Pharmaceutical and biotech startups with tight budgets may think twice before adding a project manager to their personnel, especially since tools like Gantt charts can be a useful way to avoid hiring a new team member.
Image Credit: DSI, a PLG Company
The COVID-19 pandemic created new challenges in the discovery and commercialization parts of the drug development process, mainly due to the increase in remote work. Continue reading to determine whether your company would benefit from hiring a project manager and how to maintain focus on your company's goals while launching a medical product on the market.
Why Should Companies Hire Project Managers?
Drug development projects can be more complex than routine meetings as there are many processes and players to consider.
Paul Long, MBA and Senior Project Management Consultant at DS InPharmatics, highlights the importance of having qualified personnel track development project dependencies.
Long says bottlenecks can occur and funnels can arise when "subject matter experts (SMEs) work on different projects and as clients have multiple tasks to perform.”
A lack of awareness around timing can affect a project when teams are located around the globe. Coordination across time zones can prevent successful documentation handoffs and keeping each team member moving toward the project’s goal.
Long suggested ensuring teams establish communication channels that correspond with the client’s needs in order to successfully move in the right direction.
He states that taking the time to establish preferred methods and levels of communication is required when meeting new clients to ensure cohesion across teams.
DS InPharmatics consultants bring various perspectives when conducting internal discussions with a client to address different service areas, including regulatory, drug substance, drug product, quality assurance, and clinical supply chain.
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Long says a project manager’s value is strong risk assessment to ensure roadblocks do not disrupt projects.”
Challenges Presented by a Virtual-First Environment
When the COVID-19 pandemic happened, companies scrambled to understand how to maintain communication to ensure seamless execution of projects in a remote-first work environment.
Face-to-face communication became near impossible and finding the correct virtual meeting software became paramount to host successful conference calls.
Long affirms the positive effect of virtual meetings, stating that comfort with virtual communication methods can allow for more fluid conversations, prevent project delays and allow a project to cycle through various stages.
The evolution of technology creates challenges in virtual environments, such as allowing multiple users access to a digital Gantt chart to collaborate across drug development projects. Long says digital documents have a “social media” component to them, allowing cross-functional teams to monitor factors outside of the scope of a project and readily contribute in group discussions.
Hiring a project manager is crucial from the start of any project as they are responsible for aligning the team with the client’s goals in order to meet expectations. DS InPharmatics consultants can ensure proper tools are in place to allow for effective cross-functional communication while strengthening relationships.
About DS InPharmatics 
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.
French-headquartered ProductLife Group (PLG) is well-known in the Life Sciences market. It has a track record of successfully managing global outsourcing programs and insourcing services for its international client base. The company is on a mission to help transform human health outcomes by optimizing regulatory affairs, safety & vigilance, and quality compliance for life sciences organizations worldwide.
The fit between our two organizations could not be more perfect. We will complement PLG's growing biotech services portfolio. US biotech sponsors recognize DSI as a leader in consulting for go-to-market strategies and RA pre-market consulting. At the same time, PLG has a strong reputation for managing end-to-end outsourcing of regulatory affairs and pharmacovigilance activities worldwide.
Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database - as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements.
We see enormous potential in this new chapter for DSI and you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we're incredibly excited to add our momentum to that effort.
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