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International Perception of Competence, Education, and Training Needs Among Biomedical Professionals Involved in Medicines Development

The below excerpt is from an article originally published on the Frontiers in Pharmacology website. To check out the full article click here.

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The development of new medicines today, requires a multi-professional workforce, both in industry and the clinical research arena. Pharmaceutical physicians (PPs) and medicines development scientists (MDS) need a certain level of competence, achieved through on-the-job experience, with a postgraduate education foundation and continuous professional development programs. In order to assess the self-perception of competence, education and training needs, an on-line questionnaire based on the seven domains of competence, developed by IFAPP-PharmaTrain, was prepared and distributed among PPs and MDS members of IFAPP’s affiliated professional associations in countries with facilities for postgraduate education. The data collection was run over a fixed period of three months in Japan, Italy, Brazil, and Spain during 2017. Results indicate low but variable levels of perceived competence for the various domains as well as seniority in the job. All respondents declared a significant need for continuing professional development in all domains. These results corroborate and support the continuous efforts, put in place by IFAPP and the PharmaTrain Federation, to foster the development of accredited education and training among professionals involved in medicines development.

Introduction

For some time now, the biopharmaceutical industry has been the key link between basic biomedical discovery and the emergence of novel medicines that prolong or improve life. However, the industry faces several ongoing and emerging challenges, including technical knowledge gaps, limitations in clinical testing, lowered productivity, higher development costs, increased regulatory requirements, growing payer pressures and patent expiration.

The lack of an adequately sized and appropriately trained multi-professional workforce, both in the industry and the clinical research field, is also a significant part of the problem. There is a perceived mismatch between the profiles and abilities of graduates from academic programs in healthcare professions, and the changing needs of the various health systems around the world. As a possible solution to achieving a transformative learning, an outcomes-based education, or competency-based education (CBE), has been proposed (Silva et al., 2013). Competent professionals would be able to perform their specific responsibilities effectively, such as bringing and maintaining new medicines to the marketplace. A need for competency-based education and training has been identified in the United States, Europe, and Latin America (Dubois et al., 2016).

These respective professional groups have been left with the responsibility to define the competencies needed to perform their function effectively. Competencies can be clustered in domains and can be learned through proper postgraduate education or continuing professional development (CPD) (Sonstein et al., 2014).

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)1 and the PharmaTrain Federation (PharmaTrain)2 assumed the task of producing the defined core competencies to orientate Pharmaceutical Medicine and Medicines Development as a discipline and profession. Three areas, seven domains and 57 core competencies at the cognitive level, were identified (Silva et al., 2013). The domains have been summarized in a Statement of Competence.

In addition to serving as a template for job profiles and portfolios, the domains can be used to identify general education and training needs. Based on these premises, an international survey among members of the IFAPP national member association was designed using an online questionnaire. Stakeholders were asked about their self-perception of competence and the need for education and training. The results were then assessed to identify gaps, in order to address the potential need for future development of pharmaceutical physicians and medicines development scientists.

By:
Kyoko Imamura1*
Domenico Criscuolo2
Anna Jurczynska3
Gustavo Kesselring4
Peter Stonier5
Tatsushi Tsuda1 and 
Honorio Silva6

Copyright © 2019 Imamura, Criscuolo, Jurczynska, Kesselring, Stonier, Tsuda and Silva.

Check out these 5 key areas for CRO process improvement

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5 Key Areas for CRO Process Improvement

Insight into 5 key areas where CRO’s should consider ongoing process improvement.

An article from the May 2018 addition of the Clinical Researcher seems especially relevant as the students of the current 2018 cohort are wrapping up Module 4, Clinical Trials: from concept to clinical study report. The article “Improving Clinical Research Trials: Best Practice Do’s and Don’ts for Managing Business Operations” (Ted Finlan, 2018), Finlan provides insight into 5 key areas where CRO’s should consider ongoing process improvement.

1.      Regulatory Compliance

Pitfall: Failure to understand and plan compliance timelines

Internal and external regulatory groups have varying deadlines, with timelines that often intersect and overlap. For instance, approval for a drug import license can vary from country to country by a matter of weeks or months. Without a clear understanding of approval processes and their impact on the critical path, a study is at high risk of schedule slippage.

Best practice: Clear project planning blueprint

CROs should ensure clarity and alignment between staff responsible for designing a regulatory blueprint (e.g., ethics committees, institutional review boards, etc.) and those responsible for building, managing, and communicating schedules. When approval processes are clearly mapped out to achieve the most efficient response, CROs can expedite the commencement of work.

2.      Information Flow and Governance

Pitfall: Lack of communication between departments and across organizations

Every department maintains critical information that other departments can benefit from. For instance, the Quality unit may be the first to become aware of new clinical trial regulations that impact the study start-up processes. If this information is not shared across the organization, various issues may arise, such as compromised core processes and missed timelines, jeopardizing overall delivery of the study.

This risk can be especially acute when working with new partners or third parties. Misplaced assumptions about “who knows what” or misaligned processes can creep in and drive quality issues or delays if initial and ongoing communication between these entities is lacking.

Best practice: Purposeful communication and collaboration

Clarity is a best practice when it comes to communication, and standard operating procedures should address optimal information flow. This requires every team member and site to have a clear understanding of their own responsibilities, as well as the roles and responsibilities of those adjacent to them. Processes should lend to proactive knowledge sharing as departments recognize how information intersects and how teams can fully leverage intelligence.

Mutually agreed-upon terms of engagement between sponsors, CROs, and vendors can also circumvent downstream quality, compliance, or timeline issues. These communication plans should ensure collaboration across all facets of the project.

3.      Getting a Fast Start

Pitfall: Final protocol delays

Delayed availability of the final protocol is one of the most significant stumbling blocks to patient recruitment. The final protocol is a critical path deliverable that impacts trial supply, site activation, and, of course, recruitment.

In fact, quite often, important work will begin before the final protocol is available. Proceeding “at risk” can lead to rework that can increase the cost and duration of start-up, and, in some cases, could lead to losing access to desirable clinical investigators or institutions. All of which impacts the ability to recruit and can affect the pace of recruitment throughout the study.

Best practice: Transparency and communication

Visibility into the availability of the protocol and expected impacts can significantly mitigate the impacts of delays. By actively planning for the delays and communicating proactively with the sites, a CRO can maintain engagement and be far more agile in adapting to change. This requires proactive communication and strong collaboration between the sponsor and CRO to make the changes needed for strategies, systems, and plans to run as smoothly and quickly as possible.

4.      Budgeting

Pitfall: Improper management of uncertainty

A key characteristic of research is uncertainty. Unfortunately, that reality can make the budgeting process a series of “best guesses.” As noted above, delays in protocol availability can delay studies for unpredictable periods of time, as can the availability of investigational product (IP) supplies.

These, and other unknowns can lead to rework, changing of staff, and other impacts that affect the overall budget, including direct CRO services, grants, and third-party costs. Without effectively forecasting communication and change order processes, studies can run into financial trouble, including an inability to compensate investigators or pay third-party costs.

Best practice: Effective change management

In an ideal world, any CRO would like to minimize risk by matching the level of uncertainty with the right amount of “insurance,” often referred to as a reserve. This is rarely possible, yet the most effective CROs move forward with a considered, deliberate approach for “out of scope” work and a smooth change order process.

Another approach is to financially ensure alignment and motivation through targeted use of bonus clauses, incenting CRO performance by aligning its financial benefit with the goals of the sponsor. For example, hitting aggressive recruitment and retention targets.

It is important to remember that these approaches are two-way streets. Change orders for unused/unrequired spending result in savings for the sponsor and should be communicated just as proactively. As this may be driven by faster recruiting or other “good news,” it may appear to some that the CRO is being punished for exceptional performance. This is another good reason to align incentives and bonuses to match the sponsor’s desired outcomes.

5.      Staff Workflows

Pitfall: Finding projects short-staffed

Inefficiency is always a concern, and the ability to efficiently allocate staff is a critical factor for service companies. A lack of consistency across organizations, various conflicting or ambiguous definitions for terms and data, misaligned assumptions, and an absence of clarity across processes and organizations can leave projects short of key staff, driving delays, quality issues, and other delivery problems.

Best practice: Aligning key resources

A holistic view of processes and clear data definition across the enterprise is key. This is usually attacked by mapping and integrating core processes, and in the case of services staffing, this is often referred to as the “quote to cash” process. As it sounds, this process takes the proposal and bidding activities into consideration, where staff capacity transitions to the reservation of specific individuals.

Once the formal assignment is in place and resources are used, the process moves into the billing and receivables portion. By clearly illustrating the processes and agreeing to common data definitions and metrics, the CRO can gain greater visibility into its “factory” and more efficiently serve its customers.

To sum up, “Good Business Operations = Effective Trials.”  Finlan, emphasizes that as the clinical research environment continues to grow and change it becomes ever important to ensure a high-quality design to overcome these common pitfalls and ensure success!

Want to learn more about how to be an effective and more productive CRO?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

 

References:

  1. Ted Finlan, P. C. (2018, May 15). Improving Clinical Research Trials: Best Practice Do’s and Don’ts for Managing Business Operations. Clinical Researcher, 32(5). Retrieved July 7, 2018, from https://www.acrpnet.org/2018/05/15/improving-clinical-research-trials-best-practice-dos-donts-managing-business-operations/

Importance of Big Data for Medical Affairs Professionals

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The Importance of Big Data for Medical Affairs Professionals

How harnessing the power of big data can give Medical Affairs Professionals the strategic edge.



The most competitive companies in pharma must inundate themselves with data to navigate and excel in an ever increasingly complex environment. But, according to Bain & Company, companies have difficulty explaining the science and data to stakeholders in an effective and meaningful way.1 Just imagine a chemical engineer trying to explain chocolate milk to a 3-year-old. According to Bain research, this shortfall is one attributing factor to the 50% of launches that fail to meet company expectations.

So how does a company manage this problem without losing sight of their main goal, the resulting product? This is where a Medical Affairs Professional comes to the rescue. The ability for a Medical Affairs Professional to collect, analyze, interpret and present data can help ensure the success of a company.

Why is big data so important? Drug development has become more focused on narrower and more personal indications resulting in a more involved treatment. This trend, along with rising costs, and a greater multiplex for physicians to navigate has left a gap that leading companies are filling with medical affairs teams to help them translate their data in a way that physicians, payers, and providers can understand. While the company can focus on their products, they can leave the Medical Affairs Professionals to sort and distribute their big data in a valuable, effective, and consumable way.

Want to learn how to leverage company big data throughout the drug development process?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

To read more about big data in the world of Medical Affairs please check out this great article from Bain & Company: Reinventing the Role of Medical Affairs.

 

References:

  1. Plantevin L, Schlegel C, Gordian M. Reinventing the Role of Medical Affairs. Bain & Company. http://www.bain.com/publications/articles/reinventing-the-role-of-medical-affairs.aspx. Published March 15, 2017. Accessed January 11, 2018.