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BIO Welcomes 21 New Companies to Industrial & Environmental Section
Press Release  •  November 28, 2018
The Biotechnology Innovation Organization today announced 21 companies have joined the Industrial & Environmental Section over the past year. BIO will work closely with these diverse new members as it continues to lead advocacy efforts that advance the development and adoption of biotechnology into industrial and environmental processes, such as the production of bio-based products and biofuels.
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BIO Statement on Proposed Changes to Medicare Advantage and Part D Plans
Press Release  •  November 27, 2018
“Today’s proposed rule to roll back critical protections afforded to some of America’s sickest and most vulnerable Medicare beneficiaries would, if adopted, severely limit seniors’ access to the drugs most appropriate for them, and is yet another unfortunate example of Administration proposals that will financially benefit insurance plans and other middlemen in the drug supply chain at the expense of patients."
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New Report Shows Global Link Between Pro-Innovation Policies and Biotech Advances
Press Release  •  November 19, 2018
Washington, D.C. (November 19, 2018) – A study released today highlights strategies, policies and best practices that have been successful in creating an environment in which biotechnology innovation can flourish around the world.The fifth edition of the Building the Bioeconomy report shows the correlation between economies with pro-innovation policy frameworks and those achieving strong biotechnology outputs. By examining 28 different indicators, the report provides a full and detailed analysis of the biotechnology environment for 33 countries from all major regions of the world.“Regulations need to strike a balance that stimulates innovation without dampening broader economic efficiencies. More than in other industry, the interplay between biotechnology innovation and regulation has important social and economic implications, said Joseph Damond, Executive Vice President, International Affairs at BIO. “As this report demonstrates, countries that are leading the biotech economy are the ones where forward-looking regulations encourage, not hinder, innovation.” This data-driven report developed by Pugatch Consilium compares economies on over 20 policy inputs and biotech outputs showing how regulations effect success or failure in driving industry growth. Economies that have stronger environments with all enabling policy factors in place yield higher biotechnology outputs. Adopting a strong policy framework is key to reaping the economic and social benefit of this important industry.“Designing policies to foster biotech innovation is not an easy task,” said Prof. Meir Pugatch, IPKM Chair, University of Maastricht and Managing Director, Pugatch Consilium. “To build a thriving biotechnology sector, whether it be agriculture, health or industrial applications, countries need strong intellectual property protections, a pro-innovation regulatory environment and robust technology transfer procedures. Funding research without establishing these elements is simply…
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BIO Comments on FDA Draft Guidance on Product Identifiers Under the Drug Supply Chain Security Act Q&A
Letters, Testimony & Comments  •  November 19, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers. BIO member companies are committed to ensuring the U.S. drug supply chain is secure, patients are receiving authentic products, and legitimate medications continue to move through the supply chain without unnecessary delays. The Drug Supply Chain Security Act (DSCSA) will improve the security of the U.S. pharmaceutical supply chain only with collaboration among all supply-chain stakeholders. In the comments, BIO says this Q&A document will help sponsors and stakeholders better understand the use of product identifiers. BIO provides suggestions on how to make the guidance more clear and effective, regarding the order and format of product identifier requirements, expiration date formatting, use of the GTIN and NDC, and the timely release of guidance documents.  
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BIO Releases Third Report in a Series on the State of Innovation in Highly Prevalent Chronic Diseases
Press Release  •  November 15, 2018
Washington, DC (October 26, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Volume III Type 2 Diabetes and Obesity Therapeutics, the third in a series on the current funding and R&D landscape for drugs to treat highly prevalent, chronic diseases.
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BIO Comments on FDA Draft Guidance on Testing of Retroviral Vector-Based Human Gene Therapy Products
Letters, Testimony & Comments  •  November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up. BIO agrees with most recommendations in the draft guidance on product testing for replication competent retrovirus (RCR). In particular, BIO commends the FDA for inviting the gene therapy community to publish findings of relevant studies, which will benefit and advance the field. BIO suggests FDA convene a public workshop with industry, academia, and other stakeholders to discuss current scientific data regarding RCR in gene therapy applications. BIO would be happy to help FDA with this effort. In addition, BIO suggested passages in the draft guidance that could be clarified.
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BIO Comments on FDA Draft Guidance on Human Gene Therapy for Rare Diseases
Rare Diseases  •  Letters, Testimony & Comments  •  November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Human Gene Therapy for Rare Diseases. BIO says the guidance will assist stakeholders developing human gene therapy (GT) products to treat rare diseases. BIO reminds FDA that complex, innovative clinical trial designs might be fit-for-purpose to execute clinical trials of GT products for rare diseases. Consequently, BIO urges FDA to provide regulatory flexibility to allow for innovative clinical trial designs – and to not otherwise use limiting language, such as recommending a specific number of treatment arms, utilizing different doses but the same product administration procedures, or the inclusion of a sham control group. The use of innovative clinical trial designs can decrease unnecessary and unethical patient exposure to clinical procedures and experimental products while still advancing clinical development. BIO also requests additional guidance on what types of patient experience data would be most helpful to inform regulatory decision-making.  
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BIO Comments on FDA Draft Guidance on Human Gene Therapy for Retinal Disorder and Hemophilia
Letters, Testimony & Comments  •  November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance on Human Gene Therapy for Retinal Disorder and Human Gene Therapy for Hemophilia. BIO says the guidance will assist stakeholders developing human gene therapy (GT) products to treat rare diseases, including hemophilia and retinal disorders, and provided specific suggestions for the FDA to clarify both guidances. The topics discussed in BIO's comments include preclinical in vitro and in vivo proof-of-concept studies and disease-specific animal models, science-based regulatory flexibility when evaluating appropriateness of animal models, the use of the word "pharmacokinetics," biodistribution studies, reproductive/developmental toxicity studies, fit-for-purpose clinical trial designs, and patient experience.
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BIO Comments on Draft Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
Letters, Testimony & Comments  •  November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). BIO says the comprehensive draft guidance effectively covers a range of chemistry, manufacturing, and control (CMC) topics relevant to gene therapy products. However, BIO notes the draft guidance is quite prescriptive and does not necessarily match modern manufacturing. BIO would like to see a better balance between the information FDA needs to see in order to allow an IND to move forward, and over-reporting of information that may be unnecessary. On the whole, it seems much of the information required by the draft guidance is more appropriate for a BLA filing, an approved product, or postapproval changes to a product rather than an IND. BIO suggests specific changes to avoid misinterpretation and clarify the scope, the stage of development the guidelines apply to, and testing expectations, among other topics.
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BIO Comments on Draft Guidance on Long-Term Follow-Up After Administration of Human Gene Therapy Products
Letters, Testimony & Comments  •  November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products. BIO says the guidance reflects the FDA’s experience evaluating the safety of gene therapy products over the past decade. In addition, the guidance provides important recommendations on how to determine and develop long-term follow-up after the administration of human gene therapy products. BIO provides general and detailed comments on a number of issues, including the safety risk and viral vector of gene therapy products, logistical challenges of long-term follow-up periods and the need to work with sponsors to develop best practices, the importance of partnering with stakeholders on biodistribution questions, and the importance of harmonization with global, multilateral organizations in the field.
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