Strategies For Today's Top Quality & Regulatory Outsourcing Challenges

The industry’s evolving currents, such as expedited regulatory pathways to approvals, the advent of groundbreaking scientific technologies and platforms, and an unprecedented level of global outsourcing, highlight why quality and regulatory teams need to work in close synergy and outsourcing partners need to maintain tight-knit collaboration to ensure alignment.

Recently, Outsourced Pharma hosted and moderated a Live! event on “Strategies for Today’s Top Quality & Regulatory Outsourcing Challenges,” and the panel focused on these pressing challenges. Outsourced Pharma Chief Editor Louis Garguilo moderated the discussion and was joined by:

• Karla Knower, global head of regulatory affairs, Paradigm Biopharmaceuticals;
• Christine Feaster, vice president, Quality Executive Partners, Inc. (QxP);
• Bikash Chatterjee, president and chief science officer, Pharmatech Associates; and
• Erin O'Brien, executive director, head of small molecule development, Biogen.

This article shares highlights from the discussion. The full event is available to view by clicking here.

Contract Organization Selection Strategy

As the industry's need for contract organizations (CMOs/CDMOs) expands, it brings along a set of challenges that require attention.

Due to the speed of the growing market, there is an increasing emphasis on outsourcing, particularly in quality and regulatory activities. Three main challenges are workforce availability, upgrading legacy equipment, and supply chain issues. Workforce availability underpins many of the challenges, highlighting the need for skilled personnel. Upgrading legacy equipment is particularly crucial for companies that are trying to adapt to new technologies like gene therapies.

Companies should not “just outsource” but form strategic partnerships that align with their specific needs and stages of development.

The Criticality of the Quality Agreement and Managing the Relationship

The panelists all agreed that the quality agreement is crucial for clear communication and defined expectations. The quality agreement should be comprehensive, covering aspects like supplier selection, starting materials, and quality expectations. If you're having environmental excursions and an aseptic filling suite and your product is made in that filling suite, how are you going to handle reviewing those deviations? The quality agreement establishes how to handle specific challenges that may arise, ensuring everyone is prepared to manage these complexities.

When it comes to managing the relationship, offer yourself and your quality folks up to help out and coach. Let your partner know the reasons why you have to have things done the way that you want them to be done. Sometimes, you have to take a few steps back and build that relationship through your rapport with them and try to get to know them. Then you can let them know your expectations for roles, responsibilities, and communications.

The industry is experiencing a change in the nature of quality management, related to the FDA's New Inspection Protocol program introduced in 2018. You need to consider not only your CDMO’s QMS but also the newer notion of quality maturity. The criteria for selecting a contract partner have evolved, emphasizing the need to assess softer characteristics like quality sensibility and expertise in specific areas like sterility assurance.

A major point of the panel discussion centered on the use of shared data to overcome challenges. The consensus was that shared data could streamline communications between different industry sectors. These are complexities that happen every single day when you use a contract manufacturing partner because of the need for confidentiality. If you haven't worked out a system, you're going to run into problems.

Technical, Quality, And Regulatory Alignment

Alignment between departments is more critical than ever. Quality and regulatory departments must work closely, especially when overseeing multiple suppliers across different timelines and geographies. A strong pharmaceutical quality system can assist with that synchrony and, hopefully, get things moving as smoothly as possible. Good working relationships within regulatory and quality departments can significantly impact the management of outsourced needs.

The Criticality of Education

As the technologies and modalities in the industry evolve, the need for education and expertise is increasingly critical for companies and contract organizations alike. The industry needs more emphasis on education and understanding the background of biotech processes. If the quality team is better able to understand the technical data, they can make more informed decisions in collaboration with regulatory.

Garguilo highlighted the challenge of converting legacy facilities to accommodate new modalities like cell and gene therapies. When you're working with workers who were in that legacy facility and now they need different skills, how does the industry move forward? This question underscores the need for continuous education and skills development among workers to adapt to new technologies. There are pitfalls to promoting individuals without the necessary expertise. Companies should be proactive in educating and coaching their contract partners, especially when expectations rise in later phases of drug development.

Due Diligence and Accelerated Approvals

The panel touched on the impact of accelerated pathways on technical aspects of drug development. Even if a program is not on a special pathway, countries are starting to ask more questions about the quality aspects of regulatory starting materials as early as Phase 2. This increased scrutiny can be disruptive but is essential for ensuring the quality and safety of the final product. It also reinforces the importance of selecting the right contract organization to ensure process transparency. Regulators want to know that there are no impurities coming through that are going to track through to the API, and that becomes even more important if you're on an accelerated pathway.

A robust quality system for supplier selection and management is important. You can do a desktop audit, phone calls, or numerous virtual interactions, which have become a lot easier in recent years, to request that the relevant credentials are provided. This approach is particularly important when dealing with suppliers that are geographically distant. There is value in on-site visits and the use of qualified auditors as strategies to ensure compliance. The ultimate goal is to view suppliers and contract organizations as extensions of your own team, working in synchrony to achieve common objectives.