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Fernandez turns tables on San Jose
Mariners prospect shuts out Giants in second game of twinbill
By David Heck / Special to MLB.com | April 26, 2012 6:32 PM ET
The Mariners prospect tossed a two-hit, seven-inning shutout in the second game of a twinbill Thursday, leading the Class A Advanced Mavericks to a 6-0 win over the Giants.
Fernandez struck out seven and walked one to earn his first win of the season. The outing marked his first complete game and shutout since he started pro ball in 2007.
"I just mentally prepared for five days for this start," Fernandez said through a translator. "Watching the first game, I was able to see what guys were swinging at. I used being shut out as a push to throw strikes and help the team win."
The Giants' first hit of the game came from their second batter as Carter Jurica doubled on a line drive to center field. Fernandez retired the next nine hitters he faced before first-rounder Joe Panik ended the streak with a one-out single in the fourth. That was all the Giants got in the frame, however, as Adam Duvall followed with a double-play ball.
"I just wanted to pound the zone," Fernandez said. "[Jurica and Panki got] a good pitch and got a good swing on it and was able to drive the ball."
Despite not giving up another hit, Fernandez did run into some trouble in the sixth. San Jose's Chris Lofton worked a two-out walk, while Jurica reached base on a throwing error by third baseman Steven Proscia. With runners on the corners, Fernandez induced a groundout by Panik to escape the inning.
The 21-year-old left-hander pitched a perfect seventh, striking out the final two batters he faced.
"I want to thank God for allowing me to perform well today," Fernandez said. "I stayed focused and just attacked the strike zone on every hitter."
Signed as a non-drafted free agent on Sept. 29, 2006, Fernandez compiled a 2.80 ERA with 107 strikeouts and 42 walks in 125 1/3 innings for Class A Clinton last year. He struggled in 28 frames for High Desert, however, posting a 7.39 ERA.
This year, the story has been different as Fernandez has put together a 3.26 ERA with 21 punchouts and six walks in 30 1/3 innings.
"I'm really hungry to go out there and pitch every start," he said. "The preparation, I've stepped it up a few notches to get better. I just keep pushing it and am trying to be a better pitcher every day."
John Hicks led the Mavericks offense by going 2-for-2 with a homer, three runs scored and two RBIs. Mario Martinez also went deep and plated a pair in the win.
In the first game of the doubleheader, Jack Snodgrass (2-1) allowed two hits over six innings to lead the Giants to a 3-1 victory. Josh Osich completed the shutout effort and notched the first save of his career by tossing a perfect seventh.
David Heck is a contributor to MLB.com. This story was not subject to the approval of the National Association of Professional Baseball Leagues or its clubs.View More


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News & Events
Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States
Statement of
Janet Woodcock, M.D.
Deputy Commissioner, Chief Medical Officer,
Food and Drug Administration
the Subcommittee on Health,
House Committee on Energy and Commerce
May 2, 2007
Mr. Chairman and Members of the Subcommittee, I am Janet Woodcock, M.D., Deputy Commissioner, Chief Medical Officer at the U.S. Food and Drug Administration (FDA or the Agency). Thank you for the opportunity to testify about the scientific and regulatory background surrounding follow-on protein products.
During the past several years, there has been increasing public interest in the development of follow-on versions of approved protein products. This interest has been fostered, in part, by advances in manufacturing technology, process control, and characterization that allow greater control over, and understanding about, the physical structure of certain of these products.
However, a number of important issues related to development of such follow-on products also have been identified. First, there is general recognition that the idea of sameness, as the term is used in the generic drug approval process under the Federal Food, Drug, and Cosmetic (FDC) Act and applied to small molecules, will not usually be appropriate for more structurally complex molecules of the type generally licensed as biological products under the Public Health Service (PHS) Act. Additionally, as a related matter, there are clearly scientific challenges involved in determining that a molecule that is not the same as an approved or licensed version is nevertheless similar enough that the Agency's conclusions about the safety and effectiveness of the approved or licensed version could be relied on to support approval of the follow-on product.
Presently, the PHS Act does not contain an abbreviated approval pathway analogous to the FDC Act section 505(b)(2) and 505(j) (21 U.S.C. 355 (b)(2) and 355 (j)), although the Agency has approved a number of protein products, such as human growth hormone, under the FDC Act.
The Administration supports the goal of making safe and effective drugs more available to American consumers. Working with Congress, the Administration has successfully taken steps to speed quality generic drugs to market. We look forward to working with Congress in a bipartisan fashion to consider issues related to a possible pathway for follow-on protein products. Such legislation should, as its first priority, protect patient safety. It should also maintain the research enterprise that has generated valuable, life-saving medications. These complex issues should be considered thoroughly through a robust scientific, regulatory and legal discussion. Such discussion should not be abbreviated for any reason.
Before I go any further, I would like to define some terms and describe the scope of my remarks, so that we can have a common understanding of the issues. I will define additional terms as needed in this testimony as I first outline the pertinent regulatory schema and then describe the scientific issues. First, I would like to recognize that the terms biologics, generic biologics, biogenerics,and follow-on biologics are often used informally to refer to certain products produced through biotechnology. These terms are imprecise and can be confusing, and the use of the term generic inaccurately implies the same meaning as exists for generic drugs.
For purposes of this discussion, I will use the term protein products to refer to certain biological products licensed under the PHS Act and to certain protein and peptide products approved under the FDC Act. I will further use FDA's informal term follow-on protein products to refer to proteins and peptides that are intended to be sufficiently similar to an approved product to permit the applicant to rely on certain existing scientific knowledge about the safety and effectiveness of the approved protein product. Follow-on protein products may be produced through biotechnology or derived from natural sources.
A biological product is defined, in relevant part, under the PHS Act as "a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . . applicable to the prevention, treatment or cure of a disease or condition of human beings." (PHS Act §351(i), 42 U.S.C §262(i)). Many categories of biological products are defined by their clinical use, for example, vaccines and allergenic products. Vaccines can include live attenuated viruses and inactivated viruses, products made from bacteria or other micro-organisms, products made from cells (human or other), and protein products made using biotechnology. Other biological products are defined by their origin (e.g., blood and blood products). Blood products may be made from human blood collections, from blood from animal species, or using biotechnology. Monoclonal antibodies are biotechnology-derived versions of certain blood proteins. Newer types of biological products include cellular therapies (beyond the traditional blood cells) and gene therapies. Many biological products are not completely characterizable using current technology.
Traditionally, some natural source proteins have been regulated as drugs under the FDC Act, including insulin, hyaluronidase, menotropins, and human growth hormones, while other natural source proteins, such as blood factors, are regulated as biological products under the PHS Act. In the late 1970s and early 1980s, recombinant proteins and monoclonal antibodies began to be developed. Certain of these products were regulated by FDA's Center for Drug Evaluation and Research (CDER) under the FDC Act as drugs (e.g., hormones such as insulin and human growth hormone), and others were regulated by the Center for Biologics Evaluation and Research (CBER) under the PHS Act (e.g., cytokines, proteins that are involved in the immune response, and blood factors, such as factor VIII for the treatment of hemophilia). In 2003, certain therapeutic proteins regulated by CBER were transferred to CDER, with no change to the applicable regulatory authority. Currently, some proteins are licensed under the PHS Act, and some are approved under the FDC Act.
At this point, it may also be helpful to set out certain terms that describe how certain products relate to each other.
The current FDA use of the term "comparability" generally refers to the comparison of a biological product before and after a manufacturing change by the manufacturer. A sponsor may be able to demonstrate that a product made after a manufacturing change is comparable to a product made before implementation of the change. This may be demonstrated through different types of analytical and functional testing and might not require additional clinical studies. The Agency may determine that the two products are comparable if the results of the comparability testing demonstrate that the manufacturing change does not affect safety, identity, purity, or potency. (It is important to note, however, that this has generally been applied in cases where the manufacturer and Agency have full access to the manufacturer's data – something that may not be the case for follow-on products.) See April 1996 FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products.
The International Conference on Harmonization (ICH) guidance defines comparable as a conclusion that products have highly similar quality attributes before and after manufacturing process changes and that no adverse impact on the safety or efficacy, including immunogenicity, of the drug product occurred. See June 2005 ICH Guidance for IndustryQ5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process.
Therapeutic Equivalents
These are approved drug products, usually made by different manufacturers, that are pharmaceutical equivalents and for which bioequivalence has been demonstrated. Therapeutic equivalents can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. Therapeutically equivalent prescription drugs will receive an "A" equivalence evaluation code in FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (Orange Book). This term has been applied only in the context of drugs approved under section 505 of the FDC Act.
This term is not defined by FDA and could have a number of different meanings. It could refer to products that are therapeutic equivalents, and thus could, in some circumstances, be substituted at the pharmacy level without a physician's intervention. Alternatively, the term could describe similar products that are not "substitutable" but which, under a physician's supervision, could be used to treat the same disease or condition in the same patient.
The concept of a follow-on protein product is that an applicant could obtain approval for such a product through the submission of an abbreviated application. An abbreviated application would be one that relies, to at least some extent, on the Agency's conclusions regarding the safety and effectiveness (or safety, purity, and potency) of an approved product and also contains whatever additional data is necessary, to establish that the follow-on product is safe and effective. It is important to ensure that facilitating the development of follow-on products through abbreviated pathways does not discourage innovation and the development of new biological products.
Generally speaking, the interest in development of follow-on protein products pertains to versions of follow-on products manufactured using biotechnology. As noted, these protein products are either approved as drugs under the FDC Act or licensed as biological products under the PHS Act. Unlike small molecule drugs whose chemical composition can easily be determined to be the same as an approved product, the very nature of protein products makes comparisons of one protein to another, including comparisons to establish safety and efficacy, more scientifically challenging.
FDA approves new drugs, as distinguished from biological products, under approval mechanisms found in section 505 of the FDC Act and licenses biological products under section 351 of the PHS Act. Under the FDC Act, in addition to the approval pathway involving the submission of a full 'soup to nuts' new drug application, there are two abbreviated pathways for subsequent versions of already approved drug products.
The Abbreviated New Drug Application (ANDA) process in section 505(j) was established through the 1984 Hatch-Waxman Amendments, and reflects Congress' intention to balance the need to encourage innovation with the desire to speed the availability of lower cost alternatives to approved drugs and to avoid ethical concerns associated with unnecessary, duplicative human testing. This is an abbreviated approval mechanism for duplicates of drugs already approved under section 505 of the FDC Act. Under these statutory standards, a generic drug generally must contain the same active ingredient as an innovator product; it must be bioequivalent to the innovator drug; and it must have the same dosage form, strength, route of administration, labeling, and conditions of use. By establishing that the drug product described in the ANDA is the same as the approved innovator drug product, the ANDA applicant can rely on the Agency's finding of safety and effectiveness for the approved drug. Most drug products approved under section 505(j) are therapeutically equivalent to the referenced approved drug. 1 Therapeutic equivalents can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. In many jurisdictions, therapeutically equivalent drugs may be substituted at the pharmacy level, without a physician's intervention. For reasons that I will discuss, it is not clear that this type of pathway, which determines that a drug is the same based on a chemical comparison to the innovator product, would be appropriate for follow-on protein products.
The abbreviated pathway described in section 505(b)(2) of the FDC Act permits an applicant to rely on published literature or on the Agency's finding of safety and effectiveness for a referenced approved drug product to support approval of a proposed product. The 505(b)(2) applicant must demonstrate that reliance on the previous finding of safety and effectiveness is scientifically justified and must submit whatever additional non-clinical and clinical data are necessary to establish that the proposed product is safe and effective. FDA has used this pathway to approve some follow-on protein products including human growth hormone.
Compared to many small molecule drug products, proteins are usually substantially larger, more complex molecules that may be mixtures of distinct entities. Even well-characterized, highly purified recombinant proteins may exhibit minor degrees of structural variability from lot to lot resulting from variations in the manufacturing process. The quality and nature of natural source products can vary depending on condition of the source material, processes used to extract and purify the product, and other factors.
Because of the variability and complexity of protein molecules, current limitations of analytical methods, and the difficulties in manufacturing a consistent product, it is unlikely that, for most proteins, a manufacturer of a follow-on protein product could demonstrate that its product is identical to an already approved product. Therefore, the section 505(j) generic drug approval pathway, which is predicated on a finding of the same active ingredient, will not ordinarily be available for protein products.
However, FDA has considerable experience with reviewing some protein products, including cases where the Agency has considered the extent to which existing conclusions about the safety and effectiveness of a protein product could be applicable to another protein product based on data and information showing the similarity of the products. One example, most applicable to this discussion, is the situation in which a different manufacturer has sought to demonstrate that its protein product is similar enough to a protein product marketed by another manufacturer that the finding of safety and/or effectiveness made for the approved product could be relied on to support approval of the proposed product (e.g., a 505(b)(2) application).
FDA has also considered these issues when manufacturers seek to demonstrate that a new version of their licensed biological product manufactured using a different manufacturing process is comparable to the product manufactured using the original process. However, it should be clear that demonstrating the similarity of a follow-on protein product to a reference product will typically be more complex, and thus require more new data, than assessing the similarity of products before and after manufacturing changes made by the approved product's sponsor.
In general, the amount and type of new data that will be needed to demonstrate the safety and effectiveness of a follow-on protein product, compared to the data that supported the safety and effectiveness of an already marketed product, will be influenced by the extent to which the follow-on product can be demonstrated to be sufficiently similar (structurally, functionally, and clinically) to an approved protein product to permit some degree of reliance on the findings of safety and effectiveness for the approved product. In addition, the amount and type of new data needed will be influenced by the clinical use of the product and the amount and type of clinical experience that has been accumulated about the approved product as well as related products.
Current technologies, such as peptide mapping, protein sequencing, and mass spectroscopy enable manufacturers to determine, with certainty, the amino acid sequence of a recombinant protein. However, the amino acid sequence is the most rudimentary characteristic of a protein. Conclusive analysis of other aspects of a protein's structure requires much more sophisticated technologies and is fraught with uncertainties that are proportional to the size and complexity of the protein itself. Such complexities include: folding of the protein's amino acid chain into highly organized structures, post-translational modification of the protein with a broad range of biochemical additions (e.g., glycosylation, acetylation, phosphorylation, etc.), and association of multiple protein molecules into aggregates. It is the combination of the protein's amino acid sequence and its structural modifications that give a protein its unique functional characteristics. Therefore, the ability to predict the clinical comparability of two products depends on our understanding of the relationship between the structural characteristics of the protein and its function, as well as on our ability to demonstrate structural similarity between the follow-on protein and the reference product. Although this currently may be possible for some relatively simple protein products, technology is not yet sufficiently advanced to allow this type of comparison for more complex protein products.
Functional characterization, using in-vitro tests, is also of great importance in assessing the similarity of two proteins. For proteins with a well-understood mechanism of action and available functional assays, extensive functional comparisons will enhance understanding of comparability. Future scientific advances may facilitate the ability to perform more meaningful functional testing.
Protein products are used for a wide variety of indications. In some cases, there is an extensive mechanistic understanding of the role of the product in the treatment process. For example, some products are used as replacement therapies to treat a known deficiency (e.g., human growth hormone for growth hormone deficiency). For some such products, the mechanism of action and the role of replacement are well understood. In the case of other products, the mechanism of action of the product is not well understood and its role in treatment was derived, in part, by trial and error. In such cases, even very extensive structural and functional comparisons between a follow-on and a comparable innovator product may not be sufficient to allow broad reliance on conclusions regarding a prior product. When the mechanism of action is well understood and there is a significant amount of clinical experience with a product, it may be easier to make a scientific assessment of the ability to rely on conclusions about safety and efficacy from a prior application.
Immunogenicity is the ability to stimulate an immune response. An immune response to a therapeutic protein can range from development of detectable but not clinically significant antibodies, to an immune response with impact on safety or effectiveness. "Neutralizing antibody" responses can decrease the clinical effect of a protein. Adverse safety events from an immune response could include hypersensitivity reactions such as anaphylaxis, rash, fever and kidney problems, to cross-reaction with an endogenous (naturally occurring in the body) protein (e.g., erythropoietin). Immunogenicity may be influenced by patient-related, disease-related, or product-related factors. Immune responses to administered protein products can be extremely serious or life-threatening; therefore, this issue requires significant attention.
The ability to predict immunogenicity of a protein product, particularly the more complex proteins, is extremely limited. Therefore, some degree of clinical assessment of a new product's immunogenic potential will ordinarily be needed. The extent of independent testing needed will again depend on a variety of scientific factors such as the indication, whether the product is to be administered chronically, the overall assessment of the product's immunogenic potential, and whether there is the possibility of generating a cross-reaction with an important endogenous molecule.
A finding by the Agency that a follow-on protein product may be approved as safe and effective is distinct from a determination that the follow-on protein product would be substitutable for the referenced protein product. To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited.
Even though protein products are more complex than small molecules, FDA has applied its expertise and experience to approve certain follow-on protein products in applications described in section 505(b)(2) of the FDC Act. Some examples of products approved in this manner are: Hylenex (hyaluronidase recombinant human), Hydase (hyaluronidase), Fortical (calcitonin salmon recombinant) Nasal Spray, Amphadase (hyaluronidase), GlucaGen (glucagon recombinant for injection), and Omnitrope (somatropin [rDNA origin]). I will discuss, in detail, two of these examples of protein products that were approved through an abbreviated approval pathway.
Omnitrope (somatropin)
Omnitrope is a human growth hormone product derived from recombinant DNA processes. Human growth hormone is a single-chain, 191 amino acid, nonglycosylated protein. Its amino acid sequence is well known and physicochemical tests are able to determine the complex folded structure of human growth hormone products. There are also clinically relevant bioassays and validated biomarkers (laboratory indicators of effect) available to assess the performance of human growth hormone products.
Human growth hormone has a long and well-documented clinical history as replacement therapy for growth failure in pediatric patients due to endogenous growth hormone deficiency, and its mechanism of action and toxicity profile are well established. Some marketed human growth hormone products are approved for other uses, such as therapy for growth failure associated with chronic renal insufficiency and replacement of endogenous growth hormone in adults with growth hormone deficiency.
The original marketed versions of human growth hormone were derived from the pituitary glands of human cadavers. The first recombinant version was approved in 1985. Since then, several more recombinant human growth hormone products have been approved under section 505(b)(1) of the FDC Act (i.e., each product approval relied on original clinical data developed specifically for that product, not an abbreviated pathway).
Omnitrope is the first recombinant human growth hormone product approved through the abbreviated pathway described by section 505(b)(2) of the FDC Act. It was approved for (1) long-term treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone and (2) long-term replacement therapy in adults with growth hormone deficiency (either childhood or adult onset). The approval of Omnitrope was based on new data specific to Omnitrope (but less new data than would be needed to support an approval under section 505(b)(1)) and also relied on the approval of Genotropin (a previously approved version of rDNA-derived somatropin) for the same indications proposed. Specifically, the approval was based on the following:
- Physicochemical testing that established, among other things, that the structure of the active ingredient in Omnitrope is highly similar to the structure of the active ingredient in Genotropin;
- New non-clinical pharmacology and toxicology data specific to Omnitrope;
- Vast clinical experience and a wealth of published literature concerning the clinical effects (safety and effectiveness) of human growth hormone;
- Pharmacokinetic, pharmacodynamic, and comparative bioavailability data that established, among other things, that Omnitrope and Genotropin are highly similar based on pharmacokinetic parameters and pharmacodynamic responses;
- Clinical efficacy and safety data from controlled trials comparing Omnitrope to Genotropin and from long-term trials with Omnitrope in pediatric patients; and
- FDA's conclusions that Genotropin is safe and effective for the indications for which approval was sought in the Omnitrope application and that Omnitrope is highly similar to Genotropin.
Omnitrope has not been rated by FDA as therapeutically equivalent (that is, substitutable) to any other approved human growth hormone product.
The hyaluronidases are enzymes that break down hyaluronic acid and chondroitin. Hyaluronidase injection is indicated for use to increase the absorption and dispersion of other injected drugs and for related uses. The enzymatic activity of this product is one of its critical quality attributes, and a method for assessing the enzymatic activity of hyaluronidase is described in the U.S. Pharmacopeia (USP). Most hyaluronidase products are natural source proteins, purified from mammalian testicles, whose amino acid sequences vary based on the species and the tissue from which it is obtained. There may also be variability within the same tissue source.
The first hyaluronidase product was approved for marketing in 1948 under the FDC Act, based on a literature review demonstrating its safety. Hyaluronidase products containing mammalian hyaluronidase enzyme preparations were subsequently determined to be effective for their current indications. In addition, an extensive body of literature has been developed supporting the safe and effective use of mammalian testicular hyaluronidase for these indications. FDA has approved follow-on versions of mammalian testicular hyaluronidase (ovine and bovine) under section 505(b)(2) of the FDC Act (i.e., via an abbreviated pathway) for the existing indications and has more recently approved a human recombinant hyaluronidase follow-on product. For new follow-on hyaluronidase products, the potential for allergic reactions is the primary clinical safety concern. Therefore, in addition to requiring that a given product have the necessary enzymatic activity, the Agency now requires clinical data to assess the allergenic potential of that product. In addition, an applicant is required to provide assurance that its standards for manufacturing ensure consistency of the drug substance and drug product. No hyaluronidase product is rated by FDA as therapeutically equivalent (that is, substitutable) to any other approved hyaluronidase product.
FDA Activity Related to Follow-on Protein Products
Because there are many challenging scientific and policy questions about follow-on protein products, FDA has actively promoted a public dialogue on these issues. FDA has held two public meetings (September 2004 and February 2005) and co-sponsored a workshop, in collaboration with the National Institute for Standards and Technology, and with the New York Academy of Sciences (December 2005), to gather input on scientific and technical issues related to follow-on protein products. These meetings resulted in a large number of comments and concerns from the interested parties that have informed our considerations of these issues.
My fellow FDA scientists and I recently published an article in Nature Reviews Drug Discovery, illustrating FDA's scientific reasoning and experience with the approval of certain protein products. This journal article outlines past examples of FDA's actions involving the evaluation of various types of follow-on and second generation protein products and within-product manufacturing changes.
The Agency previously indicated its intention to issue guidance documents to specifically address human growth hormone and insulin. But, as our knowledge of this issue expanded, we reconsidered our focus and determined it would be more appropriate to initially promulgate guidance that is more broadly applicable to follow-on protein products in general. We are in the process of developing such guidance, which would first be released in draft form for public notice and comment, with respect to products approved under the FDC Act. Of course, as you know, even in the absence of published guidance, a sponsor may contact the Agency to request advice on a case-specific basis regarding the development of a follow-on protein product for submission in an application under section 505 of the FDC Act. Thus, the Agency continues to review and approve certain follow-on protein products under its current authority and works to do this as effectively and efficiently as possible. Although we currently work closely with all product sponsors to assist them through the FDA review process, as discussed earlier, the Agency plans to address scientific considerations related to the approval of follow-on protein products in a comprehensive manner through issuance of a series of guidance documents. We expect this approach will provide useful guidance to industry while ensuring that we not stifle innovation or the use of state-of-the-art technologies. We appreciate the interest that Congress has always demonstrated in working to provide safe, effective, and affordable medicines to consumers.
I appreciate the opportunity to provide this background information on the important issue of follow-on protein products.

subset: commoncrawl


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'Bettman met with reporters after the first period. He was asked about Mario Lemieux's charge that calls went against the Penguins during their first-round series because Lemieux is an owner. "I also read the other side of that – that he was getting too many breaks because he's an owner," Bettman said.'
The Sabres Report - May 9, 2001


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Words from the Wise: A Night of Spirit Messages
Jenna Terlosky
Saturday, January 26, 2013 at 7:30 PM (PST)
Who's Going
San Francisco, California
London, United Kingdom
Florence, Italy
Event Details
Jenna Terlosky & Nora Stone invite you to join them for an uplifting evening of Spirit Messages of love, peace, and guidance on Saturday, January 26th at the Beverly Garland Hotel! There will also be a Special Guest Star Host! Please come join in on the fun.
CLICK HERE to get biographies and more information about Jenna, Nora, and Words of the Wise!
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When & Where
Beverly Garland Hotel
4222 Vineland Ave
North Hollywood,
Saturday, January 26, 2013 at 7:30 PM (PST)
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Jenna Terlosky
Jenna was blessed to have Spirit unveiled to her at an early age. As a 5th Generation Spiritual Intuitive, it was not surprising that her gifted grandmothers aided her spiritual development, exposing her to mediums, seances, and metaphysics frequently throughout her childhood. Jenna has been nudged frequently to pursue spiritual work, taking her first class in meditation and messages at 13 years old. In 2012, she began studying with Lisa Williams in advanced mediumship development and platform demonstrations, and continues her involvement with Lisa at her International School of Spiritual Development in Los Angeles. Jenna performs demonstrations with a talented group of mediums known as The Mediums: A Spiritual Voice, based in West Los Angeles, who also aid each other in development. She will be studying with Tony Stockwell at Arthur Findlay College in the United Kingdom in August 2014.


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Axl Rose tops list of largest vocal ranges
Listen to Guns N' Roses on iHeartRadio
Axl Rose is leading a new list that ranks the vocal ranges of some of the world's most well-known singers.
ConcertHotels.com made note of the highest and lowest notes a number of artists hit in the recording studio, and the data shows that the Guns N' Roses frontman has an impressive range of a little more than five octaves.
It doesn't come close to the world record of ten octaves, but it does put Axl ahead of Mariah Carey. The R&B diva, however, easily hits the highest note of any other singer on the list, while Rose hits the lowest. The rest of the top five after Axl and Mariah includes Prince, Aerosmith's Steven Tyler, and James Brown.
Radiohead's Thom Yorke comes in at number ten, while the gravely-voiced Tom Waits surprisingly beats out the likes of Beyonce, Michael Jackson, Aretha Franklin, Whitney Houston, and Adele. The full list and the songs at each end of the singer's range are available to browse at ConcertHotels.com/worlds-greatest-vocal-ranges.
Top Ten Vocal Ranges:
1. Axl Rose
2. Mariah Carey
3. Prince
4. Steven Tyler
5. James Brown
6. Marvin Gaye
7. Christina Aguilera
8. David Bowie
9. Paul McCartney
10. Thom Yorke
Photo Credit Getty Images


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Growth, like the vine, knows no boundaries. Therefore, several years ago the family decided to export wines worldwide. In the United States they joined with the Deutsch Family, an importer, and together consistently increased Villa Pozzi's presence in the U.S. Daniele Pozzi - the 4th generation family winemaker - continues to catapult the inspiring legacy and tradition of the Pozzi family wine business into the future. View all Villa Pozzi Wines
About Sicily(SIH-sih-lee) Nero d'Avola, this hot and hilly region is diverse. Sicily was at one time more quantity focused than quality, and while it's still producing a great deal of wine, the quality coming out is much better. With poor soil (great for grapes), warm sunshine, little rainfall and good mountain terrains, this little island is perfect for making the good stuff.
Notable FactsThere are still delicious sweet wines coming from Sicily, including Marsala, Moscato di Pantelleria & Malvasia delle Lipari. But the reds are the wines making people stand up and notice. Nero d'Avola is demonstrating its potential for making deep reds with the ability to age. Some winemakers are taking a chance with international varieties, like Merlot and Cabernet Sauvignon. These grapes are sometimes blended with the Nero d'Avola or other native Italian varietals – adding a bit of international sophistication to regional charm.
About Italy
A little ditty about Italy...This country has about as many wines as its had governments. With 20 different regions, hundreds of DOCs and even more indigenous varieties, the amount of wine made in Italy is mind-boggling. Most of the juice, however, remains in the country for thirsty Italians. Wine is food in Italy and its rare that a meal is consumed without a glass of vino. That said, it's not common to find many folks drinking wine without food either. In turn, it's a match, and a mighty good one at that. In fact, it's safe to say that Italian wine is a foodie wine – one that goes on the table for a myraid of meals.
For regions, the most popular are Tuscany (home of Chianti), Piedmont and the Tre-Venezie, which includes Veneto, Trentino Alto-Adige and Friuli. Other communes of note are in Southern Italy, and a few good wines are made elsewhere in the country. The islands of Sardinia and Sicily are members of the Italian winemaking community as well.


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Teacher Busted in $6M Drug Raid
A middle school teacher who doubles as a soccer coach was nabbed after cops in Georgia raided her home and found $6.2 million in cocaine and heroin, reports Fox 5.
Karla Alvarez, 28, and two others face drug trafficking and gun charges following Thursday's arrest. Hall County Sheriff's Office Lt. Scott Ware told reporters that police "got information that there was probably a substantial amount" of drugs in the house in Oakwood and obtained a search warrant, the Gainesville Times reports.
They reportedly found 61 kilos of coke, a kilo of heroin, and two semi-automatic assault rifles. "I've worked drugs and gangs for a long time and it was one of the larger cocaine seizures I've ever seen," says Ware.


text: Toxodon was probably the most common large hoofed mammal in South America during the Pleistocene Epoch. On his famous voyage aboard HMS Beagle, English naturalist Charles Darwin collected fossil specimens of Toxodon, which were subsequently described by British anatomist and paleontologist Richard Owen. Because Toxodon indicated that the fossil mammals of South America were different from those of Europe, it figured prominently in late 19th-century debates about evolution.


text: Welcome to Wheaton The 2013 Orientation Committee welcomes new students and parents to Wheaton College. Meeting new roommates, getting to know campus, discussing classes with advisers and saying goodbye to the family – this week, incoming Wheaton students will be experiencing the many activities that Wheaton's Orientation Committee has been planning for months. More > Wheaton's Next Moves President Ryken's strategic priorities continue to grow in the coming school year. Building upon the core values on which Wheaton College was founded and is run, President Ryken's strategic priorities aim to better each student's education through four targeted areas of enrichment and change. More > Wheaton Sports Preview A look ahead at the 2013-2014 year in Thunder sports. It's about that time: time to start caring about classes and homework again, time to condense the story of your life-changing summer down to three minutes for all of your acquaintances and of course, time to start following Thunder athletics again. Here is a look at what this school year could bring for all of the Wheaton sports teams. More >


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A creature with low-light vision can see twice as far as a human in starlight, moonlight, torchlight, and similar conditions of shadowy illumination. It retains the ability to distinguish color and detail under these conditions. A spellcaster with low-light vision can read a scroll as long as even the tiniest candle flame is next to her as a source of light.


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Talk about the E83 BMW X3 in this forum!
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Transmission fluid and filter change
Hello all,
I am trying to find out if its time to do a automatic Tranny and filter change. I bought the X3 2005 at about 70,000 km pre owned. After a lot of highway travels I now have 140,000 km. Since buying the car I have not done any transmission fluid or filter changes. No real tranny problems other than the the fact that as with age most auto trannies get sluggish.. In any case, could ppl chime in here on their experience with changing the tranny fluid and filter and what I might expect in terms of performance improvements etc. Approximate costs would help as well. Thanks.
I have an 2004 X3 and have similar concerns. I spoke to a BMW dealer and two independent BMW shops and all three mechanics said do not change the tranny oil or filter unless something is amiss (poor shifting or leaking fluid).
I think that if changing fluid causes a worn tranny to stop working it was probably close anyway. If it were mine I would change it/have it changed. You're not getting all the old fluid out anyway unless you get it flushed through one of the cooler lines. The real benefit is getting the pan cleaned out, the ability to see whats on the magnets, and a new filter. My suggestion is to drain the fluid, drop and clean the pan, replace the filter, and top it off. I wouldn't bother flushing it. Any transmission shop can do this. If it were me, and I weren't having it done at a dealer, I would buy the filter from the dealer and take it with me.
As for the fluid... I like Redline and run their MTL in my 6 speed manual. If you have any questions you can contact them. They are usually pretty good about getting back with you.
Last edited by SWMc; 08-27-2010 at 02:50 PM.
Re ATF .What about just changing fluid every 40-50,000km.It seems like changing the filter is a lot of work for a DIY ??? I think this would be better than nothing ,afterall they say it is "LIFETIME"
It's been a source of discussion for years
First, I don't think you'll see any performance improvements from changing transmission fluid. It's common knowledge, BMW says their fluid is lifetime. Perhaps that's legitimate, perhaps is related to the fact that they have a maintenance free program for the first 50k miles and with fluid at $25 per liter, the cost would add up pretty fast.
I think the consensus is that you can't harm the car by changing the fluid. I would definitely change it at 75-100k miles but it's not something you have to do with the frequency of an oil change.
I just changed the fluid in my M5 this spring and will probably change the fluid in my X3 next year.
The next big discussion topic is always what to use for fluid. Many like Redline, Mobil1, and Royal Purple. Rather than losing any sleep over it, I chose to go back with the OEM fluid. I probably wouldn't go to the effort of trying to change the filter unless I were going into the tranny for maintenance reasons.
Last edited by bimmernut1; 09-05-2010 at 09:28 PM.
I also read a lot about frequency. I almost have 71k on my X3 now. I will try and change it this fall but worse case in the spring. I just did a quick look-over on the X3 in preparation for the Inspection II and the entire vehicle looks very tight as far as leaks and all the rubber boots and the drive belt look in excellent shape. Rotated my tires also and checked the brakes. They will probably go to 100k miles (they were changed under warranty which helped a lot)!
My garage: 2013 BMW 550xi GT, 2007 BMW Z4 3.0si Manual, 2006 BMW 530xi
Retired: 2007 BMW X3, 1998 BMW Z3
Member of BMWCCA!
I'm not disagreeing with you; I'm just not sure the benefit outweighs the risk if the tranny fluid is changed on a regular basis.
I've enjoyed reading this thread in regards to BMW's B***S**T theory on their "lifetime" Fluid. About 10K miles back, around 80K Miles the 2006 330ZHP started getting a little funky on the shifting and was also making a "Growling Noise". The better half dropped by the dealer (we have probably the WORST RIP OFF DEALER in the country, here in Bend, Oregon!) and they drove it around the lot and told her it was time for a $7,300.00 transmission! AND they told her it was going to be an additional $2,300.00 for a new rack an pinion steering gear!
She called me and I told her to take it home and "park it".
Couple days later, I'm back in town and decide to service the transmission myself. Not much to lose I figured.....A few hundred bucks and if it's still FUBAR - then it's transmission time.
Lucky for me, I was able to procure a T-Tech Trans Flush Machine (BTW - I'm a total gearhead on this end - have to have my toys in my home shop)
Dropped the pan, cleaned it out, installed new filter, buttoned it up and topped off the trans with Red Line D4. Next, I loaded up the T-Tech with the 18 quarts of D4 and hooked up. The trans cooler lines are a snap! Just push then on a little further, then reach up and gently push the plastic clips up into the hose to release and pull the line off. "Voila" - you are unhooked. Very similar in design to ford Fuel Injection lines. Did the flush of the trans.
Next, I unhooked the return line to the Power steering reservoir and did a 7 quart flush there. Fluid exchanges QUICKLY, so be johnny on the spot to crank the wheel from stop to stop a couple times to flush all the old out. Again, Used Red Line for this.
Ever since this was done, all transmission issues have vanished, steering is perfect and quiet.
All in All, I spent the following:
T-Tech Trans Machine from Craigslist: $500.00
3 Cases of Red Line D4 ATF @ $120.00/case: $360.00
Trans Filter Kit from ECS Tuning: $24.00
Total Expendature for this project: $884.00
RESOLD the T-Tech on Craigslist for: $1,000.00.
FOUND 2 More T-Tech on Craigslist for: $250.00 each for a total of $500.00. Sold One for $500.00 and am keeping the last one for my home shop!
So with a little patience, perseverance and wheeling and dealing, I was able to service the vehicle (as well as several of my other vehicles) with little to no cost out of pocket.
Had I listened to the service vultures here at Carerra Motors here in Bend, I would have shelled out $9,600.00
So my advice? If at all possible, if you can do this stuff yourself - DO IT!
For those of you who live up around my area, look me up. I'm the "Central Oregon Regional Events Coordinator" (Translation - "A Highly Paid Volunteer Position!) for the newly formed BMWCCA Oregon Chapter! .....
Cam Scott
Central Oregon Events Coordinator
BMWCCA Oregon Chapter
aka "mOnsTEr GaRAge" keeper
Just got a question about the 2004 X3 auto transmission on a 3.0i gasoline engine - does anyone know if it is a GM auto or ZF auto? Also, is the BMW OEM fluid the same for these two transmissions or are the fluids different?
Thanks in advance!
It's a GM (France) transmission.
The required fluid is indicated on a colored decal/plate attached to the casing.
You can't make any assumptions - not necessarily the same fluid as in other BMW A/T's,
and might vary year to year, or even within a model year.
Thanks very much for the response.
I bought a 2004 BMW X3 without doing much research and had just assumed that it had the ZF 5 speed auto.
I will be getting the transmission fluid changed and filter replaced by a trusted auto trans specialist that I've used for all my vehicles. They have confirmed that they do work on GM gearboxes and have the appropriate fluid for the gearbox. Whilst it is shifting smoothly at 101,000 kms, I'd like to do some preventative maintenance so that it remains that way for a long long time!
Changed my lady friends X3 transfer case which by the way is WAY more important to change periodically than the transmission and also the transmission fluid and filter.
Transfer case had 63K and I wish I had done it at 50K but oh well. It was very black and holds only 0.6L of BMW fluid. Easy to change. Drained and dropped the pan, cleaned the magnets and replaced the filter and reinstalled, pumped ESSO Lt 71411 which is the same thing as Lifeguard5 spec'ed for this transmission. I believe around 5L. Transmission warm to temp added another 3/4L. Job done.
Only issue is using a inch pound torque wrench since the values are so low. By the way the Lifeguard5 I drained out was Coke colored and smelled bad however Esso smells bad anyway so I didn't think it was actually shot. I will do this in another 30-40K miles and for sure 30K miles for the transfer case since it is where all the power is sent from the engine and just too important and contains such a small amount of fluid to not change it often.
I didn't have guts enough to stray away from the OEM like using Redline or other fluids...
For extended engine drain intervals, they have the large oil capacity on their side.
Not so with the transfer case, which as you say, conducts proceedings in the final drive.
Either differential has an easier life in comparison.
I did my TC around 30K miles (48K km) and the fluid was quite dark
(pictures in a post in the DIY sticky).
Might have been a bit early - agree that 63K miles is getting near the must do point.
Other members who have waited to around 80K miles have seen metal flakes in the drained fluid.
Some variability in the reported capacity (allowing for minor spillage) - some even close to the full 1L.
Mine was 0.6L too, so 2 bottles from the dealer of the expensive stuff might be good for 5 or 6 years assuming average annual miles.
The need for A/T fluid changes can be debated at length, but for the TC - just do it.
I've had my 2005 X3 for three years and my extended warranty hs expired. I've serviced every car I've owned but this one is giving me a fit. I have a problem changing the tranny fluid. The check/add resevoir remains full after draining the fluid. How do I get it to empty allowing me to add the fluid? Sounds a little stupid, I know, but don't want to screw up.
Last edited by James Hamilton; 10-01-2011 at 09:12 AM.
I did the auto trans fluid change and the old fluid was black like used engine oil. So it was definitely a worthwhile exercise to get the fluid replaced.
My next task is the x-drive transfer case fluid.
Last edited by tempestv8; 10-05-2011 at 03:59 AM. Reason: Correction of facts
It also uses ATF.
You have to refill the tranny from underneath the car.There is a refill plug as well as the drain plugI think approx.6 qts.but check for sure.
Hi James,
Just out of curiosity, what was the condition/colour of the old trans fluid when you drained it? For me, the old fluid looked really bad - it was black like used engine oil.
I found the fill point very troublesome because the twin exhaust pipes ran past that general area. When I was doing up the fill plug, I managed to accidentally brush my hand against the hot exhaust pipe a few times. Ouch!! I'd be interested to know if you had the same challenges.
What fluid did you end up putting into your auto trans? My 2004 is the GM 5 speed auto, so I put in Dexron VI.
transmission fluid and filter
Actually I haven't replaced the fluid yet, the car is still in my garage. I didn't want to do the wrong thing so waited for advise from a couple of forums and a friend. The fluid is pretty clear, not dirty at all. Since it has the lifetime fluid I think I will put the same fluid back in and count all this as education. The car has just over 70K miles. From here to fore any transmission service will go the the dealer. Too little savings and too much work.
Many thanks for the feed back.
I've responded to your query from the transfer case fluid thread using this pre existing automatic transmission fluid change thread, so as not to dilute (no pun intended) the content of the two separate subject threads.
I didn't bother to undo the pan or replace the original filter. In my past experience with auto gearboxes where I did undo pans, replace pan gasket and fluid filter, wipe down any swarf that may have settled on the bottom of the pan or collected around the magnet, etc, is that it's mostly unnecessary.
I've never found any big chunks of friction pad material in the filters, and if there were, the transmission is beyond just a fluid change anyway, as the friction material only breaks away when severely overheated.
My personal opinion is that a simple fluid drain and refill with fresh fluid of the correct specification is sufficient to extend the longevity of the automatic transmission. Removing the pan/filter only increases the risk of introducing foreign materials into the gearbox, especially if the immediate area surrounding the gearbox is dirty (but who takes an X3 offroad anyway? ) Or possibly risk damaging the threads on the sump pan bolts by over torquing.
So I've simply renewed the fluid. Easy and cheap job and most importantly, significantly lower risk of damaging the gearbox.
My biggest challenge was to top up the fluid using my home mechanic style oil syringe, because the twin exhaust pipes run alongside the transmission, very near the fill plug location. With the engine running to warm up the fluid in the gearbox to achieve proper fill level, the exhaust pipes get quite hot.... Since I don't have asbestos hands, I had to endure some pain as I hand threaded the fill plug back on. Ouch!
I checked the amount of old fluid that I got out and it was around 5.5 litres, according to my oil catch pan. This is roughly the same amount of fresh new fluid that I was able to put back into the gearbox, so I think the fluid level inside the gearbox is about right.
I've driven the car around now for a week, and seems like the fluid change has had no adverse effects to the shift quality of the gearbox, which was very good to begin with.
I would highly recommend changing the auto trans fluid, especially after I saw just how black the old fluid was. It was truly in a disgraceful state - black like engine oil, but being auto trans fluid, it doesn't stain. The new Dexron VI fluid was a dark red colour.
Last edited by tempestv8; 10-06-2011 at 11:39 PM. Reason: Adding more details.
Automatic Transmission fluid change
My only real problem was getting the car up and level which is required to make sure the fluid is at the proper level. That is the only way to know you have the right amount of fluid in the transmission. For that reason alone I will never take on the job of changing the transmission fluid again. The exhaust pipes were a problem for me too. Again, in order to know the transmission takes the right amount of fluid is for the motor to be running while you are filling the transmission. If you have to change it again, I would suggest you buying a manual pump instead of using a syringe. I purchased one at Harbor Freight Tools for 7.95 that did the job perfectly. I did not remove the pan as advised by most people I talked to but I doubt if that will be a problem because of the magnets.
Ordered gasket, filter, pan bolts and drain plug. $102 total at dealer. Trans supposedly takes 8 quarts of Dexron VI, so about $40 but I doubt I will get 8 out. May just get fluid from BAVAUTO which is more money, about $100 for 10 quarts. Have to buy 1 more pair of jack stands, so whole job should be around $200 to $250 which is worth me doing it.
I really think pan should be removed. That way you can replace filter, clean magnets and assess condition.
Anyone know torque values for GM6 bolts and drain plug? I saw some numbers for the ZF trans which were about 53 inch pounds, so I need a smaller torque wrench too which I can use. Looks like a trip to Sears tomorrow! I will ask service for the values if needed.
Need pump too, which I will get this week.
Job looks messy but not too bad.
My garage: 2013 BMW 550xi GT, 2007 BMW Z4 3.0si Manual, 2006 BMW 530xi
Retired: 2007 BMW X3, 1998 BMW Z3
Member of BMWCCA!
Last edited by madurodave; 10-08-2011 at 01:44 PM.
That price for the Dexron VI doesn't sound right - it sounds too cheap. Are you sure you didn't get the roman numerals switched around? VI = 6, and IV = 4.
In Australia, the BMW dealer sells 4 litres of BMW part number 83220397114 for around $70, so it's quite expensive, and the bottle supplied isn't even labelled as BMW fluid. I did a quick check and 1 US quart is nearly the same as 1 metric litre. (1 qt(US Liq) = 0.946352 L)
I managed to drain out nearly 6 litres of fluid when I drained the pan using the drain plug.
The quote that you got from your dealer actually sounds about right, if they do drop the pan and replace the filter inside.
Last edited by tempestv8; 10-08-2011 at 04:03 PM. Reason: Added more information
I have read the same comments on my E39. I purchased the kit and sat on it somewhat fearful that if it is working, why mess it up.
Last year, I drained and filled the fluid. Last week I dropped the pan and finished the job. So far all is well. My 530i has 130,000 miles on a steptronic tranny.
I am original owner.
94 530i sold (That was difficult for me)
01 530i >144,500+ miles SOLD
06 330XI winter's especially fun drive (SOLD)
10 M3 Sedan (sweet)
13 Nissan GT-R Black Edition
14 Porsche Cayenne Platinum Diesel
15 Porsche GT3
16 Porsche GT4
Hi Dale,
I did do the full pan removal on my e39 a couple of years ago. It had the expected amount of metallic reside at the bottom of the pan, and cut up the filter to have a look inside but it did not have anything in it. What was the condition of your transmission when you had the pan out?
I used the same Esso LT fluid as what BMW specifies for the ZF gearbox. Gearbox still feels very strong today and the car has 240,000 kms on the odometer which is roughly 150,000 miles. If I were to do another service to the gearbox again, I will just change the fluid and wouldn't bother with opening up the pan.
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Center for Computational FinanceCCF Home Conferences Seminars Working Groups Nash Lectures Heath Lectures People Open Positions Contact
Computational Finance at Carnegie Mellon
The Center for Computational Finance hosts the Nash Lecture Series, which brings to campus distinguished researchers who have applied mathematical methods to solve problems in finance. Past lecturers were Robert Merton, Stephen Ross, Harry Markowitz and Darrell Duffie.
The series is named for John F. Nash, Jr., who earned his bachelor's and master's degrees in mathematics in 1948 from the Carnegie Institute of Technology, which has since been renamed Carnegie Mellon University. In 1994 Nash shared in the Alfred Nobel Memorial Prize in Economics.
The Center also hosts the Heath Lecture series, in honor of David Heath, who retired from Carnegie Mellon in 2006. Heath is best known for the Heath-Jarrow-Morton model of the term structure of interest rates.
Ph.D. students at Carnegie Mellon may choose financial mathematics as a dissertation topic. Some of these students intern in the finance industry during their Ph.D. programs and about half these students ultimately enter the finance industry. The other half take academic positions after completing the Ph.D. degree.
The Department of Mathematical Sciences is a partner in the interdisciplinary Master of Science in Computational Finance (MSCF). The MSCF program, begun in 1994, was the first computational finance Master's degree in the world, and it has established Carnegie Mellon as a leader in this new discipline.
The Bachelor of Science in Computational Finance (BSCF) is administered by the Department of Mathematical Sciences. This program was founded because recruiters sought undergraduates with skills in the same key areas of finance, mathematics, statistics and programming as they desired at the Master's level. The first BSCF class graduated in 2003, and since then most BSCF graduates have taken positions at major banks.The Bachelor of Science program in Computational Finance (BSCF) at Carnegie Mellon is an applied mathematics program with finance as a well-developed application area. BSCF consists of courses in mathematics, finance, probability/statistics, and computer programming. It is a joint program of the Mellon College of Science (MCS), the Tepper School of Business, and the Heinz School of Public Policy and Management. A student in either MCS or the Tepper School can have Computational Finance as a primary major. Students in any college can have Computational Finance as a secondary major or minor. The BSCF program includes advanced undergraduate mathematics. Because most graduates are expected to enter banks or other financial firms, students who major in BSCF prepare for their careers by also taking graduate courses in the Heinz School on professional speaking, professional writing, and organizational design.


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Justin Bieber announces new music on 'Music Mondays'
Listen to Justin Bieber on iHeartRadio
Christmas has come early for Beliebers.
On Thursday, pop star Justin Bieber took to Twitter to announce his plans to release new material in a series called "Music Mondays." His tweets suggest that fans can expect one new song from him every week, for the next ten weeks.
Sunday Midnight #heartbreaker #MusicMondays #10weeks— Justin Bieber (@justinbieber) October 3, 2013
Are you ready? #10weeks #musicmondays http://t.co/poEKTsUWOk— Justin Bieber (@justinbieber) October 3, 2013
The first will be his much-anticipated new single "Heartbreaker," which he started teasing previews of months ago. "Heartbreaker" is set to be released at midnight on Sunday. Bieber's "Music Mondays" fall in line up his manager Scooter Braun's earlier hints regarding his new releases.
Scooter had tweeted last month that the star has come up with an innovative way to deliver new music "in October until December." Another concert documentary following Bieber on his "Believe" tour is expected out before the year's end as well.
Photo Credit Getty Images


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PHILADELPHIA – In a game that had a little bit of everything, the University of Pennsylvania sprint football team fell to Franklin Pierce in overtime Friday night at Franklin Field, 33-27.
After Franklin Pierce (3-2) scored on its offensive possession to take the lead -- the kick was no good -- Penn (2-2)appeared to be on its way to the tying touchdown and potential winning PAT when Mike McCurdy found Freddy Ordonez near the goal line. However, Ordonez was rocked as he turned to put the ball over the goal line, the ball popped out of his hands and into the end zone, and the Ravens recovered to end it.
When everything was tallied up, the teams had combined for 164 plays (88 of them passing)and 895 yards; 27 penalties that totaled 245 yards; eight sacks. The game itself lasted nearly three-and-a-half hours.
Franklin Pierce started the game with the ball, but that didn't last long. On the Ravens' second play,Ed Caidrove around the right end and sacked FPU quarterback, forcing a fumble that Penn recovered. Three plays later, Mike Beamish ran it in from two yards and the Quakers were up, 7-0.
Franklin Pierce responded. The Ravens forced a 3-and-out on Penn's next possession, and then Jhamel Cohen blocked the Quakers' punt attempt. FPU's recovery put the ball on the Penn 18-yard line, and just two plays later Cohen finished what he started as he ran a reverse around the left end and was almost untouched all the way to the end zone.
Penn came right back, using just six plays to go 68 yards. The scoring play came when McCurdy found Andrew Donald in the right corner of the end zone for a 29-yard passing play.
Penn had a chance to really gain momentum on its next drive, taking it all the way down to the 2-yard line and in fact crossing the end zone not once but twice. Both TDs were brought back because of penalties, however, and insteadthe Quakersmissed a 37-yard field goal wide left.
The touchdown instead came on the next drive. The Red and Blueneeded less than a minute to go 54 yards, the final 28 coming when McCurdy threaded a pass along the left sideline between two defenders into the arms of Jack Epstein.
Both teams put points on the board late in the half in a final flurry. Franklin Pierce used six plays and just 39 seconds to go 73 yards for a score, a drive that ended with a Ryan O'Kelly 11-yard run to the right corner of the end zone.
Penn came right back and got three points just before halftime, going 49 yards in nine plays that took just 49 seconds and allowed Aron Morgan to kick a 39-yard field goal. It was 24-13 at the break.
Franklin Pierce scored the first points of the second half, driving 84 yards in just seven plays for another O'Kelly rushing touchdown -- this time he scrambled out of trouble, found daylight along the right side, and ran to paydirt. The Ravens unsuccessfully went for two, but Penn's lead was a precarious 24-19.
Penn got the lead back up to eight, thanks to a 34-yard field goal by Morgan after the Quakers drove 66 yards down to the Ravens' 17 with 3:08 left in the third.
Penn dodged a huge bullet early in the fourth quarter, when Franklin Pierce's Tyler Holdsworth returned a Beamish punt all the way to the Quakers' 4-yard line. However, a penalty brought the ball all the way back to the 30, and FPU eventually lost the ball on downs.
Penn had no such luck on the Ravens' next drive. Spurred by a 44-yard run by D.J. MacDonald, FPU went 74 yards in just six plays and scored when O'Kelly found Michael Holdridge on a misdirectionpass for 20 yards to the left corner. Franklin Pierce then went for two and got it this time, O'Kelly rushing it in over the right side. That tied the score at 27-27 with 5:35 left.
Both teams stagnated after that,although the game came right down to the last playof regulation when Franklin Pierce tried a field goal for the win. The kick never had a chance,as it wasbooted right back into the line of scrimmage (a play that would be repeated in the OT).
McCurdy finished the night with 314 passing yards and added 40 rushing yards, while Beamishled the ground gamewith 81 yards. Michael Bass caught nine of McCurdy's passes for 93 yards, while Donald had six catches for 80 yards and Ordonez had five receptions for 83 yards.
Penn returns to action next Saturday at Post, kickoff is set for noon.
Download: Franklin Pierce Box Score.pdf


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Military Spouses
As a military-supportive school, Regent University recognizes that military spouses are the "heroes at home" who love and support our service men and women defending our precious freedom. We are proud and honored to support the education of our military spouses as a Military Spouse Career Advancement Account (MyCAA) school. All of Regent's eight schools offer a military spouse discount, up to 25%. Please contact your individual school's admissions office for details.
- School of Communication & the Arts
- School of Divinity
- School of Education
- School of Global Leadership & Entrepreneurship
- Robertson School of Government
- School of Law
- School of Psychology & Counseling
- School of Undergraduate Studies
Other financial aid resources and a list of financial aid for military spouses.
MyCAA Program Overview
Spouses of active-duty military and activate National Guard and Reserves may apply for up to $4,000 of financial assistance to help pay for licenses, certifications and education (up to associate's degree) in high-growth, high-demand, portable career fields. As a participating institution, Regent University provides eligibility for students to take advantage of this program. For details, visit the official MyCAA website.
Here's how MyCAA works:
- Visit https://aiportal.acc.af.mil/mycaa/ to open an account.
- Complete the online application, telling the MyCAA counselor what course(s) you want, how much tuition the courses will cost, when they start and what your career objective is.
- Once approved by MyCAA, submit your Letter of Authorization to Regent University's Business Office, who will bill the Department of Defense directly and deduct from your MyCAA account.
See what students are saying about MyCAA benefits.
Transfer of Post-911 GI-Bill® Benefits to Dependents (TEB)
For the first time in history, service members enrolled in the Post-9/11 GI Bill® program will be able to transfer unused educational benefits to their spouses or children starting Aug. 1, 2009.
Any member of the Armed Forces (active duty or Selective Reserve, office or enlisted) on or after August 1, 2009, who is eligible for the Post-9/11 GI Bill®, and:
- Has at least 6 years of service in the Armed Forces on the date of election and agrees to serve 4 additional years in the Armed Forces from the date of election.
- Is or becomes retirement eligible during the period from August 1, 2009, through August 1, 2013.
Eligible Dependents
An individual approved to transfer an entitlement to educational assistance under this section may transfer the individual's entitlement to:
- The individual's spouse
- One or more of the individual's children
- Any combination of spouse and child.
For details on any of these benefits and discounts, please contact the respective school or the Military and Veterans Affairs Office.
"GI Bill®" is a registered trademark of the U.S. Department of Veterans Affairs (VA). More information about education benefits offered by VA is available at the official U.S. government website at www.benefits.va.gov/gibill.


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Mother's Day Cryptogram Generator
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On her way, Amelia rescues young Evelyn Barton-Forbes, who has been "ruined" and abandoned on the streets of Rome by her rascally lover. With a typical disregard for convention, Amelia promptly hires her fellow countrywoman as a companion and takes her to Cairo.
Eluding Alberto, Evelyn's former lover, who wants her back, and Evelyn's cousin, Lord Ellesmere, who wishes to marry her, the two women sail up the Nile. They disembark at an archaeological site run by the Emerson brothers - the irascible, but dashing, Radcliffe and the amiable Walter. Soon their little party is increased by one - one mummy, that is, and a singularly lively example of the species. Strange visitations, suspicious accidents, and a botched kidnapping convince Amelia that there is a plot afoot to harm Evelyn.
Don't miss the rest of the Amelia Peabody series.
©1975 Elizabeth Peters; (P)2002 Blackstone Audiobooks
"The indomitable Amelia Peabody carries the listener along as easily as she carries her umbrella." (AudioFile)
"Crocodile on the Sandbank"
This is a wonderful book. There is a problem, however. Barbara Rosenblatt should be the narrator. She was the first voice to give life to Amelia Peabody. To listen to another, less talented reader, who gives very little differentiation to the characters is very unsatisfying.
I prefer a reader who is easy to listen to. This means I don't have to listen with such utter intensity to differentiate one character from another. Barbara Rosenblatt is so good at this that listening to her is a relaxing experience. One immediately knows Amelia and her wonderful British womanness from her husband Emerson or her son Ramses.
Get Barbara Rosenblatt as the narrator!
This is one of the best books I have listened to in years. It was my first Elizabeth Peters book. I started with this one to see if I would enjoy the Amelia Peabody series. Obviously, I can hardly wait to hear more. I was a bit hesitant to pick this one after reading the negative reviews of the narrator, but I personally thought she was outstanding. The characters in this book are superb and the ending extremely satisfying. Thank you Ms. Peters!
"Have always loved Amelia (but not ms o'malley)"
I, too, am familiar with both readers of these stories. And I've ordered other books she narrated before I realised that I really don't enjoy her reading voice.
As for Amelia, it may seem that she bashes men, but she is highly intelligent in an era when women were expected to be stupid. When mem treat her like an idiot, she tends to reciprocate in kind. When she is in the company of men who don't patronize her, she meets them as equals... which doesn't mean she doesn't argue with them, just that the arguements aren't one sided.
I greatly enjoyed the Egyptology involved in the books, the more so since Peters has a degree (can't remember if it's masters or doctoral) in Egyptology. She is also Barbara Michaels, many of who's books are also available here, if you prefer a contemporary setting.
Narrative makes the world go round.
"light fiction that doesn't insult reader"
Thank you, Audible, for the "addictive series" starter sale! I had given up on finding a series of light historical fiction to leaven my listening diet after trying many, including Stephanie Barron, Lauren Willing, Ken Follett, Amanda Quick, etc. In those cases, one was enough, and in other cases, books were either painfully written with boring charaters; others approached softcore porn. $4.95 tempted me to try again--to me, Amelia Peabody is a winner.
Although the plot was predictable, "Croc on the Sandbank" had good dialogue with, as advertised, an "indomitable" heroine. Both features are strong enough to make a listener smile and escape 21st century for a few hours respite. It's not primarily a "whodunnit" as much as Mary Poppins for adults. One drawback: although the narrator seemed very capable and the voice in this novel would be appropriate for Dorothy Parker or a 1920s American flapper, O'Malley's un-British accent was out of place for Amelia Peabody. I will download other titles in the series, but with Rosenblat as narrator. (And I would download other books narrated by Susan O'Malley, as long as she is not speaking for a late Victorian force of nature.)
So - if you are buying with a credit, I'd strongly recommend the more expensive Rosenblat version of "Croc" - otherwise the regular price of the O'Malley version makes that one more attractive, as long as you aren't thrown by the absence of a Brit accent for Amelia and friends.
"It just doesn't get any better than this."
This is the first novel to feature Ms. Peters's Egyptological heroine, Amelia Peabody. It is truly delightful. Although it introduces a recurring character, this book is a treat on it's own--you don't have to commit to the whole series in order to enjoy it (although after you enjoy it, you will be unable to resist the next one.... and the next....). If you like mystery, romance, adventure, and/or humor, you cannot do better than this book. Nor can I imagine a better narrator for the book than Susan O'Malley. The pacing is excellent, the reading is clear, the characters' voices are distinct without being annoying, and the humor of the writing comes through perfectly.
Elizabeth Peters is a fine writer whose books are smart, funny, well-structured, and beautifully written. Her best books (like those of Georgette Heyer, Mary Stewart, Dorothy Sayers, and a handful of others) follow in the steps of P.G. Wodehouse and Jane Austen, proving that reading can be light and enjoyable without sacrificing quality or even delicate social satire. And this book is indisputably one of her best.
I love to read and hope you do too! Audio books are great for people on the go!
"O'Mally my pick for the early Amelia books"
I've read all the books from the series and did not start reading the audiobooks until after Thunder in the Sky was issued. I originally got the O'Mally audiobooks from audible.com then I got some of the Rosenblat audiobooks from the library, prior to audible getting them. It's nice that Rosenblat has the authentic English accents, but I prefer the energy that O'Mally gives to her readings. I particularly love her portrayal of the feisty Emerson, particularly this book and The Deeds of the Disturber. Also the tongue in cheek tone of O'Mally's delivery suits the tone of the early Amelia books well. So I have decided to stick to O'Mally for the early books and Rosenblat for the later. I think both narrators do Amelia well.
"Delightful to listen to!"
I love Elizabeth Peters! I remember when this book first came out. It begged to be read aloud! This is great romantic suspense and also has lots of interesting facts about Ancient Egypt!
"I have to agree with the Barbara Rosenblat fans!"
This is one of my favorite books and I have read it over a dozen times. It's a classic - adventure, mystery, humor and wonderful dialogue. Having heard both of the book's narrators (Barbara Rosenblat and Susan O'Malley) and I have to agree - search AUDIBLE until you find Barbara Rosenblat's reading - that goes for all of the books in this series.
"I agree with Morgan from Philadelphia"
I had assumed that the reader would be Barbara Rosenblat, who is the perfect voice for this series. Only after purchasing did I find out that it had a different narrator. While Susan O'Malley is fine, she just can't much Barbara, and I'm very disappointed and will have to track down the version by Barbara Rosenblat elsewhere.
These are fun, fun books. I can't think of other series like these -- Egyptology, Victorian Romance, mystery.
I'm disappointed.
"Fantastic, funny cozy/mystery."
Elizabeth Peters is an incredible writer. Her humor and dry wit, along with her finesse with the english language, combine to make a wonderful character, Amelia Peabody, and her adventures with her fellow characters are fun and a great adventure. I read the entire series, years ago, and decided to go back and enjoy them again. I got this one first, of course, and was very impressed with the narrator, not to mention the story. Amelia Peabody is an independent, confident, strong-willed woman, with a heart and soul of delicate flower. She is fantastic, and I won't reveal any of the plot, but you'll love the ending...!
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Review Details
B-6 Sheepskin Jacket
- Product Review (submitted on July 28, 2010):
I picked up my B-6 two weeks ago at you NY facility. I wanted to wait for the excitement to wear off before writing to you. It hasn't. I want to thank you for all of the special touches, from ordering the correct weight shearling, to adding my original squadron patch and hiding its felt damage. This is the perfect weight jacket for the weather we are having. The M-444 I had purchased from you was just to warm in the above teens weather.
The B-6 Fits perfectly. I is extremely comfortable while driving, and surpasses even my USN issue G-1. I have been stopped no less than seven time with compliments and questions. Perhaps you have received requests for more B-6 jackets. Once again, Thank you.


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Harbor Light Center
The Harbor Light Center at 1010 Currie Ave., Minneapolis, is a safe place for people to stabilize their lives and begin the process of healing. We offer a wide range of basic needs to anyone in need, without discrimination. Our shelter is Minnesota's largest homeless adult outreach facility and includes a clinical treatment program for men working to beat chemical dependency.


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24-Hours in Waikiki
Waikiki is a constantly evolving expression of the spirit of aloha, where old traditions and new ideas are meeting in unexpected ways. With so much to see and do, here's how you can spend 24-hours in Waikiki:
6 AM: Start your day with a stroll down Waikiki's beaches and around Kapiolani Park under the shadow of Leahi (Diamond Head).
7 AM: Grab fresh fruit or an omelet at any one of the al fresco options along Waikiki Beach.
8 AM: Take a photo at the statue of famed surf legend Duke Kahanamoku, then take a surfing or canoe lesson on Waikiki Beach.
10 AM: See the humuhumunukunukuapuaa at the Waikiki Aquarium.
NOON: Eat lunch at Duke's Canoe Club and see classic photos of Duke.
1 PM: Discover other Waikiki Attractions including the Honolulu Zoo, the U.S. Army Museum, and the surfboard shaped markers of the Waikiki Historic Trail.
3PM: Schedule a massage at one of Waikiki's fine resorts and indulge in some Oahu wellness and rejuvenation.
4 PM: Take a hula or ukulele lesson on the grounds where Hawaiian Royalty relaxed at the Royal Hawaiian Center.
6 PM: Watch the lighting of tiki torches along Kuhio Beach, then watch an amazing sunset from Kapahulu pier.
7 PM: Experience Hawaii Regional Cuisine at Roy's in Waikiki Beach Walk or Alan Wong's Restaurant beyond Waikiki. For Waikiki fine cuisine, visit Doraku in the Royal Hawaiian Center or Top of Waikiki.
8 PM: Shop unique stores like Mana Hawaii and Aloha Army in the Waikiki Beach Walk. Then get off the beaten path and discover stylish boutiques like Spark between Kalakaua and Kuhio Avenues.
9 PM: Hear live music at Tiki's Grill & Bar and the Lewers Lounge.
11 PM: Hit bars and nightclubs like The Yard House in Waikiki Beach Walk or RumFire in the Sheraton Waikiki. After-hours, go beyond Waikiki to places like the chic Pearl in the Ala Moana Shopping Center.
4 AM: Head back to the Hilton Waikiki Beach to tackle Mac 24/7's massive pancakes.
5 AM: End the night by watching the surfers start their morning in the inviting waters of Waikiki.


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"I knew with my size teams weren't willing to take a chance," Roy said. "For me, it's … good motivation for teams that didn't draft me. Today I'm ready (for) whoever's willing to take a chance on me. I'm going to take that chance and prove them wrong that they didn't draft me."'
Patrick Roy's son acting on NHL dream with Sabres
July 15, 2012 Submitted by
Via: Niagara Gazette


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7 U.S. Code § 428b - Wheat and feed grains research; regional and national research programs; utilization of services of Federal, State and private agencies; authorization of appropriations
In order to reduce fertilizer and herbicide usage in excess of production needs, to develop wheat and feed grain varieties more susceptible to complete fertilizer utilization, and to improve the resistance of wheat and feed grain plants to disease and to enhance their conservation and environmental qualities, the Secretary of Agriculture is authorized and directed to carry out regional and national research programs.
In carrying out such research, the Secretary shall utilize the technical and related services of the appropriate Federal, State, and private agencies.
There is authorized to be appropriated such sums as may be necessary to carry out the provisions of this section, but not more than $1,000,000 in any fiscal year.
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