Principles for COVID-19 Healthcare Communications – 2 – The Virtual Medical Meeting

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be the last type of activity to resume some sort of normalcy in the future, it is quite likely that many more will make announcements that meetings are going to be virtual in the foreseeable future. There are many communications issues associated with this new way of having a major medical meeting.

The coronavirus pandemic is a challenge to medical meetings on two fronts. First medical societies must address the logistics of a virtual meeting. But given the realities of conducting clinical trials in a time of contagion the exchange of future data may mean that meetings will contain less information than in the past, if held at all. Here is a great resource providing an overview of clinical trial disruption on a company-by-company basis.

Medical conferences are dynamic in nature fulfilling a number of important purposes. First and foremost of course they are the venues for the exchange and presentation of scientific data. Results from clinical studies for new treatments are presented not only for the practitioners in attendance, but for media and patient organizations. This provides a finger on the pulse of progress, representing not only scientific advancement and positioning companies vis a vis their investors, but hope for those whose future may rely on the advances in science and medicine. They are also a venue representing multiple commercial opportunities. And it is a place where networking occurs – where patients, investors, innovators, scientists and companies can engage in dialog and even protest. It is all reported out by media, both top tier and trade. So how does all of that happen virtually?

Virtual conferences have had to happen in short order and it seems apparent that those organizing such events are building the bicycle while riding it. There is no guidebook or established set of best practices for this. The various ways for stakeholders to participate – from presenters to patients – is likely going to vary and over time, the experience is likely to improve. There are, of course, any range of virtual tools available and platforms by which information can be exchanged. Tools used by participants obviously should include multi-media press kits that contain as many separable and shareable components as possible such as podcasts and videos. Here is where stakeholder organizations that have invested in their social media muscle will see some of that work payoff. And it is also where those who have established lines of digital communication with stakeholders – some of whom will be key opinion leaders and patient organizations – will also experience the wisdom of that investment. While always an important factor, having others to carry your water for you – your messages and content – beyond the venue is even more essential in a virtual setting than it was in a more traditional one.

But of course one of the most important aspects of data presentation is the media who write about the data. These days COVID-19 is taking all of the oxygen out of the mainstream media room. But for trade media, it is still important news. I asked some colleagues to reach out to a few reporters and ask them about operating in this virtual environment. Here is some of the wisdom that was captured for both meeting organizers and presenters:

  • Pre-meeting materials. A big, long, in-person meeting is being compressed into a short-time window on a computer screen. That makes it even more important to help reporters plan and prepare before a meeting starts with advance access to materials such as abstracts.
  • Embargoed updated data. While pre-meeting materials play an important role they can be out of date by time of the presentation starts. Sharing embargoed data in an email or with a link the day before a presentation facilitates reporters’ ability to get the story right.
  • Prior Access for Interviews. Ideally both presenters and executives who can provide some context for the data beyond the study should be available before a presentation rather than after.
  • Accessible and Digestible Materials. Posters and slide decks should be made available online at the time of the presentation either through link or QR code. The maximum time for a webinar should be 3 hours in length with breaks built in for each hour as reporters are still required to be available to others during the time spent covering the conference.
  • Virtual Press Room. There should be a meeting place for the reporter and interviewee with such a venue allowing for both to dial into a virtual press room and enter a private chat for conducting an interview.

These are obviously only meant to be thought starters, but come from the perspective of a few trade reporters. Not only should the pharma, the medical and professional societies organizing medical meetings should take note, but FDA as well as the agency undoubtedly is involved in planning eventual virtual Advisory Committee meetings.

Eventually the bicycle will be built and once done, there will be many ways to improve it. What becomes the central question now, given the wrinkle in future data, is for how long?

Photo by Tyler Callahan on Unsplash

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Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused on enhancing the development of new treatments and presumably vaccines for COVID-19 called the Coronavirus Treatment Acceleration Program (CTAP).

According to the press release from FDA, Health and Human Secretary Alex Azar was quoted as saying that FDA would be “redeploying staff” in order to review potential new therapies. Staff from CDER and CBER will both be working to triage and provide support quickly with the underlying goal of maintaining FDA’s standards for evaluation of safety and efficacy on a fast-track basis.

There is certainly an urgency to develop strength in a “four-legged stool to address the pandemic. One leg involves the development of treatments that address symptoms of COVID-19 – both bringing new ones to market and assuring continued access to existing ones; one leg involving new therapies that directly address COVID-19; one additional one that is centered on vaccine development; and finally one that addresses diagnostics with rapid, reliable testing. The last has moved quickly in development. The others must move quickly.

Needless to say the current environment demands that COVID-19 development be priortized and facilitated. However, along with the pervasive interruption to clinical trials of non-COVID-19 therapies in research and development, the shift in resources to CTAP also signals that it may not be business as usual in the coming months with respect to the pipeline. This is true even where non-COVID-19 approvals occur as evidenced by the announcement last week that the approval of a new compound for MS would be delayed due to the COVID-19 pandemic.

In addition to shifting regulatory focus, research and development within industry is being deployed to the important task of the four-legged stool. The devotion of both research and regulatory assets and resources is extremely important but also factors in the equation when it comes to assessing the impact of this pandemic on the pipeline of new treatments – on research, regulatory review and even launch.

As noted in the last posting on this topic, I will continue to monitor and report out on developments.

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Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2

Empty FDA Advisory Committee Meeting Room

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose questions to FDA regarding the impact of the current circumstances on future approvals and the ability to meet PDUFA dates in a timely manner. The Center for Drug Evaluation and Research (CDER) responded as specifically as they apparently could under the circumstances. Bottom line – it would appear that while disruptions to the approval process are possible, the agency is operating and attempting to put into place measures to mitigate disruption. And while virtual AdComms are not a certainty, it would also appear to be something that is possible – at least they are thinking about it.

Here is what they said verbatim:

  1. What is the expected impact on approvals of the recent decision to postpone inspections? On 3/18/2020, for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we announced that we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks, and other public health emergencies involving FDA-regulated products. Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting certain onsite inspection on an interim basis when travel is not permissible, when appropriate.
  2. Does FDA plan on attempting virtual advisory committee meetings? As this remains a dynamic situation, we will continue to assess and calibrate our approach. Where possible the agency will leverage technology to host meetings allowing for remote participation. We thank you for your patience. In considering necessary steps for protecting public health, including our sponsors, our committee members and our workforce, we are cancelling or postponing all non-essential meetings through the month of April. We will reassess on an on-going basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.
  3. Is there an expectation that PDUFA dates will be missed, or will they be extended due to the crisis? CDER is fortunate to have existing policies on the use of flexible workplaces, as well as the IT infrastructure to support a large number of staff simultaneously working offsite This gives us the ability to ensure the safety of our workforce and the continuity of our important public health mission during government disruptions. CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak. As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and transparent as possible.
  4. Will new drug applications be considered during this time when presumably the FDA workforce is working remotely? CDER continues to perform our drug review activities as well as contribute to other vital functions of the Agency. As you may know, we are working around the clock to monitor and mitigate emerging coronavirus-related issues with our federal partners, international regulators and medical product developers and manufacturers to advance response efforts to combat the coronavirus disease (COVID-19) outbreak. Our application review teams remain focused on their work, and we are doing everything possible to maintain continuity of operations in a very dynamic situation.

What do we know from this? The situation we are presented with means that certainties in any conversation are off the table given the situation we are facing. But what this tells us is that the FDA workforce is equipped to work remotely. It does say the agency is striving to find alternative means to do what it cannot do in person and to meet the necessities of the review process. It does foreclose the possibility of delays, but affirms that efforts are going into getting work done as usual. That means that we will not really know for certain until upcoming PDUFA dates come and go. To that end, I track all the dates of which I am aware and record decision dates and will let you know that tells us as we tread further along in this environment.

Be well. Be safe. Be kind.

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Principles for COVID-19 Healthcare Communications – 1 Keep it Simple, Keep it Organized

On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the COVID-19 pandemic. It seems a good idea to look at some of those things I discussed in the piece a little more close up – and so I am thinking a series of postings here on the topic.

A frequent communications pattern with emerging pathogens is going from too little information to a deluge of information, sprinkled in with a dose of misinformation. We have all been receiving in our in-boxes emails with updates from everyone in business – banks, airlines, car rental companies, even my hardware store. It is a lot to digest and it is coming at us during a time of stress. Moreover for those in healthcare there are special considerations to communications given the range and impact of topics that must be covered – from supply chain to workforce to business continuity and even eventually, recovery.

Let’s begin generally, however. I reviewed a missive today sent by a healthcare manufacturer that was long and thick with narrative. The range of topics was pretty vast, covering everything from managing business continuity to financial impact on current sales to products in the pipeline and the status of clinical trials. It was all important information. But it was long and thick narrative.

In crafting communications about the very important range of things about which medical manufacturers must communicate, it may be good to borrow some common tips from media training about organizing messages for the spoken word and apply them to the written word. A long press release or statement with paragraph after paragraph is a lot to ask of people – especially now. Another thing I stress in media training is that you have a person’s full attention for the first few minutes you speak – and then minds naturally begin to wander.

Therefore in creating either general statements, or ones that are geared to very specific audiences, here are some guidelines:

  • Plan your messages – It is always important to define what the goal of the communication you are writing actually is – what do you want audiences to walk away with? If you don’t craft the communication with those goals in mind – and shape it so that the audience walks away with the three most critical things you want them to remember – then it is not likely the audience will get their on their own.
  • Lead with the important messages – Given that people may not read the whole communication – lead with your most important messages – and may it be suggested that in this time, at least a part of that be centered on the impact of what you are doing on people
  • List topics – If you are covering a range of things, organize your messages and sort it out for the audience. Guide their eye to the material which interests them. Not every audience needs to read every single thing in the release and the presence of a long narrative may discourage a thorough reading rather than promote it. Parsing your messaging into categories allows the audience to sort out what is important to them – and it doesn’t overwhelm them.
  • Flag the really important message – If there is something you really want to have stand out, flag it for the audience. This can be done visually with bold-face and italics and underscoring (or any combination thereof) or by including it upfront in a quote from a CEO or agency lead with very pointed language – “The most important thing we want people to know….”

These are straightforward tips and communications at its most basic – no rocket science here. But in a time of crisis it is sometimes easy to overlook some basic principles because there is so much to say and that must be said urgently. But when that is the case, what often happens is that in our zeal and need to push messages out, we do so in a way that undermines the ability of our audiences to absorb them. And so we begin with this simple reminder.

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FDA Guidance on Clinical Trials During COVID-19 Pandemic

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care alone during the past few years have been breathtaking. The medicines pipeline is the focus of many who need and hope for a new treatment for a life-threatening condition.

This week FDA issued a new guidance document entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic“. This would seem to set a record for the development of any guidance document from FDA, some of which take years to cultivate through the draft stage. In it, FDA concisely enumerates some of the many obstacles to conducting a clinical trial in our current circumstances – quarantines, travel restrictions, sites that are under lockdown, supply chain of the investigational compound to name a few.

There has already been a lot written about it providing explanation already and there is no point in recreating the wheel and here is among the best courtesy of the Regulatory Affairs Professional Society. But briefly, FDA encourages sponsors to consult with Institutional Review Boards (IRBs) very closely and sanctions also the deviation from protocols of the trial may be initiated unilaterally in order to protect health and well-being of study subjects. It is a worthy goal, to be sure, but where there are such adjustments made by study sponsors, one can imagine that it will later ultimately complicate the assessment of the trial when it comes to the approval process.

FDA also stated that sponsors should be prepared to assess patients for safety from a distance given the potential of travel restrictions. This most certainly means the use of the telephone, but makes the case – as the pandemic does across many areas – for creativity when it comes to exploring virtual means for exchanging information. That goes from telemedicine, to the release of data at virtual medical meetings.

Much of the document is geared to considering the impact of the pandemic on the role of study participants. But there are also likely to be issues where those who are involved in conducting the trial itself – the investigators – are also negatively affected, impacting the collection of data.

In short, FDA has injected more fluidity to respond to circumstances into the process. While important, it is not likely enough to overcome absolutely all the obstacles to conducting clinical trials in this environment. And once this is over, there will be more complications as these trials are assessed for approval and as the gold standard for consideration of new medicines is preserved during this difficult time.

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