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The Lancaster Community Meal Program started in 2002. Since its inception, this loose network of churches and organizations has provided free daily meals to community members in Lancaster City and County who are confronting food insecurity. The program relies upon hundreds of volunteers who plan, prepare, and serve the meals. It serves well over 150,000 meals to our friends and neighbors every year.
Meal Providers
Listed in alphabetical order, last updated on 11/30/22
Anchor Lancaster
Monday-Friday Breakfast 8:30-9:45am
First UMC 29 E. Walnut St. Lancaster, PA 17603
Anchor Lancaster, formerly Anchorage Breakfast Program, is located inside First United Methodist Church on the corner of Walnut and Duke. Look for the sign for Anchor at the doors on Walnut St. for breakfast. Showers are also available before and after breakfast; appointments are required and can be made in person the day before. Guests go through a simple security check when entering the building.
Click here to visit the provider's website.
Anchorage Breakfast Program
Saturday Lunch 12:30-1:30pm
41 W Vine St., Lancaster, PA 17603
They serve a bagged to-go lunch. Enter along the side alley which leads to kitchen door.
No Sunday Lunch
218 N. Duke St, Lancaster PA 17603
City Gate is no longer serving meals. Holy Trinity Lutheran is providing Sunday lunch by giving a bagged lunch at Sunday breakfast.
Crispus Attucks Center
Tuesday and Thursday Lunch 11:00am-12:00pm
407 Howard Ave, Lancaster, PA 17603
The Crispus Attucks Center is run by CAP and hands out a hot to-go lunch on Tuesdays and Thursdays to anyone. Come to the front door on Duke St for to-go meals.
East Chestnut St. Mennonite Church
Monday Supper 5:00-6:00pm
432 E. Chestnut St. Lancaster, PA 17603
Look for the menu sign on the sidewalk and enter at the front door of the church on E. Chestnut St. Hot meals are served for either sit-down dining or to-go.
Wednesday Supper 5:00-6:15pm
701 N. Lime St. Lancaster, PA 17602
Hot meals are available every Wednesday, starting at 5pm until food runs out.
First Reformed United Church of Christ
Tuesday Supper 5:00-6:00pm
Saturday Breakfast 9:00-10:00am
40 E Orange St, Lancaster, PA 17603
Stop by First Reformed for a to-go meal. Enter through the courtyard off of Christian St. On Saturday, food is included for breakfast and lunch.
First Reformed UCC
517 N Queen St, Lancaster, PA 17603
Saturday supper, 5:00-6:00pm
served by Parish Resource Center
Sunday supper, 5:00-6:00pm
Grace's Wednesday night meal is sit-down dining. Enter at the double doors in the middle of their parking lot, behind the church building, accessible from Queen St. and from Christian St.
Parish Resource Center serves Saturday supper and Sunday supper at Grace Lutheran Church (these meals are served to-go).
Sunday Breakfast 7:45-8:45am (includes bagged lunch)
31 S. Duke St. Lancaster, PA 17603
To-go bags are handed out from the parking lot behind the church, accessible from Mifflin St. Limited indoor seating is available. A bagged lunch is also provided.
Parish Resource Center (PRC)
served at Grace Lutheran Church
PRC has worked with faith communities for years, supporting and resourcing their missions and visions. During the pandemic, they stepped into a more direct service role by helping fill the gaps in the Community Meal Program. They also built and maintain this schedule website.
Thursday supper, 5:15-6:15pm
500 Pearl St. Lancaster, PA 17603
Redeemer Lutheran has switched back to in-person sit-down meals. Enter from their carport off of 5th St.
Spanish American Civic Association (SACA)
Monday-Saturday lunch 12:00-1:00pm
(only distributed at lunchtime but includes enough food for lunch and supper)
545 Pershing Ave. Lancaster, PA 17602
SACA hands out meals at lunchtime Monday through Saturday, but gives each person one hot meal to eat immediately and one cold meal for supper. Enter through the front gate on Pershing or from the back parking lot from Plum St. Come to the lower entrance door on the side of the building.
Spanish American Civic Association
St. Anne's Catholic Church
Monday-Friday lunch 11:30am-1:00pm
929 N. Duke St. Lancaster PA 17603
Cold bag lunches are handed out every weekday from the porch facing Duke St. Meals are to-go bags; there is no seating. Hot sandwiches are served on Wednesdays. St. Anne's does not serve on Holy Days.
St. Anne's Catholic Church
St. Mary's Catholic Church
Friday supper, 5:00-6:00pm
119 S. Prince St. Lancaster PA 17603
Enter the driveway from Vine St. at the front of the church. Follow the driveway back between the church and school buildings to the courtyard. Meals are served in the courtyard.
Download Schedule poster - English & Spanish
Download schedule handouts - English & Spanish
This website is maintained by Parish Resource Center (PRC). Questions and changes can be directed to PRC.
Parish Resource Center is grateful to our leading sponsor:
info@parishresourcecenter.org
www.ParishResourceCenter.org
© 2021 | Parish Resource Center


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Jane Hanner Allen and Rebecca Hanner White are sisters, lawyers, and purse lovers. Each comes to their new venture, Hanner Clarke, after distinguished legal careers.
Attention to detail, expectations for quality of the highest order, and responsiveness to client needs have been carried over to Hanner Clarke. Additionally, years of searching for the perfect handbag have given them a clear sense of what the market needs.
Their experience in and out of the workplace, coupled with decades of working with and mentoring young professionals, have given them an insight into what women of all ages are looking for in a handbag, allowing them to create purses that are functional, feminine, luxurious, and elegant. Hanner Clarke bags are classic and timeless.
In 2000, Jane founded Counsel on Call, a legal services company that has been named to Inc. magazine's list of the 500 fastest-growing, privately held companies in the U.S. three times and that has grown to become the leading new model legal services provider. The company currently has offices across the country and three Managed Services Centers. As Founder, she currently leads the development of the company and serves on Counsel on Call's Board of Directors.
Rebecca is Dean and J. Alton Hosch Professor of Law Emeritus at the University of Georgia. She is the only woman to have served as the law school's dean. She joined UGA's law faculty in 1989, and prior to her deanship served as associate provost and associate vice president of academic affairs for UGA. She is a specialist in labor and employment law.
Both Jane and Rebecca credit their passion for the law to their father, Ivan Hanner, who strongly encouraged his daughters to become lawyers, at a time when few women were in the profession. Jane and Rebecca's love of fashion, including their love of purses, comes from their mother, Dolores Clarke Pelc. Hanner Clarke, a brand exemplifying professional yet feminine design, is named in their honor.
© 2023 Hanner Clarke

redpajama_set_name: RedPajamaCommonCrawl


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"Lunging" and Other Bodily Contortions: The Textual Tracking of Visual Motifs, Part III
Always interested in the intersections of language and visual representation, in this post I examine the variety of bodies—and range of bodily contortions—encompassed under the single search term "lunging" as a continuation of my series on WBA text tags (see my earlier posts about textual tagging broadly and "streams of gore").
The comprehensive list of search terms used to tag images in the WBA includes a variety of categories relevant for describing figures, including figure type (blacksmith, demon, queen), specific character (Athena, Cerberus, Judas), positions (facing left, leg raised, twisted), and physical attributes (long hair, nude, young). Often, such descriptors are relatively straightforward to identify based on either the compositional evidence or the literary context. However, in our tagging process we aim to communicate as much information as possible about a figure, including what the depicted figure is doing. We currently have 136 terms to describe action. Most are phrased as present participles and range from the mundane (bending forward, walking, standing) to the more, shall we say, Blakean (petrifying, howling, cannibalism, weaving). And much like the dreaded "action verb" category in my family's favorite holiday game, Pictionary, actions are frequently the most difficult to both interpret and tag according to a set list of terms.
When searched, the term "lunging," for example, appears at least once in 19 discrete works that span the majority of Blake's oeuvre and thus demonstrate the variety possible within a single textual tag. Several results from Blake's illuminated books illustrate that he repeatedly depicts a nude lunging male figure seen from behind. The lunging figures in Urizen and Jerusalem are particularly muscular—perhaps an homage to Michelangelo's similarly strapping figures—and all appear to labor strenuously, even violently.
From left: Urizen, copy A, object 13; Jerusalem, copy E, objects 97 and 21.
A similar connection between lunging figures and violence is clear in two of Blake's engravings of John Flaxman's illustrations for The Works Days and Theogony of Hesiod, in which we see combative, lunging women—here, the Furies—as well as men. As commercial engraving commissions, the Hesiod compositions attest to the broader interest in the lunge as an action, both contemporaneously by Flaxman and historically in the Greek and Etruscan vase painting that inspired Flaxman.
From left: Blake's engravings of John Flaxman's The Works Days and Theogony of Hesiod, "Brazen Age," object 12, and "Iron Age," object 14.
In contrast, the lunging figures in the Marriage (seen in two details below) are much smaller, as they are interlinear figures. Although the lunging figure in object 6, directly below the first letter of "Memorable," is also seen from behind and may be nude and male(?), the figure's body type and position appears, here, quite lithe and graceful. Moreover, the figure hovers directly above the word "walking," and the visual/textual pairing thus provides a fuller representation of the narrated action. The second example from Marriage further underscores the breadth of the term as the one lunging is not a human figure but rather a horse, which is also tagged as "leaping."
From top: Marriage of Heaven and Hell, copy A, object 6 and 14.
Following somewhat appropriately, we also find a lunging animal-human hybrid (an enchanted follower of Comus) in the center of Blake's illustration of Milton's "Comus." Yet whereas the bodily movement in the previous image attests to the encompassing celebratory atmosphere, similarly exaggerated lunges in Blake's illustration of Robert Blair's "The Grave" underscore the drama of the death and despair in the composition. Indeed, the complementary, active positions of the top figure (likely the spirit of the dead man below) lunging left out the window and the middle female figure lunging right toward the dead man below create a stark compositional contrast with the stillness of both the dead body and the standing figure at left.
From left: Illustrations to Milton's "Comus," Thomas Set, "Comus with his Revellers," object 1; Illustrations to Robert Blair's "The Grave," "Death of the Strong Wicked Man," object 8.
With such an investigation of a single action term—something as simple as "lunging"—we can begin to think through Blake's oeuvre in new ways. In particular, we can examine the variety within many depictions of a movement with attention to repeated motifs, such as the depiction of male lunging figures from behind or the intensely expressive faces that accompany female figure who lunge, to continue interrogating and identifying new connections within Blake's visual imaginary.
artDigital Humanitiesimage markuptagging
by Katherine Calvin
William Blake's letters: Date dilemma and Keynes's commas
Q&A with Naomi Billingsley
BAND, Q&A, Tutorial Videos
Waves of Regret and Waves of Joy: Searching for the End of the World in the Blake Archive
Blake's Afterlife: Howard Finster, the Backwoods Blake
BAND, Digital Humanities
Insights from a Doubly Digital Humanist


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The Best Christmas Fashion Short Movies 2018
by Angelica Corà, December 9, 2018
Christmas is the most magical moment of the year, but it is also one of the most fashionable! Between Christmas collections and themed showcases, fashion certainly helps to reinforce and communicate the beauty of Christmas, during which we daydream about the clothes and accessories we could ask Santa Claus or the ones that we could, instead, gift.
To emphasize even more the splendor of Christmas are the fashion shorts movies, which show the different ways, traditions and emotions that characterize the holidays season, all represented with a stylish eye. Also this year we've seen some very sentimental short movies, but which were the best ones?
CHRISTMAS FASHION SHORT MOVIES 2018
Tiffany & Co.— Believe In Dreams: A Tiffany Holiday
And you, do you believe in dreams? Tiffany's Christmas campaign, directed by Mark Romanek, begins in the iconic flagship store of Tiffany & Co. on the Fifth Avenue and sees as protagonist Zoë Kravitz, who plays a Tiffany's shop assistant who works late. During one of her shifts, she is transported in a sort of Tiffany-colored Wonderland where there is a secret Christmas workshop where artisans, led by an eccentric manager (Xiao Wen Ju), are working. It marks the beginning of a series of demonstrations of the Tiffany & Co. craftsmen's extraordinary skill, during which there is also space for some fun moments, one on all the final "Tea Party" organized by the Mad Hatter, played by Naomi Campbell. The Christmas campaign "Believe in Dreams" shows both the iconic and new collections by Tiffany & Co. including Tiffany Paper Flowers, Tiffany T and Tiffany Keys, while the soundtrack could only be the song "Dream On" by Aerosmith.
"The Christmas season is the time of year when we are most likely to dream," said Reed Krakoff, Chief Artistic Officer of Tiffany & Co. "The craftsmen of Tiffany work to instill magic and beauty in every jewel. We created this video to let people know about their skills and to capture Tiffany's Christmas spirit, where everything is possible."
Burberry – Close Your Eyes and Think of Christmas
Burberry has launched the fashion film "Close Your Eyes and Think of Christmas," directed by Juno Calypso. The protagonists are Kristin Scott Thomas, M.I.A, Matt Smith and Naomi Campbell with her mother Valerie Morris-Campbell. The campaign shows an eccentric Christmas in full British style, exploring the different traditions, with a focus on the iconic garments of Burberry, both for men and women; from the trench coat to the monogram TB, passing through the printed scarf with archival motifs, up to the belt and a preview of the new collaboration between Vivienne Westwood and Burberry, which can be admired on Naomi Campbell and her mother.
The description of the video says: "Juno explores the dance between reality and imagination of a very British Christmas, drawing from its experiences and its rituals, from the unpredictable British climate to being with your family, up to the trains, always late during the festivities."
John Lewis & Partners Christmas Ad 2018
Like every year, the brand John Lewis has put together a moving Christmas spot: the protagonist this time is Elton John, who retraces the salient moments of his career on the notes of Your Song, until the first time when he played the piano, belonging to his grandmother's, changing his destiny forever. The spot set is on display at the John Lewis store in Oxford Street, London, where customers can visit Elton John's dressing room, the recording studio and the living room used in the video. Craig Inglis, partner and customer service Director of John Lewis & Partners said, "Think back to all of the Christmases that you have enjoyed over the years – I'm sure there is one very special gift that stands out above all others. That's the feeling we wanted to bring to life this year."
Elton John commented on his involvement in the project by saying, "The Christmas campaign of John Lewis brings back so many sweet memories for my family and me. It was a wonderful opportunity for me to think about my life with music and the incredible journey I have taken, and how the first time I played my grandmother's piano was the moment when music entered my life."
Zalando | 2018 – Christmas. Never out of fashion
The online fashion platform focuses on the warmth of holidays, the meeting between generations and the time spent with the people we love in its new Christmas campaign. "Never out of fashion" shows a cast with an age that goes between 1 and 106 years old, singing while wearing Zalando-signed looks. Directed by British director Jake Nava, the spot opens with the smile of a child and, on the notes of "Silent Night," a varied cast of all ages sings the song in his/her own language. Harry, 106 years, closes the spot holding in his arms the smallest of the group.
"Christmas and the Holidays are the time of year when we all feel closer to each other, where distant generations and different life stories meet and come together again. As a leading online fashion platform in Europe, with an assortment of over 2,000 brands, we want to offer our over 24 million customers the chance to create their own style, even for special occasions such as parties," said Jonny Ng, Marketing Strategy & Campaigns Director of Zalando.
Gucci – Gucci Gift 2018 Campaign
Gucci has launched the Gift Giving 2018 campaign to show all its holiday products, from jewelry to handbags, from shoes to perfumes, from the Décor line to baby clothing. Inside the historic Italian ballroom Le Roi, inaugurated in Turin in 1926, the campaign, shot by Petra Collins, talks about a kaleidoscopic feast, with a retro allure, while in the background plays "Take Me Home" by Cher: the protagonists dance and have fun wearing the eccentric creations by Alessandro Michele, between midnight kisses, balloons and luminous details.
Coach – Coach Presents Lights, Camera, Holiday with Selena Gomez
Coach celebrates the Christmas holidays with the video "Lights, Camera, Holiday," starring the actress, singer and brand ambassador of the brand Selena Gomez. In this short fashion movie, written and directed by the creative duo Henry and Rel of Supermarché, the star and an unexpected cast of animated animals take part in an audition to become the protagonists of the event of the season: the Coach Christmas storefronts.
Miu Miu – Miu Miu More
"Miu Miu More" is the new short by Gordon von Steiner, which includes tributes to the cinema and aesthetic suggestions almost abstract in the alternation of light and soft colors that creates a kaleidoscopic choreography, as illusory as it's intense. The protagonist is Elle Fanning, who plays with the perceptions of the audience, attracting them to the irresistible world where too much is never enough. In the cast, all feminine, there are also Eniola Abioro, Olivia Anakwa, Olivia Forte, Lucan Gillespie, and Oumie Jammeh.
H&M – H&M Hotel Mauritz: Episode 1/2/3/4
H&M for Christmas thought about a series of episodes set in the imaginary Hotel Mauritz, where the protagonist (the actress Aubrey Plaza) finds herself living many unexpected, but fun and glamorous, situations!
Aubrey Plaza is checking in at the Mauritz Hotel for the holidays when she is involved in an unexpected duet with another guest.
Wear your dress and all your charms: it's time to celebrate! Aubrey and the other guests are getting ready for a night of partying at the hotel.
Aubrey can't sleep because of the volume of the music coming from the room next door. Will she end up joining the party?
Aubrey and another guest end up leaving their rooms wearing the same black dress, creating an epic moment. Who will win?
Relative Thinking: The Multisensory Encounter Between Art and Fashion at Polimoda
Voodoo Jewels: "IMPERFECT BEAUTY" and the Art of Loving Yourself
Ferragamo SS23: Dawn of A New Hollywood
Ermanno Scervino SS23: The Beauty of the Future, Today
H&M always killing it.


Kids, let's not get all excited at once now.
Skimping on science is akin to apathy and signals a lack of engagement with our physical world. Science shapes us. It is everywhere. We should let it in more.
Bumper stickers. The analog, nano pre-tweet. Humorous, sobering, pithy calls-to-action. And we're here to stay. Thank you, cars, planes, trains and unmotorized transportation, for lending some of your mobile real estate to the causes we ply.


text:
Q: How to insert value in dynamic radio button into database? Please help me..I have problem on inserting value in radio button into database. My code is dynamic radio button per row. How can I insert the value into the database? Help me. Im new in PHP programming. Need expert help here. tq

<?php
session_start();

$sql = new mysqli('localhost', 'root', '', 'cpsdatabase');

// Create an array to catch any errors in the registration form.
$errors = array();
if (!empty($_POST) && empty($errors))
{
       $query = "INSERT INTO answer (id, staff_id, module_id, question_id, ans)
   VALUES(?,?,?,?,?)";
   $success = $sql->prepare($query);
   //bind parameters for markers, where (s = string, i = integer, d = double,  b = blob)
   $success->bind_param('issss', $id, $staff_id, $module_id, $question_id, $ans);

 if($success->execute()){
 echo '';

   }
   else{
    $errors['registration'] = "Tidak Berjatya";
    }

$success->close();
}
?>

<!DOCTYPE html>

<title></title>

<form action="usersurvey.php" method="post">
<?php
$con=mysqli_connect("localhost","root","","cpsdatabase");
// Check connection
if (mysqli_connect_errno()) {
  echo "Failed to connect to MySQL: " . mysqli_connect_error();
}

$sectionid = $_SESSION['section_id'];
$result = mysqli_query($con,"SELECT * FROM question WHERE section_id='$sectionid' AND module_id='1'");

?>

Soalan
1
2
3
4
5

<?php for ($i = 0; $row = mysqli_fetch_array($result); $i++) : ?>

<?=$row["question_name"];?><input type="hidden" name="question_name[]" value="<?=$row["question_name"];?>">

<input type="hidden" name="staff_id" id="staff_id">
<input type="hidden" name="module_id" id="module_id">
<input type="hidden" name="question_id" id="question_id">
<input type="radio" name="ans[<?php echo $i; ?>]" value="1">
<input type="radio" name="ans[<?php echo $i; ?>]" value="2">
<input type="radio" name="ans[<?php echo $i; ?>]" value="3">
<input type="radio" name="ans[<?php echo $i; ?>]" value="4">
<input type="radio" name="ans[<?php echo $i; ?>]" value="5">

<?php endfor; ?>

<input type="submit" name="submit" value="Submit" />
</form>

A: After pressing the submit button the values of your radio buttons will be passed to your usersurvey.php. Use the $_POST[ParameterName] to get the values from your post.

    if (!empty($_POST) && empty($errors))
    {
    $id = $_POST['radiobuttonvalue1'];
    $staff_id = $_POST['radiobuttonvalue2'];
    $module_id = $_POST['radiobuttonvalue3'];
    $question_id = $_POST['radiobuttonvalue4'];
    $ans = $_POST['radiobuttonvalue5'];

redpajama_set_name: RedPajamaStackExchange


Our linen pants come with three different color, black, Beige and white. Basic colors are the best. They are definitely look more formal and sophisticated but relax, they can go with any tops including formal and casual. The textures of the fabric distinctively characterize the design. Made of 100% linen, the yarns are very strong and washable like cotton and it gets better with washing.


text:
Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 – JD Supra
By admin December 18, 2019 Stem Cell Clinics
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA teams second year-end post will provide an overview of 2019 with a focus on the drug, biologic, and regenerative medicine programs at the agency. In many ways, the past year could be called a business as usual year for the FDAs drugs and biologics centers in that they continued to make progress on all of large-scale programs and priorities initiated by former-Commissioner Scott Gottlieb, who left the agency in April. FDA has been under the leadership of an Acting Commissioner since that time, although Texas radiation oncologist Dr. Stephen Hahn will be taking the reins soon following his confirmation by the full Senate in a 72-18 vote on December 12, 2019. (The Senate HELP Committee advanced the nominee on December 3, 2019; see our blog post just prior to that committee vote here.)
At the same time, however, the final months of 2019 have exposed several challenges for various FDA programs that operate under the extensive drug and biologic authorities contained in the Food Drug & Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), respectively. The agency will be forced to grapple with many of these issues directly and deliberately in 2020as a result of deadlines of the agencys own making as well as external pressures coming from other parts of D.C. and from the rapidly changing nature of the U.S. health care system.
Business as Usual When Getting New Drugs, Generic Drugs, and Biosimilars to Market and Promoting Competition under Various Action Plans But Challenges Are Emerging Related to Accelerated Approval and Breakthrough Products
According to data presented by the Office of New Drugs in early December (see ONDs slides here), FDA had another extremely productive year when it comes to its approval of new molecular entities that address a unique blend of therapeutic areas. The agency approved 45 new molecular entities in FY 2019 (October1, 2018 to September30, 2019), of which 71%, or 32 products, received priority review status and 23 were designated as orphan drugs intended to treat rare diseases. As OND emphasized in the presentation, several of those new product approvals are notable for their uniqueness and therefore, in the agencys view, 2019 reflects not only quantity but [also] quality. The OND presentation also highlights a significant amount of other information on new molecular entity approvals and may be of interest to those readers who want to take a deeper dive into the data.
In addition to advancing important new drugs and biologics to market, former Commissioner Gottlieb is well-known for having spearheaded to development of a Drug Competition Action Plan (DCAP) and a Biosimilars Action Plan (BAP) during his nearly two-year tenure as head of the agency. Some of our prior coverage of the DCAP and BAP is available here. In general terms, the DCAP encourages market competition for generic drugs and helps to bring greater efficiency and transparency to the generic drug review process; the BAP aims to achieve similar goals for biosimilar products as the agency continues its implementation of the 2010 Biologics Price Competition and Innovation Act (BPCIA), including the critical drug-to-biologic transition that will occur by operation of law in March of 2020.
FDA continued to make progress on its various goals under these two initiatives during 2019. Some examples of this progress can be captured with these two data points:
With all of these wins, however, FDA still faces its fair share of challenges related to its expedited drug and biologic programs, especially as it appears to have accelerated its review of products intended for diseases with an unmet need to breakneck speed. Indeed, the OND presentation from early December also added that for FY 2020 and as of November 21, 2019, the agency had already approved 13 such drugs, suggesting that next year could be a record-breaking one in terms of innovative drug product approvals. A recent Bloomberg Law article (available here) used the phrase breakneck speed to describe the agencys actions in this space based on several recent FDA approvals of new molecular entities that have come months in advance of their assigned target dates. The Bloomberg Law article highlights that in response to FDAs speediness in reaching approval decisions on new drugs and biologics for diseases with unmet needs, patient advocates and, increasingly, insurers that have to pay for those treatments are starting to raise concerns that these products lack sufficient safety or effectiveness data.
Relatedly, there has been increasing pressure on FDA to remove certain accelerated approval drugs from the market following a failure by the drug product sponsor to confirm the efficacy or clinical benefits of the product in the required post-marketing confirmatory clinical trial. The most visible example of this regulatory challenge came in October 2019 when FDA convened an advisory committee to recommend whether it should withdraw accelerated approval from hydroxyprogesterone caproate injection (marketed under the brand name Makena for the prevention of preterm birth in pregnant women). FDAs Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval, with the dissenters favoring leaving Makena on the market while requiring the sponsor to conduct a new confirmatory trial. (Notably, no one voted for the option of leaving it on the market without requiring a new confirmatory trial.)Among the concerns of some members who voted to leave the product on the market with a new clinical trial obligation was that the drugs withdrawal would leave no safe treatment options for pregnant women at high risk of preterm birth. FDA will have to make a final decision regarding what to do about Makena in 2020, and it undoubtedly will face intense criticism (and potentially legal challenge) no matter what route it chooses to take for this public health quandary in which it finds itself.
In a similar vein, FDA official Dr. Richard Pazdur participated in a Senate briefing on December 10, 2019, in which he and other speakers defended the Breakthrough Therapy Designation program. FDA insisted again that the designation was intended to let the agency have earlier interactions with drug sponsorsand that it was not meant to be an early rating system for drugs or a signal of how they might do commercially. Given that the Breakthrough program was created in 2012 and is considered to be wildly successful, some speakers at the briefing expressed surprise that there was still any confusion about its purpose and function. Whether Congress picks up any of these emerging areas for consideration as part of FDAs 2022 user fee reauthorization packages remains to be seenas those negotiations will begin in earnest after the New Year, but the issues certainly are complex enough to allow for robust policy discussions to occur.
Finally, there are expected to be bumps in the road with the upcoming March 2020 transition of proteins previously approved under New Drug Applications (NDAs) to Biologics License Applications (BLAs)for which FDA only finalized its guidance for industry last year. The March 2020 transition date was established under the BPCIA and the agency does not have discretion in getting the transition done (only in how it handles the logistical and administrative issues created by transitioning approved products in this way). Check out our prior blog post on the final deemed to be a license transition guidance.
Business as Usual with the Rapid Pace of FDAs Issuance of Agency Guidance But Challenges Are Emerging Related to Judicial Deference to FDA Decision-Making
FDA guidance documents for all regulated product categories continued to be released on a regular basis this year, including several related to areas of agency priorities under the DCAP and BAP including the final biosimilar interchangeability guidance issued in May (see our blog post here) and a draft guidance on insulin interchangeability issued in November 2019. The latter also relates to the March 2020 NDA-to-BLA transition, as insulins are one of the largest class of products that will be transitioning into regulation as biologics, making them open to what is expected to be more efficient competition through the BPCIAs biosimilar pathway than what was possible in the past as insulin NDAs.
Despite the accelerated pace of the issuance of Agency guidance, however, FDA is beginning to face more challenges related to its decision-making and the scope of its exercise of agency discretion. In particular, a significant District Court for the District of Columbia ruling issued on December 6, 2019, Genus Medical Technologies, LLC v. FDA, provides hints of a potential shift in judicial deference to certain agency actions. The court vacated FDAs classification of a medical imaging liquid as a drug rather than as a device after determining that FDA did not have discretion to decide how to regulate a product merely because the definitions of drug and device overlap in the FD&C Act.
According to the district court judge, FDA was not interpreting the drug/device definitions in the statute properly, and Congress did not intend to allow the agency unfettered discretion to pick between the two categories. Rather, the court found that the text of the definitions are clear and do not create a gap or any ambiguity for FDA to fill with an exercise of agency discretion. This recently issued decision may indicate a potential shift in how courts are going to apply long-standing precedents related to judicial deference to agency decisions. If FDA decides to appeal the Genus ruling, it may end up at the Supreme Court as one of many expected challenges to the doctrines that established our current framework for judicial deference of an administrative agencys interpretation of an ambiguous statute.
Business as Usual with FDAs Comprehensive Regenerative Medicine Framework and Stepped up Enforcement Against Stem Cell Clinics Offering Unlawful Products But What Happens in November 2020 When the Enforcement Discretion Period Ends?
One of the first FDA press releases for 2019 was co-authored by former Commissioner Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks and was focused on the agencys new policies aiming to advance the development of safe and effective cell and gene therapies. In the press release, the agency leaders predicted that by 2020, FDA would receive more than 200 Investigational New Drug Applications (INDs) for cell and gene therapies each year. The agency has continued to work diligently to increase its staff in CBER to conduct clinical reviews for such INDs and to try to keep pace with the industrys development of these innovative technologies.
As we discussed in our update on FDAs Comprehensive Regenerative Medicine Policy Framework earlier this year, the agency is prioritizing two parallel goals: (1) clarifying the regulatory criteria for product marketing and providing support and guidance to legitimate product developers; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market. The second prong of this comprehensive plan for regenerative medicine products was the topic of one of Dr. Gottliebs very last statements as Commissioner before he left the agency, issued on April 3, 2019 in conjunction with CBER Director Dr. Marks, indicating how important this area is to the agencys current public health priorities.
In the April 2019 statement, Drs. Gottlieb and Marks acknowledged FDAs challenges and efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, citing several Warning Letters issued to manufacturers that violated current good manufacturing practices (CGMPs) for human cells and tissue products. They noted that it was of particular concern given that the industry was nearly halfway through the period during which the FDA intends to exercise enforcement discretion for certain regenerative medicine products with respect to INDs and premarket approval requirements. Now that it is December 2019, that deadline is even closer with less than one year left. November 2020 is the end of the three-year period of enforcement discretion announced by FDA when it first articulated the policies and goals of this comprehensive framework in 2017. See our prior posts on the topic here and here.
Under the Comprehensive Regenerative Medicine Policy Framework, FDA appears to have stepped up the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019. In conjunction with a Warning Letter issued on December 5, 2019 to two related companies for processing and marketing unapproved umbilical cord blood-derived cellular products, Dr. Marks of CBER reiterated the agencys concerns about safety and reminded the public of the upcoming compliance deadline: As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the [FD&C Act] and FDAs regulations.
Dr. Marks was referring to two Untitled Letters that were issued to stem cell product distributors on November 20 and November 25, 2019, respectively. The press release cited above also added that the agency had also recently sent 20 letters to manufacturers and health care providers noting that it has come to [FDAs] attention that they may be offering unapproved stem cell products, reiterating the FDAs compliance and enforcement policy.
FDA also prevailed this year in the U.S. District Court of the Southern District of Florida against a stem cell clinic charged with violating the FD&C Act and the PHS Act. In June 2019, the court held that the defendants adulterated and misbranded a stem cell drug product made from a patients adipose tissue without FDA approval and for significant deviations from CGMPs, issuing a permanent injunction as requested by the Department of Justice on FDAs behalf. The agencys statement on that important court win by the government is available here.
Lastly, on December 6, 2019, FDA issued a Public Safety Notification on Exosome Products. The safety notification informed the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes, which came to FDAs attention through the Centers for Disease Control and Prevention, the Nebraska Department of Health and Human Services, and others. There are currently no FDA-approved exosome products and, to be honest, we are not even sure what such a product would be since an exome consists of all the sequenced exons within a single human genome after the introns are removed. (So were the clinics administering complete exomes to patients? that seems unlikely.)But what we found noteworthy about this public safety notice is the forceful and direct language FDA used when describing the unscrupulous conduct of the sellers of these products:
Certain clinics across the country, including some that manufacture or market violative stem cell products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that they these products do not fall under the regulatory provisions for drugs and biological products that is simply untrue. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the [PHS Act] and the [FD&C Act] and are subject to premarket review and approval requirements.
The clinics currently offering these products outside of FDAs review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.
As we enter the final year of FDAs enforcement discretion period, perhaps these public notices and Warning/Untitled Letters will become even more frequent and the agency will become even more frustrated by the ongoing violations and medical practitioners who flout federal law. This area will see substantial activity in 2020 and we will be watching closely to see what changes, if anything, about FDAs approach in November when the deadline to come into compliance ends. Will there be widespread FBI raids on stem cell clinics engaged in this kind of bad behavior? Only time will tell.
Final Thoughts: A Few Other Business as Usual Activities in the Therapeutic Product Areas and Prescription Drug Advertising Enforcement
Although we have highlighted what we view as some important challenges for the FDA to address in the coming months, other areas continue to be business as usual without anything very new to report. FDA continues to invest significant resources into improving the quality of compounded drugs and ensuring compliance with Sections 503A and 503B of the FD&C Act. Drug compounding was another topic of one of Dr. Gottliebs very last statements as Commissioner on April 3, 2019, in which he laid out the 2019 compounding priorities that included maintaining quality manufacturing and compliance and regulating compounding from bulk drug substances.
Notwithstanding all the efforts by FDA and State regulators in this area over the past several years, the agency continues to see concerning activity when it comes to compounded drugs, such as problems related to the condition under which compounded sterile medicines are made, which raisesignificant risks to patients. As a result, FDA has made it an intense area of focus to take enforcement actions against compounders who fail to produce sterile drugs in compliance with the law. During the past year, for example, FDA has won at least four permanent injunctions against various compounders after the agency identified behavior that posed a significant risk to public health and safety.
In addition, in 2019 FDA also increased its activities towards reducing and mitigating the impact of drug shortages on the health care system. See our prior blog post on Drug Shortages.
Finally, after a fairly slow year of enforcement in the prescription drug advertising space, the last two months of 2019, at least as of December 12th, have given us three (!) letters two untitled and one warning from the FDAs Office of Prescription Drug Promotion (OPDP). Most interestingly, the Warning Letter issued on December 2, 2019 for omitting warnings about the most serious risks associated with [a medication-assisted treatment] drug from promotional materials was announced to the public via FDA press release, which is not a typical action for normal-course OPDP letters to industry. The drug in question, approved for the prevention of relapse to opioid dependence following opioid detoxification, is associated with several significant risks including potential opioid overdose. Given the countrys public health emergency that is the opioid epidemic, FDA appears to have felt the need to make the deficiencies in the advertisement and those risks more widely publicized. So another thing we will be watching for in the New Year is whether this OPDP action represents the beginning of a new trend by the agency to publicize these Warning Letters more directly, or whether its advertising enforcement activities may be picking up due to industrys evolving approaches to promoting therapeutic products.
If you made it to the end of this post, thank you for reading our tome, and we hope you found it helpful and interesting! Stay tuned next week for our third and final FDA year-end blog post.
Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 - JD Supra
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text:
This Week in Crowdfunding (12/4)
By: Selina
This Week In Crowdfunding is a column dedicated to new projects that need help from the public in order to reach their goal.
We here at Trust the Dice love to support indie creations.
The list of popular, mainstream, films that began labeled 'indie' is staggering. So before you start picturing a black and white short film of a naked clown smoking a cigarette and flipping pancakes off a bulldog's back, remember that some of your favorite films may very well have started out as indie.
Some indie films you may have heard of include: Pulp Fiction (1994), Clerks (1994), Requiem for a Dream (2000), Memento (2000), and The Terminator (1984). Keep in mind, that's a very short list. A comprehensive list of indie movies that have been essential to shaping the entertainment world would be too long for anyone to want to read.
Hollywood doesn't prefer to take risks and, as much as artists don't like to admit it, creativity is risky. That's the reason we see so many familiar tropes used over and over again. It's safe. It makes money. However, some of the best films in history have become legendary because they took the risky route and shunned the tropes their genres are known for.
Indie films are a breeding ground for risky creativity.
In this column, you'll find ten of the best projects Trust the Dice found hosted on crowdfunding sights this week. These are Films/Web Series'/Shows of varying lengths and genres that we believe in. If you like any of the projects you see here, donate to them, tell your friends, and/or post their information on social media.
These projects don't just need money, they need people to care and spread the word that they exist.
Support creativity. Support indie artists.
Remember that every actor, director, writer, and movie you have ever fallen in love with had to start somewhere.
Trust the Dice does not, and will not, accept payment from project creators for
appearance on this list. Projects are chosen solely on the merit of the idea,
proposal, and people involved.
10 – Silver Moon
Crowdsource Platform: INDIEGOGO
Director: Elias Benavidez
Writer: Elias Benavidez
Other Staff: Allison Vanore (Producer), Dylan Jury (Casting Director), Justin Martinez (VFX Supervisor), Hamdija Ajanovic (Composer)
Amount Requested: $11,000
Current Standing (as of Saturday night): $688 raised by 14 backers
Type of Goal: Flexible (This campaign will receive all funds raised even if it does not reach its goal.)
Link: https://www.indiegogo.com/projects/silver-moon-a-short-film#/
When film makers delve into dementia, they enter into a realm of reality that's so harsh that it's almost always a harrowing experience. In this case, Elias Benavidez (April's Last, A Boy's Life, A Note to Etienne), the writer/director of Silver Moon, actually watched his grandmother deteriorate due to the disease. In his introduction video, he credits that experience as the inspiration for this short film.
Benavidez has outlined an in depth proposal for the funds he receives from backers for this film, with stretch goals that include improved equipment, song licensing and compensating volunteers for their time. He has also expressed desires to take the completed film to festivals.
Any proceeds Silver Moon garners will be donated to the Alzheimer's Association.
Between the intense heart of this film and the generosity of those working on it, this is not just a film we believe might work out, but one we genuinely hope succeeds.
EDIT -
I was able to speak to writer/director Elias Benavidez today (12/6). I asked him if there was anything he might want people to know about his project that wasn't on his Indiegogo page.
"Much of the inspiration is already on the page, but dementia care has impacted me even prior to losing my grandma. My high school job was working in a dining hall at a retirement home and I gained great friendships with the residents (many of whom had dementia).
"Many of us went to the University of Arizona together and we wanted to collaborate on a project that can honor those who've been impacted by Alzheimer's or dementia (which is why we want this film to support the Alzheimer's Association).
"On a creative note, I love movies that tackle this issue. Movies like Away From Her (2006) and Still Alice (2014) -- and I wanted to create a project that honors those themes while infusing genre and heightened surrealism, staying true to my personal aesthetic."
Had I gotten to speak to Benavidez before finalizing this list, his project would have been listed higher up. When a writer/director touches on something as serious as Alzheimer's Disease, passion is absolutely everything.
Obviously, that passion is present here. That is going to shine through in the finished product.
Lowest Fund Reward: $10 – Neptune – You are now a part of our intergalactic team! As such, you will receive periodic updates about the fundraising and the film production itself. To infinity…! (Anywhere in the world)
Highest Fund Reward: $1,000 – Sun – You're the center of this film's solar system! In recognition, you are listed in the film credits as CO-EXECUTIVE PRODUCER for helping bring SILVER MOON to LIFE! Also, YOU'RE INVITED TO THE SET WHEN WE ARE SHOOTING (Los Angeles)! A VIP invite to the premiere screening, plus downloads (movie and music) and shoutouts! PLUS you'll have a STAR adopted on your behalf, a TREE planted in your honor, AND ADMISSION FOR 2 TO VISIT THE SPACE SHUTTLE ENDEAVOUR and the IMAX film JOURNEY TO SPACE! (Anywhere in the world)
9 – Barren
Crowdsource Platform: KICKSTARTER
Director: Sarah Hickey
Writer: Sarah Hickey
Other Staff: Jessica Pearce (Producer), Josh Mitchell Frey (Director of Photography), Jasmine Jakulpi (Production Designer), Luke Bicevskis (VFX Supervisor), Phillip Klimek (Composer), Lachlan Harris (Sound Designer), Vanessa Crouch (Cast), Tom Beaurepaire (Cast), William Whyte (Cast), Verity Higgins (Cast),
Current Standing (as of Saturday night): $815 raised by 25 backers.
Type of Goal: All or Nothing (This project will only be funded if it reaches its goal by the deadline)
Link: https://www.kickstarter.com/projects/855098413/barren?ref=category_newest
This short film is a very emotional drama based on the true story of one woman seeking to escape a significant loss.
In reality, Sarah Hickey (Communion Day, Waiting on Sound, The Mole), writer/director of Barren, lost someone very near and dear to her heart. As a way to deal with her grief, she carried a stuffed animal belonging to that person on a nearly 500 mile walk from Melbourne to Adelaide in Australia. It took her a grand total of 31 days.
The story is easy to relate to, heartbreaking, and inspiring. In short, it's the perfect subject for a crowdfunded campaign. Furthermore, production has already started on this film. That means, one way or the other, this short film will be made.
The people involved in this film will be putting their funds toward the last days of filming and post-production. It will cover things like music composition, VFX, and editing.
Lowest Fund Reward: $0.75 ($1AU) – SHUFFLE – walk without lifing the feet – Thank you for joining us on a little shuffle - every dollar counts! We appreciate your company and that you're being a part of the film. We will make sure we give you a big THANK YOU and shout it to the mountains on our social media channels! (Only Australia)
Highest Fund Reward: $5,966.40 ($8000AU) – A JOURNEY – from one place to another – If you pledge $8000AU or more, it's safe to say you've made the full journey with us. And we want to hear all about it! Come join us for a THREE-COURSE DINNER with the Director and Producer to hear all about the story of the film (Travel not included). And for your next journey, we are giving you a OSPREY AURA 50L backpack (the same one Sarah used on her walk!) You also receive: Associate Producer Credit, Coffee Table Book, Cast and Crew screening tickets, T-SHIRT A3 Poster Signed by the Director, Cap, Waterbottle, Enamel Camping Mug, 5 Pack of BARREN Postcards, exclusive access to the full Behind the Scenes Diaries including the Making of and Sarah's video diaries from the original walk and a big THANK YOU and SHOUT OUT on our social media channels. (Anywhere in the world)
8 – Balloons: The Movie
Director: Jeremy Weiss
Writer: Jeremy Weiss
Other Staff: Unknown
Current Standing (as of Saturday night): $2,140 raised by 13 backers.
Type of Goal: Fixed (This campaign will only receive funds if amount requested is raised by deadline)
Link: https://www.indiegogo.com/projects/balloons-the-movie-animals#/
I was absolutely charmed by the introduction video on the Indiegogo page for Balloons: The Movie.
This is another film based on a true story, but there's a slight change of pace. Jeremy Weiss is not telling a drama or documentary-based story, he's introducing his project as a comedy. The story is based on his one embarrassing day as a balloon salesman.
Judging from the video, I'm sure we'll be able to expect some physical comedy along with the cringe-based stuff.
We all know cringe isn't really my thing. I have a very low threshold for tolerating embarrassing scenes, but with the proper balance of cringe, relate-ability, and physical comedy… it becomes something much better.
This film creator is another that has his eyes set on putting good into the world. All leftover proceeds from what he raises will be donated to the Lange Foundation – an animal rescue.
Lowest Fund Reward: $20 – A Special Thank you! – A special thank you for your contribution! You'll get a special thank you shout out on social media! Items included: A Special Thank You!
Highest Fund Reward: $25,000 – Executive Producer – Holy cow! What an incredible donation! For this one you'll be an Executive Producer of Balloons. You'll have your name in the opening credits of the movie. Plus all of the Friends of Lange perks. You'll also receive the official T-Shirt, poster, and digital copy of the movie. Items included: Executive Producer Credit, Friends of Lange.
7 – Dying: 101
Writer: Larry Clarke
Other Staff: (All cast members listed are possible, not necessarily confirmed) Leslie Ann Warren, Brian Dennehy, Mike O'Malley, Sam Trammel, Kate Walsh, JK Simmons, Billy Gardel, Chris Bauer, David Koechner, Jeffery Donovan
Amount Requested: $200,000
Link: https://www.indiegogo.com/projects/dying-101-a-new-film-by-larry-clarke-independent#/
This is another film inspired by the death of the writer's loved one. The difference between the previously mentioned film and this one is the method of storytelling. In this case, the writer, Larry Clarke (Road Hard, The Secret Life of the American Teenager, Contagion), has decided to tell the story inspired by his father's passing through the use of dark comedy.
He's described the film as a mix of Garden State (2004), Eternal Sunshine of the Spotless Mind (2004), Happiness (1998), and Welcome to the Dollhouse (1995). He says it's told in the flashback style of a Charlie Kaufman (The Edge, Being John Malkovich, Confessions of a Dangerous Mind) movie with a Todd Solondz (Storytelling, Dark Horse, Palindromes) tone.
That's a mouthful right there and Clarke seems to be raising expectations incredibly high. Of course, with a requested budget of $200k, those expectations were already pretty up there.
With many crowdfunded films, investors are taking a risk on new talent. However, Clarke is backing up his project with established and respected cast members. Many of the people speaking on his behalf in the introductory video are well-know, if not household name, actors.
Clarke did shop his film around, and there were no mainstream takers. I urge you not to put too much stock in that fact. As I mentioned above, Hollywood doesn't like too much creativity.
They forget the audience does.
Lowest Fund Reward: $10 – Honorary Club 101 – You have full access to the Dying 101 website including my director's video diary all through production. Items included: Website Access/Film Diary.
Highest Fund Reward (1): $5,000 – CoProducer Perk – We will have you as a part of the team. Screen credit as a Co-Producer with carte blanche access to production. Our producers will include you in all pre-production correspondence. VIP access to all events. In short, you will be our best friend forever. Items Included: Co-Producer Credit.
Highest Fund Reward (2): $5,000 – Walk On Part – You will have a walk on part in one scene. You will have a line. I guarantee you will be in the movie. You, of course, will be listed with the cast. You also get all VIP perks. Items included: Walk On Part with lines.
6 – HELLo tHERE
Director: Ashley Eberbach
Writer: Dylan Wayne Lawrence (also cast)
Other Staff: Sing Howe Yam (Director of Photography), Reid Waterer (Producer), David T. Woodruff (FX Artist), Marianna Von Fedak (Concept Artist), Tamika Katon Donegal (Cast), Jessica Joan (Cast)
Current Standing (as of Saturday night): $1,375 raised by 6 backers
Link: https://www.indiegogo.com/projects/hello-there-a-psychological-thriller-film-lgbt#/
This is one of the important films I found this week.
Aside from a very eye catching introduction video, this film has an incredible message. The plot of a character seeing demons that may or may not be real is not exactly unheard of. However, HELLo tHERE is not just a random ghost story. There is a really purpose behind the demons they use.
This psychological thriller is based around the trauma caused by inequality, racism, and homophobia.
More and more often I find myself seeing people argue that the aforementioned issues are really not a big deal anymore. They don't see the hate, so it obviously isn't there, right?
Every person walks a different path and, for many people, that path is lined with thorn-bearing bushes. They can get to their goal, but only after cutting themselves to bits on other people's hate.
Inequality, racism, and homophobia are diseases that can only be cured by reversing ignorance. The only way to do that is to flood the world with information that combats the lies that cause such hate. Sometimes, that information is easier to swallow when it's in the form of some manner of entertainment. In this case, you get a badass thriller that helps provoke some thought when it's over.
Ok, I'll admit, the title of the film is… rough, but I've been clear about this in the past: You cannot judge a film/TV show/web series by its name. After all Reservoir Dogs (1992) is a phenomenal film, yet people have been arguing over the terrible name since it came out.
Lowest Fund Reward: $10 – RUN, IT'S GONNA GET YOU! – Although we appreciate your donation, it wasn't enough to escape the monster's grasp. Rest assured it was a quick demise, but it's hungry for more! Items Included: Special Thanks in Film Credits, Shout-out on Social Media.
Highest Fund Reward: $101 – CHOOSE YOUR WEAPON – Any donation over $100 (even by $1) earns you an Executive Producer credit in the film. Your name will be seen worldwide as a key player in the next iconic horror film! Items Included: Special Thanks in Film Credits, Digital Poster Download, Stream the Film for Free, VIDEO Shout-out on Social Media, HD Digital Download of Film, Behind the Scenes Footage, Executive Producer Credit.
5 – Artemis One
Director: Brendan O'Toole
Writer: Brendan O'Toole
Current Standing (as of Saturday night): $159 raised by 4 backers
Link: https://www.indiegogo.com/projects/artemis-one-feature-film-initial-funding#/
Artemis One is a science-fiction film about two women going on a road trip with the intent to steal a space ship in order to test an invention one of them created. The creator describes his vision as a mix of Thelma & Louise (1991) and Interstellar (2014).
The plot seems interesting enough, but that's not what drew me to this project.
What drew me in was the sheer level of passion this creator has for film and space. The introduction video on the Indiegogo page is simple. Much simpler than the majority of the other videos that accompany the projects on this list, but the monologue of the creator was so impassioned that it MADE me care in a way that most of the projects I came across simply didn't.
When it comes to crowdfunding and creative enterprise there is nothing more important than passion. Passion for the art and passion for the subject matter are equally important. Brendan O'Toole has both in spades.
I truly believe that, given the funding, O'Toole will be able to make a film that accurately portrays his heightened level of devotion to the subject and its vehicle.
Lowest Fund Reward: $1 – Thank You! – I get it. You want to support us, but you don't have much to give. We thank you for your support. Every dollar helps. Items Included: Our Thanks.
Highest Fund Reward: $1,000,000 – Holy Crap!!! – Seriously, if you've got this much to give, just contact us and we'll work something awesome out for you. Items Included: Movie Download, Have a Hoody, Signed Script, This will look good on a wall, Come Visit the Set, Post Production Visit, Executive Producer.
4 – Slingshot Prince
Director: Sixin (Dandelion) Lin
Writer: Sixin (Dandelion) Lin
Other Staff: Jana Sue Memel (Executive Producer), Khoi Ly (Director Photography)
Link: https://www.indiegogo.com/projects/slingshot-prince-a-short-about-bullying-feminism#/
This film shines a significant light on the topic of bullying.
Bullying is a subject that is very near and dear to my heart. From elementary school until I grew so angry that I developed a violent streak in High School, I was bullied mercilessly.
I was an absolute magnet for bullies. I was a poor, fat, book-wormy, role-player girl. I had no father, wore glasses, and was confused about my sexuality. To top it off, in order to try to tolerate my own loneliness, I turned to lying in order to make myself look better. Literally any quality that could trigger a bully to get cruel, people would find in me.
I was a one-stop victim shop.
Although Slingshot Prince seems to focus mostly on bullying triggered by homosexual/transgendered people, it still pokes at a subject that absolutely NEEDS to be poked at.
A friend of mine killed himself when I was thirteen. After high school, I started a group to help bullied children. When one of the kids coming to the meetings walked off a building, I found it absolutely impossible to continue.
It screwed me up for a long time.
Bullying is a HUGE problem. It inspires suicide, school shootings, violence… at some point people need to stop pointing fingers and start really looking for the source of the problem.
I had the absolute pleasure of talking to the writer/director of this film, Dandelion Lin (Bifrost, 6915 Miles, The Screenwriter in the Restroom).
I asked Lin if there was anything the Slingshot Prince team would want to tell people about their project that wasn't already on the Indiegogo page.
"We hope more people can accept people who are different," Lin said. "…I used 26 years to identify and accept my gender. I want other kids don't need to feel less and shame about themselves, they can dress whatever they like, and be themselves. No one should take so long to accept themselves."
The story of Slingshot Prince is about a tomboy girl in 1995 living in the south of China. The film explores the bullying she experiences from her classmates due to her apparent sexuality. The story twists into one of revenge, but that does not cheapen the meaning behind it all.
Children are being hurt every day because people can't handle what is not like them. Projects like this one could make more of a difference than people realize.
Lowest Fund Reward: $5 – STAND UP AND SHOUT! – Thank you so much for standing up and being with us! There will be a big THANK YOU note for you on our social media and website. Please share our site on social media and shout with us "People who are different deserve to be treated equally!" Items Included: THANK YOU Note on Social Media.
Highest Fund Reward: $2,500 – CO-PRODUCER CREDIT – We sincerely appreciate for your contribution! Your altruistic support will receive everything above. Plus, as our Co-producer, your name will be showed on the end credit of this film as well as on IMDb. You will get THE PRINCE'S SLINGSHOT which hands crafted by our director. Moreover, you will get FOUR PREMIERE TICKETS as our BIG STAR! Items Included: THANK YOU Note on Social Media, Collectible Movie Poster, Digital Documentary Film, FOUR Premiere Tickets, Prince's Slingshot, Co-Producer Credit, Printed Storyboard Book, Printed Behind the Scenes Book, Slingshot Prince DVD.
3 – Don't Kill It
Director: Mike Mendez
Writer: Unknown – Script was delivered to Mendez by Robert Yocum according to an interview he gave Movie in Focus
Other Staff: Scott Martin, Michael Slifkin, Heather Brawley, Alex Scott-Webster, Dolph Lundgren, Kristina Klebe
Current Standing (as of Saturday night): $2,483 raised by 28 backers
Link: https://www.indiegogo.com/projects/don-t-kill-it-see-dolph-lundgren-as-a-demon-hunter-movie-horror#/
As a reader of this blog, the name "Mike Mendez" (Lavalantula, Big Ass Spider!, The Convent) should ring a bell. Mendez is one of those underestimated directors that can turn a minor horror idea into a phenomenally memorable B-Flick. The last film of his that we've mentioned on the blog was The Last Heist (2016) starring Henry Rollins (Con Man, He Never Died, The Legend of Korra).
Any creator that's smart enough to want to work with the great Henry Rollins will always get my attention.
In this case, we have an entire Indiegogo page filled with that awesome cheesy horror/action/comedy stuff that all of us at Trust the Dice just love. Especially when you add in the part of the main character, played by Dolph Lundgren (Shark Lake, The Expendables 3, Army of One).
The last film we reviewed with Lundgren in it, didn't quite thrill us. Then again, Kindergarten Cop 2 (2016) was poorly handled. Marketing it as a sequel when it was actually a reboot was the movie industry insulting our intelligence.
In Don't Kill It, Lundgren plays a demon hunter in Mississippi. He works with an FBI agent, played by Kristina Klebe (The Last Heist, Slay Belles, Free Fall), to figure out how to kill the demon they are tracking through a series of deaths.
The Indiegogo site is very clear with nearly everything you need to know about this film, but I was able ask the producer, Scott Martin (Time Rush, A Fighting Man, Battle Force), a couple of questions, so I thought I might be able to get him to expand on the plot and the demon used within it.
Trust the Dice: Many of our readers tend to find interest in where the ideas for projects come from. Were the demons utilized in the film unique creations or were they taken from various legends/religions and adapted for your needs?
Scott Martin: This is a single demon and it is entirely unique. How it changes bodies, if you kill the demon, it jumps into your body and becomes you. Then someone kills you and the demon jumps into their body. This obviously makes it very difficult to stop, and creates opportunity for lots of Mayhem.
Trust the Dice: Was there a specific inspiration for the storyline in general?
Scott Martin: We wanted to take the familiar demon in a small town story and add a big twist too it. It's also fun to have Dolph be the one trying to stop the Mayhem, when in most of his movies, he's the one driving it.
Trust the Dice: Also, would you classify this film as straight horror, horror/action, horror/comedy, or another genre altogether?
Scott Martin: It is definitely not a straight horror movie. We would classify it as horror/action/comedy. There is a lot of fun moments and Dolph is very funny in DON'T KILL IT. People are going to really enjoy his performance. We haven't seen him like this before.
When it comes down to it, this project has the potential to become a great finished film.
Lowest Fund Reward: $5 – THANK YOU – You are awesome! Our team will send you a digital "Thank You" for your support! Items Included: THANK YOU.
Highest Fund Reward: $10,000 – Executive Producer – Be an Executive Producer on "Don't Kill It"! Receive Screen Credit and IMDB Credit as an Executive Producer. Also receive our team's "Thank You", the exclusive Sticker, a Digital Download & DVD of the film, the exclusive T-Shirt AND Hoodie, lunch w/ the Producers and Distributors, and the Screenplay signed by Mike Mendez and Dolph Lundgren. Items Included: THANK YOU, EXCLUSIVE DON'T KILL IT STICKER, DIGITAL DOWNLOAD, DVD, EXECUTIVE PRODUCER, EXCLUSIVE DON'T KILL IT HOODIE, EXCLUSIVE DON'T KILL IT TSHIRT, LUNCH W/ DISTRIBUTORS & PRODUCERS, SCREENPLAY SIGNED: DOLPH & MENDEZ.
2 – Transhuman: A Documentary
Director: Ford Fischer
Other Staff: Alejandro Alvarez (Outreach Producer), Zoltan Istvan (Advisor), Mike Ricciardi (Research Assistant), Emily Bank (Production Assisstant)
Current Standing (as of Saturday night): $250 raised by 1 backer
Link: https://www.indiegogo.com/projects/transhuman-a-documentary-news-film#/
We don't do many documentaries on Trust the Dice for one simple reason.
They're boring.
Ok, not all of them. You take an interesting subject and give it to someone with a new perspective on it, and you have something very much worth watching. That's the reason we don't completely rule out the genre.
For a documentary to not only be chosen for a Top 10 on this site, but to be placed as high as second, you know there's some substance behind it that makes it intensely interesting.
I had never heard of transhumanism before.
That statement alone probably doesn't mean much, I'm sure there's a ton of stuff I've never heard of. However, I questioned a great deal of people out-and-about on Friday. Only two out of fifty knew what transhumanism was… and I'm fairly certain one of them was lying.
For me, technology is life. Everything I do is based around my computer, my phone or my gaming consoles. I work with technology, all my hobbies involve technology… there's never a moment when I don't have a complex machine touching my hand or my lap. Even when I sleep my phone is mere inches from my head. And my husband is even more of a technophile.
Transhumanism seems to be the next step in that evolution.
According to the Indiegogo page, transhumanism is all about using technology to enhance humanity in ways that are beyond what we currently understand to be possible. The final goal of transhumanism seems to be using technology to overcome death completely.
Due to the fact that no one involved with Trust the Dice knew absolutely anything about transhumanism, we were thrilled to hear back from the director, Ford Fischer.
I asked Fischer what triggered his interest in transhumanism.
"…I actually heard about Zoltan Istvan's Transhumanist Party Presidential run," he explained. "I contacted him and did an interview … I ended up becoming very interested in the topic and watched several news stories about it and read Zoltan's book, Transhumanist Wager. Before announcing the film, he also agreed to participate as an advisor and be interviewed for it."
What that means is that this all started with a politician that had the future in mind (shocking, I know). It's not uncommon for a documentary film to take something small, like an unknown politician running for president, and turn it into something worth learning about.
This is exactly the kind of documentary Trust the Dice is willing and happy to support.
This will be the first full-length documentary that Fischer directs, but he's hardly a newbie to the genre. Three years ago, he co-founded News2Share – an online news source. He has an eye for intriguing truths.
"I'm up to the challenge and believe the topic is perfectly suited for a successful film," he said. "Transhumanism is a relatively fringe philosophy right now, but I anticipate it emerging and shaping our future both socially and politically."
I can't claim to know what will happen in the future, but I do know that technology seems to be leaning toward taking over the world… and that make Transhumanism a fascinating subject.
Lowest Fund Reward: $5 – The Mention – We will thank you by name on Facebook or Twitter, and include you in a list of backer on our donor website.
Highest Fund Reward: $2,500 – Executive Producer – You will be granted exclusive access to the film in progress and be able to give feedback to help shape the film, and all perks above. We will also include your name in marketing materials such as posters, trailers, etc. Included: Social media shout-out, Inclusion on online donor list, Digital copy of the film, DVD copy of the film, Signed poster, "Executive Producer" in film credits, "Executive Producer" on IMDB, Inclusion in meetings with film producers, Thank you video.
1 – The Lyosacks Movie
Director: Alvaro Calmet
Writer: Alvaro Calmet
Other Staff: N/A
Amount Requested: $3,000
Current Standing (as of Saturday night): $490
Link: https://www.indiegogo.com/projects/the-lyosacks-movie-movies#/
I have always been and will always be a big fan and supporter of YouTubers.
Alvaro Calmet began posting the Lyosacks series on YouTube in 2010. Like many, his channel started slow. Sure, he doesn't post as often as some of the really big names out there, but he does post regularly and his Lyosacks series is adorably hilarious.
I'll be honest, I had never heard of the series when I first came across this project on Indiegogo. My initial interest in the film stemmed solely from the fact that it was based off a YouTube series.
I have a mild obsession with YouTube. Well, more than mild. I've actually been working on getting my own channel up and running.
On this blog, we've seen some interesting projects that were created by YouTubers. Riley Rewind (2013), SMOSH: the Movie (2015), Video Game High School (2012), etc. We seem to always enjoy these kind of projects. I have a theory that the quality is better because the sheer amount of passion and dedication necessary for a YouTuber to stand out among the rest and force their work into existence is staggering. Especially since YouTubers never start off getting paid for their work.
It's a labor of love.
The audience can always tell when extra effort has been put into a project and it DOES pay off.
In the case of the Lyosacks Movie you have Alvaro Calmet, a YouTuber that animates and writes his series alone. The only reason he intends to work with anyone for this film is because he needs voice actors.
The film is about three friends trying to save the world. From what? Well… everything. The movie will involve everything from zombies to ninjas to aliens. It's sure to be crazy fun.
Not only that, but Calmet has stated that, although it helps to be a fan of the series beforehand, the story works just fine as a stand-alone film for people unfamiliar with his previous work.
When I asked Calmet what he might want to tell people about his project/channel, he explained that he wanted people to understand that everyone has a chance to make their projects and dreams become a reality if they put their minds to it and exert as much effort as possible.
I urge you to take a look at Calmet's channel. Watch a few Lyosacks episodes. After an hour, you'll see exactly why this project landed our number one spot this week.
Lowest Fund Reward: $5 – THANK YOU POSTCARD! – Thanks for pledging $5! Everything helps to reach our goal! As a token of our gratitude, we would send you a postcard! This includes a pictures of the Lysacks world and a phrase thanking you by name.
Highest Fund Reward: $100 – PRODUCER ACCESS! - $100! You're now officially a producer of the movie! Of course, this comes with its own privileges: You get access to a closed Facebook group with the voice actors where I'll be updating the movie as it progresses and discuss it! This means YOU'LL BE WATCHING THE MOVIE AS IT'S BEING MADE all the way to the release date, and be able to help improve it! You'd also get ALL the Lyosacks music from the show and movie! Finally, your name would also be in a special category in the credits.
Labels: Animation, Article, Crowdfunding, Documentary, Indiegogo, Kickstarter, Movies
Thanks a lot for featuring my project as number one, Selina! And thanks for the kind words :)
What's New At Trust The Dice?
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Gilmore Girls: A Year in the Life (2016)


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text:
package com.company.crm.model;

import java.text.ParseException;
import java.text.SimpleDateFormat;
import java.util.Date;

import com.company.crm.exceptions.ClientPropertyValidationException;

public class Client {
    private int id = 0;
    private String name = null;
    private String location = null;
    private String notes = null;
    private SimpleDateFormat dateFormat = new SimpleDateFormat("dd.MM.yyyy");
    private Date contractDate = null;
    private String logoName = null;
    private boolean isDeleted = false;

    public Client(String name) throws ClientPropertyValidationException {
        this.setName(name);
    }

    public Client(String name, String location, String notes, String contractDate, String logoImageName, boolean isDeleted)
            throws ClientPropertyValidationException {
        this(name);

        this.setLocation(location);
        this.setNotes(notes);
        this.setContractDate(contractDate);
        this.setLogoFileName(logoImageName);
        this.setDeleted(isDeleted);
    }

    public Client(String name, String location, String notes, String contractDate, String logoImageName, boolean isDeleted, int id)
            throws ClientPropertyValidationException {
        this(name, location, notes, contractDate, logoImageName, isDeleted);

        this.id = id;
    }

    public void setId(String idAsString) throws NumberFormatException {
        int id = Integer.parseInt(idAsString);
        this.id = id;
    }

    public void setId(int id) {
        this.id = id;
    }

    public void setName(String name) throws ClientPropertyValidationException {
        if (name.length() <= 50) {
            this.name = name;
        } else {
            throw new ClientPropertyValidationException("The value of name is not correct.");
        }
    }

    public void setLocation(String location) throws ClientPropertyValidationException {
        if (location.length() <= 50) {
            this.location = location;
        } else {
            throw new ClientPropertyValidationException("The value of location is not correct.");
        }
    }

    public void setNotes(String notes) throws ClientPropertyValidationException {
        if (notes.length() <= 100_000) {
            this.notes = notes;
        } else {
            throw new ClientPropertyValidationException("Notes are too long.");
        }
    }

    public void setContractDate(String contractDate) throws ClientPropertyValidationException {
        try {
            SimpleDateFormat dateFormat = null;

            if (contractDate.indexOf("-") > -1) {
                dateFormat = new SimpleDateFormat("yyyy-MM-dd");
            } else if (contractDate.indexOf(".") > -1) {
                dateFormat = new SimpleDateFormat("dd.MM.yyyy");
            } else {
                throw new ClientPropertyValidationException("The format of date is not correct.");
            }

            Date parsedDate = dateFormat.parse(contractDate);
            this.contractDate = parsedDate;
        } catch (ParseException e) {
            throw new ClientPropertyValidationException("The value of date is not correct.");
        }
    }

    public void setLogoFileName(String logoNameName) {
        this.logoName = logoNameName;
    }

    private void setDeleted(boolean value) {
        this.isDeleted = value;
    }

    public int getId() {
        if (this.id == 0) {
        }
        return this.id;
    }

    public String getName() {
        return this.name;
    }

    public String getLocation() {
        return this.location;
    }

    public String getNotes() {
        return this.notes;
    }

    public String getContractDate() {
        String formattedDateString = this.dateFormat.format(this.contractDate);
        return formattedDateString;
    }

    public String getContractDate(String datePattern) throws ParseException {
        SimpleDateFormat dateFormat = new SimpleDateFormat(datePattern);
        String formattedDate = dateFormat.format(this.contractDate);

        return formattedDate;
    }

    public String getLogoFileName() {
        return this.logoName;
    }

    public boolean checkIfDeleted() {
        return this.isDeleted;
    }

    @Override
    public String toString() {
        // TO DO: Optimization, for loop (each field)
        StringBuilder resultBuilder = new StringBuilder();
        String newLine = System.getProperty("line.separator");

        if (this.getId() > 0) {
            String id = String.format("Id: %s, ", this.id);
            resultBuilder.append(id);
        }

        if (this.name != null) {
            String name = String.format("Name: %s, ", this.name);
            resultBuilder.append(name);
        }

        if (this.location != null) {
            String location = String.format("Location: %s, ", this.location);
            resultBuilder.append(location);
        }

        if (this.notes != null) {
            String notes = String.format("Notes: %s, ", this.notes);
            resultBuilder.append(notes);
        }

        if (this.contractDate != null) {
            String contractDate = String.format("ContractDate: %s, ", this.contractDate);
            resultBuilder.append(contractDate);
        }

        if (this.logoName != null) {
            String logoName = String.format("Logo File Name: %s, ", this.logoName);
            resultBuilder.append(logoName);
        }

        String isDeleted = "Is Client Deleted: " + this.isDeleted;
        resultBuilder.append(isDeleted);
        resultBuilder.append(newLine);

        return resultBuilder.toString();
    }
}

redpajama_set_name: RedPajamaGithub