At LucasPye BIO, we get it…from the perspective of the biotech/biopharma industries, we’re just another CDMO; and from the perspective of the general public, i.e. patients & family members of patients, etc. – you’re probably wondering what the heck is a CDMO, and why are we “Sooooo Special”?!
LoL! No worries, let me break it down in “regular” words. First, CDMO is an acronym for Contract Development Manufacturing Organization. In other words, we are a Medicine Manufacturer…we make medicine for other pharma companies. To be specific, we make medicine for biopharmaceutical companies. These types of drugs are prescription drugs that are administered either by licensed medical staff, a patient or a family member of a patient via IV or Infusion. These drugs often treat serious viruses and/or diseases such as:
- Rheumatoid Arthritis
- Crohn’s Disease
However, I’m sure you all are aware that these types of prescription drugs are not cheap. As a matter of fact, they’re ridiculously expensive. So expensive that most of us, including me…I’m a broke Start-Up Company Founder & CEO (for now anyway), make hard decisions such as:
- Putting Gas in your Car vs. Purchasing Prescription Medicine
- Buying Groceries vs. Purchasing Prescription Medicine
- Paying Car Insurance vs. Purchasing Prescription Medicine
It’s no secret that our respective Health Insurers, including public aid such as Medicare & Medicaid, are also feeling the same financial “pinch”; thus, causing them to deny coverage for many of these types of prescription drugs.
Now what most people don’t know…is the costs to manufacturing these types of prescription drugs. The average cost to manufacture a biopharmaceutical drug and perform Phase I Human Clinical Trials is a minimum of $15Million. Collectively, the average cost to fully complete clinical development and receive FDA approval for a new biopharmaceutical drug is $2.7Billion.
Why does it cost so much ?
The primary reasons for the high costs are:
- It takes an average of 15 years to clinically develop biopharmaceuticals and place them into the commercial market.
- The Biotech/Biopharma industry is one of the only industries that refuses to digitize their manufacturing operations. To put things simple, Big Pharma and other medicine manufacturers still utilize paper documentation.
- Medicine Manufacturers still utilize stainless steel equipment. When utilizing stainless steel equipment, it must be cleaned, steamed, and re-cleaned after its been tested to ensure that there is no medicine residue from the previous manufactured batch.
- Big Pharma controls access to the biotech/biopharma market. Meaning, they limit new companies with new drugs from entering into the market by:
- “Buying Them Out” – purchasing their new drug, and shelving it because of its similarity to what they already have in the commercial market or its similarity to what they’ve developed in the clinic that is under review for approval by the FDA.
- Keeping the new drug developer in court via a lawsuit to prevent them from placing their “generic”, i.e. biosimilar or biobetter into the commercial market.
At LucasPye BIO, our mission is to change the way biopharmaceuticals are manufactured and clinically developed for FDA approval. We are actively changing this by:
- Fast-tracking the clinical development of our customers’ drug products and cutting-down the timeline from 15 years to 6-7 years.
- Digitizing the manufacturing process by utilizing electronic documentation, including mobile & web applications.
- Utilizing disposable automated equipment to reduce our operating costs for our utilities, i.e. Water.
- Helping our customers strategically navigate the FDA approval process as well as making our manufacturing services affordable for smaller companies with new and/or “improved” (i.e. biosimilars, biobetters) drug products.
To further put it simple, LucasPye BIO is democratizing the drug-making process & market-entry access for our new medicine discoverers and their respective patients.
To learn more about LucasPye BIO (LPB), please check back biweekly for new blog posts here @ www.LucasPyeBIO.com
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