Medical, legal, regulatory and compliance (MLRC) professionals play critical roles as the biopharmaceutical and device industries face new challenges that require bold thinking. When MLRC leads with a business mindset, they are more effective at asking strategic questions and helping to identify functional opportunities that enhance innovation, reputation and marketing excellence.
Our Business Acumen Tool identifies five key drivers of MLRC value. Simply place your cursor on the link and the drop down list of questions will appear:
- What outcomes matter to patients/other stakeholders (at least 5 years pre-launch)? Are we listening to the commercial and medical customer voice?
- Will the data from the development program address relevant unmet medical need(s); define optimal patient populations?
- Are we evaluating ways to provide claims that meaningfully differentiate the product from key competitors (on market/in development, other treatment options)?
- What are the essential elements of the development plan (claims) for initial licensure and what can be part of life cycle management?
- What research will maximize the current pipeline as well as replenish the pipeline with new products?
- Have I anticipated strategies to address regulator requests for safety data and post marketing surveillance?
- What else could I do to strengthen the product's potential differentiation from competitors? Are we optimizing all real-world commercial considerations?
- How can my interactions with regulators secure the targeted product profile?
- What differentiating factors would persuade payers that our product has added value over existing therapies?
- What about the impact of future competitive products which could potentially impact the reimbursement status of our product based on their claims?
- Can we advance patient reported outcomes measurements in this therapeutic area/diseases state/patient population and demonstrate enhanced quality of life?
- Are we demonstrating cost-effectiveness or other economic benefits?
- Could there be secondary endpoints built into studies for further differentiation that are meaningful to payers?
- Does the product would work more effectively or have a greater benefit in one patient type or segment?
- Are there factors relating to reimbursement status across different market segments in different regions (such as public funded vs. private for example) that could impact product success?
- Are we prepared to recommend language/descriptors for the label to minimize putting the product at competitive disadvantage?
- What assessments of competitor labeling and promotional activities will support the business team?
- What are we learning from customers that can help shape the product (Regulatory plus other R&D functions such as Medical Affairs)?
- What regulatory/legislative trends or enforcement actions are pending that could impact the development and marketing of products?
- How can I help shape regulatory and legislative texts connected to healthcare policies?
- Has all information regarding existing, emerging and evolving policies/laws/trends that may affect our product been catalogued and evaluated for strategic advantage?
- Am I thinking globally about all these factors so we can address challenges and opportunities in all targeted regions?
- What risks (based on previous studies or competitor's products) or regulatory/health policy changes should we anticipate and address?
- How can we ensure efficiencies if the development plan includes multiple country requirements with diverse regulatory scenarios?
- Can I anticipate the final labeling to provide timely guidance in developing the business and marketing plan?
- Can I inform marketing research to test hypotheses about product value?
- Do I have Brand books with regulatory history and key learnings from labeling negotiations and advisory comment submissions to ensure efficient and wise decision-making?
- Am I making a business case for:
- Holding early concept reviews?
- Benchmarking regulatory gaps within the marketing department and among promotional vendors to decrease unnecessary rewrites?
- Assessing the money wasted on agency fees from the submission of noncompliant materials and the strategies to reduce these unnecessary costs?
- What strategies can I put in place to speed up promotional review without sacrificing comprehensiveness?
- How can I help the marketing team stretch their marketing budget?
- Am I really listening to all stakeholder voices -- internal and external?
- Is my mind open to changing the way the company has been operating to address concerns and complaints?
Each driver listed above includes a drop-down list of questions that MLRC professionals can use to enhance interactions with their business partners and to help ensure that the entire team understands what is needed to drive the business. The answers to the drop-down questions can also be used as talking points to trigger new ideas and strategies and to communicate the value of the MLRC to commercial operations
In this podcast, five executive women from different companies share their thoughts on the tool’s value for your career:
Anita Burrell, head of global commercial effectiveness, Sanofi Diabetes
Carlotta Dillon, senior director, pipeline portfolio, Aptalis Pharma
Vickie Landolfi, associate vice president, global products, Sanofi Pasteur
Cathy Pariser, president, Pariser Consulting
Michelle Radney, senior director, portfolio management, established products business unit, Eisai
A poster on the Business Acumen Tool was accepted for presentation at the DIA 2014 50th Annual Meeting.
"Value story' podcasts:
Listen to Anne Arvizu, director, Baxalta Medical Affairs, speak on her value story of "medical information (functional awareness) "
Listen to Jennifer De Camara, assistant general counsel, Johnson & Johnson, speaker on her value story of "legal social media engagement"
Listen to Stacy Joseph-Reese, director, regulatory promotional review, Teva Pharmaceuticals, speak on her value story of "regulatory (internal guidances)"
Listen to Terri Ledva, senior manager of compliance, Iroko Pharmaceuticals, LLC, speak on her value story of "compliance speaker engagement"
There is also a mobile app with the Business Acumen Tool and other resources to accelerate leadership talent and impact.
To download: Go to iTunes App Store or Google Play Store to download Mobile Health Library. Launch our app, tap “Enter MHL App Code” and type “HBA”. Tap “Submit” to launch.