3 Scenarios for BPS Success in Life Sciences
BPS can take companies beyond simply partnering for submission document management and toward true transformation.
by Michelle Gyzen
Life sciences companies are pulled in all directions. They must stay abreast of complex regulatory developments that affect their entire product life cycle. They must innovate to grow. And they must embrace digital technology and the disruptions that come with it — the new ways of thinking, collaborating and engaging with partners, affiliates and health authorities.
With so many demands on time and resources, business leaders want to procure compliant technology and proficient personnel efficiently and cost effectively. Business process services (BPS) can meet those needs. BPS spans strategic consulting, business process development, technology expertise and document analysis — right down to the preparation of regulatory documents.
Here are three scenarios in which BPS takes life sciences companies beyond simply partnering for submission document management and toward achieving true transformational change.
Agile workload management
Life sciences leaders must sustain a delicate but critical balance between run-and-maintain and build-and-grow.
The industry’s global nature means that companies will likely have products in regions where the primary focus is on life-cycle maintenance, and systems and data centers must be properly resourced. On the other hand, companies must also manage times of constraint, while ensuring that the business doesn’t falter when challenges arise. BPS lets companies not only maneuver the overflow from multiple regulatory activities, but also engage SMEs to improve processes.
Regulatory departments are particularly subject to the peaks and troughs of global submissions, with staff members underutilized for some periods and overtaxed at others. BPS helps fill those gaps.
A midsize pharmaceutical company with a focus on pioneering pain management underwent significant corporate cost reductions, taking its regulatory department from 18 people to five. As this occurred during a period of increased regulatory submission demand, the loss of expertise made it difficult to meet those demands. Choosing a BPS partner that could support significant increases in workload was a priority.
The company selected a robust document management system and a cloud-based solution to flexibly manage electronic document submissions and allow both its staff and its BPS partner to perform publishing and quality control. By selecting a partner with follow-the-sun capabilities, the company took advantage of both onshore and offshore capacity to effectively manage its workload.
Operationalizing business change
Change is the one constant. Whether it’s a new product, new region, downsizing, an acquisition, diversification or meeting new requirements, life sciences leaders are continually assessing their ability to manage change.
It’s key to determine what is required to support business change and how best to respond to an increasingly patient-centric healthcare marketplace. BPS aligns technology and processes to increase efficiency and create a productive environment for change.
For more than 10 years, a small biotech company with a focus on rare diseases has worked with an outsourcing partner to handle full submission management to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. At first, the company had a small regulatory group with no publishing capabilities in-house and no expertise for managing Electronic Common Technical Documents (eCTD) submissions. In recent years, the company wanted to bring some publishing in-house and sought help to manage this change through a software-as-a-service platform and ongoing BPS support. Thanks to the guidance gained through a long-term partnership, the company has matured and changed to the point that it can now take ownership of publishing while working with its BPS partner as needed.
Life sciences companies of all sizes are trying to cut costs while delivering higher-quality outcomes. Company growth and divestments occur frequently, often creating situations where companies are growing rapidly, changing direction, or trying to integrate new businesses or products — all with fewer people.
Small innovative companies with little regulatory expertise might be focused on getting a product through research and development and approval, and must remain lean to attract buyers or partners. Larger companies might focus on diversification and reinvention, while having a partner handle the day-to-day activities involved in getting submissions out the door. BPS lets companies grow, at whatever stage they are, without having to add permanent head count.
A small oncology-focused life sciences company had an investigational new drug and was preparing its first electronic submission to the FDA. Its small regulatory group had no publishers in-house, no tools to leverage an electronic submission and no expertise to manage the process properly.
With a BPS partner, the company gained access to high-performance tools, domain expertise and submission-publishing best practices. Through the partnership, the company has gained a flexible and scalable model for submissions, allowing it to focus on value-add and core competency activities.
The life sciences industry is evolving rapidly, and today’s healthcare ecosystem is becoming increasingly complex. By combining flexible, progressive processes and technology with deep domain experience, a strategic business process services approach can help companies drive change
MICHELLE GYZEN is global head of life sciences business process services at CSC.