January 2010  -  NUMEROF "SECOND OPINION" PUBLISHED IN MEDICAL PROGRESS TODAY

Rita Numerof, President of NAI, was invited to contribute to Second Opinion, a regular feature of Medical Progress Today in which experts publish brief commentary on current policy issues. The focus in the January 28 forum was conflict of interest regulation, specifically by academic medical centers constraining participation of staff in work with pharmaceutical companies. To read her comments and those of the rest of the expert panel, click here.

November 2009  -  NAI PUBLISHED IN PHARMACEUTICAL EXECUTIVE

Reimbursement has taken on new importance to pharmaceutical manufacturers, as control over treatment decisions has moved increasingly from physicians to payers. In Reimbursement Strategy: Marketing’s Stepchild No More, published November 1, 2009 in Pharmaceutical Executive magazine, authors Michael Abrams, M.A., Managing Partner, and Rita E. Numerof, Ph.D., President of NAI, illustrate the impact of reimbursement strategy on corporate financial results. Two examples -- one in which proactive reimbursement efforts led to enormous success, another in which reimbursement addressed as an afterthought led to catastrophe -- serve to highlight key aspects of reimbursement strategy adapted to today’s evolving market environment.

October 2009  -  NAI PRESENTS AT LICENSING EXECUTIVES SOCIETY ON ECV CONSIDERATIONS IN DEAL STRATEGY

Jill Sackman, DVM, Ph.D., Senior Consultant with Numerof & Associates, Inc. (NAI), presented to members of the Licensing Executives Society (LES) at their 2009 Annual Meeting, October 19-21 in San Francisco, California.

Dr. Sackman conducted a workshop on Economic and Clinical Value Considerations in Global Biomedical Device Deal Strategy. Presenters from Stanford University, Intuitive Surgical, and Advanced Sterilization Products joined her in a post-presentation panel discussion.

Commenting on the main focus of the workshop, she said "Too often, ECV assessments of potential investment opportunities are conducted in isolation by clinical research associates focused on trial design and compliance, or by regulatory affairs alert to in-country requirements for registration and approval. Although these are critical and necessary inputs into opportunity assessments, they don't substitute for an integrated analysis of economic and clinical value relative to alternatives in the target market". Dr. Sackman and panel members shared approaches they have successfully adopted for obtaining, analyzing and integrating relevant ECV data in their licensing and acquisition decisions in developed and emerging markets.

October 2009  -  NUMEROF PRESENTS TO MISSOURI HEALTHCARE EXECUTIVES GROUP ON HEALTHCARE FINANCING

Rita E. Numerof, Ph.D., President of Numerof & Associates, Inc. (NAI), presented to members of the Greater St. Louis HFMA, the Missouri Healthcare Executives Group and the Midwest Gateway Chapter of Health Information Management Systems Society at their 4th Annual Conference, October 22, 2009 in Saint Charles, Missouri.

Entitled The Future Of Healthcare Financing, the focus of the meeting was on overcoming financial challenges raised by the current economic environment. Dr. Numerof joined representatives from Anthem Blue Cross/ Blue Shield, SSM Healthcare, Ascension Health, and others in a series of moderated panel discussions addressing finance-related issues. She presented as part of a panel session on Sustaining a Financially Vibrant Healthcare Organization.

For a complete agenda and information on the presenters, click here.

October 2009  -  NAI PRESENTS ON COMPARATIVE EFFECTIVENESS AT ORTHOPEDIC SURGICAL MANUFACTURERS ASSOCIATION MEETING

Jill Sackman, DVM, Ph.D., Senior Consultant with Numerof & Associates, Inc. (NAI), presented to members of the Orthopedic Surgical Manufacturers Association (OSMA) at their annual member Update On U.S. Issues, October 8-9 in Arlington, Virginia.

Dr. Sackman joined executives from Johnson & Johnson, the FDA, CDRH, and other organizations to discuss evolving regulatory trends for the medical device industry. Her presentation -- Comparative Effectiveness Research: Implications for the Orthopaedic Industry -- spoke to the status of the comparative effectiveness research initiative funded by ARRA in early 2009, and the likely consequences for medical device manufacturers.

Commenting on the growing importance of economic and clinical value provided by orthopedic products, Dr. Sackman pointed out that "CER [comparative effectiveness research] is a two edged sword -- it will clearly force new modes of thinking on the industry, but it also represents an opportunity for agile organizations to differentiate themselves in ways that have positive economic consequences."

For more information on NAI's Special Report, "The Impact of Comparative Effectiveness on the Healthcare Marketplace", please click here.

September 2009  -  NUMEROF, BLUNT, KINDER SPEAK AT HEALTHCARE INFORMATION FORUM

Rita Numerof, Ph.D., President of Numerof & Associates, Inc. (NAI), joined Congressman Roy Blunt, Lieutenant Governor Peter Kinder and other presenters at an Information Forum on Healthcare sponsored by Winning Women, September 22, 2009 in St. Louis.

The forum brought policy makers, healthcare providers, Dr. Numerof and other business leaders together in a panel discussion on the latest developments in healthcare reform. Representatives from the National Committee for Quality Assurance, Washington University, UnitedHealth Group, St. John's Mercy Medical Center, and Express Scripts offered their views on current proposals and likely outcomes of the debate.

Dr. Numerof’s comments focused on the importance of payment reform as a key element in realigning decisions made by patients, physicians, hospitals, and payers with the objective of cost effectiveness. "Any legislative solution to the problem of runaway healthcare cost inflation must start with a diagnosis of what the underlying problem is and address it", she said, adding that "An approach that was systemic in scope, that realigned incentives, and that meaningfully reduced waste and fraud would make it unnecessary to spend more money to fix the problem."

Click here for details on Winning Women's Information Forum on Healthcare.

September 2009  -  NUMEROF, GINGRICH DISCUSS HEALTHCARE REFORM

Rita Numerof, Ph.D., President of Numerof & Associates, Inc. (NAI), joined Newt Gingrich, Founder of the Gingrich Group and other presenters at The Center for Health Transformation’s 5th Annual Medicaid Summit: Solutions for Government Healthcare Reform member meeting, September 17, 2009 in Washington, DC.

The day-long meeting included updates on the status of the reform effort by Gingrich, and individual and panel presentations on healthcare solutions to provide better quality care at lower cost. Dr. Numerof joined executives from Wellpoint and Cancer Treatment Centers of America on a panel discussion on The Need for Payment Reform.

Click here for details on The Center for Health Transformation’s 5th Annual Medicaid Summit: Solutions for Government Healthcare Reform.

September 2009  -  NUMEROF INTERVIEWED ON COMPARATIVE EFFECTIVENESS SPECIAL REPORT

Rita Numerof, Ph.D., President of Numerof & Associates, Inc. (NAI), was interviewed on her firm's recently released Special Report, The Impact of Comparative Effectiveness on the Healthcare Marketplace, on Clear Channels' Health Today talk radio program, 55KRC (550AM Cincinnati, www.55KRC.com) on September 20, 2009.

"The comparative effectiveness research initiative being driven by HHS demands a change in thinking by all healthcare manufacturers and service providers", said Dr. Numerof. "The focus on increased cost effectiveness puts all of the players on notice -- they’ll have to prove the value of their products in contrast to existing options, not just that they’re safe and do what they claim. That’s a significantly higher bar, and it will require core process changes in order to adjust. It adds a whole new dimension to the competitive landscape."

"Dr. Numerof’s broad experience with the entire range of organizations that shape healthcare position her to add a unique perspective on what’s really going on in the industry", said Kurt Weingand, Ph.D., producer and host of Health Today.

Click here for details on NAI's Special Report, The Impact of Comparative Effectiveness on the Healthcare Marketplace.

Click here to listen/download the complete interview with Dr. Numerof.

September 2009  -  UPCOMING WEBINAR: ESTABLISHING A DEFENSIBLE FAIR MARKET VALUE FRAMEWORK

• Date: Thursday, October 8, 2009


• Time: 12:00 p.m. - 1:00 p.m. CST
• Pre-Register online now! We will call you to arrange payment.

Pharmaceutical and medical device companies’ financial relationships with physicians are a large and growing focus of OIG and DOJ enforcement activity. That makes it more important than ever to ensure that these arrangements can withstand critical examination. Determining fair market value (FMV) fees is difficult, and little practical guidance is available. Finding a defensible way to value the specialized services physicians provide as speakers, advisory board members, clinical researchers, etc. is central -- but not the whole answer to the FMV challenge.

Learn More >>

September 2009  -  UPCOMING WEBINAR: COMPARATIVE EFFECTIVENESS -- IMPLICATIONS FOR THE HEALTH CARE INDUSTRY

• Date: Thursday, September 24, 2009


• Time: 12:00 p.m. - 1:00 p.m. CST
• Pre-Register online now! We will call you to arrange payment.

Regardless of the outcome of healthcare reform, comparative effectiveness research (CER) is already a fact. With $1.1 billion in ARRA funding behind it, the current Administration has already put CER in motion.

The mandate of CER is to compare treatments -- pharmaceutical, medical device and diagnostics -- and to advise HHS and Congress on how to save money. Of all the new health care initiatives proposed, CER has perhaps the greatest potential for patient benefit -- and for economic disruption. CER will change the rules of the game for every manufacturer and service provider selling in the healthcare sector.

Learn More >>

August 2009  -  NAI PUBLISHED IN PHARMACEUTICAL COMMERCE

Many executives within the healthcare industry think that the fate of Comparative Effectiveness Research (CER) hangs in the balance along with the details of healthcare reform, currently under intense discussion. They’re wrong. Funded with $1.1 billion in stimulus bill money, a centralized Federal CER initiative is already well under way. What’s more, it promises to radically alter the rules for every provider of goods and services to the healthcare industry. In her opinion column Getting Ready for Comparative Effectiveness Research, published August 22, 2009 in Pharmaceutical Commerce, author Rita E. Numerof, Ph.D., President of NAI expands on the drivers behind CER, and the near- and longer term implications for the pharmaceutical industry. Click here to view her column.

July 2009  -  NAI PUBLISHED IN HEALTH AND HOSPITAL NETWORKS

All health care leaders are trying to develop new, transformative strategies in this climate of healthcare reform. Translating those strategies into action is where the real work begins, as this almost always requires fundamental changes to decision making, work processes and daily task activity. In their article The COO’s Leadership Role in Implementing Strategy, published June 2009 in H&HN, authors Rita E. Numerof, Ph.D., President and Bill Ott, M.B.A., Senior Consultant expand on the critical role of the COO in implementing transformative strategy.

The COO must be the champion in the organization who identifies the implications of the ambitious and visionary strategies adopted during strategic planning. Often exciting vision gets embraced as strategy without completing the hard work of thinking through what will be done differently on the ground, to achieve a different outcome.

Translation of such strategy into action is usually attempted through broad, formulaic operational initiatives such as "six sigma" or "lean". The authors suggest an alternative approach that leverages existing operational leadership to embed a more effective approach to managing change. The result is both quick wins and sustainable improvements, without having to create new cost centers to support formulaic initiatives.

July 2009  -  NAI PUBLISHED IN PM360

Even the most successful companies often find their annual planning efforts devolving into a rut. Instead of re-thinking their business models and go-to-market strategies in response to a dynamic market, they often end up simply projecting current business into the future as a basis for establishing next year’s budget. In their article Getting Out of the Planning Rut: Mapping the Proper Relation Between Business-Market-Product Strategy -- Part 1, published July 2009 in PM360, authors Bill Ott, M.B.A., Senior Consultant and Rita E. Numerof, Ph.D., President, discuss the risks of "business as usual" plans and how to properly connect business and market strategy.

In dynamic markets, strategic plans have to start with market strategy, as a company rethinks which customers it is competing for and how it will differentiate itself to win those customers. Once market strategy is clear, business strategy must be developed to address everything the company must do to operationalize its market strategy.

The authors note that operational excellence pursued in a silo is not the goal. Rather, must be seen as the means of achieving ROI and serving customers. Business strategy must make sense in the context of market strategy.

July 2009  -  NUMEROF INTERVIEWED ON HEALTHCARE REFORM

NAI’s president, Rita Numerof, Ph.D., was recently interviewed on her insights as an industry consultant into proposed health reform legislation by Dr. Kurt Weingand, host of the Clear Channel Communications show, Health Today, on 55KRC, Cincinnati. She is currently serving as an advisor to members of Congress, providing perspective on healthcare reform proposals and initiatives.

Dr. Numerof agreed that reform is overdue, but expressed reservations about the legislation currently under consideration. She noted that "The US is currently spending more than twice what other developed countries spend, and not getting the corresponding value. There’s enough money already in the system to improve outcomes, broaden coverage, and lower costs, if we realign financial incentives and eliminate existing inefficiencies. More spending isn’t necessary to fix the problem, especially with deficits at record levels."

Dr. Numerof pointed out that in the history of modern healthcare delivery, systemic progress on efficiency and quality has often been driven by changes in reimbursement by CMS, but those changes need to be structured to address the underlying causes of the problem. "The current legislation does not do that", she said.

NAI’s advisory perspective is based on a breadth of experience helping healthcare industry providers, payers, and manufacturers proactively act on health reform challenges. Click here to listen/download the complete interview with Dr. Numerof.

June 2009  -  NAI PUBLISHED IN SOCIETY FOR PHARMA AND BIOTECH TRAINERS

Today’s key hospital customers are far different from the customers of just a few years ago. Expectations have changed, and good products at a competitive price aren’t enough anymore. In their article Building a Capability to Sell to C-Suite Hospital Leaders, published Spring 2009 in Society for Pharma and Biotech Trainers, authors Bill Ott, M.B.A., Senior Consultant and Rita E. Numerof, Ph.D., President, discuss the key elements of major account management discipline necessary to acquire and keep strategic hospital accounts.

There are two primary aspects to key account management in healthcare. The first is to identify specific opportunities to provide strategic value beyond product transaction value. Once such opportunities have been identified, the job changes to planning and coordinating the necessary task activities within the rep’s own organization to realize that strategic value.

The discipline of key account management requires a broad range of competencies for product sales reps. It takes someone who can offer business acumen to clients, and also function as an effective collaborator with limited direct authority within their own organization. The authors discuss the key accountabilities and requisite competencies for an effective hospital key account management role.

June 2009  -  NAI ANNOUNCES RELEASE OF NEW INDUSTRY SPECIAL REPORT: The Impact of Comparative Effectiveness on the Healthcare Marketplace.

Numerof & Associates, Inc. announces the release of a new industry special report: The Impact of Comparative Effectiveness on the Healthcare Marketplace.

Comparative effectiveness research funded through the American Recovery and Reinvestment act of 2009 may be the first step toward a radical redefinition of the U.S. healthcare industry. It has the potential to redefine:

• What drugs are reimbursed and prescribed for a given ailment
• Who qualifies for treatment with a medical device, under what circumstances
• The course of treatment from initial presentation to release from care

…and much, much more.

This report provides in-depth coverage and analysis of questions like: "What is behind this massive expansion of funding for comparative effectiveness research?", "Who are the people who will decide how the research gets used?", "What are those uses likely to be?", and "What does that mean for the industry?"

Each report includes industry-specific content -- so whether you’re in the pharmaceutical, medical device, diagnostics, or healthcare delivery business, the implications you need to know about are clear.

Please click here for more information.

May 2009  -  UPCOMING WEBINAR: MEETING THE NEW COMPLIANCE BAR -- ACCOUNTABILITY AND IMPACT

• Date: Thursday, June 4, 2009


• Time: 11:00 a.m. - 12:00 p.m. CST
• Pre-Register online now! We will call you to arrange payment.

As compliance enforcement activity becomes more complex and demanding, pharmaceutical and medical device companies need to make sure programs, policies, and procedures can withstand heightened scrutiny. Companies need to be able to demonstrate the behavioral impact of their program to show effectiveness and demonstrate good faith effort.

The message for you is clear - you need to be certain you can demonstrate program effectiveness - checking off the boxes is simply not enough.

Learn More >>

May 2009  -  NAI PUBLISHED IN MX: Business Strategies for Medical Device Professionals

Even the most successful medical device companies are finding today’s rapidly changing and increasingly competitive global market a challenge. To be successful requires not only flawless execution of traditional marketing activities, but a critical evaluation of a product’s economic and clinical value proposition. Customers expect improved clinical outcomes; however, in the face of rising healthcare expenditures, these expectations come with costs that are at or below current pricing.

In their article, Building A Strategic Market Claims Strategy published in MX: Business Strategies for Medical Device Professionals, authors Rita E. Numerof, Ph.D., President and Jill E. Sackman, D.V.M., Ph.D., Senior Consultant of NAI provide insight into how purchasing decisions, globally, are increasingly being made based on data that supports real economic and clinical value. The authors also provide concrete recommendations on ways that organizations can cost effectively provide evidence that supports both premium reimbursement and market differentiation of their products.

March 2009  -  NAI PUBLISHED IN HEALTH AND HOSPITAL NETWORKS

Joint ventures in free-standing clinics with physician groups have become an increasingly common and important aspect of hospital operations. In their article Making Joint Ventures Work, published March 2009 in H&HN, authors Michael Abrams, M.S., Managing Partner, and Mark T. Morgan, M.S.(R), Senior Analyst, discuss ways to structure these partnerships to the advantage of both parties.

Partnering with physicians in a free-standing clinic is often an ambivalent proposition for a hospital. In most cases, the clinic will cannibalize the hospital’s existing business, siphoning off some of the most profitable cases. But since the clinic is likely to find backing even without the hospital, and physicians have so much control over where procedures are done, partnership is often the reluctant choice.

However, joint venturing offers significant opportunities for what is, in effect, product development – if the hospital is able to properly structure and utilize its participation. The authors explain how the joint venture situation can be used to benefit both parties as a test bed for new operational and clinical models, and to give the hospital an important competitive edge.

March 2009  -  NAI PUBLISHED IN PHARMA EXEC

Increased portfolio and market complexity have created additional pressure for product managers to truly understand their markets. In their article Capitalizing on Strategic Market Insight, published March 2009 as a PharmaExec web exclusive, authors Mark T. Morgan, M.S. (R), Senior Business Analyst and Rita E. Numerof, Ph.D., President, offer insights into the specific challenges of strategic product management in a global market, the kinds of data that will be required to meet them, and how to obtain that data.

As portfolios have become more complex, and markets have become increasingly diverse, the ability to strike an optimal balance between global brand concerns and responsiveness to local competitive forces at the product level has suffered. The authors discuss the need to develop "strategic market insights", which provide the foundation for portfolio-level decision-making across global markets. The authors describe what strategic market insights are, how they are developed, how they are used to segment markets and position products, and how they help an organization maximize the value of its brands.

February 2009  -  NAI PUBLISHED IN MX: BUSINESS STRATEGIES FOR MEDICAL TECHNOLOGY EXECUTIVES

Success in the dynamic and increasingly cost-conscious healthcare environment today requires medical device companies to fundamentally rethink the way they position their products. Critical to success is the need for companies to understand how their products contribute to improved clinical outcomes and better economic value. In their article Economic and Clinical Value: Key Drivers for New Product Development, published February 2009 in MX: Business Strategies for Medical Technology Executives, authors Jill E. Sackman, DVM, Ph.D., Senior Consultant and Rita E. Numerof, Ph.D., President, offer guidance on the strategic approach needed to incorporate economic and clinical value considerations into product strategy and the product development process.

The cost for medical device companies of not having the right economic and clinical value proposition can be high. With new federal mandates for demonstrated comparative clinical effectiveness and a global focus on healthcare cost containment, having compelling economic and clinical data with which to approach payers will play an increasingly critical role in products’ commercial success.

Using real-life examples, the authors illustrate best practices in incorporating the development of an economic and clinical value case into product development. Based on their extensive consulting experience, they provide guidance as well on building economic and clinical value considerations into critical product development and commercialization processes.

February 2009  -  NAI PUBLISHED IN ANIMAL PHARM

Faced with an unprecedented set of challenges on a variety of fronts from rising R&D costs, elevated demands from consumers for improved safety, the overall economic downturn, animal health companies more than ever need to be attentive to how they can extend the life of their brands. In their article Strategic Ways to Prevent the Death of a Brand, published February 2009 in Animal Pharm, authors Jill E. Sackman, DVM, Ph.D., Senior Consultant and Rita E. Numerof, Ph.D., President, offer guidance on strategic approaches to intelligently managing product life cycle and extending the profitability of products.

All products move through predictable stages in the product life cycle. Although commoditization is inevitable, it can be managed intelligently and doesn’t necessarily mean the death of a brand. Many product managers face commoditization by pouring resources into advertising, but they rarely see a meaningful return on investment. In specific terms, the authors discuss how to build business strategy capable of sustaining a product’s value proposition and minimizing commoditization, as well as successful tactical approaches to lengthening a product’s profitable life span.

February 2009  -  NAI PUBLISHED IN PM360

Facing growing pressure from payers and other stakeholders, pharmaceutical and medical device companies are increasingly challenged to demonstrate the value proposition of their products. In their article Economic and Clinical Value as Marketing Strategy, published February 2009 in PM360, authors and Rita E. Numerof, Ph.D., President, and Stephen E. Rothenberg, J.D., Business Analyst, offer guidance on the strategic approach needed to incorporate economic and clinical value considerations into product strategy and the product development process.

Companies increasingly face rising product development costs and greater pricing sensitivity. At the same time payers are demanding clinical and health economic data before agreeing to reimbursement at premium, or even par levels. The authors discuss problems with the traditional marketing approach in today’s environment and the type of change needed. In concrete terms, the authors describe the key elements, competencies, and new capabilities required to successfully develop products that meet unmet needs and provide real value.

January 2009  -  NAI PUBLISHED IN PM360

The traditional model of brand management is unraveling. Payers are assuming increasing control over access to the playing field. Patient consumers are becoming more involved in healthcare choices and decision-making. As a result, healthcare decisions and strategies are revolving around maximizing the tangible benefits of superior outcomes while minimizing cost implications. In their article It Takes a Real Value Proposition to Build Brand Loyalty, published in the December 2008 edition of PM360, authors Bill Ott, Senior Consultant, and Rita Numerof, President of Numerof & Associates, Inc. contend that in this environment, brand strategy that does not have economic and clinical evidence as its centerpiece is fatally flawed.

Significant effort and money are used to build and sustain brand identity. Executives who are serious about building brand loyalty in the new healthcare marketplace must go beyond simple tweaks to marketing tactics. The authors highlight how several business functions and processes can play critical roles as an organization develops differentiated economic and clinical value propositions that earn payer, practitioner and patient loyalty.

January 2009  -  NAI PUBLISHED IN ANIMAL PHARM

Jill E. Sackman, DVM, Ph.D., Senior Consultant, Stephen E. Rothenberg, J.D., Business Analyst, and Rita E. Numerof, Ph.D., President, discuss the blockbuster model’s development in the animal health industry and its current painful evolution in Breaking out of the Blockbuster model in Animal Health, published in Animal Pharm, January 2009.

It’s become increasingly clear that despite its past successes, the animal health industry faces serious challenges, such as rising product development costs and greater pricing sensitivity, even as the animal health market , especially the companion animal segment, continues to grow. The animal health industry now faces issues which are remarkably similar to human pharmaceutical companies. The authors discuss why the blockbuster model is failing, and the likely next evolutionary step. They offer strategic guidance for animal health companies regarding how to best navigate changing market realities, and the competencies that will be essential for success.

January 2009  -  NAI PUBLISHED IN EYE FOR PHARMA

The pharmaceutical industry is in the midst of a gathering storm in which rapidly changing global forces are challenging even the most successful companies to adapt their business models and rethink their strategic positioning. In their article Real Strategic Marketing: Managing in a Turbulent Market Environment, published January 5, 2009 in Eye for Pharma, authors Bill Ott, M.B.A., Senior Consultant, and Rita E. Numerof, Ph.D., President, elaborate on the strategic marketing issues challenging executives and offer insights and guidance culled from years of strategic management work with clients.

In the face of a such adversity, the challenge for executives is to maximize the performance of today’s business, while laying the groundwork for strategic marketing to reinvent, reinvigorate and reposition their strategic business approach in order to fuel future growth. Winners in this contemporary market storm must develop a strategic marketing capability to identify new "white space" opportunities and enable growth platforms -- which may fly in the face of convention. Real Strategic Marketing is a framework for executive leadership teams to identify and operationalize the strategic opportunities hidden beneath the surface of today’s emerging market challenges.