Recent posts about publication planning

Pharmaceutical organizations must constantly evolve in order to stay competitive in the market and compliant with regulations.

Recent years have seen significant change in the role of medical affairs teams in the pharmaceutical industry. COVID-19 accelerated these changes. As a result, many medical affairs departments now face a pressing need to meet shifting expectations.

Technology is in a unique position to alleviate some of the growing pains that medical affairs teams experience as they take on greater responsibilities. Process automation, in particular, can play a valuable role in streamlining and improving the efficiency of medical affairs workflows.

With process automation solutions, medical affairs leaders can:

• Deliver actionable insights to key decision makers
• Reduce administrative overhead to enable team members to spend more time on stakeholder engagement
• Digitally engage HCP’s and KOL’s increasing the capacity of the team to engage these key stakeholders
• Streamline collaboration across departments to speed up the new drug development
• Contain costs, by introducing new efficiencies

The role of process automation is becoming more critical as the field of medical affairs continues to grow. In this article, we’ll walk through why and how medical affairs is changing (including the role played by the COVID-19 pandemic), and dive deep into how technology must adapt to meet the needs of this growing sector.

How medical affairs is changing

Historically, medical affairs provided support to the research and commercial pillars of pharmaceutical and medical device companies, but that's changed drastically over the past decade.

These organizations are faced with increasing regulatory pressures, rising drug development costs, and a faster-paced competitive market. To meet the increasing market demands, medical affairs departments are facing greater expectations and workloads without a proportionate increase in budgets. 

To address this challenge, companies are turning to process automation solutions to help medical affairs teams do more with less. By automating routine tasks and optimizing resource utilization, medical affairs teams can focus on delivering high-quality, credible information to physicians and patients in a timely and efficient manner.

Medical affairs is brought to the table earlier in the drug development process to foster more seamless collaboration with other departments and contribute to strategic decision-making.

COVID-19's impact on medical affairs

The changes to the medical affairs industry have been in the works for the past decade, but the COVID-19 pandemic galvanized the situation further by rewriting the script on (a) how pharma develops and brings drugs to market, and (b) how the HCP/MSL engagement model functions.

Developing and bringing drugs to market

When we talk about how the pandemic changed the way drugs are developed and brought to market, there’s no way not to mention the impact that Operation Warp Speed (OWS) had on the time-to-market speed for pharmaceutical products.

OWS was initiated by the United States government in spring 2020 to help accelerate the development and distribution of testing, vaccines, and therapies for COVID-19.

In addition to saving millions of lives and helping gain better control over the pandemic, the operation demonstrated that it was possible to move pharmaceutical products through the development and approval process much faster than previously thought.

Of course, developing a vaccine to combat an active pandemic is a unique situation. Most drugs do not warrant emergency use authorization, nor are they backed by the whopping $10 billion budget granted to Operation Warp Speed by the CARES act.

Even so, it’s an incredibly valuable case study for medical affairs teams and their colleagues to consider in medical planning. The process for developing and approving drugs often takes between 10-15 years. Imagine a pharmaceutical market that reduces that timeline estimate by half.

That's not only a game changer for patients – it's a competitive advantage for businesses in the pharmaceutical industry.

While the conditions for developing drugs under a pandemic are not replicable for most other drugs, investment in automation technology can emulate some of these fast-paced outcomes. Upgrading medical affairs software with automated solution can not only help teams move faster and more efficiently, but they also provide a better experience for users.

Shifts in the HCP/MSL engagement model

The first year of the pandemic marked a significant increase in digital engagement interactions between healthcare providers (HCPs) and medical science liaisons (MSLs).

Due to pandemic-related travel restrictions, MSLs were now conducting the vast majority (or in some cases, all) of their work remotely.

This new mode of working meant that they could easily engage with multiple HCPs in a single day.

But how did HCPs feel about this change?

According to a June 2020 EU5 report, 55 percent of HCPs said they preferred transitioning to virtual engagements with MSLs. However, only 30 percent of HCPs expressed satisfaction with the quality and value of these digital interactions.

These stats illustrate that the demand for digital MSL engagements is there, but there is still work to be done to ensure these experiences are useful for HCPs.

In the white paper, “Beyond the Field: Evolving Field Medical Engagement and Talent for the Future,” the Medical Affairs Professional Society (MAPS) suggests that the increase in digital MSL engagement presents a golden opportunity for the medical affairs industry to take steps to improve their processes:

“The move to virtual conferences and meetings, where data is not consumed in real-time, has highlighted an opportunity for the industry to revisit compliance, review and approval processes to keep pace with information needs. The timing and consumption of information changes significantly when it’s available online for a clinician to download at their convenience. […] This amplifies the need for the accurate and accelerated review/approval of materials to accommodate the speed that data is consumed virtually.”

The most effective way for pharmaceutical organizations to grasp this opportunity and satisfy the needs of KOLs is to prioritize technology investments that can improve the quality of digital engagements.

Oversight and compliance challenges 

Another critical way medical affairs is changing comes down to compliance and oversight. As scientists and pharmaceutical leaders seek innovative treatments as quickly and safely as possible, the regulatory environment grows more complex by the day.

A significant reason for this complexity has been the outgrowth of pharma applications to more technical, niched scientific areas. Today, pharmaceutical companies are making important advancements in the realms of biologics, mRNA technologies, gene therapies, and more.

These advancements necessitate greater scientific rigor and oversight for medical affairs processes across the board – which is important for safety and validation, as well as for ensuring the sponsoring organization can remain competitive and reduce their legal risk.

The challenge is that as regulations grow more robust and complex, an organization’s SOPs must evolve to meet those requirements. This is another area in which technology must play a critical role.

Investing in purpose-built technology can lessen the challenge of updating SOPs to match the complexities of the moment, as well as help teams work faster because automation makes it easier to meet compliance requirements and check for debarments.

Medical affairs technology needs are also changing

In addition to the impact of COVID-19 and the pharmaceutical industry’s ever-changing regulatory requirements, medical affairs faces greater pressure to provide better customer experiences (CX) and user experiences (UX) to physicians, payers, regulators, journals, and congresses that must access and review drug information digitally.

There are a variety of different tools and technologies that medical affairs professionals can use to improve efficiency and productivity both within their organization and outside of it. These technologies range from custom applications to licensed outsourced solutions, but choosing the right ones is not always simple.

Pharmaceutical companies face three main challenges when researching and selecting technologies:

1. Identifying functionality that can evolve with them

With how quickly medical affairs teams are growing and changing, it’s imperative that the technology they use can evolve with them. That is why any technological solutions under consideration should:

• Meet the emerging needs of the medical affairs professionals.
• Offer the flexibility to customize solutions within its architecture.

For example, in our discussions with medical affairs leaders about their publication planning systems, one of their primary motivations for seeking out a new technology is frustration with the functionality of their existing solutions, including out of date user interfaces, failure to keep up with changing business or regulatory requirements, and insufficient customer support. These incumbent solutions are often longstanding in the industry but have grown complacent, neglecting to prioritize innovative improvements.

As the role of medical affairs grows more complex and wider in scope, these mission critical teams are chafing against the confines of technology that can no longer meet their needs and expectations.

That is why our team of process automation experts created a new publication planning solution, PubPro.

PubPro is designed to improve the speed and efficiency of publication planning processes for medical affairs and medical communications teams. Customers can reduce their publication planning costs by as much as 50%, in addition to solving high stakes compliance issues.

2. Overcoming the perceived burden of switching technologies

Another major hurdle to overcome involves all the perceived barriers associated with switching technologies.

When an organization has used the same system for managing a process for many years, it can feel daunting to make a switch to a new solution. Even if the new solution promises outstanding improvements in efficiency, accuracy, and user experience, organizations may feel tethered to their existing systems and processes for "sunk cost” reasons or they may rationalize that it’s simply “not the right time to shake things up.”

There may also be concerns about the transition itself. Will the implementation and training period cause disruptions to critical projects? How difficult will it be to migrate from the old system? How challenging will it be to train employees on the new system?

The fact is, medical affairs leaders do not have the luxury of taking their time to onboard software slowly, which is why technology partners must prioritize delivering a fast and seamless transition to their customers.

3. Ensuring seamless integration with existing technology

One of the functions of a medical affairs team is to help connect various departments at their organization with external stakeholders, such a HCPs, KOLs, and patients.

In order for medical affairs teams to work effectively, the organization's data must be able to move seamlessly across departmental and organizational boundaries while maintaining privacy and compliance standards.

That is why it is imperative that technology buyers at these organizations ensure they are making investments that can easily integrate with existing tools and legacy systems. The end result should be a streamlined, cross-functional workflow that provides clear visibility into any bottlenecks.

The ideal choice of technology to meet these needs should provide multiple options to enable single sign-on and multiple formats for exchange with the existing technology platforms.

Maximizing competitive advantages

With how rapidly the medical affairs landscape is changing, it’s important for pharmaceutical leaders to bring in technologies that can match the gait of this fast-paced growth and be ready to adapt quickly to new developments and requirements.

Ready to level up your medical affairs team? Contact our team of process automation experts to learn more about implementing one of our process automation solutions at your organization.

With all the hard work that goes into the complex and delicate process of medical innovation, the last thing pharmaceutical and biotech companies want is to see publications delayed by an incomplete or unnecessarily lengthy debarment check process.

The good news is that new technologies can now automate and introduce new efficiencies into checking for debarments. 

Let’s dive into a comprehensive refresh about what debarment checks are, how they work, and how to work them into your pharmaceutical publication processes so that you can more readily identify the advantages of refreshing your company's approach to this regulatory responsibility.

What is an FDA debarment?

In regulatory terms, a debarment is when an individual, organization, or any affiliates are excluded from conducting business with a federal agency.

In the case of the Food and Drug Administration (FDA), there are two types of debarments that apply to the development, approval, or regulation of food and pharmaceutical products:

• Mandatory debarments are the result of a felony conviction for the individual in question. These debarments are typically permanent.
• Permissive debarments usually result from an individual's misdemeanor conviction or a conviction of accessory or conspiracy charges. Corporations can also be debarred for a period of time for direct or indirect violations of FDA law. Permissive debarments can last up to several years.

The FDA maintains a list of individuals who have been convicted of felonies (permanent debarment) and misdemeanors (permissive debarment) related to the development, approval, or regulation of a pharmaceutical product.

What are the business risks of collaborating with debarred individuals?

Working with debarred individuals or entities could have serious ramifications on the development of pharmaceutical products. For example, if a debarred individual is found to have contributed on the planning or development of a new pharmaceutical drug or device, the company and team associated with the project could face fines, delays, and potentially even the temporary debarment of organizations that have neglected to terminate debarred individuals in their employ.

Failure to identify the engagement of debarred individuals or entities can have serious repercussions on the publication and on the company at large. Fines can reach levels of $250K per debarred individual or $1M per organization.

Consider how the failure to screen for or terminate a debarred person would impact your competitive edge in the market. Years of hard work and investment could be jeopardized by a few bad faith collaborators.

With so much at stake, how do medical affairs teams in the pharmaceutical industry ensure they are working above board? By performing thorough debarment checks.

The importance of debarment checks

A debarment check ensures that you have not hired debarred individuals or contracted with debarred entities at any point in the process of bringing a drug to market. When applying to the FDA for approval of a drug, medical affairs professionals at pharma and biotech companies are required to certify that they have not and will not engage in such a hire.

Regular debarment checks are necessary to avoid regulatory penalties, not to mention the bad press or approval delays that could also result for your business if you fail to catch a debarment issue.

When it comes to publication management, the debarment check protects your company against liabilities financial, reputational, and even social. Thorough and regular checks help medical affairs professionals avoid costly fines, protect against damage to company credibility, and prevent go-to-market delays. They also protect consumers and help to maintain the integrity of the FDA as it works to protect consumers as well. When debarment checks work as advertised, it benefits everybody.

Ensuring ongoing compliance with the FDA debarment list

Of course, with the FDA debarment list being continuously updated, ensuring compliance requires ongoing debarment checks. This does not mean that the process has to remain laborious, or turn into a cost that you “just have to eat.”

This is where automation comes in. With the power of low-code automation, medical affairs professionals can build a solution designed with their complex SOPs and compliance requirements in mind — all without having to spend an unreasonable amount of time and money on manual or outsourced debarment checks. 

Automated debarment checks in publication management

The benefits of automation in the publication management process, including debarment checks, are numerous.

First, consider the sheer number of administrative tasks that medical affairs teams need to complete to support the development and approval of a new drug, in compliance with regulations both domestic and international. 

Extending to debarment checks and beyond, smart automations that fit to your existing processes and workflows are sure to introduce new efficiencies that save time and money, resulting in better margins on R&D as well as greater speed-to-market.

PubPro by BP Logix was created with these specific goals in mind. With PubPro, medical affairs directors and managers can:

• Manage publication process timelines, including via metrical data for identifying efficiencies and bottlenecks
• Intelligently route and approve tasks
• Collaborate across document authoring, to conduct quality checks and manage feedback
• Customize reviewer assignments
• Resolve high-stakes compliance gaps, including debarment checks and training verifications
• And more!

This robust automation system produces many efficiencies, including ensuring compliance more quickly, so that you and your team can focus less on administrative work and more on the remainder of the publication management process. PubPro can conduct automated debarment checks for not only the FDA database, but also the OIG (Office of Inspector General) and SAM (System for Awards Management) databases.

Improve compliance and speed up your publication process with PubPro.

Contact us today to learn more about our solution built for medical affairs teams.

Heavily regulated industries inherently have a lot of rules. The biotech and pharmaceutical industries are no exception. Adhering to complex regulations requires significant amounts of administrative work to ensure that the proper directives are being followed. Extensive regulations also present significant risks of hefty fines for noncompliance. Failed clinical trials also present a significant risk to pharmaceutical companies and can cost billions a year. 

Getting a new drug to market involves an infinite number of variables, many of which influence who needs to sign off on content development and research projects. This leads to a very complex process that, if done manually, can be very inefficient.

While eliminating steps in the approval process can lead to losses, waiting for approvals that delay a new product’s launch can be equally costly. Streamlining the approval process improves time to market while reducing risks. An effective business process automation strategy is key to a much more efficient approach.  

Research concept approval

The process of getting a clinical trial approved and budgeted often requires the collection and organization of significant amounts of data. Researchers must submit information on the type of study, the objective of the study, the subject of the study, and use case descriptions. This data needs to be accurately and completely documented for researchers to have any chance of obtaining the resources to move forward. Automating this process with digital forms that enforce requirements can ensure all the necessary application data is present, mitigating the risk of delays or bad clinical studies moving forward. 

Once the data is collected, the proposal needs to be vetted and approved. Who needs to approve the project and in what order is often driven by several variables. Whether a project is studying a molecule or a device may dictate whether legal, medical, or regulatory experts need to approve it. Significant efficiencies can be realized by incorporating these rules into an automation system that defines the approval path.

Pharma Content Approval Processes

Once research is completed or drugs are ready for the market, the process of disseminating information and data on these advancements requires significant scrutiny. 

Scientific Publication Review

Once new findings from research studies are ready for publication, an extensive review process is initiated. Reviewers may include third-party experts and professionals with diverse backgrounds. The appropriate protocol depends on the type of product being studied, the country or region the data is being published, or the type of data being presented. For example, some products may require review by a minimum number of statisticians or lawyers. Finding the right resources and routing the document efficiently to each expert for their review is a complex process that can easily be held up or delayed. Automating the routing process based on these variables can eliminate the manual process of designing workflows for each individual project. 

Marketing Content Review

Publishing marketing content also requires multiple levels of approval before it can be made available to the general public. But, marketing content comes with an additional level of complexity and risk. 

Marketing content can be delivered through a variety of channels and in different forms, leading to a much more complex approval process. Video is created for TV or the internet, web copy and brochures also need to be created to publicize the benefits of a new drug or device. Content can also be developed for different markets that speak different languages. All this content is required to go through a specific approval process and each of these variables dictates the appropriate path. 

Managing the approval process through multiple levels including legal, medical, marketing, and patent review slows the process of getting products to market. But, it is vital marketers get this approval process right. Ineffective management of the process can lead to misleading messaging reaching the public resulting in significant penalties. For example, publishing content that overemphasizes the benefits of a new product that is not balanced with acknowledgments of side effects and risk factors can result in hefty fines. In 2012 GlaxoSmithKline was fined $3 billion and Abbott paid $1.6 billion for miscommunicating information in direct to consumer advertising

Automation

Automating the approval process provides many benefits. Rules and variables can be used to automatically route content to the appropriate reviewer. By digitizing and automating the process, sophisticated systems can not only ensure content is signed off on by the appropriate authorities but can also calculate the most efficient route to final approval. For even greater efficiency, leading platforms can also create parallel paths so reviews can happen simultaneously on a single document. 

Time to market is a competitive differentiator in the pharma space but shortcuts can be costly. A solid automation strategy can streamline the approval process, reducing risk and increasing competitiveness.