Bioresearch Compliance Report
The Insider’s Guide to GCP and GLP Compliance and Enforcement

Online Update Page, July 24, 2006

Human subject protection

New members appointed to HHS’s Human Research Protections National Advisory Committee

Department of Health and Human Services (HHS) Secretary Michael Leavitt announced July 19 the appointment of seven new members to the Secretary’s Advisory Committee on Human Research Protections (SACHRP).

The 11-member committee, which meets three times a year, comprises leaders in human subject protections and/or clinical research. Its members are appointed to four-year terms and provide recommendations to the secretary on the responsible conduct of research involving human subjects.

The SACHRP also is responsible for reviewing and evaluating the activities of Office for Human Research Protections (OHRP) and other offices and agencies within HHS that are responsible for human subject protection in both biomedical and behavioral research.

Additionally, the SACHRP committee also offers advice and recommendations on policy and program development, program implementation and evaluation, and other matters of significance to the human research-related mission and goals of HHS.

The new members include:

• James Powell, M.D. — Powell serves as senior medical director and head of the clinical pharmacology and pharmacokinetics (PKs) department at Proctor & Gamble Pharmaceuticals. Powell also serves as a member of the Physician Investigator Certification Council for the American Academy of Pharmaceutical Physicians.

• Neil Powe, M.D. — Powe is a professor of medicine at the Johns Hopkins University School of Medicine, a professor of epidemiology and health policy and management in the Hopkins’s School of Public Health, and holds a joint appointment in the Hopkins’s School of Nursing. Powe also serves as director of the Welch Center for Prevention, Epidemiology and Clinical Research, a multidisciplinary research and training center at the Johns Hopkins, which is focused on clinical and population-based research.

• Jeffrey Botkin, M.D. — Botkin is a professor of pediatrics and medical ethics and associate VP for research integrity at the University of Utah. He also is a fellow of the Hastings Center and chair of the American Academy of Pediatrics Committee on Bioethics. Additionally, Botkin serves as a member of the SACHRP Subcommittee on Research Involving Children.

• Myron Genel, M.D. — Genel serves as professor emeritus of pediatrics at Yale University School of Medicine. Genel served for 19 years as the associate dean and director of the Yale University School of Medicine office of government and community affairs. Genel also is a former chair of the Assn of American Medical Colleges Council of Academic Societies and the American Medical Assn Council on Scientific Affairs.

• Daniel Nelson — Nelson is associate professor of social medicine and pediatrics and director, office of human research ethics, at University of North Carolina. Nelson has responsibility for providing global oversight for seven Institutional Review Boards (IRBs) and approximately 400 research studies. His previous work experience includes faculty appointments at the Mayo Clinic and the University of Rochester, where he was director of research in a clinical unit and chair of a hospital IRB.

• Francine Romero, Ph.D. — Romero, an epidemiologist, serves as the director of the Northern Plains Tribal Epidemiology Center, Rapid City, SD. Romero also serves as a member of several health boards and has been active in the Indian Health Service’s Portland Area IRB.

• Samuel Tilden, M.D. — Tilden is a professor of pediatrics, deputy provost for human subjects research and research compliance officer at the University of Alabama.

More information about the work of SACHRP is available at http://www.hhs.gov/ohrp/sachrp/.

Drug/device review

FDA announces plan to strengthen advisory committee processes

FDA July 24 announced several steps it plans to take “to help make its advisory committee processes more effective at providing timely, top-tier, independent scientific advice to the agency and at reassuring the public about the basic integrity of this process.”

This effort includes the development of guidances to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts-of-interest, as well as additional efforts to implement more streamlined approaches that will improve the transparency in the appointment of members to the agency’s advisory committees, the agency said in a press statement.

Proposed future guidances include:

• Issue a guidance identifying more clearly the conditions under which conflict-of-interest waivers are granted. For example, the agency noted that currently waivers can only be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities;

• Issue a guidance specifying when waivers of conflict-of-interest will be disclosed to the public and what information will be made available;

• Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available;

• Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee listserv and postings on FDA’s website; and

• Implementation of a more streamlined approach to the appointment of members to the agency’s drug-related advisory committees.

In addition, FDA previously announced that the agency’s Center for Drugs is launching an internal assessment of its use and involvement with the advisory committee program of the agency. Led by senior management within CDER, this comprehensive look at current advisory committee practices will include, among other things:

• Processes for choosing members with expertise specific to meeting topics,

• Development of an agenda and questions for the committee, and

• Preparation of background materials and presentations for the meetings.

“The primary role of an advisory committee is to provide the agency with expert, independent advice on complex scientific issues presented to FDA,” the agency emphasized.

“This advice contributes to the quality of the agency’s regulatory decision-making and strengthens the credibility of the FDA decision-making process by having public discussions of difficult scientific questions by leading experts, the agency staff and the agency’s stakeholders.”

Stem cell research

Stem Cell Bill gets Bush’s first veto, but Congress fails to override

President Bush issued the first veto of his five-year-old administration July 19 rejecting Congress’s bid to lift funding restrictions on human embryonic stem cell research. The House and Senate passed the bill but not with the two-thirds majorities required to override a veto. The Senate voted 63–37 July 18. The House voted 235 to 193 to override Bush, falling short of the threshold and negating the need for a Senate override attempt.

However, Bush did sign one bill on the same day, which was unanimously passed by the House and Senate — to ban the creation of human fetuses for the sole purpose of harvesting organs. But, the House thwarted prompt passage of another bill Bush had hoped to sign, which would have promoted efforts to conduct stem cell research without destroying human embryos. Bush called it “an important piece of legislation,” but several Democrats said it was nothing more than a “political fig leaf” intended to distract attention from his veto of the long-debated funding measure for embryonic stem cells.

In an overtly dramatic flair, at a White House ceremony, Bush was joined by children produced from what he called “adopted” frozen embryos. In a speech, Bush said taxpayers “should not support research on surplus embryos at fertility clinics, even if they offer possible medical breakthroughs and are slated for disposal.” The vetoed bill “would support the taking of innocent human life in the hope of finding medical benefits for others,” Bush stressed.

Democrats said voters will penalize GOP candidates for the demise of a popular measure, and predicted the issue could trigger the defeat of Bush allies, such as, Sen. James M. Talent (R-MO) who faces a tough reelection battle in Missouri.

“Those families who wake up every morning to face another day with a deadly disease or a disability will not forget this decision by the president to stand in the way of sound science and medical research,” Sen. Richard Durbin (D-IL) told the press.

Even some conservatives criticized the veto. “I am pro-life, but I disagree with the president’s decision,” said Senate Majority Leader Bill Frist (R-TN), a heart surgeon who is considering a 2008 presidential run. “Given the potential of this research and the limitations of the existing [human embryonic stem cell] lines eligible for federally funded research, I think additional lines should be made available.”

On Aug. 9, 2001, Bush signed a bill banning government funding for research using human embryonic stem cell colonies created after that date. Over the next five years, public sentiment increasingly moved away from him as celebrities — such as, Nancy Reagan and Christopher Reeves — became spokespersons for the potential that embryonic stem cells offer in treating Alzheimer’s disease, Parkinson’s disease, diabetes, spinal cord injuries, and other conditions and diseases. Unlike “adult” stem cells, embryonic cells can replicate themselves and turn into almost any human tissue.

Officials say that about 400,000 frozen embryos are stored at U.S. fertility clinics. The vast majority await disposal because the couples that produced them have completed their pursuit of children and do not want another person to raise their biological child. Bush praised those who “adopt” such embryos, implant them in a woman’s womb and bring them to term. But, experts say there are few such adoptions because most couples seeking a child through in vitro fertilization want a genetic connection to that child.

“Even with federal funding available to encourage adoption, the number is 128, which makes it conclusive that these 400,000 embryos will either be used for scientific research or thrown away,” Sen. Arlen Specter (R-PA), a proponent of the bill, told the “Washington Post.”

EU to continue stem-cell research funding

Despite President Bush’s veto of the U.S. Stem Cell Bill July 19, the European Union (EU) announced July 24 it will continue financing human stem cell research. Ministers from the bloc’s 25 member states made the decision, overcoming opposition from a group of mostly Catholic countries.

The funding — to come from the EU’s $65-billion research budget for 2007-2013 — will be available only in those EU countries that allow embryonic stem cell research, and under strict conditions including a ban on research aimed at human cloning for reproductive purposes or intended to modify the genetic heritage of human beings.

In a concession to the original eight opposing countries, the ministers agreed EU money would not be used to finance research activities directly intended to destroy human embryos. However, EU funding of “subsequent steps” involving human embryonic stem cells would be allowed. Poland, Austria, Malta, Slovakia and Lithuania voted against the updated rules; but Germany, Italy and Slovenia (initially opposing the rules) changed their stance at the last moment and backed the proposal.

Most European laboratories already work with adult stem cells. The new rules will be in place until 2013.

Stem Cell Authority offers ethical alternative to alleviate political stem cell deadlock between U.S. Congress, President

Following President Bush’s veto against stem cell progress, Stem Cell Authority Ltd., Akron, OH, issued a press release announcing what it calls “an ethical and non- controversial alternative to the national embryonic stem cell debate.”

The ethical alternative offered by Stem Cell Authority Ltd. is the use of Wharton’s Jelly matrix stem cells, which recent evidence has indicated can differentiate into neurons, glia, skeletal muscle cells, heart muscle cells, bone cells, cartilage cells and liver cells, the company said.

Stem Cell Authority said its subsidiary company, OB/GYN CellSecure, Inc., is the exclusive licensee of technology developed by Kansas State University, which allows for the collection of the matrix stem cells from the Wharton’s jelly that is within the human umbilical cord.

The collection is accomplished safely and painlessly without risk to the child after birth, Stem Cell Authority explained, and the collection of the matrix stem cell is compatible with collection of umbilical cord blood stem cells.

The company said it believes its ability to collect and cryogenically store human pluripotent umbilical cord matrix stem cells could give it the potential to be one of the most important sources of stem cells available, and to become a market leader in this expanding biotech industry.

Calif. gives $150 million to stem cell research

In the wake of President Bush’s stem cell funding veto, Gov. Arnold Schwarzenegger, a conservative Republican, unexpectedly authorized a $150-million loan to the California Institute for Regenerative Medicine, an agency that intends to spend $3 billion on stem cell development in the next decade.

Schwarzenegger told the press that he felt there was a risk that the industry and movement would be set back by the veto. “He wants California to be a leader in industry,” Adam Mendelsohn, Schwarzenegger’s communications director, told the “San Francisco Chronicle.”

In 2004, Californians passed Proposition 71, a research-funding bill that positioned the state to become a leader in the stem cell research. But despite popular support for the Institute, funding is at a stalemate because of legal objections by those who oppose stem cell research and the $3 billion price tag it carries.

In April, a state judge handed the institute its first legal victory, but more than a year of litigation is expected before the California Supreme Court delivers its final word.

Mendelsohn told the Chronicle, Schwarzenegger hopes the loan, combined with another $50 million of funding from private foundations, will expand the institute’s budget to $200 million this year.

Geron announces publication of study results supporting safety, utility of human embryonic stem cell-derived therapeutic product for treatment of spinal cord injury

Geron Corp., Menlo Park, CA, July 19 announced the publication of preclinical studies that support the safety and utility of GRNOPC1, Geron’s lead human embryonic stem cell (hESC)-based therapeutic product for the treatment of spinal cord injury.

In the studies published in “Regenerative Medicine,” Hans Keirstead, M.D., and his colleagues at the University of California–Irvine, explained how they injected GRNOPC1 into the lesion site of rats that received either very mild or moderate spinal cord contusion injuries. GRNOPC1 survived in both the mild and moderate lesion sites, with a broader distribution of transplanted cells and robust remyelination in the more severe injuries, replicating previous studies, the authors said.

Specifically, rats that received the mild injury exhibited a transient decrease in hind limb ambulatory activity, which resolved completely within one to two weeks. Because these animals completely recovered in a relatively short period, they serve as a sensitive model to detect any intervention that may interfere with recovery, the researchers emphasized. Transplantation of GRNOPC1 did not impede the rate or stability of recovery in the mildly injured animals.

GRNOPC1 is a population of oligodendroglial cells differentiated from hESCs. Oligodendrocytes are the cells of the central nervous system that provide insulation, known as myelin, for axons, the conduits of nerve impulses. After spinal cord injury, axonal damage occurs from either physical trauma or demyelination leading to aberrant nerve conductance. Geron said GRNOPC1 has been shown to restore myelination to axons after injury and to stimulate axonal survival and growth, both in tissue culture and in the injured rodent spinal cord.

Gene research/genomics

Israeli scientists find genetic DNA code

Scientists at the Weizmann Institute of Science, Rehovot, Israel, in collaboration with colleagues at Northwestern University, Evanston, IL, announced July 19 they have discovered the genetic code for organizing DNA.

According to the announcement, the researchers have identified the genetic code that sets the rules for where on the DNA strand the nucleosomes will be situated. For many years, scientists have been unable to agree whether the placement of nucleosomes in live cells is controlled by the genetic sequence itself.

Now, Eran Segal, a professor at Weizmann Institute, and colleagues, say they have found the DNA sequence does encode “zoning” information on where to place nucleosomes. They characterized that code and then, using the DNA sequence alone, were able to accurately predict a large number of nucleosome positions in yeast cells.

The research is detailed in the journal “Nature.”

Blood test predicts sickle cell disease complication, identifies patients at high risk of death

A team of scientists at NIH’s National Heart, Lung and Blood Institute (NHLBI) said July 21 they have found that a hormone detected in a simple blood test, which can identify patients with sickle cell disease who have developed a life-threatening complication called pulmonary hypertension.

The team also found that the same hormone is a clear predictor of death in adult sickle cell patients. The hormone — called brain natriuretic peptide (BNP) — is released by the heart ventricles and helps predict death in heart failure patients.

Previous research has found that in patients with pulmonary hypertension, higher levels of BNP are associated with greater pressure in the pulmonary arteries. NHLBI researchers theorized that BNP levels might also correlate with the severity of pulmonary hypertension and risk of death in sickle cell patients.

Lead scientist Roberto Machado, M.D., an investigator with NHLBI’s Vascular Medicine Branch, and colleagues, including scientists in NIH’s Clinical Center, measured BNP levels in 230 patients with sickle cell disease enrolled in the NIH Pulmonary Hypertension Screening Study between 2001 and 2005. BNP levels also were measured in 45 healthy African-American controls, since the disease is more prevalent in African Americans.

The scientists found that high blood levels of BNP greater than 160 pg/mL in these patients independently predicted mortality, increasing the risk of death by as high as fivefold. The team also found that BNP levels could help identify the patients with pulmonary hypertension. NIH study patients who had a BNP of 160 pg/mL or higher had a 78% chance of having pulmonary hypertension identified by echocardiogram.

To validate and confirm the findings, the team then measured BNP levels in 121 stored blood samples from patients who had been enrolled in a sickle cell drug treatment study — the Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia Follow-up Study — which began in 1996.

The researchers found that 30% of patients in the MSH study had a BNP level greater than 160 pg/ml, consistent with a diagnosis of pulmonary hypertension. Most importantly, these patients had a threefold increased risk of death compared with patients without pulmonary hypertension.

“The MSH analysis validated the connection between high BNP blood levels, pulmonary hypertension and risk of death, found in the NIH study patients,” said Mark Gladwin, M.D., chief of NHLBI TMs Vascular Medicine Branch. “It also revealed that almost a third of sickle cell patients in the 1996 MSH study had undiagnosed pulmonary hypertension.

“Perhaps the most intriguing finding, these data suggest that it is pulmonary hypertension — not painful crises or acute chest syndrome — that is the major risk factor for death in adults with sickle cell disease.”

Pulmonary hypertension often leads to heart failure and it is a major risk factor for death in adults with sickle cell disease, the scientists noted. Currently, echocardiograms and other heart tests are used to diagnose pulmonary hypertension, but there has not been a blood test to help detect the condition.

The study was published in the “Journal of the American Medical Assn.”

NHGRI announces latest sequencing targets; gibbon genome sequence to be added to primate tree

NIH’s National Human Genome Research Institute (NHGRI) July 19 announced several new sequencing targets including the Northern white-cheeked gibbon (Nomascus leucogenys), setting the stage for completing a mission to sequence the genome of at least one non-human primate genome from each of the major positions along the evolutionary primate tree and making available an essential resource for researchers unraveling the genetic factors involved in human health and disease.

NHGRI’s Large-Scale Sequencing Research Network and their international partners have already sequenced — or have been approved to sequence — at high-density coverage the genomes of several non-human primates including the chimpanzee (Pan troglodytes), the rhesus macaque (Macaca mulatta), the orangutan (Pongo pygmaeus), the marmoset (Callithrix jacchus) and the gorilla (Gorilla gorilla).

The gibbon genome is unique because it carries an extraordinary high number of chromosome rearrangements, even when compared to other primates, the researchers noted. These rearrangements occur when small or large segments of a chromosome become detached and reattach to the same chromosome or another chromosome. Such chromosomal rearrangements can contribute to birth defects or other diseases in humans.

NHGRI researchers said the gibbon genome also will help scientists better understand rearrangements called segmental duplications, which are large, almost identical copies of DNA present in at least two locations in the human genome. A number of diseases are known to be associated with mutations in segmental duplicated regions.

“The gibbon genome sequence will provide researchers with crucial information when comparing it to the human genome sequence and other primate genomes, shedding light on molecular mechanisms implicated in human health and disease — from infectious diseases and neurological disorders to mental illness and cancer,” noted Francis Collins, M.D., director, NHGRI.

According to Collins, segmental duplications cover 5.3% of the human genome, significantly more than in the rat genome, which has about 3%, or the mouse genome, which has between 1% and 2%.

Segmental duplications provide a window into understanding how the human genome evolved and how it may still be changing. Moreover, the researchers emphasized, the high proportion of segmental duplications in the human genome shows how human genes have undergone rapid functional innovation and structural change during the last 40-million years, presumably contributing to unique characteristics that separate humans from non-human primate ancestors.

Scientists coax nerve fibers to regrow after spinal cord injury

In findings published in the “Proceedings of the National Academy of Sciences,” researchers at Johns Hopkins University and the University of Michigan said they have developed a treatment that helps spinal cord nerves regrow after injury.

The researchers treated experimental nerve injuries in rats with an enzyme, called sialidase, which they isolated from bacteria. Four weeks later, more than twice as many nerves in the spinal cords of sialidase-treated rats grew new nerve fibers compared to untreated rats.

The experimental injury in rats mimicked an injury in humans that may occur during childbirth or in motorcycle accidents when an arm is pulled violently away from the body, the researchers explained. Such an occurrence causes nerves to be yanked out of the spinal cord.

Molecules in the environment of an injured spinal cord specifically instruct the nerve ends not to regrow, explained the study’s director, Ronald Schnaar, Ph.D., professor of pharmacology and neuroscience in the Institute of Basic Biomedical Sciences at Johns Hopkins.

“The brain and spinal cord are extremely crowded with nerves and nerve fibers, which may be why we have developed careful controls that tell cells to stop making new connections,” Schnaar elaborated.

He said the researchers looked at the boundary between the spinal cord and the periphery to see if they could coax a nerve end to grow out of the inhibitory spinal cord into a more permissive environment that contains fewer ARIs [axon regeneration inhibitors]. They chose to mimic the injury commonly seen in motorcycle accidents, called brachial plexus avulsion, because it involves nerves at the boundary between the spinal cord and periphery.

The researchers surgically severed nerves that normally extend from the spinal cord to the shoulder of anesthetized rats. They then transplanted a nerve from the hind leg of the same animal into the spinal cord to reconnect the injured nerve ends. To coax the injured nerve ends to grow fibers and connect to the transplanted nerve, they used an implanted pump to bathe the area with one of three different enzymes known to destroy ARIs.

Four weeks after transplantation and enzyme treatment, the researchers injected dyes into the nerves to see whether and how many nerve fibers grew from the injured cells of the spinal cord into the transplanted nerve. Rats treated with one of the three enzymes tested, sialidase, showed well over twice the number of new nerve fibers than rats treated with saline, which is not expected to enhance nerve growth. Moreover, the researchers saw that the new fibers were made by nerve cells residing in the spinal cord.

“We have established that the enzyme sialidase, which destroys one of the molecules that inhibits nerve regeneration, is sufficient to robustly improve nerve fiber outgrowth from the spinal cord,” added Schnaar.

Schnaar said there is some evidence that this transplant technique coupled with sialidase treatment can coax other, nearby nerve cells within the spinal cord to grow out as well. “Once you rewire, then the brain does an amazing job of sorting it all out,” he said.

Having established the ability of sialidase to improve spinal nerve regeneration into transplanted peripheral nerves, Schnaar and his research team at Hopkins are testing the same treatment to see whether it will help nerve regeneration in other types of spinal cord injuries.

“Even a small improvement might mean a lot. People with spinal cord injuries generally are not looking to play football,” noted Schnaar, “but to regain basic functions. A modest improvement in nerve regeneration might make a big improvement in a patient’s quality of life.”

Research and development

Scientists develop SARS vaccine with common poultry virus

Scientists at the Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM), College Park, MD, said they have engineered a recombinant Newcastle disease virus (NDV), an avian paramyxovirus, to create a vaccine that holds promise to protect humans against multiple diseases, including SARS and human parainfluenza viruses.

Additionally, the researchers said their future research will include a vaccine for the avian influenza H5N1 and other human viruses for which vaccines are currently not available.

“The NDV makes a very good vector for creating human vaccines,” noted Siba Samal, the research team leader and associate dean of the VMRCVM.

“NDV replicates in species other than poultry, but not enough to cause disease. Also, there are nine types of paramyxoviruses and NDV is Serotype 1, so we can make similar vaccine vectors with other avian paramyxovirus types, which can be used to protect against more than one disease.”

Samal said the research team is collaborating with researchers at NIH to develop such vaccines for humans.

New NIAID program aims to model immune responses and key infectious diseases

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) announced July 16 a new program designed to better understand the complex biochemical networks that regulate the interactions between infectious organisms and the cells they infect.

The Program in Systems Immunology and Infectious Disease Modeling (PSIIM) will employ a powerful new approach called computational systems biology to develop a deeper understanding of how pathogens cause disease and how the immune system responds to them.

The goal of the PSIIM, which is a component of NIAID’s Division of Intramural Research (DIR) under the leadership of immunologist Ronald N. Germain, M.D., is to create a way to ask how whole systems of molecules, cells and tissues interact during an immune response or when confronted with an infectious agent.

“Once we understand these interactions, we can make strategic decisions about how to interfere with infectious disease pathology or how to direct immune responses to better fight infections,” explained Kathryn C. Zoon, Ph.D., director, DIR. Zoon pointed out that these new insights could serve as the starting point for the design of new drugs to treat diseases or the development of new vaccines.

By creating computer models of complex molecular interaction networks, PSIIM investigators will be able to simulate the biology of cells, tissues and, eventually, organisms. The program will also use state-of-the-art experimental approaches to determine how closely these simulations predict real behavior. As the models improve, scientists should gain the ability to predict how drugs and other interventions will affect a cell or organism and whether such treatments will be tolerated by the host while they fight the infectious agent.

Although most of the studies will be conducted with less dangerous pathogens, special facilities in the new C. W. Bill Young Center for Biodefense and Emerging Infectious Diseases at NIH also will enable PSIIM scientists to examine such questions with microbes that cause diseases, such as, anthrax, virulent forms of influenza, tularemia and plague.

The cornerstone of the PSIIM research project is a software package called Simmune, which enables biologists to model many types of biological systems. Created by NIAID scientist Martin Meier-Schellersheim, Ph.D., and his colleagues, the software allows a scientist to use a simple graphical interface to easily define the interactions between individual molecules in a large network, or the behaviors of cells in response to external signals.

Once a scientist inputs quantitative information obtained by laboratory measurements, Simmune can then simulate the behavior of the whole signaling network or of an entire cell. The software does this by automatically creating a mathematical model involving special equations and then solving these equations for the specific conditions the user entered into the program.

“The hope is that these models will provide a deeper understanding of how complex behaviors arise, leading to new insights into disease,” Germain noted. “One of the great advantages of Simmune is that it gives biologists a way to do the difficult mathematics needed for such modeling without having to actually be involved with the mathematics.”

In the first stringent test of the new software, Germain and colleagues demonstrated that Simmune can accurately predict cell function in both time and space. The study, published in the July 21 edition of the journal “PLoS Computational Biology,” describes how the researchers used the software to model a complicated cell-biological behavior known as chemosensing — a biological process whereby cells sense and respond to external signals. Using Simmune, the NIAID team modeled what happens in a stimulated cell to the distribution of a phospholipid. The concentration of the phospholipid changes during chemosensing mainly due to the action of two enzymes that synthesize or break down this molecule.

Scientists had thought that the destructive biochemical reaction that helps produce high and low concentrations of the phospholipid in different parts of the cell was regulated through some unknown mechanism acting throughout the cell. But a new model developed with Simmune predicted that the enhanced concentration of phospholipid at the “front” end of the cell (facing the source of chemical signals) resulted from a combination of two known mechanisms — a very rapid local inhibitory activity and the slower movement of another molecule to a distant part of the cell.

NIAID researchers, who tested their predictions in the laboratory, found that the experimental data matched very closely what they had predicted with Simmune.

CROs

Czura Thornton announces acquisition of leading, independent clinical CRO: Chiltern International

Czura Thornton, Ltd., London, July 21 announced the acquisition of Chiltern International, one of the world’s leading independent clinical contract research organisations (CROs), for an undisclosed sum.

Established in the U.K in 1982, Chiltern has extensive experience in running national and international Phase I to Phase IV clinical trials across a broad range of therapeutic categories. The company has offices throughout the U.S., Europe and India, with headquarters in Slough, U.K., and Carlsbad, CA.

Chiltern provides clinical operations, project management, bio-analytical, data management, biostatistics, medical writing, quality assurance and regulatory and medical affairs services to the pharmaceutical, biotechnology and medical device industries. The company also offers clinical contract personnel services to pharmaceutical and biotechnology clients.

Czura Thornton has extensive experience in international business and particularly in the CRO industry. Czura Thornton’s other investments to date include medical diagnostic laboratories and commercial search directories and services.

ARUP Labs to expand client outreach services

ARUP Laboratories, Salt Lake City, July 20 said it is expanding its outreach program to include a comprehensive suite of services that will enable its clients to have a positive impact on their local health community.

ARUP is a national clinical and anatomic pathology reference laboratory. According to Ronald Weiss, M.D., a professor of pathology, and president and COO of ARUP Labs, ARUP Direct will serve as an umbrella structure for the outreach services to provide clients with critical services and skills necessary to compete in the local and regional marketplace.

As part of the expansion, the company announced that Anne Messing joined ARUP as outreach development manager. She will work closely with clients to maximize growth through effective outreach programs. Messing has over 15 years experience in the health care industry and has extensive experience in laboratory operations and management, outreach operations and management, funding procurement for capital equipment and budgets, as well as other laboratory-related business disciplines.

Electronic health information

NCI adopts BioFortis’s translational research software; software has applications for human tissue repository and research data management

BioFortis, Baltimore, announced that National Cancer Institute (NCI) has selected its software, Labmatrix, for use within its Center for Cancer Research (CCR).

CCR, NCI’s intramural research program, comprises multiple labs, branches and core facilities supporting both clinical and basic sciences, with a focus on translational cancer research.

Labmatrix, a Web-based, enterprise translational research information management software product, is being used by CCR to support human subjects research by integrating clinical data with genomic, proteomic and laboratory experimental data, as well as maintain annotated tissue banks, BioFortis explained.

NCI said it chose Labmatrix because of the product’s ability to track human biological specimens, IRB consents, sample usage and downstream analytical results. Moreover, it is especially important in today’s regulatory environment, which demands responsibility and accountability from researchers and research administrators to document and maintain audit trails of all use of human specimens for research.

“NCI’s decision to implement Labmatrix, after extensive trials and very positive user feedback, is clear demonstration of the value of our technology for clinical and translational research,” added Jian Wang, M.D., president and CEO, BioFortis. “The relationship with NCI is a key element of our strategy to support collaborative biomedical research for a much wider user base in the government, academic and biopharmaceutical industry segments.”

Most states developing roadmap to support health care quality improvements through electronic HIE: survey findings

Over half of the states in the U.S. are either initiating planning as a result of state legislation or an executive order, or have planning well under-way, related to health information technology (HIT) adoption or health information exchange (HIE); and, an additional seven states are in the process of implementation, according to new survey findings from the eHealth Initiative (eHI) and its foundation.

The 2006 survey reviewed over 165 multi-stakeholder efforts across the U.S., representing initiatives in nearly every state, Puerto Rico and the District of Columbia. The survey also looked at a recent rapidly emerging phenomenon — the role of state leaders in planning, coordinating and implementing policy and in some cases, practical issues related to the use of HIT in improving health and health care.

“Many states are now launching public-private collaborative efforts to develop plans and roadmaps for improving health and healthcare through HIT,” said Emily Welebob, VP, program operations, eHI.

Other key findings of the survey included:

• About half of the states in the U.S. have either an executive order or a legislative mandate in place that is designed to stimulate the use of HIT to improve health and health care; Emphasis on quality, patient safety and curbing rising health care costs rank high as the primary drivers for state leadership around HIT;

• Most states are convening or participating in multi-stakeholder groups engaged in dialogue to develop plans for improving health and health care through HIT;

• States are increasingly providing grant funds to support not only regional and local HIE efforts, but also the development of plans;

• In most cases, either the Governor’s Office or the state’s Department of Health is taking leadership in state-wide efforts related to HIT; and

• States are recognizing the importance of local efforts, and are taking steps to closely integrate state initiatives with efforts at the regional and local levels.

Moreover, according to eHI’s July 2006 analysis of state legislative efforts, about 125 HIT-related bills have been introduced in 38 states, with 36 bills in 24 states passed into law. The most common provisions establish a task force to study the impact of HIT, or authorize a committee to create a strategy for the development, implementation and adoption of electronic medical records and/or a health information infrastructure.

Most executive orders authorize a planning committee to develop an HIT strategy or policy. States vary in the level of involvement in activities. According to eHI:

• 38 states are participating in a state-wide or local dialogue related to HIT and health information exchange, while 21 states are actually convening stakeholders for planning, communication and coordination;

• 16 states are providing staff to plan activities or serve in a project-management role; and,

• 17 states are providing funds to support regional and local efforts.

eHI said the full survey report will be released in September in conjunction with eHI’s Third Annual Health Information Technology Summit, Sept. 25-27 in Washington. [See “Conferences” for more information].

FDA management

CBER names first medical director for emerging and pandemic threat preparedness

CBER July 20 announced the appointment of Mark Goldberger, M.D., as medical director for emerging and pandemic threat preparedness.

In this newly created position, Goldberger will serve as a senior advisor for CBER’s pandemic flu program to plan, coordinate and implement activities related to the development and evaluation of products for emerging and pandemic threats.

Goldberger began his career with the agency in 1989 as a medical reviewer, and currently serves as director of the Office of Antimicrobial Products in CDER. Prior to his work with the Center for Drugs, Goldberger, taught clinical infectious diseases at Columbia University for nearly 10 years.

Goldberger also served as an epidemic intelligence service officer at Centers for Disease Control and Prevention.

“Emerging infectious diseases present a constant challenge for public health agencies, and FDA is committing resources and leadership to combat this growing threat,” said acting FDA Commissioner Andrew von Eschenbach, M.D., in a press statement.

“Dr. Goldberger has been at the forefront of combating other emerging infectious diseases, and we are grateful he has agreed once more to help tackle another monumental challenge, preparing for pandemic influenza and other future threats.”

People

Registrat appoints McHugh as VP, strategy and development

Registrat, Lexington, KY, July 19 announced the appointment of Peggy McHugh as VP, strategy and development.

Registrat is a CRO, which provides services for the biopharmaceutical and medical device industry.

At Registrat, in addition to assisting sponsors to optimize clinical and commercial benefits that contribute to a successful product launch and support ongoing commercialization efforts, McHugh will provide input regarding the company’s strategic direction, planning, resourcing and ongoing initiatives, the company said.

McHugh brings over 17 years experience managing projects in Phases I- III, IIIb, and IV, post-marketing studies, and patient registries in excess of 10,000 patients. She developed medical affairs and clinical operations departments and participated in the realignment of a safety surveillance group.

McHugh’s past positions have included recruiting, training and supervising clinical directors, medical affairs managers and CRAs. Her former employers include Intermune, where she was senior director, clinical operations; Amgen, where she was director, medical affairs; Immunex, where she was director, clinical trials; and, Rhone-Poulenc-Rorer, where she was senior research specialist.

Vical announces management changes

Vical, San Diego, July 21 announced several changes in the company’s senior management team. According to the press statement, David Kaslow, M.D., chief scientific officer, resigned effective July 31, having accepted an opportunity to return to Merck in the area of vaccine research.

Vical said it is not planning to replace Kaslow. However, Alain Rolland, Pharm.D., senior VP, product development, and Ronald Moss, M.D., VP, clinical development, will now report directly to Vijay Samant, Vical’s president and CEO.

Rolland joined the company as VP, Product Development in August 2002 and was named senior VP, product development in April 2004. Moss joined the company in June 2006 with more than 10 years of clinical and regulatory experience at Telos Pharmaceuticals, at the Merck Research Laboratories Division of Merck and Co., Inc., and at the Immune Response Corp.

Vical also announced that Robin Jackman, Ph.D., has been promoted to senior VP of business operations. Jackman joined Vical as VP, business development in June 2004.

“Over the past five years, we have assembled an excellent vaccine development team that has advanced the company’s lead vaccine programs consistent with our development strategy, including our vaccines for cytomegalovirus, anthrax and pandemic influenza…The latest changes in the senior management team reflect the company’s continued advance toward commercial vaccine development,” noted Samant.

Wajda joins Lynx Medical Systems

Lynx Medical Systems, Bellevue, WA, July 20 announced Jeffery Wajda has joined the company as VP, clinical support services.

Wajda will be responsible for clinical software and coding services product development and will act as liaison with the international health care community.

Lynx is a provider of emergency medicine documentation and revenue management solutions.

Wajda is a board certified emergency physician whose experience includes positions as emergency department medical director and chair of the credentials committee at Providence Everett Medical Center. He acquired more than 18 years of emergency medical clinical experience and over nine years of group/hospital management experience.

Wajda also has extensive experience in compliance, billing and operational consulting, Lynx noted in a press statement.

Hong Kong scientist given top honors from Royal Society for SARS discovery

Britain’s Royal Society, a prestigious scientific academy, announced July 16 it has made Hong Kong-microbiologist Malik Peiris — who cracked the code that helped identify and control the SARS virus — a fellow in the academy.

The Royal Society was set up in November 1660 and counts among its fellows — past and present — some of history’s greatest scientists, including Sir Isaac Newton, Charles Darwin and Stephen Hawking.

Induction as a fellow is considered second only in prestige to winning a Nobel Prize, the society claims.

Although Peiris was inducted into the academy for his work on SARS, the pneumonia-like virus that killed almost 300 people in Hong Kong in 2003, he also is at the forefront of research into the deadly H5N1 avian flu.

Moreover, according the Society’s announcement, Peiris also has “ made immense contributions to our understanding of avian influenza and to antibody enhancement in Dengue and West Nile virus infection.”

Trial news updates

Abiomed, Danvers, MA, July 17 announced the start of the Impella 2.5 pilot study in the U.S. with the enrollment of the first patient at William Beaumont Hospital, Detroit. The Impella 2.5 is the world’s smallest ventricular assist device (VAD) and is currently available in Europe under the CE [Conformité Européenne] Mark. The treatment involves utilizing Abiomed’s Impella 2.5 minimally invasive VAD during high-risk angioplasty, and providing strong hemodynamic support with over two liters of flow for the patient throughout the procedure. In the case of the first U.S patient, Abiomed said the patient had previously received a bypass, a defibrillator, had poor heart function and needed angioplasty to open a complex lesion in the vessel supplying blood to the heart. The Impella 2.5 was implanted quickly and easily through the groin, and resulted in a favorable procedural outcome for the patient who has already been discharged from the hospital, approximately 48 hours after the procedure. On May 25, the company announced that it had received FDA approval to commence its pilot clinical trial in the U.S.. The indication for use is support during high-risk angioplasty and subsequent to the procedure, if needed, for up to five days as a left VAD. Angioplasty, performed in the catheterization lab, is the insertion of a catheter-guided balloon and is used to open a narrowed coronary artery. A stent (a wire-mesh tube that expands to hold the artery open) is usually placed at the narrowed section. High-risk angioplasty is defined as patients undergoing angioplasty on an unprotected left main coronary artery lesion, or the last patent coronary conduit, and poor cardiac function.

Adeza, Sunnyvale, CA, July 18, announced its NDA for Gestiva will be reviewed by FDA’s Reproductive Health Drugs Advisory Committee on Aug. 29. Gestiva, a long acting form of a naturally occurring progesterone, is the company’s drug candidate to prevent preterm birth in women with a history of preterm delivery. In May, Adeza announced the submission of its Gestiva NDA; Adeza was subsequently granted Priority Review and FDA has set a goal to complete its review or otherwise respond to Adeza on the Gestiva NDA by Oct. 20. The Gestiva NDA includes positive data from a 463-patient clinical study with 17 alpha-hydroxyprogesterone caproate (17P) in pregnant women with a history of preterm birth conducted by NIH’s National Institute of Child Health and Human Development. Patients were enrolled at 16 to 21 weeks of gestation and randomly assigned to receive weekly injections of 17P or placebo until delivery or 37 weeks of gestation. Treatment with 17P resulted in an overall reduction in the preterm birth rate of 34% and a reduction of 42% in the rate of preterm births prior to 32 weeks. In addition, infants born to women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen and mean number of days of respiratory therapy.

AGA Medical Corp., Minneapolis, July 20 announced that it has enrolled the first patients in its PREMIUM clinical trial, a study examining the connections between certain types of migraine headaches and a heart defect found in more than 20% of all adults. The first patient was enrolled at Abbott Northwestern Hospital. The PREMIUM (Prospective Randomized investigation to Evaluate the incidence of headache reduction in subjects with Migraine and PFO [patent foramen ovale] Using the Amplatzer PFO Occluder compared to Medical Management) trial is a prospective, randomized, two-arm, double blind multi-center trial in the U.S. to determine whether patients who undergo closure of a PFO with an Amplatzer device have a reduction in both the frequency and severity of migraine headaches. A PFO is a small flap-like opening between the upper chambers of the heart. This opening is normal in fetuses but usually closes shortly after birth. When it remains open, or “patent,” it allows blood to bypass the filtering system of the lungs. Substances such as very small blood clots or chemicals in this unfiltered, non-regenerated blood traveling directly to the brain may trigger migraine attacks. The study is expected to enroll approximately 400 patients at up to 35 medical centers.

AstraZeneca July 18 announced it has submitted an NDA with FDA for a sustained-release formulation of Seroquel (quetiapine fumarate) for treatment of patients with schizophrenia. Seroquel tablets, in the currently available immediate release formulation, are approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia. In clinical trials supporting FDA submission, the investigational once-daily formulation demonstrated an effective dose range of Seroquel SR of 400-800 mg/day. In addition, these trials aimed to show that an effective dose could be achieved as early as day two. The company said it also expects to make a Seroquel SR filing in the EU towards the end of 2006.

Avi Biopharma, Portland, OR, July 20 announced it has entered patients to fill two new cohorts to extend the duration of treatment with AVI-4065 in its hepatitis C virus (HCV) clinical trial. One cohort will be treated twice daily for 28 days and the second will receive therapy twice daily for 56 days. This extension of the treatment duration from 14 days to 28 days and 56 days is the first of several variables that the company is considering. This extension of duration of treatment is based on PK indications from previous cohorts, including normal subjects and HCV patients, after evaluation of preliminary data released in May 2006, the company said. The treatment is designed to potentially enhance the PKs and viral and clinical response to treatment with Avi Biopharma’s proprietary Neugene antisense compound, AVI-4065, in patients with HCV. In previous studies, AVI-4065 exhibited favorable safety and tolerability profiles in all patients, and there were no drug-related adverse events (AEs) or tolerability issues reported during either the 14 days of treatment or the 28 days of follow-up. Preliminary data from the first three cohorts of normal subjects were reported in January 2006 and the trial was completed in March 2006. Those cohorts included 31 healthy volunteers who received 14 consecutive days of treatment with AVI-4065 at one of three dosage levels. Avi Biopharma said it expects to be able to report clinical and viral response data from the previous cohorts of HCV patients treated for 14 days with AVI-4065 by the end of the third quarter of 2006.

Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Emeryville, CA, July 20 announced that Nexavar (sorafenib tablets) has been granted Fast Track designation by FDA for the treatment of advanced (including locally unresectable and metastatic) melanoma, a form of skin cancer. Nexavar was approved by FDA in December 2005 for the treatment of patients with advanced renal cell carcinoma. The PRISM study, a Bayer and Onyx initiated Phase III, double-blind, randomized, placebo controlled trial of Nexavar administered in combination with a standard dosing schedule (21-day cycles) of carboplatin (AUC 6) and paclitaxel (225 mg/m2) is currently underway, having recently completed patient enrollment. The study is designed to measure the safety and efficacy of Nexavar when co-administered with chemotherapy, and has progression-free survival as its primary endpoint. Approximately 250 patients with disease progression following one previous systemic chemotherapeutic treatment (with either dacarbazine or temozolomide) were enrolled into the study. In addition, a Phase III double-blind, randomized, placebo-controlled trial, sponsored by the Eastern Cooperative Oncology Group, is underway. The trial will evaluate carboplatin and paclitaxel with or without the administration of Nexavar in patients with unresectable Stage III or Stage IV melanoma, and has overall survival as its primary endpoint. Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both cell proliferation and angiogenesis. These kinases included RAF kinase, VEGF[vascular endothelial growth factor]R-1, VEGFR-2, VEGFR-3, PDGF[platelet-derived growth factor]R-B, KIT and FLT-3. Nexavar is being studied in a variety of cancers; to date, more than 8,000 clinical trial patients have received the drug; and, it has demonstrated combinability with multiple anti-cancer agents, the companies noted. Nexavar also is being evaluated in Phase III clinical trials for the treatment of hepatocellular carcinoma and was granted Fast Track designation for this disease in June.

Cell Genesys, South San Francisco, July 18 announced that enrollment has been opened for an expanded multi-center Phase I clinical trial of CG0070 to evaluate escalating multiple-dose regimens of CG0070 in patients with recurrent bladder cancer. The expanded trial was prompted by encouraging interim safety and efficacy data recently reported for single-dose administration of CG0070 and will include up to 45 additional patients who have failed previous therapy with Bacillus Calmette-Guerin (BCG), the current standard therapy for recurrent bladder cancer. Cell Genesys explained that CG0070, an oncolytic virus therapy that is being developed through a global alliance with Novartis AG, has been shown to destroy cancer cells of multiple types in numerous preclinical studies. CG0070 can potentially destroy cancer cells by two different mechanisms: direct cell killing by the virus and immune-mediated cell killing stimulated by GM-CSF. The open-label, dose-escalation trial is evaluating intravesical administration of CG0070 in patients with superficial bladder cancer who have failed previous therapy with BCG. The trial was designed to first evaluate escalating single-dose levels of CG0070 and has now been expanded to evaluate escalating multiple-dose regimens. The primary endpoints of the study are safety and the determination of a maximum tolerated dose. Other endpoints include clinical response based on follow-up cystoscopy and recurrence-free survival. The expansion of the trial from single-dose to multiple-dose regimens was prompted by data reported in May. The duration of the complete responses after just a single administration of CG0070 was six, nine and over three months, respectively. Treatment was generally tolerable and the majority of treatment-related side effects were local bladder toxicities. No serious AEs or dose-limiting toxicities have been reported to date.

CryoLife, Atlanta, July 19 announced it has completed the enrollment of patients in its BioDisc Spinal Disc Repair System study. The 10-patient study, being conducted at a hospital in the U.K., targets disc herniations in the lumbar spine at the L4/L5 and L5/S1 vertebral levels, and is designed to gather basic safety and performance data. The surgical removal, or discectomy, of the herniation leaves a void within the spinal disc that can cause spine instability, loss of disc height and recurrent herniation; BioDisc is designed for easy, simple delivery into the spinal void, with the goal of preventing or reducing these complications, the company explained.

Endo Pharmaceuticals, Chadds Ford, PA, and Vernalis plc, Winnersh, U.K., announced that Endo has submitted to FDA a supplemental NDA (sNDA) for Frova (frovatriptan succinate) 2.5 mg-tablets for the short-term (six days per month) prevention of menstrual migraine. This submission contains data from previously reported pivotal Phase III studies that met their primary efficacy endpoints of reduction in incidence in MM. If the sNDA is approved by FDA, Frova will be the only triptan indicated in the U.S. for the prevention of menstrual migraine. Currently, Frova is FDA-approved for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established. The sNDA for Frova is supported by data from four studies, including two Phase III studies examining the efficacy and safety of once- and twice-daily dose regimens of Frova in the short-term prevention of MM, a PKs and tolerability study of once- and twice-daily dosing of Frova, and a 12-month, open-label safety study evaluating a six-day dosing regimen of Frova in 525 women.

GTx, Memphis, TN, July 20, announced completion of recruitment of its proof-of-concept Phase II clinical trial of its first- in-class drug candidate, ostarine, a selective androgen receptor modulator (SARM). GTx said it expects to report data from the trial in the fourth quarter. GTx initiated the proof-of-concept Phase II clinical trial of ostarine in May 2006. The three-month, placebo-controlled clinical trial is evaluating multiple doses of ostarine in 60 elderly men and 60 postmenopausal women. The trial is designed to evaluate the activity of ostarine on building muscle and promoting bone as well as to assess safety in both elderly men and postmenopausal women. GTx expects to report the data from the Phase II clinical trial in the fourth quarter of 2006. Based on ostarine’s Phase II clinical data profile, GTx will select specific acute and chronic bone and/or muscle wasting diseases for further development. The company plans to initiate a Phase IIb or Phase III clinical trial in the first half of 2007.

Human Genome Sciences, Rockville, MD, July 20 announced it has initiated dosing of patients in a randomized Phase II clinical trial of HGS-ETR1 (mapatumumab) in combination with Velcade (bortezomib) in advanced multiple myeloma. Bortezomib, a proteosome inhibitor, is indicated for use in multiple myeloma patients who have received at least one prior therapy, and has produced partial or complete responses in approximately 50% of these patients in Phase II and III clinical trials. Moreover, the results of preclinical studies demonstrate that HGS-ETR1 enhances the tumor-killing activity of bortezomib. These data, along with emerging clinical results, support the evaluation of HGS-ETR1 in combination with bortezomib in a Phase II study in patients with relapsed or recurrent multiple myeloma, the company surmised. The primary objective of the study is to evaluate disease response to HGS- ETR1 in combination with bortezomib, versus bortezomib alone, in patients with relapsed or refractory multiple myeloma. The Phase II trial is a randomized, multi-center, open-label study to evaluate the efficacy and safety of HGS-ETR1 in combination with bortezomib in patients with relapsed or refractory multiple myeloma. Approximately 100 patients will be enrolled in the U.S. and Canada and randomized into two treatment groups, with one treatment group receiving the combination of HGS-ETR1 and bortezomib, and the other treatment group receiving bortezomib alone. Secondary objectives are to evaluate safety and tolerability, and to determine plasma concentrations of HGS-ETR1 for use in a population PK analysis.

Innovive Pharmaceuticals, New York, July 17 announced that the first two patients have been enrolled and treated in a Phase I trial investigating compound INNO-406 in imatinib-resistant or intolerant Philadelphia positive leukemias. The study is a multi-center, open label, dose escalation trial and will investigate the safety, tolerability, PKs and preliminary efficacy of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia positive (Ph+) leukemias or relapsed/refractory Ph+ acute lymphocytic leukemia (ALL). Positive (Ph+) leukemias include chronic myeloid leukemia in chronic, accelerated or blastic phases (CML-CP, CML-AP, CML-BP, respectively). The trial is expected to enroll up to 100 patients at the MD Anderson Cancer Center in Texas and the Johann Wolfgang Goethe University Hospital in Germany. INNO-406 is an orally bioavailable, rationally designed, dual Bcr-Abl and Lyn kinase inhibitor. According to a study published in Dec. 2005, INNO-406 is 25 to 55 times more potent than imatinib in vitro, and at least 10 times as effective as imatinib mesylate in suppressing the growth of Bcr-Abl bearing tumors in vivo. INNO-406 has demonstrated activity against 12 of 13 imatinib-resistant cell lines with point mutations of the Bcr-Abl protein, the company noted.

Intracel, Frederick, MD, July 19 said it was granted a special protocol assessment (SPA) by FDA for the execution of a confirmatory, Phase III clinical trial of OncoVax, a patient-specific active immunotherapy, in stage II colon carcinoma. If successfully completed, Intracel believes the pivotal Phase III trial could form the basis of a biologics licensing application for OncoVax in the U.S. The randomized multi-center study will be conducted in the U.S. and Europe with 560 patients enrolled over two years. An interim analysis will be performed one year following randomization of the last patient, with primary analysis conducted three years after all 560 patients have been randomized to the study. Intracel’s previous randomized study, published in “The Lancet” and “Vaccine,” demonstrated a statistically significant 33% increased overall survival and 40% reduction in deaths or recurrences in treated Stage II colon cancer patients, compared to controls at a five-year median follow-up. OncoVax immunotherapy is based on a long-standing attempt by scientists to manipulate the body’s immune response and its long-term memory to prevent the return of disease months or years after surgery, Intracel explained. Such an approach has already been successful in preventing a number of infectious diseases. Immune stimulation should be able to create a population of white blood cells that can kill tumor cells wherever they arise in the body, years after surgical removal of the original tumor. Intracel’s scientists prepare a vaccine from the patient’s own tumor. The cells are dissociated, irradiated to make them non-tumorigenic and administered to the patient by three weekly injections, starting four to five weeks after surgery. A booster vaccination is administered six months later. The OncoVax vaccine is a somatic cell (whole cell) therapy considered an active immunotherapy, because once injected it triggers the body’s immune system to attack and destroy cancer cells. Active immunotherapy vaccines cause the immune system to produce cytotoxic T-cells. OncoVax is tumor-specific, meaning it does not provoke a generalized immune response.

MedImmune, Gaithersburg, MD, July 19 said FDA wants more information about a new liquid formulation of the firm’s nasal flu vaccine FluMist before making a decision on whether to let the company sell it. The biotechnology firm did not disclose the exact information sought by FDA in a recent letter, but MedImmune spokesperson Jamie Lacey told the press the agency’s queries related to technical clarification of clinical and testing data already submitted. MedImmune expects to respond in two to four weeks, Lacey said. MedImmune executives have said they do not think FDA’s request will affect the chances of winning approval of the liquid formulation in time for the 2007-08 influenza season. The company wants to introduce the liquid version of the vaccine so that it does not need to be stored in a freezer. Many doctors balked at the frozen storage requirement, particularly because flu shots need only to be refrigerated. Last year, the company announced that studies showed that the liquid version worked just as well when stored in a refrigerator as the old one does when it is frozen. MedImmune also wants to expand the use of FluMist to children age 1 to 5. The vaccine is approved for people age 5 to 49, leaving a large market untapped.

Seikagaku, Tokyo, July 20 announced it will begin Phase III clinical trials of Gel-200, a new hyaluronic acid gel for intra-articular injection in knee osteoarthritis patients, in the U.S. in August. According to the company, the new gel is expected to have a highly analgesic effect with only one shot. In the U.S., Seikagaku has marketed injectable hyaluronic acid gel under the Supartz brand name since 2001, and currently claims a 20% share of the market. Seikagaku hopes that the new drug will help expand its market share further since it requires just one injection compared with multiple injections required of Supartz. The company said it hopes to bring the new drug to market within four years. Further details of the Phase III trial were not provided.

Shire plc July 21 announced it has submitted an NDA to FDA for SPD465, an investigational amphetamine compound for the treatment of attention-deficit/hyperactivity disorder (AD/HD) in the adult population. SPD465 has the same active ingredient as Adderall XR (mixed salts of a single-entity amphetamine product), but is designed to provide AD/HD symptom control for up to 16 hours. Upon approval, this novel product will be the first and only AD/HD stimulant product that controls inattention, hyperactivity and impulsivity for up to 16 hours, Shire said.

Spectranetics, Colorado Springs, CO, July 20 announced the first patient was enrolled in the CELLO trial, which is an FDA-approved trial that will enroll 85 patients at up to 15 sites. The trial will provide clinical data on the reduction of the arterial blockage in above the knee arteries following use of the Spectranetics’s Turbo-Booster product. The first patient enrolled in the trial is a 72-year-old female suffering from severe, life-style limiting claudication. The artery treated was six millimeters in diameter and was 85% stenosed prior to the procedure. Following multiple passes with the Turbo-Booster device, the stenosis was reduced to 25%. The results of the procedure were sufficient for a stand-alone case result that did not require further adjunctive treatment with other devices.

Starpharma Holdings, Melbourne, Australia, July 19 announced that the IND for the clinical development of VivaGel (SPL7013 gel) for prevention of genital herpes has successfully completed the mandatory review period within FDA. According to Starpharma, this is the first microbicide clinical development program specifically for prevention of genital herpes to be funded by NIH and the first IND submitted to FDA for a microbicide with prevention of genital herpes as the indication. The company said it expects the clinical trial to commence in the third quarter of 2006 following local ethics committee approvals. The trial will be conducted at two sites — San Francisco and in Kenya with safety as the primary endpoint. Thirty women, aged 18-24 years, will be enrolled at each site. The IND was submitted by NIAID in April 2006. VivaGel is being developed in parallel for the prevention of HIV, also with the support of NIAID.

Trial briefs

GlaxoSmithKline (GSK) July 21 said it has conducted the largest biopsy study to date, and the study demonstrated that a lower dose of an inhaled corticosteroid (ICS) with the addition of a long acting beta2-agonist (LABA) is as effective in maintaining control of airway inflammation as a medium-dose ICS alone in patients with moderate asthma. The study, published in the “Journal of Allergy and Clinical Immunology,” compared Advair Diskus (fluticasone propionate and salmeterol) 100/50 mcg with fluticasone propionate (FP) 250 mcg over a 24-week treatment period in patients requiring a medium-dose ICS. It was a randomized, double-blind, parallel-group study conducted in 88 patients 18 years of age or older with asthma; and, it was designed to evaluate whether clinical asthma control and airway inflammation could be maintained after switching therapy from medium-dose FP to a combination of low-dose FP and salmeterol. During the trial screening phase, patients with stable symptoms on a medium dose of ICS (220 mcg of FP twice daily or equivalent) demonstrated deteriorating asthma control after being stepped-down to 100 mcg of FP twice daily. Treatment was then increased to 250 mcg of FP twice daily for four weeks, and patients had to re-establish asthma control (based upon pre-defined criteria) to be included in the treatment phase of the study. Patients included in the trial were randomized to therapy with an ICS alone (FP 250 mcg) or an ICS plus a LABA (Advair 100/50 mcg) twice daily and evaluated for 24 weeks of treatment. Bronchial biopsies and bronchoalveolar lavage were performed prior to randomization and after the 24 week treatment period. Clinical control of asthma and airway inflammation measures did not differ between the two treatment groups. Additionally, the study provided direct evidence that reduction of an ICS when done in conjunction with the introduction of a LABA does not lead to worsening airway inflammation. Both treatments were well-tolerated, and the incidence of common adverse events was similar in the two treatment groups. Reported AEs related to the study occurred in six (15%) and eight (17%) subjects treated with Advair 100/50 mcg and 250 mcg of FP, respectively. No AEs occurred in more than one patient in each treatment group and included oral candidiasis, palpitation and headache. There were no serious drug-related AEs during the treatment period.

Hoffman La Roche announced July 16 that its investigational Continuous Erythropoietin Receptor Activator (C.E.R.A.) anti-anemia drug maintained stable hemoglobin levels in dialysis patients with up to once every four week dosing in Phase iii clinical studies. According to Roche, this was the first Phase III study for its initial registration that examined a once every four week dosing interval. The primary objective of the three multi-center, Phase III maintenance studies was to demonstrate that intravenous (IV) or subcutaneous (SC) C.E.R.A. can maintain Hb concentrations in dialysis patients on prior epoetin alfa/beta or darbepoetin alfa therapy. This involved directly converting or switching patients from very frequent therapy to either a once every two week or once every four week regimen. In the maintenance studies (which refers to keeping Hb levels in a defined range over time in dialysis patients whose Hb levels have been corrected), patients were randomized to continue their frequent treatment or convert directly to C.E.R.A. given once every two weeks or once every four weeks. The primary endpoint was the mean change in Hb between baseline and the evaluation period. In these trials, dosage was adjusted to maintain Hb (plus or minus) 1.0 g/dL of the baseline level. The data from the studies showed that both IV and SC administration of C.E.R.A. every two weeks or every four weeks maintained hemoglobin levels in dialysis patients who were converted from epoetin alfa or beta at more frequent doses. In addition, data from an IV study demonstrated that C.E.R.A. administered once every two weeks maintained hemoglobin levels in dialysis patients who were converted from darbepoetin alfa. Specifically, the first study was designed to evaluate IV C.E.R.A. dosed once every two weeks or once every four weeks in the maintenance of Hb levels in dialysis patients previously maintained on IV epoetin alfa/beta dosed up to three times weekly. Close to 90% of patients were receiving a three-time weekly dose of epoetin at the time they were converted. The difference between IV C.E.R.A. dosed once every two weeks and epoetin in the mean change in Hb was 0.004g/dL. The difference between IV C.E.R.A. dosed once every four weeks and epoetin in the mean change in Hb was 0.05g/dL. The results demonstrated that IV C.E.R.A. — whether dosed once every two weeks or once every four weeks — was as effective as IV epoetin in maintaining Hb levels. The second study mirrored the first but evaluated SC C.E.R.A. at the same dosing intervals and in a patient population previously maintained on SC epoetin alfa/beta. The trial found that the difference between SC C.E.R.A. dosed once every two weeks and epoetin in the mean change in Hb was 0.14g/dL. The trial found that the difference between SC C.E.R.A. dosed once every four weeks and epoetin in the mean change in Hb was - 0.02 g/dL. The results demonstrated that SC C.E.R.A. whether dosed once every two weeks or once every four weeks was as effective as SC epoetin in maintaining Hb levels. Lastly, the third study was designed to evaluate IV C.E.R.A. dosed once every two weeks in the maintenance of Hb levels in dialysis patients previously maintained on IV darbepoetin alfa. Darbepoetin alfa was dosed once a week or once every two weeks. The difference between once every two weeks IV C.E.R.A. and darbepoetin alfa in the mean change in Hb was 0.18g/dL. The results demonstrated that IV C.E.R.A. once every two weeks was as effective as IV darbepoetin alfa in maintaining Hb levels. The most frequent AEs, which were similar between the treatment arms, were diarrhea, nasopharyngitis, hypertension, procedural hypotension or influenza.

Myriad Genetics, Salt Lake City, June 19 announced results of its completed Phase II follow-on study of Flurizan in patients with mild Alzheimer’s disease. The data suggested that study participants taking 800-mg BID (twice per day or bis in die (Latin)) of Flurizan demonstrated a substantial benefit over other dose groups in the study and that this benefit continued to increase over 24 months, for each of the evaluated areas of cognition, memory loss, global function and activities of daily living. The data also suggest that during the follow-on period from months 12 to 24, the benefit of Flurizan increases in terms of both effect size and significance, the longer patients remain on Flurizan. At month 24, patients taking 800 mg of Flurizan BID had an effect size of 72%, with a highly significant value of p=0.0005, as measured by their global function on the CDR-sb test. In terms of the performance of activities of daily living (ADCS-ADL) at 24 months, the patients showed a 67% effect size, with a value of p=0.015, which was also significant, the company said. Flurizan also improved the rate of cognitive decline, as shown by the effect size of 52% at 24 months on the ADAS-cog scale. These data suggested that there was a substantial benefit from Flurizan on activities of daily living and global function, and that the benefit was increasing over time. The vast majority (~94%) of patients in this Phase II study, at the time of enrollment, were receiving stable doses of acetylcholinesterase inhibitors, FDA-approved drugs for symptomatic treatment of Alzheimer’s disease, at the time of enrollment. Thus, the benefits of Flurizan observed in these patients were over and above the current standard-of-care, Myriad emphasized. Importantly, the Phase II trial also studied the occurrence and timing of serious psychiatric events in patients with Alzheimer’s disease. The occurrence of psychiatric problems, such as, agitation, aggression, confusional state and depression was monitored throughout the study. Over the course of the 12-month study, approximately 35% of participants taking placebo experienced such an event. However, patients on 800 mg BID Flurizan experienced a 60% reduction in psychiatric events (14%) compared to those on placebo and the time to such an event was significantly longer with patients on Flurizan than those on placebo (333 days vs. 106 days, a difference of over seven months). These data provide an indication that their disease had progressed more slowly than those on placebo. After completion of Myriad’s 12-month Phase II trial of Flurizan, study participants who had previously received placebo during the Phase II trial were randomized into the 400 mg-BID group or the 800-mg BID group. In this randomized-start design, former placebo patients were then followed for an additional 12 months. Results from this analysis indicated that patients treated with 800 mg twice daily of Flurizan for 24 months declined more slowly with regard to cognition, activities of daily living and global function than those treated with the same dose for just 12 months in the follow-on study. Additionally, those former placebo patients who were randomized onto 800 mg Flurizan twice daily declined more slowly than those randomized to 400 mg on both the ADAS-cog and the CDR-sb measures of disease progression, the company noted. On the ADCS-ADL measure, the two groups experienced a comparable decline. Unlike currently marketed drugs for Alzheimer’s disease, which show only symptomatic benefit, there was no indication that patients who had been on placebo for 12 months would catch up to patients treated for all 24 months. Myriad added that it has begun to enroll a Global Phase III trial in patients with mild Alzheimer’s disease including investigators in Italy, France, Germany, Spain, Sweden, Switzerland, the U.K., Netherlands, the U.S., Belgium, Canada and Denmark. The trial will enroll approximately 800 participants into two groups, 800 mg twice daily and placebo, and the participants will receive treatment for 18-months. Myriad also is enrolling patients with mild Alzheimer’s disease into a Phase III trial, at 130 centers across the U.S.. This enrollment is expected to be complete this summer. Flurizan is the first in a new class of drug candidates known as selective amyloid beta-42 lowering agents.

Nabi Pharmaceuticals, Rockville, MD, July 18 announced the results of a study that provided further demonstration that its PhosLo (calcium acetate) offers better control of serum phosphorus when compared to sevelamer. Serum phosphorus is a key determinant of morbidity and mortality among end-stage renal disease (ESRD) patients. The researchers of the study analyzed data from 1,000 adult patients admitted to large commercial hemodialysis provider clinics for initiation of dialysis. Of the 1,000 initial patients, 181 patients were treated exclusively with sevelamer and 321 patients were treated exclusively with calcium acetate. Patients who received calcium carbonate only, patients who received both sevelamer and calcium acetate, and patients who received phosphate binders were excluded from the analysis. The analysis of the data indicated that the patients treated exclusively with calcium acetate during the first year of hemodialysis showed superior control of serum phosphorus and calcium phosphorous product compared to patients treated with sevelamer, Nabi noted. That was the case whether analyzing mean changes in serum phosphorus levels, or whether analyzing the number of patients who achieved serum phosphorus levels and calcium-phosphorus product in accordance with K/DOQI guidelines. Averaged serum phosphorus over a one- year period was 5.05 +/- 1.14 mg/dL in the calcium acetate group and 5.42 +/- 1.22 mg/dL in the sevelamer group; the averaged calcium-phosphorus product was 44.94 +/- 10.62 mg2/dL2, and 49.85 +/- 11.44 mg2/dL2 in the groups respectively. There were no significant differences in serum calcium, or bio-intact PTH between the two groups. Additionally, Nabi said its CARE-2 study, in compliance with National Cholesterol Education Program guidelines, is designed to demonstrate that when lipid levels are kept constant with Pfizer’s Lipitor (atorvastatin calcium), there will be no difference in cardiovascular calcification in patients treated with PhosLo versus Genzyme’s Renagel (sevelamer hydrochloride). The results of the study would, if positive, strengthen PhosLo’s position as the treatment of choice for ESRD patients, and provide evidence that a combination of PhosLo and a statin will offer the most cost-effective control of cardiovascular risk factors in these patients, the company added. The company also announced that it has received an updated timetable from European regulators related to the inspection of the PhosLo manufacturing facility, which is the last step required for approval for PhosLo in the EU.

Topigen Pharmaceuticals, Montreal, July 18 announced preliminary data from its first Phase II clinical trial of inhaled TPI-ASM8 as a single agent in patients with allergic asthma. The company said results indicate that inhaled TPI-ASM8 demonstrated protection in early- and late-stage allergic responses in patients with asthma, but did not give data details. The 17-patient, randomized, placebo-controlled, multi-center, crossover, allergen challenge Phase II trial was designed to assess overall safety and tolerability and to demonstrate proof-of-principle that inhaled TPI-ASM8 would show biological activity in the respiratory tract of patients with mild-to- moderate asthma. The study evaluated repeated administration of once daily doses of inhaled TPI-ASM8, given for four days at delivered doses similar to currently marketed steroids. TPI-ASM8 is a new inhalation drug currently in Phase II clinical development for the treatment of asthma. The drug consists of two modified antisense oligonucleotides designed specifically to reduce the recruitment and persistence of chronic inflammatory cells, two key components underlying the cause of the disease. Using Topigen’s proprietary antisense chemistry designed for the lungs, the drug targets two distinct cellular pathways involved in allergic airway inflammation by inhibiting the recruitment of allergic inflammatory cells, called eosinophils, via the CCR3 receptor and reducing the persistence of allergic inflammatory cells via inhibition of a common beta sub-unit for the receptors of interleukin 3, 5 and GM-CSF. This pioneering multi-targeted approach of blocking the expression of specific genes with antisense oligonucleotides is expected to have advantages over current medications.

Conferences

LAST CHANCE TO SIGN UP!! ExpertBriefings.com audioconference: Using Deviations to Improve Quality Systems in Pharmaceutical R&D and Commercial Production by Martha M. Bennett, July 27, 2-3:00pm (EST). Martha M. Bennett, President of Bennett & Co., will define the concept of pharmaceutical deviations and provide some practical recommendations for R&D and commercial production controls. Experience indicates that appropriately designed quality systems — including deviation controls — can improve and streamline the research process, and result in better-designed and -manufactured products. After participating in this audio advisory, you will be able to apply simple principles to improve the quality of your deviation controls, add credibility and validity to study results, and help streamline the product-development process. To register, visit http://www.fdainfo.com/expertbriefings/ or call (703) 779-8777.

ExpertBriefings.com audioconference: Tablet Bisects and Managed Care: How HMOs are Influencing Bisect Design and May Impact Validation, Aug. 1, 2-3:00pm (EST). Tablet bisects are little understood. They appear on many of the tablets we make, but are almost never mentioned in the literature, the patient information provided with the prescription or the Physician’s Desk Reference. But the political climate is being changed by the HMOs and their attitude toward cost cutting. “Pill cutters” are now being dispensed with prescriptions in an effort to have the patient cut larger doses into smaller doses. But can the bisects stand the cutting process and does the patient receive the right dose they need? Our speaker, Fred Rowley of Solid Dosage Training, will examine the issue and presents some of the potential solutions for the problem. To register, visit http://www.fdainfo.com/expertbriefings/ or call (703) 779-8777.

CCRA (Clinical Research Associates), CCRC (Clinical Research Coordinators), CPI (Physician Investigators) and CCTI (Non-Physician Investigators) Exams, Sept. 9. For more information, please visit the Certification page on the Assn of Clinical Research Professionals (ACRP) website at http://www.acrpnet.org/certification/index.html. The following certification preparatory classes also are available. For more information, visit http://www.acrpnet.org/education/examrev/index.html.

Drug Discovery Technology & Development: Providing Coverage of the Most Vital Topics in Drug Discovery and Development, Aug. 7-10, Boston. Now in it’s 11th year, the industry’s premier, international conference and exhibition provides education on the most vital topics in drug discovery and development to help accelerate products to market. Sponsored by IBC Life Sciences. For more information, visit http://www.drugdisc.com/.

Genomics, Race and Health Disparities: A National Dialogue, Aug. 18-19, Claremont Hotel and Spa, Oakland, CA. The conference will bring together the country’s leading researchers and opinion leaders to discuss the use of genetic/ genomic information to assess variations in health care needs and treatment options among racial and ethnic populations. For more information, visit http://nutrigenomics.ucdavis.edu/nutrigenomics/index.cfm?objectid=227EB527-65B3-C1E7-02663DECDF4F5823.

24^th Annual Meeting of the American Society of Retina Specialists, Sept. 9-13, Cannes, France. For more information, visit http://www.asrs.org/meetings/asrs_annual_meeting/.

2^nd Annual Merging Electronic Health Records and Electronic Data Capture, Sept. 18-19, Sheraton Four Points, Washington. Sponsored by ExL Pharma. For more information, visit http://www.exlpharma.com/events/ev_descrip.php?ev_id=40.

4^th Successful, Compliant Investigator-Initiated Trial Programs: Best Practices and Key Strategies for Optimal Outcomes, Sept. 18-19, The Westgate Hotel, San Diego, CA. Sponsored by Exl Pharma. For more information, visit http://www.exlpharma.com/events/ev_descrip.php?ev_id=36.

Society of Clinical Research Associates (SoCRA) conferences: Certification Preparation and Review Course, Sept. 20, Marriott Chicago Downtown, Chicago. For more information, visit http://www.socra.org/html/CRP_Cert_Prep_Course.htm.

SoCRA’s Annual Conference, Sept. 21- 24, Chicago. For more information, visit http://www.socra.org/html/2006_conference.htm.

Regulatory Requirements for Pharmaceutical Products, Sept. 25. This is a University of Californina–Irvine extension course offered online. The course is designed for pharmaceutical professionals involved in drug discovery, manufacturing, quality control and clinical studies. For more information, visit http://www.extension.uci.edu or call (949) 824-5414.

Crossing the Line: How Much Risk is Acceptable? Sept. 25-26, Durham, NC. Sponsored by Office of Human Research Protection. For more information, visit http://www.hhs.gov/ohrp/education/conference.html#upcoming.

eHI’s 3^rd Health Information Technology Summit, Sept. 25-27, Washington. For more information, visit http://www.hitsummit.com/.

Discovery 2 Diagnostics: Maximizing Microarrays, Biomarkers and Molecular Diagnostics to Scientifically Advance New Discoveries and Novel Technologies into the Clinic, Sept. 25-27, Boston. This event focuses on the strategies, tools, and alternative uses of technologies and standards that will solve your challenges with the use of biomarkers through discovery to the clinic, proactive approaches to diagnostic commercialization, and emerging applications and scientific advances for microarrays. Sponsored by IBC Life Sciences. For more information, visit http://www.discovery2diagnostics.com/.

13^th National HIPAA Summit, Sept. 25-27, Washington DC Renaissance Hotel, Washington. For more information, visit http://www.hipaasummit.com/.

10^th Annual International Conference on Malignancies in AIDS and Other Acquired Immunodeficiency’s: Basic, Epidemiologic and Clinical Research, Oct. 16-17, Marriott Bethesda North Hotel and Conference Center, Bethesda, MD. Presented by the AIDS Malignancy Program and Office of International Affairs, National Cancer Institute. For more information, visit http:/www/palladianpartners.com/aidsmalignancy/index.htm.

Antiangiogenesis: New Frontiers in Therapeutic Development, Oct. 16-17, Boston. The 4th Annual Antiangiogenesis conference will serve the unmet need of bringing together companies involved in anti-angiogenesis to discuss the major advancements in target identification, clinical development and new clinical trial results. Sponsored by IBC Life Sciences. For more information, visit http://www.ibclifesciences.com/d3204.

NIH Research Festival, Oct. 17-20, Natcher Conference Center, NIH Campus, Building 19, Bethesda, MD. For more information, visit http://researchfestival.nih.gov/.

5^th Annual Clinical Trials Summit, Oct. 23-25, Monte-Carlo Bay Hotel, Monaco. Organized by Marcus Evans. For more information, visit http://www.evolution-summit.com/.

Assays & Cellular Targets 2006, Oct. 30–Nov. 2, Green Valley Ranch, Las Vegas. You will hear case studies of assays and screening applications and their proven results, as well as the latest trends and developments on targets and diseases research. Sponsored by IBC Life Sciences. For more information, visit http://www.ibclifesciences.com/act.

Medical Technology Software Conference, Nov. 8-9, Doubletree Rockville Hotel & Executive Meeting Center, Rockville, MD. Sponsored by AdvaMed. Some of the pertinent issues to be discussed include the review of software in submissions, electronic submissions and HL7 data standard, the use of computers in clinical trials, software classification and electronic health records, cybersecurity and patch management, and HIPAA and other privacy issues. For more information, visit http://www.advamedmtli.org/mtli/mtg06-33.cfm.

55^th Annual Meeting of the American Society of Tropical Medicine and Hygiene, Nov. 12-16, Marriott Marquis, Atlanta. For more information, visit http://www.astmh.org/meeting_2006/index.cfm.

Drug/Device Summit 2006, Dec. 4-5, Hyatt Regency, San Diego. The Biotechnology Industry Organization and BIOCOM, in partnership with Windhover Information, Inc. and AdvaMed, will bring together the key stakeholders in biotechnology, pharmaceutical and medical device companies working to develop combination products and therapies, as well as leading investors in the industry. Plenary sessions will be offered on trends in the health care convergence industry, with special focus on successful partnering strategies, criteria for strategic and corporate investors and modernization in the combination product approval process. In addition, there will be formal and informal networking opportunities with industry CEOs, investors and prospective partners. For more information, visit http://drugdevice.bio.org/opencms/summit/2006/index.jsp.

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