Automation & Control / Compliance Management / Continuous / Regulatory Guidance

Top Pharma Manufacturing Predictions for 2019

From new tech to innovative business models and shifting regulations, industry experts weigh in on what changes are coming down the pipeline.

What will 2019 have in store for pharma manufacturers? From new tech to innovative business models and shifting regulations, industry experts weigh in on what changes are coming down the pipeline. 

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Innovations in Manufacturing 

Automation continues its rise: The entire pharmaceutical industry is focused on the goal of reaching zero defects. Stringent quality requirements demand higher reliance on automation, and as a result, drug delivery system manufacturers and their pharmaceutical and biotechnology customers will continue to invest in process excellence programs and automation within their global operations. This will occur due to the heightened quality standards to which drug manufacturers and their packaging and delivery systems partners must adhere, and the ability these companies now have to minimize risk by removing human interaction in various processes. ~David Montecalvo, senior vice president, Global Operations and Supply Chain, West Pharmaceutical Services, Inc.

Companies will look for new ways to have the edge: As the demand for personalized medicines rises,smaller volume biotech products are therefore likely to be prevalent across 2019 as breakthroughs for rare and hard to treat conditions are made.

This could also trigger advancements in technology for medicine administration, as companies try to add value and differentiate their products from competitors by improving patient experience and creating more personalized approaches. ~Daniel Tedham, managing director, Wasdell Manufacturing  

Packaging will get smarter: There will be greater exploration into how to integrate printable electronics with pharmaceutical products. Incorporating sensors into product packaging, and the product itself, could deliver information to manufacturers on how a product is used and its storage conditions and ensure security, help determine resupply requirements and identify which market a product is being supplied to.

This kind of insight could be revolutionary for the industry as companies can begin to access real-time information that would have previously been difficult to accurately obtain. ~Daniel Tedham, managing director, Wasdell Manufacturing  

Companies will make better use of data: As patients become more involved in their care and evaluate options available to them, pharma organizations are working on new care models to work more closely with the patients and not just with physicians, healthcare organizations and payers. Focus on the patient experience will force the payers, pharma, and providers to come together and provide a holistic approach towards overall wellness. 

Getting there requires a well thought-out data strategy that helps bring together all patient data in a compliant way and uncover relationships between patients, physicians, caregivers, hospitals, payers, plans and prescriptions. As a next step, pharma will use advanced analytics and machine learning on reliable data to identify the next best action for timely and compliant patient engagement in order to achieve the best health outcomes. ~Manish Sood, CEO, Reltio

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The rise of non-traditional dosage forms: A number of factors in the market are reshaping the approach to dosage forms and we are seeing a definite rise in non-traditional dosage forms such as nasal sprays. About 40 percent of marketed drugs and as many as 90 percent of drugs in the development pipeline are poorly water-soluble APIs making this an increasingly common issue in pharmaceutical development. 

When these drugs are introduced through traditional dosage forms such as oral solid dose, they fail to dissolve, have severely limited bioavailability and therefore have limited therapeutic effect. There are multiple techniques available to increase the solubility of drugs and improve their delivery, particularly the use of amorphous solid dispersions and nanoparticle formulations. ~Barbara Morgan, general manager, Particle Science

More R&D dollars could shift from drugs to medical devices: While drugs still have the ability to provide larger multiples on returns, there are three factors that may drive investors towards medical devices instead. First, large molecules are running into reimbursement issues that are keeping some very effective drugs on the shelf. Second, outside of cancer drugs and rare disease treatments, the regulatory approval process for drugs have not seen the same attention as medical devices, wherein medical device regulatory scheme seems to promise a faster and more efficient regulatory process. 

Lastly, NIH funding (adjusted for inflation) has been flat for the past 15 years, causing academia to look towards the private sector. While partnering with the private sector has its advantages, the science needs to be closer to something that can be commercialized, possibly delaying the discovery of some new and exciting tools or schemes for treating diseases. ~Thomas Wolski, partner, Webb Law Firm

Changes in Regulations

Regulatory strategies could shift and become stricter: Countries that have not traditionally held stringent regulations, such as India and China, are going adopting tighter controls. In China there’s a big shift towards non homeopathic medicines. The FDA is looking to apply more of a risk-based approach. This reduces the burden on the FDA, but also is a smarter approach. 

Regulatory agencies are there to serve the health and well-being of the population, and if the patient is more knowledgeable and has higher expectations, it’s going to have an impact on regulatory agencies. You’ll also see more demanding regulations because of the increase in disruptive products such as 3D printed devices and personalized meds. ~Steve McCarthy, vice president, Digital Innovation, Sparta Systems 

One case could change the landscape of patent partnerships: The Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. is a critical case that is currently being considered by the U.S Supreme Court. The case questions whether the American Invents Act (AIA) permits certain type of partnering agreements before a patent application is filed. The Supreme Court heard oral arguments on Dec. 4. I believe that the Supreme Court will agree with the Federal Circuit and find that the AIA on-sale bar can invalidity a patent if you partner with a third-party to sell a drug before you even know specifically what the drug is, and that it will not address a critical question of whether secret sales (e.g. sales under confidentiality agreements) can invalidate a patent under the AIA.

The fall-out will be that small and large molecule companies will need to bring their folks dealing with distributors in line with the overall patent strategy, and may delay the introduction of drugs into the marketplace after FDA approval. Also, we may see drug companies filing a string of provisional patent applications directed to a similar invention to give themselves a broader scope of priority dates. Put simply, the Helsinn case may increase the patent costs to smaller drug companies, and delay the commercialization of drugs. It may also drive smaller biotech companies to partner will larger pharmaceutical companies earlier to avoid some of the pitfalls and fall-out of the Helsinn case. ~Thomas Wolski, partner, Webb Law Firm

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