Solutions Gallery
by Objective

Strategic resources to help analyse and assess the evidence to bring local management teams up to speed quickly and supply evidential insights to best inform market access decision making.

Mitigating evidentiary issues arising from the potential impact of government initiatives such as post- market reviews of Pharmaceutical Bene its, product cancellations and re- scheduling of products.

Supporting companies with full product development projects such as systematic reviews or HTAs in support of a new market initiative on commercial opportunities for their established product portfolio currently not realised.

Reviews informed by market research to determine market potential and economic viability of these types of projects:

• – Product in-licensing,

• – Product registrations,

• – Funding applications,

• – Rescheduling applications,

• – White papers.

Facilitation of multi- disciplinary /department brand teams discussions to work through strategic issues and challenges.

Meta-Works has an enviable track record in salvaging applications through full therapeutic category literature reviews and statistical analyses to provide new evidence and insights into current best treatment practices and patient management care options.

High risk and complex projects integrating cutting-edge analysis, communications and evidential education, supported with the most robust and relevant evidence. Examples include, Advertising to consumers, removal of black box label warnings, collateral to boost sales force effectiveness in dealing with distribution channels.

We work on complex industry problems with much of our activity concerned with drug pricing related issues. We also support research on the economic contribution of the industry through Socio- Economic Footprint studies etc. to have a better understanding of their impact and more accurately guide policy-making.

These studies establish how an area of activity contributes to the whole of economy effects – including GDP and employment – using methodological frameworks that are widely recognised and requested by public sector and Trade Association stakeholders. During these assignments Meta-Works deliver recommendations, studies, assessments, strategies and a final report that supports the client’s communications priorities and goals with holistic cost-effective data-driven methodologies.

Pre-qualifying value through confirming; Existing pre-clinical and clinical data, scientific publications, likelihood of full regulatory approval, Achievable strategy to seek reimbursement in key markets, Robust clinical trial program to secure evidence supporting application, plus Key Opinion Leader (KOL) support, Clear milestones and deliverables for the program demonstrating success.

Vocational and tertiary programs to help Industry become fluent in using evidence in shaping and delivering brand strategies and stakeholder messaging. Effectively further penetrating market verticals. Our programs are globally recognized award- winning qualifications, delivered through blended and advanced distance learning technology from one of the world’s top accreditation organisations.

Regulatory Affairs consulting supporting Product In-licensing, Product registrations, Product line extensions and major variations, Literature-based submissions and feasibility assessments. Prescription (NCEs and Biosimilars), Biotech, and Generic medicine registration, OTC and Medical Device registration.

Leading rapid-cycle, integrated evidence generation across HEOR, RWE, Phase IIIb/IV, and all other data, supported by microanalysis such as HTAs and systematic reviews to tailor information to the needs of specific issues of therapeutic/ marketing importance.

Addressing the clinical and economic evidence on alternative courses of action for new (and existing) medicines versus standard of care from a healthcare system perspective supported by microanalysis such as systematic reviews and adaptation of CE and budget impact models.

• Ultra/Orphan drug applications and submissions.

• Global reviews of Orphan drug manufacturers’ incentives.

Mitigating evidentiary issues arising from the potential impact of government initiatives such as post- market reviews of Pharmaceutical Benefits, product cancellations and re- scheduling of products.

High risk and complex projects integrating cutting-edge analysis, communications and evidential education, supported with the most robust and relevant evidence. Examples include, Advertising to consumers, removal of black box label warnings, collateral to boost sales force effectiveness in dealing with distribution channels.

Proven track record delivering high value and high-risk projects including: Advertising to consumers, Removal of black box label warnings, Reclassifications, Collateral to boost sales force effectiveness in dealing with distribution channels.

When you have deficient or complex data that is limited in its marketing application. MW has a long successful history in working with heterogeneous datasets integrating RWE and efficacy trials.

Such as industry code challenges/defences or regulator responses that may require high level expertise.

Scoping and Rapid systematic review on areas of commercial enquiry such as expanded indications, licensing reviews, new data to motivate stakeholders (Drs, Reps), value assessments, bibliographic submissions, government initiatives. Delivering the Body of Evidence (BOE) towards your research and planning.

Meta-Works has an enviable track record in salvaging applications through full therapeutic category literature reviews and statistical analyses to provide new evidence and insights into current best treatment practices and patient management care options.