All Posts by christilnorfleet

The #V3Podcast Launches on The Pharmacy Podcast Network


Welcome to the inaugural episode of The V3 Podcast, which launched Tuesday, July 2, 2019. The V3 podcast will showcase the vision, the voice and the value of Medical Affairs. Biopharma industry executive veteran, Dr. Anne Arvizu, will interview like-minded leaders and key global strategists who will share their knowledge, insights and new cutting-edge information. This higher-level look, at what keeps your patients first in our industry, will help you to position the role of medical affairs as the key driver for your organization and the Biopharma world moving forward. This is the Future of Medical Affairs.

The V3 Podcast is great for you if you: wishing you had a focused bit of time to learn more about medical affairs from a leadership perspective. V3 will give you the gift, first Tuesday of each month, to take about 30 minutes or more, to be equipped from the mindset at the executive levels. It’s also a great show for doctoral level leaders entering the industry, wanting to learn more and fast track their careers. As the show progresses, we’ll focus on various functions and hot topics within medical affairs that will be edifying and informational. You can expect to glean some actionable insights from every episode that you can immediately put into action. 

This first episode has been recorded as a solo anchor episode for our future guests. In this great standalone episode, Anne breaks down the threein V3; Vision. Voice and Value, as strategic elements pertaining to medical affairs. You’ll walk away understanding the impact that our practice has on the business that we support, and ultimately the patients we serve.

Please follow the show so you don’t miss an episode. And if you like what you hear, please tag and or follow @annearvizu and share on social media with the hashtag #V3Podcast and #medicalaffairs 

This show is being produced by the Pharmacy Podcast Network and is parter-sponsored by The Accreditation Council for Medical Affairs (ACMA) to help better serve the next generation of medical affairs leadership and adding value by supporting the medical experts and compliance leaders in our industry. You can find out more about ACMA here

ACMA – 2019 Rare Disease Forum – Philadelphia


CEO of RxER Communications Corp, Anne Arvizu has been named co-chair of the 2019 Medical Affairs In Rare Disease Forum. 

"It's an honor to support the biotech and pharma industry in this pivotal event. The agenda is superb and contains everything you need to focus on your patients and execute against the many objectives across Medical Affairs. As an expert in organizational design, I can add so much value to those working in precision medicine and it will be exciting to have the interaction and meeting of the minds specific to rare disease and precision medicine. Patients with rare life-debilitating diseased are globally widely under diagnose or untreated. Patient advocacy, patient access and other medical affairs operational tactics, such as targeted publications plans are game changers for patients that can go undiagnosed for years and even decades. I look forward to presenting, chairing and hearing the other experts in the room raise the bar for patients and the entire industry standard", says Dr. Arvizu. 

This forum is presented by Dynamic Global Events and ACMA.

For more information visit: 

https://dgevents.com/medical-affairs-rare-diseases-event/

Medical Affairs 101


Medical Affairs, what is it? What do you do with it? How does it work? What do you eat it with? These might be some of the questions that pop up in your mind if you are outside of the medical affairs profession wanting to know more.

The trend in biotech is the small startup.  Many small startups produce one or 2 molecules or have a limited pipeline. For a new company that’s just taking its first steps in the field, or a mid-size company developing and globalizing its departments, you may want to know how to best operationalize 

for compliance and effectiveness.  For me, as a recent graduate student intern, who is learning about the pharmaceutical industry and its departments, understanding medical affairs and what good looks like within its walls is a project I was willing to research.

Medical Affairs is a key division found in Pharmaceutical/Biotech companies with the overall responsibility to explain the information about their marketed products.  The data, can be disseminated in many ways, and used by health-care providers. Their Objective is to educate the use of therapies developed by the company for managing better treatment and care for the patients who used said products. This division is made of other subdivisions or departments and employ medical and scientific personnel (PharmD, MD and PhD, generally) that help run the operational functions. For example, you can find sections for patient advocacy and diagnosis, Medical Information, and Medical Communications, Publications and Post-Marketing Clinical Research to name a few. Those sections are made up by team holding various titles and functional responsibilities medical officers, medical managers, directors, and advisors.

Medical Affairs is involved in oversight of medical activities and roles, such as, Field Medical Teams, Post-launch clinical trials, Medical-Information services, Medical Communications, Medical education, Medical strategic activities and sometimes Health economics and outcomes-research activities. You must be thinking, as I did, “What? they do all that!” The answer is yes, they do and much more. Now the vision that surrounds a Medical Affairs department for its company involve around:

  • Patient access to the ideal medical treatment

  • Embracing healthcare.

  • Facilitating the direction and integration of different medical data and types of Disseminating a medical information I response to unsolicited inquires.

  • Obtaining and evolving the talent for cultivating and building a strong, multi-faceted Medical Affairs organization for the future healthcare scene across the globe.

While researching this post, I found another article that was written by a clinically based PharmD that gives a very similar point of view. The author was taking the approach of looking at the industry from the outside in to further understand the Medical Affairs scene within the Industry. If you enjoy reading this feel free to take a look at the ACMA post titled “Why I Became a Board Certified Medical Affairs Specialist (BCMAS) By Christine Megalla, PharmD, BCMAS.

I hope that Medical Affairs world now seems less complex to you but if you still have any questions, contact us. Feel free to click on the Discovery call button, located on the home page if need help for the development or organization of your Medical Affairs operational departments.

 Author: Jamie Arvizu, B.Sc., Biotechnology; Post Baccalaureate Intern

The Multifaceted Medical Information Department


It pains me when I hear, “How can you help make my Medical Information (MI) department become more strategic”. 

I already begin to picture disheartened pharmacists and physicians who are seen and rarely heard, performing a functional role like a vending machine. I come in to consult, assess and analyze what are they currently doing and then show them the missing pieces.

The pain leaves, when enlightenment takes place.

What does an MI Department do?

The MI Department is typically known for responding to inquiries, writing standard responses, going to lunch and leaving to go home. Even in mid-sized to large companies, the MI manager is typically a well-trained PharmD in the US, or a pharmacist or physician in ex-US markets. These highly trained, medical professionals can get disheartened when the workload is high, ideas are undervalued and communication and interaction with the departments they support are low.

Outside the US, when volume inquiry is ramping up, a multitude of other departmentally related tasks can be initiated creating a model of operational excellence.

In reality, the MI department is a vital and strategic force that can be leveraged so effectively for the success of the business. 
    
Bringing order into chaos and communicating strengths and ability cross-functionally is key.

What types of activities does the MI Department perform? 

The Medical Information role is not limited to inquiry management but includes the following types of activity categories 

  • content generation

  • content development

  • MLRC review and support

  • dossier leadership

  • compendia or PI review and content generation

  • insights reporting

  • monthly or quarterly inquiry analysis and reporting by Therapy Area

  • meeting support

  • TA Strategy support

  • vendor and call center management

  • TA expertise

  • custom response generation

  • spontaneous event and crisis support

  • launch support

  • fields medical team training and support

  • sales team training and support

  • globalization compliance

  • and so much more... 

Email us at Anne@rxercommunications.com to set an appointment to help bring your launch activity chaos into order with Medical Information consulting and outsourcing. 

 

We can help you build a department from scratch or get the support you need to be more strategic and value producing inside so you can focus and streamline staff to be lean, organized and high performing.