Meeting Summary by Marla Weingarten

You can see the speakers' presentation slides here:
Ian Therriault | Robert Seguin | Peter Dale | Bob Tam | Denis Boucher

For its spring Education Day meeting, the OPMA welcomed a distinguished panel of speakers to share their experiences and provide practical recommendations on the key elements of a successful product launch. 

In the current environment, the pharmaceutical industry in Canada is not experiencing the market growth it once did. There is less tolerance for risk and a greater need to ensure that every new product entering the market meets its full launch potential. The panel's secrets for success included: the four key drivers for launch excellence; the essential role of the Marketing Manager; KOL development plans; Market Access considerations; and the true power of PR. 

What Drives Launch Excellence?

Ian Therriault, IMS Health Canada

Ian Therriault (IMS Health Canada) summarized the key findings from a recent IMS study that analyzed pharmaceutical launches across all therapeutic areas from 1997 to 2004 in the world's eight leading markets (US, Germany, France, UK, Italy, Spain, Canada, and Japan). Of 4,225 promoted products, only 35 achieved product excellence by outperforming in two or more countries. 

According to the IMS study, there are four key drivers to achieve launch success: 

1. Engage all decision-makers and expand the market
- It is important to focus beyond just the prescriber and engage policy makers, payors and patients, as they are all significant decision-makers. 
- Market expansion can occur in five ways: increasing the diagnostic rate, increasing the speed to diagnosis, establishing a new standard of care, driving the initial take up, and improving longer-term compliance.

2. Adapt locally to meet new models
- Canada and the UK have reputations as tough Market Access environments.  In the US and Japan, where health economic evaluations are not required, detailing activities have driven the product launch.  We will likely see changes in the future as the UK and Canada will be markers for the direction in which other markets will evolve. 

3. Align the organization across chasms
- It is vital for companies to demonstrate their commitment to the planning and launch of a new product and this commitment must be established from the top of the company through the various layers to all employees. 
- Any disconnect across teams or between the local and global markets could be very damaging.  You may have a great launch plan, but if it is not executed properly, it will result in failure. 

4. Optimize and Adjust within the launch window
- The launch window is incredibly small, as companies have only 13 1/2 weeks in which to engage prescribers. A contingency plan developed prior to launch is essential. New-to-brand metrics, a data analysis technique that provides insight into patient uptake on a weekly basis, can help to predict the future. If the results are less than expected, modifications from the contingency plan can be implemented immediately.

The Importance of Non-Positional Leadership
 

Robert Seguin, The Productive Leadership Institute

Whereas the first speaker addressed the question, "What makes a launch successful," the second speaker, Robert Sequin of the Productive Leadership Institute, focused on the question, "Who makes a launch successful?" He presented the idea that it is the people behind the product who really make the difference in launch success. 

Seguin referred to his own experience of taking on the lead role for a new cosmetic product, Botox.  He and his team faced the challenge of taking what was actually a poison that is injected into a woman's face, and making it a winning product. He called attention to the significance of the Product Manager's role and cited three key guiding principles for Product Managers to follow:

1. Get the Best People "on the bus."
- This applies to everyone associated with the launch from internal departments to external experts.  Don't always inherit your predecessor's agency of record; take the time to ensure you hire the best.  "If you ruffle some feathers along the way, too bad!"

2. Chair a collaborative Planning Effort that incorporates the following aspects:
- Conceive a team vision that contains BIG ideas.
- Identify the team's values and state how you want to conduct business (single out what you will always do from what you will never do). 
- Know all your obstacles and find creative ways to solve each barrier.
- Establish how you will celebrate your success milestones up front, so people can visualize their goals.

3. Lead the Process:
- Although good communication skills may be useful, the most important skill is to be a competent and notable listener. (Robert provided the example of Bill Clinton, who, during a book signing, demonstrated his listening skills by looking people in the eye, asking a question, and truly listening to their answers. Within 13 seconds, he knew enough about each person to sign their books with a personal comment.)
- Reward and recognize successes to motivate your people.
- Given the unpredictability of customers and the competition, Product Managers must be smart and quick on their feet.

Robert highlighted the significance of a leader's role with a quote from Margaret Mead, the distinguished anthropologist and scientist who was named "Mother of the World" by Time in 1969. She said, "Never Doubt that a small group of thoughtful, committed people can change the world.  Indeed, it is the only thing that ever does."

KOL Development

Peter Dale, EURO RSCG LIFE

Peter Dale of Euro RSCG Life, cited three key trends in developing Key Opinion Leader partnerships:

1. Going from Silos to Cross Functional Involvement:
- We are accustomed to looking at KOLs in silos, where information flows from national opinion leaders to the teaching centre specialists, then to regional specialists and finally to the general practitioner. It's not that this model is untrue, but it is important to look beyond this simple approach and explore KOL Mapping and Profiling. Using this approach, we can ask: What do we know about the MD?... What can this MD deliver?... What does this MD want?

2. Move from Short term to long term relationships:
- Opinion Leaders should be involved in all stages of Product development from preclinical R&D (where they can identify gaps in the scientific information) to clinical development (where they can advise on clinical trial design) through to commercialization of the product (where they can deliver key messages). 
- Conducting clinical trials in your own country can have a huge impact on KOL endorsement of your product. (Peter illustrated this point with the HOPE study and how this one study catapulted the use of Altace in Canada.  When the study was presented in November 1999, it did not have a tremendous impact on market share in the US. However, in Canada where there were 400 investigators, prescriptions for this product skyrocketed. Each of these 400 investigators had intimate experience with Altace and endorsed its use with colleagues and with the media.)

3. One size does not fit all; a customized approach is required.
- Despite the fact that Vioxx was launched after Celebrex, it was able to surpass this first COX-2 inhibitor by bringing into play a customized approach with KOLs.  
 
According to the MD Insight Survey, "Specialists spend more than 10 hours a week on-line," and understanding how to communicate using this technology must be central to any development plan. 

Market Access Considerations

Bob Tam, Nycomed Canada

KOL endorsement of a new product is a must in today's world, but significant uptake of the brand is most often dependent on formulary approval. Bob Tam of Nycomed Canada noted that every launch plan he has come across has had the objective "to gain timely (fast) market access on all private and public formularies equal to or better than competitors." As this goal is becoming much more difficult to reach, Bob offered some useful "Don'ts and Do's" regarding a drug submission. 

The following list provides some of the Do's for market access success:

1. Understand the data and its limitations, and plan for questions.
2. Develop listing criteria that is supported by evidence (open listings are not usually granted for new drug listings).
3. Budget time and money for listing agreements.
4. Recognize that you can submit a lower price and once approved, prices can be increased by 3% annually.
5. Relationships with decision-makers (private and public) do matter and can influence the outcome
6. Approach formularies with an offer to share the risk.
7. Patient advocacy groups can have powerful voices through the media.

Although Market Access may be more restrictive now than ever before, adhering to the above guidelines should help to achieve more timely listing approvals. 

The Power of PR

Denis Boucher, National

Denis Boucher of National Public Relations addressed the position of PR within a product's overall marketing mix. We are living in a time when the public wants information and more control over their health, he said. Patients have a very powerful voice and can influence both governments and physicians. 

The traditional pillars of marketing are no longer enough to build a winning launch plan. A well-thought-out PR plan can have tremendous impact and can accomplish the following objectives:

- Position a disease
- Position a product
- Support reimbursement
- Build relationships
- Build corporate recognition and reputation
- Protect corporate image

Unfortunately, PR is still treated as an afterthought on most launch plans. PR budgets are often established without any consultation with an agency or internal Public Relations staff. PR is much more than just a press release. Many companies call in their PR department or an outside agency after receiving a negative response from CDR instead of readying themselves with a PR strategy containing a contingency plan that could be put into place immediately.

PR departments and agencies must be seen as a strategic partner and need to be involved with the launch team at least 2 years prior to market entry. Agencies need to have a solid understanding of the product's objectives and its strengths and weaknesses. They must be informed of the product's upcoming indications and the KOLs involved in the launch process. The budget will need to reflect the PR goals and given the monies allocated, there needs to be realistic expectations. 

Denis shared with us the example of Fosamax, which was able to generate over 100 million media impressions by growing awareness for osteoporosis through a well designed PR plan of action, at a time when this disease was generally ignored. He ended his presentation by stressing the power of PR and the necessity for companies to ensure it is no longer handled as an afterthought. 

Overall, this event featured five articulate and insightful speakers. The results of the multi-country IMS study, along with a better understanding of the Product Manger's role, the development of a reliable KOL plan, tips for earlier formulary approval and the true power of PR within the marketing mix, will all help companies reach the full potential of their next new product launch.

About the author:
Marla Weingarten is a marketing consultant, specializing in the Canadian pharmaceutical industry. She can be reached at marla.weingarten@sympatico.ca.