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Original Article

By Márcio Barra

Over the years, I have created a multitude of documents to help me in my projects. I have thus decided to create a useful documents tab to go along with my articles on medicines tab, which is by far the most popular tab of Pharmupdates.

To quick start the tab, I have published both a Word template and an Endnote Style for anyone looking to submit articles to the British Medical Journal (BMJ). I will be updating the tab with new documents that I feel would be useful to someone.

British Medical Journal (BMJ) journal template and Endnote style

I created both a Word template which I used for the submission that has all the required fields for a Research Article (this includes systematic reviews as per the journal rules). I also created an Endnote style, since the link that the journal provides is broken, and the one provided in the Thomsom Reuters website is incomplete.

If you require assistance with the submission procedure (formatting, image creation, referencing) contact me.

For the BMJ Endnote style and template, send me an e-mail.

MA

Guest article by Anabela Farrica

The Medical Affairs (MA) function is known to be a rather broad and hard one to define. (1)  Its operations are essentially founded on the scientific exchange with internal and external stakeholders, with the ultimate goal of translating medical science into value – not only value for the business, but also, and most importantly, value for the patient through an adequate and safe use of their products. The methods MA groups employ to support and fulfill this goal are of great diversity: scientific congress support; advisory board realization; data generation (by providing support to both pre- and post-marketing studies); implementation of educational programmes for healthcare professionals (HCP) and patients; promotional material review; providing answers to medical enquiries; and many others. (2)

The success of a MA group is highly dependent upon the understanding, by its members, of how the regulations surrounding their activities apply and, at the same time, of the commercial implications of their work. (1) Maintaining this delicate balance is no small task, especially considering the intensified public and regulatory scrutiny applied to the pharmaceutical and medical device industries. (3)

Furthermore, the job of MA has become increasingly complex, not only because of this scrutiny on the industry, but also because there is a host of external challenges that increases the expectations for these professionals:

  • HCP’s information needs have grown and become more demanding; (4)
  • A sharper focus on Risk Management; (5)
  • The growing prevalence of chronic diseases; (5)
  • An increased industry focus on niche diseases, with products characterized by a larger amount of complex scientific information; (5)
  • The emergency of new types of data (e.g. Real World Data) and an expanding number of its users; (6)
  • A rise in digital media as sources of medical information that have made patients a pivotal stakeholder in today’s industry communication initiatives. Specifically, there is a growing interest on the patient’s satisfaction as a consumer of care. (5)
  • A more demanding market access environment, with strict pricing and reimbursement policies that difficult access to the often costly therapeutic novelties. (5)

Additionally, the focus of a MA team on the sound scientific interpretation of drug-specific and data-specific information and its implications has been recognized by the companies has a valuable asset for strategic planning. In this role, the MA professionals have become crucial by helping to bridge science with commercial aspirations. (6)

In the face of these challenges, MA’s purpose of enhancing medical care will not only require a deep comprehension of product knowledge, but also a robust, informed view of the needs, requirements, expectations and perspectives of various healthcare stakeholders. (7) Advisory boards, while not a novelty for MA teams, are of particular relevance as a strategy for obtaining non-binding but informed guidance on a range of business aspects. (8)

Advisory boards are commonly held with Key Opinion Leaders (KOLs) in the company’s fields of expertise in order to obtain expert feedback on various aspects related to a product or disease state. (2) An effective advisory board is a precious tool to gain insights on possible research opportunities, including guidance on clinical development and trial protocols, as well as unmet medical needs that might drive future clinical strategies. Input on marketing strategies, plans or materials can also be acquired through these meetings. (2, 7) By allowing a direct engagement with the medical community, advisory boards help pharmaceutical companies in product development, data generation, strategy refinement and in creating relevant and reliable educational and promotional content. (7)

Advisory boards can, thus, take place virtually at any stage of product development, depending on the needs identified by the company. However, as the regulatory requirements get tougher and payers look for ever more clear-cut proof of products’ value, MA should seek out to include insights from a broad range of external medical decision-makers and influencers into early clinical development. (7, 9) Expert input might guide, for instance, the risk management plan for clinical trials and the identification of the ideal target groups for the product, to ensure optimal clinical effect is achieved. The importance of this input grows as the a product moves along the development and regulatory pathways – especially as it progresses onto Phase III or Pivotal Clinical Trials, which are often determinants of product success. It might be beneficial to taken this type of advice from both Global and Regional advisory boards, to take into account regulatory and clinical differences, or even physiological variations between populations. (10)

Once a drug is licenced, advisory boards might be useful to: (2)

  • Understand the appropriateness and effectiveness of marketing strategies;
  • Identify and design the necessary post-marketing clinical trials;
  • Perfect the medical and/or patient education measures that have been adopted;
  • Increase understanding of how satisfied physicians and patients are with the product and of how to best fill in the gaps and voids that may exist.

A successful advisory board is one that generates actionable deliverables and that fosters positive relationships with prominent members of the scientific community. (7) The trend for tighter budgets and the pressure to do more for less represent great challenges to MA professionals. To maximize the return on investment, it is important to invest optimal resources in structuring an advisory board appropriately. (8) Cost reduction should not mean that meeting quality is compromised, as poorly executed advisory boards fail to provide companies with instructive medical insights and added-value recommendations from the medical experts in attendance. (7) Some of the elements to consider in an advisory board to ensure the desired outcomes are:

  1. Have a clear objective: the MA team responsible for organizing the advisory board must set a focused goal that not only justifies holding the meeting, but will also determine its members and guide the discussion. (11)
  2. Choose the right people: ideally, the group of advisors should be representative of the variety of skills, expertise and experience related to the specific topic under discussion. This means that the board should not necessarily consist of product supporters only, for example. In some cases, the best insights and ideas come up when opinions diverge. (7) Having members that are good communicators and are open-minded is also important to foster discussion. “Big names” can be a powerful addition to an advisory board, but an uneven peer group, with a mixture of elements with various levels of notoriety or responsibility, may create barriers instead of opportunities. (12)
  3. Clarify expectations: when inviting an expert to join an advisory board, it is essential to lay down the expectations the MA team has for the meeting in terms of time, areas where help is being sought out and end result. If the object of discussion includes private information, members should be notified of the need to sign a confidentiality agreement. (12)
  4. Compensate the participants: money should not be the main motivator for participation in an advisory board. Nevertheless, it is good form to provide some sort of compensation, such as meals, travel expenses or even a small fee. Members that feel appreciated will be more willing to engage in active discussion. (12)
  5. Make sure board members are prepared: distributing information to board participants before the meeting increases the chances of an interactive, successful meeting. (11) Pre-readings or other materials ensures that all participants are equally prepared, thus facilitating the flow of the session and promoting an active and open participation by the group.
  6. Assign a great moderator: preferably a person from the MA team that is familiar with the details of the issue for which input is being collected. This helps energizing the meeting onto an end result that is effective and actionable. (7)
  7. Organize the meeting appropriately: from a member-driven agenda that stimulates interest to a meeting location that is comfortable and free of distraction, a carefully thought out meeting is essential to maximize potential benefits. (12)
  8. Diversify the communication methods: typical Powerpoint presentations may not work for everyone, due to the natural heterogeneity in learning and group discussion styles. Handouts with relevant graphics, videos or questionnaires are interesting alternatives to consider. (7)
  9. Assess the meeting: obtain feedback immediately after an advisory board ends. Self-assessment and monitoring are key. (11)
  10. Convert meeting results into action steps: in order for the core objective of the advisory board to be fulfilled, the insights gained from the meeting should be capitalized under the form of practical company activities. (7) A board where the solicited feedback results in action steps is a successful board. (2)
  11. Follow-up with board participants: keeping the members of the advisory board informed on the outcomes of the meeting is vital to foster continued scientific exchange with these KOLs. Updates on what is being planned and on what the company has worked on as a consequence of the meeting should be made on a regular basis.

These practices ensure advisory boards are founded on professional dialogue and informative feedback, which can help identify key issues needing clarity or exploration and set a framework for value-added change. (13)

In the (recent) past, the biopharmaceutical industry was under a considerable amount of criticism around the unduly use of allegedly scientific advisory boards as promotional events to influence physician’s prescribing habits. Accusations of promotion of either unlicensed products or indications emerged, as well as suspicions of disproportional compensation and hospitality given the nature of the meetings. Nowadays, these and other types of interactions between the industry and healthcare professionals are governed by a set of rules: European and/or national law; companies’ Codes of Conduct; and ethical standards defined by EFPIA and by national associations of the pharmaceutical industry (APIFARMA, in Portugal) that have been increasingly advocating for a culture of transparency. (10)

Advisory boards have been a part of the MA landscape for a long time, functioning as sources of expert insight into a wide range of issues related to products’ lifecycle.  Today, they are more useful than ever, as regulatory requirements get tougher and patients, payers and healthcare providers demand more and more diverse clinical data and health outcomes information to prove product vale. Effectively managed advisory boards help MA teams to achieve this and more – as the ultimate goal of the knowledge gained should always be to improve the quality of life for patients. Biopharmaceutical companies are expected to seek and employ innovative ways of conducting advisory boards and capitalizing on the wisdom gained, so as to balance the value added to their clinical and commercial goals with the compliance with the relevant codes and laws.

References

  1. Wolin MJ, Ayers PM, Chan EK. The Emerging Role of Medical Affairs within the Modern Pharmaceutical Company. Drug Information Journal. 2001;35(2):547-55.
  2. Evens R. Medical Affairs and Professional Services. In: Evens R, editor. Drug and Biological Development: Springer US; 2007. p. 240-74.
  3. Werling; K, Carnell; H, McCormick; D, LLP; M, Chicago I. Focus on Life Science Compliance: The Evolution of Medical Affairs Departments. AHLA Connections. 2011;15(11).
  4. Bloom; L, Andre; T, Chandran; P, Dabbs; E, Keen. K. Raising the Bar in Biopharma Medical Affairs: Three Critical Success Factors Boston Consulting Groups: Boston Consulting Groups; 2013 [cited 2015 27-06-2015]. Available from: https://www.bcgperspectives.com/content/articles/biopharmaceuticals_raising_the_bar_in_biopharma_medical_affairs/.
  5. Morgon P. Medical Affairs. CEGEDIM, 2014.
  6. Evers; M, Fleming; E, Ghatak; A, Hartmann; J, Nathoo; A, Piervincenzi; R, et al. Pharma Medical Affairs 2020 and beyond. McKinsey & Company: McKinsey & Company, 2012.
  7. Dyer; S, Tolmachev. A. Nine Key Elements To Ensure Advisory Board Success pm360online: pm360online; 2014 [cited 2015 27-06-2015].
  8. Best Practices L. New Study Presents Insights to Advisory Board Effectiveness in the Pharmaceutical Sector prnewswire.com: prnewswire.com; 2015 [cited 2015 27-06-2015]. Available from: http://www.prnewswire.com/news-releases/new-study-presents-insights-to-advisory-board-effectiveness-in-the-pharmaceutical-sector-300076091.html.
  9. Presson J. ADVISORY BOARD FUNCTIONS EXPANDING IN PHARMA INDUSTRY Cutting Edge Information: Cutting Edge Information; 2013 [cited 2015 27-06-2015]. Available from: https://www.cuttingedgeinfo.com/2013/advisory-board-functions-expanding-pharma-industry/.
  10. Liftstream. Scientific Advisory Boards and the Impact of Compliance Liftstream: Liftstream; 2015. Available from: http://www.liftstream.com/blog/scientific-advisory-boards-and-the-impact-of-compliance/#.
  11. Moltz B. 10 Steps To Forming An Effective Advisory Board American Express American Express 2011 [cited 2015 27-06-2015]. Available from: https://www.americanexpress.com/us/small-business/openforum/articles/10-steps-to-forming-an-effective-advisory-board-1/.
  12. Stengel G. Ten Tips to Creating an Effective Advisory Board Stengel Solutions: Stengel Solutions; 2003 [cited 2015 27-06-2015]. Available from: http://www.stengelsolutions.com/tips19.htm.
  13. Joyce D. Medical Affairs: The Catalyst for Effective Medical Communications. PharmaVOICE. 2013:46-7.

March 11, 2015 | By Márcio Barra

 

pharmu2

(Note: all references used are in the comments)

The modern clinical trial is a significant undertaking, and one that requires a multidisciplinary team(1). The current research team includes the principal investigator, sub – investigators, data managers, statisticians, clinical research coordinators (CRC), and the monitor or clinical research associate (CRA).

The International Conference on Harmonization (ICH) E6 Good Clinical Practices guidelines defines monitoring as “The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)”. CRAs are responsible for monitoring the trial, a task which ensures the integrity of the data that is being collected. It also allows the sponsor to closely follow the study centres, evaluate their conduct, and identify bottlenecks in patient recruitment(3).

In the past, it was the sponsor that would send their personnel to research sites to carry out the monitoring activities. This changed in the early nineties, with the emergence of contract research organizations (CROs). Like many other aspects of trial conduction, monitoring began to be outsourced (4).

The ICH guidelines state that data should be accurate, complete, legible, and timely. However, they do not provide instructions on how to approach data monitoring or individualized approaches for different types of trials. This leaves room for the industry to experiment with different strategies for trial monitoring, and with the advent of EDC, news ways to monitor clinical trial data are becoming more and more common.

On-Site Monitoring

On-site monitoring is the current industry standard, and one that has stuck with clinical trials for some decades (6). Here, the CRA is assigned to monitor a clinical trial or an observational study in a study centre or group of study centres, and then carries an in-person site evaluation (6). The most significant activities carried out by a CRA include: (1) the study initiation visit, where the CRA visits the centre to prepare the study staff for conducting the study; (2) several monitoring visits to a centre during the course of the trial; and (3) the study closure visit.

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November 1 ,2013 | By Márcio Barra

Remsima, one of the Biosimilars of a Monoclonal Antibody approved by the EMA

What follows is a list of Biosimilar drugs available in Portugal. This data has been compiled from the INFOMED database, managed by the Portuguese National Competent Authrority on Medicines, INFARMED.  The Portuguese Marketing approval date was also provided. In the Market Status, you may find “no data” on some drugs. This means that the drug in question has no information displayed on the INFOMED database, save for its name.

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October 28 ,2013 | By Márcio Barra

Tafamidis (vyndaqel), from Pfizer, sold in Portugal since 05 May 2012

What follows is a list of Orphan Drugs available in Portugal. This data has been compiled from two different databases, the INFOMED database, managed by the Portuguese National Competent Authrority on Medicines, INFARMED, and the OrphaNet database, from which sales numbers from Portugal were obtained, when available (note, sales numbers were, according to the Orphanet Website, last updated in September 28, 2013). The Portuguese Marketing approval date was also provided,

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June 24 2013 | By Márcio Barrapharmu2

The institutional management of the Portuguese National Health Service is of public domain, with healthcare services being provided by public entities or by entities contracted by the Government. The National Health System also includes insurance companies and job related health subsystems. There is also a long standing tradition of private clinical practice by the physicians. While most of the Population is covered by the “potentially free” health system through the payment of taxes (following the Beveridge Model), the Portuguese Health System is currently a mix of both free and paid services.

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