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Articles
11.11: In Vivo
Next Generation Combination Therapy in Oncology
Contributing Authors: Aidan Finley, Consultant; Vivek Mittal, PhD, Manager
Traditional cancer development in the 1970s and 1980s focused on individual druggable targets and combinations were
developed empirically post-approval. In the new age of molecular medicine, this incremental empiricism is no longer
acceptable to patients, physicians, and payers. Drug developers need to seize upon the FDA's combination therapy
guidance to accelerate the development of rational combinations.
Health Advances outlines how achieving this new future in cancer therapy will require evolution in drug
development, with better and earlier collaborations between developers, clinicians, and regulatory
agencies. Companies will need to seek partnerships or strategic licensing early in development, and
business development professionals will need to work closely with research and development to identify
and fill pipeline gaps.
The recent launches of Xalkori and Zelboraf demonstrate the real world benefits of both companion
diagnostics and the potential for rational combination therapy. However, the real revolution in
cancer care will occur when clinicians can prospectively identify the right combination of these
agents for their patients, and fortunately these trials are actively enrolling now.
Along with this article, Aidan has authored a summary post on Elsevier's In Vivo Blog.
 read the article (PDF498KB).
read Aidan's post on the In Vivo Blog.
learn more about our expertise in oncology.
02.11: In Vivo
Oral Molecules in an Injectable World: What Developers Need to Do Now
Contributing Authors:
Andrew Funderburk, Vice President; Kimberly Howland, Vice President; Kate McLaughlin, Consultant
Therapeutic areas currently dominated by injectable or infused therapeutics are beginning to see competition from oral
therapies intent on taking market share because of their perceived delivery advantages. However, the head starts enjoyed
by injectables in these markets – and the physician, payer, and patient familiarity they create – translate into higher
efficacy and safety hurdles for oral therapies. Oral delivery is not without downsides – including poorer compliance and
reimbursement challenges in specialty markets dominated by injectable competitors. Companies willing to face these issues
head-on and engage constituents early about the drawbacks and advantages of their new oral agents can fully realize the
value of their therapies.
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learn more about our work in product postioning.
01.11
The Reimbursement Landscape for Novel Diagnostics: Current Limitations, Real-World Impact, and Proposed Solutions
Contributing Authors:
Kristin Pothier, Partner; Gary Gustavsen, Associate; Kerry Philips, Senior Analyst with support from BIO
Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare
system through personalized medicine is to deliver the right treatment to the right patient at the right time. Novel
diagnostics hold great promise as tools that allow physicians to differentiate patient-specific characteristics, design
personalized treatment approaches, and ultimately improve patient outcomes. The successful delivery of novel diagnostics
is the foundation of personalized medicine in our evolving healthcare system.
However, the success of personalized medicine is dependent on the healthcare industry's ability to overcome several
clinical, economic, and logistical challenges to commercialization. Some of the most pressing challenges relate to
the reimbursement system, specifically in obtaining affirmative coverage, appropriate coding, and value-based payment
for novel diagnostics.
The current reimbursement system was designed to support relatively simple diagnostic tests that formed the basis
of the traditional diagnostics industry. The system was not designed to support novel complex diagnostics, and
research suggests that its shortcomings are compromising the progress of personalized medicine today. This report
offers stakeholders a clear description of the current reimbursement system, its limitations, and an examination
of how these limitations impact investment in novel diagnostics and may ultimately impede patient access to
personalized medicine. Finally, this report offers a critical exploration of potential solutions for reform.
read the report now (PDF: 1.8MB).
request a paper copy of the report.
read BIO's press release.
learn more about our expertise in diagnostics.
11.10: In Vivo
Continuous Glucose Monitoring: A Case Study for Commercializing Products in the Era of Patient-Driven Health Care
Contributing Authors:
Marie Schiller, Partner, Sheela Hegde, Vice President, and Brittany Carroll, Associate
While continuous glucose monitoring offers significant value to a broad range of patients, the technology has
still not fulfilled its market potential. Many hurdles to adoption still exist including product accuracy issues,
ease-of-use hurdles, and insufficient payer coverage. However, for patients who have successfully built CGM into
their therapeutic plan, the results have been impressive. So why is a technology that can have such a meaningful
impact on some individuals gaining traction so slowly?
Continuous glucose monitoring presents an example of how an individual product has far less value than the integrated
solution the technology enables. The greatest obstacle in CGM is the disconnect between CGM and treatment planning;
CGM produces mounds of data that patients and even physicians don't know how to use. If this powerful dataset could
be optimized, shared, and applied, it could shift CGM from a niche product for a small number of type 1 diabetes
patients into a standard of care for many metabolic diseases.
Such a shift, however, will require changes in the mindset of product companies. Traditional commercialization strategies
involve driving discrete products and maximizing product value through lifecycle enhancements. In a new patient-driven system,
alternative strategies to develop a broader solution to treatment planning will capture new sources of value.
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learn more about Health Advances' expertise in diabetes.
09.10: Point-of-Care Journal
Has Point-of-Care Come of Age?
Contributing Authors:
Health Advances: Kristin Pothier, Vice President and Sonia Gupta, Former Consultant
LipoScience: Mark Kirtland, Vice President of Strategy and Business Development
The prospect of point-of-care (POC) testing, enabling near immediate diagnosis and subsequent
treatment, has been alluring to clinicians for years. Science and technological progression, evidence
based clinical and economic drivers for POC use, and the current health care system's demand for
streamlined options suggest that POC products should be instrumental in today's diagnostic paradigm.
Nevertheless, relatively few POC tests have attained commercial success. The article reviews the
current barriers to the use of POC, the emerging success factors, and the evolving future of this space.
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learn more about Health Advances' expertise in diagnostics.
04.10: Future Medicine Journal
Advocacy in Personalized Medicine: A Developing Strength in a Complex Space
Contributing Authors:
Health Advances: Kristin Pothier, Vice President and Michael Dunn, Senior Analyst
bioMérieux: Iain Miller, Senior Director, Oncology Strategy and Theranostics Business Unit
Multiple stakeholders play a role in the adoption of personalized medicine, including payers, patients,
policy makers, diagnostic manufacturers and providers, and clinicians. These stakeholders span multiple
positions, institutions and points of view, and are interested in making sure that each diagnostic launch
covers a particular, sometimes contradictory, market need. A growing number of advocacy groups have emerged
to unify these stakeholders in this increasingly complex marketplace. This article identifies examples of
these advocacy efforts in personalized medicine today. It discusses how far these groups have been able to go,
what they are currently pursuing, and how they and others can continue to work to move personalized medicine
from concept to reality.
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learn more about Health Advances’ expertise in diagnostics
03.10: IVD Technology Magazine
Manufacturing Obstacles in IVD Product Development —
Perspectives from Health Advances and KMC Systems Inc.
(an Elbit Systems of America company)
Contributing Authors:
Health Advances: Donna Hochberg, Ph.D., Manager
KMC Systems: Walter Gilde, Business Development Manager
With the IVD market changing rapidly, the pressure to deliver new products to market less expensively and more
efficiently is mounting. The changes in the IVD industry are being driven by increased laboratory test volumes
and growing pressure to lower turnaround times (TAT) with fewer skilled lab technicians. Any new product launch
must be able to address this demanding environment. Such sweeping demands in the industry are accelerating the
development of three specific areas of advancement: point-of-care (POC) technologies, automation, and graphical
user interfaces. To reduce costs and shorten product development cycles, some OEMs and start-up companies have
been turning to contract instrument developers and manufacturers for their guidance and relevant experience to
overcome common development challenges. This article will examine these trends, outline common obstacles
associated with them, and discuss how working with contract partners can overcome product development challenges
by showing examples of instruments that were introduced to the market with the help of a contract partner.
Also available is an audio discussion with Donna Hochberg and Walter Gilde.
request a reprint.
listen to discussion (mp3).
learn more about our expertise in Diagnostics.
01.10: Medical Device & Diagnostic Industry Magazine
Medical Devices Deserve More Respect
By Mark Speers, Partner and Managing Director, Susan A. Posner, Vice President, and Jennifer Kim Cutie, MD, Professional Development Manager
Should devices be considered earlier in the treatment paradigm? Devices are often reserved for patients who have
already failed multiple drug therapies, but in some cases, devices may ultimately provide better long-term outcomes
more cost-effectively than drugs. In order to pursue these opportunities, manufacturers must effectively develop
technologies that can surmount traditional therapeutic hurdles, including physician perceptions of drugs and devices
and the short-term payer outlook. Health Advances Medtech Practice Group shares their insights on the potential
paradigm shift that would move devices to an earlier position in the treatment pathway, potentially expanding the
market opportunity for devices and the medtech industry.
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10.09
Maintaining Attractive Biopharma Returns in the Face of Healthcare Reform —
Perspectives from Health Advances and Cowen Healthcare Royalty Partners
Contributing Authors:
Health Advances: Marie Schiller, Sheela Hegde, Kerry Phillips, and Urvesh Shelat
Cowen Healthcare Royalty Partners: Greg Brown M.D., Paul Hadden, and Wendy Liu
Healthcare reform is the Obama Administration’s top domestic priority. Although the Administration’s original
goal was to have a reform bill passed in October, it now appears that a final vote will not take place before
December. The rigorous debates have focused on three key components: access to care, cost of care, and value of
care in the US healthcare system.
Investors are grappling with how these three components of reform will affect the favorable returns
traditionally captured in the biopharma sector – a sector that is already feeling pressure from patent
expirations, fewer drug approvals, and growing development costs. Biopharma executives are working hard to
influence the path that the government takes and are seeking solutions that will offset both top-line and
bottom-line pressure created by cost containment measures.
So what can be done by biopharma companies? In addition to reducing costs through traditional means,
biopharma will need to change fundamental elements of its business model and adopt new solutions. Examples include
participating in follow-on biologics, integrating products as part of larger healthcare solutions, sharing risk with
payers, prioritizing personalized therapies, and continuing to work on reducing overall R&D and promotional expenditures.
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09.09: Medtech Insight
Value Proposition is Key to New Product Success in a Cost-Conscious Medtech Market
By Susan A. Posner, Jennifer Kim Cutie, MD, and Anna Chen
Management teams are well aware of the need to demonstrate compelling economic data, but can a product still be successful
without an economic benefit in the increasingly cost-conscious health care marketplace? Overcoming negative economics requires
a combination of positive attributes; many compelling advantages like clinical or safety benefits are well-known, but other key
attributes may be overlooked. Recognizing all of these potential advantages is crucial for appropriate planning to compile relevant
data and position the product accordingly, thereby optimizing product success. Health Advances Medtech Group shares its thoughts
and observations on current products that have overcome negative economics, highlighting the keys to their success and lessons
learned for emerging products.
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03.09: In Vivo Magazine
How to Earn the Economic Payback Diagnostics Companies Deserve
By Gary Gustavsen and Kristin Pothier
For most diagnostics companies, the prospect of premium pricing has been an evasive
dream. The health care landscape is peppered with expensive novel drugs priced to
underscore their clinical impact on patient care. A similar strategy for pricing
novel diagnostics with significant clinical impact makes sense, especially since
many of them are driving the decisions to deploy novel drugs in the first
place. But logic has only recently translated into reality for most novel
diagnostics. The existence of an antiquated CPT code system which bases
reimbursement for diagnostics largely upon the cost of their underlying
laboratory procedures, rather than on their benefit, made for a slow
start. In addition, many diagnostic companies did not fund studies to
document their products' ability to affect clinical outcomes. However,
strong system economics arguments are becoming more mainstream and payers
are beginning to reward companies with reimbursement of their premium priced
tests. Rewards are based upon rigorous clinical arguments supporting the
diagnostics' benefits to clinical decision-making and compelling economic
arguments customized to each major payer. Identifying and documenting these
arguments for each product is the key to attaining sustainable premium
pricing in diagnostics.
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12.08: Start-Up Magazine
Will Simpler Devices Tap the Largest Diabetes Market?
By Marie Schiller, Andrew Funderburk, Sheela Hegde, and Kathryn Strayer-Benton
Historically, technological advances to the insulin pump market have concentrated on slow but
steady improvements to the pump's functionality, size and design. What the market hasn't yet
experienced are dramatic improvements that would embrace the needs of both type 1 and type 2
diabetes patients while keeping costs low. This may be changing as companies expand their focus
on developing simpler, lower cost insulin pumps that will benefit a broad spectrum of diabetes
patients and providers. Health Advances Diabetes Practice Group shares its thoughts on the push
to move insulin pump therapy into the larger type 2 diabetes population and some of the hurdles
that will need to be overcome.
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09.08: MX Magazine
Taking the High Road: Building the Right Foundation for a Medtech Product Launch
By Mark Speers, Managing Director and Partner, and Susan Posner, Vice President; Health Advances
Many companies launch products onto the medtech market concurrent with their initial FDA approvals in an effort
to realize revenue as soon as possible. Delaying a market launch may seem counterintuitive, however having the fortitude
to delay revenue may lead to far greater returns. Executives must be careful to differentiate between their regulatory and
commercialization strategies. Each device company should carefully consider whether it has amassed the critical clinical
and/or economic data necessary to catalyze purchase decisions by physicians and payers before launching. The article describes
an analytic approach to optimizing the commercialization plan including launch timing.
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01.08: InVivo Magazine
Biomarker Diagnostics: Place Your Bets Wisely
By Kristin Pothier and Donna Hochberg; Health Advances
Biomarker diagnostics are critical to achieving the promise of personalized medicine.
Unfortunately, building a successful business around such tests is difficult, given
the complexities associated with both their development and commercialization.
Many biomarkers present the risks of drug development and only the profitability
of devices. Therefore, molecular diagnostic companies need to think carefully before
they choose a "go it alone" strategy. It may make far more sense to forge a partnership
with another diagnostic company or a drug developer with the goal of sharing costs, risks and profits.
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Tools
Proprietary Diabetes Forecasting Tool
For the past 17 years, Health Advances has analyzed the diabetes market and developed sophisticated product forecasts for its clients. Our work has consistently demonstrated that developing accurate product forecasts in diabetes is more complicated than in other therapeutic areas. Specific factors that make this process more challenging include:
- Prevalence is growing due to increases in both incidence rates and survival rates
- Age at diagnosis and rate of disease progression are highly variable
- Mortality is not directly linked to stage of disease
- Treatment paradigms are shifting
- Penetration varies by specialty
request more information.
learn more about Health Advances' focus on Diabetes.
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