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Get to know the students of the IFAPP Academy!

News from IFAPP Academy

Get to know the students of the IFAPP Academy!

Each month the IFAPP Academy will highlight the achievements and successes of a current student or alumnus.

The IFAPP Academy is proud to provide continuing professional development to Medical Affairs Professionals worldwide. To showcase our students and their achievements, the Academy is starting a new feature where we will highlight a current student or an alumnus of the IFAPP Academy each month.

This month, we would like to introduce you to, Olena Kurayeva, a current student of the IFAPP Academy/King’s College, Medical Affairs in Medicines Development, Certification Program.

Featured IFAPP Academy Student: Olena Kurayeva

What is your name and job title?

Olena Kurayeva, Western Belt PEH Medical Lead in Pfizer

What do you feel is your greatest achievement?

Being Pfizer Medical Lead, with close collaboration with National key decision makers to get the process of National antimicrobial stewardship program creation initiated

What is your favorite hobby and/or activity outside of your work?

Family, Reading, Jogging. I enjoy being with my husband and our daughter. This is where I charge my batteries and fuel my professional life.

What do you enjoy most about being a Medical Affairs Professional?

“Working as a physician in a premier innovative biopharmaceutical company in the upcoming era of Big Data medicine puts me in a unique position to link scientific and clinical results to patient outcomes.”

What has been the most beneficial aspect of the IFAPP Academy Program?

Flexible schedule-opportunity to study in the most convenient time and place, mature experts in different areas and nice delivery.

How has your view of the medical affairs profession altered and/or improved?

This program helped to identify more areas where I can make a difference as a Medical Lead, which results in bringing additional value to the company, and where my background is essential.

Any additional comments that you would like to make about the IFAPP Academy/King’s College, Medical Affairs in Medicines Development, Certification Program?

Thank you and keep going with the same spirit!

Thank you, Olena! The Academy looks forward to seeing your many great achievements and contributions to the Medical Affairs arena.

Want to learn more about the IFAPP Academy?

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.

The IFAPP Academy’s Core Competencies are truly ‘the Core of Medical Affairs’

News from IFAPP Academy


The IFAPP Academy’s Core Competencies are truly ‘the Core of Medical Affairs’


Core Competencies of Medical Affairs

The IFAPP Academy/King’s College, Medical Affairs in Medicines Development, 2018 Cohort is finishing up Module 4 exams, starting this week. This means there are only 2 Modules remaining before the End of Program Assessment, to culminate in the Certification of this year’s qualifying students. Students successfully completing the program will be able to use the post-nominal letters CMD as a designation of their earned competencies.

The IFAPP Academy Core Competencies align with the McKinsey & Co report on the Core Capabilities of Medical Affairs Professionals.

MCKINSEY & CO CORE CAPABILITIES IN MEDICAL AFFAIRS
IFAPP STATEMENT OF COMPETENCE IN MEDICINES DEVELOPMENT
Scientific and technological leadership
and strategic vision
Can identify unmet therapeutic needs, evaluate the evidence for a new candidate for clinical development and design a Clinical Development Plan for a Target Product Profile.
Scientific and technological leadership
Can design, execute and evaluate exploratory and confirmatory clinical trials and prepare manuscripts or reports for publication and regulatory submissions.
Learning agility
Can interpret effectively the regulatory requirements for the clinical development of a new drug through the product life-cycle to ensure its appropriate therapeutic use and proper risk management.
Deep understanding of compliance
Can evaluate the choice, application, and analysis of post-authorization surveillance methods to meet the requirements of national/international agencies for proper information and risk minimization to patients and clinical trial subjects.
Strategic vision & scientific leadership
Can combine the principles of clinical research and business ethics for the conduct of clinical trials and commercial operations within the organization.
Deep understanding of compliance
Can appraise the pharmaceutical business activities in the healthcare environment to ensure that they remain appropriate, ethical and legal to keep the welfare of patients and subjects at the forefront of decision making in the promotion of medicines and design of clinical trials.
Emotional intelligence and communication skills
Emotional intelligence and communication skills

According to McKinsey & Co. (Evers, et al., 2014), “the bar is high for Medical Affairs talent. They need to collaborate with R&D colleagues and deeply understand the science that underpins their work; they must understand the rules and regulations governing the industry almost as well as their compliance and legal department colleagues; and they should have the strategic thinking capabilities of their marketing counterparts as well as the customer-interaction skills of their colleagues in sales.”

IFAPP Academy students gain the necessary knowledge and understanding to create patient-centric environments where they can interact with a broad range of stakeholders to provide a more tangible value to patients. This has become increasingly important as “the right talent is often scarce, especially at the local country level.” The IFAPP Academy is proud to help fill this gap by providing online Continuing Professional Development for Medical Affairs Professionals.

For more information and to apply for the 2019 IFAPP Academy/King’s College, Medical Affairs in Medicines Development Certification Program click here.

References

Evers, M., Edd, F., Ghatak, A., Hartmann, J., Westra, A., Nathoo, A., . . . Suresh, B. (2014, July). Pharma Medical Affairs: 2020 and beyond. Retrieved July 18th, 2018, from McKinsey & Co.: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharma-medical-affairs-2020-and-beyond#0

Check out these 5 key areas for CRO process improvement

Hot Topics in Medical Affairs


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

Hot Topics in Medical Affairs


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.