Oct 29th NevBio Meeting at Nevada Cancer Institute

"How to Manage Early Stage Drug Development" Dr. Peter Sausen of Covance Labs at the Nevada Cancer Institute
One Breakthrough Way, Las Vegas, NV 89135
Wednesday Oct 29th 11:30 AM Check-in, Speaker & Lunch 12 PM Cost: $35
Please RSVP-Judy at 839-7222 or jrebholz@cvbt.com

Sausen on "Managing Early Drug Development"

Dr. Peter Sausen of Covance Laboratories is focused on early stage drug development. He leads a team of scientists and project managers to help drug companies with their drug development needs from preclinical safety assessment through clinical proof of concept (Phase II) clinical trials. Dr. Sausen received his Doctorate in Toxicology from the University of Wisconsin-Madison in 1992. He completed a Postdoctoral Fellowship at the Chemical Industry Institute of Toxicology and has worked at G.D. Searle and Eli Lilly, before moving to Covance in 2005. In his article, "Effective Project Management for Multi-Sourced Early Drug Development," he noted the components associated with Investigational New Drugs (IND) and Clinical Trial Application (CTA):

· Genetic and molecular toxicology · Mammalian toxicology
· Safety pharmacology · Bioanalytical
· Drug metabolism · Dose formulations
· Program management · Regulatory strategy
· Pre-IND meetings · Investigator's brochure
· IND/CTA preparation · GMP analytical support
· Pharmacokinetics

He also noted the some of the causes for delays in development nonclinical stages such as:
· Interruption of drug supplies
· Unavailable validated analytical methods
· Lack of process for timely problem resolution
· Lack of process to assess data and interpret for inclusion in summary documents
· Failure to match nonclinical program with clinical goals

In Phases I & II, some of the causes for delays were as follows:
· Failure to prepare suitable formulation for clinical use
· Insufficient stability data to support clinical trials
· Lack of compliance with cGMPs
· Failure to prepare acceptable container label
· Inadequate information for ethics committee
· Inadequate insurance for trial participants
· Inadequate informed consent forms
· Lack of clearly focused clinical endpoints

Sausen summarized the article saying, "A well-designed development strategy is crucial to the success of a drug candidate which also requires developing a team with scientific and regulatory expertise to ensure that a streamlined and comprehensive development pathway is attained. The ability to funnel all phases of a study through a common pathway of data management, analysis, and reporting generates more efficient, consistent, and accurate results. Throughout the process the cumulative applied technical and scientific expertise of the study team is required to meet project requirements. In some cases, no amount of preplanning can predict all of the situations that may arise. The team must respond rapidly to scientific issues and regulatory requirements thereby ensuring the continued progress of the project towards critical milestones."

Sausen will be talking at the October 29, 2008 NevBio luncheon to be held at the Nevada Cancer Institute. The program will be two hours; although those who need to leave early, will be able.

Covance is a drug development services company that provides early-stage and late-stage product development services primarily to the pharmaceutical, biotechnology, and medical device industries worldwide. The company has over 8,000 employees and revenues over a billion. Covance believes in supporting growing biotech organizations and has graciously flown Dr. Peter Sausen to Las Vegas for this meeting. NevBio appreciates their support. COVANCE-HELPING TO BRING MIRACLES TO MARKET SOONER.

We also want to thank Nevada Cancer Institute for hosting this meeting.

Dr. Robert Webber of DSX Therapeutics to Present - Friday, September 12th

Dr. Robert J. Webber is the founder and CEO of DSX Therapeutics, Inc. Dr. Webber was trained at the UCLA School of Medicine in the Department of Biological Chemistry. He was the founder, CEO and Chief Scientific Officer of Research & Diagnostic Antibodies®, the parent company of DSX Therapeutics, Inc. He is a pioneer in producing monoclonal antibodies, their use in diagnostic tests, and their utility as highly targeted treatments of disease. Dr. Robert Webber is the inventor or co-inventor of four issued patents and 13 pending US and foreign patent applications.

DSX Therapeutics, Inc. -Going After $19 Billion Sepsis Market

North Las Vegas-Based DSX Therapeutics has developed the first new diagnostic test to identify Sepsis 24 to 48 hours before the symptoms become apparent. In addition, DSX Therapeutics has also discovered a breakthrough therapy to treat this life-threatening problem.

Over 7 million people annually become susceptible to Sepsis and 250,000 Americans die from Sepsis each year. DSX Therapeutics is going after the $864 million diagnostic market and later the $19 billion treatment market for Sepsis. The scientists at DSX Therapeutics Inc. were conducting clinical trials for a new sepsis in vitro diagnostic (IVD) test, when they discovered that iNOS was an early biochemical marker for the onset of sepsis. They also realized that iNOS appeared to be centrally involved in the pathology of sepsis. The initial discovery culminated in the filing of patent applications to protect three novel therapeutic treatment modalities for sepsis and severe sepsis.

Sepsis Kills 250,000 Americans: Tenth Leading Cause of Death

Sepsis is the number one cause of death in Intensive Care Units. Most people believe that Sepsis is an infection. It is not. Sepsis results from an individual's hyperinflammatory response to cell wall components from dead micro-organisms, such as bacteria, fungi, and yeasts. Unfortunately, Sepsis has very low Standard of Care in hospitals and hospital-acquired infections (nosocomial infections) are preventable events that affect approximately 2 million people in the USA every year and result in approximately 250,000 deaths per year. Currently, no early diagnostic test nor effective treatment exists for sepsis and severe sepsis. DSX Therapeutics has identified a biomarker and a treatment.

Chem Society Meeting in Las Vegas Researchers from UNLV & NevCancer

A number of Researchers from UNLV and Nevada Cancer Institute will be presenting at the American Chemical Society - 42nd Western Regional Meeting at the Riviera Hotel in Las Vegas from September 23rd to the 27th. Some of the topics are as follows:

"Proteomics in Cancer Research" by Dr. Ron Gary, UNLV

"Medicinal Chemistry in Cancer Drug Development" by Dr. Ron Fiscus, NevCancer

"New Developments in Biofuels Research" by Dr.Oliver Hemmers, UNLV

"Biodefense and Emerging Pathogen" by Dr. Ernesto Abel-Santos, UNLV

"Materials for Renewable Energy Applications" by Dr. Clemens Heske

"Lab-on-a-Chip Technology: Microfluidics/nanofluidics, for Chemical and Biochemical Applications" by Dr. Shizhi Qian, UNLV

"Radiochemistry in the Advanced Nuclear Fuel Cycle" by Dr.Ken Czerwinski, UNLV

More information can be found at http://membership.acs.org/W/wrm2008/index.htm
The Southern Nevada Section of the American Chemical Society and the Two Year College Chemistry Consortium (2YC3) are hosting the conference.

Pre-Med Advising Program at UNLV is Outstanding! 87% Acceptance into Med Schools

UNLV College of Science implemented a comprehensive Pre-Health Science Professional Program in January of 2005. As a result of this program, 87.5% of the students, gained acceptance to medical school. UNLV now exceeds the national acceptance percentage for medical school applicants of 48% for the last five years. Pre Med Program

UNLV Genomics Lab is Productive-51 Research Papers So Far

The Genomics Laboratory has enabled UNLV to publish 51 scientific peer reviewed science journals form 2005 to 2007 in the areas of BioMedical, Molecular Biology and Bioinformatics, and Physiology.

UNLV's College of Science's Fascinating Research

Ken Czerwinski leads a radiation chemistry program to improve medical treatment for cancer and to improve disposal of nuclear materials.

Frank van Breukelen studies hibernating ground squirrels to improve human organ transplant techniques.

Michelle Elekonich investigates aging and muscle use in honey bees to address human illness.

Ron Gary examines cellular responses to DNA damage with cancer treatment applications.

David Lee applies biomechanics to create robotic equipment with applications for human prosthetics and the repair of knee and ankle joints.

Carl Reiber looks at the physiology of shrimp to improve our knowledge of human cardiovascular functions.

Jeffrey Shen focuses on bioinformatics tools for genome analyses and gene annotations.

Anton Westveild creates mathematical models to spur cancer research investigations.

Helen Wing explores the biology and pathogeneses that causes dysentery in humans.

Clemens Heske studies hydrogen fuel applications and is in charge of a large DOE- funded hydrogen fuel project.

Dong-Chan Lee researches new electron-deficient semiconductors, organic field effect transistors, photovoltaic cells and nanostructured materials.

Brian Hedlund conducts research on unique thermophilic life forms in Nevada's hot springs which has resulted in promising industrial enzymes for use in biomass applications.

Ernesto Abel-Santos explores biotoxins and anthrax remedies.

Steve Roberts studies the biomechanics and aerodynamics of insects to create miniature robotic flying machines.

Adam Simon explores volcanoes to better utilize thermal energy resources in Nevada and around the globe.

Chulsung Bae experiments with energy storage and fuel cell membranes for hydrogen cars.

Balakrishman Naduvalath applies theoretical and computational algorithms to study chemical reaction and processes of interest in the earth's atmosphere with issues for atomic and molecular physics.

UNLV Energy Symposium: BioFuel, Solar, Hydrogen, Algae & More

August 20th at UNLV -Public Welcome

This year's Renewable Energy Symposium will have a number of timely talks:

"Solar Thermal Power" by John O'Donnell, VP of Ausra. Ausra has built a 130,000-square-foot facility in Las Vegas that opened in July 2008 that will eventually employ 50 people, who will be able to manufacture about four square miles of solar-thermal collectors a year, enough to generate 700 megawatts of electricity. (A megawatt can fuel anywhere from 400 to 1,000 homes depending on their energy consumption)

"New Bio-Energy Technologies" by Jay Johnson of Noresco. NORESCO is one of the largest U.S. energy services companies specializing in the development, design and operations of energy efficiency projects. Over the past two decades, NORESCO has implemented more than $2 billion in energy projects at more than 2,000 sites throughout the United States and abroad.

"Micro-Algae Could Play a Significant Role in Achieving Energy Independence" by Thomas Nartker of UNLV. UNLV could become the center of research and development of this promising, bio-fuel. Algae-biofuels could easily replace oil in the United States.

"Solar-Thermochemical Hydrogen Production Project - Progress Toward Industrial Scale Water Splitting" by Dr. Roger Rennels of UNLV. Hydrogen production by thermo-chemical water-splitting is a chemical process that accomplishes the decomposition of water into hydrogen and oxygen using only heat or a combination of heat and electrolysis instead of pure electrolysis. It is a goal of clean, renewable energy to create hydrogen production using only water and clean renewable solar energy.

"FCAST - The Fuel Cell and Storage Technology Project at UNLV" by Dr. Clemens Heske of UNLV. Dr Clemens is running this million dollar, DOE-funded research to establish develop hydrogen fuel cells and storage. The project includes 12 researchers at UNLV studying fuel cell membranes, nanomaterial fabrication, nanospectroscopy, carbon nanotubes, hydrogen absorption and other areas.

"New Functional Polymers for Alternative Energy Applications" by Dr. Chulsung Bae of UNLV. Dr. Bae is also working Dr. Heske Fuel Storage project. He received a Ph.D. in chemistry at USC in 2002 . In 2002, he moved to Yale University to carry out postdoctoral studies with Professor John F. Hartwig investigating functionalization of C-H bonds in alkanes and polyolefins.

"Saving 35% Electricity by By Improving Efficiency" by Brian Taylor of Power Efficiency Corporation (PEC). Las Vegas-based PEC has a patent pending device that saves up to 35% of the energy of electric motors. PEC has sold three of its units to Las Vegas hotels for their elevators and escalators. Brian Taylor is a Senior VP with PEC

Dr. Hemmers Makes The Case Algae-Based Biofuels -5,000 Gallons an Acre

"One acre of algae can produce 5,000 gallons of biodiesel as compared to corn which produces 420 gallons per acre," said Dr. Oliver Hemmers, the Director of Strategic Energy Programs at UNLV. Dr. Hemmers gave a presentation to the Nevada Biotechnology and Bioscience Consortium at their June 2008 meeting on biofuels.

Asked how long it would take to produce 5,000 gallons, Dr Hemmers went on to say, "One season. The longer and colder a winter is the shorter the period, similar to other crops. In warmer areas the production could be as high as 15,000 gallons per acre just because of the longer warm period." Some of the proposed algae-based fuel projects have suggested building the systems next to coal burning power plants.

The CO2 emissions could be used to feed the algae along with sun. Algae can capture up to 80% of the CO2 output of a plant which on average, produces over 5 million metric tons of CO2. A coal burning plant combined with an algae-pond system could produce 156 million gallons of biodiesel a year, at $2.25 a gallon that would be $351,000,000 in revenue a year.

A number of the researchers at UNLV believe that an algae pond system should be set up next to the Reid-Garnerville plant outside of Moapa, Nevada (90 miles north of Las Vegas) and it could be used to clean up one of the dirtiest per capita coal burning plants in the country and produce millions of gallons of biodiesel.

Dr. Hemmers said that Dr. Thomas Nartker, a Chemical Engineer at UNLV approached him about the potential of algae-based biofuels. A project like this would require scientists and engineers to work together. Because the algae grows exponentially, the challenge would be how to effectively deal with the volume that is produced. These are good challenges especially during these times of rising fuel prices.