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Modern BioPharma Podcast
Jesse McLaughlin
33 episodes
1 week ago
The Modern BioPharma Podcast was born out of the 2020 COVID-19 Pandemic and the desire to connect professionals in the pharmaceutical engineering community to the stories of others around them and what they are doing to make a difference. This industry is one of resistance to change all while life altering medicines and therapies are coming into existence that demand a different kind of manufacturing plant. The same people work on these facilities across the industry. Let's get to know each other.
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All content for Modern BioPharma Podcast is the property of Jesse McLaughlin and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
The Modern BioPharma Podcast was born out of the 2020 COVID-19 Pandemic and the desire to connect professionals in the pharmaceutical engineering community to the stories of others around them and what they are doing to make a difference. This industry is one of resistance to change all while life altering medicines and therapies are coming into existence that demand a different kind of manufacturing plant. The same people work on these facilities across the industry. Let's get to know each other.
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Business
Episodes (20/33)
Modern BioPharma Podcast
Season 4 - Andrew Lamore - ASME BPE

Today's episode is with Andrew Lamore from Burkert USA Corp and ASME BPE Chair for Multi and Single-use Process Instrumentation.  

As this show airs at the same time as the 30th Annual ISPE CASA Life Science Technology Showon Feb 28 2023, we thought it would be great to discuss some of the ways these two industry groups (ISPE and ASME) compliment each other to build a safer and more effective pharmaceutical manufacturing industry.  In case you were wondering...they work "hand in glove". While you certainly could have one without the other...you wouldn't want to.  

Listen in. Andrew is a wonderful guest and for anyone that has met him, you know, he's just a delight to speak with.  

www.asme.org/Communities/Technical/BPE 

Andrew Lamore on LinkedIn

ISPE CASA Annual Show 2023 

Say hi to Jesse on LinkedIn

www.modernbiopharma.com

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2 years ago
34 minutes 22 seconds

Modern BioPharma Podcast
Sumit Verma of Iovance Biotherapeutics - 1 Time Therapy for Solid Tumors

When we think about the future of medicine, we think about companies like Iovance. Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. Their lead, late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer.  

At this year's ISPE Annual Meeting in Orlando FL, I had the chance to sit down and talk about some of the things that Iovance is doing with Sumit Verma, Senior Vice President Global Strategic Manufacturing.  It was obvious to me that not only is Sumit very engaged on the "facility" level of what needs to happen to make a successful facility for our modern therapeutics, but he is passionate about the patients that Iovance is helping. This isn't just a job, its a mission.  

The future of cell and gene therapy is a fascinating one, and what Sumit and his team at Iovance Biotherapeutics are doing will have monumental, life saving effects in the lives of so many where before there was little hope. Listen in our conversation!

Modern Biopharma Podcast
Say hi on LinkedIn

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2 years ago
24 minutes 45 seconds

Modern BioPharma Podcast
Rapid Microbiological Testing with Peggy Banarhall and Tracy Radcliffe of Mettler Toledo

Peggy Banarhall and Tracy Radcliffe on Rapid Microbiological Testing in Pharma Waters

It is hard to overemphasize the importance of water in the pharmaceutical manufacturing process. And when it comes to microbiological contamination, one of the biggest hurdles to understanding what is going on in your system is the time it takes to test.

On this episode of the Modern Biopharma Podcast, I get to speak with Peggy Banarhall and Tracy Radcliffe from the Mettler Toledo team in their studio about their new technology for the rapid testing of bioburden in pharmaceutical water systems.

This is a paradigm shift in understanding and dealing with bioburden. You don't need to only do a 100 year old test to figure out the health of your water system anymore. You can know what is going on RIGHT NOW...not find out in 3 days. Join us as we discuss the ins and outs of this technology and how it could help you with your system.

At around the 46 minute mark we start a Demo on the unit, which may not make sense just listening to it. You can always switch over to the Youtube video at: https://youtu.be/2N5YFQYJQzQ

Connect with our guests:

Peggy - https://www.linkedin.com/in/peggy-banarhall-ba72412/

Tracy - https://www.linkedin.com/in/tracyradcliffe/

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

Learn more about the 7000RMS at: www.mt.com

Learn more about what we do at www.modernbiopharmapodcast.com


Transcript Here 

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3 years ago
1 hour 10 minutes 27 seconds

Modern BioPharma Podcast
Jake Adams - CRB - The Future of ATMPs

ATMPs...or Advanced Therapeutic Medicinal Products, are the "next big thing" in the world of #Pharma. If you are in the space, the big ones you hear most about are Cell & Gene Therapy and...lately...mRNA vaccines (thank you COVID-19).  

This world isn't as simple as 2 or 3 therapies...it's more than that. Investment in Cell&Gene Therapy has been setting records with $20 and $23 Billion in the last 2 years alone. This is kind of a big deal. 

Jake Adams, from CRB, joins me to discuss this and also the world of #RNA modulating therapies (not all as well known as mRNA Vaccines).   

We discuss what makes these different therapies unique, what makes them effective, and more. Also a few rabbit trails including how did Jake turn into a go-to man for RNA as a young engineer. So listen up... :)  

Check at Jake on LinkedIn!  

Subscribe to our channel!


Want to learn more about investment into the Cell & Gene Space?
CGT 2022 Investment Outlook

Learn about Oligonucleotides HERE!

Quick overview about TPDs HERE!

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3 years ago
55 minutes 47 seconds

Modern BioPharma Podcast
Jon Browne - Qualification & Commissioning in Pharma

If you are anywhere around the commissioning and qualification space, you know how important it is to any #Pharmaceutical facility. There are so many resources out there to understanding how to approach these processes and on today’s episode of the Modern Biopharma Podcast I spoke with Jon Brown about his experience coming into a new facility and how he approached the substantial task of managing the commissioning of one of the largest Water For Injection (#WFI) systems in the world.

Jon is a graduate of the University of Utah and currently works as a consultant in the RTP area serving pharmaceutical manufacturers there. I really enjoyed getting to know Jon through our conversations

Questions we cover in the podcast:

Tell me a little about yourself and what you currently do.

2:05 - What is a book that you’ve recently read that you especially enjoyed? Algorithms to Live By (already started it and really enjoying it)

6:00 - Today we’re going to talk about commissioning and qualification of water systems…tell me more about why you enjoy working on water systems

8:00 What was your “task” and how did you approach CQ differently for this project?

15:00 - What do you care about in your quality system?

26:00 - How do we determine system boundaries?

36:30 - How important is it to both define those boundaries and DEFEND those boundaries from a quality perspective?

49:40 - What’s the number #1 thing you’d encourage a CQV team to do as they embark on a new system?

As some follow-up reading, here is a great article about Good Engineering Practices in Risk-Based Commissioning and Qualification by Chip Bennett.

https://ispe.org/pharmaceutical-engineering/may-june-2020/good-engineering-practice-risk-based-commissioning

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3 years ago
52 minutes 36 seconds

Modern BioPharma Podcast
AI-ML in Pharma Manufacturing - Vijay Yadav - Merck

When you think of Artificial Intelligence, you may think of some scene from a movie where robots are taking over the world…well, I can’t say that won’t happen :), but I can say, that some people are starting to find ways to make manufacturing medicine more efficient using it.

On today’s episode of the Modern Biopharma Podcast, I had the pleasure of talking with Vijay Yadav, from Merck.

We didn’t talk about robots taking over the world, but we did talk about how Vijay’s team is leading the industry and finding new ways to make AI and Machine Learning useful towards a more efficient and higher quality future in the modern biopharmaceutical plant. While many are talking about it, Vijay and his team are doing it.

Listen in…today we talk about:

AI vs ML – Explain the difference

The Automated Vision Inspection process

What made this process a success?

What were the risks/downsides of running this technology?

What makes the culture different that you’ve been able to make such progress with AI in an industry that is so resistant to change?

How have you been able to build a team for this work? It seems that other industries are driving this kind of work

Learn more about Vijay through one of his articles:

https://ispe.org/pharmaceutical-engineering/november-december-2020/vision-inspection-using-machine

https://towardsdatascience.com/quantify-the-business-impact-of-your-data-science-project-b742e4b3208f

https://www.linkedin.com/pulse/artificial-intelligence-vs-machine-learning-whats-what-vijay-yadav-1/

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3 years ago
43 minutes 52 seconds

Modern BioPharma Podcast
Blockchain in Pharma - Tanya Sharma and Najib Rehman

In today's emerging BioPharma space, the importance of transparent and accurate records related to therapies, how they are made, where they are in a process, and the patient they are for has never been more important.

A need this large should not be relying on technology from 30 years ago. The Pharma 4.0 world has a lot of components...One way of helping the Pharma Industry catch up with the technologies they are creating is by utilizing Blockchain.  On today's episode, Najib Rehman from ATMPS and Tanya Sharma from Assurea, join me to talk about how Blockchain can be used to help our industry make a JUMP towards more available therapies for more people.    

Here are some things we discuss today:  

  • Explain Blockchain to me like I'm a 10 year old.  
  • Who owns blockchain? It has a reputation for being very secure...why is that?  
  • Why are you advocating for using blockchain in the Pharma Industry? Are there particular areas within the industry that blockchain is best suited for?  
  • Is there a certain level of adoption needed to make this "work" or is the infrastructure already in place?  
  • How does blockchain impact 21 CFR Compliance?   
  • What downsides are there to instituting blockchain?  
  • How does using blockchain as a tool in Pharma help to serve the patient?  

Some other items that we touch on are: 

  • Need for competitor cooperation 
  • Paper versus digital 
  • Digital disintermediation of supply chains 
  • Personalized medicine - patient centric  
  • How do you "manage forever"?  

Tanya Sharma - https://www.linkedin.com/in/tsharma2/ 

Naj Rehman - https://www.linkedin.com/in/najib-rehman-54011412/ 

Jesse McLaughlin - https://www.linkedin.com/in/talktojesse/ 

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

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3 years ago
54 minutes 8 seconds

Modern BioPharma Podcast
The Pharma Job Market - An Interview Mashup

It is a RED HOT Job Market (at least right now it is in 2021)...and the Pharma market is leading the pack.  On this episode of the Modern BioPharma Podcast, I interviewed 3 different organizations to talk about what the Pharma Job Market looks like right now, how it has changed due to COVID, ways to stick out in a crowded marketplace, and more...!!!  

Our Guests today include:  

Jonathan Hart-Smith from the CK Group, a staffing and outsourcing services for the science and technology community.  

Bill Burg (https://www.linkedin.com/in/bill-burg-22651531/) and Kyle Reagan (https://www.linkedin.com/in/kyle-w-reagan-2218731/) from DECCO Inc., a mechanical contracting company that specializes in construction, maintenance, and fabrication services to leading biopharmaceutical, technology and industrial clients throughout New England.  

Shawn Fitzpatrick and Charlie Maher from Resilience, a pharmaceutical organization that is changing the way medicine is made – leveraging innovation to better serve scientific discovery, withstand disruptive events, and reach those in need.  

Listen in as we see the job market from different angles... 

Where are the biggest needs? 

What has changed since COVID changed our world? 

How to best position yourself for a position? 

How are companies changing how THEY approach the talent pool? 

How are companies developing talent as early as high school to serve in jobs that we just don't have people for?  

I hope you enjoy this episode. As always, reach out if you have any suggestions for future episodes by connecting with me on LinkedIn at https://www.linkedin.com/in/talktojesse/ or at www.modernbiopharma.com.

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3 years ago
46 minutes 22 seconds

Modern BioPharma Podcast
Women in Pharma - An Interview with Jennifer Lauria Clark

Diversity gives you access to a greater range of talent, not just the talent that belongs to a particular world-view or ethnicity or some other restricting definition. It helps provide insight into the needs and motivations of all of your client or customer base, rather than just a small part of it.  

One way this is being addressed in the Pharmaceutical industry is with a group called Women in Pharma (WIP) in ISPE.  

On today’s episode, I am joined by Jennifer Lauria Clark from CAI. Jenn has worked on the WIP committee both locally in the Southeast and with ISPE International for a few years. It continues to gain momentum and have a TON of energy at all the ISPE events around the world. Jenn was kind enough to spend some time with me while we were both at the 2021 ISPE Annual Meeting in Boston to discuss:  

Why she thinks Women in Pharma has such momentum? Why is diversity (in this case women) so important in the workplace?

Where are we seeing some of the biggest successes around the world in with the Women In Pharma efforts? 

How is Women in Pharma an advantage to our industry as we “compete” for new talenting coming out of universities around the world?  

We'd love feedback on this episode and others and more subjects that are important to you in the industry. Please reach out with any questions or suggestions at modernbiopharm@gmail.com

For more resources or to say hi to either Jenn or Myself:

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

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

https://ispe.org/women-pharma 

https://cagents.com/ 

https://www.modernbiopharma.com/

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4 years ago
27 minutes 30 seconds

Modern BioPharma Podcast
MBP - Ravi Samavedam - Cleanrooms on Demand

Ravi Samavedam

What do you know about cleanrooms and why they are used in the pharmaceutical manufacturing space? How does the need for them impact your ability to get a facility operational and ready for "gametime"? If you are an early phase manufacturer, how do you make sure you protect your IP as you move forward with initial process development?  

On today's podcast, Ravi Samavedam, President and COO of Azzur Cleanrooms on Demand and I discuss the basics of cleanrooms, why they are used, where they are used, what they look like, the different ways they are implemented, and more.  The industry continues to get more efficient at setting up manufacturing facilities and new technologies help enable this. 

Unfortunately, it isn't that easy. Sometimes the time to get from the lab to small scale GMP manufacturing is prohibitive and and the line to get on the CMO roller-coaster is just too long...another solution is needed.   

Learn more about how Azzur has started helping their customers set up "Cleanrooms on Demand" so that they can get to where they need to be quickly and minimize the capital and resources needed to get there.   

Early-phase manufacturers face a myriad of challenges when it comes to starting up and scaling out: Need for clinical manufacturing capability Lack of GxP expertise Limited quality management systems Lengthy facility design-build timeframes Insufficient warehouse and materials storage Truly unique to the industry, Azzur's hybrid model allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs).    

Join us to learn about cleanrooms AND what Azzur is doing different.   

Learn more about Azzur Cleanrooms on Demand Here!  

Say Hi to Ravi on LinkedIn!  

http://www.modernbiopharma.com or our LinkedIn Page

Say hi to me, Jesse, on Linkedin

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4 years ago
33 minutes 16 seconds

Modern BioPharma Podcast
Integrated Project Delivery - Josh Miksch - CRB ONEsolution

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

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4 years ago
48 minutes 27 seconds

Modern BioPharma Podcast
Predicting Diaphragm Valve Failure - Milena McFeeters

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.

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4 years ago
1 hour 10 minutes 23 seconds

Modern BioPharma Podcast
Maintenance 4.0 - Tobias Kuners of Koenders - Season 2

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?

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4 years ago
40 minutes 31 seconds

Modern BioPharma Podcast
Emergency Use Authorizations - MMS Holdings Interview - MBP Season 2

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/.

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4 years ago
53 minutes 55 seconds

Modern BioPharma Podcast
MBP - Ross Youngs - Biosortia - The Future of Drug Discovery

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/.

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5 years ago
50 minutes 6 seconds

Modern BioPharma Podcast
MBP - Gil Roth - Pharma and Biopharma Outsourcing Association

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 gil.roth@pharma-bio.org.  

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

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5 years ago
49 minutes 8 seconds

Modern BioPharma Podcast
MBP - Jesse Coiro - Erlab

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 modernbiopharm@gmail.com.

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


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5 years ago
29 minutes 49 seconds

Modern BioPharma Podcast
MBP - Jarrod Wrampe - CRB

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

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5 years ago
20 minutes 49 seconds

Modern BioPharma Podcast
MBP - Kevin Chronley - A/Z Corp

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/


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5 years ago
19 minutes 59 seconds

Modern BioPharma Podcast
MBP - Brian Hagopian - Clear Water Consulting - Part 3 Rapid Microbiological Monitoring

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

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5 years ago
30 minutes 41 seconds

Modern BioPharma Podcast
The Modern BioPharma Podcast was born out of the 2020 COVID-19 Pandemic and the desire to connect professionals in the pharmaceutical engineering community to the stories of others around them and what they are doing to make a difference. This industry is one of resistance to change all while life altering medicines and therapies are coming into existence that demand a different kind of manufacturing plant. The same people work on these facilities across the industry. Let's get to know each other.