Friday, October 29, 2010

23 views on the community of physician-scientists

This week, I’ve been referencing some classic medical literature.  Now, there’s a recent title that I’m interested in picking up.

It is The Vanishing Physician-Scientist? edited by Dr. Andrew I. Schafer.

Dr. Schafer is the Distinguished Professor and Chair of the Department of Medicine at Weill Cornell Medical College and Physician-in-Chief at New York Presbyterian Hospital–Weill Cornell Medical Center. He is past president of the American Society of Hematology, the founding editor in chief of its publication, and President-Elect of the Association of Professors of Medicine.

According Dr. Schafer, physicians throughout history have played a vital role in medical discovery. These physician-scientists devote the majority of their professional effort to seeking new knowledge about health and disease through research and represent the entire continuum of biomedical investigation. They bring a unique perspective to their work and often base their scientific questions on the experience of caring for patients. Physician-scientists also effectively communicate between researchers in the "pure sciences" and practicing health care providers. Yet there has been growing concern in recent decades that, due to complex changes, physician-scientists are vanishing from the scene.

In this book, leading physician-scientists and academic physicians examine the problem from a variety of perspectives: historical, demographic, scientific, cultural, sociological, and economic. They make valuable recommendations that – if heeded – should preserve and revitalize the community of physician-scientists as the profession continues to evolve and boundaries between doctors and researchers shift.

Contributors to the book are:
  • James M. Anderson, MD, PhD, University of North Carolina at Chapel Hill School of Medicine
  • Ann J. Brown, MD, MHS, Duke University School of Medicine 
  • Barry S. Coller, MD, Rockefeller University
  • Fabio Cominelli, MD, PhD, Case Western Reserve University
  • Paul E. DiCorleto, PhD, Cleveland Clinic and Case Western Reserve University School of Medicine
  • Mark Donowitz, MD, The Johns Hopkins University School of Medicine 
  • Stephen G. Emerson, MD, PhD, Haverford College
  • Gregory Germino, MD, The Johns Hopkins University School of Medicine
  • Stephen J. Heinig, Association of American Medical Colleges
  • Margaret K. Hostetter, MD, Yale University School of Medicine
  • Reshma Jagsi, MD, DPhil, University of Michigan Medical School
  • Kenneth Kaushansky, MD, MACP, University of California, San Diego School of Medicine David Korn, MD, Harvard University and Harvard Medical School
  • Timothy J. Ley, MD, Washington University School of Medicine
  • Philip M. Meneely, PhD, Haverford College
  • David G. Nathan, MD, Harvard Medical School
  • Philip A. Pizzo, MD, Stanford University School of Medicine
  • Jennifer Punt, VMD, PhD, Haverford College
  • Andrew I. Schafer, MD, Weill Cornell Medical College and New York-Presbyterian Hospital
  • Alan L. Schwartz, MD, PhD, Washington University School of Medicine
  • Roy L. Silverstein, MD, Cleveland Clinic 
  • Nancy J. Tarbell, MD, Massachusetts General Hospital and Harvard Medical School
Reviews of the book have been positive. Glenn Bubley, MD of Beth Israel Deaconess Hospital and Harvard Medical School writes, "In The Vanishing Physician-Scientist? Dr. Schafer makes the case that truly effective translational research can go from bench to bedside and back again in dynamic fashion; he describes a view of the future in which physician-scientists will be members of research teams. This book does an excellent job of placing physician-scientists in historical context and highlighting the fact that the problem of the endangered physician-scientist is not a new one. The Vanishing Physician-Scientist? outlines a long-term problem that is likely to get worse, and, most important, provides a number of possible solutions. Given the current constraints—on NIH-funded research and an understandable retrenchment for funding by industry and foundations—its descriptions of strategies that have been successful in the past and are likely to be successful in the future are more valuable than ever."

Thursday, October 28, 2010

19th century innovation classic: Medical Essays by Oliver Wendell Holmes, Sr.

In yesterday’s blog, I shared 5 book recommendations from Dr. Verghese at Stanford University.

If you are interested in classic medical literature, I want to offer you a complimentary e-book copy of the seminal text, Medical Essays, by Oliver Wendell Holmes, Sr.

This is a collection of essays by a man who defines the persona of a “poet-doctor.”

Whether Oliver Wendell Holmes, Sr. was more poet than doctor remains debatable. He wrote poetry, prose, criticism, history, and memoir from 1830 until his death. His medical “practice” was largely confined to the training of doctors, although several of his medical research projects were path-breaking contributions to modern epidemiology.

Holmes became distinguished for his articles written on such medical issues as treatment for malaria, though his passion for writing verse was expressed in his Poems of 1836. Later, Dartmouth College appointed him professor of anatomy, but he moved to Harvard to teach and rose to the position of Dean at the Harvard Medical School.

A man of contrasts and contradictions, Holmes lived his life between the poetic and the realistic. He is a bundle of contradictions: an old-fashioned modern; a primitivist scientist; a Protestant sympathetic to Roman Catholicism; a gossipy man. In short, he was the poet-doctor of 19th-century America. He is largely, and somewhat inaccurately, remembered today as a consummate aristocrat who opposed women’s rights and believed blacks to be physiologically inferior; he also supported the admission of women to Harvard medical school and believed African-Americans to be victims of history.

Click here to download the complimentary e-book. 

Wednesday, October 27, 2010

5 best books on doctors' lives, as prescribed by Dr. Abraham Verghese

Dr. Verghese is a professor of medicine at Stanford University. His own books include the novel Cutting for Stone and the memoir My Own Country.  Earlier this summer, he listed his choices for the five best books about doctors' lives in The Wall Street Journal, along with his first-person commentary.

1. The Life of Sir William Osler
By Harvey Cushing
Oxford, 1925

This two-volume work tops my list not just because William Osler is endlessly fascinating but because his biographer was the pioneering neuro surgeon Harvey Cushing, himself the subject of more than one biography. Cushing won the 1926 Pulitzer Prize for this meaty but immensely readable work. It captures not only the character of the charismatic physician and teacher who shaped American academic medicine but also a late 19th-century era when Europe and America were waking to germ theory and antisepsis. Osler went from naughty Canadian schoolboy to Regius Professor at Oxford, his last position. He was brilliant, inspiring and kind but also a practical joker: Under the pseudonym of Edgerton York Davis of Caughnawaga, Quebec, he once submitted a case report of "penis captivus," claiming that an amorous couple was unable to disengage. It astonished Osler no end that a medical editor published the piece.

2. Mortal Lessons
By Richard Selzer
Simon & Schuster, 1976

I read Mortal Lessons as a medical student and was astonished by the prose, the introspection, the lyricism of this practicing surgeon. Richard Selzer is the model "physician-writer," if there is such a thing, in that he does so much more than cater to readers' sometimes prurient interest in things medical; his language is baroque and musical, his epiphanies profound and personal. Here he is writing about the stomach: "Yet, interrupt for a time the care and feeding of this sack of appetite, do it insult with no matter how imagined a slight, then turns the worm to serpent that poisons the intellect for thought, the soul for poetry, the heart for love."

3. The Puzzle People
By Thomas Starzl
University of Pittsburgh, 1992

From humble beginnings in Le Mars, Iowa, where he was born in 1926, Thomas Starzl became one of the most recognizable names in American medicine, truly the father of modern transplantation, the liver transplant in particular. As he recalls in this engrossing memoir—which is essentially a history of transplantation itself—his first few liver transplants were failures, and he was vilified by the media as engaging in human experimentation. Had Starzl given up at that point, hundreds of patients now living with a new liver wouldn't be. He perfected the technically complex operation to remove the damaged liver and put in the new, but he also advanced our understanding of rejection and how to overcome it.

4. Adventures in Two Worlds
By A.J. Cronin
McGraw-Hill, 1952

Doctors often speak of a book that "called" them to medicine. The novels of A.J. Cronin, such as The Keys to the Kingdom and The Citadel, had that effect on many budding doctors of earlier generations. Even better is Cronin's Adventures in Two Worlds, a memoir by this gifted writer and doctor. As a young physician in the 1920s, he worked in a gritty Welsh mining town and became a medical inspector of mines. The hard lives of the coal miners sharpened his sense of injustice. But we also learn that he was concerned with matters of faith and temptation. Retiring from medicine in 1926 due to ill health, he began writing novels—work with themes that were also the themes of his life.

5. Henry Kaplan and the Story of Hodgkin's Disease
By Charlotte Jacobs
Stanford, 2010

Charlotte Jacobs, an oncologist and biographer, tells the story of the man who was instrumental in making Hodgkin's lymphoma, a cancer of the lymph glands, a curable condition. In Dr. Jacobs's capable hands we experience the thrill of clinical research and the hard slogging of clinical trials, which are the only way to tell if treatment is beneficial. We also meet the maverick doctors—Kaplan's colleagues and rivals—who helped bring about the cure's discovery. Most people know about Jonas Salk and the polio cure, but Kaplan and the Hodgkin's-disease tale is even more compelling—and wonderfully told in these pages. A budding Kaplan out there, one hopes, might read this book (or one of the others on this list) and be "called" to medicine. It's a great journey, and I'd do it all over again in a heartbeat.

Monday, October 25, 2010

939 Wal-Mart based McDonald's locations to get a makeover

In an effort to boost sales, McDonald's is looking to give their Wal-Mart based locations a facelift.

As part of McDonald's global reimaging program, all 939 Wal-Mart based locations will see expanded menus, including fruit smoothies and frappe coffee drinks, updated technology, and other improvements.  While these locations, which are primarily owned by franchisees, don't generate a large amount of profit for the corporation, they are hopeful that they will boost profits for the franchisees.  McDonald's is hoping that the profit boost will encourage most of these franchisees to renovate their other freestanding locations.

Click here to read more.

Friday, October 22, 2010

7 WordPress brands sites to admire

In preparing an assessment of web design and experience for one of our brand engagements, we took a look at features on some of these sites. All have been developed using WordPress, but there's nothing cookie-cutter or template-like about them.

What do you think?

fernwoodcoffee.com
simple can also be graphically pleasing with the right photography

healogix.com
pretty copy heavy, but looks modern. Needs more photos.

ehrtv.com
don’t get overwhelmed by all the video on this one; just consider the “sections”

weborchard.co.uk
simply, easy to read, no bells-and-whistle to slow people down

ericdies.com
it seems like everything is on one page – including the contact box

pixeltree.us
I like that the top tells the big picture; and the bottom offers you details

www.walktowashington.org
uses lots of features and tools. But you don’t need them all to start; just add later.

Thursday, October 21, 2010

Seminar with researchers at UIC: Akt/PI 3-Kinase Signaling in Cell Death and Cell Survival


Last week, a colleague and I had the pleasure of attending a seminar for researchers at The University of Illinois at Chicago. The talk was given by Chandra Mohan, PhD of EMD Millipore Biosciences on the topic “Akt/PI 3-Kinase Signaling in Cell Death and Cell Survival.”

As Dr. Mohan said, “Akt (protein kinase B) has emerged as a critical enzyme in signal transduction pathways involved in cell proliferation, apoptosis, angiogenesis, and diabetes.”  The principal role of Akt is to facilitate growth factor-mediated cell survival and to block apoptotic cell death, he said.

“A number of oncogenes and tumor suppressor genes that function upstream of Akt influence cancer progression by regulating Akt. Akta is expressed to various degrees in breast cancer cell lines and is important in estrogen-stimulated growth. Treatment of multiple myeloma cell lines with the Akt inhibitor, 1L-6-Hydroxymethyl-chiro-inositol 2-(R)-2-O-methyl-3-O-octadecylcarbonate, results in reduced survival of both drug resistant and drug sensitive cells,” he presented.

“Akt plays a critical role in tumorigenesis, becoming activated when tumor suppressors such as p27 and PTEN lose their functions. Phosphorylation of p27 at Thr157 by Akt impairs its nuclear import. Cytoplasmic mislocalization of p27 has been strongly linked to loss of differentiation and poor outcome in breast cancer,” he said.  “Akt is also reported to physically associate with endogenous p21, a cell cycle inhibitor, and phosphorylate it at Thr145, causing its localization to the cytoplasm and subsequent degradation.”

Akt and p53 play opposing roles in signaling pathways that determine cell survival – and the interaction between these two molecules is becoming an important area of study.

In addition to the presentation, Dr. Mohan offered copies of his book, Signal Transduction: A Short Overview of its Role in Health and Disease.

Who are the researchers and why are they studying Signal Transduction?

1.    Diabetes and other metabolic disorders
  • To elucidate the mechanism of binding and action of insulin and identify the causative factors in the development of diabetes. Also, identify the intracellular sites of insulin action.
  • Product categories: hormones, protein kinases, protein phosphatases activators and inhibitors, cyclic AMP and GMP related products, calcium channel modulators

2.    Cancer
  • To identify how and why certain cells respond abnormally to environmental signals and then design and develop new therapeutic measures to prevent and treat cancer in its earliest stage.
  • Product categories: protein kinases, MAP kinase inhibitors, phosphatase inhibitors and activators, phorbol esters, nitric oxide related products, GTP-binding proteins, farnesyltransferase inhibitors, tyrosine kinase inhibitors, calmodulin related products

3.    Apoptosis, programmed cell death
  • A failure of cancer cells to die. The interest in this field has been growing rapidly also in relation to Alzheimer’s disease where too many neurons die prematurely.
  • Product categories: caspase inhibitors and substrates, proteasome inhibitors, inhibitors and inducers of apoptosis, reagents for cell cycling

4.   Hypertension and other cardiovascular disorders
  • Design new treatments to reduce the incidence of hypertension, angina, and the risk of stroke and related complication
  • Product categories: calcium channel modulators, nitric oxide related products, calcium probes, ionophores

5.   Osteoporosis and mineral metabolism
  • To elucidate the mechanisms involved in bone growth and in increased mineral loss. Design and develop appropriate therapies for prevention of osteoporosis
  • Product categories: growth factors, cytokines, calcium probes, second messengers, protein kinases

6.   Infection, trauma, and sepsis
  • Design and develop new treatments to prevent and treat infection and sepsis. Help in the wound healing process.
  • Product categories: cytokines, growth factors, protein kinases, calcium modulators, oxidative stress tools

7.   Neuroscience
  • To identify the mechanisms involved in the development of Alzheimer's disease, neurochemical complications in muscular dystrophy, mental disorders, neuritis, and abnormalities in neuronal development, and design appropriate therapies.
  • Product categories: regulators of calcium metabolism, neurotoxins, nitric oxide related products, protein kinases and related products, calmodulin and related products

Click here for more information about this research – along with a request form for the book. 

Tuesday, October 19, 2010

4 building blocks for a biosimilars strategy

Pharmaceutical Executive called biosimilars “this decade’s most disruptive technology.”

Biosimilars are the pharmaceutical industry’s segment that will finally seize momentum over the next few years, paced by the growing dominance of biologic drugs as top industry revenue producers and the scheduled launch of a few high profile biosimilars in 2014.

Here’s the basic forecast from Decision Resources data crunchers: by 2016, seven of the 10 top selling brands will be biologics, opening up new pathways in the biosimilars space, and resulting in biosimilars accounting for roughly a quarter of the total biologics market in 2019, or $14 billion annually. Another factor likely to accelerate prospects for biosimilars is that nearly all the revenue growth in biologics through 2019 will be driven by therapies already on the market.

Major healthcare companies are making biologic and biosimilar development a priority. Merck & Co., which recently merged with Schering-Plough, has made biosimilars the focus of MerckBioVentures, a division created in December 2008. Following the company's recent portfolio prioritization, Merck has five novel biologics and two biosimilar candidates in clinical development.

Moving forward, experts indicate that biotech firms will continue to face a challenging funding environment. Companies best poised for success are those that will increase financial and R&D efficiency and find creative models for funding and partnering.

To better position themselves against generic manufacturers, pharmaceutical and biotechnology companies are investing in their own biosimilar research. Expected to reach a market value of $10 billion by 2017, there is great interest in the development and manufacturing of these products. As a result, Novartis and Merck have established biosimilar development divisions. However, legislation regarding regulatory pathways and patent infringement could impact investment in this area.

The editors of Pharmaceutical Executive believe that what still makes it hard to assess prospects for biosimilars is the challenge of defining the terms of engagement. “The concept itself is open to interpretation, which leads to definitional problems,” they write. “In addition to biosimilars, which are essentially generic versions of branded off-patent biologics, there are biobetters, which are conceived to differ from the originator in formulation or delivery mode with the overall aim of obtaining an improved pharmacokinetic profile. This leads in turn to a lack of clarity in figuring where the real opportunities are and defining a strategy to exploit them.”

Here are four building blocks for a biosimilars strategy presented at a recent conference:
  1. Biosimilars are a classic “disruptive technology” that will change the competitive landscape in unforeseen ways.
  2. The biggest companies may be having second thoughts about entering the biosimilars space.
  3. Pricing and market access remain unsettling questions for strategists.
  4. Key policy issues must be resolved before the sector can truly obtain its market potential.
Click here to read the details of these four building blocks. 

And to help marketers study the landscape, a PharmaLive Special Report has been published entitled, “Biotech/Biopharma/Biosimilar Review and Outlook 2010.”  Click here to learn more.

Monday, October 18, 2010

Critical needs for patients – and business – met with orphan drug research

Industry experts estimate that orphan drugs bring in about $40 billion in annual sales. With drug companies facing devastating patent expirations and new drug opportunities drying up in existing markets, orphan drug development has become an enticing solution.

FDA and Congress have further lured pharma companies to this niche sector with various incentives. The Orphan Drug Act of 1983 provides seven-year market exclusivity, tax breaks, and regulatory help for companies developing new drugs for orphan diseases. Since its introduction, more than 2,100 compounds have been submitted for orphan status in the United States and more than 350 have received designation. FDA is urging large drug makers, such as Roche and Johnson & Johnson, to determine if existing medicines may be able to help neglected disorders. Drugs with orphan drug designation are likely to receive fast-track status.

Despite the small patient pools they are being developed for, the most successful orphan drugs have more than recouped R&D investment for their developers. Merck's brain cancer drug Temodar was originally approved in 1998 for treating the orphan indication anaplastic astrocytoma, has since been approved for other brain cancer forms, and generated sales of more than $1 billion in 2009. Genzyme Corp., the leader in the orphan drug sector, realized $793 million in sales in 2009 with its Gaucher disease drug Cerezyme. Genzyme's success with Cerezyme and other rare disease treatments is likely the driver behind sanofi-aventis' attempted takeover of the company. More large companies are entering the orphan drug sector. Earlier this year, both GlaxoSmithKline and Pfizer Inc. opened research units dedicated to developing new biologics to treat rare diseases.

The most transformational devices to be developed in recent years are drug-eluting stents. These devices improved procedural quantities in two major cardiology markets. Another device success, Vitrasert, is an intraocular sustained delivery system for AIDS-related cytomegalovirus retinitis. This device has been very effective for this indication and, more importantly, has lead to commonplace use of intraocular drug delivery for other indications, including Lucentis for age-related macular degeneration.
     
A newly released PharmaLive report listed many developments in the orphan drug market, including partnerships, acquisitions, and investments that could be of interest to you.

Thursday, October 14, 2010

Biopreneurs: The Molecular Millionaires

In today's video blog, I discuss the book BIOPRENEURS by Dr. Ryan Baidya.  You can learn more about it at http://www.biopreneur.org/download-e.htm




video

Wednesday, October 13, 2010

Survey says...clinicians still love pharma perks

Medical centers may ban them...
Med schools may rule against them...
Congress may investigate them...

...but pharma perks are still popular among clinicians.

This according to a new study published over the summer in JAMA. A survey of faculty and trainees in the The Mount Sinai School of Medicine consortium in the New York area found that attitudes toward industry and pharma items were generally positive.

In fact, 72.2 percent of participants found sponsored lunches appropriate. Notably, 74.6 percent found large gifts unacceptable.

As in previous surveys, most believed that OTHER physicians were more likely to be influenced by gifts and food from industry than they were.

Tuesday, October 12, 2010

4 traits of the "empowered" patient

HealthCentral partnered with Professor James Burroughs of the University of Virginia, who specializes in marketing and consumer psychology and behavior. Together, they designed a survey to identify traits and habits of a person who feels empowered to take a lead role in managing his or her health care.

Making treatment choices and selecting health care providers are high stakes decisions for people living with chronic conditions.  So, they were asked about:
  • Relationships with doctors
  • Treatment history
  • Social habits 
  • Need for cognition
  • Self-confidence
  • Media preferences
The survey found that people who take a direct role in managing their treatment plan have 4 traits that other more traditional patients lack:
  1. Need for cognition drives the empowered patient
  2. Education, income, source of health insurance had no effect
  3. Empowered patients are leading the way online
  4. This group is the most demanding but the most loyal
Click here to read more detailed findings and commentary.

Monday, October 11, 2010

HFEs for innovative drug delivery – collaboration with creative coprocessed excipient partner can mean faster time to market

Here at Stinson Brand Innovation, we’re always on the lookout for good example of partnerships that accelerate the development and commercialization process of new therapies.

One recent case was shared by Herman Mitchell in “Life Science Leader” (August 2010).  Mr. Mitchell is global director of marketing for Mallinckrodt Baker, a business unit of Covidien, a global provider of healthcare products.

We value the insights from Mr. Mitchell because he has more than 33 years of experience in the pharmaceutical industry, with commercial responsibility for performance chemistries supporting both pharmaceutical research and manufacturing worldwide.

Read what he has to say about speeding up time-to-market through collaboration.


“Whether generic or branded, in the high-stakes race to bring a therapeutic drug to market, manufacturers are engaged in two simultaneous challenges. The first is against the clock — a race to market approval; the second — to contain development and manufacturing costs.

“A manufacturer will invest years and millions of dollars to optimize a formulation and process. In the case of oral solid dosage forms, the manufacturer needs to perfect the finalized drug for safety, efficacy, and desired tablet properties. With respect to tabletability and cost per unit dose, the final formulation and manufacturing process are equally important to the development of the final drug. The drug manufacturer must formulate using a suitable, cost-effective process. This all adds up to speed to market. The speed and efficiency with which a drug maker formulates, develops a scalable manufacturing process, and gains regulatory approval is key to succeeding in today’s economic climate.

“For drug manufacturers who are tasking their organizations to improve time to market while reducing development and manufacturing costs, there are now innovative and cost-effective options available to streamline formulation development and manufacturing processes. By collaborating with experts in the supply chain, such as excipient manufacturers who have developed a wide range of solutions to meet formulation challenges, drug makers have greater access to novel coprocessed excipients and innovative drug delivery systems. These coprocessed, or high-functionality excipients (HFEs), are engineered particles which interact at a subparticle level to provide enhanced functionality and tableting performance that may, for example, enable direct compression of difficult-to-formulate active pharmaceutical ingredients (APIs). This allows the drug maker to focus resources on its core competencies rather than on inventing new processes.

“These collaborations between excipient suppliers, contract service suppliers, and the pharmaceutical firm’s research and development specialists have proven their effectiveness in developing solutions that maximize speed to market while enabling the regulatory compliance sometimes associated with the use of HFEs and new technology in general.

“Many marketed therapeutics have formulations that incorporate HFEs, in which a single excipient fulfills two or more functions (e.g. as a binder, filler, and disintegrant). Using HFEs can improve content uniformity and in many cases will allow manufacturers to eliminate time-consuming processes like wet granulation. Manufacturers can take advantage of well-established techniques and procedures for creating simplified formulations with challenging APIs. Additionally, HFEs can significantly reduce development time and costs by enabling products to get into clinical trials sooner and out to market faster.

“Leveraging their own R&D resources, capabilities, and spending, some leading-edge pharmaceutical manufacturers are cultivating innovative approaches to product development and manufacturing. Working in partnership with excipient suppliers and formulation specialists, drug manufacturers have created new platforms that utilize HFEs in their formulations. Best of all, HFEs with a well-defined design space help drug manufacturers implement quality by design (QbD) initiatives to develop robust, scalable formulations and manufacturing processes, again reducing time to market.

“HFEs, in addition to increasing speed to market, provide benefits to the drug manufacturer for years after the product launch. HFEs can produce significant gains in productivity, due to simplified processes, and higher throughput with fewer tablets rejected. In addition, reductions in cycle times and inventory turnover increases can also be achieved. These are all advantages that can improve a manufacturer’s bottom line from the day the product is launched until far into the future.”

Wednesday, October 06, 2010

Personalized Medicine: 3 key developments in this innovation trend

The $232 billion personalized medicine market in the U.S. is projected to grow 11% annually over the next several years. Advancements in science and diagnostic technology are required to reach this standard of care. In addition, health agencies need to establish clear regulatory frameworks for this complicated field, insurers must allow for adequate reimbursement, and medical providers will need to adopt new methods and procedures.

Once the groundwork is laid, the benefits will be many, including reduced costs of healthcare by eliminating ineffective treatments, faster approvals due to predictable safety and efficacy, lower rates of adverse reactions, earlier detection and prevention.

Personalized medicine will help developers and marketers identify patient populations most likely to respond to their medications.

A newly released PharmaLive report listed many developments in the personalized medicine trend, including these:
  1. Strategic alliances, such as the sanofi-aventis alliance with Scripps Genomic Medicine, are being formed with academic and private research institutions as well as small biotech companies as major pharma companies increasingly look for alternative ways to strengthen their pipelines.
  2. Roche's Herceptin, Novartis' Gleevec, Agendia's MammaPrint, and Genomic Health Inc.'s Oncotype Dx are all examples of early success stories in personalized medicine.
  3. According to FDA, MammaPrint was the first approved product that profiles genetic activity. The genetic test determines the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer.
At Stinson Brand Innovation, we’re identifying companies involved in personalized medicine research.  If you have a drug or technology in development, we can work with you to address the challenges and capitalize on the opportunities.

Tuesday, October 05, 2010

8 mobile medical apps

Your doctor is likely using his mobile device to access healthcare technology in mobile app form as part of your care. Access to accurate, up-to-the-minute information enables healthcare practitioners to provide better treatment at lower costs while saving time, minimizing errors and legal challenge.

Mobclix, the industry's largest mobile ad exchange, mined data that showed record growth in healthcare apps: over 1,399 are currently available, up from just 616 last June.

Some apps are built out of necessity by the doctors, while others are created by knowledgeable developers, to improve patient care and reduce the likelihood of medical errors. 

Utilizing trusted, valuable resources and tools, some of the most popular healthcare technology apps include:
  • Skyscape: Offers customizable content by specialty to medical professionals directly at point of care.  Skyscape’s MedAlert™ offers instant drug updates, journal summaries, clinical trial results and other up-to-the minute information by specialty on your cell phone, smartphone, PDA or desktop.
  • Discoverant: analyze and integrate discrete and continuous data for delivery to mobile devices and is used by many of the world’s life sciences manufacturers including Abbott Labs, Baxter, Biogen, Bristol Myers Squibb, Eli Lilly, Genzyme, Merck Serono and others for better process understanding.
  • Epocrates: One user called it an “updated PDR at your fingertips;” it also has drug interactions, lab results references, disease information and more than 900,000 healthcare professionals, including one in three U.S. physicians, use Epocrates’ innovative mobile and web-based products to help them reduce medical errors, improve patient care and increase productivity.
  • HealthMap: tracks global disease outbreaks.
  • Medscape Mobile: search 6,000 brand name or generic drugs, check for drug-drug interactions and get medical news.
  • Papers: search and download scientific papers; forward with your notations.
  • PubMed on Tap : access the NIH’s library of more than 19 million citations for biomedical research and email them to your colleagues.
  • Transpara: visual key performance indicators for manufacturing operations.
If your doctor is making decisions about your treatment based on these mobile apps, would you like to know that the information is accurate?  So, the big question: Is the FDA is going to require that it provide clearance before new apps go to market?

Currently, the FDA has no overarching regulation in place for mobile medical apps, despite the fact that they have indicated in the past that under certain circumstances the iPhone may be considered a medical device and therefore regulated as one, according to a report by Brian Dolan on Mobihealthnews.

What do you think? How might the FDA regulate wireless health under its existing system?

Monday, October 04, 2010

Phase I assets get 68% more upfront than a year ago and phase II products 39% more -- Big Pharma isn't waiting

We’re seeing a trend that Big Pharma isn’t waiting in the push for new biotech's drugs.  This trend is relevant because of the rising pressure to find new products is prompting companies to license or acquire experimental medicines – even if they've barely been tested in human trials.

A recent report in The Wall Street Journal said that while traditionally the sector's big players preferred drugs with solid clinical evidence to show they work, they are faced with the loss of patents on some big sellers, an overhaul of its own research-and development-priorities, and demand for more innovative medicines.  That means Big Pharma is gambling more of its deal dollars on riskier bets in an effort to replenish its pipeline with new technologies.

For example, in June, Bayer AG paid $40 million to Redwood City, Calif.-based OncoMed Pharmaceuticals Inc. for access to its experimental anticancer stem-cell therapeutics, which haven't yet been tested in human trials.

All these deals provide for further payments if the drugs are successful in later stages of development and royalties on eventual sales. The average upfront payment for a Phase I asset was 68% higher in 2009 than a year earlier at $46 million and 39% higher at $37 million for a phase II product, according to data from research firm EvaluatePharma. Total deal values, which include payments for hitting development targets and royalties on eventual sales, also rose.

Daniel Mahony, a health-care fund manager at Polar Capital Holdings PLC, was quoted as saying one reason drug makers will continue to scoop up biotechs' early-stage programs is because they've overhauled their research-and-development activities to focus more on clinical trials and less on lab work.

With funds for R&D limited, the economics of spending more on "development" and less on "research" will continue to stack up for a drug maker, said Franceso De Rubertis, a partner at venture-capital firm Index Ventures.

It can take 20 scientists five years and $30 million to turn an idea into a drug ready to be tested in humans, and to reach this stage once typically means there have been dozens of other lines of research that have also cost time and money but turned out to be dead ends. On top of that, fixed costs such as payrolls and running laboratories are high. If a biotech can offer a drug maker an interesting compound ready-made, "it becomes a no-brainer to pay out $50 million for a Phase I asset," said Mr. De Rubertis.

For AstraZeneca, licensing promising early-stage assets is a way of filling gaps in its pipeline. The company hasn't stopped looking for late-stage products, but after a string of deals in the past 12 months for near-to-market or marketed medicines, AstraZeneca's attention is turning to more experimental drug candidates, said Shaun Grady, vice president of corporate business development. "You have to train your guns at different places at different times depending on your needs."

An AstraZeneca brochure for industry conferences mentions Alzheimer's disease and obesity among the areas it is interested in preclinical assets.

Mr. Grady said a drug program brought in from outside isn't inherently riskier than a program born in Big Pharma's own labs. And in the context of a whole pipeline, licensing gives a company more options about which programs to press on with. "For us, the goal is to bring external projects into the company that help upgrade the overall quality of the pipeline," said Mr. Grady.

Friday, October 01, 2010