Good Processes Help the Medicine Go Down

Pharmaceutical companies must constantly balance the need for speed—getting medications to market as quickly as possible—with the need to ensure quality and regulatory compliance at every step. Smaller companies can benefit from being nimble and quick in comparison with the large multinationals that dominate the industry. When Tunde Adesunloye joined Sagent Pharmaceuticals as director of project management, he thought he would be leaving behind the delays and obstacles faced by those industry behemoths, but found that small pharma companies face their own difficulties.

“Working at big pharma, we used to complain that there were too many processes,” Adesunloye says. “Coming to a smaller company, I quickly learned that smaller companies have their own unique challenges.  As small companies grow and diversify, one of those threats is how to maintain the entity’s agility and entrepreneurial spirit, while ensuring the right mix of risk mitigation activities exist in the structure.” 

Chicago-based Sagent Pharmaceuticals (a wholly owned subsidiary of Japanese-based Nichi-Iko) partners with contract research organizations (CROs) and contract manufacturing organizations (CMOs) to develop pharmaceutical products for the North American market, with a specific emphasis on injectables. Sagent’s US-based team of over 150 employees coordinates the planning, development and regulatory approval processes and collaborates with partners to manage the timely and high-quality manufacturing and distribution of the products.

Creating generic versions of established medicines is not a quick or simple process. Once key decisions have been made about formulation, manufacturing process, color, packaging and other details, the generic product must pass regulatory approvals before it can be launched in its target market. Problems at one stage can cause a cascade of delays, so it’s crucial for everyone involved in the process to have accurate, updated information. The more applications team members are using to manage an individual project, the more variations can creep into the system. 

It was clear that Sagent needed a tool that would give project teams access to a single source of accurate information, but would also be easy for new users to learn. As Adesunloye was considering the formal project management software he had grown used to using at larger companies, he started talking with two colleagues at Sagent who were using Smartsheet to manage their own tasks. The easy-to-use interface and ability to quickly report exactly the information needed at any given time sparked his interest, and before long Adesunloye had configured a project tracking system that fit the specific process for a product in development.

With the implementation of Smartsheet, stakeholders can easily access the information they need for their own roles or responsibilities. Sagent executive leadership appreciate the dashboards, which provide a clear visual overview of the ownership and status of projects in the pipeline. Mid-level managers use the flexible reporting to share details such as development costs, risk management, and progress updates with a variety of decision-makers. And as a project manager, Adesunloye loves the integrated timeline that keeps deadlines and assignments on track without forcing users to jump between applications.

Sagent works with CMOs and CROs located throughout the world. Smartsheet enables project teams to communicate and collaborate with their partners directly within the solution, saving time and eliminating a lot of potential confusion. Partners can share the specifics of the ingredients they are using, surface any problems they need to solve, and outline their strategies; Adesunloye and his team can offer feedback, challenge their assumptions, or share regulatory updates that may affect the project. Because everyone is sharing the same information, it’s easier to collaborate with a focus on problem-solving and results.

“We are working with a partner in Europe right now; the partner has access to our timeline and multiple reports via Smartsheet.  Requests for regulatory submission documents or reminder for updates are made via Smartsheet prior to meetings. All we do is share a few reports with them and say this is what we’re looking for, please fill this out before we meet again tomorrow,” Adesunloye says. “Partners like the fact that we’re sharing information with them. It’s not piecemeal; they can see everything that they need to see real-time, and that really makes working together much easier, friendlier and more productive. This enhanced collaboration has the potential to make Sagent the preferred partner of CROs and CMOs”.

“I personally see the implementation of Smartsheet as opportunity to use project management tools to enhance the corporate culture.  Accurate and reliable development information are transparent throughout different levels of the organization.  People are excited about Smartsheet; people are asking for more of it, not less of it,” Adesunloye says. “Right now, we’re using it just from initiating development to launch; I see us actually going down to the pipeline development and portfolio management, the programs that happen before development. The possibilities are unlimited, and we are excited.”