3 key biopharma manufacturing stories to keep an eye on in 2016
With the new year upon us, the biopharma industry has plenty of new opportunities—and, concurrently, many new challenges—to address in 2016.
2015 represented the advancement of several new and exciting therapeutic classes, including the rise of immuno-oncology treatments, gene editing, CRISPR-Cas9, and others. It also came with a fair share of trouble for biopharma companies producing goods abroad thanks to the continuing challenges surrounding quality control and good manufacturing practices.
Here are just some of the biggest stories to keep an eye on in the world of biopharma manufacturing in the coming year.
1) Dealing with manufacturing woes in India
2015 was not a great year for several major India-based pharma firms and manufacturing plants. The FDA sent out a bevy of warning letters (most recently a pair to Gujarat-based Cadila) to facilities in the country, which produces an outsize share of drugs (particularly generic medications) distributed throughout the world.
This means the pressure will continue to be on in 2016, especially in light of a high-profile battle between U.S. and EU regulators and Indian generic drug producers. India's foreign secretary has called the EU's temporary ban on more than 700 generic drugs manufactured in India (over safety and quality concerns) "unwarranted." The ban has stymied hopes of a finalizing a free trade agreement between Europe and India that's been in the works since 2007.
One big part of the problem is that certain key firms, such as Apotex, have begun treating FDA warning letters as if they're just another regular part of business rather than serious and worrisome violations (while insisting that they've made strides in improving manufacturing quality).
Another hurdle is the sheer number of factories in India relative to the available number of inspectors. One recent study found that there are just 1,500 qualified inspectors compared to more than 10,000 drug manufacturing facilities, presenting regulators with a daunting task.
The FDA and EMA are unlikely to let their feet off the gas when it comes to this issue considering the devastating effect that non-compliant manufacturing procedures may have on the drug supply. Bottom-line: How will Indian firms and plant respond to the pressure?
2) New drug delivery technology
The evolution of drug delivery systems is often just as exciting as the creation of new drugs themselves. It is also fraught with the possibility of disappointment.
One (very) recent example of a marketing flop is Sanofi's abandonment of MannKind's Afrezza inhaled insulin. The product was one of the first attempts at creating a new tech for diabetes maintenance that doesn't involve injections. Several other firms had tried and failed before.
Unfortunately, it hasn't broken through to physicians and patients, potentially due to the challenges of shifting away from a longstanding (if somewhat cumbersome) administration process for insulin.
That's the same challenge staring down firms hoping to create ambitious new delivery methods such as pellet implants. During BIO2015, BioPharma Dive spoke with Titan Pharmaceuticals president Sunil Bhonsle on the California-based biotech's ProNeura platform. ProNeura is a matchstick-sized implant inserted into the upper arm to supply a steady stream of medications. Titan believes this delivery system will work particularly well with Probuphine, an opiate-addiction fighting medication.
Other new early-stage technologies will move towards human trials and the market over the next several years. For instance, Prometheon Pharma (whom we also spoke with last year) is attempting to create a transdermal patch capable of passively administering everything from insulin to vaccines in safe doses. The company hopes its insulin patch could reach market by 2019, as all of the ingredients used are already designated as safe by the FDA and available for mass production.
Meanwhile, bigger pharma firms such as AbbVie and Sanofi have struck deals with companies like Unilife for the production of more conventional auto-injector delivery systems.
3) Figuring out large-scale production of hot new therapies like CAR-T
One obvious problem with groundbreaking new therapeutic spaces such as CAR-T treatments for cancer is that the production of the therapies themselves can become extremely expensive endeavors.
CAR-T, which has shown particular promise for the treatment of blood cancers, usually involves extracting T-cells from individual patients and then re-engineering them to create cancer-killing cells. As you might imagine, this is a costly, involved process with many large-scale manufacturing challenges.
That's why larger companies pursuing this space, such as Novartis, may have a competitive advantage over smaller upstart biotechs such as Kite and Juno. Production costs can range anywhere from $50,000 to $100,000 for each individual patient. A pharma giant like Novartis enjoys the luxury of not needing to pass as much of these expenses onto patients. This could feasibly give it a leg up when it comes to pricing battles.
Alternatively, a firm may be able to come up with better, more universal tech that doesn't necessitate such a strenuous production process. French firm Cellectis made history last year apparently cleared a terminal baby girl's leukemia with its own "universal CAR-T" therapy— a therapy which (ostensibly) will not require individual-by-individual cell extraction. Cellectis just may wind up fitting this more universal mold if the results hold in more patients.