Live In-Person FDA-Regulated Speaker Programs. The Physician Perspective

Transcription

1 Live In-Person FDA-Regulated Speaker Programs The Physician Perspective Leslie Citrome, MD, MPH Clinical Professor of Psychiatry and Behavioral Sciences New York Medical College Valhalla, NY

2 Disclosure Leslie Citrome, MD, MPH In the past 36 months Leslie Citrome has engaged in collaborative research with, or received consulting or speaking fees, from: Acadia, Alexza, Alkermes, Allergan, AstraZeneca, Avanir, Boehringer Ingelheim, Bristol- Myers Squibb, Eli Lilly, Forum, Genentech, ITI, Janssen, Jazz, Lundbeck, Merck, Medivation, Mylan, Neurocrine, Novartis, Noven, Otsuka, Pfizer, Reckitt Benckiser, Reviva, Shire, Sunovion, Takeda, Teva, Valeant, Vanda. Over 2,100 presentations throughout the USA, Canada, Europe, and Asia, almost all from 1999-present, and of which >50% have been FDA-regulated promotional speaking events.

3 Perspectives Clinician Educator Researcher Medical journal editor Promotional speaker Consultant Speaker training facilitator

4 Engaging HCPs at FDA-Regulated Promotional Speaking Events Current landscape Product launch the honeymoon period Why should I go? Not showing up Finding engaging speakers

5 Engaging HCPs at FDA-Regulated Promotional Speaking Events Current landscape Product launch the honeymoon period Why should I go? Not showing up Finding engaging speakers

6 Current Landscape: The Cookie Cutter Approach The FDA, OIG, and Corporate Integrity Agreements remain the driving forces Slide sets on lock-down: PPS, secured PPT, PDF, and proprietary software No changes, additions, deletions For most slide sets, can t even change the order of the slides Some slide sets do allow for hiding some slides that have been declared optional by the sponsor

7 Current Landscape: The Cookie Cutter Approach (Continued) Venue selection and logistical arrangements by third parties now the norm Speaker caps limiting annual payments per speaker per company Based on optics, varies greatly from company to company, and sometimes differ from HCP to HCP New! Prospective endorsement of attendees Must be HCP in the specific field for which product in intended Pre-registration

8 Response to Off-Label Questions Universal rule: Must never solicit off-label questions Some companies allow a brief answer to an unsolicited off-label question, with caveats, in front of the entire audience Some companies allow a brief answer to an unsolicited off-label question, with caveats, on a one-on-one basis after the program Some companies prohibit the answering of any off-label questions under any circumstances (even in the parking lot after the program) Referral to the Medical Affairs Department is being routinely advised; some companies will capture information regarding the person asking the question (and the question) in order to ensure appropriate follow-up

9 Current Landscape: Forays into Peer Discussion Groups (Roundtables) and Bad Ads

10 Engaging HCPs at FDA-Regulated Promotional Speaking Events Current landscape Product launch the honeymoon period Why should I go? Not showing up Finding engaging speakers

11 Product Launch: After This, Nothing Will Be the Same Clinicians (both the Speaker and the HCP Attendees) get excited about new products, new indications, and novel formulations, and very forgiving regarding the commercially-oriented and productfocused presentation In 6-12 months this won t be new anymore and it will be more difficult to attract attendees Tremendous opportunity to educate, but need to watch out for: Speakers who are not knowledgeable about the disease state Speakers who are not knowledgeable about the product (even after being trained) Speakers who are clinically inexperienced Speakers who lack platform skills (even after being trained) Potential tools Using a third-party to identify potential speakers who have a footprint regarding the disease state, product, or formulation Engaging a third party to provide training in speaking skills Caveat: companies doing this type of training vary in their competence

12 Product Launch: Slides Beware of reproducing the product label with generic blue and white slides Beware of repetition (does that drug class-level boxed warning really need to be shown three times?) Beware of non-sequiturs (inserting random safety slides ensures compliance with fair balance in case speaker drops dead in the middle of the talk, but transitions need to be smooth) The Important Safety Information (ISI), although necessary, is often glossed over in training and subsequently by speakers an opportunity lost! Can denote which warnings are found with other similar agents and which items are unique to the product being presented

13 Quote from a Speaker Content development is also critical, solicit as much input from KOLs and clinicians as possible. Try as much as possible to declutter slides. Be more selective and sophisticated in speaker selection. Most HCPs have little to no experience with, training about or understanding of research and clinical trials, so it is very ineffective and potentially counter-productive for them to present research data. - anonymous

14 Product Launch: Speakers Prioritize contact by sales representatives and medical science liaisons Once trained, there should be follow-up relatively quickly Problem: When speaker training occurs weeks/months before a field sales team is ready Whenever possible, prioritize the delivery of product samples Getting the forms completed at the time of speaker training is a best practice

15 Product Theaters: High Risk but High Reward Large audience of interested clinicians within the context of a professional meeting Need effective speakers with excellent platform skills Also in the audience are your company staff (Brand Team, sales representatives, medical science liaisons, compliance persons), and your competitor s company staff, and maybe also FDA personnel Need effective speakers who remain on-label, and not gloss over the ISI This is not the time to bring out an academic speaker who hasn t done an FDA-regulated talk other than during the Wild West era of a few years ago

16 Engaging HCPs at FDA-Regulated Promotional Speaking Events Current landscape Product launch the honeymoon period Why should I go? Not showing up Finding engaging speakers

17 Why Should I Go? If a new product, indication, or novel formulation, this is easy If something old, the presentation should contain something new If the presentation is old, the speaker MUST be able to add value by providing clinical context and appropriate interpretation of the data in a way that is new to the audience Often the reason someone is going is because someone else they know is going It is not unusual for an entire office staff to attend, particularly if the venue is not one they go to otherwise It is not unusual that an HCP attends because the sales representative has made a personal appeal for them to do so

18 Reasons Why I Attend I was invited to attend by the person arranging the event The speaker is someone I know or heard of as being knowledgeable, articulate, and believable If a local speaker, I personally know him/her and want to be supportive The presentation is of a new product or a new use of a product The presentation is about something I do not know much about The location is convenient

19 Local speaker Challenges Selected for all the wrong reasons by the sales representative, including prescribing volume, influence in getting attendees (i.e. friends and work colleagues who otherwise would not be interested at all in attending) Is the attendee involved in the research or treatment of persons with the disease in question? Some companies require pre-registration prior to attending, otherwise attendees have to be turned away Some attendees are prohibited by their workplace to attend but do so anyway Some attendees are prohibited by the sponsoring pharmaceutical company to attend but do so anyway For example, some companies have agreed in their corporate integrity agreement to not invite certain governmental employees Some companies prohibit their contracted speakers from attending

20 End of Branded Life: Special Considerations Clinicians notice when companies decrease their promotional activities towards the end of a product s market exclusivity Sense of abandonment of the product, the disease state, and of them There remains an opportunity to engage attendees with speaker programs and to foster good-will Unbranded programs focusing on disease state, novel approaches to clinical evaluation, technology, etc. This is not the time to bring out a local speaker who will show a cookie-cutter presentation from slides everyone has seen before

21 Engaging HCPs at FDA-Regulated Promotional Speaking Events Current landscape Product launch the honeymoon period Why should I go? Not showing up Finding engaging speakers

22 Not Showing Up Fears of being on the list as having received $$$ from the pharmaceutical industry Although they said yes to the invitation, they never intended to in the first place (if they never have gone to any programs in years, why should they now?) They got a better offer (varies by locality) This can get nasty such as a competitor arranging at the last minute another event to compete with the big name coming in from out of town They got swamped at work They got swamped at home There friend decided not to go The big game is on TV that night It is raining

23 Engaging HCPs at FDA-Regulated Promotional Speaking Events Current landscape Product launch the honeymoon period Why should I go? Not showing up Finding (and keeping) engaging speakers

24 Finding Engaging Speakers Knowledgeable speakers can be found by looking at their footprint in terms of publications and involvement in CME activities Effective speakers are highly utilized An unintended consequence of the Sunshine Act will actually make this fairly easy to determine Have Brand Team members attend programs to vet effectiveness (or lack thereof), and them champion the utilization of the most effective speakers elsewhere However, this remains a subjective process

25 Finding Engaging Speakers (Continued) Many academic, governmental, and other institutions are placing restrictions on the activities their faculty and staff may engage in with industry Can be in the form of prohibiting participation in a speaker s bureau, or at the extreme, even attending an FDA-regulated promotional speaking event Can also be worded in terms such as Faculty may not engage in compensated activities that involve the presentation of slides over which they do not have direct control Speaker fees can now be monitored through corporate integrity agreement-mandated reporting and now, also through the Sunshine Act Outing transgressors is becoming somewhat of a sport Maintaining a high-quality speaker pool will become more challenging

26 Speaker Training Events Both live and web-based speaker training emphasize the Rules of the Road for fair balance and remaining onlabel But, attendees vary greatly in terms of knowledge, clinical skills, presentation ( platform ) skills, experience, and motivation Adherence to the Rules of the Road is not guaranteed with rogue speakers and rogue sales representatives Time spent on presentation skills is often too little, and for some, too late

27 Words of Wisdom "We need to use the science of communication to more effectively communicate the science of our treatments. If we are learner centric in the design of the delivery of our information than it will evidence itself in how much is learned and to what degree it is applied, all of which can be measured. This is accomplished when the same care and effort is applied to the "How something is said" and not just to the "What is said". - Richard Davis, co-author of the Cambridge University Press "Best Practices for Medical Teachers"

28 Training Engaging Speakers Becoming learner-centric often does not come naturally Training to become an even more effective speaker takes time and effort There is always room for improvement Some outside vendors are better than others in helping train effective speakers

29 Retaining Engaging Speakers Landscape is competitive for highly utilized speakers Lead time for programs needs to be respectful of a speaker s time commitments However, last-minute opportunities may still be present Compensation (FMV) is oddly variable by a factor of 2 Speakers do prioritize on rates of compensation Travel policies are variable and sometimes inflexible Speakers will avoid scheduling if arranging travel in a timely manner is problematic Cancellation policies vary widely and not always transparent Once bitten, twice shy

30 Engaging HCPs at FDA-Regulated Promotional Speaking Events Summary

31 Engaging HCPs at FDA-Regulated Promotional Speaking Events The regulatory environment has dramatically changed the conduct of promotional speaking events, including mandating pre-approved materials and changing the way off-label questions are handled Platform skills become even more important in order to engage the attendee Training for this is as important as training regarding content The most effective speakers are learner-centric, knowledgeable, and utilized often by everyone

32 Questions?