LAUPHEIM Germany and MUNICH/MARTINSRIED, Germany—Rentschler Biopharma and Leukocare reported results yesterday from their joint publication of the 2018 Survey “Formulation in the Drug Product Development Process,” based on research from Informa Pharma Intelligence. The survey was conducted by among biotech and pharma companies worldwide, and completed by 150 respondents active in the biopharmaceutical and/or vaccine industry.
Formulation issues have led to either the failure of drug development projects, or significant delays, for about 60% of companies responding to the industry survey, making formulation a key aspect in drug development. One important finding was that, of the projects which were delayed or failed due to formulation challenges, a project delay of over 12 months was reported by more than 50% of the respondents, while 10% of respondents experienced the complete failure of a project.
“Given this very obvious and significant impact on the success of drug development, we were surprised to see that about half of all respondents thought the deployment of a ‘commercially viable’ formulation should take place only during or after Phase IIa clinical trials or as late as the start of Phase III trials,” said Michael Scholl, CEO of Leukocare.
“There are many opportunities that can be realized if formulation is properly considered in early drug product development and an optimized formulation is developed,” added Dr. Frank Mathias, CEO of Rentschler Biopharma. “For example, amendments such as longer shelf life, advantages in intellectual property, accelerated market entry and most certainly reduced costs are vital considerations to the success of a drug.”
When asked about important aspects of formulation, 83% of respondents attributed “competitive advantage” as “very important or important” on a five-point scale and 75% found a “reduced time to market” “very important or important.”
“The competitive advantages to be gained from strategic formulation planning are potentially vast. For instance, a vaccine that must be transported in cold store or frozen becomes expensive and bulky to transport, while a vaccine that can simply be transported at 4°C or room temperature is relatively inexpensive and the potential geographical markets are much greater,” noted Scholl. “Another area of formulation is the ease of use. Intravenous (i.v.) is good to use in hospitals with trained administrators, yet, expensive and very inconvenient both for patients and physicians. Subcutaneous (s.c.) administration gives enormous flexibility and the potential for self-administration in treatments of chronic diseases. Last but not least an improved safety profile of a biologic via i.v. to s.c. switch may add enormous value to patients and pharma.”
In terms of early stage formulation, the responses show a willingness to invest more funds in early stage formulation within the next five years, as indicated by a 3-fold increase of companies planning to spend between US$1 to US$5+ million on formulation per project over the next five years.
“We found that the industry is expecting an approximate mean average doubling of investments. This does indicate that companies are beginning to understand the real potential of drug product formulation. However, the question remains if the current spending on formulation is adequate given the importance that respondents allocate to formulation,” Mathias mentioned. “The indicated raise could also be related to the growth of biosimilar and generic drugs which our clients expect and where they feel a higher investment will put them in a much better competitive position in terms of early market entry, competitive pricing and ease-of-use, for instance.”
This view is backed by the survey where IP, time to market and development time topped the respondents’ formulation priorities in response to the question, “How important are the following considerations in evaluation of your formulation strategies?”
It became clear that commercial aspects need to be considered when evaluating a formulation strategy but surprisingly, this is not reflected in the “departments included in the formulation decision making process.” Looking at the data, commercialization specialists such as business development, management, along with marketing and sales, seem to be involved to a much lesser extent at the earlier stages of decision making. Formulation development, bioprocess, drug product development and clinical development are the main decision-making departments at the earlier stages of drug product development.
“It appears there are many different understandings of formulation and the potential it delivers in overcoming drug development challenges. For instance, the costs of putting clinical trials on hold for reasons of formulation are significant and often put massive pressure and risk on R&D budgets,” continued Scholl.
“Beyond this, to know the final market positioning of approved products from an early stage can help companies in business development and licensing deals, as well as IP positioning. This study has raised several vital points for the formulation and drug manufacturing industries and we are ready to take these lessons forward in our business,” Mathias said.
To learn more about the findings mentioned in the article, you can view and download the complete report here.
