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Clinical Development 201: Phase I
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BIO Professional Development Courses  •  August 28, 2024
Clinical Development 201: Phase I provides insights into Phase 0 and Phase I clinical trials, including their purpose and regulatory requirements. This class, the second in the Biotech Primer Clinical Development series, showcases the indispensable role of gathering preliminary pharmacokinetics and pharmacodynamics data to determine the appropriate dosage of experimental treatments. Strategies of Single Ascending Dose (SAD), Multiple Ascending Doses (MAD), and Maximum Tolerated Dose (MTD) protocols are explained in thorough detail. Clinical Development 201 outlines how researchers vigilantly monitor participants, meticulously collect vital safety data, and expertly evaluate the effectiveness of new treatments using well-defined endpoints. Don't miss this opportunity to enhance your clinical trials expertise. Enroll now to secure your seat! 
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Biopharma Business Acumen Primer
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BIO Professional Development Courses  •  August 28, 2024
Biopharma Business Acumen Primer provides a comprehensive understanding of the business considerations needed to develop and bring a life-saving cure to the marketplace. It begins with an exploration of the financing vehicles and sources required to develop a cure. The class then examines the intricacies of intellectual property management, followed by a focus on lifecycle management strategies for medicines so sponsors can wring out the maximum value of each asset. Biopharma Business Acumen ends by breaking down the complex world of U.S. drug pricing. This course provides the knowledge necessary to navigate the challenges and opportunities in the healthcare field. Enroll today and contribute to the vital mission of bringing cures to those in need!
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Clinical Development 101: General Principles
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BIO Professional Development Courses  •  August 28, 2024
Clinical Development 101: General Principles sets the stage for the entire Biotech Primer clinical development series by covering the essential terms, milestones, and considerations needed to understand the clinical development process. This Primer dives into the core principles of current Good Clinical Practices and how to manage risk for study volunteers. Clinical Development 101 focuses on the most relevant study designs, inclusion/exclusion criteria for selecting participants, and ethical considerations that must be met. The class ends by establishing master data management and reporting standards required for regulatory filings. Register now for Clinical Development 101: General Principles and establish a baseline understanding of clinical trials.
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Biosimilars Primer
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BIO Professional Development Courses  •  August 28, 2024
Biosimilars Primer explains the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. Beginning with an overview of protein structure, function, and production, this class hones in on different types of biologics and how each fights disease. This class highlights how production conditions can alter a biosimilar, causing it to function differently than its reference product. The course ends with a Safety and Regulation section that examines immunogenicity and approaches to demonstrating biosimilar safety and efficacy that have been acceptable to the FDA and EMA. Four real-world case studies illustrate the complexity and versatility of biosimilars in treating various medical conditions. Enroll today! 
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Biomanufacturing Primer
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BIO Professional Development Courses  •  August 28, 2024
Biomanufacturing Primer introduces the ever-evolving world of biomanufacturing. It gives a scientific overview of essential topics such as the intricacies driving cell lines, cell banks, upstream/downstream bioprocessing, and the latest advancements in this dynamic field. The class compares the fascinating differences between bacterial and mammalian cell lines and explains which drug products each can and cannot produce. The concept of cell banks, both master and working cell banks, and their critical manufacturing roles are explained in detail. This primer outlines the art of upstream bioprocessing (optimizing cell growth and scale-up) and downstream bioprocessing (harvesting and purifying protein drug products). The class ends by highlighting incredible advancements such as continuous bioprocessing, single-use technologies, and critical quality attributes. Register today for this informative class and gain a foundational understanding of biomanufacturing!
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Cell Therapy Primer
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BIO Professional Development Courses  •  August 28, 2024
Cell Therapy Primer offers a comprehensive introduction to cell therapy development, manufacturing, and commercialization. This class delves into the scientific benefits and challenges of autologous and allogeneic cell therapies. Cell Therapy Primer focuses especially on Chimeric Antigen Receptors (CARs), their proven approach to treating blood cancer, and their potential applications in solid tumors and beyond. The course also introduces stem cell therapies and applications in regenerative medicine. Enroll now to gain an understanding of the groundbreaking potential of cell therapy! 
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BIO Files Amicus Brief Challenging IRA Drug Price Controls
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Amicus Brief  •  August 26, 2024
BIO filed an amicus brief July 19 in the case of Bristol Meyers Squibb and Janssen, who are appealing a decision by the U.S. District Court for the District of New Jersey. The companies argue that the Inflation Reduction Act (IRA) drug price control program is not a negotiation at all, as it coerces drug makers to agree to sell their products at below-market prices. This amounts to an unconstitutional “Taking” of the companies’ property, in violation of the Fifth Amendment. The IRA program also forces them to endorse government messaging on what is, and is not, a “fair price,” in violation of the First Amendment.BIO’s amicus brief supports these assertions while focusing on two specific arguments: countering the government’s position that participation in the price “negotiation” program is voluntary and sounding the alarm regarding the IRA’s impact on innovation.
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BIO files amicus brief in suit challenging IRA price controls
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Good Day BIO Newsletter  •  August 26, 2024
We have details on BIO’s amicus brief in a suit challenging the Inflation Reduction Act price controls, the latest on updated COVID-19 vaccines, plus more news you need to know. (769 words, 3 minutes, 50 seconds)
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BIO Membership Compact & Social Responsibilities
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To be eligible for membership in BIO, a firm or organization must fit into one of the membership categories outlined in BIO’s bylaws (i.e., Core, Associate, Affiliate, and Center members). Further, membership in BIO is open only to firms or organizations that generally support BIO’s public policy positions, and whose own positions and business practices are generally consistent with BIO’s reputation and its policies and principles in support of innovation, including intellectual property rights. As part of the application and membership renewal process, each firm or organization is required to affirm that it meets such criteria.As an indicium of a Core Member’s “support for innovation,” an important criterion includes an assessment of whether a Core Member company invests significantly in innovative (i.e., new and novel) biotechnological research and development (R&D) activities.Beyond these core requirements of membership, BIO expects that its members will not engage in conduct that is detrimental to the purpose or reputation of the organization.BIO Statements and Principles regarding Biotech Social Responsibilities:In addition to BIO’s membership criteria, BIO’s Board of Directors has, over the years, adopted a series of official Statements and Principles that help to set expectations regarding the social responsibilities of our members and the broader biotechnology community, and to encourage societally beneficial conduct. While non-exhaustive, we have provided below the links to some of the most important Statements and Principles adopted by BIO’s Board.Developing an Inclusive and Impactful Approach to Transparency for Biotechnology in Food & AgricultureStatement of BIO Ethical PrinciplesPrinciples on Protecting Research and Research ParticipantsPrinciples on Responsible Sharing of Truthful and Non-Misleading Information About Medicines With Health Care Professionals and PayersStatement of Ethical Principles for the Care and Use of Animals in…
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Statement on Ethical Use of Biotechnology to Promote Public Health and National Security and to Fight Against Bioterrorism
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Bioethics
BIO has long expressed its commitment to the use of biotechnology only to benefit humankind. BIO's Statement of Ethical Principles contains several provisions that describe responsible uses of biotechnology and ethical behavior standards developed by the biotechnology industry. After the September 11, 2001 attack on America, questions have been raised about broader uses of biotechnology, including its use to detect, diagnose, prevent, or treat victims of possible future biological attacks as well as the potential for misuse of the technology.BIO hereby re-affirms its long-standing policy opposing the use of biotechnology to develop weapons. As importantly, however, BIO strongly supports the use of biotechnology to promote and protect the public health and national security. To these ends, appropriate uses of biotechnology include the research, development, and commercialization of products and services to detect, diagnose, protect, and treat all people against harmful pathogens and other agents.Such products should be developed and distributed under statutory, regulatory and ethical frameworks that address issues including informed consent for patients and participants in clinical trials, independent review of clinical trial protocols, licensing and other importation and exportation rules, and technology transfer. BIO member companies believe in the responsible progress - and use - of science. Biotechnology companies support the use of appropriate safeguards for technologies, including security for employees and facilities.BIO will continue to work with government agencies, policy makers, and other leaders to develop policies and procedures that embody these important bioethical principles.To improve public understanding about biotechnology and how it can maintain and improve public health and security, BIO and its member companies also will educate policy makers and the public.Through biotechnology more than 100 new, breakthrough biopharmaceuticals, vaccines, and…
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