Survey Predicts Drug Product Formulation Recognition and Increasing Budgets

On Nov. 6, 2018, Rentschler Biopharma, a Laupheim, Germany-based contract development and manufacturing organization, and LEUKOCARE, a Munich, Germany-based provider of biopharmaceutical formulation platforms, reported results from their joint survey, “Formulation in the Drug Product Development Process,” based on research from Informa Pharma Intelligence. 

Survey highlights include: 

• Formulation issues cause significant drug project delays and project failures, as experienced by 60% of survey participants.

• Majority of participants reported experiencing clinical development delays by more than 12 months and 10% experienced a complete failure due to formulation issues.

• Mean average doubling of investments on formulation per project over the next five years is anticipated.

• Importance of early stage formulation is currently underestimated.

The survey was conducted among 150 biotech and pharma companies worldwide active in the biopharmaceutical and/or vaccine industry. Formulation issues have led to 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, according to the companies.

Importance of early stage formulation currently underestimated

One important finding suggested 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,” noted Michael Scholl, CEO of LEUKOCARE, in a company press release.

“There are many opportunities that can be realized if formulation is properly considered in early drug product development and an optimized formulation is developed. 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,” added Dr. Frank Mathias, CEO of Rentschler Biopharma.

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,” said Scholl. “Another area of formulation is the ease of use. Intravenous (IV) is good to use in hospitals with trained administrators, yet expensive and very inconvenient both for patients and physicians. Subcutaneous (SC) 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 IV to SC switch may add enormous value to patients and pharma.”

Investment in early stage formulation set to increase

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 three-fold increase of companies planning to spend between $1 to $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 said. “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 intellectual property (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 was strongly suggested that commercial aspects should be considered when evaluating a formulation strategy, but this is not reflected in the “departments included in the formulation decision making process”. Looking at the data, commercialization specialists such as business development and management, along with marketing and sales, seem to be involved to a much lesser extent at the earlier stages of decision making. Whereas 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,” noted 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 added.

Source: Rentschler Biopharma