Home Diagnostics searches for new president, CEO
FORT LAUDERDALE, Fla. Home Diagnostics on Thursday announced that the board of directors has retained the executive search firm DavenportMajor to recruit a successor to J. Richard Damron, president and chief executive officer, who will be departing the company following a transition to the new president and chief executive officer.
Damron will remain in his present role until a transition is completed, which is expected to be in the first half of 2009.
“We appreciate the dedication that Dick has provided to Home Diagnostics over his eight-year tenure at the Company,” George Holley, chairman of Home Diagnostics, said. “[Damron’s] leadership in growing Home Diagnostics and the transition to public ownership has been invaluable in positioning the Company for future growth and success. We wish him the best in his future endeavors and appreciate his commitment to work with the company through the transition to a successor.”
“Since becoming president, chief executive officer and a director of Home Diagnostics in February 2001, we have achieved a number of major milestones,” Damron said. “With these accomplishments, I believe the company is poised for its next stage of growth and the time is appropriate for me to move on to my next professional challenge.”
CRN announces webinar to help guide producers through FDA ingredient regulations
WASHINGTON The Council for Responsible Nutrition and Virgo Publishing last week announced plans for a new webinar—“Bringing New Ingredients to Market: FDA Guidance and Developments in the New Dietary Ingredient Notification Process”—to be held Dec. 10.
The Food and Drug Administration’s Bill Frankos, director of the Division of Dietary Supplement Programs, is one of the featured speakers and will provide the agency’s perspective on what kind of data is required to file a successful new dietary ingredient notification, as well as offer insight into other expectations from the agency.
Frankos will be joined by regulatory experts, including George Burdock, president of the Burdock Group; Claudia Lewis-Eng, a partner at Venable; Andrew Shao, vice president, scientific and regulatory affairs, CRN; and Debbie Trinker, vice president of regulatory affairs, Kemin Health.
The webinar will provide a historical analysis of the NDI notification process since its inception by the Dietary Supplement Health and Education Act, and will include a legal review of the process as well as offering practical, actionable approaches for bringing new dietary ingredients to market.
“There are still a lot of questions surrounding this process including what steps companies should take in order to make sure they are meeting FDA’s expectations,” stated Shao. “While not everything can be answered in this two hour webinar, it is our goal to provide clarity along with substantive guidance and help companies feel they are up-to-date and well-informed about this process, particularly as we anticipate FDA will soon publish a guidance document on this topic.”
This is the third webinar produced by CRN and Virgo. The first webinar centered on the general aspects of the final good manufacturing practices rule. The second webinar focused on the specific tools for managing the supply chain and practical approaches to help address safety concerns and ensure GMP compliance.
NCI pulls plug on study of supplements and effects on prostate cancer
BETHESDA, Md. The National Cancer Institute last week reported that selenium and vitamin E supplements, taken either alone or together, do not prevent prostate cancer, citing an independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial that was funded by NCI and other institutes that comprise the National Institutes of Health.
The data also showed two concerning trends: a small but not statistically significant increase in the number of prostate cancer cases among the more than 35,000 men age 50 and older in the trial taking only vitamin E and a small, but not statistically significant increase in the number of cases of adult onset diabetes in men taking only selenium. Because this is an early analysis of the data from the study, neither of these findings proves an increased risk from the supplements and both may be due to chance, NCI noted.
As a result of the review, NCI is pulling the plug on the study. SELECT participants are receiving letters explaining the study review and telling them to stop taking their study supplements. However, participants will continue to have their health monitored by study staff, which may include regular digital rectal exams and PSA (prostate-specific antigen) tests to detect prostate cancer. Investigators intend to follow the participants for about three years to determine the long-term effects of having taken either supplement or placebo and to complete a biorepository of blood samples that will be used in extensive molecular analyses to give researchers a better understanding of prostate cancer, other cancers, and other diseases of male aging.
“SELECT was always designed as a study that would answer more than a single question about prostate cancer,” stated Eric Klein, a study co-chair for SELECT, and a physician at the Cleveland Clinic. “As we continue to monitor the health of these 35,000 men, this information may help us understand why two nutrients that showed strong initial evidence to be able to prevent prostate cancer did not do so.”
SELECT was undertaken to substantiate earlier, separate findings from studies in which prostate cancer was not the primary outcome: a 1998 study of 29,133 male smokers in Finland who took vitamin E to prevent lung cancer surprisingly showed 32 percent fewer prostate cancers in men who took the supplement, and a 1996 study of 1,312 men and women with skin cancer who took selenium for prevention of the disease showed that men who took the supplement had 52 percent fewer prostate cancers than men who did not take the supplement.
Based on these and other earlier findings, in 2001, men were recruited to participate in SELECT. They were randomly assigned to take one of four sets of supplements or placebos, with more than 8,000 men in each group. One group took both selenium and vitamin E; one took selenium and a vitamin E placebo; one took vitamin E and a selenium placebo; and the final group received placebos of both supplements.
SELECT has been funded by NCI for $114 million, with additional monies from the National Center for Complementary and Alternative Medicine, and with sub-studies funded and conducted by the National Heart, Lung and Blood Institute, the National Institute of Aging and the National Eye Institute at NIH. The sub-studies were evaluating the effects of selenium and vitamin E on chronic obstructive pulmonary disease, the development of Alzheimer’s disease, and the development of macular degeneration and cataracts, and will continue without participants taking study supplements. An NCI-funded substudy is looking at the effects of the supplements on men who developed colon polyps.