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Chasing the Long Tail of New Media
USCHO.com's Jim Connelly and Ed Trefzger host our weekly live program and podcast covering D-I men's hockey, with coaches, players, officials, and the journalists who cover the sport.
The Journal Star in Peoria, Illinois covers everything from local news to sports... and so does this podcast.
Podcast by CoxHub
While most movie reviewers focus on films out now, David and Michael Rainey decided to review movies from ten to twenty years ago. These are movies that were ignored when they were first released, didn't get the marketing push to be well known, or simply had the bad luck to be released opposite a much more popular blockbuster. It's time to give these movies a second chance.
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CMC Live - Chemistry, Manufacturing & Controls
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CMC Live - Chemistry, Manufacturing & Controls
Meranda Parascandola, Ed Narke
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing ...
The World Is Listening To DAVE RABBIT Are You? ”Dave Rabbit”, the “Godfather Of Pirate Radio”, welcomes you to "The Rabbit Zone". So Fasten Your Seat Belts, bring your seats and tray tables to their Fully Upright Position, then bend over and Kiss Your Ass Goodbye, because the “Dave Rabbit” & “Radio First Termer” Pirate Radio Experience is an Extremely Dangerous & Bumpy Ride! Everything Here Is FREE To Enjoy & Share! DAVE RABBIT LOVES JESSICA RABBIT Military EntertainmentNetwork In 2006, Dave ...
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From the Newsroom: The Journal Star
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State of Peoria: District 3 council candidates
1:48:08
1:48:08
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1:48:08
Marc Supreme of 90.7 FM and Chris Kaergard of the Journal Star talk to Gale Thetford and Tim Riggenbach. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
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State of Peoria: District 2 council candidates
1:52:36
1:52:36
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1:52:36
Marc Supreme of 90.7 FM and Chris Kaergard of the Journal Star talk to Charles Grayeb and Peter Kobak. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
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State of Peoria: District 5 council candidates
1:05:52
1:05:52
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1:05:52
Join Marc Supreme of 90.7 FM and Chris Kaergard of the Journal Star as they talk to the candidates for Peoria City Council District 5: Denis Cyr and Ryan Hite. See omnystudio.com/listener for privacy information.By Gannett
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CMC Live - Chemistry, Manufacturing & Controls
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025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll
31:51
31:51
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31:51
What We Covered 00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development 04:28 – Mike talks about his involvement in the Parenteral Drug Association (PDA) 07:51 – Lessons Mike has learned throughout his career and expounds on the relevance of PDA technical reports 15:03 …
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CMC Live - Chemistry, Manufacturing & Controls
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024 - Quality Management Systems Explained!
38:59
38:59
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38:59
What We Covered 00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS) Explained! 07:53 – The panel expounds on the timing necessary for QMS and what role the quality manual plays 13:06 – The panel explains the Code of Federal Regulations (CFRs) 17:30 – The panel defines Phase A…
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CMC Live - Chemistry, Manufacturing & Controls
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023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel
43:53
43:53
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43:53
What We Covered 00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation 07:46 – The importance of Proven Acceptable Range (PAR) and Critical Process Parameter Program (CPP) 11:14 – The evolution of the batch documentation and the value of critical parameter studies 18:07 – Registration laws …
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CMC Live - Chemistry, Manufacturing & Controls
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022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly
32:10
32:10
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32:10
What We Covered 00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation 05:41 – Shelli talks about the process of selecting a filter and why not all filters are the same 09:03 – The evolution and importance of sizing filters 11:26 – Shelli speaks to…
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From the Newsroom: The Journal Star
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State of Peoria: Mayoral candidate Jim Montelongo
1:16:19
1:16:19
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1:16:19
Chris Kaergard of the Journal Star and Marc Supreme of 90.7 FM talk to Peoria mayoral candidate Jim Montelongo. See omnystudio.com/listener for privacy information.By Gannett
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CMC Live - Chemistry, Manufacturing & Controls
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021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola
1:00:18
1:00:18
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1:00:18
What We Covered 00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) and the different starting points for drug process development 19:45 – Ed and Meranda talk about characterization, the process of manufacturing drug s…
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From the Newsroom: The Journal Star
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State of Peoria: Mayoral candidates Chama St. Louis and Andres Diaz
2:30:34
2:30:34
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2:30:34
Chris Kaergard of the Journal Star and Marc Supreme of 90.7 FM talk to Chama St. Louis and Andres Diaz, candidates for Peoria mayor. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
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State of Peoria: Mayoral candidates Rita Ali and Sid Ruckriegel
2:04:35
2:04:35
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2:04:35
Join Chris Kaergard of the Journal Star and Marc Supreme of 90.7 FM as they talk to Rita Ali and Sid Ruckriegel, candidates for Peoria mayor. See omnystudio.com/listener for privacy information.By Gannett
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CMC Live - Chemistry, Manufacturing & Controls
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020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke
48:13
48:13
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48:13
What We Covered 00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest 01:56 – Ed speaks to his extensive background in CMC and the importance he places on building relationships based on trust 11:06 – Ed expounds on his role at DSI and the impact he, Brian, Meranda and the entire DSI team are having on the …
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From the Newsroom: The Journal Star
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State of Peoria: Township Supervisor candidates
1:26:26
1:26:26
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1:26:26
Chris Kaergard of the Journal Star and Marc Supreme of 90.7 FM talk to the candidates for Peoria Township Supervisor: Frank Abdnour and Latrina Leary. See omnystudio.com/listener for privacy information.By Gannett
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CMC Live - Chemistry, Manufacturing & Controls
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019 - Complexity of Project Management in Drug Development with Paul Long
43:17
43:17
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43:17
What We Covered 00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management consultant and speaks to some of the benefits and challenges of virtual project management 17:09 – How Paul manages working with clients virtually 19:08 – Tools Paul integrates in his project management process …
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From the Newsroom: The Journal Star
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State of Peoria: District 1 council candidates
2:31:30
2:31:30
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2:31:30
Marc Supreme of 90.7 FM and Chris Kaergard of the Journal Star talk to District 1 City Council candidates Denise Moore, Aaron Chess and Denise Jackson. See omnystudio.com/listener for privacy information.By Gannett
A conversation with Peoria City Manager Patrick Urich, hosted by Chris Kaergard of the Journal Star and Marc Supreme of 90.7 FM. See omnystudio.com/listener for privacy information.By Gannett
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CMC Live - Chemistry, Manufacturing & Controls
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018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola
52:38
52:38
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52:38
What We Covered 00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok 10:11 – Ed, Brian and Meranda reflect back on their conversations with Rick Offerman, Les Mintzmyer and Dave Blasingame 19:06 – Ed, Brian and Meranda talk about a recent panel discussion th…
The Journal Star's Chris Kaergard and 90.7 FM program director Marc Supreme interview Peoria Mayor Jim Ardis about his tenure and the city's future in the inaugural episode of our new series. See omnystudio.com/listener for privacy information.By Gannett
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CMC Live - Chemistry, Manufacturing & Controls
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017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know
34:30
34:30
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34:30
What We Covered 01:03 – Ed, Brian and Meranda welcome to the show a panel of drug substance services experts, Daniel Torok, Dave Adams, Jim Mencel and David Blasingame who speak to trends they’ve observed in the landscape of API manufacturing 07:04 – The panel speaks to the types of drug manufacturing requests they’ve been seeing 14:42 – The panel …
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CMC Live - Chemistry, Manufacturing & Controls
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016 - Brexit: What You Need to Know for Drug Development
32:41
32:41
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32:41
What We Covered 00:54 – Ed, Brian and Meranda welcome to the show Amber Sheriff who speaks to her background as a regulatory affairs specialist in the pharmaceutical industry and the three procedures for obtaining market authorization in the European Union 06:15 – What CMC drug development looks like in the EU and how it differs from the United Sta…
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CMC Live - Chemistry, Manufacturing & Controls
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015 - Outsourcing in China: How far can it go?
33:40
33:40
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33:40
What We Covered 00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemist as well as the advantages and disadvantages of manufacturing drugs in China 10:20 – The importance of person in-plant activity and the White Coat Effect 11:29 – David speaks to the issues he’s experienced wi…
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CMC Live - Chemistry, Manufacturing & Controls
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Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story
49:53
49:53
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49:53
What We Covered 01:12 – Introducing a very spooky Halloween Special where Ed, Brian, Meranda and the rest of the DSI Team share stories of time spent in creepy labs and other scary situations 21:58 – Paul tells a story of working the graveyard shift at a hospital 25:06 – Valerie and Meranda share their own spooky experiences working in pharma 35:01…
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CMC Live - Chemistry, Manufacturing & Controls
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014 - Why now is the most important time for selecting a CMO
48:01
48:01
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48:01
What We Covered 01:19 – Ed, Brian and Meranda welcome to the show Dr. Rick Offerman who speaks to his experience as a process chemist, the drug development process and what goes into selecting a solvent 15:41 – The importance of selecting the right CMO partner 19:05 – Questions that must be asked in the beginning of the drug manufacturing process 2…
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CMC Live - Chemistry, Manufacturing & Controls
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013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola
41:57
41:57
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41:57
What We Covered 01:16 – Ed, Brian and Meranda take a deep dive into analyzing CMC strategy and submissions 11:26 – Ed, Brian and Meranda discuss resources required for compiling CMC dossiers and the importance of understanding roles and responsibilities within this process 20:09 – Essential aspects of putting together an effective authoring team 25…
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CMC Live - Chemistry, Manufacturing & Controls
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012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference?
44:38
44:38
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44:38
What We Covered 00:59 – Hedley Rees joins the show to share his background in the pharmaceutical industry, his thoughts on Big Pharma and issues he’s observed with medicine coming to market 09:43 – Hedley speaks to the importance of designing supply chains strategically and why your supply chain is actually your value chain 17:51 – Hedley discusses…
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CMC Live - Chemistry, Manufacturing & Controls
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011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros
41:49
41:49
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41:49
What We Covered 00:53 – Kyriakos Michailaros joins the show to share his background and expertise in the subject matter of drug product services 02:59 – Kyriakos shares his thoughts on appropriate timing for a development report, the validation process and the importance of having your development report be a living document 08:53 – Addressing risk…
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CMC Live - Chemistry, Manufacturing & Controls
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010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok
39:40
39:40
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39:40
What We Covered 00:46 – Daniel Torok joins the show to share his experience as a process chemist and collaborating with CMOs in the pharmaceutical industry 07:54 – Daniel speaks to the importance of building trust in order to become an effective in-plant person 19:59 – Daniel details best practices he utilizes for site visits 24:15 – The informatio…
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CMC Live - Chemistry, Manufacturing & Controls
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009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola
50:50
50:50
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50:50
What We Covered 00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry 5:12 – The process of filing an Investigational New Drug (IND) and a New Drug Application (NDA) 18:54 – What it means to have ‘rest-of-world awareness’ as you author an NDA 22:37 – Ed, Brian and Meranda spe…
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CMC Live - Chemistry, Manufacturing & Controls
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008 Trust the Process with a CMC Process Champion - Dave Adams
49:26
49:26
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49:26
What We Covered 01:15 – Dave Adams joins the show to discuss his experience with active pharmaceutical ingredients (APIs) and provides examples of how he’s solved problems with APIs in the past 09:41 – What Dave looks for in a comprehensive, well thought out development program and how he works and interacts with process engineers 15:02 – Dave prov…
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CMC Live - Chemistry, Manufacturing & Controls
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007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer
45:49
45:49
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45:49
What We Covered 01:32 – Les Mintzmyer joins the show to discuss his background in biologics manufacturing, speak to CMO selection, and break down the RFP process 08:14 – Les speaks to the criteria he uses to identify the best CMO to work with and the importance of timely correspondence 18:59 – Lessons Les has gleaned from the RFP process throughout…
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CMC Live - Chemistry, Manufacturing & Controls
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006 Analytical Method Development - Colman Byrne
50:05
50:05
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What We Covered 00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analytical method development and validation 10:27 – Colman’s recommendations for method development and validation plans 15:04 – Colman speaks to the commonality of changing methods mid-stream 22:01 – Regulatory par…
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CMC Live - Chemistry, Manufacturing & Controls
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005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard
35:21
35:21
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35:21
What We Covered 03:00 – Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical industry 07:35 – Dr. Catherine speaks to some of the challenges associated with preparing a CMC dossier 10:38 – Dr. Catherine speaks to the vital role project management plays in submissions and explains realistic t…
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CMC Live - Chemistry, Manufacturing & Controls
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004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan
33:15
33:15
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What We Covered 02:08 – Bettina Kaplan joins the show to discuss her background in quality assurance, compliance and auditing within the pharmaceutical industry 09:43 – Trends in quality auditing that Bettina observed before the shutdown and strategies to ensure a successful audit 12:48 – Bettina expounds on when it’s appropriate to have an expert,…
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CMC Live - Chemistry, Manufacturing & Controls
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003 Effective Strategies for Early Stage Drug Development - Judy Magruder
28:41
28:41
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28:41
What We Covered 02:10 – Judy Magruder joins the show to discuss her background in early stage drug development and best practices for creating integrated product plans 06:21 – Judy provides her insights on CMC and the importance of identifying effective ways of executing strategy shifts in this ever-changing industry 13:09 – Other communication too…
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CMC Live - Chemistry, Manufacturing & Controls
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002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel
35:16
35:16
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35:16
What We Covered 00:54 – James continues his discussion of expedited drug development programs, focusing on the importance of establishing regulatory starting materials 07:34 – James provides best practices for working with clients who don’t want to approach the FDA proactively and curating fallback plans 11:45 – James speaks to strategies for estab…
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CMC Live - Chemistry, Manufacturing & Controls
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001 Expedited Drug Development - James Mencel
18:51
18:51
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What We Covered 00:23 – James discusses regulations and the importance of starting with big ideas when it comes to expedited drug development programs 05:44 – Breakthrough designations that occur as a result of expedited drug development programs 08:20 – When a sponsor should consider applying for expedited drug development 11:14 – James speaks to …
Enjoying the show? Please leave us a rating and review at http://ratethispodcast.com/cmcliveBy Ed Narke, Brian Lihou, Meranda Parascandola
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From the Newsroom: The Journal Star
1
Election 2020: Peoria County State's Attorney candidate Jodi Hoos
30:17
30:17
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30:17
Jodi Hoos, a former judge and incumbent candidate for Peoria County State's Attorney, speaks to the Journal Star editorial board about her campaign and proposals. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
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Election 2020: Chris McCall, Peoria County State's Attorney candidate
29:05
29:05
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29:05
Peoria trial lawyer Chris McCall, candidate for Peoria County State's Attorney, speaks to the Journal Star editorial board about his campaign and proposals. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
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Election 2020: Rachael Parker, Peoria County Clerk candidate
21:53
21:53
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21:53
Rachael Parker, incumbent candidate for Peoria County Clerk, speaks to the Journal Star editorial board about her campaign and proposals. Parker was appointed in August to succeed Steve Sonnemaker, who died in June. Her appointment lasts through Dec. 1, 2020, and her candidacy is for the Democratic nomination to fill the remaining two years of the …
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From the Newsroom: The Journal Star
1
Election 2020: Gabe McLeod, Peoria County Clerk candidate
22:29
22:29
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22:29
Gabe McLeod, candidate for Peoria County Clerk, speaks to the Journal Star editorial board about his campaign and proposals. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
1
Election 2020: Anni Reinking, PPS Board District 3 candidate
32:18
32:18
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32:18
Journal Star executive editor Dennis Anderson and associate editor Chris Kaergard interview Peoria Public Schools Board District 3 candidate Anni Reinking. See omnystudio.com/listener for privacy information.By Gannett
Journal Star crime reporter Andy Kravetz discusses Peoria's recent, record-setting spate of deadly violence with Urban Acres owner Andy Diaz, New Millenium Institute founder Agbara Bryson and community organizer Chama St. Louis. The City of Peoria recently set a new modern-day record of 25 homicides in one calendar year, surpassing the previous rec…
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From the Newsroom: The Journal Star
1
Peoria Music Lady Edith Barnard and 'It's A Wonderful Life'
11:19
11:19
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11:19
Edith Barnard of peoriamusiclady.com chats with the Journal Star's Chris Kaergard about the upcoming screening of the Christmas classic "It's A Wonderful Life" at the Apollo Theater and the the popular singalong before the show. The movie airs at 2:30 p.m., Sunday, Dec. 15 at the theater, 311 Main Street, in Downtown Peoria. See omnystudio.com/list…
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From the Newsroom: The Journal Star
1
Comings and goings at the Peoria Riverfront Museum
24:15
24:15
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24:15
Executive editor Dennis Anderson talks with Peoria Riverfront Museum chief curator Bill Conger and president & CEO John Morris about some exhibits leaving soon and new ones to come. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
1
Emily Cahill and Brent Wheeler of the Peoria Park District
31:09
31:09
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31:09
Peoria Park District Executive Director Emily Cahill and Deputy Director Brent Wheeler join the Journal Star's Chris Kaergard and Nick Vlahos to discuss what's new for Peoria's parks and possible plans for the future. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
1
The Big Picture with Doug and Eileen Leunig
21:53
21:53
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21:53
Peoria artists Doug and Eileen Leunig chat with the Journal Star's Chris Kaergard about the upcoming Big Picture Peoria street festival on Oct. 12, 2019 in Peoria's Warehouse District. The festival will feature chalk artists, live music, an open-mic competition and much more, with funds raised going towards arts education at after-school programs a…
Recent data shows that violent crime in Peoria has increased, but more-common property crime is on the decline. Reporter Andy Kravetz talks to Peoria Police Chief Loren Marion about the trends. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
1
Activists push for reform of the cash bond system
37:03
37:03
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37:03
Community activists Ryan Hidden of Change Peoria, Chama St. Louis of the Black Justice Project and Peter Kobak join the Journal Star's Andy Kravetz discuss reforming the current cash bond system for criminal arrests. See omnystudio.com/listener for privacy information.By Gannett
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From the Newsroom: The Journal Star
1
From the Newsroom: Illinois Comptroller Susana Mendoza
18:19
18:19
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18:19
State Comptroller Susana Mendoza joins the Journal Star's Chris Kaergard to discuss issues with the state's finances in light of the recent tax legislation and state budget signed by Gov. Pritzker. See omnystudio.com/listener for privacy information.By Gannett
