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Category Archives: Progress

EFFINGHAM PROGRESS: Bus driver shortages hope to change in 2022 – Effingham Daily News

Posted: February 3, 2022 at 3:35 pm

There is an ongoing problem nowadays regarding the lack of bus drivers.

Simply put, there isn't enough of them, and, locally, Effingham is seeing the struggle of finding people to want to do it.

"We are currently short three drivers, so we don't even run one route because we use our subs for two other routes," Effingham Community Schools Transportation Director Kristin Harvey said. "Then, with sports going on this year, we also have to use subs to cover those, so when we have extra trips, you have a sub that will drive the regular route. So, I'm already using two daily every single day, and that's not including if I need three tomorrow. That would be five subs in one day, and with driver shortages, it's not an easy task."

Harvey said that the struggles have loomed large over the past year, putting her in a difficult spot.

"We were at a maximum capacity of 50 per bus, and many of our in-town routes have an easy 70 kids. So, what we ended up doing was for the five buses in town; they ended up making two loops," Harvey said. "They did their route twice. They would go K-5, take them home, and then go to the junior high and high school and take them home. It ended up being like 10 routes, but only five drivers were doing it. That was our saving grace to stay under the 50 mark. Luckily, this year, they lifted that, and we did not have to keep it under 50, but we still kept the two loops because the number of students riding was even bigger this year.

"Right now, we have 1,773 students we're busing A.M. and P.M., and typically more in the afternoon than in the morning."

She added that numerous drivers were out at different times, leaving her to try and find replacements quickly and forcing her to take different alternatives.

"We were short seven buses; we had seven drivers out at one time, so we had to combine all of those and put them on other routes and go with that and make it work," Harvey said. "It was extremely challenging having that, but our mechanic will also drive when needed. But he's doing the role of several people. He has to disinfect the buses every morning and afternoon and go through and spray all 26 buses, vans, and things like that. It's a very time-consuming process."

Why is it so difficult to find capable individuals for this profession?

Harvey said that the training to become a certified bus driver is strenuous.

Additionally, implementing the Moving Ahead for Progress in the 21st Century Act, otherwise known as MAP-21, makes the process even more challenging for a profession with enough challenges already.

"The federal government has come out with MAP-21 President Obama signed it in 2012 but it was postponed and postponed. This year, it's taking effect on Feb. 7," Harvey said. "It requires more training for CDL drivers and bus drivers, as well. We already have our drivers in an eight-hour course, and they have to get their CDL through the state. So, they still have to do all of those things, but now, on top of it, do a classroom portion, and the regional office in Vandalia will offer it. That's where we'll send people from now on."

For those who do pass the test, though, there are rewards that come with the job.

In the Effingham County School District, Harvey said that being a school bus driver may not be a full-time position, but it does offer full-time benefits.

"Even though you work only four hours a day, you can get full-time benefits," Harvey said. "But some districts don't offer those full-time benefits, so it's really hard to ask people to come and work minimum hours."

But it isn't only the benefits that come with intrigue. To Kim Knierim, it's also working with the youth.

Knierim said that she takes great pride in what she does and added that she never imagined doing it this long, saying that she doesn't truly believe that people understand the benefits you receive from it.

Knierim has been driving for 37 years.

"You talk to people, and you say, 'Come and be a bus driver?' and they say, 'No, I can't handle those kids,'" Knierim said. "They don't want kids behind them, and I think how large the bus can intimidate them sometimes. They don't think they can do that, but I didn't think I could drive a bus, either. The first time I sat in the seat of the bus, behind the wheel, I looked down the side of it, and I thought, 'I don't think I can do this,' but I love it."

Overall, it is no secret that bus drivers are necessary for any community, even with the lack of them around.

Harvey, however, hopes that trend will spike in the coming months.

One way to increase that number is to advertise just as they currently do.

Harvey said they reach out to numerous mediums to get their message across about bus drivers and why they are essential.

"We [advertise] in the newspaper, social media platforms, the regional office of education, and the City of Effingham and the Chamber came out with a platform as well that we will look to utilize."

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Black Health and Wellness: Pain, Pride and Progress – Gallup Poll

Posted: at 3:35 pm

by Camille Lloyd and Whitney DuPree

WASHINGTON, D.C. -- This Black History Month, we at the Gallup Center on Black Voices look forward to honoring the triumphs, contributions and struggles of Black people in U.S. history. As the global pandemic enters its third year, this year's focus on health and wellness provides an opportunity to honor our past, celebrate our achievements and press for progress.

Frankly, we can't talk about health and wellness without also talking about Black history -- a story of struggle, overcoming, trauma, resilience, exploitation and joy. It's a story of racial disparities in healthcare access and quality, and the involuntary sacrifices made by Henrietta Lacks and many others. At the same time, we take great pride in the numerous medical breakthroughs from Dr. Charles Richard Drew to Dr. Kizzmekia Corbett and the contributions we continue to make.

While we have made great progress, there remains much to do. Health and wellbeing are one of the key pillars of our research at the Gallup Center on Black Voices. This month, we will present our latest findings in this area, including the Black experience with the U.S. healthcare system and the state of Black Americans' health and wellbeing. We are focused on reviewing historical trends but also highlighting how current conditions can be improved.

We know that representation in the workplace benefits the work lives of Black employees, but how does representation in healthcare impact patient experiences and, by extension, patient life outcomes? And what does a lack of representation mean for Black Americans in overall health and wellbeing? We look forward to sharing our insights on those questions with you this month.

We encourage you to visit our site throughout February, where we will showcase our latest findings on Black Americans' health and wellbeing, and to subscribe to keep up with all of our ongoing research and insights on the perspectives and experiences of Black Americans.

Camille Lloyd is the Director of the Gallup Center on Black Voices.

Whitney DuPree is the Associate Director of the Gallup Center on Black Voices.

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Sarepta Therapeutics and GenEdit Share Progress on Research Collaboration and Announce Agreement to Develop Gene Editing Therapeutics for…

Posted: at 3:35 pm

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, and GenEdit, Inc., a developer of genetic medicines that leverage its NanoGalaxyTM polymer nanoparticle platform for tissue-selective delivery,today announced a research collaboration and option agreement under which the companies are employing GenEdits NanoGalaxy platform and Sareptas gene editing technology to develop gene editing therapeutics for the treatment of neuromuscular diseases. As part of the agreement, Sarepta obtains exclusive option rights to license polymer nanoparticles developed by GenEdit in the collaboration for up to four neuromuscular indications selected by Sarepta.

Initial in vivo results from the research collaboration between GenEdit and Sarepta have demonstrated the potential of GenEdits polymer nanoparticles to deliver therapeutic cargo to specific muscle tissue after systemic administration to allow for targeted, non-viral systemic delivery of genetic medicines. The research collaboration and option agreement commenced in December 2020.

Weve been impressed with the diversity of GenEdits NanoGalaxy platform and its screening and selection process, which has generated a number of distinct polymers that deliver to muscle, said Doug Ingram, president and chief executive officer, Sarepta Therapeutics. Sarepta is committed to the development of therapies for rare neuromuscular diseases, and we look forward to continuing to work with the team at GenEdit to advance effective gene editing-based treatments for these patients.

Gene editing has the potential to revolutionize the treatment of diseases caused by genetic mutations by permanently modifying the genes that lead to disease. Sarepta is pursuing a variety of approaches to genetic medicine, including gene editing, as a potentially curative treatment for rare neuromuscular diseases. GenEdit has demonstrated in preclinical studies that its NanoGalaxy platform can selectively deliver to different tissues a variety of functional genetic medicine cargos, including CRISPR-Cas9 ribonucleoprotein, for targeted in vivo gene editing.

GenEdit has demonstrated in this collaboration and in our own studies that the NanoGalaxy platform can overcome historic challenges in the field and achieve tissue-selective delivery of a broad range of genetic medicine cargos, said Kunwoo Lee, Ph.D., co-founder and chief executive officer of GenEdit. GenEdit is excited to continue to advance our collaboration with Sarepta and work together to identify and develop gene editing therapeutic candidates for neuromuscular diseases with the goal of having a tremendous impact on patients.

In addition to research payments, under the terms of the collaboration and option agreement, GenEdit may receive up to $57 million in near-term payments and is also eligible for significant future development, regulatory and commercial milestones and tiered royalties ranging from upper-single to low-double digits on future product sales. Additional financial details were not disclosed.

About GenEdit, Inc.

At GenEdit, our mission is to discover and develop innovative genetic medicines with targeted in vivo delivery. Our NanoGalaxy platform of non-viral, non-lipid polymer nanoparticles will enable a universe of opportunities to launch the next generation of safe and effective genetic medicines. To bring these medicines to patients, we are developing our own internal pipeline and delivering a wide variety of therapeutic payloads for our partners programs. For more information, please visit http://www.genedit.com and follow us on LinkedIn and Twitter.

About Sarepta Therapeutics, Inc.

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visitwww.sarepta.comor follow us onTwitter,LinkedIn,InstagramandFacebook.

Sarepta Forward-Looking Statements

This press release contains "forward-looking statements." Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the parties obligations and responsibilities under the agreement; potential payments and fees; the potential for gene editing to revolutionize the treatment of diseases caused by genetic mutations by permanently modifying the genes that lead to disease; and the potential benefits of the collaboration between Sarepta and GenEdit, including the potential of GenEdits polymer nanoparticles to deliver therapeutic cargo to specific muscle tissue after systemic administration to allow for targeted, non-viral systemic delivery of genetic medicines, Sareptas option to license polymer nanoparticles developed by GenEdit in the collaboration for up to four neuromuscular indications selected by Sarepta, the potential to advance effective gene editing-based treatments for patients with rare neuromuscular diseases, and the identification of development candidates for further testing.

These forward-looking statements involve risks and uncertainties, many of which are beyond our control. Known risk factors include, among others: the expected benefits and opportunities related to the collaboration and agreement may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development. In particular, the collaboration may not result in any viable treatments suitable for commercialization due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement; success in preclinical trials does not ensure that later clinical trials will be successful; Sarepta may not be able to execute on its business plans and goals, including meeting its expected or planned regulatory milestones and timelines, clinical development plans, and bringing its product candidates to market, due to a variety of reasons, many of which may be outside of Sareptas control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover Sareptas product candidates and the COVID-19 pandemic; even if Sareptas programs result in new commercialized products, Sarepta may not achieve the expected revenues from the sale of such products; and those risks identified under the heading Risk Factors in Sareptas most recent Annual Report on Form 10-K for the year ended December 31, 2020, and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Companys business, results of operations and the trading price of Sareptas common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.

Sarepta ContactsInvestors: Ian Estepan, iestepan@sarepta.com, +1 (617) 274-4052, Media Contact: Tracy Sorrentino, tsorrentino@sarepta.com, +1 (617) 301-8566

GenEdit ContactsCompany Contact: Kunwoo Lee, Ph.D., GenEdit, Inc., info@genedit.com, +1 (510) 766-2575Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1 (858) 344-8091

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Marking 5 decades of progress in cancer care – Urology Times

Posted: January 5, 2022 at 8:52 am

As we celebrate 50 years since the inception of Urology Times, it is important to also commemorate the 5 decades of progress in cancer care, including prostate cancer, that have occurred in parallel. In December 1971, the National Cancer Act was signed into law.1 This legislation granted sweeping authority to the director of the National Cancer Institute (NCI) and to develop a national cancer program. Importantly, that provided funding for the NCI and other research institutes with federal and nonfederal programs, funding to establish 15 new cancer research centers and local control programs, and an international cancer research data bank.2At the time, the increased funding for the NCI amounted to nearly $700 million during the first 7 years following implementation of the law.2 Today, the NCI budget stands at $6.56 billion.

The National Cancer Act also established the first NCI-designated cancer centers, which today number 71, located across 36 states and the District of Columbia.3

Importantly, the National Clinical Trials Network allows clinicians and scientists to focus scientific efforts on the understanding, prevention, detection, and treatment of a wide variety of cancers, including those affecting patients with urologic cancers.4 Because of this network, most of our patients today have access to important clinical trials that hold the hope for improvements in cancer outcomes tomorrow. Many of the trials that have advanced the care of men with prostate cancer were developed and/or administered via these mechanisms. These include advances in androgen deprivation therapy, the development of first and now second antiandrogens, androgen synthesis inhibitors, chemotherapy, radionuclides, and immunotherapy. In addition, we have seen impressive advancements in robotic surgery, radiation therapy, genetic testing, and imaging, all of which have contributed to the improved outcomes of men with prostate cancer.

The nations investment in the war against cancer that was initiated by this legislation 50 years ago has been well worth it. The death rate from cancer in the US declined by 29% from 1991 to 2017, including a 2.2% drop from 2016 to 2017, the largest single-year drop ever recorded, according to an annual statistics reporting from the American Cancer Society.5 Although the largest declines were appreciated in patients with lung cancer, prostate cancer death rates in men declined 52% from 1993 to 2017, and the impact was impressive. Additionally, consider the sheer number of cancer survivors that has grown over the years. The number of people diagnosed and living with cancer has increased from 3 million in 1971 to over 16.9 million today, and the number of cancer survivors is expected to increase to 26.1 million by 2040. Approximately 67% of todays cancer survivors were diagnosed 5 or more years ago, and about 17% of all cancer survivors were diagnosed 20 or more years ago. Nearly half (47%) of survivors are 70 years or older. Among those, 21% of these survivors are men with prostate cancer, and more than a quarter of all cancer survivors have been treated for urologic cancers.

Despite these shining examples of reductions in cancer death rates and improvements in survivors, the harsh reality remains that cancer is still the second leading cause of death in the US behind heart disease. Among our urology patients, prostate cancer remains the second leading cause of cancer deaths in men with 34,130 in 2021 alone. So as we celebrate the tremendous victories against cancer and commemorate 5 decades of progress, we are also reminded of the harsh reality that we have a war still to be won. Treatment for many patients with advanced stage cancer continues to often be ineffective, result in significant adverse effects, too expensive, and unavailable for many patients. We will look forward to the progress in cancer as we strive for a cure. And for urologists and those patients urologic cancers, we will harness the collective power of the modern-day NCI-sponsored cancer resources set in motion by the National Cancer Act 5 decades ago. As we move forward, Urology Times will be there to cover progress over the next 50 years.

References

1. National Cancer Act of 1971. National Cancer Institute. Updated February 2, 2021. Accessed December 19, 2021. https://www.cancer.gov/about-nci/overview/history/national-cancer-act-1971

2. Kalberer JT Jr, Newell GR Jr. Funding impact of the National Cancer Act and beyond. Cancer Res. 1979;39(10):4274-4284.

3. The NIH Almanac: National Cancer Institute (NCI). National Institutes of Health. Updated November 27, 2019. Accessed December 19, 2021. https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-cancer-institute-nci

4. NCTN: NCIs National Clinical Trials Network. National Cancer Institute. Updated May 29, 2019. Accessed December 19, 2021. https://www.cancer.gov/research/infrastructure/clinical-trials/nctn

5. Simon S. Facts & Figures 2020 reports largest one-year drop in cancer mortality. American Cancer Society. January 8, 2020. Accessed December 19, 2021. https://www.cancer.org/latest-news/facts-and-figures-2020.html

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Ranch group recognizes progress but skeptical of White House action plan – The Fence Post

Posted: at 8:52 am

BILLINGS, Mont. Today, the Biden-Harris Administration announced an Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain. The plan includes massive amounts of government funding intended to slowly rebuild the now dismantled competitive marketing channels for cattle and beef, which has created what the administration calls a bottleneck in the nations food supply chain.

R-CALF USA CEO Bill Bullard said the funding announced in the plan should help increase both the number of marketing channels for Americas cattle farmers and ranchers as well as distribution channels for Americas consumers.

We recognize that this level of government involvement is unprecedented, and that its critical for reversing the decades of inattention, neglect and denial that facilitated the elimination of competition in our U.S. cattle industry, he said.

But Bullard said his group remains skeptical about the plans strategy for addressing decades of nonenforcement of U.S. antitrust laws and the 100-year-old Packers and Stockyards Act.

He said his organization waited for years and by 2019 it was clear the government was disinclined to protect the cattle industry from alleged packer buying practices that R-CALF USA alleged were harming Americas cattle producers in the groups private antitrust lawsuit filed against the largest packers in April of that year.

Our nations cattle industry is in a serious crisis and while we appreciate the administrations plans to write rules with which to implement portions of the Packers and Stockyards Act, correct the exploitive Product of USA beef label, and increase market transparency by requiring more information, as well as its attempt to identify any new, potential violations of competition laws, the fact remains that the administration has not announced that it will take decisive enforcement action to protect Americas cattle producers from the harms theyve been experiencing for the past seven years, and we remain disappointed with that omission, Bullard concluded.

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Some signs of progress on Hogarth Ave. in Flint – ABC 12 News

Posted: at 8:52 am

Some signs of progress on Hogarth Ave. in Flint

FLINT, Mich. (WJRT) - Progress on Hogarth.

It's been more than a month since a deadly home explosion rocked a west Flint neighborhood.

A section of Hogarth Avenue in Flint had been blocked off by barricades since the night of the explosion because of debris lying in the road way.

This is the closest that ABC12 News has been able to get to where that horrific explosion took place Nov.22.

ABC12 News is told that on Tuesday morning, a couple bulldozers came through and cleared the debris from the roadway

So now residents no longer have to drive around, they can actually drive through on the street

It's been a long six weeks for the very few residents who now live on Hogarth Avenue in Flint.

It was six weeks ago that a home on the street exploded, destroying two other homes with it.

The explosion could be heard and felt for miles yet on Tuesday night, it is still not known as to what caused that deadly blast.

The blast claimed the lives of 3-year-old Nuveah Lucas and 55-year-old Lisa Rochowiak and injured several others.

Dozens of families were displaced just before the Thanksgiving holiday only to find out weeks later that their homes were condemned because of the amount of structural damage as a result of the blast.

Michigan Security patrolled the area for 28 days 24/7 to prevent outsiders from coming in and looting.

More recently, Premier Security took over those services.

It was just Tuesday morning that the bulldozers began clearing debris from the middle of the road.

"I took a picture. I'm like wait what is that? It was pretty exciting to hear the noise and then seeing them do something about it," said Hogarth Ave resident, Marie Copeland.

It's important to remember here that while the majority of homes on this street have been condemned, several have not so people still do live here on Hogarth.

It's been a journey to say the least for Marie Copeland.

After what happened at her home Tuesday morning, she has every reason to be smiling.

Some signs of progress on Hogarth Ave. in Flint

"I'm excited about being able to move home sometime soon," said Copeland.

ABC12 News has talked with Copeland too many times to count this last month and a half.

If there's one thing learned about Marie, is that she doesn't give up.

Phone call after phone call, email, texts, appointments, she has fought her way to get her power back on, her water back on, and finally, her natural gas.

Consumers Energy just so happened to show up while interviewing Copeland.

Now that all the utilities are back on, the real work inside can begin.

Remember, the blast broke her front living room window.

"I've got one window. I had the glass put in. That was last week and then I just have a couple windows that need to be checked out-- looks like there's some cracking around them," she said.

Copeland's home was deemed structurally sound and safe by the City of Flint.

Her repairs are mainly cosmetic with lots of cracks in the walls and also a ceiling and roof repair in her son's bedroom.

Friends, family, people she hardly even knows have all offered to help get those repairs done so Copeland can move out of her mom's house where she's been staying and back in the place she calls home.

"I don't know if there's words to tell them how grateful I am and how much I appreciate their prayers, their concerns, I'm beyond grateful," she said.

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Better Country Beyond: Progress … and then the big freeze – The West Volusia Beacon

Posted: at 8:52 am

The early years of the 1890s were indeed proud ones for the city of DeLand, and the minutes of the Old Settlers annual meetings reveal an abiding attitude of optimism.

In 1891, the group met in the home of Mrs. Killcoff on a typical New Years Day of balmy atmosphere and sunshine, as noted by Secretary Hettie Austin.

The women carried in several well-filled baskets, and all those gathered around the tables did ample justice to an elegant dinner.

New Years Day of 1892 again brought bountiful sunshine to the Old Settlers gathering, and picnic baskets overflowed once more when 50 members met at the home of John Banta. Much of the meeting time was taken up in recalling the difficulties of the early years that were in such contrast with the prosperity they now enjoyed.

The high spirits of the group continued for their 1893 gathering, as well.

At this gathering, two new families were admitted under the recent eligibility changes made to the bylaws. In other business, plowman Thomas Brinly was honored for the active part he took in assisting to develop this country in her early days.

In April of that year, a woman identified only as Miss Robinson and all the pupils in her private school took part in an innovative, two-day business carnival at the Putnam Inn. Each business in town was represented by children wearing costumes depicting the work of the business.

The residents were happily entertained by this novel presentation, and most believed that the continued upward curve in the citys prosperity would be sustained well into the future.

That same month, when the Town Council met, the mood of heightened optimism was reinforced by financial data that was presented. The citys first-ever yearly budget was considered quite sound at $5,604.

In other business conducted that day, two more health ordinances were passed: Fowl were prohibited from running loose within the city limits, and, in all places where food was sold or served, flytraps were required at the front and back doors. This former settlement of farmers and homesteaders was gradually gaining a more urbane lifestyle.

However, the seemingly unrelenting prosperity of the city would take a sudden and drastic downturn before the Old Settlers gathered for their next meeting.

The citrus industry, the engine that drove all the areas initial development in the early 1870s, remained the major force in DeLands prosperity through the early years of the 1890s.

By 1894, the orange crop alone had swelled to 146,000 boxes, and a newspaper editorial could proudly boast that oranges were 26 times as profitable as cotton.

It was said that many homes were virtually buried in a sea of orange trees.

With this perspective in mind, it is easier to comprehend how the severe back-to-back freezes that struck the area in the winter of 1894-95 could wreak the kind of economic havoc that they did.

The catastrophe was particularly ill-timed, coming just as the city was poised for a jubilant celebration of the 20th anniversary of its founding.

Orange trees, under the right conditions, are hardy and long-lived. Unfortunately, over time, as more of the overstory pine forests were cut, killing freezes took hold more easily.

By 1894, most of the areas citrus growers had experience in coping with freeze damage. Many still remembered the freeze of 1886 as particularly devastating. In fact, it was Henry DeLands losses from that disaster that led the trustees of DeLand University to seek another wealthy patron for the school in the person of the then newly arrived Philadelphia hatmaker, John B. Stetson.

Yet despite the vivid and lingering memories of that events destruction, no one could have been prepared for the level of annihilation that would occur in the winter of 1894-95 and how abruptly it would bring the mighty steamroller pace of the two-decade-long citrus craze to a crashing halt.

Ryder and her husband, Bob Wetton, live in DeLand and are active members of the West Volusia Historical Society. To order a copy of her book Better Country Beyond, call the Historical Society at 386-740-6813, or email delandhouse@msn.com.

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Bicycle Therapeutics Announces Continued Clinical Progress and Updates to Management Team – Business Wire

Posted: at 8:52 am

CAMBRIDGE, England, & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, today announced continued progress in its ongoing Phase I/II clinical trials of BT8009, BT5528 and BT7480.

Last quarter, we reported interim clinical results from ongoing trials of two of our Bicycle toxin conjugates, BT8009 and BT5528, demonstrating preliminary anti-tumor activity in two tumor types, and announced the first patient dosed in the Phase I clinical trial of BT7480, our first tumor-targeted immune cell agonist to enter the clinic. In our trial of BT8009, we are pleased to confirm the preliminary activity and see that these patients remain on trial. We look forward to presenting interim BT8009 Phase I results at a medical meeting and initiating the BT5528 expansion cohorts this year, said Kevin Lee, Ph.D., Chief Executive Officer. We are also pleased with our progress advancing BT7480 in the ongoing Phase I clinical trial and look forward to sharing additional details regarding the potential for Bicycles beyond our toxin conjugates as we strive to become a leader in the development of targeted oncology therapeutics.

Bicycle Toxin Conjugates (BTCs) BT8009 and BT5528

In the ongoing Phase I portion of the Phase I/II clinical trial of BT8009, a second-generation BTC targeting Nectin-4, four out of 11 patients were previously reported to have a partial response under Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including one out of four (25%) in the 2.5mg/m2 dose and three out of seven (43%) at the 5.0 mg/m2 cohorts. All four patients previously reported as responders have since received at least one subsequent scan, and all have been confirmed as ongoing RECIST 1.1 responses. One patient in the 5.0 mg/m2 cohort, who previously was reported to have a partial response with an 89% tumor reduction, has now received two subsequent scans, which each showed that total tumor volume has been reduced by 100%, constituting a confirmed complete response. All four patients previously reported to have a RECIST 1.1 clinical response remain on therapy. The tolerability profile of the 2.5mg/m2 and 5.0 mg/m2 cohorts remains consistent with that previously reported.

Dose escalation in the BT8009 Phase I trial remains ongoing, with patients currently being dosed at 7.5mg/m2 weekly or every-other-week. Bicycle intends to present interim Phase I results from the ongoing clinical trial at a medical meeting this year.

The Phase I/II trial of BT5528, Bicycles second-generation BTC targeting EphA2, is also ongoing, with plans remaining on track to initiate the expansion cohorts this year, with an expected recommended Phase II dose of 6.5mg/m2 every-other-week.

Bicycle tumor-targeted immune cell agonist (Bicycle TICA) BT7480

Bicycle also initiated a Phase I clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137, in the fourth quarter of 2021, and dose escalation in that trial remains ongoing. BT7480 and other Bicycle TICAs, including a novel NK-cell-engaging molecule, were the subjects of four posters at SITC in November 2021.

Management Team Updates

Bicycle is also announcing the expansion of and transition in its management team. Michael Skynner, Ph.D., the companys Chief Operating Officer (COO), has been appointed to the newly created position of Chief Technology Officer, effective January 3, 2022, to focus on leading and overseeing the growth of Bicycles proprietary phage display discovery platform in oncology, as well as on creating innovative opportunities for the platform outside of oncology. Dr. Skynner joined the company in January 2016 as Vice President, Operations and Discovery and had served as COO since March 2018. Alistair Milnes, who has served as the companys Vice President, Human Resources and Communications since January 2021, has assumed the COO role. Mr. Milnes previously led human resources and communications at multinational energy and mineral companies. Both Dr. Skynner and Mr. Milnes are based in the United Kingdom.

We are delighted to announce our recent management team appointments, with Mike Skynner becoming our new CTO and Alistair Milnes moving to the COO role. Mike has been an invaluable contributor to Bicycles success to date and has led our platform discovery efforts since joining in early 2016. Following recent promising clinical progress, we believe it is time to focus on accelerating the growth of our proprietary oncology pipeline and on identifying innovative ways to potentially capitalize on our unique technology beyond our current therapeutic focus. I am confident that Mike can help us achieve these objectives. Dr. Lee added, I am similarly enthusiastic about Alistairs appointment as COO and believe his operational experience and track record of successfully identifying, recruiting, and retaining key talent at large, multinational companies will be instrumental in helping guide Bicycle through our next phase of growth.

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the discovery, development and potential commercialization of potential product candidates using Bicycles technology; Bicycles anticipated advancement of its product candidates, including BT5528, BT8009 and BT7480; the advancement of Bicycles product candidate pipeline; anticipated design of, initiation of expansion cohorts in and progression of Bicycles clinical trials; the availability of data from clinical trials; the therapeutic potential for Bicycles in oncology and other applications; and Bicycles ability to accelerate its product pipeline and identify potentially innovative applications of its technology beyond oncology. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to clinical trial site initiation, patient enrollment and follow-up, as well as to Bicycles abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycles product candidates; the risk that Bicycle may not realize the intended benefits of its technology; availability and timing of results from clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycles product candidates; the risk that Bicycle may not be able to identify additional product candidates or additional applications of its technology; and other important factors, any of which could cause Bicycles actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled Risk Factors in Bicycles Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 4, 2021, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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Legislative topic today is education. Bottom line: progress slight over last two decades. – Arkansas Times

Posted: at 8:52 am

Legislative topic today is education. Bottom line: progress slight over last two decades. - Arkansas Times

On

The Arkansas House and Senate Education Committees are hearing this morning from the Bureau of Legislative Research on a study of the states effort in education, including what progress has been made since the landmark Lake View ruling in 2002 that the state was failing the constitutional requirement of equal and adequate education.

A mountain of information was prepared for todays meeting, to wit:

The state has made some progress in financial support for schools since Lakeview (though teacher pay has essentially flat-lined against national growth in recent years.) But the rubber meets the road on student performance. You can find an extensive look at measurements in the starting slate presentation.

Spoiler alert, the concluding slides:

The report comments:

The first decade or so after the Lake View reforms were instituted, many of the indicators Kilgore cited saw improvement. Progress on most, however, has stalled or, in some cases, declined since around 2013. When current data is compared with other states, Arkansas often ranks among the lower performing states.

Arkansas spending has improved since Lake View but hasnt kept pace with national changes. A couple of illustrations.

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Legislative topic today is education. Bottom line: progress slight over last two decades. - Arkansas Times

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‘PAUL’ IT ALL TOGETHER: Resolutions And Empty Spaces – mvprogress

Posted: at 8:52 am

By CHARLENE PAUL

The Progress

Charlene Paul

As I reflected over the past 365 days of 2021, it seems impossible that they passed so quickly. So quickly! After the chaos that was 2020, I had so many plans for 2021, and I set about writing New Years resolutions to my feet firmly planted and my mind keenly focused.

I wish I could report that I accomplished each of those resolutions made on that first day of 2021 that Im in tip-top shape, that I scanned all of my photos and papers, that I published my first book, that I am in control of my emotions, that I no longer procrastinate, that I sleep eight hours every night, that my laundry is under control, and that I check everything off my to-do list every day. But the truth is, I am still a work in progress.

In the past, that would have affected me in one of two ways: 1) I would have been a mess of depression, or 2) I would have made a list of resolutions that was twice as long as last years.

But New Year 2022 was different. I didnt beat myself up because of my inability to get everything done. It was a year of ups and downs, challenges and cheers, joys and sorrows. I know. What an understatement.

Being the mother of adult children and in-law children has taught me lessons in dealing with trials I have no control over. Watching our kids go through their challenges kept me on my knees in fervent prayer. But, unfortunately, that wasnt on my list.

Spending time in conversation with a newly-widowed friend wasnt on my list. Talking to friends and neighbors about everything under the sun also didnt make my list. Taking time to watch a sunset and enjoy the all-too-infrequent rain wasnt on my list. Spending time with grandchildren wasnt on my list. Daydreaming and scheming, crocheting and crafting werent on my list.

My husbands job as a middle school principal was stressful last year. Sometimes when he got home, he wanted to walk and talk. That wasnt on my list.

No matter what my New Years Resolutions were, life happened. And that had to be okay. Dont get me wrong, resolutions are good, and to-do lists keep me centered. But somewhere in those resolutions and lists, I need empty spaces for wiggle room when life happens.

Life is precious and unpredictable, and I dont want to miss any more of it than I already have. On my last day on earth, I hope to look back over my lists of resolutions and find I have made a difference in the lives of those I came in contact with. I want those I love to know that they are more important than anything on a to-do list.

So, heres to empty spaces in 2022.

Charlene Paul and her husband Ken raised their family in Moapa Valley. She loves reading, writing, baking, crochet, and talking. She is the owner of Look on the WRITE Side, a freelance writing and proofreading company.

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'PAUL' IT ALL TOGETHER: Resolutions And Empty Spaces - mvprogress

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