By Sergio Lucero – Director & CEO
In the pharmaceutical industry, product development is a priority and foundational stage. It is not my intention in this article to refer to the development of new molecules, which is restricted to large companies or companies that can obtain significant funds from long-term investors who are at high risk of not recovering their investment.
I will focus on the development of generics or alternative ideas for products with approved active ingredients, to be developed in a different pharmaceutical form known as NDA505 (2) (b) in the USA or Hybrids in the EU.
I will consider the case where the owner of the idea has a clear concept about the desired transdermal product but does not have the experience, knowledge or transdermal development capacity and he needs to contract a company to carry out his idea.
Who can this company or person hire to take their idea and develop a transdermal pharmaceutical product?
I.-These are the initial factors I propose to review when selecting the developer. Should we look for:
It should be highlighted that every project is a special case and we cannot define a general “norm or rule” for all cases. In turn, all the alternatives have their strengths and weaknesses that must be taken into account when deciding.
For example, many large companies with internal capabilities, often subcontract developments to third parties since their internal bureaucracy requires a period of approval and execution that would slow down the time to reach the market, being this one very important factor in our industry.
Many times, companies that are already established and with an important focus on their growth, do not pay full attention to the needs of their client, but instead, see an opportunity to add a project to their growing client portfolio.
Let’s talk about small companies in size, but solid in their professional staff, with a proven track record and with products developed and being commercialized in several international markets. They clearly exceed the concept of the startup or newcomers.
One of the most important characteristics, in the last case, is that the client can have direct contact with the owners and the people who will run their project (which could be the same people) and not with a Project Manager of a larger company who acts as an intermediary between the customer’s needs and the people doing the job. In turn, this Manager will surely has responsibilities for multiple other projects for different clients.
Now, once we have evaluated the profile or size of the company that we can consider as a suitable partner, we must not forget the reason for such selection: to develop a transdermal pharmaceutical product, usually known as “patches”
And in this aspect, there are other elements that we must consider in this evaluation:
II. What services do we seek in the company we will work with?
Can it be just a formulator or someone with development and manufacturing capabilities? Do we also look forward to his participation in clinical studies and regulatory aspects?
In the proposed approach, we see an advantage in selecting a partner who can provide us with the broadest possible service, to have a single interlocutor in the project and not a different partner for each stage of the project.
There is no doubt that the selected company must have the necessary knowledge and experience to entrust it with the development of our project. But, why not going further on it and consider that the selected company can also manufacture the product in various stages?
For example, it is of little use to us to have a good formula on lab-scale if we cannot bring it to a scale of GMP batches which allow us to carry out clinical and stability studies and which lead us to conclude a solid feasibility stage, guaranteeing the appropriate performance of the developed prototype.
This allows us to avoid the division between the “who develops” and the “who produces” that so often finds grey gaps in the responsibilities.
We see as an ideal the fact of being able to work with a company that can carry out the complete development from the beginning and finish an intermediate stage with a concrete definition of the feasibility of the project (Feasibility & Proof of concept)
As a complement to the above, and considering commercial manufacturing, we should evaluate the following:
Does our potential partner have adequate and sufficient production capacities for our project?
Does he have GMP Certifications for the markets where we plan to commercialize the product?
If not, does he have experience in transferring manufacturing and analytical methods to a third party?
There may be other important points to take into consideration, but I consider as basic the three mentioned.
This topic is truly another very important challenge in our industry. It is not only necessary to have laboratory capacities, but also to be able to define the “available technical space” for development, based on the patents and applications existing at the beginning of the project.
These restrictions constitute a very complex subject and require a team of professionals who combine the necessary knowledge for development but also being trained in the search and evaluation of patents that may collide with the objective. By having a team with both capabilities, we again avoid the grey areas between product developers and patent appraisers. It is also desirable that our partner has the interaction and availability of patent attorneys with experience in the pharmaceutical industry.
A simple way to verify this aspect is to search or request the patents that the company or its researchers have previously filed. The performance of the company in this regard can easily be analyzed. For example, we will know if the patent applications have been approved and in which markets (USA, Europe, etc.)
Every pharmaceutical product must satisfy the necessary requirements of content, bioavailability, dosage, shelf life, efficacy, etc. Here arises the need that the formulation which is successful in its pharmaceutical aspect must also prove its performance in regulatory clinical studies.
In the development stage, bioavailability studies are usually done comparing the generic with the original in a limited number of volunteers. And then, it must be demonstrated to the corresponding Health Authority that the developed product is bioequivalent to the original and has a behaviour closely similar to it in terms of adhesiveness and irritation (specific requirements for patches). There are already established criteria to determine the number of volunteers in each of these cases.
An important asset in selecting our partner is to determine if he has enough experience and practice to prepare the clinical study protocols, that will be evaluated by the Health Authorities, and to be responsible for conducting and monitoring the Study.
Perhaps the contracting company has its own team in charge of these protocols in general, but writing them for the transdermal pharmaceutical form has its special characteristics, so it would be very useful and time-saving if the teams of both companies (developer and contractor) specialized in this item can work together.
This point is also easy to assess: How many protocols and clinical studies have been carried out? With which clients? In which markets have they been presented and approved?
In the transdermal pharmaceutical industry, there is a variety of offer in development services. The intention of this article is to highlight that, apart from the necessary knowledge and experience of the service provider, it is also very important to evaluate:
As mentioned, the times from the conception of the idea up to reaching the market are traditionally long in pharma. It is important to avoid making them longer, so a good selection of the developer partner is very important.
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