San Diego Biotech

Biotech Directory

Aug
27

3 Steps for Tackling a Devastating Disease

Posted under 21st Century Cures, 21st Century Cures Initiative, Alzheimer's, Alzheimer’s disease, Blog, Companies, Corporate, Diagnostics, Funding, Jim Greenwood, Jim's Corner, Medical Devices, Medical Supply, Path to cures, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization) Jim's Corner

An estimated 24 million people worldwide have dementia, most from Alzheimer’s disease. That number is predicted to double by 2020 – just over five years from now – and triple by 2040.

The numbers are equally striking for the U.S., where more than a million people over the age of 65 are afflicted today – a number that is expected to triple by 2050.

The financial cost to the U.S. healthcare system of caring for individuals with the disease is estimated at over $200 million today and will rise to over $1 trillion by 2050.

The societal costs are inestimable. These predictions do not include individuals with early-onset of the disease, who are under the age of 65 at first onset or diagnosis.

Without intervention or prevention to delay or slow Alzheimer’s progression in patients, or the discovery of a cure, the disease will overwhelm the U.S. healthcare system within the next 25-30 years. Even incremental improvements in treatment, however, can generate substantial savings. The Alzheimer’s Association projects that a medicine that delays the onset of the disease by five years would decrease the number of American patients with Alzheimer’s by nearly half in 2050 and save $447 billion in related costs.

Something must be done.

I believe there are three key steps that will help expedite the development of cures and treatments:

  1. Collaborate by forming public-private partnerships and coordinating efforts with existing initiatives;
  2. Collect health care data, genomic data, and biospecimens to identify potential risk factors, causes, biomarkers and targets for intervention; and
  3. Communicate the outcomes of the study publicly to translate the results into treatments and, potentially, a cure.

There is broad agreement that advancements in biologic and drug development will best be accomplished through collaborations that bring together knowledge, skills, and expertise, as well as funding, from the public and private sectors to enhance what each sector is capable of and is doing on its own.

Such partnerships and consortia already are making progress in a number of areas with high public health impact, including Alzheimer’s.

Public and private entities worldwide are engaged in efforts to understand the disease, to determine how best to develop therapies, and to address the enormous challenges facing caregivers.

In the U.S., many such efforts also are under way, in part as a result of the mandate of the National Alzheimer’s Project Act and under the National Alzheimer’s Strategic Plan.

In addition, the International Genomics of Alzheimer’s Project combines the efforts of the Alzheimer’s Disease Genetics Consortium, the Cohorts for Heart and Aging Research in Genomic Epidemiology, the European Alzheimer Disease Initiative, and the Genetic and Environmental Research in Alzheimer Disease consortium. These groups are working together to identify Alzheimer’s genetic risk factors. Thus far, their cooperative efforts already have identified more genes than had been identified in the previous 20 years.

There is recognition that these multiple efforts need to be coordinated effectively for the greatest possibility of realizing a return on investment that expedites prevention of the impending Alzheimer’s crisis.

The lack of effective treatments is not for lack of desire to address the current and impending impacts of chronic disease in general and Alzheimer’s, specifically. Indeed, from the perspective of the biopharmaceutical industry, this is a top priority. However, the high failure rate of potential treatments, in particular, discourages R&D and investment.

It is well recognized that a first step toward a cure is to try to identify the cause of the disease, individuals who are at risk for the disease, and potential targets for intervention.

I propose the development and execution of a large-scale, longitudinal study that will include sequencing the genomes of 100,000 volunteers in age cohorts from those in their 20s through those in their 80s, as well as obtaining biospecimens and additional health care data from those individuals, to develop biological markers that may predict Alzheimer’s or other chronic diseases for which the cause is unknown or poorly understood. This large-scale, long-range study will not only yield data necessary to find ways to cure and prevent Alzheimer’s, it would help researchers find ways to treat hundreds of other diseases for which we still lack adequate therapies.

Our hopes for cures hinge on understanding how to intervene to halt the disease’s progress. Through this proposed study, we would identify precursors and early signs of disease or disease risk. This information could be made publicly available so drug and device developers would have defined targets and potentially could develop ways to prevent and treat the disease.

The urgency of finding a cure for Alzheimer’s cannot be overstated. It is difficult to find anyone whose life has not been affected by this devastating disease. Biotech holds the greatest promise for finding a cure. We must act now for the patients and their families who are counting on us.

NOTE: Jim will be participating in a 21st Century Cures Initiative Roundtable in Lancaster, Penn. tomorrow to discuss how to expedite cures and treatments for devastating diseases such as Alzheimer’s. For more information on the event, please visit this link.

Aug
27

3 Steps for Tackling a Devastating Disease

Posted under 21st Century Cures, 21st Century Cures Initiative, Alzheimer's, Alzheimer’s disease, Blog, Companies, Corporate, Diagnostics, Funding, Jim Greenwood, Jim's Corner, Medical Devices, Medical Supply, Path to cures, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization) Jim's Corner

An estimated 24 million people worldwide have dementia, most from Alzheimer’s disease. That number is predicted to double by 2020 – just over five years from now – and triple by 2040.

The numbers are equally striking for the U.S., where more than a million people over the age of 65 are afflicted today – a number that is expected to triple by 2050.

The financial cost to the U.S. healthcare system of caring for individuals with the disease is estimated at over $200 million today and will rise to over $1 trillion by 2050.

The societal costs are inestimable. These predictions do not include individuals with early-onset of the disease, who are under the age of 65 at first onset or diagnosis.

Without intervention or prevention to delay or slow Alzheimer’s progression in patients, or the discovery of a cure, the disease will overwhelm the U.S. healthcare system within the next 25-30 years. Even incremental improvements in treatment, however, can generate substantial savings. The Alzheimer’s Association projects that a medicine that delays the onset of the disease by five years would decrease the number of American patients with Alzheimer’s by nearly half in 2050 and save $447 billion in related costs.

Something must be done.

I believe there are three key steps that will help expedite the development of cures and treatments:

  1. Collaborate by forming public-private partnerships and coordinating efforts with existing initiatives;
  2. Collect health care data, genomic data, and biospecimens to identify potential risk factors, causes, biomarkers and targets for intervention; and
  3. Communicate the outcomes of the study publicly to translate the results into treatments and, potentially, a cure.

There is broad agreement that advancements in biologic and drug development will best be accomplished through collaborations that bring together knowledge, skills, and expertise, as well as funding, from the public and private sectors to enhance what each sector is capable of and is doing on its own.

Such partnerships and consortia already are making progress in a number of areas with high public health impact, including Alzheimer’s.

Public and private entities worldwide are engaged in efforts to understand the disease, to determine how best to develop therapies, and to address the enormous challenges facing caregivers.

In the U.S., many such efforts also are under way, in part as a result of the mandate of the National Alzheimer’s Project Act and under the National Alzheimer’s Strategic Plan.

In addition, the International Genomics of Alzheimer’s Project combines the efforts of the Alzheimer’s Disease Genetics Consortium, the Cohorts for Heart and Aging Research in Genomic Epidemiology, the European Alzheimer Disease Initiative, and the Genetic and Environmental Research in Alzheimer Disease consortium. These groups are working together to identify Alzheimer’s genetic risk factors. Thus far, their cooperative efforts already have identified more genes than had been identified in the previous 20 years.

There is recognition that these multiple efforts need to be coordinated effectively for the greatest possibility of realizing a return on investment that expedites prevention of the impending Alzheimer’s crisis.

The lack of effective treatments is not for lack of desire to address the current and impending impacts of chronic disease in general and Alzheimer’s, specifically. Indeed, from the perspective of the biopharmaceutical industry, this is a top priority. However, the high failure rate of potential treatments, in particular, discourages R&D and investment.

It is well recognized that a first step toward a cure is to try to identify the cause of the disease, individuals who are at risk for the disease, and potential targets for intervention.

I propose the development and execution of a large-scale, longitudinal study that will include sequencing the genomes of 100,000 volunteers in age cohorts from those in their 20s through those in their 80s, as well as obtaining biospecimens and additional health care data from those individuals, to develop biological markers that may predict Alzheimer’s or other chronic diseases for which the cause is unknown or poorly understood. This large-scale, long-range study will not only yield data necessary to find ways to cure and prevent Alzheimer’s, it would help researchers find ways to treat hundreds of other diseases for which we still lack adequate therapies.

Our hopes for cures hinge on understanding how to intervene to halt the disease’s progress. Through this proposed study, we would identify precursors and early signs of disease or disease risk. This information could be made publicly available so drug and device developers would have defined targets and potentially could develop ways to prevent and treat the disease.

The urgency of finding a cure for Alzheimer’s cannot be overstated. It is difficult to find anyone whose life has not been affected by this devastating disease. Biotech holds the greatest promise for finding a cure. We must act now for the patients and their families who are counting on us.

NOTE: Jim will be participating in a 21st Century Cures Initiative Roundtable in Lancaster, Penn. tomorrow to discuss how to expedite cures and treatments for devastating diseases such as Alzheimer’s. For more information on the event, please visit this link.

Aug
27

Back to School: Consider a STEM Career

Posted under back to school, Battelle, biotechnology jobs, Blog, Companies, Diagnostics, Funding, Inside BIO Industry Analysis, jobs, Medical Devices, Medical Supply, Pharmaceuticals, Startups, STEM, STEM Education, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization) Inside BIO Industry Analysis

With school resuming for many throughout the country this week, one question that may be on a lot of students’ minds (not to mention their parents) is how to ensure their education best prepares them for a successful career down the road.

For high school and college students considering which major to choose, a new survey from PayScale, reported by the Washington Post, offers a revealing look at which majors are most (and least) likely to lead to underemployment. The survey found that graduates with science, technology, engineering, and math (STEM) degrees were the least likely to be underemployed. In fact, 9 of the top 10 least underemployed majors were in a STEM field.

Biotechnology and bioscience companies are a major employer of STEM graduates. In 2012, they employed about 1.6 million Americans across more than 73,000 individual businesses. Over the past decade the industry has added nearly 111,000 new, high-paying jobs or 7.4 percent to its employment base. The industry continues its tradition of creating high-wage, family-sustaining jobs with average wages 80 percent greater than the overall private sector and growing at a faster rate.

Yet these jobs cannot be filled without a properly educated workforce. Research shows that over the next decade almost all of the 30 fastest growing job fields will require some science, technology, engineering and math (STEM) knowledge, yet people with strong science and technology backgrounds can be a scarce resource in today’s workforce. There are too few university students graduating in STEM fields to fill the positions available. For the U.S. to maintain its leadership in the STEM fields, we need to produce about one million more STEM professionals over the next decade than are currently projected.

With numbers like that, STEM fields are a great choice for students today to consider. For more information, visit stemcareer.com/students.

Aug
27

BIO Submits Amicus Briefs in Braintree v. Novel, Gilead v. Natco, and Bristol-Myers Squibb v. Teva Pharmaceuticals

Posted under Blog, Braintree v. Novel, Bristol-Myers Squibb v. Teva Pharmaceuticals, Companies, Diagnostics, Funding, Intellectual Property, Medical Devices, Medical Supply, Patently BIOtech, Pharmaceuticals, PhRMA, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization) Patently BIOtech

BIO has submitted briefs in three recent cases which could significantly impair drug and biotechnology efforts, urging reconsideration and review from both the Supreme Court and the U.S. Court of Appeals for the Federal Circuit.Untitled-1

BIO, in conjunction with PhRMA, submitted an amicus brief to the Supreme Court in Braintree v. Novel, arguing that the majority’s decision creates an unpredictable climate for patent claims. Vacating the prior claim construction precedent which had repeatedly interpreted “a” to mean “one or more” patients, the court instead deemed the term “a patient” to mean “a patient population.” This has narrowed the reading to exclusively more than one item, disrupting the consistency of claim terms and potentially harming the interests of BIO members.

In a brief to the Court of Appeals for the Federal Circuit in the case of Gilead v. Natco, BIO and PhRMA urged the court to review the case en banc. The court’s decision expanded the OPD doctrine in ways that conflict with Congressional intent and established precedent, risking immediate effects which could chill investment and development in biotechnology. The expansions of the ODP doctrine to limit the expected patent-derived marketplace exclusivity for some new drugs will reduce incentives for companies to invest and bring new drugs to market, endangering lives and suppressing innovation.

In Bristol-Myers Squibb v. Teva Pharmaceuticals, BIO argues that the panel’s decision to reject the patent for the BMS drug Baraclude® threatens to reduce incentive for researchers and investors in life saving compounds. Prior cases held that differences between a claimed compound and a prior art may be relevant evidence of non-obviousness, even if those differences are discovered after the patent application is filed.

The panel instead ruled that the evidence of the prior art compound’s toxicity, compared to the non-toxic inventive compound was not a relevant difference, and the non-toxicity of the inventive compound was not a relevant “unexpected result” because the prior art’s toxicity was not known at the time of invention. Researchers and investors will be unwilling to fund compounds with uncertain patent applicability, and may delay patent filing in case new, unexpected differences between the invention and prior art come to light during clinical testing. BIO strongly asserts that the patent system should promote research which seeks the best treatment, and this decision jeopardizes the future development of those treatments.