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

  1. SPC /TL [SUMMARY OF PRODUCT CHARACTERISTICS / TARGETED LABELING]
  2. PRP [PRODUCT PROFILE]
  3. USPs, product differentiation & positioning in the disease environment
  4. IP - Patent situation and security

Cluster B. Market

  1. Assessment of the competitive environment and the key competitors
  2. Assessment of the political and health environment
  3. Market development retrospectively in Germany and other relevant markets
  4. Market development prospectively in Germany and other relevant markets
  5. Quantification of market potentials / opportunities for life cycle
  6. Aspects and criteria for pricing and reimbursement (also G-BA, IQWiG, NICE (UK) and HMO’s etc. USA) etc.

Cluster C. Customers

  1. Aspects of the various stakeholders and marketing: planning, implementation, controlling, finetuning
  2. Selection and prioritization of customer groups (specialist practice, clinic, MVZs, KKs, etc.) laymen
  3. Competition-relevant investment requirements in premarketing, marketing, sales for customers
  4. Results of a qualitative / quantitative market study / Competitive Intelligence

Cluster D. Strategies & Actions

  1. Promotion Strategies & Key Actions
  2. Communication Strategies & Key Actions
  3. Customer Binding Programs / Key Account Management / MSLs
  4. Visit and sales planning / customer contacts standard sales force(s)
  5. Publication Strategies & Key Actions
  6. Strategies & Actions "Clinical Trials“; "NIS / Monitoring“; IITs, Register etc.
  7. Strategies & Actions for congresses, symposia and further education / CME activities (doctors, specialists)

Cluster E.  Financial planning & Forecasts

  1. Core assumptions and requirements for financial forecasts (investments, sales, earnings)
  2. Baseline-Projections SOV‘s vs. MS /Sales & Return [Investment-Return-Sensitivity-Analysis, Trade-offs, Break evens, NPV‘s etc.]
  3. Up to 5 Forecast scenarios for costs, sales and earnings - baseline, + ambitious (?) + very ambitious (?), + conservative (?), + very conservative (?)
  4. Resource Allocation Planning (Manufacturing, Administration, Marketing, Sales, Management), with regard to the up to 5 scenarios
  5. Projections of market shares: Sales vs. Sales Investments and RoI with regard to the up to 5 scenarios

Cluster F. Final plans

  1. Cooperations & Licenses, Royalties, Downpayments etc.
  2. Further activities Market research (pre-launch, launch, post-launch)
  3. Organization and structures: Management, Executives, Teams
  4. Final commercial master plan / action plan (1 year, 2-3 years and projection 5 years), along with downpayments and partial takeovers etc.
  5. IT technology, data provision and reporting
  6. Long-term map of key activities and actions