Insight Pharma

New Product Strategy

With new drug molecules approval drying up and stricter regulatory norms, innovator companies as well generic companies are facing difficulty to fill up their pipeline with enough products to meet their target. Innovator companies face high stakeholder expectations, numerous market-access hurdles, and stiff competition, all of which are made more formidable by the business realities of the industry: pipelines are boasting fewer promising candidates than they did only a few years ago, and many are not true breakthroughs. As new molecules pipelines are thinner and blockbusters are fewer, pipeline of generic companies are also drying up.

A balanced pipeline of products in a pharmaceutical company to meet the expectation of future growth is the need of the hour. IBRSoluTions provides new product strategy for both innovator and generic companies to fill up their product pipeline with other means of innovation and new products.

IBRSoluTions provides the following New Product Strategy Services:

New Product Strategy Services
  • Drug Repositioning Solutions

  • Identification of New Products

  • Generic Product Selection

  • API Product Pipeline

  • Para IV & Niche Product Opportunities

Drug Repositioning Solutions

  • IBRSoluTions play a critical role in identifying novel uses for drugs that span the therapeutic pipeline. Data from public resources, compound screening databases, internal proprietary data of the pharmaceuticals and clinical trial information play an important role in the success of drug repositioning. We bring together a best-in-class service line that serves various needs in this niche.

    Review of existing literature with an eye toward new drug combinations or diseases indications
    Data integration of disparate sources with disease and drug information to identify newer associations
    Develop network models of biological and pathological conditions to elucidate new useful compound intervention points ( key proteins nodes that play role in disease)
    Profiling of side effects due to off-target action of marketed drugs to determine the likelihood of them acting on the same target molecule and identification of novel potential therapeutic applications.
    Capabilities in patent curation enables to understand IP issues relating to new use of known drugs

Identification of New Products

  • New drug development is a challenging way to make a profit. Drug manufacturers are often racing against the clock and each other, to obtain approval for and bring new drug products to the market. So developing new drug products without having to conduct the full complement safety and efficacy trials, which is often the most time-consuming and expensive part of the drug development process, is a potentially appealing regulatory pathway for many manufacturers. Identification of new products for which the drug manufacturer can rely on the already approved drug molecule’s safety and efficacy date is need of the hour which reduces the requirement for amount of clinical data, risk of failure and time to develop and approval.

    IBRSoluTions provides new product identification service helping companies to identify new dosage forms, strengths, route of administration, substitution of an active ingredient in a combination product, formulation, dosing regimen, combination product, indication, Rx/OTC monograph, new salts and esters, new polymorphs, for existing product.

Generic Product Selection

  • The competition to be the first generic on the market after patent expiry is fierce. Achieving that coveted number one slot is preceded by many years of development work and negotiation with regulatory authorities, and also involves an intricate journey through the complicated patent network. Generic-drug industry has its own set of challenges and opportunities even after patent expiration. Generic-drug companies face increased competition not only within the sector, but from newer entrants, including from the pharmaceutical majors and emerging-market players.

    A balanced product portfolio according to the capability of a generic company is the need of the hour. IBRSoluTions provides generic product selection services to generic companies helping them to build a robust product pipeline. We help companies from identification of generic product for selection till a balanced product pipeline which will achieve the present and future goal of the company. We provide product identification, evaluation, selection, and product portfolio management services to all size of pharmaceutical generic companies

API Product Pipeline

  • The Active Pharmaceutical Ingredient (API) market is very competitive with many producers but at the same time API production is a highly sophisticated, technically demanding chemical and biochemical fermentation and/or synthesis process. With so many API producers, API manufacturers have to be specialized and target their manufacturing based on a combination of the market opportunities and firm skills. When factors such as the increasing incidence of life style and age related diseases, increasing prevalence of cancer and HIV across the world, technological advancements in the APIs Manufacturing, and increasing scope for highly potent active ingredients are driving market growth, stringent regulatory requirements and global economic recession may restrict market growth of the API manufacturers.

    IBRSoluTions provides consulting services helping API manufacturers to build a strong product pipeline for sustained growth. We take into consideration of various factors when selecting any molecule for development like competition, patent expirations, complex manufacturing, gaps in the patent coverage, major program drugs and generic bulk drugs etc. along with company’s capability and risk taking ability.

Para IV & Niche Product Opportunities

  • Differentiation is one of the rudiments that success thrives on and the company strategically selects difficult to develop, patent protected, high technology products and niche markets to get ANDA approvals. Paragraph IV challenges needs scientific and legal expertise to prepare non-infringing formulation while niche generics is targeted on developing those generic drug products that are difficult to develop for technical reasons, very limited API source, high value but low volume products .

    IBRSoluTions provides consulting services helping generic companies to identify Para IV / Niche Product Opportunities. We help to identify products which involve higher level of technology and complexity and patent protection but eventually face less competition and command relatively higher value. We recommend products depending on the company’s existing technology capability and risk taking ability. We help companies create a more differentiated and sustained portfolio to enhance present and future offerings.

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