Category Archives for "Blog"

The Business of Pharmacy Podcast™ hosted by Mike Koelzer and his guest, Dr. Anne Arvizu

Join pharmacist Mike Koelzer and his guest, Dr. Anne Arvizu, for an in-depth, behind-the-scenes podcast on the business of pharmacy.

In this episode, Anne and Mike discuss the different lanes of Medical Affairs, why Medical Affairs is a great career choice and how Medical Affairs is the key driver and the wave of the future!

Anne Arvizu, PharmD, FASCP, PCC, is a global consultant and to Fortune 500 biotech companies, and a successful entrepreneur in Miami, FL. The companies she builds & affiliations she keeps all share a common focus of promoting productivity, health & life balance in the lives of entrepreneurial women executives. In 2002, Anne founded RxER Communications Corp., a management consulting firm partnering with biotech companies that require operational capabilities build within Medical Affairs. Anne is a premier Medical Information expert and sought after keynote speaker that brings 22 years of pharmaceutical medical affairs and operations globalization expertise to the table. For more information, visit our site. www.rxercommunications.com. In 2018, RxER launched its proprietary executive coaching model and business framework, Corecentryx®, and the Corepreneur® podcast concept was born. ​Anne also gives back to her community, currently serving as Chair of the YMCA Board of Directors in her local area.

Anne reveals her feelings regarding how there is no training that can prepare you for being the expert and that the learning curve went straight up the mountain. Then Mike and Anne discuss, why do pharma companies bring in a consultant? Anne explains it is often a result of a bridge, stop-gap solution, or sometimes a necessity to re-vamp or re-vitalize current operations. Change has occurred or something is coming down the pipeline and the company cannot scale as quickly.  Anne then theorizes how you cannot see the return of value that Medical Affairs offers.

Later, Anne explains her executive coaching model and business framework, Corecentryx® and Corepreneur®, for those who are corporate but entrepreneurial.  The Corecentryx® business growth model: What is the center of all you do? Is that tied into your integrity?  Anne also shares that she is writing a book about the Corepreneur®.

You will enjoy this insightful and genuine conversation.

#V3PODCAST Episode 3: Future Focused Trends in Medical Affairs and Leveraging Technology


Welcome back to the #V3Podcast.

This is The Vision, the Voice & the Value of Medical Affairs.

This month’s guest is Dr. William Soliman. Will is the founder of The ACMA, the first and only global accreditation council for medical affairs professionals, he is also a seasoned media figure and thought leader in the biotech industry, with several years of leadership experience in the Pharma industry under his belt. Will has been instrumental in launching a variety of innovative platforms and expanding the role of medical affairs across the industry. He is often invited to speak at crucial pharmaceutical industry conferences focusing on medical affairs, patient navigation, and its relationship to field-based medical teams, and the ever-changing role of the medical science liaison (MSL). Will has held a variety of critical management roles across the industry at companies such as Retrophin, Veeva Systems, Eisai, and Gilead Sciences.

In this episode, Anne opens the show describing some future focused trends in the medical affairs field. She and Will speak on controversial drug pricing issues – such as, what does the election year mean for the industry from an innovation perspective? There is no doubt that we want to make drugs as affordable for as many people. However, the challenge comes in when a majority of the clinical trials fail. The solution to drug pricing may be thinking about more efficient and effective ways to design clinical trials. Machine learning and AI can come into play for a clinical trial designer. The V3 team discusses here.

Ultimately, whether a device or product is going to work could be determined early on in the research. There is a strong correlation with what is happening in research and how we can make the overall system more efficient and effective.

Medical affairs is a value producer for companies, says Anne So how do we view value? William Soliman says that medical affairs will be taking more of a forefront in big-name companies. Global scientific output doubles every nine years. We need people who are going to be well-trained and formally knowledgeable.

Then, Will Soliman answers questions around the benefit of formalization Board Certification in Medical Affairs, as it brings uniformity within the culture of medical affairs. For example, medical directors entering industry from Academia don’t know how to create a clinical trial. When you go to medical school, you don’t get trained on how to create an adequate trial – there needs to be some uniformity.

Pharmaceutical companies need to rebrand – they have to demonstrate to patient groups that they are putting their money where their mouths are. Companies always say they are going to do things; however, rarely do they follow through. Patient advocates want physicians who are working from the highest standards.

“If you don’t stand for something, you will fall for anything.”

In this Episode the team discussed the following topics:

  • About drug pricing [ ~3:55 ]
  • Understanding how to leverage technology [ ~8:15 ]
  • How we can utilize patient input [ ~12:35 ]
  • Medical affairs is a value producer [ ~15:30 ]
  • Board Certification in Medical Affairs [ ~21:45 ]
  • How we can do our job with the highest level of caring [ ~27:50 ]
  • You have to tough it [ ~37:30 ]

Anne’s Favorite Quotes:

  • “The industry can do a better job of leveraging technology to create more efficient clinical trials.” -Dr. William Soliman
  • “The opioid crisis casts a poor light on pharmaceutical companies.” -Dr. William Soliman
  • “When you make a decision based on fear, then you aren’t willing to put your foot down and make the hard decision.” -Dr. William Soliman

Links Mentioned: 

#V3PODCAST Episode 2: Is The Cure For Cancer Around The Corner?

Welcome back to the #V3Podcast.

This is The Vision, the Voice & the Value of Medical Affairs.

On today’s episode, we discuss Artificial Intelligence (AI), blockchain technology and the future of global Medical Affairs. Is biopharma lagging behind compared to other industries? And what’s the reason? Who is really pushing for change? And how can the C-Suite catch up and catch the wave before it’s too late?

The number one medical affairs podcast tackles new ground in this episode as Biopharma global executive veteran, Dr. Anne Arvizu, interviews Medical Affairs influencer and frontrunner, Dr. Sotirios Stergiopoulos, President & CEO at A2A Pharmaceuticals. Dr. Stergiopoulos is an awarded physician executive and oncology thought leader. He’s also been recipient of the prestigious lifetime achievement award, by the American Cancer Society, for his long-standing dedication to fighting cancer. He serves on the Board of Governors for the Accreditation Council for Medical Affairs. Previously, at Ipsen he was Chief Medical Officer, SVP and Head of Global Medical Affairs. Sotirios has held numerous other leadership positions in the pharmaceutical industry with companies including Novartis, Bayer, and Celgene. Dr. Stergiopoulos holds a B.S. from Stony Brook University, an M.D. from Poznan University of Medical Sciences, and an M.B.E.E. from the Johns Hopkins University; and has trained at the National Institutes of Health, the Albert Einstein College of Medicine, and Harvard University.

As the conversation starts, Dr. Stergiopoulos reveals his thoughts on the future of global medical affairs. Artificial intelligence can have significant value and be one of the greatest assets for the biotech industry. Plus, the team discusses how blockchain will drastically alter patient anonymity and privacy reports. Crypto machinery will protect the interest of our patients by keeping their data safe. Anne highlights how the medical affairs segment of the biotech industry is not using AI as much as other industries like entertainment, telecommunications, technology, and professional services. Dr. Stergiopoulos thinks the medical sector is pressure tested – they are first waiting to see if AI is a fad or something that is going to be ubiquitous in society.

With such a daunting task ahead, Anne theorizes asks how the biotech industry might become knowledgeable enough in the technology to utilize it daily. Dr. Stergiopoulos insists that ‘middle management’ and the technologically savvy people, are the new content experts. They’re the ones that keep pushing corporate heads to find and adopt new and relevant technologies. Many people don’t even realize they are already using AI, and they don’t even know how the technologies are rapidly evolving. One foundation is even giving out generous rewards to teams who can solve problems using AI. XPRIZE gives out millions of dollars to groups who can tackle big problem, i.e., find ways to ensure society has an indefinite supply of clean water. Then, Anne and Sotirios discuss what roles medical affairs need to focus on moving forward. Dr. Stergiopoulos reveals the top three are medical affairs services (such as medical information and medical communications), content expertise, and ensuring their MSLs are topnotch.

Later, Dr. Stergiopoulos reveals his feelings on patient-centricity. Currently those words are being used as a disturbing catchphrase. However, he believes we are moving in the right direction now. Dr. Stergiopoulos thinks we have some excellent patient-centricity officers out there, but both agree there is a need for more. The goal of the officer is to make sure that number one, most importantly, the company realizes that everything they do is all about the patients. In his previous role, the Chief Patient Centricity Officer reported directly to him, to advocate for the patient, with the number one goal to educate everybody within the company and to ensure people understand that the patient’s voice needs to be heard.

This power hour illuminates applications in AI as used in medical affairs and brings our minds up to the highest goal: seeing the potential cure for cancers in our lifetime via genetic therapies and other modalities. Keep ears perked up to hear Dr. Stergiopoulos reveal the new technologies we need to be on and what keeps his heart in the game.


In this Episode:

  • The future of global medical affairs [ 4:30 ]
  • AI deficits in the medical industry [ 11:20 ]
  • Closing the skills and knowledge gap to implement new technology [ 16:30 ]
  • People don’t even know they are utilizing AI [ 22:15 ]
  • The roles medical affairs needs to focus on moving forward [ 25:00 ]
  • What is patient-centricity? [ 31:00 ]
  • What advice would you give for companies who want to identify as patient centric? [ 36:00 ]
  • Patient centricity example [ 37:45 ]
  • New technologies to look out for, and how we may see some cancers cured in our lifetime with genetic therapies [ 42:40 ]
  • What keeps your heart in the game? [ 45:15 ]

 

Quotes (Sotirios Stergiopoulos):

  • “People don’t even realize they are utilizing AI right now.”
  • “The last thing you want to do is be the last one at the table.”
  • “Seeing patients just kept giving me energy.”
  • “The ability to touch patients on a grander scale is a motivator.”
  • “Do what you’ll love, and you’ll never work a day in your life.”

Links Mentioned: 

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

So, You’re Now Under A CIA. How can the Medical Information function help?


According to the last DIA MedComms, March 2016 in Orlando, Med Info Departments within companies that have recently gone under CIA can help their companies adjust to the new level of scrutiny in several ways. 

First, by ensuring CIA Compliance. 

Med Info CIA requirements include maintaining a robust database documentations requirements such as name, nature and topic of interest, exact language used in inquiry, name of sales rep, evaluation of off-label inquiry, nature and form of response, etc. 

Most companies seasoned in MI practice generally use a program, such as IRMS or other content manager to accomplish this, but under CIA, it time to step up your game and train team members to not skimp. 

Finding a standard training plan that works can be complicated, but it doesn’t have to be. Consistency and harmonization are key. RxER helps companies design these training and operational plans.

Second, performing a quarterly analysis of inquiries.

Performing a quarterly analysis of inquiries can help retrospectively drive continuous improvement.

  • inquiry reports for each therapy area

  • sales reps with the most number of inquiries for each product and assessment of off-label requests generated by sales rep by geographic area

This can lead to separate reports that provide valuable insights to the organization and can be of great use to MA TA teams as well as field medical teams. 

Finally, there are other policies to consider revamping, including: 

  • what type of medical information can be distributed

  • how to respond to off-label requests

  • internal review process of responses

  • how sales reps and other medical personnel handle off-label requests

  • submission of product information to compendia

  • HCP signatures for rep-facilitated questions

 If your company needs help developing SOPs, or needs a second pair of eyes to review and revitalize your department operations, partner with us to get you compliant quickly. 

Email anne@rxercommunications.com.

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.

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