show episodes
 
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.
 
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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show series
 
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 …
 
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…
 
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 …
 
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…
 
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…
 
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 …
 
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 …
 
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…
 
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 …
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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,…
 
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…
 
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…
 
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 …
 
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 …
 
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…
 
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…
 
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…
 
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