Application of Artificial Intelligence in Drug R&D

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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

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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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Adapting to the Future: Mastering Change Management

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Change management is notoriously difficult. One of the reasons may be because the organizations are making the same errors all over again and they do not learn from good or bad experiences. I have seen the same pitfalls across the biopharmaceutical sector to various extent. The new executives coming in, big ideas are flashed out, and then everybody is asked to implement what they were told. The results: poor or just plain bad. Even if the initial implementation phases go pretty successfully, the sustainability of the change is usually short-lived.

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Simple Guide to Smarter Networking

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Overwhelmed by the virtual world of infinite connections, we should never forget that non-virtual social network is of crucial importance to your professional and personal development. The strategic partnerships you form throughout your life are going to benefit you at every level. It is clearly advantageous for anyone to be surrounded with people who inspire, support you but also challenge you and help you to grow. Continue reading →

The Entrepreneurial Quest: Unraveling the Path to True Entrepreneurship

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In today’s business landscape, the term “entrepreneurship” is often used loosely, sometimes diluting its genuine meaning. It is important to recognize that running a lemonade stand or similar small-scale ventures may fall under the realm of small business rather than true entrepreneurship. Similarly, working within a corporation may align more closely with the concept of being an intrapreneur. However, if you have a genuine interest in delving deeper into the world of entrepreneurship, I invite you to continue reading as I share valuable lessons learned from my GMP program at HBS. Together, we’ll explore the fundamental principles and insights that can pave the way to entrepreneurial success and fulfillment.

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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 →

The Missing Piece in Biotech Puzzle: Early Commercial Product Planning

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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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Strategies for Efficient Financial Planning and Control in Research and Development

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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 →

Bridging the Knowledge Gaps: The Impact of Incomplete New Product Planning on Biotech Companies

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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 →