Lorenzo Nanetti, MBA

Client (top MedTech) discovered that a large diversity of diagnostics products were sold in the different points of care (PoC), but transfer of data between the different appliances at PoC-level were poor or inexistent with the consequence of poor service provision across the diagnostic products and poor support of health care professionals and patients.

The project team Identified and studied Point of Care-Primary Care needs (hospitals, laboratories and GP practices) and evaluated solutions to enhance client’s business services footprint by:

• Providing clear picture of customers’ needs for the IT support and connectivity within Primary Care

• Identifying and evaluating IT solutions available in the markets both existing and under development for Primary Care patient management

• Delivering a short-term implementation strategy for an IT solution in Primary Care in selected markets

• Outline the key IT requirements for integrating Primary Care into client’s long-term IT strategy.

For a global leader in primary care business. One year after launch of a Customer Engagement program, leadership experienced limited visibility on the exact adoption level of the approach in the countries combined with low CRM usage, different quality levels of Key account plans and varying countries’ buy-in. Original business case and promised increase of sales performance were in danger.

Need to measure the adoption levels in eleven European countries and then align and co-create actions required for improving adoption. Applied approach:

• Combined 1:1 personal interactions and document reviews with objective online assessment and KPIs from the CRM system

• Each qualitative dimension requiring assessment was broken down into granular questions which allowed for an objective assessment of the adoption levels

• The underlying root-causes were also discovered using a change management lens, a special set-up for aligning and lately co-creating action roadmaps with countries

• The approach was particularly designed to perform a large number of assessments in a short period of time

• Performed a neutral and unbiased exercise increasing the buy-in of key stakeholders to the need for change and suggested interventions.

Countries’ assessments revealed a substantial need for urgent corrective actions and food for thoughts:​

• Other systems (previous investments, or to comply to local regulations) used in parallel / addition to the standard CRM

• Different processes not in-line with those recommended from the Customer Engagement program and with different level of documentation (often not formalized), interpretation and implementation

• For the brand therapy in scope, local healthcare systems were functioning in different manners, which were yet reflected into the local affiliates’ processes and set-ups, but partially not in-line with elements of the Customer Engagement program

• One of the affiliate was vehemently pushing back on the program. Personal interviews revealed that the country already implemented a similar program, which was by far superior from the one presented by the HQ. Sales success was already proven, opening up another thought dimension around shared best practice.

For a top pharma company existing Key Performance Indicators (KPIs) were too numerous and with questionable steering value. In addition, existing reporting systems required intensive manual data integration, while delivering too many inconsistent figures.

Initiative scope covered two main areas:

1. definition of new KPIs, which are (i) sufficient to steer the company, while consistently reflecting performances, customer impact, execution and strategy (ii) aligned with today’s markets’ dynamics in healthcare and (iii) also leveraging insights of modern data points like social media, primary and secondary research.

2. build an outsourced system including (i) automated data loading capabilities with extensive quality assurance procedures, (ii) a flexible repository able to adjust structured and unstructured information, (iii) reporting capabilities sufficient to serve strategic, managerial and commercial requirements of top 15 countries, 10 key brands and 3 organizational levels (country, region, global).

Client – a new global franchise at top pharma – had two challenges: (1) the broad scope of therapeutic areas and (2) pilot of a new drug development model. This new model unified within the franchise two historically separated functions: commercial operations and drug development (very diverse groups in terms of objective, processes, measurements).

The leadership saw the urgent need for aligning the team around a common vision for the franchise.

An innovative workshop methodology emerged as an appropriate way to achieve the objectives of refining and sharing a common vision, strengthen the team’s affiliation and embracing a unified working approach.

Three weeks intensive preparation were focusing on setting the stage around six key areas consolidated in a “Factbook” for all the stakeholders.

A three days' workshop session with 150 participants took place in Berlin with the overall objective to:

• Get a common understanding of vision and strategy

• Share best practices along core business processes

• Create ideas to enable effective and efficient team work

• Develop plans to meet next five years objectives and gain commitment for implementation.

Outcome of the session were 15 initiatives in areas like e.g. market roundtables, resource allocation, value chain analysis.

Client’s Global Commercialization leader (top global pharma) were appointed to implement Key Account Management globally. Program initiation proposed and executed within 2 months and including:

• Initial SWOT analysis for KAM program's needs and situation.

• Shared lessons learned about successful implementations of KAM programs in other industries.

• Discussion of first ideas about the transformation strategy and identification of program's deliverables.

• Held series of workshops, to highlight the complexity inherent to the KAM program as well as need to create further alignment between members of the Global Commercialization team and HR team for appropriate program's set-up.

• Alignment of the project team and sound preparation of program set-up to achieve required transformation.

• Extensive preparation for Steering Committee meeting during which decisions about the program was taken.

• Challenge current client thinking and draft program plan, work-streams, budget, team composition and implementation roadmap.

• Preparation of an RFP to select program's consulting partner.

For business intelligence purposes, client (top pharma) aimed to leverage all available information around the business generated with Institutional Customers in Asia, Pacific, North Africa and Middle East.

Supported client in developing the Business Case for Institutional Sales during two months by:

• Analyzing the data requirements of 42 countries

• Determining the report requirements, while advising based on IMS best practices

• Identifying the gaps comparing with the today’s situation (data, reports and processes), especially regarding competitive intelligence at country level (e.g. tenders)

• Summarizing expected benefits for client

• Quantifying resources required for the implementation (roadmap, deliverables, timeframe, team composition, costs).

All deliverables populated the Business Case.

Client (top pharma) selected Germany to run a Proof of Concept (PoC) for using Google technologies (adwords, adsense) with eMarketing campaigns on hypertension.

PoC intentions were to:

• Prove or disprove the hypothesis that incremental online activity drives incremental sales

• Test and learn how to use online activities to influence Rx sales

• Show evidence for top-line impact as incremental sales

• Deliver initial ROI calculation and recommendations.

Supporting the global implementation of a Key Account Management (KAM) structure at a top pharma, project’s objective were to determine, define and implement Key Performance Indicators (KPIs) aligned with both company strategy and market requirements. The emphasis was on unequivocally demonstrating progress at key account level, while allowing KAM teams learning and sharing of best practice.

The engagement included:

• Identification of globally aligned, measurable KPIs essential to foster and manage client’s key accounts business (business- and aspirational-KPIs)

• Detailed KPI definitions considering all necessary data sources and their integration & harmonization

• Key communication instruments and processes to deploy the KAM KPIs

• A dashboard prototype.

Overall client's objective: achieve substantial efficiency gains in managing global market definitions, while lowering operational costs and at the same time increasing information quality.

Client (top pharma) appointed our team to take over Business Rules Management and Market Data Warehouse operations from an offshore vendor in order to increase cost savings, simplify system landscape and increase data process speed & reliability.

The team transitioned and run current operations. In parallel, an off-premises-hosted new Business Rules Management solution and Market Data Warehouse were built along with streamlined service processes.

The program saved CHF 750k p.a. from the implementation year and beyond. All system components have been re-designed, Business Rules have been cleaned and streamlined, which allowed the data management processes to run within 30 min. instead of 2 days. Properly documented, stable solution in place, which has business rules versioned and is auditable. Extensive manual processes were automated, while increasing reliability of results and output quality.

Following numerous successful presentations to senior stakeholders (business, finance and IT), client (top pharma) agreed to start five simultaneous pilots to build the business case in using GOOGLE Enterprise Search.

Selected areas and related pilot projects’ work:

• global talent management – search for unique skills across 10+ different HR systems; pre-select candidates for a specific leading position; present an easy-to-use report for final decision

• medical call center – based on call center request, access a large number of internal and external systems to collect information on e.g. adverse event, drug interactions, study results, publications, reimbursement rules, off-label use; consolidate finding into report for call center operator

• adverse event management – following registration of suspected adverse event, access a large number of internal and external systems to collect information on e.g. drug’s ingredients, pre-clinical and clinical studies, publications, drug interactions, marketing and educational materials; consolidate findings in report for adverse event verification committee

• animal health marketing – collection, catalog, categorization and organization of all animal health marketing materials; present an easy-to-find, intuitive platform to search and retrieve marketing artifacts

• retail partnership – connect client’s relevant systems with retail partner’s point of sales systems to allow direct verification of inventory status.

Client’s unit supports the research organization in the drug discovery process across various disease areas by providing discovery technology platforms of highest standards, in alignment with the overall research strategy. While experiencing increasing challenges from the enormous amount of information generated in research, key question was how to make sure that all information can be leveraged throughout their daily work and no opportunities is overseen. The initiative was fueled by:

• the need to continuously understand changing customer service and information requirements, future trends and how they can be met based on new technology standards

• the pressure on work performance and efficiency regarding internal processes and organizational units

• the requested realignment of strategic roadmap with expected changes in customer requirements (business strategy), new technologies, changing external environment and scientific insights. 

Several workshops and meetings disclosed the need for an intelligent and differentiated three-step-approach that addresses a thorough Alignment of unit’s

• strategy and vision,

• customer and employee requirements, and

• supporting infrastructure through internal informatics group.

The phased approach resulted in a successful implementation, while achieving the following objectives:

• transparency regarding globally existing information sources

• automatic integration of available information sources into the research processes

• substantial increase of the ability to leverage all potential opportunities (lead generation).

Within the frame of a vendor selection for mobility services, client (top pharma company) was looking for benchmarking figures to populate the Request for Information (RFI) and Request for Proposal (RFP). Unfortunately, comparable, specific, well-structured industry figures around mobility service provision are not available, therefore a specific benchmarking method was applied.

In a three-phases approach the team addressed the situation delivering benchmark results perfectly fitting client’s requirements. Key activities of the project team were:

• coach the client’s team in identifying most useful benchmark figures for the scope

• identification of the best fitting companies to include in the benchmarking initiative

• selected and motivated companies’ contact persons to participate and commit to deliver information

• negotiate confidentiality areas

• preparation of questionnaires

• collection, documentation and consolidation of benchmarking figures

• management presentation of benchmark results

• distribution of anonymized results to the participating companies

• support for RFI and RFP process.

Aiming to review internal protein production performance against other companies, client (top pharma research company) was looking for detailed benchmarking figures. Unfortunately, comparable, specific, well-structured industry figures around protein production are not public available, therefore a specific benchmarking method was applied. While the methodology was very similar to the one used in the project “Benchmark for Mobility Services” described above, the following benchmark parameters required by the client were of special interest:

• general outline of process for the production of purified and quality-controlled proteins

• internal and external services involved in the protein production process

• number of successfully completed customer requests versus desired time lines in %

• success rate in meeting the expected delivery date of purified and quality-controlled proteins versus customer expectation

• protein preparation process timelines

• protein expression systems used in-house

• protein preparation operations headcount distribution and headcount distribution per expertise

• productivity versus success rate and to staff category

• total cost distribution of protein production operation

• successfully delivered proteins in relation to costs and staff.

Challenged by diverse data privacy rules in different countries, client required support in establishing data compliance in the area of CRM across all European affiliates:

 • Due to lack of documentation on real data database contents, client expected that some data privacy compliance issues

    were internally known, but others possibly existed​

 • Commercial Operations aimed to ensure alignment to EU regulations, but data compliance skills were not within client’s

    internal capabilities

 • Possibility of upcoming regulatory audit following changes in some information management systems was pressing to

    manage eventual risks.

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Therefore, a third party review of data privacy were desired.

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The project team assessed seven aspects for their effect on the outcome:

 • External Constrains: level of understanding of external regulations and their integration into company policies

 • Organization: how managers, employees and data management were approaching data privacy based on guidelines

    and policies

 • Geography: how global policies and country specific requirements are understood and applied

 • Systems and Tools: whether system related data, input methods or specific information sources are root cause

    for issues

 • Technology: extent of existing system configuration dedicated to enforce policies and regulations

 • Data: eventual not compliant data already being stored

 • Business Processes: level of alignment between business processes and policies & regulations.

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With an approach combining top-down (from the information assets upwards) and bottom-up (from relevant policies downwards), the team documented the status-quo within four weeks, while exactly identifying all issue areas.

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The remediation initiative were then both correcting root causes, fixing impacted data and delivering the evidence of data privacy compliance.

Client (drug development organization of a top pharma) required support, coach, mentoring and advice for the internal QRM project team. The QRM project focused on proactively identifying and mitigating risks to Patient Safety and Clinical Data Integrity for studies conducted by the client and in cooperation with Quintiles and Covance.  Project’s scope covered all areas related to Patient Safety and Clinical Data integrity relevant for the US FDA GCP (Good Clinical Practice) regulations and guidelines, and leveraged contemporary Failure Modes, Effects and Criticality Analysis (FMECA) concepts.  The scope excluded clinical trial sample material manufacturing, packaging and labeling but included sample quantity reconciliation.

An Information Management Review was conducted delivering recommendations for solutions, process and organisational change, together with a value-case and roadmap for moving forwards.

A review with three work packages – people and process, technology and compliance – was used to:

• understand background to requirements and issues by meeting key business and IT stakeholders

• understand details of the requirements and issues by assessing the current situation and status and interviewing representatives within the appropriate departments at key sites (Switzerland, UK, and US)

• analyse findings, prepare report and present potential options, recommendations and agree on next steps.

Work Package 1: A rapid, focused Information Management Review of current status and ongoing plans for the QRM project formed the basis of the Mentoring & Facilitation approach for the system implementation phase. This review allowed effective on boarding and immersion of the supporting team and enabled the establishment of a thorough risk assessment and continuous improvement baseline.

Work Package 2: The mentoring and facilitation work was designed and agreed with client. The comprehensive risk assessment and continuous improvement approach (called the “QRM Change Incubator”) was established during this phase.

Work Package 3: Translation of the “Ideal” Roadmap into a “Real” Roadmap based upon readiness of the organization, people & processes, technology and compliance. External support, mentoring and facilitation work was performed and the QRM project was able to proceed in the most efficient and low risk manner. Thanks to the QRM Change Incubator, the external and internal factors affecting the project were continuously monitored, including full on boarding of partners.

Expecting a FDA inspection in one of the countries of operation, client (top pharmaceutical) required to conduct a computer system validation (CSV) compliance assessment towards FDA’s Code of Federal Regulation (CFR) part 210, 211, and 11 of its manufacturing operation in Switzerland covering the following business systems:

• The ERP-System SAP R/3 with the modules SD, MM, PP, PM

• LVS-system

• The MES-system (PK/PDKS)

• The LIMS-System (HP and Millennium from Waters)

• The technical infrastructure and systems

• The user and support organization.

The simulated inspection achieved the objectives to identify potential CSV compliance gaps, categorize those according to severity, present recommendations based on the above categories, and propose a high-level action plan for remediation.

Client (top pharma) requested to assess global process and service for electronic software distribution to improve internal customer satisfaction.

Process in scope was the one used by virtually every client’s employee to request IT applications; granted applications were then distributed via electronic installation.

Key element of this 8 months project were:

• Setup of Steering Committee with sponsors and roadmap for assessment and implementation activities

• Assessment of current issues with surveys of up to 800 users and 40 key stakeholders.

Resulting 18 work packages to improve service, organization and processes included:

• Process re-engineering and documentation

• Revision of organizational setup defining roles & responsibilities

• Revision of service descriptions

• Providing service and process MIS concept

• Training decks for all involved roles.