Product Lifecycle Management Pharma
Jessica Wilson
The development phase alone of a novel drug can take 10 to 15 years and cost billions of dollars. How are companies using pharmaceutical lifecycle management strategies to maximize exclusivity, gain a competitive edge, and improve patient outcomes?
Seeing as only one in 5,000 compounds will ever make its way to market; small pharmaceutical companies must go above and beyond to position themselves for success. Today, patient-centricity lies at the heart of such efforts. To that end, HHS and the FDA recommended that companies deploy the following strategies for a patient-first focus:
An insights management platform closes the insight gaps detrimental to the new drug development regulatory process. This technology can identify, engage, and analyze input from medical affairs, clinical, commercial, internal, and payer groups worldwide to help you answer your most pressing questions.
With technologies like natural language processing and sentiment analysis, you can fine-tune your trial processes, identify new target markets, strengthen relationships with key opinion leaders (KOLs), and prevent costly mistakes or delays that so often occur because of the insights gap.
Also known as the market exclusivity period, this stage covers the years between the launch of a new drug and the market launch of its first generic. While this period could span as long as 20 years, typically, the R&D phase can take so long that by the time the product is available on the market, its patent has already begun to expire.
An insights management platform could provide significant value to your pharma marketing and commercialization efforts, especially when it comes to monitoring your post-launch data, better understanding customers, and improving communication between stakeholders.
Developing, launching, and selling a new pharmaceutical product is an incredibly complex, expensive, and time-intensive process. And because the costs are so high and the odds of success so low, performing robust pharmaceutical lifecycle management is imperative.
Fortunately, insights management platforms designed for pharmaceutical companies can support identifying key experts, engaging audiences, and obtaining a 360-degree view of disease communities. This technology empowers teams to perform the data analysis required to make the best strategic decisions possible at each crossroad.
Pharmaceutical Product Lifecycle Management is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal. Lifecycle Management forms the product information backbone for a company and its extended enterprise.
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This guidance provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance, and improving supply of medicinal products.
Product Lifecycle Management (PLM) is the process of managing a product from conception through end of of life (EOL), and clearly includes conception (design and development) and commercialization. It includes the people, data, manufacturing, supply processes and the technical systems that are needed to get a product out the door and into the hands of stakeholders. The product lifecycle incorporates several functions within an organization including regulatory, quality assurance (QA), and chemistry, manufacturing, and controls (CMC).
Executing the phases of PLM efficiently can save money and achieve projected, on time revenue goals. Getting this wrong can cost millions of dollars, jeopardize trust with the patient and provide populations with an unpredictable product.
Process Management is central to Product Lifecycle Management (PLM). It realizes the goals of PLM by creating the structure around the product. Process management can automate and accelerate repeatable manufacturing processes like design changes, approvals, change orders, and any other applicable product workflows. It includes concepts such as project management, process design/characterization/optimization, technical implementation, and organizational change management to ensure PLM is successful.
Process management brings a systematic approach to activities performed by both people and automation. If the process is repeatable with an established logic in the organization, it can be improved with PLM-based process management.
Successful PLM must utilize strong communication and collaboration across all phases. Although the product lifecycle is divided into various phases, as outlined above, each phase is not a silo and cannot be thought of separately or autonomously. This is especially important in the management of product data, change management, document management, optimization, enterprise resource planning (ERP) and customer relationship management (CRM).
PLM must also consolidate all of the product data into a single accessible and manageable resource while allowing the free flow of information between individuals and the different phases of the product lifecycle. PLM can cover these needs during the conception stage and create and manage the corresponding product data during the design and manufacturing stages.
From conception to end of life (EOL), the successful management of a product during its lifecycle will ensure that high quality and cost-effective products are produced without budget overruns, delays, or design failures. Managing the product lifecycle can be complicated. But effectively defining the processes to identify efficiencies, choosing the right technology tools to enhance data transparency, reporting, and decision-making, and collaborating with the appropriate partners will help lead to PLM success.
Other opportunities afforded by LCM strategies include finding new delivery devices and packaging solutions; more efficient logistics; improved formulations; and improved manufacturing processes aimed at optimizing batch sizes, shortening process lead times and making the process more robust (Exhibit 1).
In one case, Fermion developed an API process for a mid-sized pharma company that had an innovative small molecule pipeline. Fermion manufactured clinical trial API batches, and manufactured commercial API after the product was launched. Two years later, the client wanted to initiate a program to decrease the manufacturing costs of the product.
Using pharma analytics, a company can drastically decrease the time it takes to get a drug from early-stage development to mass production. Through machine learning and other artificial intelligence in pharma, clinical trials may be able to be completed more rapidly over time.
Finally, the digital transformation in pharma allows for healthcare companies to make use of technological advancements faster than ever. Making use of advancing technology that focuses on lessening how long a drug takes to get to market is vital to the success of future pharmaceutical brands.
This can come in the form of predictive maintenance for pharma, which helps to identify an issue before it becomes a problem and eliminates revenue loss. It can come in the form of artificial intelligence, which can minimize costs for drug discovery and development, improve quality control opportunities and more.
Overall, life cycle management pharma strategies always aim to show off the value present in a product. Using strategic asset lifecycle management and the appropriate asset management software can help you even more.
Another industrial revolution is surging forth, building up in the background for at least two decades. Life cycle management pharma aims to increase both branded and generic pharmaceutical competition, address the decline in research and development productivity and lock in on stricter demands for investment reimbursement.
The product life cycle is managed by understanding the market, the competition and the product. From there, life cycle management must implement sound strategies that engages with the market, stomps the competition and increases overall value for the product. The right strategies can increase the lifecycle of a product and even get it to the market faster than conventional methods may currently allow. Poor life cycle management in pharma is what can cost a healthcare company billions.
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The role of the product manager in effectively managing the product life cycle in the pharmaceutical industry is crucial. A product manager is responsible for overseeing a product from its conception to its eventual decline, and ensuring its success in the market.
- Sales: Sales growth is an important indicator of a product's stage in the life cycle. During the growth stage, sales typically increase rapidly, while during the maturity stage, sales growth slows down.
- Market share: The market share of a product can also provide insight into its stage in the life cycle. During the growth stage, a product's market share may increase, while during the decline stage, it may decrease.
- Competition: The level and intensity of competition is another important indicator of a product's stage in the life cycle. During the growth stage, there may be little competition, while during the maturity stage, competition increases.
- Industry trends: Observing trends in the industry and market can also help determine a product's stage in the life cycle. For example, the introduction of new products or changes in consumer behavior may indicate a decline in the product's life cycle.