Life Science Leader Magazine Supplements

CMO 2017

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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Page 23 of 81

By B. Chatterjee HARMONIZING QUALITY MANAGEMENT SYSTEMS IN EARLY DRUG DEVELOPMENT CONTRACT SERVICE PROVIDERS Collaboration LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 22 several elements of a QMS that can become points of contention between a sponsor and CSP and should be considered when evaluating a partner. CHANGE CONTROL Change control processes are notorious for their ability to impede a program. Poorly designed change control programs are known to suffer from a myriad of weak- nesses, including a poorly defined or missing risk component, poorly defined structure and content, and a propensity for subjectivity. Each of these weaknesses is magnified when engaging a CSP. An initial due diligence audit is an excellent opportu- nity for determining how change control is adminis- tered at the development site, and how and when the sponsor will be involved in its evaluation. Often, it's stated that "any change that could impact the sponsor's product will include an evaluation by the sponsor." But as always, the devil is in the details. For example, does a one-for-one replacement, typically described as a "like and kind" replacement, include a sponsor sign-off? When evaluating the change control process, consider the following four questions: 1. Does the procedure clearly articulate what con- stitutes a minor, major, or critical change? 2. Does the change control procedure clearly define under what circumstances and to what extent a sponsor can be involved in a change control pro- cess and decision? A LOOK AT DIVERGENT PRIORITIES The challenges that face the sponsor company and CSP are often divergent. For example, a CSP must balance the unique requirements for a new program with the commitments and systems it has already in place for existing commercial clients and products. The com- pliance tolerance and philosophy of a sponsor, on the other hand, can be moving targets, complicated by evolving regulatory standards and industry best prac- tices, and to a great extent, innovation and technology. The CSP's ability to juggle and accommodate these customer variances will often define its suitability as a long-term and fully aligned partner. In a recent industry survey, 315 respondents cited no less than 18 criteria for evaluating a CMO. But while every outsourcing decision has program-specific ele- ments integral to the selection criteria, there are com- mon elements to be considered that help avoid unex- pected surprises – on both parties' behalf. HARMONIZING QUALITY MANAGEMENT SYSTEMS A core challenge to a successful engagement with a CSP is aligning the quality management system (QMS) for both the sponsor and the provider. For virtual orga- nizations, there may be very little to harmonize, and partners are often selected in large part based on the maturity of their QMS. However, as programs move through development, and the sponsor establishes its own internal expertise and oversight, the potential for divergent processes and practices increases. Here are Today, most biopharma development programs include the support of a contract service provider (CSP) for everything from early development contract research to commercial manufacturing and analytical support. The factors that drive the decision to engage a CSP for commercial manufacturing are many, and there are multiple collaboration elements that impact organizations' ability to work together effectively. Let's explore one of the most important considerations when establishing a relationship with a CSP for early development programs. Harmonizing Quality Management Systems In Early Drug Development B I K A S H C H A T T E R J E E

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