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Meet Dr. Sandra Bosold

News from IFAPP Academy

Get to know the students of the IFAPP Academy!

The IFAPP Academy is proud to highlight the achievements and successes of our current students and alumni.

We would like to introduce you to, Dr. Sandra Bosold, a current student of the IFAPP Academy/King’s College London, Medical Affairs in Medicines Development, Certification Program.

IFAPP Academy featured student: Dr. Sandra Bosold

What is your name and job title?

Dr. Sandra Bosold, Scientific Advisor PIH

What do you feel is your greatest achievement?

One daily achievement is to manage my job responsibilities and the activities and needs of my family. Due to the flexibility of my employer and the appropriate infrastructure, it is possible to balance both.

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

Gardening and family.

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

Working as a MAP you are at the interface between the medical/scientific world and the interests of a company. Scientific exchanges with HCPs, participation in conferences, and discussions with patients are at the center of our activities and make this job incredibly interesting.

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

Besides the well-structured and detailed lectures, the live webinars with the opportunity to discuss certain issues with top experts but also with the IFAPP colleagues are extremely valuable.

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

While going through the curriculum it became clear that Medical Affairs is at the center of all activities and cannot be underestimated. The discussions with KOLs, the insights into patients’ journeys, the scientific knowledge and the cooperation with academia are the foundation of our business.

Any additional comments that you would like to make about the Program?

I have greatly benefitted from the exchange with colleagues from all over the world. IFAPP’s program is a truly global one.

Thank you, Sandra! 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. Applications are now being accepted for the 2019 Cohort. Click here for more information. Application deadline is December 1st, 2018.

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

3 Reasons why medical affairs professionals need to be savvy with social media

Hot Topics in Medical Affairs


3 Reasons why medical affairs professionals need to be savvy with social media.



The worldwide reach of social media has changed how people communicate. Social media platforms are becoming the go-to source for communication.  Patients are more likely to share their medication side effects, such as the itchy rash they got on their butt or the achy joints that prevented them from playing golf with friends, on social media than to their doctor. Social media channels not only have the potential to act as a way of reporting adverse events but also help companies understand the wants and needs of patients.

Therefore, with the ever-increasing importance of patient centricity and personalized medicines, more and more companies are relying on social media to provide them with answers. These are just some of the many ways that companies are leveraging social media.

1.  Creating a truly patient-centric approach

“There has been a lot of talk in recent years of a need to increase patient-centricity within the pharmaceutical industry. Indeed, there have been many great steps towards a more patient-centric approach, and a greater recognition of the value of patient choice and the need for increased self-management across healthcare systems” (Rees, Sumira, & Morton, 2018).  However, to put this into practice companies must provide patients with the necessary tools and education. Companies are now relying on data from social media sites to help them learn how to provide patient-friendly information.  “Listening to social conversation can add layers of insights. Online conversations can uncover valuable insights about the audience, whether this be patients, healthcare professionals or key opinion leaders.” (Rees, Sumira, & Morton, 2018)

[caption id="attachment_2000" align="aligncenter" width="845"] Figure 1 Sciformix Corp. “The Impact and Use of Social Media in Pharmacovigilance”

2. Product Vigilance (PV)

In a whitepaper by Sciformix, “social media has the potential to become an added new-age tool to monitor data in real-time, making it an early indicator of potential safety issues for further investigation. Further, this would enable companies to generate more robust product safety profiles by leveraging the additional social media information” (Sciformix Corporation).

3.  Clinical trial recruitment

According to Medrio.com, “Social media has the potential to be a powerful tool in the clinical trial recruitment process because of its low cost and ability to reach a diverse and broad audience. In 2014, Facebook boasted over 1.2 billion monthly active users, Twitter had 255 million, LinkedIn was at 187 million.  These numbers outweigh the traditional recruiting numbers in every way.  This capability is something that one-sided print/TV ads or even clinician/patient referrals cannot provide: access to diverse cultures, age groups, gender, and income levels” (Medrio, 2015).


Want to learn how to expand your skillset and continue your professional development in Medical Affairs?

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

Medrio. (2015, August 6). Using Social Media to Recruit Subjects in Phase I Clinical Trials. Retrieved from Medrio: https://medrio.com/blog/using-social-media-to-recruit-subjects-in-phase-i-clinical-trials/

Rees, N., Sumira, D., & Morton, A. (2018, June 13th). The Patient Journey. Retrieved June 19, 2018, from PM LiVE: http://www.pmlive.com/pharma_thought_leadership/the_patient_journey_1239641

Sciformix Corporation. (n.d.). The Impact and Use of Social Media in Pharmacovigilance. Retrieved June 19, 2018, from Sciformix: https://www.sciformix.com/wp-content/uploads/Social_Media_in_PV_Whitepaper.pdf

World Pharma News. (2017, October 9). Social Media in the Pharmaceutical Industry. (SMi Group) Retrieved June 6, 2018, from World Pharma News: http://www.worldpharmanews.com/events/4139-social-media-in-the-pharmaceutical-industry

The Changing Face of Medical Affairs

Hot Topics in Medical Affairs


The Changing Face of Medical Affairs

MA is set to become a fully-fledged strategic partner. But what has driven this change & what can we expect in years to come?

By: Deirdre Coleman on Nov 22, 2016, originally posted here: https://social.eyeforpharma.com/clinical/changing-face-medical-affairs

The remarkable surge in the size and importance of the Medical Affairs function within pharma companies has roots going back decades. Over many years, pressure from regulatory agencies, payers and healthcare professionals, as well as public sentiment, has led to a clearer separation between the Medical and Commercial functions. It was between these separating tectonic plates that Medical Affairs emerged.

As the traditional single-customer pharma engagement model is replaced by a village of interconnected stakeholders, Medical Affairs is uniquely placed to engage with them. It is equipped to understand the challenges pharma’s stakeholders face and to work as a genuine partner to find solutions, improving patient care and creating value for all stakeholders.

“We are now looking at the medical community as an ongoing strategic investment, a long-term, mutually beneficial partnership, whereas before it was more transactional, more sporadic,” says Keith Allan, former Medical Director at Novartis. “The customer base is far broader now, with payers and regulators looking for evidence of the medical, clinical and economic value of our medicines. The needs of the medical community has expanded enormously, together with the technical complexity associated with the interactions. The [Medical Affairs] function is more strategic as we act as ambassadors and facilitators of information exchange, delivering insights back into Development. It calls for a broader set of capabilities, more business acumen and greater alignment with the commercial goals of the company.”

“Companies have to become the trusted scientific partner. Earning that trust comes through the science, not just pumping out commercial messages. If we’re not able to do this well, we will struggle. “

For Michael Zaiac, Head of Medical Affairs at Celgene, it is long-term engagement within a therapeutic area that builds and maintains long-term strategic partnerships with key opinion leaders. “To move from transaction to true partnership, you need to be in it for the long haul,” he says. “We develop a 15-year plan for what we’re going to do in each therapeutic area. We listen to HCPs and interpret what they want and produce items in partnership with them. We have to understand what our partners want to hear and generate the information they want to hear. We are the mediators – we are there to work with people”.

Critical capabilities

An expansion of capabilities is required if companies are to understand the patient experience, access, and influence a broad array of external healthcare stakeholders, and act as a liaison between the medical community and the internal research organization.

Medical Affairs teams need a wide range of capabilities, says Danie Du Plessis, Head of Medical Affairs at GlaxoSmithKline. “As part of our new business model, which puts Medical staff increasingly at the forefront of HCP interactions, we have emphasized four areas of medical competency and capability: scientific and product expertise, value and access, governance, and communications skills. We really recognize the need to bring those areas together into the ability to translate information into value – to be an engaging communicator, able to moderate and facilitate a conversation between peers with credibility and balance – a considerable skill in itself. They also need to have business acumen, understanding commercially what we need to do and translating the scientific data in a strategic way that would genuinely improve outcomes for patients,” he says.

However, the critical capability is a deep scientific knowledge in order to address unmet need and advance the treatment of the disease, says Gundula Schneidewind, VP, Medical Affairs, Europe and Canada at Takeda. ““In particular, this is true for specialty treatment; companies have to become the trusted scientific partner, earning that trust through the science not by pumping out messages. We owe it to the patients to generate knowledge and, in collaboration with external partners, help advance science.” This starts with deep therapeutic insight, including a better understanding of the epidemiology across geographies right through to data generation, she says. “Starting by recognizing unmet needs and working towards patient-centric solutions, companies can find ways to provide genuine value to those we serve. It’s our job to spread this top-notch knowledge and make it available to the wider community of treating physicians.”

The Trends Driving the Growth of Medical Affairs:

Physicians seeking peer-peer interaction; Physicians requesting greater scientific and evidence driven dialogue information on innovative medicines from industry; conventional commercial interactions are decreasing; customer-facing model is becoming increasingly ‘medicalized’

Tougher regulatory controls; societal expectation; Impacting relationships with HCPs & HCOs, with public scrutiny. Harsher compliance measures, with complex changing guidance, regulations & laws that differs between countries & carries risk of harming reputations through heterogeneity of approaches & leading to severe fiscal penalties

Increased transparency expectations; Rapidly emerging world-wide regulations demanding greater transparency on data from trials, publications, data disclosure, HCP financial transparency, non-HCP interactions, oversight of patient engagement

Increasing safety concerns; Growing concern about safety of medicines and requirement to increase the early signal detection, the speed of response on safety issues, utilization of big data approaches to better understand benefit-risk and encompassing social media as a source of safety information

Rising development costs; Impacting time & ability to deliver locally relevant evidence in a timely and cost-effective manner; increasing pressure on medical plans for local data. Adaptive licensing will require new approaches including need to innovate more early on for efficient in Life Cycle Management

Greater requirements for post- marketing evidence; Most approvals accompanied by Post-Marketing Surveillance and Risk Management Plan requirements. Creating capabilities and focus on developing and executing low-cost efficient observational studies is an imperative

Payors pushing for Real World Evidence; There is a rapid shift towards the requirement of community-based local evidence and higher hurdles for proving product value and defining relevant patient outcomes. In parallel with the increased availability of local data on outcomes and big-data analyzing capability, the shift towards mastering RWE is fundamental

Vocal patient populations; Influence of patients is fundamentally changing, with increased empowerment and social media rise of “consumerism”. Impact of Influential POLs blogging on trials & products, rapidly forming patient advocacy groups, alter perception of marketed drugs. Patient groups could also become critical sources of development /medical funding, and providing insights into shaping programs and educational needs

Shifting global demographics; Understanding heath care systems in rapidly developing countries will be essential to ensure the medicines can fit into the new system and ethnography. Building the evidence into the development programs will be challenging. Medical teams will need to address gaps and have local capabilities to execute studies

Source: Sanofi Medical Affairs Roadmap Presentation

The future for medical affairs

Medical Affairs has to become more proactive about bringing insights from a broader range of external medical decision-makers and influencers into early clinical development. Furthermore, it must also take a lead in demonstrating improved comparative efficacy and cost-effectiveness to payors by employing the real-world evidence and data generated by others. At the same time, it is important for Medical Affairs to re-establish pharmaceuticals’ integrity and credibility by communicating higher quality medical information that is of the highest relevance to customers. The time is right for Medical Affairs organizations to earn their place at the leadership table by creating opportunities to deliver new value for both patients and the healthcare ecosystem.

Nicola Smith, Regional Head of Operations, Field Medical Affairs at QuintilesIMS emphasizes the scope that exists for MA to add huge value to the development and commercial teams. “Their strength lies in their ability to gather insight and to help the organization understand how this information can be translated into strategy and value for stakeholders, the greater the level of actionable insights from the medical affairs teams, the better for everyone. Where could the function go? A long way. MA needs to stand up strongly for its strengths in and around the translation of research evidence into clinical practice in a compliant environment, with strong communication and scientific engagement which, like any scientific method, is listening, iterating, testing, and is flexible to both internal and external stakeholders, while meeting all the regulations. MA needs to strengthen its reach back into clinical development starting at the planning stage and be critically involved. It needs to reach in an appropriate way into the commercial organization – giving advice and inputting into the plan. Who knows the patient pathway better than MA? Is it the answer to every question? Absolutely not and there needs to be mutual respect of other team members including marketing, market access, clinical therapy teams and of the need to work together as a team. The challenge in the future will be maintaining a strong external focus, listening to the prescribers and taking that insight back into the organization to guide future strategy and future development”.

A fundamental challenge going forward will be to ensure that medical affairs as the public face of the organization is seen as a strategic leading partner with external and internal stakeholders, according to Antonio Tataranni, SVP, Head of Medical Affairs, Sanofi. “It means a number of things. MA need to have the right attitude – after all, what brought us here won’t get us there. It’s about taking ownership and leading certain strategic decisions. It’s crucial that we commit to providing the right data at the right time, moving from clinical trials increasingly into the Real World Evidence sphere – we need to own that. The future that we can create as an innovating function is largely dependent on talent and anticipating future needs, identifying knowledge gaps and filling them. I am profoundly convinced that the MA function needs to evolve with a constant reassessment that the offer matches the needs of the marketplace”.

This article is extracted from Trends in Medical Affairs. To download the magazine, click here.

Want to learn more about the many faces of Medical Affairs?

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.

King’s College London: “From Molecules to Medicines”

News from IFAPP Academy


King’s College London: From Molecules to Medicine

King’s College London, IFAPP Academy’s academic partner, has a strong tradition in pharmaceutical science.

King’s College London has a strong tradition in pharmaceutical science, world-class pharmacology, clinical pharmacology, and therapeutics. This has led to the creation of a number of spin-out companies, including MedPharm and Proximagen Neuroscience plc.

The School of Cancer and Pharmaceutical Science was created to bring together the relevant research groupings across King’s College London.

Molecules to Medicine’s strategy is designed to capture and highlight the broad sweep of research at King’s ranging from pharmacological and chemical studies that can identify novel drug targets and new chemical entities, through formulation and drug development, to clinical trials and the use of medicines by patients. The all-embracing strategy is for researchers to work together towards the discovery of novel medicines and new formulations that can be evaluated in patients in the clinic.

To achieve this goal, and to provide focus, research activities are organized into three related themes: Drug Discovery, Medicines Development, and Medicines Use. Each of these themes includes clusters of research activity, some of which have evolved during the past decade (e.g. drug delivery, chemical biology, pharmaceutical biophysics, pharmacology), and some of which have joined King’s more recently such as enhanced activity in anticancer and anti-infective drug discovery, nanomedicines, substance abuse, health psychology, and clinical pharmacy. Researchers within and across the three themes interact both informally and via joint initiatives to promote cross-disciplinary research. For example, the drug delivery activities of Forbes, Jones, and Daily, working closely with colleagues in pharmacology (Page/Spina) have led to consortium funding and several Ph.D. studentships from the MRC to investigate the safety of nanoparticles in the airways.

This excerpt was originally published on the King’s College website at https://www.kcl.ac.uk/lsm/research/divisions/ips/about/index.aspx

The IFAPP Academy in partnership with King’s College London offers Academic and Professional Certification for students successfully completing the Medical Affairs in Medicines Development course. To learn about the benefits of Certification from the IFAPP Academy, visit us at https://ifappacademy.org/index.php/ifapp-academy-benefits/

Professor Peter Stonier, Co-director of the Medical Affairs Certification program says: