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Being a trader takes confidence. In the markets, in your strategy, in your self – in having the confidence to execute that trade. In this unique series, we talk to the experts in their own fields to uncover what gives them the confidence to succeed. We also look at the dangers of overconfidence, and ways in which top performers keep their egos in check. Join us as we uncover confidence and unlock the secrets behind resilience, preparation, determination and growth - and how it can make you a ...
 
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 ...
 
What every business needs to survive and to grow are new clients. In the B2B world, new clients equal generating highly qualified sweet leads. Well, for BizzBee Solutions, the way to that was via outreach. Dancho Dimkov, MBA, CMC, CEO of BizzBee Solutions, author of "Sweet Leads" and BizzBee's Outreach COO - Natasha Razmoska reveal all their outreach knowledge and experience to this podcast's host Vera Eftimovska, MA, and BizzBee's Content COO. It's a dream team with tons of valuable insight ...
 
Merideth Bisiker, Certified Money Coach (CMC)® and mentor to entrepreneurs brings you industry experts who inspire you to find success in your business and in life on your own terms. These are powerful conversations that provide you with inspiring stories and strategies to rise above the mediocre and struggle you're facing now so you can finally live a life you love. Merideth and her guests inspire you to feel good about wanting to make money in your business so that you can make a bigger im ...
 
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show series
 
In the 4th episode of the BizzBee podcast, "Sweet Leads, Dancho, Natasha and Vera discuss about: 1. From which services you can expect countless sweet leads? 2. Which services shouldn't even bother with outreach? 3. What you can do if you feel under the impression that outreach couldn't possibly work for you Check out Dancho's latest book on B2B pr…
 
In the 3rd episode of the BizzBee podcast, "Sweet Leads, Dancho, Natasha and Vera set the bar straight on what are warm leads. Or, as we like to call them - sweet leads. If someone schedules a meeting, can we hall them a sweet lead? Not every outreach campaign goal is to schedule a meeting. Are sweet leads relevant in this context? What do sweet le…
 
In the 2nd episode of the BizzBee podcast, "Sweet Leads, Dancho, Natasha and Vera talk on numerous topics: 1. Why should one decide on prospecting or outbound growth? 2. The difference between inbound and outbound 3. Why paid ads don't work? 4. Who does it work best for? 5. Is their ego/credibility affected when they do outreach? 6. Isn't it spammi…
 
The first episode of the BizzBee podcast "Sweet Leads" is out for the world to see. Or, to listen to is, in this case. The stars of the show? We swear by the B2B Outreach Bible, "Sweet Leads", you'll be in great company. 1. Dancho Dimkov, MBA, CMC, CEO of BizzBee Solutions, author of "Sweet Leads" 2. Natasha Razmoska, BizzBee's Outreach COO 3. Vera…
 
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 …
 
Join us for the part 2 round table discussion, where we chat with our three CEOs Tim Fung (CEO of Airtasker), Oleg Vornik (CEO of DroneShield) and Drew Bilbe (CEO of Nexba). We walk through their start up journeys, company fundamentals, company culture, missions and how resilience, determination and an unshakeable sense of purpose contributed to th…
 
Join us as Michael McCarthy sits down with three CEOs who each turned ideas into empires, disrupting the industries they work within along the way. In this episode, we talk to Tim Fung - CEO of Airtasker on creating an outsourced service marketplace, Drew Bilbe - CEO of Nexba and his battle against the Coca-Cola giants with healthy beverage options…
 
Join us as CMC Markets UK Chief Market Analyst, Michael Hewson chats to Mouhammed Choukeir – the Deputy CEO and Chief Investment Officer at Kleinwort Hambros. In the first UK-based Artful Trader episode, Michael and Mouhammed discuss the benefits of consistency and using an evidence-based approach to drive results when trading or investing – regard…
 
Denise Shull leverages neuropsychoanalyst and her own experience at the New York Stock Exchange to solve the challenges of mental mistakes, confidence crisis and slumps for Olympic athletes, Wall Street traders and corporate titans. The character, Wendy Rhoades, from US Showtime Billions is based on Denise. We chat to Denise on understanding the ‘h…
 
Join us as we talk to Harry, Associate Professor and Chancellor's Excellence Scholar in Statistics Rutgers University USA, who specialises in probability, statistics, logic, and the foundations of complex data analysis. Harry also talks about both the mathematical side and the emotional side of any probabilistic situation, revealing how intuition i…
 
Host Michael McCarthy sits down with Australian tennis legend Pat Rafter, the serve and volley champion. Rafter wrapped up a career in professional tennis as the only Australian athlete with back to back US Open men’s titles. In this interview, Pat talks about his journey to success in overcoming losses, navigating overconfidence and the mental sta…
 
Two renowned traders come together in this unique episode of the Artful Trader – Dave Floyd (founder of Aspen Trading) and John Netto (founder of Netto Number). Although the two have a wildly different approach to trading, there are some surprising similarities; both Dave and John attribute their success to preparation, sticking to a trading strate…
 
Sara Laamanen coaches trading experts and executive CEOs using world-renowned Rapid Transformational Therapy (RTT). Sara unlocks the subconscious minds of her clients to reclaim lost confidence by unpicking the root causes of low self-esteem and helping traders to manage the relationship between emotions and its impact on behaviour. Host Michael Mc…
 
Being a trader takes confidence. In the markets, in your strategy, in your self – in having the confidence to execute that trade. In this unique series, we talk to the experts in their own fields to uncover what gives them the confidence to succeed. We also look at the dangers of overconfidence, and ways in which top performers keep their egos in c…
 
If anyone was born to trade it’s John Netto, a cross-asset class trader and author of The Global Macro Edge. In high school he provided the ‘liquidity’ for sports betting. In the Marines he learnt discipline. On the markets, he discovered his super power - versatility. That’s why he’s called the Protean trader. John talks to the Artful Trader about…
 
Jake Bernstein built his impressive trading career in the Futures market. Over five decades of trading, he’s lived through it all, the booms, the crashes, but always sticking to a strict set of rules and methodologies. Jake was an early adopter of new technology, asking a former college roommate to build him a computer program that could forecast p…
 
Having grown up on a petrol station, Anas Alhajji feels homesick when he smells gasoline. Now he’s one of the most sought-after energy economists and commentators on the oil markets. Anas Alhajji talks to the Artful Trader about the geo-political events that affect oil prices. Will US sanctions be able to stop Iran from exporting oil and are we hea…
 
As a champion ex-poker player, Annie Duke turned decision making into an art form. With a background in cognitive psychology, the card table became Annie Duke’s real-time lab where she could study uncertainty, recognise cognitive bias and also win a few million. Annie talks to The Artful Trader about her new book, “Thinking In Bets: Making Smarter …
 
Will medical marijuana be the next bitcoin? In this episode - why green is the new black - James Helliwell explains with forensic detail how he profited early by investing in the hardware around medical marijuana. He also talks about how he was able to remove himself from the herd and see the potential and the pitfalls of Bitcoin. As Chief Investme…
 
In trading and markets, pain is a great teacher. So what does it feel like to lose everything? To bring down a two-centuries old Merchant bank? The Artful Trader’s Michael McCarthy sat down with Nick Leeson, the original rogue trader, whose unchecked risk taking caused the collapse of Barings Bank in the biggest financial scandal of the 20th Centur…
 
20 years ago, computers were being introduced at the Australian Stock Exchange, as the transition from paper slips to digital transactions revolutionised the trading floor.The manager of Equity Derivatives Sales at the Australian Stock Exchange in Sydney, Graham O’Brien, witnessed the transformation of the trading world, and the risks and rewards t…
 
How are emotions involved in the decision making process of a trader? Do traders set aside their emotions or analyse them to make better decisions? Dr Brett Steenbarger is a psychologist and a performance coach who counsels traders and hedge fund portfolio managers in the US, Europe and Asia. He wrote the first definitive book on The Psychology of …
 
Why do some global disasters barely cause a ripple on the markets while a small blip can cause them crashing? How dependent are the markets on the 24 hour media cycle? Who better to ask than Ticky Fullerton, one of Australia’s top business journalists and the host of the daily business finance news report on Sky News Business channel called ‘Ticky’…
 
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