Mediaboss Marketing

Articles throughout December explored advertising, promotion and labeling in addition to the role of social media in regulatory communications. Leading experts in the profession shared valuable insight on a wide range of issues impacting APL professionals today, including optimizing ad/promo regulatory affairs communications, Facebook chat study results and the use of hashtags, social media influencers and considerations, price transparency and assessing risk and strategic business decision-making.

Regulatory professionals, DiDonato, Lee and Roychowdhury, discuss the emergence of social media for use in pharmaceutical advertising and promotion in The Brave new World of Social Media: Regulatory Perspective on Hashtags and Facebook Messenger. The authors cover what hashtags mean, how they function, their uses and potential misuses and provide results of their investigation into how pharmaceutical companies using the social media platform Facebook Messenger respond to consumer questions received through social media. They conclude that the pharmaceutical industry and regulatory professionals should use social media carefully and remain complaint with standard advertising and promotion regulations.

Over the past seven years, there has been a steady decline in the number of FDA enforcement letters pertaining to the advertising and promotion activities for prescription drug products. At the same time, the Office of Prescription Drug Promotion (OPDP) have issued guidance documents to provide a framework for industry to address the current issues facing todays regulatory professionals. Regulatory enthusiast, Jurcik, discusses how regulatory professionals can make benefit-risk decisions with limited agency guidance materials or enforcement examples in Assessing Risk and Strategic Business Decision-Making Without Consistent FDA Enforcement. She concludes that with a scarcity of enforcement letters from FDA in recent years, regulatory professionals must turn to other tools to understand FDA and other government agency issues related to drug promotional activities.

Advertising and promotional (Ad/Promo) review committees in the pharmaceutical industry serve an important role in helping to protect the company, its employees and, most importantly, the patients who take prescription medicines. Ad/Promo committees review and approve product advertising and promotional materials and other internal and external communications. In Optimizing the Review Process of Advertising and Promotional Communications, Gomba, Jameison and Sadowski discuss how medical, legal and regulatory review committee members can best function to provide efficient and effective communication as well as a productive environment aimed at yielding creative, yet compliant, materials. The experts make suggestions for optimizing communications as part of the internal review process by providing clear understanding of regulations and establishing clearly defined processes to foster compliance. They also touch on the importance of timelines and work prioritization, having a unified committee perspective and the need for respectful behavior in team meetings.Engaging social media influencers for prescription drug promotion can present a challenge for most pharmaceutical companies; however, by working with the right social media influencer and operating within standing regulations, companies can reach appropriate patients via social media. In Clarity in Chaos: Best Practice Tips for Engaging Influencers for Pharmaceutical Promotion, Blackmon and Williams demonstrate how one pharmaceutical company used social media to offer guidance to pharmaceutical companies considering using media influencers to promote their products. The experts cover internal collaboration and alignment, identification of creative guardrails for brand teams and regulatory requirements and recommendations.

Whether you are a patient, healthcare provider, industry professional or just have access to news, you have probably witnessed conversations regarding drug pricing transparency, an issue unfolding across America. In Drug Pricing Transparency: the Conversation is far From Over, Walker and Lem discuss the US governments attempts to require drug pricing transparency in advertising. The thought leaders explain the events following the Centers for Medicare and Medicaid Services (CMS) publication of a proposed rule for regulation to require drug pricing transparency. They outline recent initiatives by a number of other federal agencies to develop ways to inform the public about drug costs, efforts by the Pharmaceutical Research and Manufacturers of America (PhRMA) to add their voice to the issue, lawsuits filed by several pharmaceutical companies against federal agencies and subsequent court decisions and appeals.

Regulatory Intelligence

To support the release of the Q4 Regulatory Focus Article Series, Regulatory Intelligence and Policy: Shaping the Global Landscape, RAPS hosted a lively discussion on Regulatory Exchange with three regulatory intelligence experts, Meredith Brown-Tuttle, Matt Medlin and Kirsten Messmer. In Regulatory Intelligence and Policy, the experts, who were all authors in the series, offered their perspectives on the importance of regulatory intelligence and the integral role RI professionals play in defining strategy for companies in regard to development, approval and maintenance of products, as well any changes to regulations impacting the global regulatory landscape. This article presents the questions and answers from the 11 December online discussion.

What you Missed at Convergence

The following two articles were based on a presentations given at RAPS Regulatory Convergence, 21-24 September 2019, Philadelphia, PA.

Global Pediatric Drug Development addresses global pediatric drug development and compares strategies and regulations in the US and the European Union (EU). Regulatory experts, Georgopoulos and McBride, identify key regulations and resources to support pediatric drug development, describe some of the most important factors to consider when developing a global pediatric drug development strategy and point out some common pitfalls in the development of a global pediatric drug development strategy.

Form FDA 1572: Challenges and Opportunities discusses considerations for conducting global clinical trials under the US Food and Drug Administrations Form FDA 1572, an agreement signed by the Principal Investigator (PI) to provide certain information to the sponsor and ensuring the sponsor will comply with FDA regulations related to the conduct of the clinical investigation of drugs and biologics. Some national authorities will not allow their investigators to sign Form FDA 1572 as from their perspective it represents a foreign legal requirement. Regulatory expert, Pangu, discusses the challenges in not signing and recommends processes that sponsors of global clinical trials can adopt to overcome the challenges of signing or not signing Form FDA 1572.

Whats Coming in January

January feature articles will explore the vital role of regulatory within organizations and throughout the product lifecycle. We have brought together some of the leading experts in the profession to share their valuable experience on a wide range of issues impacting regulatory professionals today, including regulatory leadership for a culture of quality, how to successfully hire and engage consultants, regulatorys role in business strategies and UDI and recall management. Other articles will cover REMS requirements for healthcare providers, independently unified drug development processes, a review and update of Chinas regulatory environment and the changing regulatory landscape for insulin. Look for these articles and more throughout January.

March Call for Articles

Regulatory Focus is looking for articles for the March 2020 topic covering regulatory ethics and history. Ethics is the assumed hallmark and unequivocal standard behind all elements of regulatory affairs and compliance. This issue seeks to examine various perspectives on this essential concept. Desired contributions will explore ethics and compliance with broad applicability to the field. Articles are sought evaluating:

View original post here:
Advertising, Promotion, Labeling and the Role of Social Media in Regulatory Communications - Regulatory Focus

If you are cracking open a brand-new calendar to bring fresh organization to 2020, you may have Anna Bond to thank. And speaking of thanking people, you may have her to thank for that too.

Ms. Bond, 35, is the chief creative officer of Rifle Paper Co., which has sold nearly 750,000 planners since 2015 and more than 500,000 thank-you cards last year alone.

She and her husband, Nathan Bond, the companys C.E.O., started Rifle out of his parents garage apartment ten years ago (choosing the name simply because she liked it, not for any connotation of shuffling through papers). We had absolutely no clue what we were doing, she said.

But their company has been operating at a profit almost from its beginning, Ms. Bond said. We have never taken on any investment or taken on any debt at all, she said. It was a common-sense approach.

Rifle employs more than 150 people between its headquarters in Winter Park, Fla., its nearby warehouse where orders are fulfilled and its office in New York. Its offerings have expanded to include wrapping paper, gift bags, phone cases, book covers, sneakers, rugs, wallpaper, water bottles, mugs and pillows. All bear Ms. Bonds signature floral designs that she, a former art student, creates with brush in hand, using gouache paint.

She got started designing posters that advertised Mr. Bonds band performances, back when they were dating. Friends started asking her to do their wedding invitations. After she did invitations for her own wedding, orders started pouring in.

This was 2009, still early days for social media. People were making more connections with friends old and new by computer and phone. One might think this would spell doom for the old-fashioned letter writing industry, but some saw an opportunity to market its specialness. Small-batch stationery companies sprouted all over the Etsyverse. Rifle has been one of the few to have broken through to a larger market that includes legacy brands like Crane & Co.

The Bonds also have three young sons Ford, 4; Ronan, 20 months; and Louis, 8 months and so when we spoke with Ms. Bond in mid-December, her own planner was stuffed: both with last-minute details for her familys 2019 celebration and ideas for how her business will approach the December 2020 holiday season.

11:30 a.m. I arrived to our New York office in SoHo after a photo shoot. I flew in from Florida on Sunday night. I come once a month to meet with the designers here. Most of the day I was with Trish Whalen, our president, and Debs Camplin, the new creative director. They worked together at Kate Spade.

12:30 p.m. Over lunch, we continued to talk about holiday 2020 ideas, because a few key accounts would like to see previews. We reviewed cards that need to get to the printer. We ordered take out from Sweetgreen and ate at the conference table in the office. In Florida, nobody eats at their desks. I didnt think that was weird until we hired New Yorkers and they would say, Where is everyone? And I would say, Theyre out taking their lunch break.

2 p.m. Trish brought up some big collaborations she wants me to consider. I passed on most of them. We have a capsule collection at Anthropologie of mugs and travel accessories, categories we have not yet fully developed. Anthropologie wants to keep some of that going and I did say yes to that.

7 p.m. I went back to Greenwich Hotel and ordered room service (spaghetti). I was in bed by 9:30. One of my goals when I come to New York is to sleep. Child-free sleep is a deep, magical sleep.

7:45 a.m. I had breakfast with a friend in the pretty parlor room at the hotel. He works at the Art Academy and weve been talking about our doing a workshop with the students, where we would end up with a limited-edition print.

9:30 a.m. I did a few emails. We use Slack at Rifle, so I checked in on some Slacks from the Florida team. I personally like Slack for group-chat back-and-forth conversation, whereas email is good for discussions you need to keep organized.

1 p.m. We had an epic two-hour meeting discussing our spring marketing initiatives, so that I can go to the creative team in Florida to talk about how we can support it all. We had lunch during the meeting. I ordered from a random Japanese place I found on Uber Eats.

3:30 p.m. We reviewed some 2021 planners and a few tech samples. Like an AirPod Pro case we are making with Case-Mate.

4 p.m. I met with one of our designers. We were talking about holiday concepts for 2020. We made advent calendars this year for the first time and theyve been very popular. So she showed me a few concepts for next year.

4:30 p.m. I met with a designer about what we are doing for our Keds collaboration for 2021.

5:30-6:30 p.m. I reviewed and approved some social posts. I try to delegate some of that work but any direct communication with the customer is so important. Its never a waste of time.

6:30 p.m. I left for La Guardia Airport and got home around 1 a.m.

6 a.m. Ford, my oldest, got up and requested some bread and butter. I pleaded with him to wait until breakfast time. I gave in.

7:50 a.m. I took Ford to school. Ronan, my middle son, came for the ride. Nathan stayed home with the baby. I stopped for coffee on the way back, cappuccino at the good old suburban Starbucks. I have learned the importance of drive-throughs since Ive had children.

8:15 a.m. I hung out at home with Ronan and Louis, the baby. When the nanny arrived at 9:15, I showered and went to work.

10 a.m. Nathan and I share an assistant. When I get in, she and I do a quick touch-base. Shes helping with our Rifle holiday party, so we talked about that too. Were doing it at a venue in downtown Orlando. It will be employees and their significant others. We also invited local vendors. Were expecting about 250 people.

11 a.m. This is when I did my most urgent task of the day, which was actually due on Friday, half a week before. I was reviewing 17 new cards, the final files that would be sent to the printer. They are all cards that I painted and that the creative team cleaned up and prepped for print. They will be available at the end of January or early February. All of our cards are printed locally in Florida, so the turnaround time is quick.

2 p.m. I snuck in dealing with our own family Christmas card. I came home from New York to a pile of Christmas cards from people who are more on time that I am and I was like, Oh shoot! Im around my own designs all the time and I think its nice to sometimes support other brands. So I used a different company, Artifact Uprising. Theyre very minimal and simple, a personal favorite.

4 p.m. My mom picked up Ford from school and they came by the office to say hi. He likes to run around. He thinks its his domain.

4:30 p.m. We met with the marketing team and talked about all of our company holiday cards, who was going to be writing what cards to whom and how we are going to get them all out the door.

6 p.m. I left and stopped at Whole Foods on my way home. The intention was to cook dinner but we ended up ordering takeout from a local Turkish place. It was better than what I would have made.

7-8:15 p.m. Bedtime for the kids. It is chaos.

9 p.m. We had dinner, watched The Crown and went to bed.

8:15 a.m. I took Ronan, my second, to run a few errands. We went to a bookstore because Fords school is having a holiday party and I forgot to get him a book for the gift exchange. Its nice to have one-on-one time with the middle child.

11:30 a.m. I spent a few hours working on a document for Trish. Its a five-page PDF that gives our rough ideas for Christmas for next year for Trish to pitch. Sketches we like, color palettes, things like that.

2 p.m. One of my designers popped in and we wrapped up discussions about our 2021 planners. We are making changes to the packaging.

2:30 p.m. I had my standing meeting with the V.P. of marketing and our project manager. We talked about the sales and announcements that will happen on the website for Christmas so I can brief the designers on anything we might need from them. I met with the senior marketing designer and she showed me social posts that are going up during the weekend.

5 p.m. I had the final meeting about the planners. I had asked for little revisions, we are trying to make our packaging more consistent. There are some updates to the fonts.

5:30 p.m. I saw the time and it just hit me that we had a guest coming to stay for a few nights. I raced home. The guest room doubles as a nursery and the sheets were clean, but the kids play on the bed while I put the baby to sleep. So I changed the sheets and freshened the room. I moved the babys stuff into our room.

6 p.m. We had the normal evening routine of feeding the kids and putting them to bed. I had intended, again, to make dinner but we decided to order in. Nathan and I caught up with our friend and hung out.

10:30 a.m. I arrived to the office. We have a small retail store in front of our offices and we do a Christmas sidewalk and I checked out how it was going. We sell any of our products that are slightly flawed at a discount, and its quite popular locally.

11 a.m. I did a few emails and hand-lettered a quote that will post on social media sometime next week. Normally I paint everything in gouache but I have these Japanese paint pens that feel like paintbrushes but are more like markers. I have been using them for lettering.

12:25 p.m. I went early to Fords school Christmas party. One of the other moms asked me to help set up and Im trying to be more involved. Ford was excited to give the book in the Rifle Nutcracker wrapping.

2 p.m. I went to the office holiday-party venue. I wanted to be sure everything was good to go. I brought my dress, so the staff who needed to get home to change could do that, and helped with final details flowers on the table and things like that.

5:30 p.m. The party! Nathan likes to have live music every year that connects to a theme. This year we had a mariachi band and the theme was Mexico City. The dcor was beautiful, very colorful, lush and festive. The band was amazing. Theyre called Mariachi Cobre and they play at Epcot. We had local food trucks, there was a taco truck where they made the tortillas right there. We had a photo booth. My friend who planned the party hired these women to make flower crowns with real flowers and attach them to headbands.

We were talking to a group who have been with Rifle for over five years and we talked about past parties and how everything has changed. Its nice to have staff thats been here a long time. There is a whole group of people who have grown up with the company and thats really fun, because Nathan and I have grown up with it too.

Interviews are conducted by email, text and phone, then condensed and edited.

Originally posted here:
The Work Diary of Anna Bond, Whose Work Includes Making Diaries - The New York Times

Influencer marketing isnt going anywhere; its just changing.

In 2019, influencers and the brands that work with them saw some big shifts around influencer marketing. A big moment came in November when Instagram announced it would start a test by hiding likes in the U.S. The news sparked concerns from influencers and led to stories on the soon-to-be death of the influencer community. Others saw it as an opportunity to look at new metrics, devaluing the like and instead focusing more on a diverse range of metrics like engagement rate, conversions and website traffic. Moving into 2020, it seems that diversifying the influencer strategy is going to be key for brands.

Pierre-Loc Assayag, co-founder and CEO of influencer relationship management platform Traackr, said companies that have already seen some success with influencers will continue to invest in this channel in 2020.

In some industries, like in cosmetics, in fashion and in CPG, as well, [influencer marketing] is starting to compete with media plans, said Assayag. Media planners, media planning firms and agencies have been dismissing influencer marketing for a long time, and now its starting to eat up some of their budget. Now they are paying attention. In 2020 and 2021, theres probably going to be an all-out war between media planners and influencer marketing.

Revolve went public in June. At the time, the companys chief brand officer Raissa Gerona said she spent many weeks traveling to meet with investors explaining the value of influencer marketing. At one point, the company shared that, in 2018, influencers drove 70% of sales for the company, which was valued at $1.2 billion.

The educational process is crucial for them to understand not only how Revolve does [influencer marketing], but also that this is how young people get information and get inspiration, Gerona said in a previous interview with Glossy.

The company reported marketing costs of $23.1 million for the third quarter, up from $18.9 million in the same three-month period in 2018. That figure accounts for a wide variety of marketing channels, like paid social and traditional performance marketing, per the companys most recent earnings call, but influencer marketing is still a major focus for the online clothing retailer.

We are pioneers of social media marketing and will continue to stay at the forefront by focusing on building upon our experiential marketing initiatives such as #RevolveFestival, #RevolveSummer, #RevolveAroundTheWorld and collaborating with influencers within our network, Gerona said. Instagram will continue to be a key platform for communicating with our customer, and its constantly evolving. Were also exploring video content heavily with platforms such as YouTube and TikTok.

While Revolve has staked its claim as a leader in the influencer marketing space, other companies are still trying to perfect their influencer strategies. And the opportunity, for those who can do it well, is only growing. In 2019, the influencer marketing economy was expected to hit $6.5 billion, according to Influencer Marketing Hub,with 86% of brands saying they planned to invest more in influencers throughout the year.

For brands continuing to focus on influencers, analysts said bringing in a variety of people with various follower counts will be key.

Successful brands will continue to use a tiered approach to influencers, from both a paid and earned perspective, to build long-term relationships with authentic, third-party endorsements, said Lindsay Johnson, group account director for influencer and social media marketing at Small Girls PR.

Overall, fashion and beauty brands worked more micro-, nano- and macro-influencers into their strategies in 2019. Sephora announced its Sephora Squad program in April, which picked 24 brand ambassadors with varying follower counts to work with the brand. Companies like Aerie, Nasty Gal and Shopbop have all forged partnerships with various influencers, as well. Over the summer, Amazon even got into working with influencers for The Drop, which launches limited-edition collections designed by influencers for Amazon Fashion customers.

What all of those brands have in common is that theyre looking to build more long-term partnerships with influential people, rather than pay them to post a few things on Instagram.

One-off influencer marketing posts do not make impact or resonate with consumers. It is essential for brands to actually invest in this form of marketing versus just dabble in it, said Sherry Jhawar, co-founder and president of Blended Strategy Group. I often remind chief marketing officers and other marketing executives that when print media plans were a larger part of marketing budgets, we would never have done just one print ad in one magazine and say that was our print plan for the year or for a product launch. So why would we do that with influencer marketing?

Johnson said this practice of investing more in influencer marketing, but working with influencers with a variety of follower counts, is only going to continue into 2020.

Depending on a brands goals, working with mega-influencers and celebrities will still be worth the spend from an individual reach perspective, as well as a media perspective. The talkability of a campaign is stretched further if you can leverage a celebrity for interviews, which is unlikely to be the case for even large-scale influencers, Johnson said.

See more here:
In 2020, fashion and beauty brands will invest more in influencers - Glossy

The Barack Obama year-end list extravaganza continued (ended?) on Monday, as the former president tweeted his favourite songs of the year. In the previous two days, hed posted his favourite books and movies, and were probably not getting a standalone TV list, since he already added a few shows to his movie list that he said he considered as powerful as movies. By now the annual tradition is expected, and in the replies to Obamas tweets any number of expressions of longing for the return of his cool-guy tastes to the White House can be found. Last week the New York Times published an op-ed titled In Praise of Barack Obama, Music Critic.

This year Obama seemed to signal his attunement to the diffuse state of popular music, where genre-agnosticism is often a virtue, by noting that his picks ranged from hip-hop to country to The Boss. He included American breakouts Lizzo and DaBaby, Nigerian artists Burna Boy and Rema, and Rosala and J Balvins 'Con Altura', although he omitted Balvins credit on the song. He said he was listening to this years folk rock darling Big Thief, and Indian artist Prateek Kuhad made it to his list with his popular heartbreak ditty, 'cold/mess'. He was well aware of 'Old Town Road', a song at the centre of all sorts of playlists, streaming records, and conversations this year but not quite as ubiquitous in the flurry of year-end lists. And he even waited until Kaytranada released a new album on December 13 to solidify his choices.

As ever, theres the sourcing question. What Spotify playlists, and which music advisers are involved here? Obamas book list raised some eyebrows, with its inclusion of The Age of Surveillance Capitalism: The Fight for a Human Future at the New Frontier of Power by Shoshana Zuboff, which, as the reporter and researcher Avi Ascher-Schapiro pointed out on Twitter, argues that the revolving door of personnel who migrated between Google & the Obama admin...helped fortify the surveillance capitalism business model.

Or is it more of a family matter? Back in Obamas second term, it didnt escape notice that his daughter Malia wore a Pro Era T-shirt.

Whatever the case, there are some relatively under-the-radar picks and opportunities for discovery here. Angelica Garcia put on a quiet, wonderful show in New York a few months ago in a 250-capacity room. On Monday she tweeted, I am tearing up right now. My grandma has kept your picture on her piano for 5 years. Thank you for listening @BarackObama.

Prateek Kuhad wrote on Instagram, "This just happened and I dont think Ill sleep tonight. Totally flipping out. I have no idea how cold/mess even reached him but thank you @barackobama, thank you universe I didnt think 2019 couldve gotten better, but damn was I wrong. What an honour."

Heres his full list:

A version of this article originally appeared on Vanityfair.com

Excerpt from:
Barack Obama Likes All Kinds of Music Too - VOGUE India

A former top official at the State Department wrote Thursday that violent protests that targeted the U.S. Embassy in Iraq were the result of President TrumpDonald John TrumpFive environmental fights to watch in 2020 Lawmakers close to finalizing federal strategy to defend against cyberattacks The 7 big Supreme Court cases to watch in 2020 MORE's foreign policies.

Wendy Sherman, former under secretary for political affairs during the Obama administration, wrote for USA Today thatTrump's failed attempts to deal with Iran and his withdrawal from the nucleardeal with Tehran resulted ina "combustible moment."

"It is President Donald Trumps failed policy toward Iran that has brought us to this combustible moment," she wrote.

"Even as the United States was confronting Iran over its nuclear program and malign behavior elsewhere, we maintained an uneasy coexistence in Iraq, where Tehran holds considerable sway," Sherman continued, adding that the coexistence"was destroyed when Trump withdrew from the Joint Comprehensive Plan of Action, better known as the Iran nuclear deal."

Sherman went on to fault Trump for "diminishing" the State Department and other agencies she said the Obama administration relied on for diplomacy in such regions.

"Three years into his presidency, Donald Trump owns the events and outcomes in Iraq and Iran, as he does in North Korea, Afghanistan, Venezuela, the Middle East, Russia, China and Hong Kong. Having diminished our State Department, intelligence agencies and military, the very institutions that could have helped him construct an effective national security and foreign policy, he is now on his own," she wrote.

Protesters at the U.S. Embassy in Baghdad reportedly withdrew and claimed victory on Wednesday after camping outside the compound the previous night.

The protesters are now calling for the nation's parliament to push for U.S. troops to leave Iraq, according to The Washington Post.

On Tuesday, demonstrators stormed the embassy, setting fires and trashing furniture, in response to U.S. airstrikes in Iraq that targeted the Iranian-backed militia group Kataib Hezbollah. Those airstrikes, which killed 25 people over the weekend, followed the death of a U.S. contractor in a rocket attack on an Iraqi military base.

Originally posted here:
Top Obama official: Trump to blame for attack on US Embassy in Iraq | TheHill - The Hill