Former SMC employee pleads guilty
A former Saint Mary’s maintenance worker charged with misdemeanor voyeurism in April pled guilty Monday, according to a WSJV report.David Summerfield, 73, also pled guilty to an additional charge of felony criminal mischief, the report stated. A felony count of theft was dismissed. Summerfield is scheduled to be sentenced Sept. 23.The College fired Summerfield fired from his position in April after a co-worker reported unusual behavior in a bathroom on the fourth floor of Le Mans Hall.Summerfield admitted to drilling holes in the floor and attic of the Le Mans showers and said he watched students through them, the WSJV report stated.Tags: SMC, voyeurism
The Notre Dame community recognized pioneering women faculty at Notre Dame with a panel discussion and celebratory reception in the DeBartolo Performing Arts Center hosted by the Office of the Provost on Wednesday.The panel featured five women who have helped “transform this university from a college for men to a university for all,” according to Provost Tom Burish, as well as moderator Mary Celeste Kearney, director of the Notre Dame Gender Studies Program and associate professor of film, television and theatre.Associate professor Sr. Kathleen Cannon, who served as associate provost from 1990 to 1997, began her remarks by recognizing the pioneering women in faculty who came before her and the four other panelists.“I know that it’s the women who were here a decade, or even more, before I came, who really were the foot soldiers, the trailblazers,” she said. “ … There were so few women faculty here at that time, and the first two who were appointed in 1965 — Josephine Ford and Suzanne Kelly — did not come in to a very hospitable environment. … And so they had their struggles.”Nancy Haegel, a member of the board of trustees and the class of 1981, said she hopes the University will continue to hire women into the faculty in leadership positions.“Certainly one thing I see is leadership that is traditionally, historically, predominantly male at Notre Dame, and there’s an important symbolism, I think, associated with that,” she said. “ … And in 10 years, I hope that the leadership symbols here continue to evolve and that Notre Dame — we’ve become increasingly confident — is making full use of all the talent that is available to it in this country, on this globe and everywhere.”Notre Dame’s role as a premier Catholic university, Haegel said, offers the opportunity for it to set an example.“I interact primarily with people who don’t know the place. They know of it,” she said. “ … They see this living experiment of faith and reason, and I think that’s just exciting and critical. There are a number of really excellent, religiously-grounded institutions, but few — if any — have the visibility, the resources and, therefore, the responsibility of Notre Dame.”Professor emerita Angie Chamblee, a self-proclaimed “happy retiree” after leaving the University in 2014, said this responsibility extends to mentoring students, something she missed out on as a minority member of one of the first undergraduate classes of women at Notre Dame.“I think that it’s so important that young people have mentors,” she said. “And I can say that at Notre Dame, I never had any. … I, luckily, found people who worked with me who valued my work, and so I was able to advance through the ranks in the First Year of Studies. I have seen change at the University — very positive change.”One way to continue with this positivity, Chamblee said, is by allowing professors to focus more on helping students grow.“I would say our students deserve more from us,” she said. “And I think that what can happen, and what can help with that is for those entities and those people who make decisions about tenure to give value and credit to mentoring our students when it comes to tenure time.”English professor and author Valerie Sayers said she acts as a mentor to students by providing an opportunity to talk through any problems.“I think that the process of mentoring, for me, continues in the sense that I do enjoy talking to people,” she said. “ … What I’ve learned about that process is that telling the narrative does move the person, very frequently, to the next step, and helps them gather themselves.”Sayers also credited her colleagues in the English department with providing inspirations for her six novels.“I feel always, all the time, that my language is being elevated,” she said. “I may be the only person in this University who can publicly proclaim that I love going to department meetings, because in the English department, people are so clever and witty, and they know how to quote and they know how to deliver a punch line.”Ann Tenbrunsel, professor of business ethics in the Mendoza College of Business, said she uses her research on the psychology of ethical decision-making in her mentoring process.“What I think is the first step is to identify the fact that we all have illusions about our ethicality,” she said. “So we all need to be aware that … in some sense, we all are biased, and we’re certainly biased — I think, probably more so — in our ethicality than in other biases we have about decision making or negotiation skills.”This same methodology can be applied to the University, Tenbrunsel said.“We have to recognize that we probably have ethical illusions,” she said. “We’re a great university [but] we have to realize where it is that we maybe aren’t so great, and recognize it.”It only takes one person recognizing areas in which the University can improve to create change, Cannon said, citing her work to close the gender gap between students at Notre Dame.“I tried to determine who might’ve been opposed to removing the gap and what their reasons were for it, and tried to talk to them to find out, and understand and appreciate why somebody would oppose this,” she said. “I did formulate … a recommendation that was sent to the board in May of 1991. They approved the removal of the cap, and now women are admitted almost at parity with men.”Tags: Angie Chamblee, Ann Tenbrunsel, Nancy Haegel, Pioneering Women, Valerie Sayers
Some of Georgia’s wildlife are feeling the sometimes deadlysting of fire ants. Entomologists and wildlife biologists havefound evidence that fire ants are hurting loggerhead turtles,brown pelicans, quail and alligators.Attacking Turtle Eggs and Hatchlings”A few years ago, we began seeing fire ants in the nestsof adult loggerhead sea turtles during hatching time,” saidBrad Winn, a Georgia Department of Natural Resources biologist.He works with the Nongame Wildlife and Natural Heritage Sectionin Brunswick, Ga.State wildlife biologists check turtle nests after hatchingto learn how many turtles hatched and how many hatchlings didn’tsurvive.”We found fire ants and small holes in eggs that we believewere caused by ants chewing into the eggs,” Winn said. “I’venever seen these kinds of holes in any nests other than ones containingfire ants.”But fire ant damage goes farther than egg holes. “Duringand just after hatching, I have found young turtles that werekilled in the shell by fire ants and others that were killed byfire ants after hatching,” he said.To evaluate the insect problem, the wildlife biologist calledon Stan Diffie. He’s an entomology research coordinator with theUniversity of Georgia College of Agricultural and EnvironmentalSciences.Diffie tracks the fire ant populations on the beaches of SeaIsland and Jekyll Island. “It’s not a major problem yet,”Diffie said. “Even with the highest incidents, they don’tappear to be hurting the sea turtle population.”ReducingPelican and Quail PopulationsOn the other hand, the researchers believe fire ants are affectingbrown pelican and bobwhite quail populations.”Two years ago, a colony of brown pelicans off the coastof Georgia completely abandoned an area of their rookery rightin the middle of the nesting season,” Winn said. “Thiswas a sure signal that something was wrong.”Winn found a large number of fire ants in the area and in thebirds’ nests. Wildlife biologists worried the fire ants mightattack other ground-nesting coastal birds like black skimmersand gull-billed terns — both on the state’s rare bird listing.To control the ants, Diffie treated the bird rookery with fireant bait before the spring nesting period.”The area the birds abandoned was recolonized that spring,”Diffie said. “We haven’t seen any evidence of abandonmentsince.”The researchers will check the rookery this fall to determinethe effectiveness of the treatments and the correlation betweenfire ant populations and the pelicans’ hatching success.Quail and Fire Ants Competing for FoodOn the Mossy Dell Quail Plantation in Leesburg, Ga., Diffiehas seen signs that fire ants are reducing the quail populationin Georgia.Both ants and chicks feed on insects. If the fire ants outcompetethe chicks, the quail don’t have enough to eat. Diffie is workingwith a local plantation owner to test his fire ant theory.Based on Texas research, Diffie knows fire ants can kill quaileggs and hatchlings in a controlled environment. Now he plansto find out how much damage they can do in the quail’s naturalhabitat. This research is being conducted on UGA’s Wolf CreekResearch Farm in Turner County, Ga.Attacking Baby ‘Gators’ TooBack on the coast, Winn has found evidence that fire ants areattacking yet another victim — the alligator.”Three or four times, I’ve seen entire alligator nestingmounds become one big fire ant colony,” he said. “Thehatching eggs were killed. And the female adults, who normallyguard the eggs and assist in the hatching process, had abandonedthe nests.”Research into these wildlife and fire ant reports has justbegun. So concrete data to support Winn’s findings isn’t available.”I have no doubt that fire ants are killing hatching alligators,”Winn said. “And lots of things can kill hatchling turtles.But I’ve seen too much evidence of fire ants not to believe they’reone of the culprits.”
The Vermont Student Assistance Corporation (VSAC) will offer forbearances of up to 90 days to borrowers who have federal or private education loans with VSAC and will have trouble keeping up with their payments as a result of the recent weather disaster.In addition, due to President Obama’s disaster declaration, VSAC may be able to provide loan relief to some of its borrowers who have defaulted on their federal loans. To qualify, borrowers must live in the counties designated by the president as eligible for individual assistance.A forbearance allows a borrower to temporarily stop payments or pay a reduced amount. The borrower is responsible for the interest that accrues on the loan during the forbearance period.VSAC stopped making new federal loans on July 1, 2010, when the government switched to ‘direct lending.’ VSAC continues to service federal loans made prior to the switch as well as its existing private loan portfolio.Vermonters affected by the storm who have federal loans with servicers other than VSAC should contact those servicers to explore forbearance eligibility.For more information, call 800-798-8722.
Colonial Pipeline Blues Lew Card Copy and paste this code to your site to embed. Drift Away Jim White 5:02 3:34 3:31 4:32 3:35 Rock Paper Scissors (With My Love) Lynn Taylor & The BarFlies 3:33 Train That Carried My Girl From Town Doc Watson 4:51 Audio PlayerJim WhiteDrift AwayUse Up/Down Arrow keys to increase or decrease volume.00:000:00 / 4:35 If It Wasn’t Broken Sunny War Hardest Thing The Maggie Valley Band 3:50 The Wilderness Grant-Lee Phillips Grow The Oh Hellos 4:01 2:59 It’s So Cruel Ruby Boots Expectations Wild Child Less Broken Now Ed Romanoff 3:49 I Didn’t Mean To Morgan Wade & The Stepbrothers 4:35 In Your Beat Django Django 3:42 Embed 5:00 Love That’s Wild Caleb Caudle Broken Wing Lowpines River Takes the Town The Wood Brothers 4:04 Black Chemicals Rainbrother 3:26 4:15 Winter Phase Revisited Nathan Kalish 3:28 Sunny War mesmerized me at first listen.The California-based folk singer and guitarist blends country blues finger picking with a social awareness in her lyrics more often found in punk rock and rap music. Such sonic dissonance – which absolutely works – is rooted in Sunny War’s early days in Nashville and wayward childhood that eventual landed her in California, being raised by a single mom, and immersion in the Los Angeles punk scene. Recent years have seen Sunny War honing her craft on the boardwalk in Venice Beach, where she has reached near legendary status. Rolling Stone recently named her as an artist you should know. Take their word for it and listen here, as Trail Mix features “If I Wasn’t Broken,” from With The Sun, her brand new record that releases this week.Every once in a while, an artist floats on the edge of my sonic consciousness for years and I don’t give him the full attention he deserves. That has happened this month with Grant-Lee Phillips, a noted singer/songwriter with a long and noted career, both as a solo artist and as a member of Grant Lee Buffalo. I dug into his catalog after dropping “The Wilderness” into this month’s mix and haven’t stopped listening. Do yourselves a favor and do the same if you don’t know Grant-Lee’s stuff.This month, Trail Mix also features another track from The Oh Hellos, who are in the midst of releasing four EPS over the coming months. With the debut of each EP, a new track will be featured here and a feature is in the works with the last release. Check out “Grow”” from the Eurus on the mix.Some great friends of Trail Mix are back again this month. New tunes abound from old favorites like The Wood Brothers, Jim White, Janiva Magness, Lynn Taylor & The BarFlies, Caleb Caudle, Julian Lage, Lew Card, Django Django, Wild Child, and the iconic Doc Watson.New tunes from artists new to Trail Mix are also tip top this month. Trail Mix is happy to welcome Morgan Wade & The Stepbrothers, Nathan Kalish, Rainbrother, and Lowpines to the family.This month’s blog has some great stuff in store for you. Stay tuned for chats with Ed Romanoff, Ruby Boots, and Western North Carolina’s own Maggie Valley Band.As always, thanks for listening. Trail Mix and these great artists appreciate your support. Help spread the word and buy some music from these good folks. 4:39 Wordsmith Julian Lage 4:18 Down Below Janiva Magness Feat. Courtney Hartman
By Dialogo August 25, 2009 The man Iran’s president has named to be defense minister is wanted in the 1994 bombing of a Jewish cultural center in Buenos Aires, and his nomination drew an outcry Friday from Argentina and Jewish groups. Ahmad Vahidi, who commanded a unit of Iran’s Revolutionary Guard known as the Quds Force at the time of the attack, was nominated by President Mahmoud Ahmadinejad Wednesday along with others named to fill Cabinet positions. The Quds Force is involved in operations abroad, including working with Lebanon’s Hezbollah militant group, which is accused to carrying out the Buenos Aires attack. Argentina Prosecutor Alberto Nisman told The Associated Press Friday that Vahidi is accused of “being a key participant in the planning and of having made the decision to go ahead with the attack against the Argentine-Israeli Mutual Association.” Nisman has led the investigation into the July 18, 1994, bombing _ Argentina’s bloodiest terrorist attack. The bomb exploded inside a van outside the Argentine-Israeli Mutual Association, killing 85 people and wounding 200. “It has been demonstrated that Vahidi participated in and approved of the decision to attack AMIA during a meeting in Iran on Aug. 14, 1993,” when he led the Quds Force, Nisman said. He added that Vahidi was never in Argentina. Argentine officials claim that Iran orchestrated the attack and that the Iranian-backed Hezbollah carried it out. The United States and Israel also say Iran is behind the bombing, but Iran has denied it. Ahmadinejad submitted his 18 Cabinet nominees late Wednesday to parliament, which must approve the list. Most of the nominees were close Ahmadinejad loyalists or little-known figures, while public critics of the president from his previous Cabinet were purged. At least four nominees _ for defense, interior, intelligence and oil minister _ had ties with the elite Revolutionary Guard, a powerful base of support for the president. “It’s significant, this nomination, but not surprising,” said Nisman about Vahidi’s nomination. “Iran has always protected terrorists, giving them government posts, but I think never one as high as this one.” The president of the Jewish cultural center in Buenos Aires, Guillermo Borger, told Argentina’s Jewish News Agency Friday that “we are completely surprised and outraged by the nomination of Ahmad Vahid. … His nomination is shameless and insulting.” Interpol said in 2007 it would help Argentina seek the arrest of Vahid and four other prominent Iranians wanted in connection with the attack. Among the others is Mohsen Rezaei, who ran against Ahmadinejad in the June 12 presidential election and is a former leader of the Revolutionary Guard. The other wanted Iranians are former intelligence chief Ali Fallahian; Mohsen Rabbani, former cultural attache at the Iranian Embassy in Buenos Aires; and former diplomat Ahmad Reza Asghari. Interpol had also sought Hezbollah militant Imad Mughniyeh, who was killed in a car bombing in Damascus, Syria, in February 2008.
10SHARESShareShareSharePrintMailGooglePinterestDiggRedditStumbleuponDeliciousBufferTumblr,Jay Kassing Jay Kassing is President of MARQUIS, a Texas based provider of marketing analytics solutions including MCIF/CRM software, MCIF services, profitability, compliance, consulting and direct mail creative/fulfillment. Jay has … Web: www.gomarquis.com Details So how will you be different? To me, that is the primary challenge for this generation of leaders at every credit union. The Digital Age is moving your prospective members to see that they don’t just have you and the other local banking options. The Internet opens the world of choice to everyone.I know plenty of people who are acolytes for the Apple movement. You may be one. I find that many of these folks love proselytizing about the power, uniqueness and cool factor of all things Apple. Yet I also know many people who are anti-Apple. They can spout the benefits of Samsung this or Android that…and they absolutely will not be caught with an Apple product. And vice versa.The same can be said for wine drinkers and/or the lovers of Single Malt Scotch. Just ask them…and 20 minutes later you know more about something you really had very little interest in to begin with.Maybe you will agree with the following: Most people have an opinion about, or an affinity for, specific things or activities. Do you agree with this? It’s why many individuals will self-disqualify themselves for certain activities, products or brands based on their opinions. Of course, the opposite is also true for those who qualify themselves for those same activities, products or brands.So what is the point I want to make? You cannot be all things to all people. You cannot try to reach and connect and build a relationship with all people in your community (however you define “community”). Some people will disqualify themselves before you even have a chance to connect with them. They are doing it already.So what? Here is the “so what.” You have to stand for something unique. Your credit union must take a hard look at what you believe in and deliver on a brand promise or position in the market – one that stakes a claim, is easily communicated, delivered and recognized. Most will love it. Some will self-disqualify. OK, again, so what? You aren’t getting business from everyone in town right now anyway. So, unless you have a “field of membership” that virtually guarantees participation and growth, you going to have to find a way to stand out.Be bold! Be so bold that many will self-disqualify. Let them. Say NO to these folks. Many will still buy products and services, even while holding their nose. My wife is ever-frustrated by her iPhone, but she wouldn’t ever change it. She just puts up with it. And she wants an I-pad mini for her birthday. Go figure.The bell curve for people who care enough to speak out or stand up is narrow. At most, 20-25% on each end of the curve will Love or Hate what you do. The mushy 50-60% in the middle will not care too much. Yet by being bold – you will immediately become a known entity. You will be a corporate stalwart in the community that people can look up to and respect. Everyone will know what you stand for. And 20-25% of your clients will brag on you, because they will be true believers.Are you a bold enough leader? Are you prepared to lead the revolution?Too few CEOs and CMOs and CFOs, and Board members in general, have the guts to be Bold. Many believe this whole positioning/branding concept is too touchy-feely. And most believe that your institution’s people and service quality makes all the difference. Let’s be clear here: Member Service is NOT a brand; it is every client’s expectation.The Digital Age will render every community financial institution with an undefined brand to the four winds of oblivion. That is, unless you stand for something people can respect as a different brand, one that is of value to them.So how will you be different? To me, that is the primary challenge for this generation of leaders at credit unions.
The leagues are working toward an agreement on a new Professional Baseball Agreement (PBA), which expires in September. “Like” Nicole Menner on Facebook and “Follow” her on Twitter. On Tuesday, a report by Baseball America claimed MiLB was ready to agree to MLB’s proposed plan to eliminate 40 minor league teams. “The respective negotiating teams of Minor League Baseball and Major League Baseball held a constructive meeting on Wednesday. The parties are continuing their discussions, with the goal of concluding a mutually beneficial long-term agreement in the near future.”
MiLB and Rumble Ponies owner John Hughes responded, saying those articles were inaccurate. (WBNG) — Following Wednesday’s negotiations between Major League Baseball and Minor League Baseball, the leagues issued a joint statement Thursday.
The most provocative news in dose-sparing has come in the past several months. In August, scientists working with a GlaxoSmithKline formula published a trial of a two-dose regimen of an inactivated split-virus vaccine adjuvanted with a proprietary oil-in-water emulsion; after the second injection, even the lowest dose of 3.8 mcg exceeded EU criteria for immune response (see Bibliography: Leroux-Roels 2007). And in September, Sanofi Pasteur reported in a press release that an inactivated vaccine adjuvanted with the company’s own proprietary formula induced EU-accepted levels of protection after two doses of 1.9 mcg. Oct 30, 2007 (CIDRAP News) Adjuvanted vaccines appear to hold the greatest promise for solving the grave supply-demand imbalance in pandemic influenza vaccine development. They come with obstaclesimmunologic, regulatory, and commercialbut they also have generated more excitement than any other type of vaccine thus far. Two other alum-adjuvanted vaccines that used whole viruses have shown some promise for antigen sparing. At a February 2007 World Health Organization (WHO) meeting, Norbert Hehme of GlaxoSmithKline Biologicals reported that a regimen of two 15-mcg doses met EU criteria for immune response (see Bibliography: Hehme 2007). And in May, Hungarian investigators reported that they had achieved an acceptable immune response in a small study using a formula (based on a seasonal vaccine already licensed in the EU) containing a single dose of only 6 mcg (see Bibliography: Vajo 2007). Two alum-adjuvanted vaccines that used the split-virus formulation common in the United States have reported levels of immune response acceptable to regulators at two doses of 45 mcg (see Bibliography: Keitel 2007) or 30 mcg (see Bibliography: Bresson 2006). But those levels of antigen are so high that deployment of those vaccines would not allow significant dose-sparing. The pandemic vaccine puzzle The US Department of Health and Human Services (HHS) issued $132.5 million in contracts in January 2007 to three companiesGlaxoSmithKline, Iomai, and Novartisto study antigen technology, including the possibility of mixing and matching adjuvants with separately manufactured antigens (see Bibliography: GSK 2007; Iomai 2007; Novartis 2007: Novartis receives US government contract). Manufacturers have welcomed the government interest because negotiating combinations of components from different companies is fraught with antitrust and intellectual-property pitfalls. Moreover, at the moment both the FDA and the European Union’s drug agency consider adjuvants to be a component of vaccines, not a product separate from vaccinesimplying that adjuvants can be brought forward only as part of a precise antigen dose/adjuvant combination that must be tested for safety and efficacy, probably in a “non-inferiority” trial against the same antigen dose without adjuvant, and then submitted for licensure (see Bibliography: European Agency for the Evaluation of Medicinal Products 2005; FDA 2007: Guidance for industry: clinical data needed to support the licensure of seasonal inactivated influenza vaccines). “We have H5N1 to thank for opening up the flu research field, which was absolutely creeping along,” said Dr. Arnold Monto, a flu epidemiologist at the University of Michigan, who has long research experience with live-attenuated vaccine. “We’ve always known that flu vaccine was good, but not greatnot a 21st century vaccine with 95% protectionbut there was a feeling that it was good enough. But H5N1 changed the risk-benefit ratio so that we are willing for instance to work with adjuvants, which may have theoretical risks but certainly may well afford tangible benefits. We’re going to learn a whole lot about the immunology of protection that we haven’t learned in the past” (see Bibliography: Monto 2007). “We have not taken the position that an adjuvant can be thought of as a stand-alone product,” Dr. Pamela MacInnes of the National Institutes of Health said at an FDA advisory committee meeting last February. “It’s a product that has antigen in combination with an adjuvant that comes forward for licensure” (see Bibliography: FDA 2007: Committee meeting transcript). Part 1: Flu research: a legacy of neglectPart 2: Vaccine production capacity falls far shortPart 3: H5N1 poses major immunologic challengesPart 4: The promise and problems of adjuvantsPart 5: What role for prepandemic vaccination?Part 6: Looking to novel vaccine technologiesPart 7: Time for a vaccine ‘Manhattan Project’?Bibliography In an example of the hope being hung on adjuvants, the WHO last week issued a statement declaring that the pandemic vaccine supply is “sharply” increasing and forecasting that annual manufacturing capacity will rise to 4.5 billion two-dose courses by 2010 (see Bibliography: WHO 2007: Projected supply). The forecast is based on the expectation that flu vaccines made in 2010 will include an adjuvant permitting the use of just one-eighth of current vaccines’ antigen content. (Adjuvants are chemicals that are incorporated in some vaccines to improve response to the vaccines’ active ingredient. Adjuvants make it possible to reduce the dose of antigen in a vaccine without dampening the immune response.)
While adjuvants hold the greatest promise for dose-sparing, they also provoke trepidation because they are by definition immune-system activators. While many have been tested over the years, few have entered the market, because they proved too reactogenic to be acceptable to consumers or safe. Only one set of adjuvants, aluminum salts or alum (aluminum hydroxide, aluminum phosphate, and potassium aluminum sulfate), is licensed in the United States. Aluminum adjuvants and MF59, an oil-in-water emulsion that contains squalene (an oil found in some fish oils), are licensed in Europe (see Bibliography: Petrovsky 2007). Adjuvants old and newEarly hopes for an adjuvanted H5N1 vaccine focused on alum, because it is well-understood and widely licensed, but those formulas have proved disappointing. A phase 1 study of alum-adjuvanted vaccine made by the Chinese company Sinovac Biotech achieved acceptable levels of protection using two doses of only 10 micrograms (mcg) of flu antigenbut that formula was based on an inactivated whole virus, a flu-vaccine type that is licensed in the European Union but not currently used in the United States (see Bibliography: Lin 2006). Mixing and matchingThere is currently no regulatory pathway by which adjuvants may be submitted for approval as products by themselvesor may be paired with a separately manufactured antigen, perhaps one produced by another company. Regulators acknowledge that could stand in the way of, for instance, converting the already-manufactured vaccine in the national stockpile (which was purchased under the 90-mcg-dose license granted Sanofi Pasteur earlier this year but is held in bulk) to an adjuvanted vaccine that could be stretched much further. “There probably are more concerns about an antigen made with one manufacturing process and an antigen made with another manufacturing process and whether when those are mixed with ideal adjuvant X in two potentially different circumstances or time points, that could raise a bunch of issues about formulation, stability, immunogenicity, safety,” Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said at the FDA meeting (see Bibliography: FDA 2007: Committee meeting transcript). Editor’s note: This is the fourth in a seven-part series investigating the prospects for development of vaccines to head off the threat of an influenza pandemic posed by the H5N1 avian influenza virus. The series puts promising advances in vaccine technology in perspective by illuminating the formidable barriers to producing large amounts of an effective and widely usable vaccine in a short time frame. Part 3 discussed the immunologic challenges posed by the H5N1 virus, including its poor immunogenicity when incorporated in vaccines and the difficulty of assessing immune responses to the vaccines. Regulatory barriers loomLike many other aspects of pandemic planning, adjuvants’ ability to solve some of the challenges of preparedness will depend on how rapidly a pandemic arrives. That is because the most promising vaccines rely on formulas that have not yet been licensed in the United States. The Food and Drug Administration (FDA) has indicated that pandemic vaccines made in the same manner as an already-licensed seasonal vaccine may be treated only as a “strain change,” in an accelerated approval process by which components are swapped out of existing seasonal flu vaccines each spring. But since there are no adjuvanted seasonal flu vaccines currently licensed in the United States, antigen-sparing pandemic vaccines may require a full Biologics License Applicationthe complete portfolio of testing and data, on both the product and the manufacturing facility, that is demanded of any new drug submitted for licensure and can take years to assemble (see Bibliography: FDA 2007: Guidance for industry: clinical data needed to support the licensure of pandemic influenza vaccines). No adjuvanted flu vaccine is licensed in the United Statesa notable oversight since federal health authorities urged such a vaccine be investigated as a preparedness measure after the pandemic of 1957 (see Bibliography: Strikas 2005). Fifty years later, the need to seek regulatory approval for novel components in adjuvanted pandemic vaccines could prove a barrier to rapid market entry of formulas that look promising. “I have heard a lot of people say they expect problems with adjuvanted vaccines,” said Hedwig Kresse, an associate analyst for infectious diseases with the British-based market analysts Datamonitor. “It is a technology that definitely has some potential, but there are a lot of issues that need to be addressed first” (see Bibliography: Kresse 2007).
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