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What to develop?

Not all clients come to us with product ideas.  Indeed, they want us to help identify a short list of suitable candidates.  Example companies might include technology platform companies. How do we go about helping these clients?

We have a four-step process: Criteria Selection, Criteria Evaluation, Candidate Narrowing, Candidate Selection.

1. Criteria Selection.  Every company will use different criteria to determine what products to develop.  In the following table, I present a possible sub-set of criteria and acceptance parameters.

Criterion Acceptable range
Unmet medical need exists  Yes/No
Regulatory Pathway  505(b)(2)/505(j) Suitability Petition/505(j)
Indication  Chronic/Acute/Cyclic
Dosage Form  Tablet/Liquid Solution/Liquid Suspension/Other
Patent  Paragraph 1 or 2 (expired)/Paragraph 3 (will expire by approval)/Paragraph 4
Clinical evidence of efficacy/safety exists  None/Some/Robust
Ability to show positive pharmacoeconomic data  Already exists/Likely/Possible/Unlikely
Clinical Requirements  Phase 1 pharmacokinetics or similar  ~$700k
Phase 1 & 2 & 3  >$1.5 <$5MM  
Phase 1 & 2 & 3  >$5MM
Approval Date  (Month/Year)
Pre-clinical Requirements  Yes/No
Exclusivity  (How long?)
Competition (needs definition: # of other drugs in space, promotional activity, ?)  High/Medium/Low

2. Criteria Evaluation. 

After establishing the criteria and acceptance range that “fits” the company business model,  the potential products can be estimated.  At this point, the products are not evaluated in depth but are based on experience.  We will be very optimistic and include products that may fall out later after more in-depth evaluation.  We develop a chart like the table below, providing a column for each product (A, B…).  How many products we list depends on the nature of the criteria, but is usually more than 10 products.

Criterion Acceptable range Product A … Product G
Unmet medical need exists  Doesn’t matter    
Regulatory Pathway  505(b)(2)    
Indication  Acute    
Dosage Form  Oral solid    
 etc.  …    
 etc  …    
Pre-clinical Requirements  No    
Exclusivity  3 years minimum    
Competition  Medium, first line therapy    

3. Candidate Narrowing. 

Using the table above, the client will often change the criteria and or acceptance.  This is a learning experience for many clients and once they see the resulting products, they will often indicate that they need to refine some aspect of the list.  In any case, the next step is to reduce the list of products to 2-3.  The process to reduce the list is to choose the most important criteria that differ among products and do an investigation in sufficient detail to separate the products where possible.  For example, let’s say that the client wants to develop products that will require a Phase 3, in order to get 3 years exclusivity.  The choice of products include Phase 3 studies that are 2-, 3- and 4 arm, that have positive and/or placebo control and some with and without previous FDA guidance (a risk factor).  the clients narrows the candidates to those with 2- or 3- arms, placebo control and guidance documents.

4. Candidate Selection. 

With the list narrowed to 2-3 products, we do a  deep dive.  We follow the Camargo assessment process for each product until we come to a stopping point – when a criterion is is not met to the satisfaction of the client.  For example, that upon deeper study, development of an extended release version of a currently marketed immediate release product is found to have too high a dose and resulting pharmacokinetic profile could interfere with sleep.

So there we have it, a product candidate (or two).  It took about 3 months of effort, time and energy well spent.  We have started out with just a wish list of product characteristics, narrowed it down to fit the business and, armed with the assessment report, we have a  product that has a full development plan including costs and timelines and full documentation to go to the FDA to get its buy-in at the pre-IND meeting.