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Articles by Jack Bacon
The FDA Quality Management System Regulation and the limits of harmonisation: Building a global QMS around a common core
1. LOGIN Log in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts. Renew your TOPRA membership for 2026 here. If you are not a TOPRA member but have already created an account to access limited free content, log in here using your registered user email and password.
China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
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An accidental profession: Finding your path in medical device regulatory affairs
1. LOGIN Log in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts. Renew your TOPRA membership for 2026 here. If you are not a TOPRA member but have already created an account to access limited free content, log in here using your registered user email and password.
Prospective multicenter study of ctDNA versus tumor tissue guiding FGFR-targeted therapy in metastatic urothelial cancer - Nature Communications
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Abstract Fibroblast growth factor receptor (FGFR) alterations are targetable in metastatic urothelial carcinoma (mUC). Identifying FGFR alterations currently requires tissue testing, which is limited by sample availability and cancer heterogeneity. Plasma circulating tumor DNA (ctDNA) offers a complementary testing strategy, but the added value of ctDNA relative to conventional FGFR alteration assessment remains unclear.
By David Muller, David Müller, Andrew Murtha, Jack Bacon, Maria Stephenson, Connor Wells Verified, Carlos Vasquez-Rios, Kimia Rostin, Lisa Rebane, Jussi Nikkola, Nimira Alimohamed, Naveen S. Basappa, Daygen L. Finch, Jenny J. Ko, Jean-Michel Lavoie, Lucia Nappi, Krista Noonan, Michael Ong, Guliz Ozgun, Sunil Parimi, Maryam Soleimani, Srikala S. Sridhar, Paul Toren, Eric Winquist, Cecily Q. Bernales, Emily Fung, Laiba Khan, Dalia Othman, Tarek A. Bismar, Gang Wang, Andreas Papadakis, Alan Spatz, Christian Kollmannsberger, Matti Annala, Kim N. Chi, Gillian Vandekerkhove, Bernhard J. Eigl, Elena Schönlau, Melissa Koudjanian, Jaskirat Atwal, Bryndan Eigl, Reem Merza, Corinne Maurice-Dror
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Nature
Verified
Stevens, Dakin Named to Watch Lists
IOWA CITY, Iowa – University of Iowa sophomore punter Rhys Dakin has been named to the 2025 Ray Guy Award Watch List, while senior place-kicker Drew Stevens has been named to the Lou Groza Award Watch List. The announcements were made Friday by the Augusta Sports Council and Palm Beach County Sports Commission. The Ray Guy Award is presented to the nation’s top collegiate punter, while the Lou Groza Award goes to the country’s best place kicker.
Dunker Named to Wuerffel Award Watch List
Football IOWA CITY, Iowa -- University of Iowa senior offensive tackle Gennings Dunker has been named to the 2025 Allstate Wuerffel Trophy Watch List, the Wuerffel Foundation announced Thursday. Dunker (6-foot-5, 315 pounds) started 11 contests as a junior and was a dominant force on the right side of Iowa’s offensive line that was recognized as a semifinalist for the Joe Moore Award in 2024.
3 Hawkeyes Named To Watch Lists
Football Three University of Iowa football players were named to preseason watch lists, the Football Writers Association of America announced on Tuesday. IOWA CITY, Iowa -- Three University of Iowa football players were named to preseason watch lists, the Football Writers Association of America (FWAA) announced on Tuesday. Senior Aaron Graves was named to the 2025 Bronko Nagurski Trophy Watch List for the national defensive player of the year.
Enneking is a United Soccer Coaches Player to Watch
IOWA CITY, Iowa - University of Iowa graduate student Macy Enneking was named a United Soccer Coaches Player to Watch on Tuesday, the organization announced on Monday. Enneking is the first Hawkeye player to earn this preseason distinction. "For a goalkeeper, there is no place to hide," said Assistant Coach J.P Valadares. "Macy has proven to be a winner. With hard work, she has consistently developed every area of her game.
Higgins Named to Wuerffel Award Watch List
IOWA CITY, Iowa - University of Iowa senior linebacker Jay Higgins has been named to the 2024 Allstate Wuerffel Trophy Watch List, the Wuerffel Foundation announced Thursday. Higgins (6-foot-2, 232-pounds) recorded 171 tackles (79 solo, 92 assists) during the 2023 season, which led the Big Ten and ranked third nationally. The total tied the program record for tackles in a single season.
B1G Life in Iowa
By JACK BACON hawkeyesports.com IOWA CITY, Iowa — University of Iowa student-athletes joined peers from 15 other Big Ten schools on June 26 at Kroul Farms in Mount Vernon, Iowa, as part of the Big Life Agricultural Experience. Participating Hawkeye athletes included football players Kenneth Merriweather, Kamari Moulton, Zach Twedt and Rhys Dakin, as well as gymnast Gianna Masella. “I was chosen because I am from a city,” said Moulton, who plays running back and is from Fort Lauderdale, Florida.
Berit Parten
By Jack Bacon via University of Iowa Athletics, Bio High School - Career totals 151 goals and 79 assists (381 points) at Minnehaha Academy... averaged at least 2.4 goals per game and at least 1.2 assists per game during final three seasons of high school... Ms. Soccer Class A, first team all-state and Pioneer Press Player of the year as a senior... three-time first team all-state honoree... four-time IMAC All-Conference...
Berkely Binggeli
Bio High School - Four-time All-Region selection at Wasatch High School... Academic All-State Champion... State of Utah Scholar Athlete honoree... Led Wasatch to four state tournament appearances... totaled 39 goals and 28 assists (106 points) during high school career... played five seasons for La Roca FC ENCL, winning the 2021 USYS National Championship and advancing to the ECNL playoffs Round of 16 the following season... National Honors Society members... four-time Rotary Club Honors...
Keira Billis
By Jack Bacon via University of Iowa Athletics, Bio High School - Played five seasons with National Girls Academy, including three seasons as team captain... two-time GA National Talent ID invitee... three-time GA Mid-America Talent ID participant... attended 2022 USYNT Regional Camp... holds Oxford High School girls golf records for 18-hole and nine-hole rounds... six high school letters for golf and basketball... four-year Scholar Athlete honoree...
Abby Warner
Bio High School - Three-time first team all-state, all-conference and all-district recognition playing for Pella High School... state all-tournament team as a junior... surpassed 100 career goals as a junior... Iowa Class 2A third-place team finish in 2023... Girls Academy Mid-American Talent ID selection... Drake Relays qualifier in the sprint medley and 4x100m. Personal - Parents are Rob and Candace Warner... father, Rob, played football at Central College...
Callie Levin
HIGH SCHOOL 19.4 PPG, 4.8 RPG, 4.0 APG, 4.0 SPG, 0.6 BPG; 1391 points through three seasons.
Ava Heiden
By Jack Bacon HIGH SCHOOL No. 36 overall prospect (ESPN.com) Four-star prospect, averaging 17.2 points, 11.3 rebounds, 4.0 steals, 3.0 assists, and 2.8 blocks. 2x Academic All-State, 2x 6A Pacific Conference First Team, 6A Pacific Conference Player of the Year, 2x All-State Second Team, 6A Pacific Conference DPOY. No. 5 post prospect (ESPN.com) Program's first Oregonian
Taylor Stremlow
By Jack Bacon HIGH SCHOOL No. 88 overall prospect (ESPN.com) Junior year: Big 8 Conference Player of the Year, First Team All-Conference, First Team All-Area, WBCA All-State First Team, AP Wisconsin All-State Second Team Averaged 16.1 PPG, 10 RPG, 9 AST, 7 STL, 0.9 BLK in her junior season WBCA Academic All-State and National Honors Society.
Teagan Mallengi
By Jack Bacon HIGH SCHOOL No. 64 overall prospect (ESPN.com) 2x First Team All-Conference, 2x Rock Valley Player of the Year, 2x First Team All-State, 2x Team MVP, 2x Team Captain. School records held at McFarland HS; all-time points, most points in a season, most points in a game (62), tied most three's in a game (9), second most rebounds in a game (19). No. 2 player in Wisconsin in 2024 (PrepGirlsHoop.com) PERSONAL Parents played sports at UW-Whitewater.
Aaliyah Guyton
HIGH SCHOOL No. 57 overall prospect (ESPN.com) Four-star prospect, averaging 21.6 points, 4.6 rebounds and 3.8 assists during her junior season. 2x First Team IBCA, 2x First Team All-Big 12 Conference, 2x All-Big 12 POY, 2x First Team All-Area. No. 1 player in Illinois in 2024 (PrepGirlsHoop.com) PERSONAL Mother played basketball for 25 years with the Brazilian National Team and was a Phoenix Mercury. Father played basketball at Indiana, professionally overseas, and the Chicago Bulls.
Sean Sullivan
Sullivan served as the director of player personnel, development, and recruiting operations at North Carolina for two seasons. In June of 2023, his title was updated to reflect his added role as an assistant coach for the Tar Heels in his third year with the program. Prior to North Carolina, Sullivan was the director of video for the women's basketball program at Pitt for two seasons.
Lacasse Makes Canadian National Team
By Jack Bacon via University of Iowa Athletics, OTTAWA, CANADA - University of Iowa graduate Cloé Lacasse ('14) was named to the Canadian women's national team on Monday. Lacasse will compete at the 2024 Paris Olympics from July 25 to Aug. 10. The Ontario, native, becomes the first Iowa women's soccer product to compete at Olympics. "Congratulations to Cloe on a monumental achievement," said Head Coach Dave DiIanni .
Madison Wilson
Bio Dayton - Played in all 20 matches for the Flyers in 2023, making 18 starts and logging 1,325 minutes... led Dayton with 16 points on the season... career bests for goals (6) and assists (4)... scored three game-winning goals... logged 1,325 minutes on the season... redshirt season as a junior... started in three of the 16 games played as a sophomore (522 minutes)... three assists and three points that season on 11 shots (6 SOG)...
University of Iowa Women's Soccer Team Adds Three Transfer Student-Athletes for Championship Drive
By Jack Bacon via University of Iowa Athletics, IOWA CITY, Iowa - The University of Iowa women's soccer team has signed three more transfer student-athletes since the end of April. Iowa announced the signing of utility player Lauren Geczik on April 29, followed by defender Alexia Griffin on May 9 and midfielder Madison Wilson on June 6. The trio joins newcomer Maya Hansen , as well as six incoming freshmen from the Class of 2028.
Alexia Griffin
Bio Southern Miss - Started 18 games a sophomore for 1,439 minutes... scored one goal against Troy on Sept. 21, 2023... totaled five shots offensively... appeared in all 16 games as a freshman, starting in 13...played 1,193 minutes...registered four shots on the year. High School - Prepped at Arnold High School... team was a state finalist... also lettered in basketball... earned First Team All-County and All-District honors in basketball...
Hawkeyes Headed to Iceland
By Jack Bacon via University of Iowa Athletics, IOWA CITY, Iowa - University of Iowa Soccer travels to Iceland from May 12-22 to compete in exhibition matches against Valur and Breiðablik professional clubs. Each opponent plays in the Úrvalsdeild kvenna, the top-tier women's football league in Iceland. The clubs have won a combined 28 Icelanic Championships and 25 Icelandic Cups.
Lauren Geczik
By Jack Bacon via University of Iowa Athletics, Bio Texas A&M - Played 39 games, including 29 starts, for a total of 2,674 career minutes... tallied 13 points on four goals and five assists for the Aggies... CoSIDA Academic All District in 2021... Fall SEC Academic Honor Roll (2021) and SEC First-Year Academic Honor Roll (2020-21)... recognized as Most Improved Player for Texas A&M in 2021... earned team "Farmer's Fight" Perseverance Award in 2021... SEC Freshman of the Week (10/26/20)...
Jessica Amoruso
Athletic trainer Jessica Amoruso joined the University of Iowa Athletic Training Staff in February 2024. Amoruso works with the women's soccer program as an outreach athletic trainer through UI Sports Medicine. Amoruso graduated from Florida State University with a Bachelor of Science in Athletic Training in 2019. Her graduate assistantship at the University of Southern Mississippi followed, where she provided athletic training services for the softball and football teams.
Hawkeye Home Game Challenge
By JACK BACON hawkeyesports.com IOWA CITY, Iowa — Barbara Thomas and Margaret Adams are two Iowa City residents on a mission: attend at least one home event for each University of Iowa athletics program during the 2023-24 academic year. “I have lived in Iowa City for four decades, but I had never been to men’s wrestling,” says Adams. “I am sure everyone will be aghast at that, but part of it is time, even when you follow the team and live here.
Iowa Ties at Michigan, 1-1
By Jack Bacon via University of Iowa Athletics, ANN ARBOR, Mich. - The University of Iowa women's soccer team tied, 1-1, against Michigan on Thursday night at U-M Soccer Stadium. Iowa moves to 9-3-4 and 3-3-3 in Big Ten play heading into Sunday's regular season finale. Despite downpouring rain, the Hawkeyes created offensive opportunities, finishing with a 13-8 advantage in shots and a 5-1 margin in shots on... Read more on Publisher's website
The Dog Days of Summer
By JACK BACON hawkeyesports.com IOWA CITY, Iowa — In life, as in sport, many great stories begin with one person and a vision. One of the best stories of the University of Iowa football team’s offseason started with an idea, not for a new trick play or defensive scheme, but for a promotion. Courtney Ralph, a volunteer coordinator at Safe Haven of Iowa County Animal Shelter, wanted to up her Hawkeye football player-to-dog ratio.
Somatic Features of Response and Relapse in Non-muscle-invasive Bladder Cancer Treated with Bacillus Calmette-Guérin Immunotherapy
1. Introduction Non–muscle-invasive bladder cancer (NMIBC) is a heterogeneous disease that accounts for 75% of bladder cancer diagnoses. After transurethral resection (TUR) of the tumour(s), patients with high-risk NMIBC typically receive intravesical bacillus Calmette-Guérin (BCG) therapy.
Gallery: NPA boys, girls lose to Sedona Red Rock at home
Gallery: NPA boys, girls lose to Sedona Red Rock at home The Northland Prep boys and girls basketball teams each lost to rival Sedona Red Rock at home Tuesday night at home. NPA versus Sedona Red Rock Northland Prep's Malakai Hanson (2) takes a jumper against a contest Tuesday night at home. Lance Hartzler, Arizona Daily Sun Northland Prep Sedona Northland Prep's Mia Blair (14) drives against Sedona Red Rock Tuesday night at home.
Iowa Football Notebook: Oliver Martin Delivers, Injury Report
Solid Under Center First thing’s first: Iowa’s biggest question mark heading into the season opener is answered. Solon grad Tyler Linderbaum is ready to play center for the Hawkeyes. The former linebacker made the switch to center over the offseason, filling the hole left by Keegan Render. Though undersized and inexperienced, consistent praise from the Iowa coaching staff had fans cautiously optimistic. Now that optimism appears justified.
Media Day Notes: Receiver Nico Ragaini Rising
IOWA CITY, Iowa – On a media day relatively light on news, Kirk Ferentz did confirm something that many Iowa fans suspected: last minute spring-ball entry Nico Ragaini will replace Nick Easley as the Hawkeye’s starting slot receiver. Ragaini didn’t receive the division one offers he was looking for out of high school, and spent last fall at preparatory school. Then, late in the middle of his second semester, he got the call from Iowa quarterbacks coach Ken O’Keefe.
Fate put Jose Fajardo in charge of City High soccer
HS journalism: Injuries prevented him from starring in Spain, but sport stayed in his blood Iowa City High head coach Jose Michel Fajardo talks to his players after the Little Hawks lost to West Des Moines Valley in the 2016 Class 3A state championship game at the Cownie Soccer Complex in Des Moines. (The Gazette) By Jack Bacon, City High senior IOWA CITY — Fate has a funny way of surprising people. Just ask City High boys’ soccer coach Jose Fajardo.
John Raffensperger was a legend among City High greats
HS journalism: Funeral for former track coach is today John Raffensperger, who has coached City High to 10 boys’ state titles, died last week and his funeral is today. (The Gazette) By Jack Bacon, City High senior IOWA CITY — City High has lost a legend. “There are many, many things that I will remember about Coach Raff,” said athletics director Terry Coleman. At a school famous for outstanding coaching talent, Coach John Raffensperger left as indelible a mark as any.
Philip Hansen Named Next Athletic Director
Philip Hansen will take over as City High's next A.D. on July 1, 2019. Philip Hansen will take over as City High's next A.D. on July 1, 2019. Philip Hansen will take over as City High's next A.D. on July 1, 2019. Jack Bacon, Reporter March 8, 2019 Filed under NEWS, SHOWCASE, SPORTS Send email to this address Enter Your Name Add a comment here Verification Current math teacher Philip Hansen has been named City High’s next Athletic Director.
“Clutch” Shooting Sends City to State Championship Game
Joens went 8-12 in the victory to score 24 points and break the state tournament scoring record . Joens went 8-12 in the victory to score 24 points and break the state tournament scoring record . Hang on for a minute...we're trying to find some more stories you might like.
One Rizla, by shame
Includes unlimited streaming via the free Bandcamp app, plus high-quality download in MP3, FLAC and more. Shame's debut full-length 'Songs of Praise' on CD in 6-panel wallet. Includes digital pre-order of Songs of Praise. You get 2 tracks now (streaming via the free Bandcamp app and also available as a high-quality download in MP3, FLAC and more), plus the complete album the moment it’s released. item ships out on or around Shame's debut full-length 'Songs of Praise' on sky blue vinyl.
Zach Jones Breaks Single Season Receptions Record
If Zach Jones’ senior season was a proclamation of prodigy to the football world, then Friday night was the exclamation point. Jones, who has a scholarship offer from Minnesota State and has piqued the interest of division one schools, capped of a stellar season with record a breaking performance and a game changing one-handed catch. Jones finished the regular season as one of only two receivers in the state with over 1,000 total receiving yards.
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