The Initiation of A Pharmaceutical Drug Launch and Its Preparation within Enterprise Systems of Supply Chain

The Initiation of A Pharmaceutical Drug Launch and Its Preparation within Enterprise Systems of Supply Chain

Ulhas Desale

Bachelors in Mechanical Engineering, Supply chain Solutions Consultant, USA

Abstract This paper undertakes a sincere effort to elucidate the process of launching a drug in conjunction with the readiness of information systems and infrastructure subsequent to FDA approval. The drug development process assumes paramount importance as it furnishes the requisite insights for a proper market introduction of a drug [1]. Within the trajectory of drug development, the company and its researchers already envisage the prospective clientele for the drug. Crafting a persona for these potential customers will facilitate the marketing team in devising advertising strategies and campaigns subsequent to the successful formulation and FDA endorsement of the drug.

The integration of novel technologies and the presentation of precise clinical trial findings are enhancing the efficiency of the drug development process, concurrently elevating the likelihood of obtaining approval. The stages of product development encompass numerous IT applications, each endowed with distinct functionalities. These systems necessitate interconnectivity to enable seamless data processing, validations, and result analysis. Some systems operate at the site level, handling data recording and activities, while others operate at a corporate level, catering to drug reports and analytical requirements.

Objective: This study intends to empirically describe the process of pharmaceutical drug launch and its readiness in enterprise systems.

Keywords Life Sciences, pharmaceutical drugs, clinical trial, SAP, ERP,

INTRODUCTION

• Drug development is a comprehensive and intricate process that involves various stages and activities aimed at bringing a new pharmaceutical product from its initial conception to its availability in the market for medical use. It encompasses a series of rigorous scientific, regulatory, and commercial steps to ensure the safety, efficacy, and quality of the drug.

• The process typically begins with the identification of a medical need or a potential therapeutic target. This is followed by intensive research into the underlying biology of the disease or condition the drug aims to treat. Once a promising target is identified, researchers embark on the journey of discovering and designing molecules that can interact with the target in a way that produces a desired therapeutic effect.

• After this initial discovery phase, the selected molecules undergo preclinical testing in laboratory settings and animal models. This phase involves assessing the compound's safety profile, potential side effects, and initial efficacy. If the preclinical results are promising, the drug candidate advances to the clinical testing phase.

• Clinical testing is divided into three phases: Phase 1, Phase 2, and Phase 3 trials. Phase 1 trials involve a small number of healthy volunteers and focus on evaluating the drug's safety, dosage range, and potential side effects. Phase 2 trials involve a larger group of patients and further investigate the drug's efficacy and optimal dosage. Phase 3 trials, which are even larger and more extensive, provide additional data on safety and effectiveness and often involve a comparison with existing treatments or placebos.

• Upon successful completion of Phase 3 trials, the drug developer submits a New Drug Application (NDA) to the regulatory authorities, such as the U.S. Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. The regulatory agency reviews the submitted data to determine if the drug's benefits outweigh its risks. If the application is approved, the drug can then be marketed and distributed for medical use.

• Post-approval, the drug's safety and efficacy continue to be monitored through Phase 4 trials and pharmacovigilance efforts. These activities help to detect any rare or long-term side effects that might not have been apparent during earlier stages of testing.

• Overall, drug development is a complex and highly regulated process that requires collaboration between researchers, clinicians, regulatory agencies, and pharmaceutical companies to ensure the availability of safe and effective treatments for various medical conditions.

  CLINICAL TRIALS

• Clinical trials are meticulously designed and conducted research studies that serve as a crucial phase within the drug development process. These trials are aimed at assessing the safety, efficacy, and potential side effects of new medical interventions, including drugs, medical

  devices, treatments, and therapies, before they are approved for widespread medical use.

• The clinical trial process is divided into several distinct phases, each serving a specific purpose:

• Phase 1 Trials: These trials involve a small group of healthy volunteers or individuals with the condition of interest. The primary goal is to evaluate the safety of the intervention, determine its appropriate dosage range, and gather initial data on its pharmacokinetics (how the body absorbs, metabolizes, and eliminates the intervention).

• Phase 2 Trials: A larger group of patients who have the specific condition targeted by the intervention is involved in Phase 2 trials. These trials assess the intervention's efficacy in treating the condition, further refine the optimal dosage, and continue to monitor its safety.

• Phase 3 Trials: These trials involve an even larger and more diverse group of patients. They aim to confirm the intervention's effectiveness, monitor its side effects, and gather more data on its overall benefits and risks. Phase 3 trials often include randomized controlled trials, where participants are randomly assigned to receive either the experimental intervention or a control (such as a placebo or standard treatment), allowing for a robust comparison.

• Phase 4 Trials (Post-Marketing Surveillance): After the intervention has been approved and is available for use, Phase 4 trials continue to monitor its long-term safety and effectiveness in a real-world setting. These trials can uncover rare or late-emerging side effects and provide valuable insights into the intervention's use in diverse patient populations.

• Clinical trials adhere to strict ethical and regulatory guidelines to ensure the protection of participants' rights, safety, and well-being. They are conducted by teams of medical professionals, researchers, and scientists who meticulously plan and execute the trials. Data collected during these trials are analyzed rigorously to draw conclusions about the intervention's benefits and risks.

• The results of clinical trials play a pivotal role in the decision-making process of regulatory agencies like the

  U.S. FDA and the EMA, which determine whether the intervention should be approved for broader medical use. Additionally, clinical trial data influence medical practice guidelines, allowing healthcare professionals to make informed treatment recommendations.

  In summary, clinical trials are a cornerstone of evidence- based medicine, providing the empirical data necessary to establish the safety and efficacy of new medical interventions, ultimately leading to improved patient care and better medical outcomes.

  Manufacturing Strategy and Marketing methodologies

• Drug manufacturing and mareting strategy are integral components of the pharmaceutical industry's efforts to develop, produce, and promote new pharmaceutical products. These strategies involve complex processes that require careful planning, adherence to regulations, and effective communication to ensure the successful launch and distribution of drugs to patients in need.

• Drug Manufacturing Strategy:

• Drug manufacturing strategy encompasses the entire process of producing pharmaceutical products on a commercial scale. Key elements of this strategy include:

• Process Development: Designing and optimizing the manufacturing processes for the drug, ensuring consistency, quality, and scalability.

• Quality Assurance: Implementing quality control measures to ensure that each batch of the drug meets regulatory standards and is safe and effective for patient use.

• Supply Chain Management: Ensuring a robust supply chain that procures raw materials, manages inventory, and coordinates distribution to avoid shortages and disruptions.

• Regulatory Compliance: Adhering to regulatory requirements set by agencies such as the FDA, EMA, and other relevant authorities to ensure the drug's safety, efficacy, and quality.

• Scale-up and Production: Transitioning from small- scale production during development to large-scale manufacturing for commercial distribution.

• Technology and Innovation: Incorporating innovative manufacturing technologies and practices to enhance efficiency and reduce costs.

• Drug Marketing Strategy:

• A well-crafted drug marketing strategy is essential to introduce the pharmaceutical product to healthcare professionals, patients, and the broader market. Elements of this strategy include:

• Market Research: Understanding the target patient population, their needs, preferences, and the competitive landscape to inform marketing decisions.

• Positioning and Branding: Defining the drug's unique value proposition and creating a brand identity that resonates with the target audience.

• Target Audience: Identifying key stakeholders, including healthcare professionals, patients, caregivers, and payers, and tailoring marketing efforts to each group.

• Promotion and Education: Developing marketing materials, educational resources, and campaigns to raise awareness and communicate the benefits of the drug.

• Regulatory Compliance: Ensuring all marketing materials and communications comply with regulations and accurately represent the drug's characteristics.

• Distribution Channels: Establishing effective distribution channels to make the drug accessible to healthcare facilities, pharmacies, and patients.

• Post-Marketing Surveillance: Continuously monitoring the drug's performance, gathering real-world data, and addressing any emerging safety or efficacy concerns.

  Both drug manufacturing and marketing strategies need to be aligned with the overall goals of the pharmaceutical company, considering factors such as the drug's therapeutic area, target market, competitive landscape, and regulatory environment. Effective coordination between manufacturing and marketing teams is essential to ensure that the drug is not only produced with quality but also introduced and promoted successfully in the market.

  Embedding Supply chain solutions with SAP and S/4 Hana ERP platforms

• Following FDA approval of a drug, the business formulates a strategic plan to anticipate product expansion and enterprise-level manufacturing. SAP's S/4HANA is a forward-looking and robust enterprise resource planning (ERP) system. Like other ERP platforms, it consolidates all pertinent business data within the pharmaceutical industry into a unified repository, expediting pharmaceutical business operations. SAP's latest S/4HANA platform elevates the established advantages of ERP to an unprecedented echelon.

  Through the integration of artificial intelligence (AI), including machine learning (ML) and advanced analytics, S/4HANA is empowered to unearth insights, discern trends, make projections, and consequently facilitate data-informed choices and transformative business strategies for drug introduction. This progression results in a platform that adeptly manages extensive datasets within the pharmaceutical realm, connects seamlessly with emerging technologies, and boasts an intuitive interface, thereby paving the way for refined pharmaceutical practices. This integration and advancement play a pivotal role in orchestrating an environment conducive to effective management of pharmaceutical endeavors.

  ANALYTICS

• AP's Data Reporting and Analytics capabilities provide a robust framework for extracting meaningful insights and generating actionable intelligence from your organization's data. Leveraging advanced tools and technologies, SAP empowers businesses to make informed decisions, drive efficiency, and gain a competitive edge.

• The core features of SAP's Data Reporting and Analytics include:

• Data Integration and Transformation: SAP facilitates the integration of diverse data sources, whether structured or unstructured, from various systems across the organization. This data is then transformed into a standardized format, ensuring consistency and accuracy.

• Data Warehousing: SAP offers data warehousing solutions that provide a centralized repository for storing and managing vast amounts of data. This structured environment optimizes data retrieval and analysis processes.

• Reporting and Visualization: With SAP, users can create comprehensive reports and visualizations that convey complex data insights in a simplified and accessible manner. Interactive dashboards, graphs, and charts help stakeholders understand trends and patterns.

• Ad Hoc Querying: SAP's tools enable users to conduct ad hoc queries on demand, allowing them to retrieve specific information promptly without relying on predefined reports.

• Advanced Analytics: SAP employs advanced analytics techniques, including predictive analytics and machine learning, to forecast trends, identify anomalies, and generate actionable predictions from historical data.

• Real-time Analytics: In many cases, SAP's solutions offer real-time analytics capabilities, allowing users to analyze and act upon data as it is generated, ensuring that decisions are based on the most up-to-date information.

• Data Governance and Security: SAP places a strong emphasis on data governance and security, ensuring that sensitive information is protected, compliance requirements are met, and access to data is controlled.

• Integration with AI: By integrating artificial intelligence (AI) capabilities, SAP's analytics solutions can automatically identify trends, outliers, and correlations that might not be apparent through traditional analysis methods.

• Self-Service Analytics: SAP promotes self-service analytics, enabling business users to explore data independently, generate reports, and derive insights without heavy reliance on IT teams.

• Scalability: SAP's solutions are designed to handle large volumes of data, accommodating the growing data needs of organizations as they expand.

• In summary, SAP's Data Reporting and Analytics tools empower organizations to extract meaningful insights from their data, enabling data-driven decision-making, fostering innovation, and enhancing overall business performance.

  Establish Business warehouse and logistics systems

• In the pharmaceutical industry, a drug storage and logistics plan is devised based on factors such as the type of drug, specific storage requirements, and geographical considerations. To efficiently manage these aspects, the industry turns to solutions like SAP EWM (Extended arehouse Management), which stands out as a premier Warehouse Management System (WMS) offered by SAP. This WMS product is not only distinguished by its best-of-breed status but also ranks as best-in-class.

  SAP EWM inherits its robust lineage from its parent systems, thereby presenting an exceptional opportunity for life science and pharmaceutical enterprises. This system possesses inherent strengths in WMS

  capabilities, positioning it ideally to cater to the intricate process and functional demands of these industries.

  SAP EWM's prowess is instrumental in addressing the complexities associated with drug storage and distribution, ensuring that drugs are managed, stored, and transported in adherence to their unique storage requirements and in line with the geographic considerations.

  HEALTH CARE REGULATIONS AND COMPLIANCE

  • Drug distribution constitutes a pivotal endeavor within the pharmaceutical industry. The processes of selling and distributing pharmaceutical products necessitate strict adherence to compliance standards and regulations. SAP Global Trade Services (GTS) emerges as a potent aid for the pharmaceutical sector, enabling adept management of international trade procedures and bolstering competitiveness on a global scale.

  • This solution serves as a conduit for ensuring that pharmaceutical enterprises align with legal prerequisites. It orchestrates the seamless handling of customs and foreign trade affairs, encompassing electronic interactions with customs authorities. By mitigating financial risks, SAP GTS guarantees that pharmaceutical entities perpetually capitalize on available trade privileges and concessions.

  • SAP GTS Compliance Management functions as a sentinel, meticulously overseeing all import and export undertakings. This vigilance engenders complete conformance with legal stipulations across the entire process continuum. Crucial to this sphere are activities such as boycotting list scrutiny, embargo assessments, and import/export controls. These verification and screening procedures can be seamlessly integrated into preexisting systems, effectuating risk mitigation and curbing the potential for penalties and fines.

  • The system offers an automatic evaluation of state- enforced embargoes for inbound and outbound goods. Moreover, it facilitates the determination and application of necessary approvals, encompassing dual- use regulations, licensing prerequisites, and assorted compliance mandates. In essence, SAP GTS emerges as a steadfast partner in assuring pharmaceutical businesses' adherence to regulatory frameworks while facilitating the complexities of international trade management.

    DATA MANAGEMENT

  • Master data serves as the foundational information within the pharmaceutical industry, existing

    autonomously from specific business transactions and serving as a point of reference in various other business processes. It establishes the bedrock for seamless business operations and enlightened decision-making. Master data embodies the essence of business entities rather than transient transactions, remaining relatively unaltered over extended periods. The ensuing are pivotal master data entities of paramount significance within the pharmaceutical sector:

• Product: Information pertaining to the pharmaceutical products, encompassing attributes, specifications, and categorizations.

• Customer: Pertinent details regarding the clientele of the pharmaceutical entity, including identification, preferences, and affiliations.

• Supplier: Information about the suppliers of raw materials and components, comprising contact data, agreements, and certifications.

• Employee: Essential particulars concerning the workforce, incorporating roles, qualifications, and responsibilities.

• Product Recipes: In-depth formulations and recipes for pharmaceutical products, including constituent ingredients and proportions.

• Price Masters: Comprehensive records of pricing structures, both for internal use and external negotiations.

• Relevant Taxes: Information pertaining to applicable taxes and duties, ensuring accurate financial planning and adherence to regulations.

• Discounts/Rebates for Trade Promotions: Data concerning special trade promotions, discounts, and rebates offered to customers.

• Effective customer support or service constitutes a critical facet of both a product's and a pharmaceutical company's triumph. While technological advancements undoubtedly drive the industry, it is equally imperative to recognize the indispensability of robust customer support for an enterprise's viability and the triumphant launch of a product. The culmination of introducing a novel drug involves extending a diverse array of online information sources. These sources stand distinct from conventional television or internet advertisements. Physicians increasingly recommend drugs to their

  patients not solely on account of their efficacy but also grounded in the broader customer experience associated with the brand.

  Effectively orchestrating a drug launch necessitates the provision of comprehensive medical information to address inquiries. Furthermore, the ability to identify patients and facilitate connections between physicians is pivotal for optimizing medical recommendations and enhancing overall healthcare collaboration.

  SYNOPSIS

  Pharmaceutical marketing assumes paramount significance when introducing a new drug to the market. To comprehensively grasp the intricacies of launching a novel product within the pharmaceutical sector, pharmaceutical enterprises must commence their journey from the outsetcommencing with drug development and culminating with customer support. This holistic comprehension of distinct processes serves as the cornerstone for devising superior strategies to effectively market pharmaceutical products and usher them into the market.

• Within this landscape, an expanding array of diverse IT platforms emerges to facilitate the planning and execution of clinical trials. The process of product launch entails multifaceted legal formalities and trade authorizations. These encompass the submission of reports detailing Good Manufacturing Practice (GMP) inspections and the formulation of Standard Operating Procedures (SOPs) delineating manufacturing processes. Once the regulatory groundwork rooted in compliance is laid and requisite applications are tendered for product labeling, the establishment of business organization structures transpires within the enterprise's framework.

• Informed by considerations encompassing product categorization, geographic location, marketing

• strategies, and regulatory imperatives, businesses determine a new organizational configuration. This involves the creation of distinct financial reporting units, sales entities, manufacturing facilities, warehouses, and distribution models. A pivotal facet of this process is deliberating whether the product should be manufactured entirely in-house or outsourced to contract manufacturing units.

• The procurement of raw materials, Active Pharmaceutical Ingredients (APIs), and packaging materials is governed by batch quantities aligned with production schedules. Upon laying this groundwork, a pilot project is instituted to validate production capacity and facilitate the production of sample-sized batches. This pilot project engages multiple teams, each dedicated to performing specialized functions. A series of documents, encompassing installation qualifications, operational qualifications, and performance qualifications, are meticulously generated. These protocols are indispensable for scrutinizing the alignment of business requisites with configurations and scenario development. Rigorous regression, stress, and performance testing ensues, essential to validating the functional integrity of distinct deartments.

• Upon the successful culmination of testing, with documentation duly compiled and endorsed by the business, the execution of master data and cutover strategies becomes imperative for the seamless upload of data into the production environment. The readiness of the production environment is conclusively achieved upon the execution and completion of cutover and master data activities, subsequently garnering endorsement for operational employment by the business.

  • REFERENCES

[1] https://www.hhmglobal.com/knowledge- bank/news/what-is-the-process-of-launching-a- new-drug

[2] https://www.forbes.com/sites/salesforce/2014/09/1 0/what-good-customer-service/?sh=7c911eff743f

[3] https://jamanetwork.com/journals/jamaoncology/art icle-abstract/2781607

[4] https://pimcore.com/en/pim-sap-integration

[5] https://nttdata-solutions.com/ae-en/products/sap- customer-experience