Biogen

1. What is Biogen?

1.1 What is the History and Background of Biogen?

Biogen is a leading global biotechnology company that was founded in 1978 by a small group of visionary scientists, including Walter H. Gilbert, a Nobel prize-winning biologist. The company is considered one of the pioneers of the biotechnology industry and has a rich history of innovation and breakthroughs.

Early Years: Biogen was founded in 1978 in Geneva, Switzerland, and was initially focused on developing interferon alpha, a protein that could be used to treat various diseases. The company's early years were marked by significant losses, with Biogen reporting a loss of $100 million by 1984. However, the company's founders remained committed to their vision and continued to invest in research and development.

Mergers and Acquisitions: In 2003, Biogen merged with San Diego-based IDEC Pharmaceuticals, and the combined company was renamed Biogen Idec. The merger brought together two companies with complementary strengths and expertise, and the combined company became one of the largest biotechnology companies in the world.

In 2015, Biogen Idec changed its name to Biogen, and the company has since continued to grow and expand its pipeline of potential therapies.

Breakthroughs and Innovations: Biogen has a long history of innovation and breakthroughs, including the development of the first approved treatment for spinal muscular atrophy, nusinersen. The company has also developed a broad portfolio of medicines to treat multiple sclerosis, and has co-developed treatments to address a defining pathology of Alzheimer's disease.

Recent Developments: In recent years, Biogen has made significant progress in its research and development efforts, including the approval of its drug aducanumab for the treatment of Alzheimer's disease. The company has also made significant investments in its pipeline of potential therapies, including the acquisition of Reata Pharmaceuticals for nearly $6.5 billion.

Overall, Biogen has a rich history of innovation and breakthroughs, and continues to be a leader in the biotechnology industry. The company's commitment to its purpose of serving humanity through science has driven its growth and success, and its continued focus on innovation and research will likely shape its future.

Rate how well Biogen lives up to its initial vision: I would rate Biogen as a 9 out of 10 in terms of how well it lives up to its initial vision. The company has made significant progress in its research and development efforts, and has developed a broad portfolio of medicines to treat complex and devastating diseases. While there have been challenges and setbacks along the way, Biogen's commitment to its purpose and its focus on innovation have driven its growth and success.

1.2 What are the Core Areas of Focus for Biogen?

The core areas of focus for Biogen are:

Neurology: Biogen is committed to advancing novel approaches for previously intractable neurodegenerative conditions such as Alzheimer's disease, Amyotrophic Lateral Sclerosis (ALS), and Multiple Sclerosis (MS).
Rare Diseases: Biogen has a strong focus on rare diseases, including Friedreich Ataxia, Spinal Muscular Atrophy (SMA), and Lupus.
Neuropsychiatry: Biogen is working to advance the treatment of depression, particularly postpartum depression, and is exploring new therapeutic approaches for neuropsychiatric disorders.
Specialized Immunology: Biogen is leveraging its expertise in neuroimmunology to develop new treatments for autoimmune diseases such as lupus.
Genetic and Neurodevelopmental Disorders: Biogen is working on developing treatments for genetic and neurodevelopmental disorders, including epilepsy, developmental delays, and intellectual disabilities.

Biogen's research and development efforts are focused on advancing a pipeline of potential therapies across these areas, with a goal of transforming the lives of patients with complex and devastating diseases.

1.3 How Does Biogen Contribute to the Healthcare Industry?

Biogen contributes to the healthcare industry in several ways:

Access and Health Equity: Biogen is committed to providing equitable access to healthcare, focusing on helping underrepresented or underserved individuals gain access to quality healthcare at every stage of the patient journey.
Digital Health: Biogen partners with digital health innovators to develop novel solutions that can transform patient care. Their digital health programs include initiatives such as Konectom, AI², Physio.me, Capsule, and Cleo, which aim to improve patient outcomes and experiences.
Healthcare Benefits: Biogen offers comprehensive medical plans, including the Health Savings Account (HSA) Plan, Preferred Provider Organization (PPO) 90 Plan, and Exclusive Provider Organization (EPO) Plan, which cover a range of medical services, including doctor visits, inpatient and outpatient care, and prescription drug coverage.
Wellness Programs: Biogen provides various wellness programs, such as digital platforms that inspire healthy habits, resources to help employees advocate for their physical well-being, and access to coaching and app-based support for mental health conditions.
Biogen Foundation: The Biogen Foundation is committed to advancing better health by engaging employees and collaborating with high-impact partners in local communities. The Foundation focuses on equitable access to healthcare, addressing social determinants of health, and building a more diverse healthcare workforce.

Overall, Biogen's contributions to the healthcare industry aim to improve patient outcomes, increase access to healthcare, and promote health and wellness through innovative solutions and programs.

2. Why is Biogen Significant in the Biopharmaceutical Sector?

2.1 What are Biogen's Key Achievements and Milestones?

Biogen has reached several significant milestones in its journey, shaping its contribution to the biotechnology industry. Some of the key achievements and milestones include:

Pioneering therapies for neurological and neurodegenerative diseases: Biogen has developed and delivered innovative therapies for patients living with serious neurological and neurodegenerative diseases, including multiple sclerosis, spinal muscular atrophy, and Alzheimer's disease.
Flagship products: Biogen's flagship products, such as Tecfidera, Avonex, and Spinraza, have contributed significantly to the company's revenue and have been successful in treating various neurological conditions.
Strategic acquisitions and partnerships: Biogen has made strategic acquisitions and partnerships to expand its market presence and therapeutic offerings, including the acquisition of Spinraza and the partnership with Ionis Pharmaceuticals.
R&D investments: Biogen has invested heavily in research and development, with a focus on neuroscience, to bring forth innovative treatments for patients with unmet medical needs.
Industry recognition: Biogen has received industry recognition for its sustainability efforts, including being listed on the Dow Jones Sustainability World Index (DJSI World) for the ninth consecutive year, making it the most frequently recognized biotechnology company on the index.
ESG leadership: Biogen has been recognized for its environmental, social, and governance (ESG) leadership, including earning top ESG leadership scores on areas such as Innovation Management and Climate Strategy.
Cost-cutting measures: Biogen has implemented cost-cutting measures, including reducing its workforce by 1,000 by 2025, to reduce operating expenses and reinvest in key products and initiatives.
New product launches: Biogen has launched new products, such as Leqembi, which has gained full approval from the FDA and is expected to increase sales rapidly.
Expansion into new therapeutic areas: Biogen is exploring new therapeutic areas, such as Alzheimer's disease and other neurodegenerative disorders, to leverage its expertise in neurological diseases and bring forth innovative treatments.

These milestones and achievements demonstrate Biogen's commitment to innovation, sustainability, and patient care, and position the company for continued growth and success in the biotechnology industry.

2.2 How Does Biogen's Research and Development Impact the Industry?

Biogen's research and development (R&D) has a significant impact on the industry in several ways:

Diversified Pipeline: Biogen's R&D focus on neuroscience, immunology, and rare diseases has led to a diversified pipeline of innovative therapies, including treatments for multiple sclerosis, spinal muscular atrophy, and Alzheimer's disease.
Collaborations and Partnerships: Biogen has collaborated with leading scientists, academia, and industry partners to advance research and development, including partnerships with Sangamo Therapeutics, Denali Therapeutics, Sage Therapeutics, and InnoCare Pharma Limited.
Quantum Computing: Biogen has partnered with Accenture to apply quantum computing to accelerate drug discovery, which has the potential to significantly improve the pharmaceutical industry's drug development process.
Digital Health: Biogen has formed a global unit, Biogen Digital Health, to transform patients' lives and the company's approach to medicine through personalized and digital medicine in neuroscience.
R&D Expertise: Biogen's R&D expertise is driven by the potential to transform the lives of patients, with a focus on disease areas with significant unmet need, including multiple sclerosis, Alzheimer's disease, and neuromuscular disorders.
Job Cuts and Restructuring: Biogen's recent job cuts and restructuring efforts aim to prioritize resources towards high-value programs with growth potential, resulting in a more focused and efficient R&D organization.
Innovative Therapies: Biogen's R&D has led to the development of innovative therapies, such as ADUHELM (aducanumab-avwa) injection 100 mg/mL solution, which has the potential to treat Alzheimer's disease.
Industry Leadership: Biogen's R&D efforts have positioned the company as a leader in the biotechnology industry, with a strong pipeline of innovative therapies and a commitment to advancing research and development.

Overall, Biogen's R&D has a significant impact on the industry, driving innovation, collaboration, and advancements in the development of new treatments for patients with serious neurological and neurodegenerative diseases.

2.3 What Sets Biogen Apart from its Competitors?

Biogen stands out from its competitors in several ways:

Diversified Portfolio: Biogen has a diverse portfolio of products, including Spinraza for spinal muscular atrophy, Tecfidera for multiple sclerosis, and Aduhelm for Alzheimer's disease. This diversification helps to reduce dependence on a single product and provides a buffer against potential setbacks.
Innovative Research: Biogen is a pioneer in neuroscience and has a strong research focus, which enables it to stay ahead of the curve in developing new treatments for complex diseases.
Strategic Partnerships: Biogen has formed partnerships with other companies, such as Innocare, to expand its pipeline and access new technologies. This approach allows Biogen to leverage the strengths of its partners while minimizing risks.
Manufacturing Capabilities: Biogen has invested in its manufacturing capabilities, including the construction of a new biologics manufacturing facility in Solothurn, Switzerland. This enables the company to produce high-quality products and meet growing demand.
Global Presence: Biogen has a significant presence in Europe, with operations in 24 countries and a commitment to supporting sustainable healthcare systems.
Commitment to Neuroscience: Biogen's commitment to neuroscience is evident in its mission to "work fearlessly, care deeply, and change lives." This focus on neuroscience has enabled the company to develop innovative treatments for complex diseases.
Adaptability: Biogen has demonstrated its ability to adapt to changing market conditions, such as the emergence of new competitors and the need to respond to patent challenges.

Overall, Biogen's unique combination of innovative research, strategic partnerships, diversified portfolio, and manufacturing capabilities sets it apart from its competitors and positions it for long-term success in the biotechnology industry.

3. How Does Biogen Develop and Commercialize its Products?

3.1 What is Biogen's Drug Development Process?

Biogen's drug development process involves several stages, including:

Discovery: Researchers identify potential therapeutic targets and develop compounds to address specific diseases or conditions.
Preclinical: The company conducts preclinical studies to evaluate the safety and efficacy of the compounds in animal models.
Phase 1: The first human clinical trial, where a small group of healthy volunteers receive the compound to assess its safety and pharmacokinetics.
Phase 2: A larger group of patients with the target disease receive the compound to evaluate its efficacy and side effects.
Phase 3: The final stage of clinical trials, where the compound is tested in a large group of patients to confirm its efficacy and safety.
NDA/BLA: The company submits the drug for regulatory approval to the FDA or other regulatory agencies.
Approval: The FDA or other regulatory agencies review the data and grant approval for the drug to be marketed and sold.
Launch: The company prepares the drug for distribution and launches it into the market.
Post-marketing surveillance: The company continues to monitor the drug's safety and efficacy after it is approved and on the market.

Biogen's pipeline includes drugs at various stages of development, from discovery to approved. The company has a strong focus on developing treatments for neurological conditions, immune-related disorders, and other therapeutic areas. Biogen's pipeline consists of drugs targeting various proteins and pathways, including Nrf2, CD40L, SOD1, F10, CD20, Nav1.7, and others.

Biogen's drug development process is a marathon, not a sprint, and involves extensive clinical trials to determine if a new treatment is safe and effective. The company's commitment to reinvesting a significant amount of its earnings into product research and development enables it to continue discovering and developing new treatments for patients.

3.2 How Does Biogen Ensure Quality and Safety in its Products?

Biogen ensures quality and safety in its products through a combination of policies, procedures, and practices. Here are some key measures:

Environmental, Health, and Safety (EHS) Policy: Biogen has a comprehensive EHS policy that sets forth its commitment to providing and maintaining a healthful and safe work environment, minimizing the impact of its business operations and products on the environment, and promoting a culture of safety and responsibility.
Quality Management System: Biogen has a quality management system in place that ensures the quality of its products, processes, and services. The system is based on international standards such as ISO 9001 and is designed to ensure that products meet customer and regulatory requirements.
Good Manufacturing Practices (GMPs): Biogen follows GMPs, which are guidelines that ensure the quality and purity of pharmaceutical products. GMPs cover aspects such as facility design, equipment, personnel, and processes.
Regulatory Compliance: Biogen complies with all applicable regulatory requirements, including those related to product safety, quality, and efficacy. The company works closely with regulatory authorities to ensure compliance and to address any concerns or issues that may arise.
Product Stewardship: Biogen is committed to minimizing the adverse health, safety, environmental, and social impacts of its products throughout their life cycle. The company works to maximize the benefits and value of its products while minimizing their negative impacts.
Patient Safety: Biogen prioritizes patient safety and is committed to complete and timely evaluation of the benefits and risks of its therapies. The company communicates this information to patients, healthcare professionals, and regulators to ensure informed decision-making.
Serialization Technology: Biogen is investing in serialization technology to make its products more difficult to counterfeit, with the goal of improving patient safety and health outcomes.
Supply Chain Responsibility: Biogen is committed to responsible sourcing and procurement practices, including ensuring that its suppliers adhere to ethical and environmental standards.
Materiality Assessment: Biogen conducts a materiality assessment to identify issues that have a significant impact on both society and the environment, as well as its company value drivers.
Transparency and Disclosure: Biogen is committed to transparency and disclosure of environmental, social, and governance (ESG) issues that are material to its business and of interest to its stakeholders.

By implementing these measures, Biogen ensures that its products are safe, effective, and sustainable, and that it operates in a responsible and ethical manner.

3.3 What is Biogen's Marketing and Distribution Strategy?

Biogen's marketing and distribution strategy involves a multi-faceted approach that includes:

Global Growth Opportunities: Biogen is focusing on key emerging markets, such as China and certain markets in Latin America and the Middle East, to expand its presence and increase revenue.
Biosimilars: Biogen is expanding its biosimilars business by launching new products, such as BYOOVIZ, and pursuing local business development opportunities.
Commercialization of Anti-TNFs in Europe: Biogen is commercializing anti-TNFs in Europe, which is expected to drive growth and increase revenue.
Phased Commercialization: Biogen is adopting a phased commercialization approach, which involves launching products in specific geographic regions or segments of the patient population, and then expanding to other regions or segments as market access is gained.
Data-Driven Feedback Mechanism: Biogen is continually improving its commercial strategy by creating an intensely data-driven feedback mechanism to refine its marketing and distribution efforts.
Collaborations and Partnerships: Biogen is collaborating with other companies, such as Eisai, to develop new products and expand its pipeline.
ESG Priorities: Biogen is prioritizing environmental, social, and governance (ESG) initiatives, such as reducing its carbon footprint, increasing diversity and inclusion, and promoting sustainability in its operations.

Overall, Biogen's marketing and distribution strategy is focused on driving growth, increasing revenue, and expanding its presence in key markets, while also prioritizing ESG initiatives and adopting a phased commercialization approach to reduce financial risks.

4. Who are the Key Players and Market Trends in the Biogen Industry?

4.1 Who are Biogen's Major Partners and Collaborators?

Based on the search results, Biogen's major partners and collaborators include:

Sangamo Therapeutics: Biogen has a collaboration with Sangamo to develop gene therapies for various diseases, including sickle cell disease and beta-thalassemia.
Eisai Co., Ltd.: Biogen is collaborating with Eisai to develop lecanemab, a potential treatment for Alzheimer's disease.
Samsung Bioepis: Biogen has a joint venture with Samsung Bioepis to develop and commercialize biosimilars.
Sage Therapeutics: Biogen is collaborating with Sage to develop zuranolone, a potential treatment for major depressive disorder and postpartum depression.
Intellia Therapeutics: Biogen is collaborating with Intellia to develop gene editing therapies for various diseases, including genetic disorders.

These partnerships and collaborations are focused on developing innovative treatments for various diseases, including neurological disorders, genetic disorders, and cancer.

4.2 What Factors Influence Biogen's Market Performance?

The factors that influence Biogen's market performance include:

Revenue decline: Biogen expects a low-to-mid single-digit revenue decline in 2024 compared to 2023, which may impact its stock price.
Earnings guidance: The company's earnings guidance for 2024, with Non-GAAP diluted EPS of $15.00 to $16.00, may not meet market expectations, leading to a decline in stock price.
Strategic uncertainties: Biogen's commercial strategy for Leqembi, demand dynamics for Skyclarys, and potential erosion of core business offerings due to biosimilar and generic competition may create uncertainty and impact stock performance.
Cost savings: Biogen's Fit for Growth program is expected to generate approximately $1 billion in gross savings and $800 million net of reinvestment by 2025, which may not be sufficient to offset revenue declines.
Market expectations: Analysts' expectations for Biogen's performance, including consensus estimates for the fourth quarter of 2023 and the full year, may not meet market expectations, leading to a decline in stock price.
Industry trends: The Medical - Biomedical and Genetics industry's average PEG ratio of 1.9 may be lower than Biogen's PEG ratio of 2.47, indicating that the company's stock may be overvalued.
Competition: Biogen faces competition from other biotech companies, which may impact its market share and revenue growth.
Regulatory environment: Changes in regulatory environments, such as the Affordable Care Act (ACA), may impact Biogen's business and stock performance.
Investor sentiment: Investor sentiment, including the Zacks Rank, may influence Biogen's stock price, with a Zacks Rank of #3 (Hold) indicating a neutral outlook.
Valuation: Biogen's Forward P/E ratio of 16.98 may be higher than its industry's average Forward P/E of 22.58, indicating that the company's stock may be overvalued.

These factors may influence Biogen's market performance and stock price, and investors should consider them when making investment decisions.

4.3 What are the Emerging Trends in the Biogen Industry?

Based on the search results, the emerging trends in the biogen industry include:

Collaborations and Licensing Agreements: Biogen is focusing on collaborations, licensing agreements, and deals for early-stage drugs, which tend to be smaller than full company acquisitions.
Rare Diseases and Immune System Disorders: Biogen is investing in rare diseases and immune system disorders, as seen in its acquisition of Reata Pharmaceuticals and the development of Skyclarys, a drug used to treat Friedreich's ataxia.
Experimental Alzheimer's Drug: Biogen's experimental Alzheimer's drug, BIIB080, has shown "favorable trends" in early studies, targeting a buildup of tau in the brain.
Postpartum Depression Drug: Biogen's postpartum depression pill, Zurzuvae, has seen "encouraging early trends" in its launch, with sales surpassing estimates.
Sustainability and Environmental Impact: Biogen is prioritizing sustainability and reducing its environmental impact, including reducing water usage, recycling, and using renewable electricity.
Gene Therapy Manufacturing: Biogen is investing in gene therapy manufacturing, breaking ground on a new facility in North Carolina, which will expand its capabilities and supply chain.
Corporate Responsibility and ESG: Biogen is committed to corporate responsibility and environmental, social, and governance (ESG) issues, including transparency in its policies and practices.

These trends indicate a shift towards more collaborative and sustainable approaches in the biogen industry, with a focus on rare diseases, immune system disorders, and gene therapy manufacturing.

5. What are the Challenges and Opportunities in the Biogen Sector?

5.1 What Regulatory and Compliance Challenges Does Biogen Face?

Biogen faces several regulatory and compliance challenges, including:

Regulatory compliance: Biogen must comply with various government regulations and guidelines, including those related to product development, clinical trials, and commercialization.
Biosimilar products: Biogen's biosimilar products may face regulatory hurdles or delays due to the evolving and uncertain regulatory environment.
Patent challenges: Biogen may face challenges to its patents, regulatory exclusivities, or other proprietary rights covering its products.
Third-party suppliers and manufacturers: Biogen relies on third-party suppliers and manufacturers, which may be subject to regulatory inspections and certification.
Global regulatory differences: Biogen's products may be subject to different regulatory requirements and guidelines in various countries, which can present challenges for development and commercialization.
Gene therapy regulatory challenges: Biogen's gene therapy products may face unique regulatory challenges, including the need for specialized regulatory frameworks and the potential for delays in approval.
Health technology assessment and payment policies: Biogen's products may be subject to health technology assessment and payment policies, which can affect access and reimbursement.
Environmental and social responsibility: Biogen must also comply with environmental and social responsibility standards, including those related to sustainability, animal welfare, and clinical research.

To address these challenges, Biogen has implemented various strategies, including:

Compliance programs: Biogen has established compliance programs to ensure compliance with regulatory requirements and guidelines.
Regulatory affairs: Biogen has a dedicated regulatory affairs team to manage interactions with regulatory agencies and ensure compliance with regulatory requirements.
Partnerships and collaborations: Biogen has partnered with other companies and organizations to share knowledge, resources, and expertise in regulatory affairs.
Investment in research and development: Biogen has invested in research and development to stay ahead of the curve in terms of regulatory requirements and guidelines.
Sustainability and environmental responsibility: Biogen has implemented sustainability and environmental responsibility initiatives to reduce its environmental impact and improve its social responsibility.

5.2 What are the Research and Development Challenges in the Biogen Sector?

The research and development challenges in the biogen sector include:

Operational Challenges: Biogen faces operational challenges, including the complexity of manufacturing biosimilars and the reliance on third-party manufacturers. Any disruptions in the supply chain or manufacturing process could adversely affect Biogen's ability to meet market demand, potentially leading to revenue losses and damage to the company's reputation for reliability.
Patent Expirations and Regulatory Challenges: Biogen's financial health is heavily reliant on a few key products, which exposes the company to significant risk if these products face generic competition or declining sales. The company must navigate complex regulatory environments across different markets, which can result in delays or denials of drug approvals, impacting the company's growth trajectory.
Intense Competition: The biopharmaceutical industry is characterized by intense competition, with numerous companies vying for market share. Biogen faces the threat of new and more effective treatments from competitors, which could erode the company's market position and revenue.
Research and Development Expenses: Biogen's research and development expenses are significant, and the company must balance the need to invest in new products and technologies with the need to manage costs and maintain profitability.
Digital Health Technologies (DHTs) in Drug Development: Biogen is exploring the use of DHTs in drug development, which presents both opportunities and challenges. The company must navigate the regulatory landscape and ensure that its DHTs are developed and approved in a timely and cost-effective manner.
Strategic Collaborations: Biogen is leveraging strategic collaborations to accelerate the development and commercialization of promising therapies. However, these collaborations also present challenges, such as managing intellectual property rights and ensuring that the company's interests are protected.
Market Expansion and Novel Drug Approvals: Biogen is expanding its presence in new markets and seeking novel drug approvals. However, this requires significant investment and resources, and the company must balance the need to expand its presence with the need to manage costs and maintain profitability.
Rare Diseases and Immunology: Biogen is expanding its presence in rare diseases and immunology, which presents both opportunities and challenges. The company must navigate the complex regulatory environment and ensure that its products are developed and approved in a timely and cost-effective manner.
Neuropsychiatry: Biogen is exploring opportunities in neuropsychiatry, which presents both opportunities and challenges. The company must navigate the complex regulatory environment and ensure that its products are developed and approved in a timely and cost-effective manner.
Cost Management: Biogen must manage its costs effectively to maintain profitability and invest in new products and technologies. The company must balance the need to reduce costs with the need to invest in research and development and other strategic initiatives.

5.3 What Opportunities Exist for Growth and Innovation in the Biogen Market?

Based on the search results, here are some opportunities for growth and innovation in the biogen market:

Personalized Medicine: The growing demand for personalized medicine is driving innovation in the biotech industry, and biogen companies are at the forefront of this trend.
Gene Therapy: The development of gene therapy is a significant area of growth, with biogen companies like Biogen Inc. investing heavily in this field.
Biosimilars: The biosimilars market is expected to grow significantly, with biogen companies like Biogen Inc. developing and commercializing biosimilars.
Oligonucleotide Therapeutics: The oligonucleotide therapeutics market is expected to grow rapidly, with biogen companies like Biogen Inc. investing in this area.
Digital Health: The integration of digital health technologies, such as artificial intelligence and machine learning, is expected to drive innovation in the biotech industry.
Sustainable Manufacturing: The increasing focus on sustainability is driving innovation in manufacturing, with biogen companies like Biogen Inc. investing in sustainable manufacturing practices.
Global Expansion: The biotech industry is becoming increasingly global, with biogen companies like Biogen Inc. expanding their operations to emerging markets.
Collaborations and Partnerships: Collaborations and partnerships between biogen companies, academia, and industry are driving innovation and growth in the biotech industry.
Regenerative Medicine: The development of regenerative medicine is a significant area of growth, with biogen companies like Biogen Inc. investing in this field.
Data Analytics: The increasing use of data analytics is driving innovation in the biotech industry, with biogen companies like Biogen Inc. using data analytics to improve their research and development processes.

These opportunities for growth and innovation are driven by factors such as advances in genomics, proteomics, and molecular biology, as well as increasing demand for personalized medicine and sustainable manufacturing practices.