Pharma Experts Cautiously Optimistic about Industry’s Regulatory Challenges

New relationship between industry and regulators

So, we should really be talking about adherence to GMP standards rather than blind compliance with them. And to achieve that, we really need a different type of a relationship between industry and regulators, as Dilip Shah pointed out in his article.

Shah, from the Vision Consulting Group, said that when expanding into highly regulated markets, generic companies face multiple challenges, including increasing scrutiny from regulators. Shah argued that generic companies will need to work closely with regulators to ensure that the industry remains economically viable. He called for efforts focused on cost containment such as the introduction of a single reference product, uniform product standards, common packaging specifications, as well as timely approvals and issuance of establishment inspection reports.

Shah also called for a new and expanded role for regulators, arguing that the role should evolve from auditor to facilitator. In particular, he said that the industry needs a regulatory framework that provides:

– science-driven, simple and practical guidance
– clear explanations of the scientific rationale behind the guidance
– consistency – rather than frequently shifting goal posts
– comprehensive training for inspectors to ensure uniform implementation.

The importance of using clear language was also a central theme of Brian Carlin’s article about regulations around excipients. In particular, he focused on the word “critical,” which can mean a number of different things. Carlin, of Open Innovation at FMC, recommended differentiating between “must have requirements” for excipients (e.g., compliance with pharmacopoeial specs, secure supply chain, and manufacture under GMP) and performance requirements (e.g., whether a particular excipient is design-critical or not).

‘Meaningful, measurable, reportable metric’

Prabir Basu and Thomas Friedli, from the Institute of Technology Management at the University of St. Gallen, Switzerland, further helped to frame the conversation by talking about the importance of GMP systems. While CGMP provides a discrete set of instructions that involve many actors, without a proper systems approach, it is difficult to see the “big picture.” They argued that, if continuous improvement is the goal, then it is not sufficient to measure the quality of the product; in addition, we must develop measurements that are linked to the process.

In collaboration with the FDA and the pharmaceutical industry, the St. Gallen research team has been working on “a meaningful, measurable and reportable quality metric” that will help the FDA to establish clearer standards for reviews and inspections and ultimately help the agency to increase the efficiency of its inspection activities.

It is important to note that quality is not the only thing on the mind of the FDA; whether or not the industry likes it, the agency is also actively involved in encouraging innovation. As Girish Malhotra of Epcot International noted in his essay in the CPhI report, the FDA “can cajole but cannot force new or better manufacturing technologies or methods.” Instead, each company has to be able to financially justify its investment in new manufacturing technology and methods.

In his article, Emil Ciurczak of Doramaxx Consulting addressed the role that 3-D printing has played driving some of the pharma industry’s recent innovation. Will 3-D printing be the next step in manufacturing-related innovation or will it be used in parallel with continuous manufacturing? We may see some synergies between 3D and continuous manufacturing, for example, where formulations are developed on continuous manufacturing units and produced on 3D units, he observed. Ciurczak also noted the potential benefits of 3D technology when it comes to drugs for small patient populations where the cost of goods may currently keep manufacturers away. This may be a boost for the generics industry; for many products on the market now, the economics are not there for generics to get involved.

CDMOs: the missing link?

Perhaps, as Gil Roth of the Pharma and Biopharma Outsourcing Association wrote in his chapter, contract development and manufacturing organizations are the answer. He explained that contract drug manufacturing organizations, or CDMOs, will have the potential to advance continuous and other new manufacturing technologies faster than in-house pharma. He also predicted that CDMOs will become a missing link in facilitating R&D into less profitable areas, such as rare and tropical diseases. And he sees a role for them in the generics space, especially when it comes to complex generics.

Alan Sheppard from IMS Health looked at global trends in his article, noting that each region around the world has specific needs and that any opportunities that arise in a market will reflect the particular and sometimes peculiar requirements at a country level.

There seems to be broad agreement that North America remains the most promising region, while the highest volume consumption may be in APAC, although the APAC region achieves low revenue per unit. As Shepherd pointed out, Latin America may remain a growth market but with local companies dominating market shares the Latin American market can be a tough one to enter for foreign companies.