The Pharmaceutical Industry has it ALL WRONG.

I was speaking to a Global Head of Toxicology and Safety at a top 10 pharmaceutical company not too long ago … and he was asking me “How do I convince my organization that SAFETY needs to be job #1 for the industry”? What a great question!

The industry is all chasing the ‘efficacy’ goal. This is most unfortunate.

In reality, it is the industry’s lack of focus on safety that is costing the industry millions and millions of dollars. We all know these statistics …

The average R&D cost of a successful drug is approximately $2.6 billion.

1. To find a successful drug, R&D teams must sift through millions of potential compounds
2. It takes approximately 12 years for a drug to make it from the lab to patients
3. Only 10% of the drugs that enter preclinical trials reach human testing

Making this drug discovery process faster and more efficient is an urgent issue for all pharmaceutical companies. However, rather than look at the ‘root causes’ of the problem, the industry is busy hiring more scouts to ‘find’ the next solution outside of their own four walls.

Why DO so many drugs fail?

If the pharmaceutical industry were to take a classic Six Sigma approach to the problem, or listen to the wise words provided in the book, The Goal, by Eliyahu M. Goldratt and his Theory of Constraints (over 3 million copies sold), the answer would be ‘as plain as the nose on your face’.

As Goldratt says, ‘no exceptional brain power is needed to construct a new science or to expand on an existing one. What is needed is just the courage to face inconsistencies and to avoid running away from them just because “that’s the way it was always done’’.’

So, let’s wake up and focus on the RIGHT problem.The SAFETY issues are the items which stop most drugs from proceeding forward. But the system is phenomenally broken!! We utilize mice, rats, dogs and chimps to ‘represent’ the human. Then, the drugs that don’t pass the animal models are tabled – yet, perhaps they would actually work in the human body!

Conversely, if the compound passes the animal stage, we move it on to humans – with a phenomenal failure rate!

To any outsider, it is OBVIOUS something is wrong here and requires a concerted, industry-wide focus in order to be able to fix it and garner more success.

I say all of this because I spend my ‘days and nights’ trying to figure out why the majority of Big Pharma (and biotech) have side-lined their Safety and Toxicology people? As to the Global Head of Toxicology and Safety I referred to above, he is actually no longer in that job … like many of my colleagues in drug safety – his role has been ‘expanded’ to include more important areas in the company (than safety!!!???). OMG.

I know I may seem biased (because we have the SafeTEC consortium with 15+ safety validation projects to evaluate this year), but I truly wonder ‘when’ will the Presidents in the biopharma industry start to fund the future drug safety and toxicology tools, assays and in silico modelling solutions that could bring ALL of us more success … and bring cures to market FASTER!??

Let’s look at the facts:

“The in vitro and in vivo preclinical models don’t predict what will happen in humans … 36% of the time,” from ‘Nature Biotechnology’ as quoted in Forbes by John LaMattina, Previous President of Pfizer Global Research and Development.

And, based on a study published in 2015, a whopping 51% of compounds from four major pharmaceutical companies listed the primary cause of failure for terminated compounds as non-clinical toxicology or clinical safety.

If you agree with me, do any of the following (or all!):

1. Read The Goal, by Eliyahu M. Goldratt (the link has a free copy for you!)
2. Tell me if you agree or disagree with my conclusion … that improving SAFETY tools for the industry needs to be JOB #1 (and tell me why you feel that way)
3. Contact me to join our SafeTEC Consortium … for the first 20 industry people, I’ll let you in for FREE for the next 4 months!
4. Let’s work on a pitch together, to your President – to convince him/her that SAFETY research, and the development of new tools for the industry, needs to be a TOP PRIORITY for them over the next 5 years. (Then, let’s take that presentation to the Pharmaceutical Research and Manufacturers of America®)

For questions, comments or to sign up for one of the 20 free slots, contact Dawn at 416-402-8274 or dawn.vandam@onemillionsolutionsinhealth1.org.

Click Links Below for Information about the SafeTEC™ Consortium to Evaluate New Technologies:  Download HERE to see the List of 15+ Technology Projects, and $3 Million Investment, for SafeTEC.

http://www.onemillionsolutionsinhealth.org/collaborate/safetech/

http://www.onemillionsolutionsinhealth.org/collaborate/signature-square/drug-safety-leaders-talk-about-safetec/