comments here.
Midsize Company Advice: Prioritize Ruthlessly
The leaders of midsized businesses often come up dry when they search for advice on how to accelerate growth, improve processes, or deal with the challenges that impair or threaten performance. Most of the literature on these topics is focused on big Fortune 500 businesses because they can afford the big fees big consultancies charge. But the problems of midsized companies are very different than those of large companies (or small ones) as are their respective resources.
That’s where Robert Sher comes in.
Sher, founding principal of CEO to CEO, a consulting firm of CEOs with a mission to improve the performance and leadership infrastructure of midsized companies, in September will publish Mighty Midsized Companies, a book on the unique challenges that midsized businesses confront, and how they can meet and overcome them. And Sher’s first HBR.org column, here, on one of those challenges – the need for midsize businesses to develop an acute sensitivity to timelines and project deadlines – appeared recently. Testifying to the hunger for midsized businesses advice, Sher’s column collected 176 comments in less than a week.
In March, we worked with Sher to help him publish his first column on HBR.org. Six more are coming.
Banks Vs. the Bad Guys: Banking.com
Governments increasingly are casting banks in the role of the global economy's first line of defense against money laundering and other financial activities that support criminals, terorrists and rogue nations. And regulators are enforcing that view by levying increasingly high fines against banks that have been used by criminals and terrorists (or the nations that support them). Financial institutions have no choice but to comply, and so they need to build functions and risk-based processes that will reduce their risk of being used by the bad guys.
Peter Brooke and Christine Moran, managing directors in the governance, risk and regulation team at FTI Consulting, have proposed several ways that financial institutions can do well by doing good: implementing policies that will reduce their risk of running afoul of the regulators and help de-fund criminals and terrorists. We worked with them to help publish this article on Banking.com.
CVS's Moment of Profitable Morality
In February 2014, CVS Caremark Corp., a $126 billion pharmacy and health care company, stunned U.S. consumers and businesses by announcing it would give up $2 billion in revenue this fall by no longer selling cigarettes at its 7,660 drugstores (most of which are in the U.S.). Our client Hank Cardello, a senior fellow at the Hudson Institute and the leader of its Obesity Solutions Initiative, seized on the historic announcement – only to find it was not-so-historic.
In fact, Cardello wrote in a Forbes.com article published on Feb. 27 that a number of other companies including Apple, Danone, Costco and Walt Disney Company have made a similar move over the last decade. That move is one Cardello refers to as having a “moment of profitable morality.”
What he means is companies deciding to give up short-term revenue by abandoning a controversial but profitable product or practice to pursue more profitable opportunities. His article, “CVS and the Rise of Corporate Profitable Morality,” which we helped him publish on Forbes.com, can be found here.
Making Long-Term Care Smarter
As the population ages, nursing homes will have to play a more central role in helping realize the national mandate of reducing healthcare costs while improving its quality. Professionals in long-term care facilities have always worked hard. They've always been smart. As long-term care facilities become a bigger part of managing the health of the growing elderly population, they need to work smarter. In this article that the Bloom Group helped FTI Consulting Managing Director Drew Goddin place in McKnight's Long Term Care News, Goddin explains how the Internet of Things and analytics will help them do that. You can read the article here.
Food Activists Go Nuts: Forbes.com
While the U.S. food industry continues to make significant strides against obesity, selling 6.4 trillion fewer calories in 2012 than it did in 2007, and receiving plaudits from the American Heart Association, the Obesity Association, and other prominent health advocacy groups, various activists and organizations keep up an unceasing, unfocused drumbeat of unconstructive criticism.
These activists disparage food industry achievements, and lash out in all directions, attacking the industry’s research, numbers, and its alleged ulterior motives. While a measure of skepticism is healthy, declaring all-out war is not, argues Hank Cardello, a senior fellow at Washington, DC’s Hudson Institute, in a January 2014 article the Bloom Group helped him publish in Forbes.com’s Leadership section.
You can read Cardello’s article, “How Big Food’s Attackers Are Undermining Their Cause,” here.