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:

1. 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.

1. 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.
2. 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-specific references and all of those are from “free sources” they likely didn’t do a good search job other than looking for free data. High quality data sources, such as proprietary scientific databases and journal articles cost money. Cheap providers don’t have that kind of budget, so they ignore it. Also, how current is the data? If data is over 6 years old or more, it’s probably outdated, and more current studies may be available.
3. Ignoring conflicting or missing data. This typically occurs in the evaluation of genotoxicity data; where you’ll have mixed results (some positive and some negative). Did the author of the PDE report do a good job of analyzing this conflicting data or did they ignore it? How did they address missing data such as missing reproductive and developmental studies?
4. Creating a different monograph for each salt form of the molecule; thus, requiring you to buy separate monographs. A large majority of all drug molecules used in medicinal therapy are administered as salts. Often, a drug substance has certain suboptimal properties that can be overcome by pairing a basic or acidic drug molecule with a counterion to create a salt version of the drug. Creating a salt version of the drug can improve solubility, stability, taste, manufacturability, and other key properties. In all but a few rare cases, the toxicology of the basic or acidic drug and the salt form are the same. Here at Affygility Solutions, when we are reviewing the scientific literature for a drug compound, the expert toxicologists are mindful of any differences.
5. Making statements that are not scientifically supported. Every source of scientific data must be cited. And you should be able to trace it down. It doesn’t have to be word-for-word, as long as the meaning is the same.
6. Relying on data from safety data sheets (SDS) of questionable credibility. The information on safety data sheets may be mentioned in a PDE report, but it should never be used as the primary source of data. This is because the backup studies are generally not available. I should mentioned that the credibility of the content of safety data sheets varies widely, from those that are outright false to those that are quite good.
7. Attempting to disguise a PDE report as a comprehensive document by non-value filler materials. Filler material can includes a report cover, a lengthy, but unnecessary table of contents, a glossary, lengthy tables of irrelevant data, and CVs in every PDE report. In addition, some providers use large header and footer margins with industry association, corporate logos and addresses on every page to make a longer document. These items provide zero value and are there to just give the false impression that it’s a lengthy and comprehensive report. I should mention that about a month ago I was speaking at a virtual conference and one of the other presenters indicated that a PDE monograph really only needs to be 15 or 16 pages long, as long as the data is well summarized.
8. Not openly disclosing that their reports expire in 3-5 years; thus, requiring that you purchase a new report upon expiration. Typically,  this is buried somewhere in the document or in the terms and conditions. So, it may be a cheap initial cost, but you’re going to have to continue to buy replacement reports for many years to come. Not a good tactic.
9. Not using qualified or certified toxicologists to prepare and review the reports. This is a big one. Qualified toxicologists don’t work for low wages. And if a person is certified, either a DABT or ERT-registered toxicologist the salary is up there. Cheap providers can’t support those kind of salaries.

O.k.  That does it for this week’s show. You can also stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

That does it for this week’s show.  We look forward to having you listen in next time.

Have a great rest of the day.

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 few weeks or months

Mark

• I will give a balanced answer and refrain from a doomsday answer 😊

 Dean

 How about more in general, what precautions and preparations should business travelers be taking when traveling outside the country? (health insurance, vaccinations, registering with the STEP program, etc.)

 Alright, so that does it for the interview, let’s now move onto events and happenings that are of interest to EH&S professionals in the biopharma industry.

First, on February 19-21st in Prague, Czech Republic there’s the 2nd Annual Highly Potent APIs Summit. Affygility Solutions is a sponsor at this event and also will be presenting. If you happen to be attending, please stop me and say hello.

Next, on March 15-18th, there is the Society of Toxicology Annual meeting in Anaheim, California. Dr. James Damewood, Sr. Director of Occupational Toxicology for Affygility Solutions will be attending this event.

And, finally, on May 5th through 7th, CPhI North America will be held in Philadelphia, Pennsylvania. Numerous employees of Affygility Solutions will be attending this event.

O.k.  That does it for this week’s show.  Remember to submit your questions to our podcast email at podcast at Affygility.com.  You can also follow us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

That does it for this week’s show.  We look forward to having you listen in next time.

Have a great rest of the day

Links

Coronavirus 2019-nCoV Tracker John Hopkins University

Smart Traveler Enrollment Program - STEP. U.S. Department of State

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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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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.

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.

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

In this episode of the Biopharma EHS Podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, interviews Ms. Stephanie Wilkins, President of PharmaConsult US, on the subject of Risk-MaPP, ADEs and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities. Risk-MaPP stands for Risk-Based Manufacture of Pharmaceutical Products. It is one of the International Society of Pharmaceutical Engineers' (ISPE) Base-line Guides. One of the essential components of Risk-MaPP is the determination of acceptable daily exposure (ADE) values. Calculation of ADEs is similar to the calculation of PDEs presented by European Medicines Agency (EMA). If you need an occupational exposure limit (OEL) or ADE for a pharmaceutical compound, please check out our entire catalog of OEL Fastrac monographs. We have many OEL monographs that come with ADEs.

BioPharma EH&S Podcast Episode No. 20

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 Sunday, July 14th, 2013 and it’s great to be here today. We have great show in store for you today and a lot of things to talk about, so let’s go ahead and get started.

 As always, I’d like to first mention what we are going to discuss in today’s podcast.  That way you can decide if it’s something that interests you, or should you just come back for our next episode.  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 19 

Then I will cover our main topic for today, which is EH&S Software – The Challenge of User Adoption

And finally, we’ll discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

So, let’s go ahead get started.  Last time in Episode number 19 we discussed the topic of “The Future of Potent Compound Safety – the next 100 years.”  In that Podcast, I presented four emerging trends that will shape the future of the pharmaceutical industry. Those trends included first, the development of medicines in space; second, the trend called “the Internet of Things;” third, the Maker Movement; and forth and finally, the Use of Big Data Tools.  If that’s something that may interest you, I would suggest that you go back and listen to Episode 19.

Alright, let’s now move on to our main topic for today which is EHS software – the challenge of user adoption. So without further delay, here we go.

 A little over a year ago, I created a post on EHS Compliance Management Software - Increasuing User Adoption and Engagement. In that post, I provide a few suggestions for encouraging user adoption of EHS software within an organization. The suggestions i provided by then included:

- Measure usage;

- Ensure data quality;

- Engage users during meetings;

- Tie individual compensation to usage; and

- Use peer pressure.

In addition to those five suggestions listed above, I would like to provide some additional suggestions. These additional suggestions include:

- Ensure executive leadership involvement;

- Identify and reward super users;

- Perform floor-walking;

- Ensure that the EHS software system is used by taking the approach, "If it isn't in the EHS software system, it didn't happen;"

- Mandate both timeliness and data quality.

O.k., that does it for our main topic, let’s now talk about some upcoming events.

Alright that does it for our main topic this week. One additional item that I would like to remind everyone of is oelfastrac.com, which is a convenient and affordable way to obtain high-quality occupational exposure limit monographs for common APIs. To learn more, please go to oelfastrac.com.

 O.k.  That does it for this week’s show.  Remember to submit your questions to our podcast email at [email protected].  You can also follow us on twitter at twitter.com/Affygility, on Facebook at facebook.com/affygilitysolutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

That does it for this week’s show.  We look forward to having you listen in next time.

Have a great rest of the day.

In this podcast, Dean M. Calhoun of Affygility Solutions discusses four key technologies or trends that will have a significant impact on the pharmaceutical industry for the next 100 years. These trends include: the development of medicines in space, the Internet of Things, the Maker movement, and the use of Big Data tools. He will also discuss taking leaps forward and barriers that we will encounter.