A Smoother Journey
The journey from large molecule to approved biotherapeutic is long, costly, complex, and fraught with risk – yet tempting with reward.
Knowing what to expect, where to go for support, and uncovering biotech startup resources can smooth the path for emerging biotechnology and biopharmaceutical companies.
Click the arrow on the right or use the buttons above to begin your journey from Discovery to Manufacturing, from funding to protecting intellectual property and complying with regulations.
A biologics candidate journey of 1,000 miles…
Funding will be necessary to validate your therapeutic compound candidate, as you take the protein-based molecule through target validation, lead identification, and optimization.
You will also need intellectual property (IP) protection. Researching and filing for patent protection – and understanding best practices to increase chances for success – is critical at this early stage.
Safe & Effective
Pre-clinical testing establishes that the target compound is safe and effective – before it can be tested in humans. The in vitro, in vivo and animal testing at this stage can take several years – as many as six.
The goal here is preparing and filing an Investigational New Drug (IND) application.
To cover toxicology and safety studies, prepare for manufacturing considerations, and outline clinical trials protocols, you need capital.
It is also helpful to begin understanding the regulatory requirements – so you’re staying the course and correctly tracking data you’ll need later when filing the IND.
It's Only Human
Phase I means you’ve filed your IND and are ready to begin evaluating your drug in humans.
More funding – in the millions – will be necessary to survive the average three-year span of Phase I clinical trials. These test the drug in a group of 20-80 healthy individuals to determine:
Is it Effective?
Phase II tests the effectiveness of the biomolecule in actual patients with the disease or illness you’re attempting to treat. These years-long (three, on average) clinical trials involve a few hundred volunteers and help determine the drug’s safety, any side effects, and optimal dosing.
Phase II is high stakes, because determining efficacy is critical to obtaining the funding you need to continue testing. Learn more about funding requirements and how to obtain capital here.
Phase III trials use a much larger patient population – in the thousands – to give statistical weight to results that can prove safety and efficacy. This phase helps determine the drug’s benefit-risk ratio. Averaging three years, Phase III trials consume the vast majority of overall investment – as much as 90 percent – because of the requirement for validation, larger size, and greater risk.
We offer technology transfer and facility design services to prepare you for transitioning from clinical to commercial production.
The Finished Product
Whether manufacturing clinical trial batches or commercial production, your manufacturing process must meet the same high standards as your R&D and clinical trials.
Things to consider in the manufacturing phase:
Lack of funding is one of the main reasons for failure of a biologic.
Estimates vary, but some project it costs $8-10 million just to get to IND stage, another $8-10 million for Phase I, and $20-40 million for Phase II, depending on design. Phase III costs considerably more.
Don’t let a good drug go to waste, or too much of its value to third parties, because of funding issues. There are ways to fund biotech, from biotech crowdfunding, nondilutive funding, and nonsoursive funding, to biotech grants, angel investors, venture capital and other resources.
Intellectual property strategy is essential to protecting ideas and the business. Emerging biotech community members shared their insights.
Stay the Course
On the journey to commercialization, be sure to stay the course by understanding the global pharmaceutical regulatory landscape.
Bringing your molecule to market. As part of our commitment to meet the needs of the life science community, we’ve developed several programs that recognize stand-out emerging biotech companies. These programs are designed to support biotech start-ups and medium sized companies in solving their current bioprocess development challenges to bring the next generation of molecules to market.
Learn more about the ABCs of venture capital including how it works and the role of a corporate venture capital.
Learn more about the advantages to work with one source on your mAb, linker/ payload supplies and conjugation services.
Review the current dynamics in the RNA therapeutics/vaccines market with a focus on process development and manufacturing strategies.
Learn more on points to consider for successful tech transfers with a focus on cGMP training requirements.
Establishing an open dialog within the biotech community....
A report from the The Economist Intelligence Unit sponsored by MilliporeSigma.
This paper, which incorporates the results of a survey of 254 pharmaceutical executives from around the world and a range of interviews with industry experts, explores in detail global pharmaceutical companies' growth strategies and their plans for managing the associated risks.