San Diego Hosts 2013 AAPS National Biotechnology Conference

17 Friday May 2013

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2013 AAPS National Biotechnology Conference, antibody-drug conjugates, biotherapeutics, John Lisack Jr.

John Lisack, Jr., CAE is the AAPS Executive Director

Welcome from “America’s Finest City”! AAPS is thrilled to be returning to San Diego for our 2013 National Biotechnology Conference (NBC)!

From May 20 to 22, the Sheraton San Diego Hotel and Marina will host 1,500 scientists from industry, government and academia devoted to advancing health through innovations in biotherapeutics. The conference kicks off with two AAPS workshops, the 2013 AAPS Immunogenicity Training Course II: Advanced Topics in Evaluation of the Immunogenicity of Biotherapeutics, and three short courses. The NBC program will consist of a plenary session, 20 symposia, 9 roundtables, contributed paper poster presentations, and 4 hot topics. An exposition hall will be hosting over 110 major companies featuring innovative technologies. And an on-site job board will highlight current career opportunities in the field.

Drug Repurposing: Discovering New Prospects in the Past

16 Thursday May 2013

Posted by AAPS Blog in Current Perspectives

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Drug Development, Drug Repurposing, innovation, Maruthi Prasad Palthur

Maruthi Prasad Palthur is a senior director of technical operations and regulatory affairs at Indigene Pharmaceuticals Inc.

The average length of time from target discovery to approval of a new drug currently averages 13 years, the failure rate exceeds 95 percent, and after adjusting for all the failures the cost per successful drug exceeds $1 billion. As serendipitous discoveries diminish, a transformative approach of finding innovative ways to position approved drugs or abandoned clinical candidates in new disease areas has emerged. This sort of approach, with its scope from obvious to the progressive innovation goes by a variety of terms: drug recycling, drug repurposing, drug repositioning, drug rescuing, drug rediscovery, etc.

Computer Simulations: Make People Talk!

14 Tuesday May 2013

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clinical studies, computer simulation, Karin Liltorp

Karin Liltorp, Ph.D., is currently working as principal scientist at Particle Analytical Aps., an analytical laboratory performing physical chemical characterization of pharmaceutical drugs.

In many of the larger pharmaceutical companies, the outcome of clinical studies is predicted using computer simulations. An example of such a program is SIMCYP—a program I have used with great enthusiasm, but other excellent programs likely exist. In some cases, the computer predictions are spot on, and in other cases they do not reflect the situation in real life at all. Then why use the simulations if you never know the reliability of the predictions? The primary reason is that whatever the outcome is, you obtain a much better understanding of your product.

In a computer simulation, the journey of an active molecule is followed from when it enters the stomach until it is excreted. The journey starts in the stomach where the drug dissolves and continues into the intestines where it is absorbed into the bloodstream. Following, it is exposed to various enzymes; it is metabolized; and finally it leaves the body. This is a journey described by a very large number (thousands!) of differential equations. At any time-point of the journey you can get information about the current situation (e.g., concentration in the intestine, plasma concentration, etc.).

BRAIN Initiative in Need of More Specifics?

09 Thursday May 2013

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Andrew Porterfield, BRAIN Initiative, research

Andrew Porterfield has a master’s degree in biotechnology management from the University of Maryland and has worked as a marketing communications consultant for many biotechnology and pharmaceutical firms.

Understanding how the brain functions is one of our grandest challenges. Today, we still lack a universal model for how neurons and other cells interact to produce thoughts, emotions, reactions, and disease. On the disease front, we are still stymied by major illnesses, including depression, schizophrenia, and autism. Not to take an electronics metaphor too far, but what may be needed is a research jump start.

Such a prodding may come from the new BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, which was proposed by the White House last month and is included in the President Barack Obama’s 2014 proposed budget. The BRAIN Initiative will appropriate $100 million through the National Institutes of Health, the Defense Advanced Research Projects Agency, and The National Science Foundation to support research on developing new technologies and tools that can provide better images of brain function—and more work on determining single-cell function as well as the dynamics of complex neural circuitries. In addition, the initiative already has identified partners who will engage in BRAIN projects; these partners include the Allen Institute for Brain Science, Howard Hughes Medical Institute, and The Kavli Foundation.

Supreme Court Wrestles with the Patentability of Genes

08 Wednesday May 2013

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Cristin Cowles, genes, patent, Supreme Court

Cristin Cowles , Ph.D., is a patent attorney at McCarter and English, LLP, with over eleven years of experience prosecuting biotechnology and pharmaceutical patents.

In a somewhat unexpected turn of events, in March 2010 a judge from the U.S. District Court from the Southern District of New York ruled that human genes are not patentable in a lawsuit brought by the Association for Molecular Pathology (AMP) against Myriad Genetics.

At issue were a number of patents owned by Myriad directed to isolated DNA encoding the BRCA1 and BRCA2 genes used in cancer testing in patients. AMP successfully argued that Myriad’s patents were invalid because they cover human genes which are a “product of nature” and, therefore, not patentable. Interestingly, AMP was represented by the American Civil Liberties Union (ACLU).

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San Diego Hosts 2013 AAPS National Biotechnology Conference

John Lisack, Jr., CAE is the AAPS Executive Director

Drug Repurposing: Discovering New Prospects in the Past

Maruthi Prasad Palthur is a senior director of technical operations and regulatory affairs at Indigene Pharmaceuticals Inc.

Computer Simulations: Make People Talk!

Karin Liltorp, Ph.D., is currently working as principal scientist at Particle Analytical Aps., an analytical laboratory performing physical chemical characterization of pharmaceutical drugs.

BRAIN Initiative in Need of More Specifics?

Andrew Porterfield has a master’s degree in biotechnology management from the University of Maryland and has worked as a marketing communications consultant for many biotechnology and pharmaceutical firms.

Supreme Court Wrestles with the Patentability of Genes

Cristin Cowles , Ph.D., is a patent attorney at McCarter and English, LLP, with over eleven years of experience prosecuting biotechnology and pharmaceutical patents.

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