Solution Providers For Your Life Science Business Challenges
Insights on Thought Leader Management
Thought Leader Management Insights: The Complete Series Senior executives need to know: Life sciences companies are under ever-increasing scrutiny over their relationships with physicians and other healthcare professionals. Federal and state legislators, feeling the pressure of public opinion, are passing new “transparency” laws. These laws are adding on layer after layer of new responsibilities on companies – for issues ranging from paying Thought Leaders fair market value for their services to new requirements for calculating and reporting aggregate spend on each contracted professional. Executives ignore these developments at their peril. These issues aren’t going away. So it’s imperative that companies put together solid central management plans for handling what’s sure to be a labyrinth of compliance issues. Up to now, there’s been no up-to-date, fact-based resource executives could turn to for guidance on what the current trends are and what the future’s likely to hold. That’s why BioPharma Advisors is offering Thought Leader Management Insights, an 11-part series designed to help company executives navigate what’s sure to be a stormy sea of new rules and regulations.
These Insights, written in an authoritative, quick-read format, offer the kind of advice today’s life sciences professionals need, from professionals they respect. These articles are invaluable for both senior executives looking for a comprehensive overview of today’s transparency climate and for front-line managers who need to drill down to day-to-day operational issues.
Insight 1 - Current Legal & Regulatory Considerations for Managing Thought Leaders
If industry members wish to continue using the services of contracted Thought Leaders, they need to acknowledge – and react to – the swelling tide of regulatory actions and public opinion regarding current business practices. What once was allowed is now forbidden. What once was overlooked will now be exposed, even prosecuted. Times have changed, and those industry members that wish to stay in the game will now need to live under new rules. In Current Legal and Regulatory Considerations for Managing Thought Leaders, BioPharma Advisors lays out the new game board. You will read about:
The scope of the problem: It’s extensive, from the unintended consequences of transparency to new considerations involving the Foreign Corrupt Practices Act that could affect KOL programs
Management issues involving the new regulations: The contract between the Thought Leader and the industry member needs to be both flexible and specific
Where the onus will lie: Those responsible for ensuring compliance with the new regulations won’t just be Legal and Regulatory
What companies are doing about it: Just because a company is small won’t make tracking KOL involvement any easier
$250.00
Insight 2 - The Impact of the Physicians Payments Sunshine Act The Federal Physician Payments Sunshine Act: You’ve heard about it, likely even read about it – but it’s sure you’ll need more information to understand what this new legislation means to your business. BioPharma Advisors wants to help you get prepared. In this article, BioPharma Advisors will explain:
What the Physician Payments SunshineAct requires: It will be more than just compiling a list of payments made to contracted healthcare professionals
How it will impact your business: Changes you’ll have to make to current practices – and they could be costly
How to stay on top of this issue: Industry transparency will not be going away; BioPharma Advisors will explain why it will require permanent, dedicated resources.
How you can prepare for this new legislation: BioPharma Advisors will advise you on how to become organized quickly, and develop a comprehensive plan of action that will mitigate some of your future risk
$250.00
Insight 3 - Federal & State Transparency Efforts
Think only the federal government intends to regulate Thought Leader-industry activities? Not true. Many states are following the same path as Washington legislators. The states, especially, see the enactment of new regulations and any industry lapses in following them as a new dynamic revenue stream. In Federal and State Transparency Efforts, BioPharma Advisors lets you know what is happening with: The states: Which ones are involved in transparency regulations, and what those regulations mean The feds: The Physician Payments Sunshine Act is now the law of the land. What does it mean to my business?
$250.00
Insight 4 - Industry Transparency Efforts
Transparency: These days, Washington and the public want to know everything about your relationship with Thought Leaders.If your company is refusing to let in the “sunshine” and release this information, it’s virtually certain that you will be forced to do so via legislative mandate. By that point, you might have little control over public disclosure, and be subject to excessive public scrutiny. And those are PR and boardroom headaches you can do without. In Industry Transparency, BioPharma Advisors discusses how some industry members are making their contractual data public. Some are doing so voluntarily, while others are complying with corporate integrity agreements. It is worth your while to see how your peers are handling their individual situations, and to possibly learn from their mistakes.
$250.00
Insight 5-Top Ways Industry Uses Its Thought Leaders Your company contracts with Thought Leaders for their professional input at the various steps of a product's life cycle, but is your company using that Thought Leader to your strategic advantage? If not, your company is likely missing out on that Thought Leader's seasoned insight, as well as his or her knowledge of the market whether that judgment concerns product profile development, a clinical trial, or public policy. Industry has often been criticzed for developing products, services or devices that do not meet medical needs. Understanding the potential array of commercial and clinical activities a thought leading physician can provide insight to is critical.
In The Top Ways Industry Uses its Thought Leaders, BioPharma Advisors can help you:
Understand the Thought Leader's importance in a product's life cycle: This may not be an easy thing to do, considering today's regulatory environment
Identify touch points: Thought Leaders do more than attend advisory board meetings and participate in speaker programs
Find Thought Leaders with backgrounds you might not think about: The perspective a Thought Leader brings to the table can seriously impact success
Leverage their input to your advantage: Centralized control of a Thought Leader's activities can significantly improve communication among all company stakeholders throughout a product's life cycle.
$250.00
Insight 6-Fair Market Value and the Impact on Your Business
Fair market value: A pretty simple theory. But putting it into practice when negotiating contracts with Thought Leaders and other contracted healthcare professionals can be tricky – not to mention hazardous to your overall business plan.
In this paper, Fair Market Value and the Impact on Your Business, BioPharma Advisors explains the pitfalls of FMV, and how you can avoid them. This paper:
Outlines recent regulations that have brought FMV to the forefront of the debate over use of Thought Leaders and contracted medical professionals
Explains the impact that FMV can have on your business
Reveals various ways to calculate FMV
Lays out the steps that can ensure that all contracts are FMV compliant – and keep you out of harm’s way
$250.00
Insight 7-Aggregate Spend on Healthcare Professionals
Firms that contract with healthcare professionals to perform advisory and consulting services must understand how and why the legislative, regulatory, and political playing fields are changing. In this paper, Aggregate Spend on Individual Healthcare Professionals, BioPharma Advisors explains, in detail, why pharmaceutical, medical device and biotech firms need to establish guidelines and processes that document how individual healthcare professionals are paid.
This paper addresses the following issues:
Why you need to stay abreast of these new regulations
Why your company must know how muchan individual healthcare professional earns, in total, from all segments of your business
Why your company needs guidelines and processes in place to document how much money isspent per healthcare professional
Why an aggregate spend initiative must have strict, established governance support
Why senior management involvement and endorsements are key
$250.00
Insight 8-Conflict of Interest: Does the Money Cheapen Medicine?
Webster’s dictionary defines a conflict of interest as “as conflict between the private interests and the official responsibilities of a person in a position of trust.” State and federal laws do not allow elected public officials to take money from individuals in exchange for favors. Such a conflict of interest is often punished with a prison sentence.
Healthcare professionals, primarily doctors, who take money from industry in exchange for their professional services have a conflict of interest, critics of the practice charge.
But do they? Some would argue that they have a “duality of interests” and that using terms like “conflict of interest” alleges inherent wrong-doing.These physicians argue that the current transparency trends will harm industry, patients, and the future of medicine.
In Conflicts of Interest: Does the Money Cheapen Medicine, BioPharma Advisors:
• Takes a look at the conflict of interest controversy • Explores whether it is warranted • Discusses what will happen when the critics get their way
$250.00
Insight 9-Contracting Efficiently-What a Commercial Marketer Needs to Know You’ve likely done it yourself; relied on Legal to work out the contract details that you’ve made with a healthcare professional.Sure, it makes sense – to a point. Legal protects the company from liability. But does Legal know the ins and outs of what Marketing, R&D, and other departments need that healthcare professional to do?Probably not! That’s why you cannot relinquish this important responsibility – but that doesn’t mean you need to assume a lot more work. In Contracting Efficiently: What a Commercial Marketer Needs to Know, BioPharma Advisors will show you how to satisfy your needs, and Legal’s. This document will reveal:
Why Commercial personnel must be involved in the contract process, from beginning to end
Why all work the contracted healthcare professional is expected to do should be discussed thoroughly before the contract is signed
Why all personnel who deal with Thought Leaders and their contracts should ‘go to school’ to learn the ins and outs of contracts
Why it's imperative that Commercial have overall control of all Thought Leader contracts
$250.00
Insight 10-Importance of Acquiring Thought Leader Input in the R & D Process The value that Thought Leaders bring to product development – from discovery to market – should not be underestimated. But many industry members do so.
In this paper, BioPharma Advisors spells out why ignoring Thought Leader input is a dangerous practice, and even why limiting Thought Leader input to only one area hampers market success. In The Importance of Thought Leader Input in the R&D Process BioPharma Advisors will talk about:
The current regulatory environment: The use of Thought Leaders has never been more necessary
Criteria in choosing a Thought Leader: BioPharma Advisors Includes the commercial considerations
When plans go awry: Why Thought Leader input is so vital when a product’s clinical development does not go according to plan
Public policy: The importance of contracting with a Thought Leader who “gets it”
Getting on the same page: How all departments need to have a coordinated approach to their use of Thought Leaders and to review those who are used within the company.
Ensuring success: The vital steps companies must take to reach their goals.
$250.00
Insight 11-How To Deploy a Thought Leader to Help in a Critical Media Crisis Being prepared for a media crisis is like breathing: You need to do it to stay alive. In this article, How to Deploy Thought Leaders to Help in a Critical Media Crisis, BioPharma Advisors explains why having an army of Thought Leaders at the ready can help your firm sail through a media storm.
In this article, BioPharma Advisors:
Makes a business case for turning to Thought Leadersin a media crisis and why it’s effective
Providesrationale for why training them to interact withmedia outlets is critical in a crisis
Argues why Thought Leaders should be well versed in various media –including Twitter, RSS feeds, and local TV
Includes various case studies depicting companies that used, and didn’t use, Thought Leaders to their advantage