Showing posts with label MA Launch. Show all posts
Showing posts with label MA Launch. Show all posts

Thursday, November 1, 2012

Topic 17 – New MA Organization – MedComm/SciComm

A reader and I discussed her dilemma the other day.  She was being tapped to create a new MA function for a small biotech that was bringing its first product to market.  She had fairly broad latitude but was not sure where to begin.  Some of the points of our discussion are captured below.

We have already discussed preparing an MA team for launch here, the effective way to manage MSL groups here  and the best way to develop a MedInfo function here, I thought I would focus on the Medical Communications or Scientific Communication group with this post.  A note about function names.  I very much prefer the term Scientific Communication because it more correctly reflects the role of the function which is to provide scientific data to the market place some of which is purely medical but some of which may be of a health economic nature that are not purely medical.

SciComm is a critical function for MA but developing one from scratch is as much a challenge in internal politics as a challenge in terms of operations.  At a small company, before there is a SciComm group the company is already publishing.  So, developing a group can be sensitive and many toes can be treaded upon if one is not careful.  The best approach is to co-opt the staff that have been driving the publication efforts in designing (and maybe leading) the new SciComm function.  But, it is critical that everyone involved realize that publications take on a broader role in SciComm than they did in CD.

In CD the role of publication was primarily focused on the results of clinical trials.  That continues to be a responsibility of SciComm but its role of sharing scientific data expands to identifying the scientific questions that the marketplace needs answered, some of which will be answered through literature analysis or through non-clinical studies.

Given that CD is typically handling the publications in advance of the SciComm function, the temptation may be to put developing the group on the back burner until other MA functions have been more fully developed.  This would be a mistake.  SciComm needs to be analyzing the scientific needs of the HCP community and ensuring that the required scientific information is available concurrently with launch.  Any delays can result in a vacuum of information and who knows what will fill that vacuum (or which competitors will try to fill that vacuum).  So, at least 18 months prior to the launch the SciComm group should be launched, right along side the MSL function.

What has been your experience with SciComm groups at launch?  Leave a comment.

Monday, July 23, 2012

Topic 6: Measuring the Value of Medical Affairs

Introduction

A reader requested a discussion of different approaches for measuring the value of medical affairs.  This is a critical question and one that I touched on briefly when I discussed strategic planning in MA as it relates to launch.  But it is equally important overall for MA.

Like any function in pharma, MA must be able to communicate its value.  Value can be a tricky concept, however, for a non-commercial function like MA.  Value is ultimately a company-specific question.  It stems from the company achieving its strategic goals, which is why defining goals is so important.  Having said this, there are some general categories of value measures that we can discuss as well as some best practices around measuring value.

Value measures in MA typically fall into two types:

  1. Objective measures

  2. Subjective measures

Objective Measures

In MA, objective measures tend to focus around activity-based measurements.  Since MA cannot be seen as promotional, the other available objective measures like prescriptions written, sales numbers, profitability, etc. are not relevant.

Activity-based measures have both strengths and weaknesses.  On the strength side activity based measures are:

  • Easy and cost efficient to gather

  • Easy to explain to non-MA colleagues

  • Non-controversial

Unfortunately, activity based measures also are:

  • Not outcomes focused

  • Not usually tied to the direct concerns of the organization

  • Potentially misleading

While it may be interesting to know that the MSL group conducted 150 meetings with KOLs in the last quarter, it tends to beg the question – So What?  Activity-based measures tend to focus on the tactics (e.g. reach out to KOLs) rather than the goals (e.g. ensure broad awareness of the latest disease state information).

Activity-based measurement is very appropriate for certain MA functions.  For example, on CME funding, which by definition must be a hands off process, the only important measure is activity-based: Did the organization fund the number of CME programs it had intended to fund?

Or, in the Medical Information function, the key measures relate to answering inquiries and responding.  Activity-based measures (e.g. total number of inquiries managed, average turn-around on inquiries, number of inquiries requiring a second contact) are very appropriate for this type of service.

Finally, activities with multi-year goals like post-approval clinical trials, use activity-based measures to ensure that the overall program is on track.  So activity-based measures like patient recruitment and data collection provides valuable insight.

Activity-based measures are a necessary for MA’s ability to track progress against its goals, but they not sufficient to account for all of MA’s goals.

Subjective Measures

Most MA organizations have goals that require a more subjective type of measure.  Some of these goals relate to the degree of awareness or understanding in the healthcare community.  Measuring understanding or awareness is not as simple as measuring the number of discussions about a certain topic.  Instead, to measure progress on these types of goals, MA needs to gather more subjective data.  Simply put – it needs to ask.

For goals related to subjective measures, the only practical way to measure success is through research.  Unless a company is very lucky and finds that one of its objectives just happens to align with a topic that is already the subject of someone else’s research, this almost always means conduct primary research.

Research-based measures have their own strengths and weaknesses.  The strength of research-based measures include:

  • Direct connection to goals related to healthcare community awareness and understanding

  • Insight into the knowledge and beliefs of the healthcare community

  • May provide insight into other, unmet needs

Research-based measures have some significant drawbacks, including:

  • Expensive to conduct, leading to limited number of data points

  • Subject to research bias

  • May be taxing to the community that the organization is trying to serve

For research-based measures to be understandable, they usually need to be measured against a baseline.  For example, the measure of awareness of new disease-state information in the healthcare community after the efforts of the MA organization is only relevant if the measure of awareness before the efforts were known.  This requires the development of a baseline which both adds to the cost and requires good up-front planning.

But by far the biggest challenge of research-based metrics is the lack of experience and budget to conduct such research.  Many MA organizations do not have experience conducting this type of “market research”.  Without such experience, it can be daunting to initiate the research and structure it in the best manner.  Additionally, many MA organizations do not have money in the budget to conduct this research in a high quality manner.  This is both a product of the lack of experience and the view that this type of research is outside of the mission of medical affairs.

Best Practices

Clearly most MA organizations can benefit from a set of mixed objective and subjective measures.  Developing such a set of measures starts analyzing the strategy and goals outlined in the MA strategic plan.   From there a set of potential measures can be defined and prioritized.  Overall, MA should have between 5 and 10 metrics.  Specific functions within MA may have from 3 to 5 additional detailed metrics.  Once these metrics are defined, the approach for gathering each metric can be identified.  The activity-based metrics are typically gathered from existing tracking systems while the research-based metrics require more active management.

Once the research-based metrics are defined, a draft of a research outline can be developed, specifying the key questions, the research targets, the number of responses expected and the number of research samples to be taken.  This outline can be used as the basis for developing a request for proposal from a research company.

One caution – many organizations are tempted to combine this research with research already being conducted by the commercial market research function.  This may be a problem if the marketing questions are, in themselves, seen as promotional.  Most of my MA clients have been unwilling to risk this crossing of the line but some organizations do follow this practice.  Please work with your compliance function to discuss this approach.  Many organizations are not even comfortable with using research companies that are primarily commercially oriented but, frankly, there is little reason to avoid these companies.

After the approach to both activity- and research-based metrics is in place the next step is to determine how the results will be communicated and to whom.  This should become an ongoing process so it should be automated and standardized as much as possible.

Closing Thoughts

Explaining the value of MA remains one of the primary responsibilities of MA management.  For MA to be perceived as valuable to the organization, its progress against its strategies and goals has to be proven.

What has your experience been with value and measures in MA?  Leave your comments below.

Click on the email link to the right to suggest a topic for future posts.

Monday, June 25, 2012

Topic3: MA at Launch – Do’s and Don’ts for MA Launch Support

An MA leader finding themselves responsible for the MA support of launch faces an interesting and challenging situation.  Launch is a great time for MA to demonstrate its value to both the healthcare community and the company.  But, launch is also a highly commercial endeavor, which can be risky compliance ground.

There are a series of Do’s and Don’ts that I would suggest may make the launch support more effective and satisfying.

DO: Insist representation in the Launch Team
The Launch Team is almost always led by someone from marketing.  The Launch Team is responsible for coordinating all the activities associated with launch.  Today, in general, MA is invited to be a part of the Launch Team.  But, if you are not invited, meet with the Launch Team Leader and push hard for a seat at the table.  Not only does everyone on the launch team need to know what MA is doing but MA needs to know what they are doing as well.  It is not at all unusual for the MA representative on the Launch Team to discover that a commercial function is planning some type of outreach that is either potentially out of compliance or better done with MA resources

DON’T: Take your seat at the table of the Launch Team for granted
While many of the activities being discussed in the Launch Team are commercial in nature, the MA representative still needs to keep engaged and offer their advice.  Ask for and read the market research that the commercial functions have produced.  While it is aimed at marketing, some insights into healthcare providers and their needs that are relevant to MA can be gleaned.  Understand the issues that the commercial leaders are facing, even if MA is not going to directly be addressing them to remain non-promotional.  By understanding those issues, the MA representative on the launch team can bring back valuable insights from both their experience and the insights captured by the MA field force.

DO: Consider outsourcing as a solution for MA operational infrastructure challenges
Just about every activity conducted by MA can be outsourced on a global basis.  Many MA organizations fail to consider outsourcing options for Medical Information needs or MA field force hiring and deployment needs. Outsourcing can be a great answer, especially when you don’t think the you can justify full-time positions.

DON’T: Rely too heavily on outsourcing companies’ strategic insight and quality assurance
Many organizations will retain outsourcing companies to do a range of activities like developing publication plans or disease state education materials (as opposed to CME).  They are hired because the MA group doesn’t have the resources to do the work itself.  While these vendors are hired for their proficiency, the hard truth is that no one will care about the launch as much as the company employees.  MA staff from the company need to have the time to engage deeply with these vendors and manage them closely.  So, when considering staffing, there must be an assumption of a percentage (1/4 to 1/2) of a full time person’s capacity is assigned to managing the vendor.

DO: Identify key opinion leaders in a data driven manner
Engaging key opinion leaders (KOLs) is critical for educating the healthcare community and other outreach activities associated with launch.  Many MA organizations that have worked in the therapeutic area in the past believe that they “just know” who the KOLs are or leave it up to the field force team members to identify the KOLs in their region.  Considering how scientifically driven MA is in general, this informal approach is not only out of character, it is also less than effective. KOLs are “opinion leaders” because other healthcare providers look to them for guidance.  The best way to know who healthcare providers look to for guidance is simply to ask them.  Through targeted research, the actual opinion leaders can be identified.  My experience has been that when you compare the list of informally generated KOLs to the list of research generated KOLs from 30 to 40% of KOLs are different.  That means without research, a huge number of actual opinion leaders can be missed.

DON’T: Limit the focus of outreach to traditional KOLs
KOLs have typically been research-oriented physicians associated with an academic institution.  But, in today’s world both treatment and networks of influence are spread much wider.  Depending on the therapeutic area in question, a number of non-traditional KOLs may strongly shape opinion.  The MA organization should not limit itself (or its KOL research) to the traditional definition.

What Do’s and Don’ts would you suggest?  Leave your thoughts in the comments.

Friday, June 22, 2012

Topic3: MA at Launch – MA Launch General Timeline

Introduction

As we discussed in a previous post, MA must have its own launch strategy to ensure that it is capable of proactively addressing the scientific needs of the healthcare community in a manner that is both effective and compliant.

In addition to having a clear strategy, another key success factor is the timing of MA launch activities.  In this post, I will share a general MA launch timeline.  However, all launches are unique, with their own set of requirements, so in order to put together even a generic timeline I will need establish a scenario as the basis:

  1. The drug being launched is a relatively recent in-license from a smaller company with no MA group.

  2. The drug is in P3 testing, with results expected in 10 to 12 months and an NDA filing expected soon after.

  3. The company managing the MA support of launch has an existing MA function but no experience in the drug’s  therapeutic area

  4. As a result, the current field force (MSLs) are not sufficient to support the new drug

When we consider launch, the work breaks down into four broad categories:

  • Operational Infrastructure:  This includes people, processes and technology needed to support the MA launch (and post-launch) activities

  • Scientific Outreach:  All activities required to educate the healthcare community about the therapeutic area, disease state and drug.

  • Research:  All activities with the goal of data generation.

  • Internal Support:  All activities in which MA assists other functions within the company.

For simplicity sake, I will consider each of these categories in four different time periods:

  • -24 to -18 Months before Launch

  • -18 to -12 Months before Launch

  • -12 to -6 Months before Launch

  • -6 Months to Launch

During each time period, I will attempt to highlight some of the key deliverables in all the categories that are relevant.  Not all categories are relevant in all time periods.



-24 to -18 Months before Launch

During this period, the primary goal is to develop and gain approval for the MA Launch Strategy.  Since our example demands a fair amount of operational infrastructure development, the budget and timing for the needed resources must be agreed upon in this period.  In some companies the Launch Team has not yet been formed, and in those cases MA will need to work with commercial leadership to ensure that its’ initial plans are in alignment with the current best thinking of the launch.

CategoryKey Activities and Deliverables in this PeriodComments
Operational Infrastructure

  • Agree on hiring plan for all MA resources, but especially for a Medical Director and MSLs

  • Develop position descriptions for new positions

  • Recruit new Medical Director (MDir)

  • Develop any new processes needed to support the infrastructure

  • Identify and begin selection of any new information systems needed

  • The Medical Director, with strong TA credibility, is key to the overall launch success and hiring such a person is a high priority t this state.

Scientific Outreach

  • After the MDir comes on board, they can begin to informally reach out to their peers in the TA

Research

  • The MDir should engage with the existing P3 research team and begin working on Data Generation Plan for P3B and post-approval studies

Internal Support

  • The MDir should become a valuable advisor to the entire Launch Team


-18 to -12 Months before Launch

This is a critical period for planning and infrastructure development.  We are assuming in our example the need to hire a new MSL team, and the bulk of this activity takes place this period as well.

CategoryKey Activities and Deliverables in this PeriodComments
Operational Infrastructure

  • Hire MSLs - this typically can take 3 to 6 months

  • Train MSLs - this can typically take 1 month

  • Implement new processes

  • Implement new information systems

  • MSL recruitment can be a slow process and should be begun as early as possible

Scientific Outreach

  • Identify national and regional Key Opinion Leaders (KOLs) for educational and research engagement

  • Develop the Publication Plan, if it has not already been developed

  • Publish according to the Publication Plan

  • Develop Disease State Education Plan

  • Develop disease state education materials

  • Develop the Congress and Meeting Plan

  • Attend initial congresses with MDir and available MSLs

  • Develop Ad Board Plan

  • Conduct Ad Boards

  • A huge amount of planning work needs to go on during this period – it is likely that the entire MA function will need to support this effort

  • The Publication Plan will likely be revised every 6 months or so during this period.

  • For compliance reasons, Ad Boards should be coordinated by MA although the purpose of the Ad Board may be commercial.

Research

  • Develop the Data Generation Plan, if not already completed

  • Develop Investigator Initiated Study Plan (IIS Plan)

  • Work with Development to start executing P3B, 4 and HEOR studies

  • Research is likely to be done in partnership with Development if not owned by them completely.

Internal Support

  • Develop REMS Plan

  • Develop Scientific Training Plan

  • Develop Access and Reimbursement Support Plan

  • REMS may be driven by another function but MA should engage to ensure that it links in with the other MA plans.

  • Scientific training plans may support a number of commercial groups including marketing and sales personnel


-12 to -6 Months before Launch

This is the period when the work of supporting the launch begins in earnest for MA.

CategoryKey Activities and Deliverables in this PeriodComments
Operational Infrastructure

  • Train MSLs, if not already complete

  • Hire or retain capacity for Medical Information

  • Train Medical Information resources

  • Medical Information should be available no later than 3 months prior to launch but 6 months is safer to handle expected inquiries

Scientific Outreach

  • Outreach to national KOLs and begin outreach to regional KOLs

  • Revise the Publication Plan, if necessary

  • Publish according to the Publication Plan

  • Conduct disease state education efforts

  • Attend congresses and meetings

  • Conduct Ad Boards

  • Develop Medical Information Plan



  • Disease state education is a critical goal for this period.  MA can establish a strong understanding of the current disease state among their targeted KOLs.

Research

  • Begin IIS outreach to alert the medical research community to the potential availability of grant funding and the grant application process

  • Continue to execute P3B, 4 and HEOR studies

  • IIS outreach must focus on the facts of the program and process not specific research goals in order to remain compliant.

  • P3B protocols should already be completed by this point, with study initiation beginning in this period.

Internal Support

  • Support REMS Plan

  • Conduct scientific training

  • Support Access and Reimbursement scientific needs


-6 Months to Launch

Like the last period, this period is focused on the execution of the plans developed earlier.  One critical role that MA should be playing during this period is providing feedback that they are hearing to the rest of the organization.  MA is not a market research function, but the questions they receive is valuable information that the commercial organization may wish to know.

CategoryKey Activities and Deliverables in this PeriodComments
Operational Infrastructure

  • Train Medical Information resources, if not completed

Scientific Outreach

  • Outreach to national KOLs and outreach to regional KOLs

  • Revise the Publication Plan, if necessary

  • Publish according to the Publication Plan

  • Conduct disease state education efforts

  • Attend congresses and meetings

  • Conduct Ad Boards

  • Develop medical information deliverables

Research

  • Begin IIS grant review process

  • Continue to execute P3B, 4 and HEOR studies

Internal Support

  • Support REMS Plan

  • Conduct scientific training as needed

  • Support Access and Reimbursement scientific needs


Closing Thoughts

Different therapies can drive very different timetables.  If the drug in question is a new formulation of an existing, well established product, very little specific work may need to be done and the whole process can begin and end in the 6 months prior to launch.  If it is a novel new oncology treatment with a companion diagnostic, you may wish to move up the timelines on certain activities like IIS which may even start before approval.

I would like to hear about your experience at launch.  Please leave a comment below.

Topic3: MA at Launch – Importance of MA Launch Strategy

The good news for many MA leaders today is that launch leaders (most of whom are typically commercial leaders) rarely need to be convinced that MA needs a role in launch.  In today’s world, most launch leaders understand that MA should have a role.

Instead, the challenge for MA leaders today is ensuring that the role and activities of MA are driven by their understanding of both MA’s proper role and their deep understanding of the scientific underpinnings of the drug being launched.  Like it or not, commercial people still often view MA as another “messaging” platform and may put MA in the position of serving as a promotional resource without understanding the risks in doing so.

Therefore, it is critical that MA leaders approach launch leader with a well thought out MA strategy to support the launch.  This strategy should not be developed in isolation – MA’s commercial colleagues should contribute to and review the MA launch strategy.  BUT, is should be MA leadership that is driving the MA launch strategy.

An MA launch strategy should have the following characteristics:

  • Thorough review of the scientific basis for the drug, including mechanism of action

  • Analysis of current treatment standards and the likely position of the new drug on those treatment standards

  • The role MA will need to play in the launch, considering the degree of scientific education required on:

    • The disease state

    • The current treatment options

    • The mechanism of action

    • The administration of the drug and management of side effects

    • Any related diagnostics

  • A gap analysis of current MA operational infrastructure’s capability to support this launch including:

    • Experience and scientific reputation of MA in this particular therapeutic area (TA) and disease state (Especially does the company currently of a medical director (MD) with a strong reputation in this TA)

    • Degree MA currently has field resources (MSLs) capable of supporting the launch:

      • Presence of the MSLs with key opinion leaders (KOLs) in TA

      • Capacity of MSLs to take on support of a launch

      • Expertise of current MSLs on the disease state and capabilities of current MSLs to support drug

    • Ability of the organization to support likely call volume within existing medical information (MI) function

    • Capability of current clinical study management infrastructure to support expected volume driven by launch

  • Plan for the likely changes in infrastructure based on the gap analysis

  • High-level (1 page) starter plans for key elements of the MA launch which may include:
    • Publication plan

    • Congress Plan

    • KOL Plan

    • Medical Information Plan

    • Advocacy Plan

    • Health Economics Outcomes Research (HEOR) Plan

    • Investigator Initiated Study (IIS) Plan

    • Phase 4 Plan

    • REMS Plan

    • Internal Training Plan

    • Access and Reimbursement Support Plan

  • Overall MA launch budget and implementation plan

Only after MA has developed its own launch strategy can it successfully negotiate with the launch leader the degree that the launch program can support its needs.  Without an MA launch strategy, MA is placed constantly in a reactionary mode.

In my next post I will discuss the timing of all of these types of activities, but one important note is that the MA launch strategy is a living document.  It is likely to be revised a number of times as new data and new realities become clear.  This is to be expected and everyone involved should have this understanding from the start.

Finally, as mentioned above, MA is only a part of the bigger launch effort and therefore must coordinate its activities with the launch leader and ensure that its work supports the overall launch plan.

What has been your experience in developing MA strategies for launch?  Leave a comment below.

Topic3: Medical Affairs at Launch

One of the great challenges for Medical Affairs is determining how to most effectively support a drug at launch.  As you may know, drug launch is absolutely critical to the success of a drug.  And since in our business that means the penetration of treatment to patients who needs them, MA must view launch as a unique opportunity to educate the healthcare community.  In discussing this topic, I will address the following topics:

As usual, I am curious to hear about your experiences at launch.  Please share them in the comments.