A knowledge-based industry needs a knowledgeable partner
The Pharmaceutical industry is driven by information and evidence. All product and brand strategies are driven by information. It is no wonder why medical information is given so much importance in our industry. People who specialise in knowledge gathering, analysis, interpretation, presentation and communication are always sought after. Medical information teams generate key insights and learnings that can have a huge impact on the overall strategies of the organisation. They are also involved in key messages generation, analysis and fine tuning. Copy approval and ensuring that the claims of the competitors or the company are compliant, scientific and evidence based are their prime function. Answering difficult scientific questions, whether related to product or sometimes therapeutic area is their forte.
We can offer a huge range of background medical information services, like;
- Writing responses to medical information queries
- Global / Generic response documents
- Standard responses to common enquiries
- Copy review
- Claims substantiation
- Therapy area analysis
- Evidence generation
- Competitor literature analysis
- Claims optimisation
- Summarising clinical trials
- Writing data on file references
- Literature search
- Q & A documents
Are you caught up in a medical information conundrum? – we would love to help!
Want us to do a strategic landscaping of your competitor literature?
Baffled with the claims your competitors are making – we can check.
Case Studies
Case study 1
Case study 2
Case Study 1 title
Scenario
The client’s Medical Information department was overstretched and under-resourced due to staff shortages and a number of impending large-scale conferences. The client requested immediate assistance in managing their sizeable back-log of job bags requiring Medical Information review and in assisting with the Medical Information workflow until the role could be resourced internally
Our Solution
My Medical Department first reached out to the client’s Medical Information team to ascertain how best MMD could off-load the team. Working with this team, we determined where the resourcing gaps existed within the current infrastructure and which therapy areas it would be most advantageous for MMD take over. MMD collated a list of all materials requiring review within each key therapy area, then reached out to the Brand Managers and Medical Advisors to better establish scope.
Using the learnings from these activities, MMD developed a priority list of job bags requiring review, stratified using a number of factors including: time-to-event, stage of material development, complexity, risk, established therapy area expertise within the team and logistical factors surrounding each event.
MMD instituted a multi-faceted approach in order to re-establish control over the workflow.
Firstly, those job bags that were of highest priority and where the team already has established expertise were reviewed first.
Concurrently, team members were cross trained on the largest therapy areas through a combination of direct observation of a subject matter expert’s review, evaluation of evidence (pivotal papers, labels, established marketing materials and prevailing guidelines) and a validation process whereby trainees conducted independents review which were then assessed by the relevant subject matter expert.
Using these methods, the team were able to clear the client’s back-log of job bags, expedite onboarding of the review team and establish a clear process for the allocation of job bags, leveraging the newly established prioritization system and existing infrastructure that MMD had previously developed for the processing of the client’s Medical Signatory activities.
End Result
- The MMD team worked closely with the key stakeholders within the client’s organization to clearly define the problem through gap analysis, develop a process for the prioritization of job bags and to expeditiously off-load the Medical Information Team, whilst maintaining the client’s high review standards.
- The team were quickly able to onboard, clear the back-log and optimize the workflow
- Having all materials requiring Medical Information review processed quickly and with a high degree of quality enabled subsequent design changes, compliance reviews, sign-off and activity logistics to be proceed smoothly and with an excellent margin with respect to the date of any associated events.
Case Study 2
Scenario
The client requested MMD’s assistance in mapping the therapeutic landscape for a key emerging class of Oncology medicines in order to support strategic decision-making concerning further research and development of their novel molecule.
Our Solution
My Medical Department collated information into all currently-approved and pipeline products within class, in the APAC, EU and US environments. The landscape analysis included indications, regulatory status, line of therapy and reimbursement structure within each jurisdiction.
My Medical Department further conducted a literature review of relevant journal articles, systematic reviews and meta-analyses on this class of medicines as well as putative biomarkers and therapeutic space which had not yet been explored.
Finally, My Medical Department gathered details regarding all registered clinical trials across both already approved medications and studies within presumptive therapeutic targets and stratified these by clinical trial phase, indication, and product.
My Medical Department codified all data collected from these activities and developed a comprehensive report for the client outlining the current market size, pipeline therapies, potential market share, opportunities with respect to target indications and reimbursement environments and threats to achieving a successful market penetration strategy.
End Result
- The comprehensive therapeutic landscape analysis conducted by MMD provided the client with the tools needed to adequately assess the business opportunity and risks associated with further development of their molecule
- This empowered the client to make the difficult decision to cease R&D activities with respect to this molecule and to re-allocate the substantial resources that would have been spent on this endeavour on more promising pipeline molecules and in funding augmented marketing activities for marketed products