White Paper - phamax

Ad-boards

Collective consensus – by engaging stakeholders in deliberative discussions, integrating ideas from structured dialogues, and with sustained stakeholder engagement processes – can pave the way to better solutions.

The phamax ad-board services provide independent strategic advice to steer companies on the right track and define the best development path for products. phamax addresses multifaceted challenges by tailoring its associations as per each organization’s objectives, market and culture by merging best research practices with hands-on support from its experts.

The phamax ad-board services develop an advisory board, expert group or panel as per the needs of its massive stakeholder network to guide in the development phase, therapeutic area, regulatory review preparation etc. The services:

Engage stakeholders before and after meetings for more customer touchpoints
Envision an orchestrated, cross-country approach with expert group members from various countries
Perform end-to-end project management with preparations, meetings and stakeholder management
Facilitate both qualitative and focus group discussion meetings, and promote peer-to-peer stakeholder engagement
Represent the working team as an external voice
Handle both client and stakeholder communications

Guidance on clinical trial protocols
Guidance on unmet medical needs to drive future clinical strategies
Actionable deliverables to foster positive relationships with prominent scientific community members
Relevant and reliable educational and promotional content

Competitive Intelligence

We transform disaggregated information on markets and competitors into actionable insights. We combine secondary and primary research to derive information as per project objectives and scope. Our team continuously tracks the key parameters, provides regular updates (monthly/quarterly/half-yearly), develops key intelligence questions, and builds customized reports to meet specific requirements.

Sustained competitive advantage and growth
Strengths/Weaknesses of key competitor products to define the market or product strategies
Continuous insights on opportunities and threats
New technologies for business models

phamax’s structured and comprehensive CI package supports pharma companies in effective strategic, tactical and operational decisions to:

Track competition – who they are, what they do, how they think, where they want to be, and their strengths and weakness
Anticipate environmental changes, emerging threats, and opportunities in time to respond strategically
Uncover the latest trends driving the pharmaceutical industry
Profile various publicly available data sources for different types of information for easy and fast access
Develop reports with relevant information and update these regularly
Summarize financial facts
Our framework identifies relationships among various parameters and their impact on each other for vital insights

Pricing Analytics

We determine the optimal price range for products by assessing the relevant internal and external factors. We support pharmaceutical companies in effective pricing decisions using analytical modeling to decrypt the real-world complexities.

Our price mapping services:

Validate a product’s price based on its clinical profile, PLC stage, competitive landscape, and performance
Identify a product’s optimal price range by benchmarking against suitable historical analogs
Develop a market reference map based on the processes and regulations impacting the pricing decisions
Build a referencing model to quantify the impact of price changes elsewhere and adapt accordingly

Insights for the ideal product price in the market
Unambiguous pricing decisions by assessing external events
Maximized commercial success by optimizing a product’s geographic launch sequence

HEOR

Health technology assessments (HTA) to reimburse a new health technology typically encompass an economic analysis. Pharmaceutical manufacturers must demonstrate the clinical and economic evidences of products to gain market access and remain competitive. Economic evidence is often generated by evaluating both costs and outcomes to prove the efficiency of a product. phamax HEOR services generate relevant evidence for products to communicate their value to stakeholders.

phamax HEOR services include:

Systematic literature reviews and meta-analysis: Our systematic literature review services answer all the important questions on efficacy, safety, quality of life and resource use. We follow the PRISMA guidelines and work with clients to define the scope of project, submit the protocol, identify databases, and shortlist articles. We critically appraise relevant research and analyse data from studies to answer the clients’ research questions and also perform meta-analysis, when required
Patient Reported Outcomes (PRO)

phamax PRO studies provide unique insights into how a therapy can affect a patient. We design studies that enable clients to capture patient perspectives on a disease/treatment under different scenarios – clinical (e.g. cure, survival), humanistic (e.g. role performance, emotional status) and economical (e.g. expenses, saving)

Economic evaluations:

Cost-effectiveness analysis (CEA)
Cost-utility analysis (CUA)
Budget-impact analysis (BIA)
Burden of disease or Illness/Economic impact analysis

Our models estimate the costs and outcomes of interventions, and compare different interventions impacting the same health effects (usually measured as life years gained) and different health effects (usually measured as utility-based outcome units (QALYs)). HEOR models for economic evaluations are the new normal for favourable reimbursement decisions. Our services demonstrate the cost effectiveness of product vs. the competition to support reimbursement submissions and highlight the incremental effectiveness of products at multiple price points.

Synthesis of systematically-derived data for clinical and economic analyses
Support reimbursement decisions by evaluating the clinical and economic impact of products
Understand the impact of technologies in a real-life context and comprehend the needs and preferences of patients
Understand the quality of life aspects and measure the burden of the disease by incorporating all the costs associated with the disease/intervention
Evaluate the long-term effects (length and quality of life) of an intervention on health outcomes and ease the comparison of costs and outcomes of different interventions
Determine the impact of implementing or adopting a particular technology on a designated budget

Whitepaper

The phamax white paper services generate authoritative and compelling reports for information on complex issues in therapeutic areas of focus. phamax generates credible information by combining expert knowledge and research to share relevant information on customers, potential customer bases and the latest industry trends.

phamax offers unparalleled commitment and quality to develop influential vantage point white papers which garner useful information about new products, markets or ways to re-hash obsolete data. We empower companies with the confidence to broadcast their products and solutions worldwide with the trustworthy information we create.

Our white paper services use:

Extensive experience in research
An envious panel of doctors doing primary and secondary research

Generate leads, build mindshare and open doors to new sales opportunities
Showcase expertise and build brand image
Educate the audience on newer perspectives in the industry

Key Account Management

phamax reviews the existing KAM structure and analyses the account-level data for robustness/integrity to identify the gaps, provide appropriate solutions based on customer needs and develop KAM as a mind-set. We help our clients in developing the best-in- class strategy, customized account-level services, optimal KAM team structure and thereby increased ROIs.

Our KAM framework utilizes:

Qualitative research to design the KAM working details, local KAM principles and guidelines, KAM vision, objectives, roles and responsibilities in collaboration with the client team
Quantitative research to review the current account segmentation, KAM team workload and performance

We develop a prioritized list of recommendations and a corresponding action plan based on the qualitative and quantitative research.

Understand the account potential, current penetration levels and value proposition
Prioritize the list of target accounts (e.g. tier 1, 2 and 3)
Optimal KAM team structure
Individual account value chain
Track account performances and relative moments (e.g. on the 3×3 grid)
Manage the challenges effectively while implementing the KAM strategy

Scientific Platform Development

The phamax scientific platform communicates a single vision for goals across multiple channels and stakeholders. phamax is a recognized leader in scientific communication platforms. We have presented original research, given invited presentations and conducted workshops at various scientific meetings. Our teams are extensively experienced in developing scientific platforms for almost any situation for de novo and top pharmaceutical companies.

Engage the relevant external stakeholders and leverage the ‘loyalists and enthusiasts’
Identify the engagement models to:

Address the gaps and resolve the issues due to unmet needs
Position organizations as the champions for change
Empower external stakeholders

Identify the potential scope for activities to:

Identify the potential opportunities/challenges (immediate and long-term)
Internally align for ‘quick responses’

Develop pragmatic action plans to realize benefits and:

Chalk out activity roadmaps
Institutionalize adherence to the activity roadmaps

Identify the feedback channels to:

Continually engage regional stakeholders
Provide opportunities to collaborate

Identify the continued outreach opportunities to facilitate:

Sustained engagement with the relevant stakeholders
Continued knowledge and experience dissemination
Plans to stay ahead of the competition

Understand the existing prescribing trends, unmet needs, and potential markets for products
Explore related health economic benefits
Continued professional development
Develop guidelines and management protocols/manuals
Enable and support decisions
Generate data wealth from the real world
Understand the target segments and geographic scopes
Leverage the existing resources, estimate the resources required and plan effective resource utilization

Sustain and implement the best protocols and guidelines in routine practice

Patient Chart Review

The phamax real-world evidence solutions empower the RWE strategies of companies with a deeper understanding of therapeutic landscapes and market-shaping dynamics. The phamax patient chart review services give pharmaceutical companies advanced inputs on the existing standards of care, healthcare resource utilization and patient-reported outcomes.

The phamax RWE division provides supporting evidence for a broad range of therapeutic areas. The phamax chart review services are widely applied in many healthcare-based disciplines such as epidemiology, quality assessment, professional education and residency training, inpatient care and clinical research.

Our patient chart review services use:

Subject matter experts to deliver unique, intelligent RWE strategies to increase clinical research efficiencies
In-house statistical teams to enhance value stories and provide compelling evidence
Rich in-house capabilities to review and understand product and disease dynamics

Transform complex transactional data into insights for drug utilization, prescribing trends, cost-of-care trends and health outcomes
Determine market niches, product usage dynamics and untapped marketing opportunities
Gain real-time insights for informed business decisions to:

Identify gaps in care
Stratify patient risks
Engage stakeholders
Create physician-patient interfaces
Manage supply chains
Extract hidden evidence

Gain valuable information for direct subsequent prospective studies

Patient Journey Modelling

Discover the unattended patient segments and access untapped markets by visualizing patient movements. Understand treatment perceptions and physician preferences via the phamax patient journey models.

The phamax patient journey offering is a proven, proprietary and solution-oriented three-pronged approach tested and validated across multiple therapy areas and companies.

A – Analyze the real-world scenarios to develop a detailed patient journey to identify hidden patient segments and barriers to access /growth drivers

E– Review the drivers and barriers with all the stakeholders to successfully expand to new segments. Prioritize the segments and develop an action plan

A – Unlock growth potential by strategically implementing the business plan at the local levels with insights from the patient journey

Unlock growth opportunities with access to unattended patients
Paradigm shift in marketing resource allocation and deployment
Greater commercialization impact through targeted approaches
Develop robust brand plans

Entry and Expansion Strategy

Make the critical decision of ‘launch or license’ with our entry and expansion support. Our team supports all pharmaceutical commercialization activities – shaping your market entry or expansion strategies with relevant market insights or launching your products in new markets. The phamax comprehensive commercial model evaluation approach helps you formulate robust market entry strategies.

Our local team of experts not only design but implement the strategies. The phamax range of services include:

Market attractiveness: Assess the market size and growth, and understand the market evolution with the drivers and barriers
Market access landscape: Identify the relevant pricing and reimbursement scenarios
Product potential assessment: Forecast the product sales in different scenarios
Commercial model evaluation: Develop the commercial models for own launches (in-house vs outsourced functions), out-licenses, co-promotions, co-marketing or complete divestments

Focused and targeted strategies to optimize resources
Realistic view of markets and product potential
Solutions for local market access challenges
Flexibility to choose the best-fit commercial models
Execution speed with minimal risks

Forecasting

Foresee market evolutions and product opportunities with the phamax forecasting services. Plan your business better by predicting overall revenues, understanding physician preferences and comprehending relevant market trends with our robust forecast models.

The phamax suite of forecasting services is either custom built as per your needs or comes in a ready-to-use format.

Our forecasting services use:

Rich inhouse capabilities to review and understand disease dynamics
Credible sources and well-documented assumptions
Inhouse uptake curves developed over a decade with 80+ launches
A flexible approach to adapt to the account/country/region/global levels
Multiple statistical techniques – Regression, ARIMA, ARMA, moving averages and simulation

Realistic view of the market and product potential
Clearer view of the impacts of changing market environments
Flexibility to choose the right one from multiple scenarios
Quantify future risks
Investment decisions to maximize product growth prospects

Regulatory Assessment

Our services help companies manage risks and unlock value by engaging effectively with regulators, policymakers, and other external stakeholders. phamax assesses commercial, clinical and market-specific regulatory factors for crucial insights on market dynamics and evolution vital to address payer expectations and secure favorable reimbursement status.

The phamax regulatory assessment uses three customizable dimensions:

Research to answer key intelligence questions (KIQs)
Collaboration with local regulatory stakeholders to address information gaps
The phamax scientific network to refine the insights

We simplify reporting processes, making regulatory filings less demanding. We provide country-specific regulatory landscape reports using the phamax scientific network with inputs from the local regulatory systems and stakeholders. Our solutions help companies comply with the local, regional and global regulatory requirements impacting products.

The phamax regulatory services:

Identify the regulatory requirements, and the market and customer drivers
Develop regulatory strategies and submissions
Help to implement compliance assurance processes
Provide direct access to on-call consulting support
Provide regulatory and research Q&A style support
Provide real-time information change notices (ICNs) on important changes
Substantiate waiver requests and read-across arguments
Provide product safety and efficacy evaluations
Provide third-party technical liaisons

– Understand the regulatory landscape to answer the KIQs on:

Pricing systems
Pricing and reimbursement processes
Roles and responsibilities of regulatory authorities
Recent case studies
Health economic evidence
Accessibility and affordability

– The realistic view of the market and product potential as per the core regulatory assessment principles
– Understand the impact of the changing market environment on the ever-changing regulatory guidelines
– Choose the right scenario from multiple options

Epidemiology Assessment

Epidemiological assessment identifies the relations between the needs and demands in the expansion of pharmaceutical and biological products. The phamax epidemiology assessment services help understand the market potential and identify the target patient segments. phamax develops an in-depth understanding of the disease landscape with scientifically-validated epidemiological analysis and forecast models.

phamax does an in-depth epidemiological analysis of therapeutic areas with primary and secondary research, real-world data and therapy-area expertise. Our scientific team includes experienced pharmaco-epidemiologists, physicians and biostatisticians. The team brings a broad range of scientific and operational experience while building forecasting models to accurately predict various epidemiological parameters such as incidence, prevalence, mortality, diagnosed population, treatment population, disease staging, risk-factors, related costs and medical management by age groups and sex. Our transparent and validated forecast models evaluating epidemiological transition and geographical extrapolation benefit global coverage.

The phamax epidemiological assessment services include:

Burden illness analysis
Disease prevalence and incidence analysis
Retrospective patient chart reviews
Longitudinal medical event database analysis
Medical chart abstraction
Pharma economic modeling
Survey research (patient and physician reviews)
Systematic literature reviews
Targeted literature reviews
Clinical practices
Patient pathways
Patient segmentation
Assessment of unmet needs
Disease-specific databases

Understand the complete disease landscape and global market sizes with real-world data
Benchmark forecasts with the total potential and addressable market data
Identify the growth opportunities and understand how populations change over time
Estimate the drug-treated populations with additional insights from therapeutic experts and primary market research

Medical Writing

phamax offers scientific writing services across the entire clinical research spectrum and is an expert in publications and medical communications services for global clients across all geographies.

Our team comprises writers with advanced degrees in medicine and other branches of life sciences. We have published various scientific publications in esteemed international journals. We have a wide range of research and clinical experience in multiple therapeutic areas like cardiovascular, medical devices, endocrinology, gastroenterology, hematology, oncology, orthopedics, respiratory, rheumatology, and urology.

The phamax medical writing services include a wide range of scientific and medical documentation ranging from manuscript writing for various research studies to regulatory submissions and medical communications documents such as:

Concept notes
Risk management plans (RMPs)
Clinical study reports (phase I-IV)
Systematic reviews
Protocols and amendments
Investigator brochures and updates
Manuscripts
Abstracts, slides and poster presentations
Medical marketing texts
White papers
Regulatory policy-shaping presentations

Works independently yet collaboratively
Produces high-quality documents with exceptional clarity, accuracy, and consistency
Proactively maintains accurate writing and delivery timelines
Anticipates the potential regulatory and publishing roadblocks

Portofolio Assessment

We maximize returns from mature products by identifying the optimal resource allocation and portfolio strategy. We identify the most attractive products for strategic focus and less attractive products for divestment with our extensive experience and comprehensive framework.

Our portfolio evaluation services:

Unbiasedly assess the complete product portfolio in line with the overall company and franchise objectives
Holistically evaluate the portfolio based on the relative attractiveness of the product, company, and market
Clearly guide on the product-portfolio fit and optimal strategic options – invest, status quo and divest
Deploy our extensive experience of 50+ projects with proven commercial benefits

Higher RoI with lower portfolio costs, optimized investments, and increased profitability
A streamlined portfolio focused on the high potential products
Identify the opportunities from the global portfolio to strengthen the existing country portfolios
Higher returns from the low potential and non-strategic products via collaboration with suitable external partners

Market Assessment

phamax offers a 360⁰ view of the competitor landscape with clinical, commercial and market access evaluations including, but not limited to, market drivers, existing and future therapies, unmet needs, disease burdens, and product potential. The phamax framework integrates clinical and commercial outputs to provide an in-depth understanding of market opportunities.

phamax offers a structured approach to understand and define the market opportunities as per needs:

The analysis of clinical factors for:

Disease outlooks
Epidemiology trends
Treatment patterns
Economic burden

The analysis of market factors for:

Market potential
Key market segments
Competition
Pricing and reimbursement
Market dynamics
Customer analysis

Our in-house clinical and commercial teams collect the data from reliable sources and rapidly analyze it for market insights and our investigative approach offers complete market/product assessments and capitalizes on the future opportunities for product development

A clear understanding of the markets and their drivers
Refined R&D strategies to focus on future market needs
Optimized R&D investments
Optimal resource utilization
A set of action points to leverage opportunities

Business Intelligence

Manage your business effectively with the phamax range of business intelligence services

Identify the KPIs for your business (Lead and Lag)
Collect, analyze and visualize the KPIs
Track the KPIs regularly for corrective actions

Our solution experts have extensive experience in designing, building and maintaining tailor-made dashboards. The highly flexible models adapt to your dynamic business needs and supply what you need, when you need it, the way you need it.

Easy and quick to update data
Real time data refresh
On-the-go access
Uniform view across users
Smart data visualizations
User-friendly navigation
Time savings as no need to communicate with others for data collection/update

KOL

phamax identifies KOLs via need assessment tools to offer customized solutions. Our robust approach identifies, prioritizes, segments and validates KOLs with in-depth secondary research. We combine qualitative and quantitative research as per various KOL activities – publications, congress presentations, clinical trials, guidelines, committees, editorial boards, company affiliations, regulatory bodies, associations and advocacy groups. We further profile the KOLs – demographics, memberships and roles in societies, abstracts of major publications, presentations and involvement in clinical trials.

phamax offers multiple KOL services:

Identification and profiling of KOLs/KEEs
Identification and profiling of rising stars
Influence mapping and network analysis of KOLs/KEEs
Progression analysis of KOLs/KEEs
Databases in MS Excel, MS Access and CRM applications

Our KOL services:

Deploy In-house physician teams for qualitative insights to identify and profile KOLs
Use different tools and advanced analytic techniques to gather data from publications, clinical trials and conferences
Have a robust methodology to rank the KOLs/KEEs as per needs
Do an exclusive name-matching analysis to identify unique physicians
Map global and local KOLs/KEEs as per their involvement in activities
Leverage flexible teams with rich experience in multiple therapeutic categories
Track activities and update the databases regularly
Comply to country regulations and guidelines

Effective product strategies by engaging the right KOLs
Brand marketing and promotional activities with the KOLs
New product research areas
Phase IV outcomes research
Ready-to to-use KOLs data which to saves time and cost

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Scientific Analytics : White Paper Development

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