Application of Artificial Intelligence in Drug R&D

The drug R&D process is lengthy and expensive. The average cost of drug development is 2.6 billion USD and typically takes 10- 12 years, and can be broadly divided into four major stages:

  1. Target selection and validation.
  2. Compound screening and lead optimization.
  3. Preclinical studies.
  4. Clinical trials. 

Majority of pharmaceutical companies face challenges in their drug development programs because of increased costs and reduced effectiveness of their research laboratories. Many discovery efforts go down the drain because 9 out of 10 candidate therapies fail between phase I trials and commercial/regulatory approval.

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Blockchain Technology in the Biotech & Pharma

The application of blockchain technology in the biotech and pharma industry can increase collaboration, trust, traceability, and auditability in clinical trials by improving the processes’ consistency. Using a “network of networks” (blockchains vs. blockchain) could allow distinct sectors like life-science to use a single, interdependent system. Due to early promise, many companies started to assess the potential uses of blockchain technologies to help with counterfeit drugs, licensing, and technical knowledge sharing. However, the implementation of blockchain technologies in the life science sector is still in its infancy.

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Pharma Basics: Portfolio Management

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The pharmaceutical R&D portfolio is usually formed by combining several assets. It can include discovery, pre-clinical and development stage small molecules and biologics (Phase I-IV) or medical devices. Less mature biotech companies, usually own either single project or platform and there is not yet a real R&D portfolio to manage. Large pharma or biotech organizations have actual and sometimes complex portfolios with numerous projects at various stages of development. Decisions around portfolio such as selection of the drug candidates, portfolio prioritization, and optimization are the most critical areas driving a total shareholder value for the organization. The portfolio management is a dynamic process and methodologies used vary among companies. The size of the company and portfolio dictates the complexity and work intensity of the portfolio management. Relevant decisions are made according to a predetermined process and by evaluating multiple parameters. Some of the portfolio management components may be outsourced if there is a need for it. Final accountability for the portfolio decisions stays with the R&D executive team and board of directors. Continue reading

Phama Basics: Drug Development Plan

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Drug development can be described as the process of obtaining the relevant information necessary to be included in your drug prescribing information. Development Plan (DP) is the strategic document that guides the lifecycle of a new product from the pre-clinical lead compound stage through Lifecycle Management (LCM). LCM starts with the first approval of BLA/NDA (first Marketing Authorization) and encompasses development of new indications. In mature pharma organization, DP is approved by the governance bodies. Once approved, it can be regarded as the agreement between executive leadership/board of directors and the program team involved in the discovery, development & commercialization of the product. The DP is a living document and should be amended when the development strategy changes. Continue reading

Biotech’s Toughest Love

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Biotech companies are a critical element of the pharmaceutical business, delivering life-saving and quality-of-life improving medicines and medical devices to patients.  They can be considered a beating heart of innovation, filling up many of productivity and innovation gaps at pharmaceutical companies. A broad array of their novel products and discoveries brings hope for patients suffering from previously untreatable conditions and diseases. Small biotech organizations tend to operate with very few experts onboard, prioritizing clinical development and regulatory expenditures to reach their value creation goals: achieving proof-of-concept and obtaining regulatory approval. Historically, commercial aspects were not at the top of the biotech’s priorities. Now, more than ever, biotech needs to get commercial aspects of drug development right. Regulatory approval of the new drug is a significant milestone; however, without commercial/market access & pricing strategy in place, it may lead to a failure further down the road.

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Budget Management in R&D Projects

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Finance is a broad term describing the management of money and other valuables, which can be easily converted into cash to achieve economic objectives of the given organization. The usual structure of the financial department in large, mature pharmaceutical company includes Tax Group (scope: tax declarations & optimization, transfer pricing), Accounting (scope: external reporting, financial data management), Corporate Finance (scope: treasury & capital markets, M&A, investor relations), Controlling (scope: internal reporting, budgeting & planning, business valuation), plus potentially additional groups. Continue reading

Small Biopharma Pains

 

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Biotechnological and Pharmaceutical companies are usually very different entities. Biotech exists primarily for the innovation and discovery. Pharma companies mainly aim to develop, commercialize and sell their own or acquired products. Therefore, those two types of companies usually take on a very different business model. Continue reading

Know the Pharma Basics: USA Healthcare

 

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The United States (US) has a population of over 324 million people and one of the most complex healthcare systems in the world. US health care system is in a constant state of change. The United States spends the most on health care per person — $9,237 – according to two new papers published in the journal The Lancet ($3.2 trillion total in 2015). For comparison, the global spending on health in 2014 was US$9·21 trillion. Continue reading