The pharmaceutical industry is highly regulated, making it critical to adhere to strict guidelines when marketing products. Proper marketing practices ensure compliance and build trust with consumers.
Pharma customers are becoming more proactive in their data strategies and need service providers to offer advanced analytics capabilities. This will allow them to better address new needs, such as facilitating medication access.
Regulatory Compliance
The pharmaceutical industry is highly regulated for a reason—because of the outsized impact their medicines and treatments have on people’s lives. As such, navigating compliance issues is top of mind for regulatory affairs professionals in the industry. These issues affect every aspect of a pharmaceutical company, including sales and marketing, drug price reporting, clinical trials and operations, preclinical work and testing, and manufacturing.
With the stakes so high, it’s important for pharmaceutical companies to understand how they can improve their ability to meet regulatory requirements, which often involve complex technical and scientific knowledge. One key way to do this is through technology that supports a more integrated and collaborative approach and automated processes that can support a greater degree of accuracy, consistency, and quality.
For example, many pharmaceutical companies have adopted systems that help them update commercial content across channels and geographies, reducing the risk of compromising compliance with regulations and allowing them to more easily share content with other departments. In addition, leveraging technology to automate processes and eliminate manual tasks allows employees to focus more time on value-added activities.
Another area of concern for pharmaceutical companies is bribery and corruption. This remains a critical issue, particularly in pharmerging markets, where strict government price controls and the prevalence of cheaper generics make it difficult for multinationals to succeed. However, a good strategy for M&A in these markets is to analyze the compliance risks and regulatory hurdles early and take steps to ensure that all commercial and legal aspects of a transaction are in order.
In terms of quality, it is important for pharmaceutical companies to establish a culture of continuous improvement. This can be done by ensuring that all employees are trained in the basics of regulatory compliance and how to recognize and address potential compliance issues in their workflows. In addition, establishing clear standards and norms for quality assurance can help a company remain compliant with the FDA’s cGMP requirements.
In a constantly evolving landscape, it’s essential for pharmaceutical companies to keep abreast of the global regulatory devices, trends, and changes that impact their business. Developing a comprehensive regulatory intelligence strategy, with regular updates that include guidelines, rulings, and modifications, is a key way to stay ahead of the curve.
Data Management
The pharmaceutical industry’s growing reliance on data requires new systems and processes. But, with the amount of distributed data, systems, and partners involved in drug development, it can be challenging to centralize storage and manage data efficiently for the long term.
Moreover, with the rapid advancements in technology and continuous innovations in the industry, pharma companies often find themselves having to adopt new technologies quickly. This can lead to confusion and inconsistencies in the systems used, which then causes data management issues.
In order to overcome these challenges, a digitalized data management system is essential for pharma companies. This will enable them to leverage data for decision-making, which can result in improved patient care and optimized resource allocation.
Effective data management is critical for the pharmaceutical industry, as it ensures compliance with regulatory standards and reporting obligations. It also helps maintain data integrity and supports effective collaboration across departments. In the future, a well-developed digital data management system will enable pharma companies to leverage insights and information in an efficient manner and improve their competitiveness.
Managing large amounts of data and data structures with multiple data management systems is a challenge for many pharmaceutical companies. As such, it’s important to develop a holistic approach to data management to ensure that all data is consistent and easily accessible.
A key component of this is the use of a reference data management system (RDMS), which provides a centralized repository for codebooks (or dictionaries) with lists of allowed values in specific domains, such as substance codes, product codes, adverse events, or gene codes. This can help reduce redundant data entry and streamline the workflow for various teams by providing a single source of truth for transactional information.
Another challenge is the need to manage data in a way that can be shared with third-party organizations. For example, many large pharma companies outsource some of their production to contract manufacturing organizations (CMOs) for logistical reasons or to access niche expertise. However, this creates the need to share large volumes of data in a timely manner, which can be difficult with traditional data management approaches.
Marketing
The pharmaceutical industry has a unique set of marketing issues to overcome. The heavy restrictions, constant updates, and endless data can make it challenging to effectively execute campaigns. Moreover, the need to comply with regulations and ethical guidelines creates additional challenges for marketers. To combat these challenges, marketers need to think outside the box and use innovative tactics to promote products that satisfy the industry’s codes of ethics and stays within legal boundaries.
One of the biggest challenges facing pharma marketers is establishing brand differentiation amongst competitors. Due to the large number of pharmaceutical companies and competing medicines with similar functions, it is difficult for a company to establish its own identity in the minds of medical professionals. This can be a serious issue for pharma companies as they seek to increase revenue and maintain customer loyalty.
Another challenge faced by pharma marketers is building trust with patients and healthcare professionals. In an era of misinformation, it is important for pharma companies to provide accurate information and remain transparent at all times. This ensures that customers and healthcare professionals can trust the content they are receiving and helps pharma companies avoid potential regulatory challenges.
Additionally, pharma marketers face the challenge of promoting their products to the right audience at the right time. Depending on the target audience, this can involve either direct-to-consumer advertising or marketing to prescribing healthcare professionals. In either case, effective marketing requires a patient-centric approach and the ability to produce high-quality content across multiple channels and platforms.
Pharma companies must also develop an empathetic approach to marketing that reflects their underlying mission of improving patient outcomes and public health. This includes identifying and recognizing the needs of different patient populations to tailor messages to their specific needs, such as highlighting financial solutions that help patients afford medications. This can be accomplished through digital channels, such as social media and email, to help pharma companies reach the right audience at the right time. Furthermore, utilizing data to identify and target healthcare providers by their preference for specific channels, behaviors, and prescribing patterns can significantly enhance the success of marketing efforts.
Advertising
Marketing is a critical element of the pharmaceutical industry as companies strive to meet consumer demand. Marketing strategies include public relations, product launches, trade fairs, and branding. In addition to traditional marketing methods, pharma marketers are also leveraging digital platforms such as social media and search advertising. However, many of these channels are regulated and often require high compliance. As a result, it can be challenging to create and distribute content that is compliant and effective.
One of the most significant challenges facing pharmaceutical marketers is the spread of misinformation. In an era when it is easy to share fabricated news stories, consumers need trustworthy information sources. Unfortunately, some of these sources are pharma-related, leaving consumers with the impression that pharmaceutical companies only care about profit, not their health.
Another challenge pharma marketers face is the impact of inflation on cost and revenue streams. Inflation has increased the price of raw materials, transportation, and labor. This has impacted the profitability of drug production and distribution. While pharma is somewhat protected by its inventory levels and long-standing dual-sourcing strategy, the impact of inflation on pricing continues to threaten margins.
In a highly regulated environment, pharmaceutical marketers must continually focus on the need for compliance. As the industry continues to evolve, marketers will need to become comfortable navigating increasingly complex ecosystems and identifying new opportunities for growth. This will require a shift in capabilities, potentially requiring reskilling and upskilling of existing staff and recruitment of external talent.
As the industry evolves, pharma commercial teams must use data-driven and relevant content to target HCPs and consumers alike. HCPs and healthcare professionals are comfortable with numbers and statistics, and utilizing this content can help bolster the credibility of your messaging. Moreover, a lack of data can lead to misguided marketing efforts. With tools that support ad optimization and data analytics, marketers can be sure they are targeting the right audiences at the right time, with the most pertinent content. This will ultimately drive more conversions and improve marketing ROI.