Modern BioPharma Podcast

When a new facility needs to be designed, built, and started up...there is a lot to consider. And a number of ways to approach it.  

Today I speak with Josh Miksch from CRB about their ONEsolution approach to delivering a facility in the Pharmaceutical space.  

From the CRB website: "ONEsolution™ is a revolutionary integrated project delivery method that leverages the combined expertise and technical excellence of ONE project team to deliver your facility in a safe, lean and collaborative way. ONEsolution™ aligns stakeholders on quality, cost and schedule, providing you with everything you need from initial planning through operational readiness. You know the old saying. “Cost, quality, or schedule. You can only pick two.” We’re throwing that out the window and disrupting the current state of the construction industry."  

It was pretty exciting to be able to do our FIRST "Live" podcast. Given my newness to this space...I have a challenge for you...see if you can spot the 2 points I had to edit the video. We had a couple of technical difficulties, but we made it through.  Josh was a great guest. Great to get to see him and his new office post COVID lockdown.  

Have any questions about the ONEsolution approach? Ask them here on our LInkedIn post here.  I'll see if I can get Josh to say hi and answer them :)  

https://www.linkedin.com/in/talktojesse/ 

https://www.linkedin.com/company/modern-biopharma-podcast

http://www.modernbiopharma.com

Ever wanted to have a Crystal Ball?  

Did you know that the #1 suspect for a process line failure is diaphragm valves and gaskets?  

On this episode of the Modern BioPharma Podcast (www.modernbiopharma.com) I am joined by Milena McFeeters from the BioProcess Institute to talk about the failure modes of Diaphragm Valves. Interesting right…? 

Well, if most of the Pharma Process failures are due to things you could do a better job predicting, this just might be the episode for you :)  The Consumer Reports of the Pharma Industry, the BioProcess Institute has put together a comprehensive failure mode test and results that show the reliability of different manufacturers and the kinds of failures that are typical under different stresses and environments (CIP and SIP).  

In this episode we discuss a number of things that are shown visually. You can both get a "cheat sheet" and the full report at https://bioprocessinstitute.com/.  you can also watch this episode on our Youtube Channel.

Make sure you say hi on LinkedIn: 

https://www.linkedin.com/company/modern-biopharma-podcast 

https://www.linkedin.com/in/talktojesse/ 

Or Subscribe on your favorite Podcast Player.

Industry 4.0 is a name given to the current trend of automation and data exchange in industrial technologies. It includes the Industrial Internet of Things (IoT), wireless sensors, cloud computing, artificial intelligence (AI) and machine learning.   Today on the podcast we discuss Maintenance 4.0 and how it is being implemented and can be implemented across the Pharmaceutical Industry.   

Our guest today is Tobias Kuners of Koenders (https://www.linkedin.com/in/tobiaskunersofkoenders/). Tobias has more than 30 years of experience across multiple facets of operations including Project Management, Facilities Services, Maintenance, Engineering, Validation, Packaging and Supply Chain within highly regulated industries. He is the managing consultant at Tob Management, a Netherlands-based consulting firm providing business and technical expertise to the pharmaceutical, biotech, medical device, and FSMP (food for special medical purpose) industries.  

Here's what we discuss on this episode:  

First off, before we get started, just to get to know you a little better...what is the last book you read? Dutch Light: Christiaan Huygens and the Making of Science in Europe https://www.amazon.com/Dutch-Light-Christiaan-Huygens-Science-ebook/dp/B085NWR3QL/ref=sr_1_1?dchild=1&keywords=dutch+light&qid=1621872488&sr=8-1 

What is Pharma 4.0 as defined by the ISPE SIG?  What is “Maintenance 4.0” and how does it fit into the Pharma 4.0 framework? (Here is one of Tobias' articles: https://www.biosimilardevelopment.com/author/tobias-kuners-of-koenders)  

We had some lag on this interview so you may notice some "cuts" as I tried to take out as much of the awkward as possible :).  

The 5 Core Aspects of Maintenance 4.0...Periodic Inspection, Prescriptive Maintenance, Preventative (Routine) Maintenance, Predictive (Reliability) Maintenance, and Corrective/Reactive Maintenance. Where do you see the largest upside from where we are at today to in the future in these 5 core aspects?  

As the data set available to us continues to grow, it seems overwhelming. How do companies prioritize data for good use rather than get buried by it and resort to either “over PMing” everything or corrective/reactive maintenance? How have you seen this done with one of your clients?  

Let’s talk about existing facilities vs new facilities. It would seem an existing facility transition to Maintenance 4.0 could be very difficult from a “culture” perspective while at a new facility, there is a lack of history to work from developing KPIs and benchmarking. Can you talk to some of the issues an older facility vs a new facility might run into?  

If you were to speak with a new client, what would be the first thing you would tell them to begin to look at to start the transition towards Maintenance 4.0?

The COVID-19 Vaccine has brought to the forefront an awareness of something called an Emergency Use Authorization (EUA). As a result, the questions swirl around what they are and what they mean to the safety of the vaccine and other therapies surrounding COVID-19. Listen in as we discuss this very important topic.  

Our guests today are: 

Dr Uma Sharma - Chief Scientific Officer - MMS  Dr Sharma provides oversight for all clinical activities especially submissions and complex regulatory projects. As needed by their sponsors, she leads advisory committee meetings and participates in advisory boards for drug development, as well as product defense strategies especially for critical safety issues and label strategy discussions. With more than 24 years of experience in the pharmaceutical industry, she has been an invited speaker at several national and international events.   

Ben Kaspar, Senior Manager Regulatory Strategy Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life-cycle. Ben and team have a deep experience in regulatory science for drug/biologic development, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas including rare diseases.  

Here are some of the topics we cover today:  

What is the last book you read?  

What is an EUA and why are we hearing so much about them now?   

Does a EUA allow a drug to be used around the world during a pandemic? Is this just a thing for the US or some subset of countries?   

Are All COVID related approvals an automatic EUA?   

If we are able to get an EUA for something like COVID, why can’t every unmet condition have an EUA? Certainly plenty of other conditions are even MORE serious to many people.   

Are EUAs easier than regular approvals? Public perception is that these are a short cut and all studies are not completed. I think the thing I hear about the most is the “long term studies”...   

Are EUAs here to stay after the pandemic? Will there be more EUAs than before? Have we broken through some imaginary barrier that will now allow us to do this more often?   

What do you think the industry can learn from this effort for future growth and streamlining discovery/testing efforts?   

Reach out to MMS Holdings... https://www.mmsholdings.com/ 

Dr. Sharma on LinkedIn - https://www.linkedin.com/in/umasharmaphd/

Ben Kaspar on LinkedIn - https://www.linkedin.com/in/benkaspar/ 

Reach out to me on LinkedIn https://www.linkedin.com/in/talktojesse/ or on my website at https://www.modernbiopharma.com/.

What if we could use the OTHER 99% for drug discovery...not just the 1%?

In the world of drug discovery, for the most part it hasn't change much in decades. Ross Youngs, CEO of Biosortia Pharmaceuticals is looking to change that with a better understanding of the microbiome.  

The Biosortia technology opens the doors to previous unobtainable drug-like signaling molecules and will impact all therapeutics, agriculture, cosmetics, and other industries.  Importantly - researchers have had less than 1% of this source previously available & that small percentage has still led to more than 50% of the drugs on the shelf - the door is now open to potentially the full 100% of the source (this is World-Changing).     

Pharma's past failures to deliver costing billions of dollars a year in combinatorial chemistry & genomics with few drug on the shelf has resulted in tunnel vision & lack of research adventurism.  Listen in on our conversation. Hear the passion Ross has for this technology and the future of drug discovery.  

Learn more about Biosortia Pharmaceuticals at https://www.biosortia.com/.  

Reach out to Ross on LinkedIn at https://www.linkedin.com/in/rossyoungs/.  

Thanks for listening to the Modern Biopharma Podcast. 

Check us out at http://www.modernbiopharma.com or hit me up on LinkedIn at https://www.linkedin.com/in/talktojesse/.

On episode of 18 of the Modern Biopharma Podcast, I got to sit down with Gil Roth, President of the PBOA (Pharma and Biopharma Outsourcing Association), the nonprofit trade association representing CMOs and CDMOs. You can find more info about PBOA at http://pharma-bio.org and contact Gil at [email protected].  

As president of the Pharma & Biopharma Outsourcing Association,Gil is responsible for developing and advancing the agenda of our member companies in the regulatory, legislative and general business areas. This involves organizing and communicating with members and other industry participants, interacting and negotiating with FDA and other regulatory agencies, lobbying Congress and working with federal agencies, building committees and working groups in a variety of areas, and developing cross-platform programs with other trade associations. He has organized workshops and conferences for our members, written and delivered presentations at FDA hearings and industry events, testified to Congressional subcommittees, conducted industry surveys, coordinated panels for our trade-show partners, developed the association's website, compiled the e-mail list for the weekly e-newsletter (which he also produces), marketed and recruited dozens of new member companies, composed press releases, and designed marketing materials.   

Among PBOA's signal achievements are successfully renegotiating a multibillion-dollar user fee agreement with terms more favorable to the CMO/CDMO sector, launching the industry's first CMO/CDMO-only conference, and becoming the point of contact for regulators seeking to learn more about this industry.   

We talk about what the PBOA is doing and where it is headed, how COVID-19 is impacting the industry as a whole, what kind of impacts there have been to the supply chain, and more.   

Gil is a fascinating guy working hard for the industry.   

You can learn more about his organization at: https://www.linkedin.com/in/gil-roth-93a6711/ or https://pharma-bio.org/  

Check out more of the Modern BioPharma Podcasts at http://www.modernbiopharma.com  

Connect with me, Jesse, on LinkedIn at https://www.linkedin.com/in/talktojesse/ or on Twitter at https://twitter.com/talktojesse

Heard of a thing called COVID? No?  

Well, today's guest is extremely knowledgeable in the way microscopic particles in the air can affect your health AND ways to help remove them from your surrounding to improve your health. Jesse Coiro is the Director of Business Development for Erlab, who's tagline is "You Can Breathe".   

On this episode we cover a number of issues, including: 

The primary means of COVID transmission and why it is important to the BioPharm community.   

While it really is amazing how much of the workforce has been able to "go remote", it certainly isn't possible for everyone, especially in the pharma space where we have to continue to manufacture, package, deliver and on the front end lots of time in the lab. Where are the biggest risk areas in these environments?  

Other than social distancing and masks...what are other means of minimizing risk/exposure in the workplace? Specifically the kind of solutions Erlab is providing.  

I hear people say frequently "What's the point if we can't get rid of all of it, why bother?"   

The difference between "dillution" and room level mitigation.  

Some of these solutions might be too big of an investment given the prospect of COVID "going away" in the not too distant future. Is it worth the money or should we just maintain our distancing with masks a little longer?  

As we continue finding our way through COVID, what is the one thing you'd most like to share with the Biopharm community?  

#10years...if you could go back and tell yourself one thing 10 years ago, what would it be?  

I hope you enjoy this episode with Jesse. I definitely learned a few things.

Look up Jesse on LinkedIn at https://www.linkedin.com/in/jesse-coiro/ or Erlab at https://www.erlab.com/usa/.

Want to see the product (Halo) we are talking about?

https://www.erlab.com/710-1076-halo-laboratory-grade-air-filtration-system.html

Want to get a hold of me? Hit me up on LinkedIn at https://www.linkedin.com/in/talktojesse/ or email me at [email protected].

Since putting up the episode, we've gotten a number of requests for more info. Just visit the Erlab website and fill in your information and they will get right back to you --- https://usa.erlab.com/contact-us

Early on in COVID I was able to sit down and speak with Jarrod Wrampe from CRB. We had some recording issues, so it took some processing to finally get this episode released. He's a busy guy, so I wanted to make the most of our time we had rather than wait for another opportunity to record a new episode.

As the Biotech Team Leader in the Kansas City office with almost 20 years experience, Jarrod is a wealth of experience in the Biopharm space.

In this episode we get to know Jarrod a little bit and then discuss a number of different topics:

Why would a facility choose single use vs stainless? What factors weigh heavily in this decision?

Why would ozone be chosen instead of heat for sanitization in water systems?

What are the risk factors with ozone?

What kind of companies are more open to this as an option vs traditional heat sanitization?

Jarrod was a great guest and I really enjoyed spending time getting to know him and understand some of his background. 

Please reach out if you have any suggestions on guest for the podcast! We'd love to hear from you.

And reach out to me on LinkedIn or Twitter 

Visit Modern Biopharma at http://www.modernbiopharma.com

Today on the Modern Biopharma Podcast we sit down to talk with Kevin Chronley, Vice President at A/Z Corp.   

Kevin and I have known each other for a number of years now as he is very active in the Boston chapter of ISPE and A/Z Corp is very active in the life sciences industry in New England.   

This discussion is getting to know Kevin, who he is, and some of his experiences in the industry.   

Here are some of the questions we discussed:  

Tell me a little about yourself  How did you get involved in the BioPharma industry? 

How have you seen the industry change since you’ve been working in it?  

Tell me about the kinds of projects you’ve worked on or maybe a specialty you have? 

What’s an improvement you’d like to see in how we manufacture medicines today?  

Tell me about something you are excited about in our industry?  

Relating to your work in BioPharma, what is something you’d tell your 10 year younger self that you wish you’d known.  

Do you have any parting thoughts you’d like to share?

Check out our other Episodes at https://www.modernbiopharma.com/

In Part 3 of our water series with Brian Hagopian we discuss Rapid Microbiological Monitoring of pure water systems.   

This is a technology that continues to get attention as it matures in the Pharma space. With microbiological control being so important to the modern water system in a BioPharm plant, understanding what is going on on the micro level is too important to have to always wait for a multi-day test result.  

Here are some of the items we discuss:  

What is the reason behind microbiological monitoring in a water system? What are you looking for? 

How do we currently monitor these things? What are the shortcomings of this way of measuring for micro? 

Explain what RMM is. 

Why is RMM all the sudden making a splash? Is it new, or has it been around a long time? 

Why does RMM make sense? 

What is holding it up as an accepted technology? 

What about endotoxins? How do we handle those? 

What does the future look like for this new technology? Do you see it being used in another industry where it can “earn” its reputation?  

Brian is an industry expert with over 30 years high purity water system design, construction, commissioning, and validation experience delivering a wide range of solutions to premiere pharmaceutical, biotech, semiconductor, research and other high technology clients. A recognized industry leader and active volunteer with numerous professional societies, past president of the Boston Chapter of the International Society for Pharmaceutical Engineering (ISPE) and contributing author and lecturer on topics associated with USP purified water (PW), water for injection (WFI) and semiconductor grade water. As a past executive for several water system companies, Brian brings extensive knowledge related to high purity systems engineering, operations, and piping system design.

Check out 2 Premier Suppliers of this technology:

Mettler Toledo

BioVigilant

#reverseosmosis #wfi #pharmawater