All Posts by Suzanne Crise

#V3PODCAST Episode 8: Going Digital & Remote Solutions in Medical Affairs


Going Digital & Remote Solutions in Medical Affairs

#V3Podcast Episode 8 with Dr. Anne Arvizu and Guest Amy Ravi

In this episode, I open the show talking about what’s going on in medical communications and medical affairs with the rise of COVID-19. My aim for this episode is to bring some digital or remote working solutions in Medical Affairs to light. Today, I bring colleague and fellow company owner, Amy Ravi on the show, to discuss creative ways for you to benefit right now. Hopefully the conversation we have sparks some ideas regarding things you can implement now to navigate change over the next few months and beyond. Are you losing staff or ramping up staff? Are you busier than ever or struggling in some way? Every company is different. We discuss virtual technologies and platforms that you can use regardless of your status. Ami Ravi is founder and CEO of Extendmed.

We discuss client trends we are seeing, including the needs for consultants and virtual advisory boards. The biggest driver is needing a back-up plan for our functions that was due to take place. Amy says her clients are shifting meetings from in-person to reconstructing it virtually. They also need to gather insights beforehand because it’s harder to stay engaged online for eight hours. Instead, people are creating discussion boards with written content. It’s incredible how people are revamping and repurposing these meetings to make things work.

That’s innovation in my opinion!

Next, I ask Amy to explain the essential elements anyone can use today to move advisory boards online. The first and most important step is to address the question of the crucial nature of an advisory board. Don’t be so product-focused – think about offering support to health care professionals and their patients. Virtual advisory boards can take on the tone of ‘overtime’. Think about how to engage with people over a series of months. Other ideas regarding engagements with HCPs and how that may change are discussed in the episode.

We agree, the world will change drastically after the COVID-19 outbreak. Companies don’t need to continue getting together for every advisory board. Consultants can be based at home. Both actions will save long term costs and help redefine what’s essential for every business.

Links below for both Extendmed and RxER Communications Corp for your convenience.

RxER V3 Resources:

For a free consultation and for medical affairs consulting, visit: https://rxercommunications.com/

RxER’s newest initiative, Corecentryx, Inc. is a productivity tool that can help us maintain projects and stay energized during this long haul.  As a response to the Coronavirus, Anne Arvizu will be conducting a series of upcoming free livecasts to gather health care professionals and help them combat burnout.  More information will be provided soon at https://annearvizu.com/.

For more information about ACMA to become board certified in Medical Affairs visit:  https://training.medicalaffairsspecialist.org/affiliate_page.aspx?unm=anne.aflt.arvizu

To listen to other podcasts on the Pharmacy Podcast Nation, our flagship home on the Pharmacy Podcast Network, subscribe on iTunes or visit: http://pharmacypodcast.com/

If you have something to add to the conversation or would like to be interviewed on the show, contact Anne. https://rxercommunications.com/

In this Episode:

  • The most significant demands right now [ 8:15 ]
  • How to move advisory boards online [ 16:30 ]
  • Is it difficult to get in touch with advisors? [ 20:45 ]
  • Are the outcomes different from virtual engagements? [ 23:30 ]
  • Are any product areas taking a hit right now? [ 26:40 ]
  • How will the world change or differ after COVID-19? [ 29:45 ]
  • About Extendmed [ 32:40 ]

Quotes:

  • “We should share information in real-time online.” -Amy Ravi
  • “Defining essential does not mean it has to be labeled COVID-19.” -Amy Ravi
  • “There are essential aspects to continuing our advancement across the board.” -Amy Ravi
  • “Without health, we can’t function.” -Dr. Anne Arvizu
  • “Don’t get bogged down in the how. Find the what and the why and the how will emerge.” -Dr. Anne Arvizu
  • “If you are listening to this episode, you are lucky, and you are blessed.” -Dr. Anne Arvizu
  • “If you are an essential worker, my hat goes off to you, and my prayers go up for you.” -Dr. Anne Arvizu
  • “I’ve seen companies ramp up so quickly without having the bandwidth to do so.” -Dr. Anne Arvizu
  • “We don’t have time for yesterday’s news.” -Dr. Anne Arvizu

All Links Mentioned: 

About Anne:

Dr. Anne Arvizu, creator and host of the V3 Medical Affairs Podcast, is founder and CEO of RxER Communications Corp (www.rxercommunications.com). With 22 years of executive leadership experience in the pharma/biotech industry, she has served in key roles such as Head of Global Medical Information, Knowledge Management & Literature Surveillance for Baxter, Baxalta & Shire; Member Executive, PhactMI; International Regional Head & Director of Medical Communications & Medical Information for GSK, LATAM; DIA MASC Program Committee & Track Chair for The Drug Information Association; Podcast Founder & Host for The ACMA (#V3Podcast) (The Accreditation Council For Medical Affairs); Board Member of The American Medical Writers Association (AMWA), and, as an advocate for community health, she serves as Chair, South Florida YMCA Board of Directors in her community. She holds degrees for University of Florida (PharmD), University of the Sciences in Philadelphia, and Villanova University.  Anne currently engages biotech CMOs and VP Level executive clients as an expert consultant for Medical Affairs Capabilities build, renovation, and value-based business expansion. We are your outsourced VP of Medical Affairs.

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#V3PODCAST Episode 7: Coronavirus – Productivity & Continued Preparedness in Medical Affairs

Coronavirus – Productivity & Continued Preparedness in Medical Affairs

#V3Podcast Episode 7 with Dr. Anne Arvizu and Guest Dr. Suzanne Soliman

In this episode, Anne provides excellent resources and links to use for knowledge base, as a means to keep up with true facts and help you and your loved ones say no to fear and false information. This podcast is meant to help healthcare professionals protect themselves and inform others. Almost every industry in the US and beyond at this point has made a massive shift and Anne shares valuable consulting advice regarding the re-direct toward a new normal in Medical Affairs, Medical Communications, Publications and Medical Information. Any company, especially those working on Coronavirus vaccines or antiviral solutions may contact RxER Communications at support@rxercommunications.com to schedule a free consultation and strategy call with Anne.

Focus:

The aim of today’s episode today, is providing guidance for the current changes in the Biotech industry.

The tone of this planned podcast has shifted dramatically in the last week since taping on March 12.  Every day, and even every hour brings with it significant changes as we track. It’s time to not be caught up in the news, but be educated with the facts and forge our new normal.

During the first half, Anne discusses how HCPs (Pharmacists, Physicians, Nurses) are affected and then opens up the second half of the show with a conversation with special guest expert, Dr. Suzanne Soliman, on continued prevention measures to help answer the most common questions we are all receiving right now from the lay public. The aim is to hopefully better equip, protect and prepare the health professional so they can better help and continue to prepare others. Although it is not mentioned in the show, our biggest risk factor right now in the US, is Millennials who continue to go out, travel and not take this seriously. It’s been said the virus rate will depend on them.

It’s a time to stay home and distance yourself from other people as much as possible.

Anne invited Suzanne Soliman, founder of the Pharmacist Mom’s Group, on the show to discuss preparedness; Suzanne earned her PharmD from the University of Illinois at Chicago College of Pharmacy (UIC-COP) in 2004. She completed a residency in primary care with an emphasis on education at Midwestern University Chicago College of Pharmacy and a teaching fellowship at UIC College of Medicine.

Dr. Suzanne Soliman is a board-certified medical affairs specialist (BCMAS). Suzy worked as a clinical pharmacist, a medical science liaison (MSL) and national field team educator prior to becoming an Assistant Dean of Academic Affairs at UIC-COP. She most recently was an Associate Dean at Touro College of Pharmacy New York and an independent pharmacy owner. Currently, she is the Chief Academic Officer for the Accreditation Council for Medical Affairs (ACMA).

More Key Points:

It’s only been two weeks, but some of the recommended household items are completely gone. Some are being restocked or produced and will be back. There is still time to get some basics prepared. The time to pick up your medications is sooner rather than later. Get your refills NOW. Suzanne also discusses what’s still available and what can still be done.

Should we get tested for Coronavirus? We need to keep our healthcare workers healthy, make sure your ER visit is valid. We can get more sick from the emergency room. Sometimes staying home is better than going to the hospital. Call ahead of time so they can have a self-quarantined room ready for you. In the US, your county will provide guidance on where to get tested.

Is there a vaccine or other therapy coming out for the virus? There are various companies and treatments on top of the crisis as well as the production of a potential vaccine. Depending on the country that is trying to develop it, there are different methods currently being tested regarding treatment. You may be able to get the virus twice, because there seems to be a mutation. This makes creating a vaccine that much harder. Stay tuned, as Dr. Soliman explains when to keep your kids at home.

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Other Resources:

For a free consultation and for medical affairs consulting, visit: https://rxercommunications.com/

RxER’s newest initiative, Corecentryx, Inc. is a productivity tool that can help us maintain projects and stay energized during this long haul.  As a response to the Coronavirus, Anne Arvizu will be conducting a series of upcoming free livecasts to gather health care professionals and help them combat burnout.  More information will be provided soon at https://annearvizu.com/

For more information about ACMA to become board certified in Medical Affairs visit:  https://training.medicalaffairsspecialist.org/affiliate_page.aspx?unm=anne.aflt.arvizu

To listen to other podcasts on the Pharmacy Podcast Nation, our flagship home on the Pharmacy Podcast Network, subscribe on iTunes or visit: http://pharmacypodcast.com/

If you have something to add to the conversation or would like to be interviewed on the show, contact Anne. https://rxercommunications.com/

 In this Episode:

  • About Dr. Suzanne Soliman and Pharmacist Moms [ 0:15 ]
  • Supplies that we need [ 3:15 ]
  • Should we get tested? [ 11:15 ]
  • Is there a vaccine coming out? [ 17:00 ]
  • Can you get the same virus twice? [ 20:15 ]
  • When should you keep your kids at home? [ 23:10 ]

Quotes:

  • “This is going to get worse before it gets better.” -Dr. Suzanne Soliman
  • “We need to keep our healthcare workers healthy.” -Dr. Suzanne Soliman
  • “Encourage all employees to work remotely if they can.” -Dr. Suzanne Soliman
  • “We see that history repeats itself…don’t get caught up in the news, learn and apply facts” -Dr. Anne Arvizu
  • “Any government has a responsibility to maintain mass hysteria and provide the facts.” -Dr. Anne Arvizu
  • “Knowledge is only power if acted upon.” -Dr. Anne Arvizu

Links Mentioned: 

For those interested: 

For prevention: *Suzanne Soliman’s Article Discussed On This Show*:

Alcohol 70% vs 90 or 99% use:

Published articles:

About Anne:

Dr. Anne Arvizu is founder and CEO of RxER Communications Corp (www.rxercommunications.com). With 22 years of executive leadership experience in the pharma/biotech industry, she has served in key roles such as Head of Global Medical Information, Knowledge Management & Literature Surveillance for Baxter, Baxalta & Shire; Member Executive, PhactMI; International Regional Head & Director of Medical Communications & Medical Information for GSK, LATAM; DIA MASC Program Committee & Track Chair for The Drug Information Association; Podcast Founder & Host for The ACMA (#V3Podcast) (The Accreditation Council For Medical Affairs); Board Member of The American Medical Writers Association (AMWA), and, as an advocate for community health, she serves as Chair, South Florida YMCA Board of Directors in her community. She holds degrees for University of Florida (PharmD), University Of Sciences in Philadelphia, and Villanova University.  Anne currently engages biotech CMOs and VP Level executive clients as an expert consultant for Medical Affairs Capabilities build, renovation, and value-based business expansion.

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#V3PODCAST Episode 6: Antibiotics-The Necessity for Them & the Resistance to Them

Antibiotics-The Necessity for Them & the Resistance to Them

#V3Podcast Episode 6 with Dr. Anne Arvizu and Guest Dr. Jill Massey

Jill Massey is a Senior Medical Affairs Executive with proven success in leading multinational and multi-functional organizations to exceptional business results. An energetic leader recognized for expertise in strategic planning, leadership development, effective business integrations and innovative solutions. Jill combines strong business and clinical experience with nearly 30 years of experience in the pharmaceutical industry following a career in academia and clinical practice.

In this episode, Anne opens the show talking about antibiotic resistance. In our not so distant future, we could see over 10 million lives a year lost to antibiotic resistance. It’s a substantial public health challenge. Each year, 2.8 million people get an antibiotic-resistant infection. As of this recording, it was reported that 1,100 people have died in China from the Coronavirus. Anne gave kudos to the CDC, WHO and other health care organizations that helped create such a rapid and global awareness campaign about this virus, which as we know, its massive reality is still unfolding. We will cover that in an upcoming episode. However, not many people know about antibiotic resistance, despite the also massive threat.

First, Jill explains how antibiotic resistance happens. Jill says that bacteria becoming resistant to antibiotics is a natural phenomenon that occurs over time. The periods of time are shortening as bacteria get smarter. This is entirely expected with repeated exposure to antibiotics.

The two thought leaders ask the question: Where are the new and innovative antibiotics? Jill shares the industry reality regarding when we set up drug development programs, and they are targeting rare, it’s an extremely costly. Once the antibiotics get to the market, the return on investment is minimal. Large pharmaceutical companies are getting out of this business. Instead, they focus on more profitable life-saving treatments. The funding of new antibiotics is difficult to come by, and companies have stopped their development programs out of necessity.

Jill says that we need to practice reasonable infection control, like washing our hands. Then, Jill explains why generic antibiotics are ‘toxic’. Usually, they are equally effective, yet higher in adverse effects. Innovative antibiotics may have less toxicity, but costs to creating them and obtaining them are significantly more.

Later, Jill spoke out about spreading educational and health initiatives to get the word out. Any organization can participate in these needed initiatives to demonstrate what they are doing to tackle the antibiotic resistance challenge. Several organizations are measuring how pharmaceutical companies are tracking the ways they are contributing to resistance.

The number one cure to this issue is ensuring people have access to the right antibiotics. The two discuss RxER’s signature tagline that Anne trademarked and been using since 2004, stating “The Right Drug, for the Right Patient, at the Right Time.” If you are using inferior products, it will interfere with the microbiome and cause additional consequences. Anne says it’s essential to get the right antibiotic, and prescribe, dispense and use only when necessary and educate people on infection control. Don’t demand an antibiotic every time you have a symptom that may or may not be a bacterial infection.

Please like, share and leave a comment.

Other Resources:

For medical affairs consulting, visit: https://rxercommunications.com/

For more about Anne, visit: https://annearvizu.com/

For more information about ACMA to become board certified in Medical Affairs visit:  https://training.medicalaffairsspecialist.org/affiliate_page.aspx?unm=anne.aflt.arvizu

To listen to other podcasts on the Pharmacy Podcast Nation, our flagship home on the Pharmacy Podcast Network, subscribe on iTunes or visit: http://pharmacypodcast.com/


In this Episode:

  • Antibiotics, the necessity for them and the resistance to them [ 1:55 ]
  • Where are the new antibiotics? [ 13:30 ]
  • Bringing awareness to the public [ 16:15 ]
  • Generic antibiotics are toxic [ 17:50 ]
  • Using educational and health initiatives to get the word out [ 19:30 ]
  • How can we bring awareness and mindset to the public at large? [ 20:50 ]
  • Biggest fear globally [ 25:00 ]
  • Importance of infection control [ 26:21 ]
  • Short-term and long-term solutions [ 30:00 ]

Quotes:

  • “There is a broad spectrum of stakeholders involved in antimicrobial resistance.” -Jill Massey
  • “We need education and awareness to combat fear.” -Anne Arvizu
  • “Access to the right antibiotics is a global problem.” -Jill Massey
  • “The lack of new antibiotics has been deemed a threat to antibiotic resistance.” -Anne Arvizu
  • “Companies need the ability to fund further research and development.” -Jill Massey
  • “Young children are prey to antibiotic resistance before they’ve been given an antibiotic because of food sources.” -Anne Arvizu
  • “We need to bring all the stakeholders to the table together and educate them.” -Anne Arvizu

Links Mentioned: 

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#V3PODCAST Episode 5: Rare Disease Day 2020

Host Dr. Anne Arvizu and Guest Dan Donovan

This special topical episode is focused and dedicated to patients around the world who are suffering with a rare disorder or rare disease. 

Dan has spent nearly three decades in the pharmaceutical industry on both the industry and service sides of the business – first with Pfizer then creating Envision Pharma, which was acquired by United BioSource Corporation. Dan’s introduction to the world of rare disease began in 2011 when he was appointed to the Board of Directors and later as Chief Business Officer of Cancer Prevention Pharmaceuticals. Dan is the primary visionary behind rareLife solutions.

Dan’s experiences and observations have led him to believe that there is a better, smarter way to engage all rare disease stakeholders and accelerate disease understanding and treatment success. He believes the power of collaboration is the linchpin to this fundamental change.

In this episode, Anne opens the show defining rare disease. A rare disease is a condition that affects fewer than 200,000 people, whereas Europe defines it as something that affects less than 1 in 2,000 people. Drug companies have not been interested in developing treatments for rare diseases; there just wasn’t the incentive. The drug companies would not be able to sustain the costs involved in developing medicine.

Dan gives his take on the importance of patient centricity in rare disease drug development. Patients have to educate their physicians because they typically know more about it than their doctors do. Patients can help develop these products in a smarter way than the drug companies could do alone.

When Dan first started working in the business, patients had little input in rare disease drug development. In the past three years, it has taken off. Now there is even a role called the chief of patient relations.

Then, Dan speaks about publications for rare diseases. These publications should differ from most medical publications. These publications should have open and free access to the public and include patients and advocates as authors on the papers.

The patient journey is not in typical medical literature. Dan sat with a patient who had a rare disease. They looked at the psycho-social elements of the disease and the impact on their family. This woman has to see about ten doctors a year; there are substantial cost implications on this. Eventually, they were able to share this patient’s journey in a publication.

Later, Dan talks about ensuring patient-centricity happens. Pharmaceutical is a highly regulated industry. Anything that suggests that companies are doing direct-to-patient promotion will scare them – it comes with huge fines. Historically, pharmaceutical companies take a long time to make changes.

Other Resources:

For medical affairs consulting, visit: https://rxercommunications.com/

For more about Anne, visit: https://annearvizu.com/

For more information about ACMA to become board certified in Medical Affairs visit: https://training.medicalaffairsspecialist.org/affiliate_page.aspx?unm=anne.aflt.arvizu

To listen to other podcasts on the Pharmacy Podcast Nation, our flagship home on the Pharmacy Podcast Network, subscribe on iTunes or visit: http://pharmacypodcast.com/

 
In this Episode:

  • About rare disease [ 1:50 ]
  • Why patient-centricity is critical in rare disease drug development [ 14:00 ]
  • Different rare disease events [ 21:10 ]
  • Publications for rare diseases [ 21:50 ]
  • Dan gives a patient example on publications for rare diseases [ 24:35 ]
  • How to ensure patient-centricity happens [ 28:10 ]
  • About rareLife solutions [ 30:35 ]

Quotables:

  • “Patients with rare disease go years and sometimes decades without receiving a proper diagnosis.” -Anne Arvizu
  • “1 in 10 Americans live with a rare disease and over 30 million people are living with a serious or life threatening lifelong illness that may have little more than symptomatic care and might not truly work.” -Anne Arvizu
  •  “Of over 7,000 rare diseases, there are only 450 drugs that are approved.” -Dan Donovan
  • “HCPs need to recognize that patients have become major experts on their rare disease.” -Anne Arvizu
  • “1,200 companies are researching 1,900 rare diseases right now.” -Dan Donovan
  • “How do you go looking for what you don’t know?” -Anne Arvizu
  • “There is no reason patients can’t be authors on medical publications.” -Dan Donovan

Links Mentioned: 

#V3PODCAST Episode 4: Should Pharma Sales Reps Answer Off-Label Use Questions?

Welcome back to the #V3Podcast.

This is The Vision, the Voice & the Value of Medical Affairs with Host, Dr. Anne Arvizu and Guest, Dr. Darshan Kulkarni.

Dr. Darshan Kulkarni is the Principal Attorney of the Kulkarni Law Firm and focuses his practice on helping FDA regulated companies successfully bring their products to market. He has over 20 years of experience in providing legal, medical, and regulatory services. Darshan has served as a pharmacist for over a decade – making him uniquely well-positioned to help clients through all stages of the development process. He advises clients on issues varying from FDA regulatory strategy, clinical trial negotiations, manufacturing audits, FDA compliant promotional and non-promotional review, FDA responses, to genericization and other interdependent processes.

In this episode, Anne opens the show explaining the term “unlabeled use.” In the United States, doctors use this all the time. They aren’t going to stop prescribing medicine if a drug will be beneficial to a patient. Darshan poses the question: is label and labeling the same thing? The goal of the FDA is to make sure the products are safe and not misbranded. The label is what is on the bottle. Labeling is anything that goes with the bottle. The term “goes with” is exceptionally broadly defined. Your sales materials can be considered labeling. If your sales rep speaks off label, that’s still part of the labeling of the bottle.

In the early 2000s, the FDA started going after companies about how medical affairs people were going off-label and acting as supercharged salespeople. The industry said that wasn’t true. The medical affairs, people are having a scientific conversation. There are categories of information that are not subject to censorship – such as a political speech. You can’t shut down political speech just because you do not like what they are saying. However, you can shut down two scientists because you do not like what they are saying. The FDA went to court with the pharma companies and lost the first case.

Every so often, people ask why the FDA won’t stop doctors from prescribing off label. The FDA has no jurisdiction over doctors. Prescribing is entirely legal, but off label marketing is not okay. All of the top fines that companies pay are from off label marketing. IMS Health Inc. collected data from people and gave the data to pharma companies. The state of Vermont said they were not able to sell the data because the companies would target the doctors too much, and it might raise the cost of prescribing. The Supreme Court asked: is it truthful and not misleading? Vermont said yes, but there was a cost to it. The Supreme Court said you couldn’t stop people from saying something simply because there will be a cost to it.

So what constitutes truthful and not misleading? To claim the FDA, you need randomized controlled studies – substantial evidence. If you want to make health economics claims, it does not require significant evidence. No one knows the difference between truthful and not misleading. Another case came up: United States v. Caronia. Ex-Orphan Medical sales rep Alfred Caronia successfully argued to a court that the First Amendment gives him a right to promote drugs for uses not approved by the FDA. The critical thing to look at is the role a person will play in a particular context – are they playing a salesperson or a physician?

Stay tuned to hear Dr. Darshan Kulkarni explain why we need medical affairs, the future of our industry, and why the industry is pushing back against the FDA.

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

If you need more information regarding achieving value in medical affairs departments or learning more about Dr. Anne Arvizu then please visit the RxER Communications website here.

This show is being produced by the Pharmacy Podcast Network and is partner-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.

In this Episode:

  • About unlabeled uses [ 2:50 ]
  • About Dr. Kulkarni [ 5:30 ]
  • The difference between label and labeling [ 9:30 ]
  • Cases from the FDA [ 12:50 ]
  • Misbranding [ 17:45 ]
  • Presenting new data [ 20:50 ]
  • IMS Health Inc. v. Sorrell [ 22:50 ]
  • United States v. Caronia [ 27:00 ]
  • Sales reps can speak off label [ 40:00 ]
  • Why keep medical affairs? [ 43:30 ]
  • The future of our industry [ 50:00 ]
  • About guidance documents [ 53:00 ]

Quotes:

  • “At this moment, a sales rep can speak off label – there’s nothing to stop them.” -Dr. Darshan Kulkarni
  • “There’s a strong line between commercial and medical affairs.” -Anne Arvizu
  • “I don’t see big pharma changing.” -Dr. Darshan Kulkarni
  • “I shouldn’t be limited whether I’m in a company or out of a company to state what I feel.” -Anne Arvizu
  • “No one knows what truthful not misleading means.” -Dr. Darshan Kulkarni

Links Mentioned: 

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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.”

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

If you need more information regarding achieving value in medical affairs departments or learning more about Dr. Anne Arvizu then please visit the RxER Communications website here.

This show is being produced by the Pharmacy Podcast Network and is partner-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.

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: