Spending on prescription drugs in the United States is expected to reach $600 billion by 2023. The continuously increasing need for pharmaceuticals is mostly driven by an aging population, a rise in chronic pathologies, and lifestyle changes that lead to poorer health.
In this highly competitive landscape, a few giants dominate the industry, leaving a challengingly shrunken environment for smaller entities. Given the fact that the FDA keeps a tight grip on approval for novel therapies, accessing the market is more uncertain than ever. And while venture capitalists invest heavily in start-ups, they also invest wisely, demanding explicit strategies and expecting successful results. In this context, companies must be aware of the most common biopharma risks and know how to prevent them.
Over years of working with pharmaceutical and biotech companies small and large, Treximo’s consulting experience has identified five common risks that cripple product development operations, ultimately resulting in failures, budgets getting out of control, and unfulfilled expectations.
Planning for Technology Transfer
Transferring the technology from the process development team to the manufacturing team requires careful consideration and planning.
- Is the process easy to scale-up?
- Are the receiving sites equipped with the same capabilities as the sending site?
- Is all process documentation comprehensive and unambiguous?
- Have communication channels been established and tested between the teams?
- Does the plan allow for an optimal time-to-market schedule?
Any gap or oversight in tech transfer inevitably creates delays and incurs extra expenses when it does not completely put the entire production process in question. Focusing on the quality of the transfer process and communication ensures a smooth transition and the ability to quickly react to unexpected hurdles, especially if production is outsourced to a CMO.
Strength of the Supply Chain
Regulatory affairs set aside, drug production and marketing are very much like manufacturing cars or electronics. It involves a complex network of interdependent partners, including:
- Raw materials suppliers
- Manufacturing plants
- Logistics providers
- Distribution centers
- Market access facilitators
According to PWC in its Pharma 2020 series, the pharmaceutical supply chain is far from performing as it should, mostly due to lack of strategic investments. Yet, as the link between laboratory and marketplace, it’s a crucial factor of success (or failure) and even more so in a fast-evolving industry with shorter product life cycles and personalized medicine.
The FDA may be the fastest agency in the world to approve new drugs. It’s also one that gets involved in all stages of the process, including preclinical studies best practices, placing a heavy administrative burden on pharmaceuticals.
The FDA intervenes in all phases of clinical trials, but to fully determine if a product is safe for use and delivers on the effects it advertises, the process also includes Current Good Manufacturing Practice (CGMP) regulations, assessing manufacturing facilities, methods, and controls, processing and packing.
Needless to say, the lack of robust regulatory experience can quickly break a trial, even though the product shows promising efficacy. To complicate the matter further, small mistakes when submitting forms via the eCTD structure can result in rejection.
Unclear or no Target Product Profiles
FDA approval is only part of the equation of success for biopharma. It is not uncommon that products reach the market, only to receive lackluster sales. A company’s growth goals and capabilities dictate much of the strategic choice to approach product development. Using TPPs from early on will act as blueprints to be refined throughout the cycle time.
The FDA defines a TPP as “a format for a summary of a drug development program described in terms of labeling concepts.” In other words, product profiles address the audience, timeframe, objectives, and merits compared to similar products.
Well defined dynamic TPPs evolve over time and become enriched with data, progress, milestones reached, conclusions, and discussions. Not only do they facilitate the dialog in regulatory meetings, but they also help keep a sharp focus at the organization’s level.
Some benefits of a solid TPP include:
- Lower risk of failure in late-stage development
- More accurate and timely safety and efficacy data
- Improved processes to decrease drug development time
- Possible reduced review time
Clinical Phases Management
In a study realized between 2006 and 2015, BIO found that only 9.6% of developmental candidates reach phase 2, and 30.7% of candidates move from phase 2 onto phase 3. This can seem quite discouraging for biopharma companies that spent so much in research only to come to a halt due to faulty design in clinical trials, among other obstacles. The field of oncology is particularly tricky, though many other fields experience failure, as the report points out.
When entering the trial phases of product development, organizations should already be aware of their capabilities and have performed a thorough assessment of the areas where they lack expertise and/or resources. Where site selection, patient recruitment, and clinical monitoring are proving too difficult to implement and manage, partnering with a clinical operations expert like Treximo can significantly increase the success rate and limit delays.
Being a Small Biopharmaceutical in a Big Pond
There is no denying that competition is fierce to be the first pharma to offer breakthrough medicine or best next-gen therapies to patients. Giants like Roche, Pfizer, and GSK appear to consistently take the biggest slices of the cake, although they too face challenges (as drug patents reach expiration, revenues drop unless they have proactively and heavily invested in R&D).
At Treximo, we know there is room for smaller entities to succeed and get the market share they deserve. It all rests with product strategy and acquiring process and planning knowledge. We’re crafting custom solutions across the entire spectrum of the industry so your products can contribute to bettering the health and life of people.
Request a no-obligation consultation to discuss your challenges and find remedies.