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Lisa Banket
Cofounding Partner/Publisher
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Taren Grom
Cofounding Partner/Editor-in-Chief
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Heather Hummel
Project Coordinator
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Dan Limbach
Producer, Webcast Network
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Denise Myshko
Managing Editor
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Kim Ribbink
Features Editor
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Robin Robinson
Senior Editor
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Marah Walsh
Cofounding Partner/New Business Development
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PharmaVOICE Editors' Blog

Thursday, February 27, 2014

Innovation in Biotech R&D

Innovation in research

By Taren Grom

The pharmaceutical industry has dramatically shifted its R&D focus from its historical concentration on small molecule drugs to include a rapidly increasing number of biotechnology products, according to a recent analysis from the Tufts Center for the Study of Drug Development.

Biotech products, which accounted for only 7% of revenue generated by the 10 top selling pharmaceutical-biotech products worldwide in 2001, accounted for 71% of the 10 top selling products in 2012. The transformation of big pharma has been driven as much by new technologies that have enabled development of new products that improve disease outcomes and command high prices, as by the expiring patents on many top-selling small molecule drugs, according to Tufts CSDD Director Kenneth Kaitin.
Biotech products and pipelines, which are extremely attractive pharma companies, are helping to drive the innovation evolution. Novel technology platforms have been developed over the last 30 or so years, some of which according to Tufts has spurred an extensive pipeline of products across a wide range of therapeutic areas. For example, in 1989, only 13 biotechnology products were commercially available. By 2012, that number had grown to 210.

I asked several C-suite biotech executives to identify the biotech innovations that they believe have had the biggest impact, not surprisingly rooted in complex science.

Lloyd Everson, M.D., CEO of MolecularHealth, says Dr. Janet Rowley’s identification of the causal –chromosome rearrangement in chronic myelogenous leukemia (CML) is the poster child for what the whole panomic/genomic movement is all about. Dr. Rowley’s discovery eventually led to the development of Gleevec, the first molecular biomarker targeted therapy for leukemia.

“This paints a tremendous picture of the potential medicine can, and should, evolve into,” Dr. Everson says. “We’re at the beginning of a revolution in medicine; how we understand disease, how we diagnose it, and how the fingerprint of a particular disease paired with the DNA of an individual can accurately spell therapeutic options. There is no greater or more pressing example of this than in cancer care. We are just now beginning to unravel the heterogeneity of cancer and how it behaves in a human being.”

Gary Rabin, CEO and Chairman of Advanced Cell Technology, notes that even with all the fanfare around the Nobel Prize winning technology of induced pluripotent stem cells (iPSC), the overall progression of iPSC technology into the clinic has been hampered by reports that iPSC lines may have epigenetic memory and replicative capacity issues, perhaps as a consequence to incomplete dedifferentiation using current iPS techniques.

“Jacob Hanna and his colleagues at the Weizmann Institute of Science have recently developed a method for generating human iPS cells in a true na├»ve ground state and maintaining them in that form,” Mr. Rabin says. “If this method has in fact solved the stability issue for iPSC lines, than it opens up the opportunities for utilizing this important technology in regenerative medicine therapies.”

Szilard Voros, M.D., CEO and Co-Founder of Global Genomics Group (G3), is focusing his attention on the large systems-biology-based studies that are currently ongoing.

He believes breakthroughs will come from trials such as the GLOBAL study, which involves the integration of data from up to 10,000 patients who will undergo coronary computed tomographic (CT) angiography (an advanced imaging technology for precisephenotyping) with pan-omicanalyses to identify diagnostic biomarkers and disease pathways for cardiovascular diseases.

For more information about biotechnolgy innovation,  read the complete article in the PharmaVOICE Digital Edition.

Monday, February 24, 2014

The Uninsured in America - podcast and white paper

Podcast: Who are the Uninsured in America?

In this podcast episode, Patricia Ensor discusses the characteristics and behaviors of the uninsured, how they relate to the Affordable Care Act (ACA), and what it means for Pharma.

PharmaVOICE


Play podcast

White Paper: The Uninsured in America - What do characteristics and behaviors tell us about likely participation in the healthcare exchange marketplace?

Based on simulations and projections conducted by multiple groups to date, it is still uncertain who and how many uninsured will, in fact, obtain insurance. Kantar Health undertook an analysis to increase the body of knowledge about the currently uninsured patients. The results are contained in this white paper.

Download white paper

PharmaVOICE

Wednesday, February 12, 2014

What is the Future of the Specialty Market Model?


Specialty Drugs in the Digital Edition

By Robin Robinson

There are so many redefining forces affecting the specialty commercial model today that it will be evolving for several years. The industry will be coping for the next four or five years will continual changes in its environment. While reimbursement issues are a prominent challenge, there are many other factors that play in to this ever-developing landscape, including the complexity in selecting a personalized health and treatment strategy, unexpected complications, unnecessary care, and a total cost that is not properly assessed or shared by the beneficiaries.

“The transformative forces that are moving healthcare from a cottage industry in recent decades to a mass produced, but still personalized system with interchangeable parts is going to be disruptive for years until we settle into a new electronics-based equilibrium,” says Doug Moeller, M.D., medical director at McKesson Health Solutions. “Where will we be in five years? What a great question.”

In order to emerge successfully through the increasing complexities, better feedback from all stakeholders will be necessary. Dr. Moeller says thoughtful discussion in various media channels, websites, and related sources of information must facilitate much more transparency about benefit–to-cost evaluations. Patient compliance is ultimately about convincingly demonstrating benefit with a data and educational process at its heart.

The pressure for performance is not unique to healthcare; banking, manufacturing (especially automobiles), retail, and information management industries are all addressing major upheavals in business models and competitive threats.

“Substantive ‘emerging technology’ is nearly always ‘disruptive’ to the status quo,” Dr. Moeller says.  “In general, the disruption of the status quo is a good thing when it creates a perpetual impetus to reassess quality and cost. Any industry that is not perpetually reassessing cost and benefit is probably in some stage of ‘dying.’”

For more information on the evolving commercial model for specialty drugs,  read the complete forum in the PharmaVOICE Digital Edition.

Friday, February 7, 2014

Introducing Innovator’s Corner


PharmaVOICE Magazine
by Denise Myshko

With the February issue of PharmaVOICE, we launched a new regular column: Innovator’s Corner. In this column, we will take a look at the new research, technologies, and discoveries that have the potential to be disruptive innovations in their area.

In the February issue, we highlight Dr. Ross Cagan’s work to create a new method for drug discovery. He has developed a more efficient screening process — by using fruit flies — that has the potential to lead to better classes of drugs. Dr. Cagan is a professor in the department of development and regenerative biology, and associate dean, graduate school of biological sciences at Icahn School of Medicine at Mount Sinai. He is also co-founder of Medros Inc., a contract discovery company.

Icahn School of Medicine
Dr. Ross Cagan
Dr. Cagan has developed models of diseases, such as diabetes and breast, lung and colorectal cancers in fruit flies, and he is using these models as a way to screen for new therapeutics. The biggest advantage of using flies instead of traditional cell screening, he says, is having the ability to do whole animal screening, which can lead to a different class of drugs that can address the complexity of human disease.
“What flies allow you to do is take advantage of a century of tool building and embrace the new genomics,” he says.

Dr. Cagan also started in July 2013 the Mount Sinai Center for Personalized Cancer Therapeutics (CPCT). The goal of the Center is to create novel cancer treatments that are based on a patient’s own cancer genome. Dr. Cagan, through the Centers, creates a fly with the same cancer as the patient. Robotics then screen thousands of drug combinations, and  use each patient’s fly line to develop a customized treatment for that patient.

If you know of any researchers or companies that are doing innovative or creative research, please email me at dmyshko@pharmavoice.com.