28 episodes

BioPharma EH&S Podcast. The latest discussion on potent compound safety, occupational toxicology, industrial hygiene, and compliance management software. To submit questions or comments to the podcast email affygility@gmail.com or call our listener voicemail line at 206-984-3214.

Biopharma EHS Affygility Solutions, LLC

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BioPharma EH&S Podcast. The latest discussion on potent compound safety, occupational toxicology, industrial hygiene, and compliance management software. To submit questions or comments to the podcast email affygility@gmail.com or call our listener voicemail line at 206-984-3214.

    Biopharma EHS Podcast Episode 28 - PDE reports

    Biopharma EHS Podcast Episode 28 - PDE reports

    BioPharma EH&S Podcast Episode No. 28.
    Hello everybody and welcome back to another Episode of the BioPharma EH&S Podcast, my name is Dean Calhoun of Affygility Solutions and this is the podcast dedicated to discussing critical environmental, health and safety issues facing the biopharma industry, helping you take your environmental, health and safety programs to the next level.
    Well, it’s Monday, June 14th, 2021 and I’m excited to be back today recording today. We have full show for today and a lot of great things to talk about, so let’s go ahead and get started.
    As always I like to mention what are we going to discuss in today’s podcast. In today’s podcast, we’re going to talk about the following topics. 
    First, I’ll briefly cover what we talked about last time in episode number 27
    Then I will cover our main topic for today, which is titled, “Top mistakes and tricks used by cheap providers of PDE reports.”
    So, let’s go ahead get started.  Last time in Episode 27 we discussed the topic of “coronavirus and precautions that should be taken by business travelers.” That was recorded back on Feb 3rd, 2020. Who would have thought at that time that this would have become such a huge global crisis. We are going to be short on time today, so I would suggest if that topic interest you that you go back to episode and listen to the entire episode.
    Alright, so let's now move into our main topic for today, which is titled the “Top mistakes and tricks used by cheap providers of PDE monographs.” The talk is about 15-20 minutes long, so let’s go ahead and get started.
    At Affygility Solutions we see dozens, if not hundreds, of PDE reports each year from different providers. Some of the PDE reports are excellent and others have a lot of room for improvement. Often, when reviewing reports from cheap providers, we see many technical errors and tactics to fool you into thinking that you’re getting quality reports. These technical errors and tactics include:
    Relying too heavily on animal data for the selection of the point of departure (otherwise known as the PoD) and ignoring currently available human clinical data. Well, if you carefully read the EMA guidance document, on page 6 of the document, in section 4.2 it states, “If the most critical effect identified to determine a health-based exposure limit is based on pharmacological and/or toxicological effects observed in humans rather than animals, the use of the PDE formula may be inappropriate and a substance-specific assessment of the clinical data may be used for this purpose.”
    This is important. Often, we see cheap providers get in a rush to find a NOAEL value to use as the point of departure, which, as you may know, is typically from an animal model. Then in the process, cheap providers may ignore the human clinical data which may show adverse effects as the minimum effective dose. This is a mistake. Selection of the appropriate point of departure requires a thorough analysis of all the possible points of departure by an expert toxicologist, then selection of the PoD that results in the most restrictive PDE that is relevant to humans. This takes time.
    Over aggressive use of F factors and adjustment factors. Often this is due to lack of experience of the toxicologist and that they are not confident in their abilities. It should be mention that if you start seeing a composite F factor mathematical product approaching 10,000 or more; it means you really don’t know much about your molecule or that there is so much missing data that the F-factor method is not appropriate. When you see the happening you should carefully examine how they justified their factors. Performing a limited search strategy or not acquiring important primary sources of information or using old data. Often, a good way to discover to see if the search strategy was too limited is to look at the number and quality of the references. If they only have 4 or 5 molecule-specif

    • 18 min
    Coronavirus and business travel

    Coronavirus and business travel

    Hello everybody and welcome back to another Episode of the BioPharma EH&S Podcast, my name is Dean Calhoun of Affygility Solutions and this is the podcast dedicated to discussing critical environmental, health and safety issues facing the biopharma industry, helping you take your environmental, health and safety programs to the next level.
    Well, it’s Wednesday, January 29th, 2020, and I’m excited to be back today recording today. We have full show for today and a lot of great things to talk about, so let’s go ahead and get started.
    As always I like to mention what are we going to discuss in today’s podcast. In today’s podcast, we’re going to talk about the following topics.
    First, I’ll briefly cover what we talked about last time in episode number 26 and then we will cover our main topic for today – which is an interview with Mark Cunningham-Hill where we will discuss the coronavirus and precautions that business travelers should take and other precautions in general when traveling on business internationally. Then finally, after the interview, we will discuss events and happenings of interest to the EH&S professional’s in the biopharma industry.
    In our last episode, episode 26, we had an interview with Dave Eherts. Dave is the Vice President of Global EH&S for Allergan, and back in October, 2019 Dave was honored by the National Association for Environmental Management with NAEM’s Lifetime Achievement Award. It was a great interview and lasted about 25 minutes, so if that is something that interests you I suggest you go back to episode 26 and listen to the whole interview.
    Alright, so without further delay, let’s get started with our main interview. With me on the line is Dr. Mark Cunningham-Hill, President of Worldwide Health Consulting, LLC. Mark has 30 years of global experience leading large multinational’s responses to pandemics such as avian flu, SARS, MERS and Zika.
     The last time we had Mark on the podcast was back in May of 2017, so I will let Mark add some additional details.
    Dean
    We have heard a lot on the news recently about this new coronavirus from Wuhan, China. From what you know, what is the latest situation? Mark:
    I will run through key facts # cases, deaths, countries – p2p spread etc Key actions taken by China, other countries and businesses so far Warning about false stories on social media … it IS NOT a deliberate plot by the pharmaceutical companies to sell more vaccines!  Dean:
    I gather MERS (Middle East Respiratory Syndrome) , SARS (Severe Acute Respiratory Syndrome) and this new virus are all coronaviruses – how similar are they? Mark:
    I will cover similarities, differences and inferences we can make from the previous SARS and MERS Source of disease  - bats, camels and wild food markets… Dean:
    I have seen reference to the R0 number for this new virus what does it mean Mark
    The R naught is the basic reproduction number ……….. give explanation and range for SARS and measles Dean:
    How is the virus spread and how can you protect yourself from getting the disease? Mark:
    …………witchcraft 😊 ……… ? a symptomless transmission Talk through prevention Dean:
    Are there any vaccines or antivirals that work? Mark
    Talk about no vaccines but with genetic code (for test) and virus isolated work starting on developing a vaccine … but ……………… Dean:
    Coronavirus and precautions business travelers should take? Mark:
    Talk about following company CDC travel guidance Hand washing Avoiding sick people etc…. ………… Letting people know where you are … Dean you are off to Nepal in March and you came across a great resource – do you want to tell the listeners about this resource Dean:
    STEP Program Mark what other resources are out there? Mark
    CDC and other travel websites Corporate travel companies such as ISOS and Travax Dr Google …. With caveats! Dean:
    What do you think will happen over the next

    • 34 min
    Interview with Dave Eherts, Vice President Global EHS for Allergan

    Interview with Dave Eherts, Vice President Global EHS for Allergan

    Welcome back to the Biopharma EHS podcast. In this episode, Dean Calhoun of Affygility Solutions interviews Dave Eherts, Vice President of Global EHS for Allergan. In this 25 minute interview we discuss a wide variety of EH&S issues that Dave was involved in over his 30+ years in EHS. These issues include managing the financial aspects of EHS, potent compound safety and the challenges with occupational exposure limits for pharmaceuticals, and other career advice for EH&S professionals.
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    • 27 min
    BioPharma EHS Podcast Episode 25

    BioPharma EHS Podcast Episode 25

    Occupational Toxicology and Occupational Medicine - Where are they the same and where are they different? In this episode of the BioPharma EHS Podcast, Dean M. Calhoun, President and CEO of Affygility Solutions hosts a discussion between Dr. Mark Cunningham-Hill, President of Worldwide Health Consulting LLC and Dr. Frank Richardson, Principal Toxicologist for Affygility Solutions LLC.
    The discussion starts out covering the basic elements of an occupational medicine program and the unique challenges posed by the pharmaceutical industry in which occupational exposure to potent compounds can cause adverse effects in workers. Then the discussion switch over to discussing occupational toxicology, dermal exposures to such compounds as fentanyl or nicotine, and hypersensitivity.
    The discussion ends and Dean Calhoun then discusses upcoming events and happenings of importance to environmental, health and safety professionals in the life sciences industry.

    • 30 min
    Biopharma EHS Podcast Episode #24

    Biopharma EHS Podcast Episode #24

    In Episode #24 of the Biopharma EHS podcast, Dean M. Calhoun, CIH discusses with Dr. Joe Nieusma, Senior Occupational Toxicologist for Affygility Solutions, the "Mystery of Cytotoxic Compounds." For multi-product pharmaceutical manufacturing facilities, this often a controversial topic since many people believe that cytotoxic compounds require dedicated facilities or equipment. It is also a topic of debate when setting occupational exposure limits and acceptable daily exposure values for active pharmaceutical ingredients.

    • 27 min
    Biopharma EHS Podcast Episode #23

    Biopharma EHS Podcast Episode #23

    In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions interviews Kevin Rosenthal of Pharmatek Laboratories. During the interview we discuss handling potent compounds, potent compound safety, and occupational control banding.

    Dean Calhoun also responds to the frequently asked question, "What type of equipment do I need to handle a highly potent compound?"

     

    If you would like to learn more, visit affygility.com

    • 18 min

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