November 06, 2017
Download our latest eBook “From Molecule to Medicine” to learn about how Patheon, part of Thermo Fisher Scientific, is accelerating drug development and delivery.
The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development. Companies must understand how the molecules filling today’s pipeline are changing our business, as they are causing a dramatic shift in how we plan for and execute drug development and manufacturing. As a CDMO, our customers’ needs give us a unique perspective on the evolution of the industry and how it is shaping today’s market. By passing this insight on to you, we at Patheon, part of Thermo Fisher Scientific, hope it gives you a better idea of industry trends in drug development.
As the biopharmaceutical industry continues to evolve, the Quality by Design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. In response to increased interest from global regulatory agencies, QbD seeks to further reduce the risk associated with drug development and bring much-needed therapies to market quicker.
Sponsors who implement QbD early can save money through increased product / process knowledge, less re-work, less product deviation, less product out-of-specification, fewer rejects and improved quality.
There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. For primary pack choices, there are traditional vials, ampoules, cartridges, pre-filled syringes and complex containers such as the various types of dual chamber syringes. Additionally, there are newer dosage forms such as wearable injection devices or pump patches. Each have their own merits and advantages, but these advantages may not be realized until the product is marketed. Consideration must also be made on the form of the product within the container and the environment in which it will be used and needs to be (or is able to be) stored.
Biologics have experienced steady double-digit growth over the last 15 years and now comprise slightly more than a quarter of all New Molecular Entity (NME) FDA approvals. Similarly, EvaluatePharma’s 2017 report on orphan drugs projects that by 2020, six of the 10 best-selling global drug therapies will be biologic sterile injectable drugs. Precision medicine is also on the rise, with the FDA approving a record number of precision drugs in 2017.
The rise in these targeted therapies and precision medicine means big changes for drug development and manufacturing companies. Learn what pharma companies should look for when navigating this new era of small-volume manufacturing.
Whether your company is built on a single molecule or you’re a global pharmaceutical leader, you need fast, cost-effective and scientifically-based insights during early-phase development. Patheon can provide you with customized early development strategies and technical solutions to solve complex development challenges.
The numerous controls and processes in place to ensure a medication is safe, effective, and manufactured with the utmost efficiency make drug development extremely complicated. The challenges of drug development can increase if a manufacturer assumes an existing formulation for an adult can also be used for a child. Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays and costs to the development process.
Given the increasing pressure to speed up drug development and make the process more cost-effective, pharmaceutical companies want to ensure that their most promising drug candidates hit the market. However, while speed to the clinic – and then to market – is often thought to be the key to success, it is equally important that formulation, process development, scalability, and stability challenges are addressed by systematic, smart scientific solutions to de-risk the drug development process so that costly late-stage failures can be avoided.
With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage (OSD) arena. Current areas of exploration include novel drug combinations, oral delivery of large molecules that were available only as injectables, and perhaps most interesting, drugs that carry digital, ingestible sensors that can send information directly to a physician.
Learn about Patheon’s full dose form capabilities and technologies, including various tablets, caplets, chewables, powders, softgels, and more.
Leverage Patheon’s broad range of expertise, from pre-formulation through commercialization, to help your project achieve success.
Your molecule has the power to change lives and shape the future. Patheon is the company that offers you the agility and speed to help you get there ahead of schedule while maintaining the highest quality. We bring deep scientific expertise to every challenge and our proven track record of scaling up biologics help ensure you gain cost and time savings at every stage of the biologic development process.
When aggressive timelines are a “must,” it’s critical that companies don’t gloss over early-phase scale-up throughout the development process. The time and effort spent on risk assessments and thinking about scalability early on will pay dividends in the long run as the path toward regulatory approval is smoother.
Regardless of whether your group has been diligently planning for scale-up since Phase I or you have delayed scale-up work until now, it would be a mistake to assume Phase III will be clear sailing. The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process development teams may be.
The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs.
Take months off the development timelines of your large and small molecule discoveries. With Patheon OneSource™ you can combine your drug substance and drug product development and manufacturing into a single customized solution to simplify your supply chain and accelerate your discovery to proof of concept. You’ll be able to develop small molecules 8–12 weeks faster than the industry-standard 15 months, and large molecules 14–20 weeks faster. And the advantages don’t end there…
Pharmaceutical companies walk a tightrope in early drug development. They have to balance speed, quality, scientific risk, and API cost. Compromising on any one of these four crucial elements can prove fatal to a product candidate. Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.
We know the cost of developing a prescription drug is estimated at $2.6 billion, and takes 10 to 15 years from target selection to drug approval with an overall success rate around 10%. Furthermore, only about 35% of drug discovery projects succeed in delivering experimental drugs ready for clinical testing.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.
What’s the best path for your low soluble molecule? Two molecules, both designed to treat the same condition, both with solubility challenges. Two biopharma companies racing to be first. Biopharma A chooses to move into trials as quickly as possible, while Biopharma B decides to address broader solubility concerns first. Who gets to market first may surprise you.