Industry Briefings

Scientia Industry Briefings is a collection of compelling articles on life science and healthcare industry trends and topics.

Briefings can be accessed through this website. They are authored by Scientia Advisors experts and cover all of our areas of expertise.

Managing the Diabetes Epidemic
by Patrick Terry
Related to: Medical Devices

As global populations gain affluence, the incidence rates of diabetes have soared. The disease is segmented into two types. Type 1 diabetes mellitus is an organ-specific autoimmune disease that destroys insulin-secreting beta cells by immune-mediated inflammation. Type 2 diabetes mellitus is a metabolic disease. Both are characterized by insufficient insulin production.

People with type 2 diabetes are at high risk of developing a plethora of additional diseases, including cardiovascular disease, renal disease, peripheral vascular disease, nerve disease, neuropathic pain, erectile dysfunction, skin ulceration, cataracts and cirrhosis, as well as increased risks from falls, bone fractures and cognitive decline . Currently, more than 170 million people throughout the world have developed diabetes (type 1 and 2 combined), and that number is expected to more than double by 2030. In the U.S., the cost of treatment was estimated at $174 billion in 2007. As the burden grows, existing models of the disease and management assumptions are being challenged.

Achieving the Holy Grail of T1DM Treatment
by John McNamara
Related to: Medical Devices

The New Battleground For Novel Diabetic Agents: Incremental Cost-Effectiveness Ratio
by Jeff Stoll
Related to: Therapeutics

Growth Opportunities: Managing Diabetes via Nutrition
by Bob Jones
Related to: Nutrition and Wellness

• Many food companies are struggling to find areas of growth
• Diabetes is a huge national health problem, growing at an epidemic rate
• Proper nutrition can play a major role in successfully managing diabetes

Developing and Commercializing Companion Diagnostics
by Aruna Rajan, Michael Jacobson, Kerry Xie and Harry Glorikian
Related to: In Vitro Diagnostics

Sequencing Trends Worth Watching: Commercial Potential of Technology Demands that Industry and Investors Alike Stay Up to Date
by Brian Clancy and Harry Glorikian
Related to: Life Sciences Tools and Technologies, In Vitro Diagnostics, Healthcare Trends

FDA's Guidance Could Disrupt Product Development, Patient Care, and Billions of Dollars in Investment
by Patrick Terry, Harry Glorikian, and Santosh Kuruvilla
Related to: Healthcare Trends

Scientia Advisors' Patrick Terry, Principal, Harry Glorikian, Managing Partner and Santosh Kuruvilla, Senior Analyst, published a blog titled "FDA's Guidance Could Disrupt Product Development, Patient Care, and Billions of Dollars in Investment."

Can an FDA Frequently Asked Questions (FAC) document be a game changer for industry? The recently introduced "Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions" may be a case in point. It is the latest in a line of documents that could profoundly affect a number of industry stakeholders, but were introduced without the formal and more thoughtful regulatory development process.

In this post, the authors provide an evaluation of the FDA's Frequently Asked Questions document and the potential implications it may have on clinical diagnostics developers, applied translational medicine enterprises, and even established patient care.

This post can be accessed on the Scientia Advisors blog.

For the full presentation on the Stakeholders Involved with FDA's Guidance, download below.

Pricing and Reimbursement: Knowing Your Value up Front is Key to Future Dealmaking

Related to: Healthcare Trends

Scientia Advisors' Patrick Terry, Principal, is featured in partneringNEWS --June 14, 2011 issue-- with an article titled "Pricing and Reimbursement: Knowing you value up front is key to future dealmaking."

As a result of today's evolving healthcare market, a new strategy is needed to evaluate pricing and reimbursement. Companies must determine viability in the market to ensure that their life science ventures will not fail. Such ventures must be scrutinized with realistic, fact-based information at the early stages of the product development cycle for their impact on payers' top and bottom lines in terms of:

• Factors of market access
• Pricing
• Reimbursement challenges

In this article, Patrick Terry presents a clear and practical approach that life science companies should take and concludes that a full understanding of one's value proposition will prevent situations from occurring in which potential partners drop out of a deal based on poor evaluations.

This article can be accessed on the parteneringNEWS website here.

Demand Escalates for iPSC Life Science Tools: Induced Pluripotent Stem Cells Prove Invaluable in Toxicity and Drug Efficacy Screening
by Lisa Carey and Michael Tapella
Related to: Therapeutics, Life Sciences Tools and Technologies

Scientia Advisors' senior analyst Lisa Carey and senior associate Michael Tapella, are featured in the May 15th, 2011 issue of Genetic Engineering & Biotechnology News with an article titled:"Demand Escalates for iPSC Life Science Tools: Induced Pluripotent Stem Cells Prove Invaluable in Toxicity and Drug Efficacy Screening."

A persistent issue for the pharmaceutical industry is the high failure rate of compounds in clinical development due to low efficacy and safety issues. Since 2006, researchers have created a solution to this problem based on cell lines known as induced pluripotent stem cells (iPSC) that have been reprogrammed to have embryonic stem cell-like properties. The benefit of iPSC method is that iPSCs are derived from nonembryonic tissue, providing opportunity for a more ethically sound approach. Although offering a clear benefit, few companies have yet to commercialize cell lines derived from iPSCs because o uncertainties on how to license or protect their intellectual property.

In this article, the authors explore the commercial opportunities along the iPSC value chain for the pharmaceutical industry and the associated risks, and conclude that, due to high demand for iPSC life science tools, a unique business opportunity exists for companies looking to commercialize iPSCs.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Do Companion Dx Make Economic Sense? Extensive Survey Identifies Four Different Scenarios and Just as Many Answers
by Amit Agarwal
Related to: In Vitro Diagnostics

Amit Agarwal of Scientia Advisors is featured in the April 15, 2011 issue of Genetic Engineering & Biotechnology News with an article titled: "Do Companion Dx Make Economic Sense? Extensive Survey Identifies Four Different Scenarios and Just as Many Answers"

As medical care moves toward the ideal of personalized medicine, companion diagnostics have emerged as critical tools enabling identification of patient sub-segments for drug treatment --and diagnostics have led to multibillion dollar sales of drugs such as Herceptin and Gleevec. However, the question remains whether companion diagnostics make economic sense in all circumstances for drug developers. Based on an extensive survey of all drugs on the U.S. market that are labeled for companion diagnostics, Scientia Advisors has isolated four scenarios that demonstrate how companion diagnostics impact sales of drugs.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Data Sharing - Power to the People: Participant Ownership of Clinical Trial Data
by Patrick Terry
Related to: Therapeutics, In Vitro Diagnostics, Healthcare Trends

Patrick Terry, Principal at Scientia Advisors, is featured in Science Translational Medicine with a commentary on Participant Ownership of Clinical Trial Data.

Participation in clinical trials is dismally low. In this age of electronic sharing of information of all sorts, trial participants can easily share clinical trial data. In this article, the authors weigh the benefits of participant ownership and sharing of trial data against the risks, and conclude that the time has come to crowd-source data for diagnostic and therapy development.

The article can be accessed by subscribers only on the Science Translational Medicine website.

Companion Diagnostics - A perfect storm
by Harry Glorikian, Kerry Xie and Jonathan Pan
Related to: In Vitro Diagnostics

Harry Glorikian, Kerry Xie and Jonathan Pan of Scientia Advisors are featured in the January-February 2011 issue of European Biotechnology News with an article on companion diagnostics and the complexity of the personalized medicine environment.

Over the last few years, there has been a tremendous amount of interest in the idea of personalized medicine. Using diagnostic insights to improve the quality and efficiency of healthcare delivered to patients has become a mainstay theme in the field. While diagnostics have long been a part of the physician's armament, we are beginning to see a keen level of excitement mounted by pharmaceutical companies that has been reflected in the increasing number of deals between pharmaceutical and diagnostic companies over the past few years. In addition to these current stakeholders, nontraditional players are emerging who are bringing added complexity to the personalized medicine environment. Entities such as pharmacy benefit managers, hospitals, health IT companies and next-generation sequencing technologies are beginning to become important contributors.

In this article, the authors analyze the movements of current and emerging stakeholders into this dynamic growth environment that is creating what Scientia Advisors calls the "Perfect Storm."

The article can be accessed on the European Biotechnology News website.

Point-of-care testing key to widespread access to healthcare
by Harry Glorikian, Aruna Rajan and Kerry Xie
Related to: In Vitro Diagnostics

Harry Glorikian, Aruna Rajan and Kerry Xie of Scientia Advisors are featured in the January 2011 issue of Medical Laboratory Observer with an article on point-of-care testing/tests (POCT).

Decentralization of healthcare is a major trend impacting the delivery of in vitro diagnostics and is driving the need for POCT. With fast turnaround times (TAT) and portability to a variety of settings, POCT offers many advantages for disease management and will be an important enabler of remote health monitoring.

In this article, the authors review the key benefits of POCT, analyze its current limitations to widespread adoption, and explain what will be the key driver toward POCT acceptance.

The article can be accessed on the Medical Laboratory Observer website.

Regen Medicine Prepares for Growth Spurt - Novel Business Models, Emerging Players, and Transformative Products Starting to Have Impact
by Arshad Ahmed, Michael Tapella
Related to: Life Sciences Tools and Technologies

Scientia Advisors' analyst, Michael Tapella, and partner, Arshad Ahmed, are featured in the November 1st, 2010 issue of Genetic Engineering & Biotechnology News with an article titled: "Regen Medicine Prepares for Growth Spurt - Novel Business Models, Emerging Players, and Transformative Products Starting to Have Impact"

The regenerative medicine industry is likely to change over the next 10+ years as numerous novel cell-based therapies enter the market and address unmet medical needs. If some of these therapies reach their promise, we are likely to see dramatic changes in the management and treatment of certain chronic diseases and significantly lower overall healthcare costs. These innovations have considerable implications for traditional players in the pharmaceutical and medical-device industries -particularly regarding current business models and market approaches.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Biomanufacturing Operations on Upswing - Biosimilars and Pharma's Growing Interest in Biologics Keep Manufacturing Plants Humming
by Amit Agarwal, Michael Omartian
Related to: Therapeutics

Scientia Advisors' analyst, Michael Omartian, and partner, Amit Agarwal, are featured in the October 1st, 2010 issue of Genetic Engineering & Biotechnology News with an article titled: "Biomanufacturing Operations on Upswing - Biosimilars and Pharma's Growing Interest in Biologics Keep Manufacturing Plants Humming"

While the bioproduction market has been posting solid growth for years driven by increasing sales of biological products, chemically synthesized therapeutics are expected to see flat-to-declining revenues in the same time period. In this article, Scientia experts discuss the trends from in-house biomanufacturing to outsourcing, the resulting market opportunity for contract manufacturing organizations, and the impact of biosimilars on the bioproduction market. The big question is: will biosimilars remain minor entrants or will they take the vast majority of product volume from the branded products?

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Scientia Authors Article for PAREXEL's Bio/Pharma R&D Statistical 2010/2011 Sourcebook
by Amit Agarwal and Jonathan Pan
Related to: In Vitro Diagnostics

Scientia Advisors' partner, Amit Agarwal, and senior associate, Jonathan Pan, co-authored an article, entitled "Theranostics and Already Approved Drugs: What You Don't Know Can Hurt You," published in PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2010/2011, a leading industry resource. The article describes the situation that led the US Food and Drug Administration (FDA) to require warning labels and recommend diagnostic testing for the blockbuster drug Plavix more than 10 years after the anti-thrombotic hit the market. Plavix is marketed by Bristol-Myers Squibb (BMS) and Sanofi-Aventis to prevent myocardiofaction (MI) or strokes.

As a result of the FDA diagnostic testing recommendation, the authors project that by 2012, BMS and Sanofi-Aventis will lose $450M to $575M in sales in the US alone— and more if regulators in other nations add requirements. Other drugs, prescribed in conjunction with Plavix, will also most likely be impacted. Agarwal and Pan recommend a number of actions that pharmaceutical executives can take to mitigate such potential post-launch losses.

Scientia is one of the few global management consulting firms to be published in the PAREXEL Sourcebook, due to its thought leadership within the healthcare industry. The article is available in the PAREXEL Sourcebook 2010/2011 at Barnett Educational Services.

Treating T2DM with Early Insulin Therapy - Lack of Comprehensive Patient Education Has Stymied Adoption of Beneficial Treatment Option
by Amit Agarwal and John McNamara
Related to: Therapeutics

Scientia Advisors' analyst, John McNamara, and partner, Amit Agarwal, are featured in the May 1st, 2010 issue of Genetic Engineering & Biotechnology News with an article titled: "Treating T2DM with Early Insulin Therapy - Lack of Comprehensive Patient Education Has Stymied Adoption of Beneficial Treatment Option"

Traditionally viewed as a primarily Western disease, diabetes is becoming a global threat. While early insulin use to treat diabetes has the potential to greatly improve patient outcomes, adoption has thus far been minimal. In this article, Scientia experts discuss the inadequacy of current treatments, analyses hurdles to insulin adoption and explain how novel, low-cost insulins, combined with patient education, will not only temper the devastating effects of T2DM on developing countries, but also usher in a hugely disruptive force in the treatment algorithm for the disease.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Cell Biology Market Shows Resilience
by Johann Maradey, Lisa Carey, Harry Glorikian
Related to: Life Sciences Tools and Technologies

Scientia Advisors' analysts, Johann Maradey and Lisa Carey, and managing partner, Harry Glorikian, are featured in the March 15, 2010 Issue of Genetic Engineering & Biotechnology News with an article titled: "Cell Biology Market Shows Resilience - Segment Encompasses a Plethora of Critical Tools from Petri Dishes to Robotics for HCS."

In the life science world, there has been a strong focus on next-generation sequencing and the $1,000 genome. The excitement in this arena should not be taken lightly; however, other segments of this market are also noteworthy. Cellular biology, for example, has demonstrated strong, sustained growth despite the sour economy. This article discusses the key growth drivers of cellular biology, including government funding, changing pharmaceutical R&D philosophy that spurs advancements in promising areas such as cell-based assays, and increasing R&D presence in emerging economy.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Prepared Foods Exclusive: No Functional Fad
by by Bob Jones
Related to: Nutrition and Wellness

Scientia Advisors' Principal, Bob Jones, is featured on Prepared Foods Network with an article titled: "Prepared Foods Exclusive: No Functional Fad"

Foods fortified with nutritional ingredients that target specific health conditions are invigorating the U.S. food industry. These functional foods represent a growing segment within the foods and beverages industry, and many wonder, "Is this just a fad, or is it a sustainable business?" This is definitely not a fad; it is the early stage of a movement that is here to stay. In this article, Bob Jones analyzes key growth drivers and briefly answers the following questions: Which Segments Will Grow the Fastest? How's the Science? Is There Anything to Look out for?

The article can be accessed on the Prepared Foods Network website here.

Influenza Scare Not the Only Vaccine Driver - Novel Production Methods, Emerging Markets, and Improved Adjuvants Also Promoting Growth
by Harry Glorikian, Managing Partner & Santosh Kuruvilla, Analyst
Related to: Therapeutics, Healthcare Trends

Scientia Advisors' managing partner, Harry Glorikian, and analyst, Santosh Kuruvilla, are featured in the Dec 1, 2009 Issue of Genetic Engineering & Biotechnology News with an article titled: "Influenza Scare Not the Only Vaccine Driver."

While fears about influenza pandemics and the associated swine flu have brought the seasonal flu vaccine industry into the media spotlight recently, it is important not to overlook the other areas in the vaccine market that may also be poised for tremendous growth in the coming years. This article discussed new health initiatives in the world's emerging economies, technological developments that will significantly advance the way in which vaccines are produced, and the introduction of therapeutic vaccines aimed at treating patients with specific conditions.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Preparing for a Successful Launch
by Bob Jones, Principal, Scientia Advisors
Related to: Nutrition and Wellness

Scientia Advisors' principal, Bob Jones is featured in the November 2009 Issue of Natural Products Insider with an article titled: "Preparing for a Successful Launch."

In this article, Bob Jones reviews key questions that must be answered before launching a new dietary supplement. While more questions should be addressed, the following three have a considerable impact on the probability of success: How motivated is the customer to fix the problem this product solves? How much will the customer see or feel the benefit from this product? How likely is it that your consumer will take your product daily, rather than episodically?

The answers can be accessed on the Natural Products Insider website here.

The Underappreciated Cost-Saving Potential of Personalized Medicine in Health Reform Debate:
The current draft includes comparative effectiveness research but does not provide nearly as much funding as is needed for CER.
by Harry Glorikian, Managing Partner, Scientia Advisors &Brian Clancy, Senior Analyst, Scientia Advisors
Related to: In Vitro Diagnostics, Healthcare Trends

Scientia Advisors' managing partner, Harry Glorikian, and senior analyst, Brian Clancy, are featured in the Oct 8 2009 Issue of Genetic Engineering & Biotechnology News with an article titled: "The Underappreciated Cost-Saving Potential of Personalized Medicine in Health Reform Debate."

The article focuses on the future of personalized medicine in the U.S. The article first highlights the potential for cost savings that personalized medicine through examples such as Genomic Health's Oncotype Dx, XDx's Allomap and Genentech/Roche's Avastin with BG Medicine's test. The article then dives in the recent healthcare reform and how each of the passed and proposed bills are poised to affect the future of personalized medicine.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

Tests to Rapidly Diagnose Sepsis Essential: Diagnostic That Can Quickly Detect Infection Could Speed Treatment and Improve Outcome
by Aruna Rajan, Associate and Harry Glorikian, Managing Partner
Related to: In Vitro Diagnostics

Scientia Advisors' managing partner, Harry Glorikian, and associate, Aruna Rajan, are featured in the Sep 15 2009 Issue of Genetic Engineering & Biotechnology News with an article titled: "Tests to Rapidly Diagnose Sepsis Essential: Diagnostic That Can Quickly Detect Infection Could Speed Treatment and Improve Outcome."

The article focuses on the sepsis market which is currently a major healthcare problem. There are approximately 750,000 cases of sepsis each year in the U.S. and the number is growing. The mortality associated with severe sepsis remains unacceptably high—20 to 50% and when septic shock is present, mortality is even higher—40 to 60%. The article highlights the need in the sepsis market for a diagnostic that can identify patients with sepsis and the emergence of molecular tests which may fulfill that need.

The article can be accessed on the Genetic Engineering & Biotechnology News website here.

US Neurostimulation Market:
An Industry Commentary
by Scientia Advisors
Related to: Medical Devices

The market for neurostimulation devices, which employ implanted electrodes to help treat certain nerve-related disorders, is likely to continue growing at an average rate of 16 percent through 2012-- along with increasing proof of efficacy, physician acceptance, an aging population, and the need for treatments that are quicker, safer and less expensive than drug-based therapies. Neurostimulation devices likely to show the greatest growth are those targeting the deep brain, the spinal cord and the sacral area. While current products are relatively straightforward, opportunities and unmet needs include smaller devices that are easier to use, longer battery life and better feedback mechanisms. Advances in remote patient monitoring, wireless technology, and microprocessor hardware may add complexity and utility, thus adding indications. Scientia recommends that device companies consider developing or purchasing technologies in this growing field.

Scientia Authors Article for PAREXEL 2009/2010 Sourcebook
by Amit Agarwal, Partner and Aruna Rajan, Associate
Related to: In Vitro Diagnostics, Healthcare Trends

Scientia Advisors' partner, Amit Agarwal, and associate, Aruna Rajan, co-authored an article, entitled "The Emergence and Future of Companion Diagnostics: A 2009 Assessment," published in PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010, a leading industry resource. The article identifies future trends in theranostics. Theranostics are diagnostis that are directly linked to a therapeutic and are required before prescription of the drug. Using an expanded definition of theranostics, which includes all types of diagnostics tests, Scientia identified 45 drugs which go far beyond the established oncology theranostics. In addition to the existing drugs, Scientia forecasts significant growth in theranostics in the next five years, based on the presence of commercial diagnostics. In addition to oncology, the article evaluates growth prospects in cardiovascular and infectious diseases. The article also discusses current regulatory trends as well as the existing economics of theranostics. Scientia is one of the few global management consulting firms to be published in the PAREXEL sourcebook, due to its thought leadership within the healthcare industry. The article can be accessed at the PAREXEL website.

Vascular Health: a Business Opportunity?
An Industry Commentary
by Scientia Advisors
Related to: Medical Devices, Healthcare Trends

A number of unmet needs in the vascular market have evaded the attention of many major cardiovascular firms. Consequently, considerable market opportunities exist surrounding these unaddressed needs. In this article, we briefly cover the vascular physiology and associated disorders, and discuss 1) the markets that sell solutions to those problems, 2) the ways in which the current solutions are unsatisfactory, and 3) the opportunities that may be emerging as a consequence of those unmet needs.

Read the full briefing »

Developing Growth Strategy in Turbulent Economics Times
A Prescription for Identifying and Executing on Growth Opportunities in Healthcare
by Arshad Ahmed, Partner, Scientia Advisors, LLC.
Related to: Healthcare Trends

We are going through turbulent economic times. The Dow Jones Industrial Average has fallen 32% from its highs at the start of 2008 while the NASDAQ has fallen more than 40%. In this environment of gloom and doom, most corporate executives have taken prudent measures, by reducing operating costs and conserving cash, to ride out the storm. We have seen major layoffs from a wide array of sectors, including automobiles, consumer products, and even health care. Meanwhile, shareholders and board members of these companies are increasingly confronting the executive leadership with a key question: What does the company do next? Or, more specifically, what is the strategic direction necessary to best navigate the company through these tough times? Any bold strategic move in such a period of economic uncertainty is understandably perceived as being fraught with risks. In such an environment, how does a company make the right strategic move, while removing as much risk as possible? Scientia has designed a structured strategy process to do just that. It is targeted to developing growth strategy in a turbulent environment and facilitates the creation of a strategic direction grounded in hard data, on which all relevant stakeholders can gain consensus and alignment to move a company forward.

Read the full briefing »

The Global Market for DHA and EPA Ingredients for Human Consumption: An Industry Commentary
by Scientia Advisors
Related to: Nutrition and Wellness, Healthcare Trends

With the prevalence of chronic diseases rising and healthcare costs increasing to unsustainable levels, the emphasis on "prevention over cure" is greater than ever before. This trend has prompted consumers to take a more active role in managing their health, with many turning to diet and exercise as a means to do so. In regard to dietary changes, many consumers no longer consume food simply for sustenance; rather, they are seeking to achieve their Recommended Daily Allowance (RDA) of vitamins, minerals, and other nutrients like protein and fiber, in an effort to reduce the risk or delay the onset of a multitude of conditions and diseases with defined dietary linkages. Additionally, the advent of functional foods and beverages, or food and beverage products that confer health benefits beyond basic nutrition through the incorporation or removal of a particular ingredient, has strengthened this trend of personally-managed health and wellness through diet.

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Functional Foods: Challenges and Opportunities
An Industry Commentary
by Scientia Advisors
Related to: Nutrition and Wellness, Healthcare Trends

Functional Foods are defined as "foods and beverages that provide a health benefit beyond basic nutrition." That is,

• They can enhance health and well-being (assist in weight loss, reduce the risk of certain diseases)
• They can enhance performance (either physical/athletic performance or memory/cognitive functions)
• Most importantly, they can help manage a chronic condition (such as diabetes or heart disease)

The majority of consumers believe that diet and nutrition have a huge impact on their health, and consequently, they buy these products as a way to manage their health.

Read full briefing »

Areas of Expertise

I am always impressed with Scientia's knowledge and understanding of life sciences, and their grasp of both the technology and the business realities of the industry. Scientia Advisors is a group that is very creative in coming up with ideas for new business opportunities, partnering solutions and novel strategic directions. And their recommendations are always supported with solid and expansive research and data.

Senior Manager
Major Life Science Analytical Instrumental Company