Example: Checklist DD re. "LOCPs" - Local Operating Commercial Plans
DD-CRITERIA with specific focus on LOCPs = Local (= national) Operating Commercial Plans of a NCE or Biological product.
Overall, more than 450 key parameters/quality drivers - as integral parts of the 30 areas - of a valid LOCP process can be assessed by our specific DD procedures.
Overview of these 6 Key Clusters of LOCPs and DD:
Cluster A. Product / technology
- SPC /TL [SUMMARY OF PRODUCT CHARACTERISTICS / TARGETED LABELING]
- PRP [PRODUCT PROFILE]
- USPs, product differentiation & positioning in the disease environment
- IP - Patent situation and security
Cluster B. Market
- Assessment of the competitive environment and the key competitors
- Assessment of the political and health environment
- Market development retrospectively in Germany and other relevant markets
- Market development prospectively in Germany and other relevant markets
- Quantification of market potentials / opportunities for life cycle
- Aspects and criteria for pricing and reimbursement (also G-BA, IQWiG, NICE (UK) and HMO’s etc. USA) etc.
Cluster C. Customers
- Aspects of the various stakeholders and marketing: planning, implementation, controlling, finetuning
- Selection and prioritization of customer groups (specialist practice, clinic, MVZs, KKs, etc.) laymen
- Competition-relevant investment requirements in premarketing, marketing, sales for customers
- Results of a qualitative / quantitative market study / Competitive Intelligence
Cluster D. Strategies & Actions
- Promotion Strategies & Key Actions
- Communication Strategies & Key Actions
- Customer Binding Programs / Key Account Management / MSLs
- Visit and sales planning / customer contacts standard sales force(s)
- Publication Strategies & Key Actions
- Strategies & Actions "Clinical Trials“; "NIS / Monitoring“; IITs, Register etc.
- Strategies & Actions for congresses, symposia and further education / CME activities (doctors, specialists)
Cluster E. Financial planning & Forecasts
- Core assumptions and requirements for financial forecasts (investments, sales, earnings)
- Baseline-Projections SOV‘s vs. MS /Sales & Return [Investment-Return-Sensitivity-Analysis, Trade-offs, Break evens, NPV‘s etc.]
- Up to 5 Forecast scenarios for costs, sales and earnings - baseline, + ambitious (?) + very ambitious (?), + conservative (?), + very conservative (?)
- Resource Allocation Planning (Manufacturing, Administration, Marketing, Sales, Management), with regard to the up to 5 scenarios
- Projections of market shares: Sales vs. Sales Investments and RoI with regard to the up to 5 scenarios
Cluster F. Final plans
- Cooperations & Licenses, Royalties, Downpayments etc.
- Further activities Market research (pre-launch, launch, post-launch)
- Organization and structures: Management, Executives, Teams
- Final commercial master plan / action plan (1 year, 2-3 years and projection 5 years), along with downpayments and partial takeovers etc.
- IT technology, data provision and reporting
- Long-term map of key activities and actions