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BIO Comments on Draft Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). BIO says the comprehensive draft guidance effectively covers a range of chemistry, manufacturing, and control (CMC) topics relevant to gene therapy products. However, BIO notes the draft guidance is quite prescriptive and does not necessarily match modern manufacturing.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 On the whole, it seems much of the information required by the draft guidance is more appropriate for a BLA filing, an approved product, or postapproval changes to a product rather than an IND.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BIO Comments on Draft Guidance on Long-Term Follow-Up After Administration of Human Gene Therapy Products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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products.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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BIO Applauds International Support of Agricultural Applications of Precision Biotechnology
Press Release  •  November 5, 2018
The following statement may be attributed to Joseph Damond, Executive Vice President, International Affairs for the Biotechnology Innovation Organization, in response to the United States and 12 other nations signing on to the International Statement on Agricultural Applications of Precision Biotechnology. The joint statement supports policies that enable agricultural innovation, including genome editing.
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BIO Welcomes Announcement of FDA’s Plant and Animal Biotechnology Innovation Action Plan
Press Release  •  November 1, 2018
Washington, D.C. (November 1, 2018) – The Biotechnology Innovation Organization (BIO) released the following statement regarding the U.S. Food and Drug Administration (FDA) Plant and Animal Biotechnology Innovation Action Plan:
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BIO Statement on the Administration’s Drug Pricing Proposal
Press Release  •  October 25, 2018
Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood issued the following statement after the Trump administration outlined proposed changes to the Medicare Part B program.
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BIO Comments on Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Letters, Testimony & Comments  •  October 16, 2018
BIO submitted comments to the National Institutes of Health (NIH) regarding the Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. BIO applauds the NIH’s efforts to support and advance drug development for gene therapies, by streamlining protocol registration and reporting requirements and by modifying the roles and responsibilities of the Recombinant DNA Advisory Committee. BIO agrees with the goal to eliminate duplication and excess in regulation of gene therapy products, as these redundancies do not exist in most other areas of clinical research. BIO believes there is sufficient and robust regulatory framework already in place for safe and effective development of gene therapy products. BIO also proposes changes to the requirement for an Institutional Biosafety Committee (IBC) approval of a study site before initiation of a study.
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BIO Comments on FDA Draft Guidance on Use of Expansion Cohorts in First-In-Human Clinical Trials
Letters, Testimony & Comments  •  October 12, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. BIO welcomes FDA’s efforts to provide clear guidance on the regulatory and scientific framework for designing and conducting adaptive trial designs in which different aspects of a drug can be assessed in a single clinical trial while enrolling the minimum number of study participants necessary. BIO’s comments cover topics including sample sizes, the need for flexibility, and balancing safety and efficacy. BIO encourages the FDA to consider expanding the use of the guidance beyond oncology.
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BIO Applauds President Trump's Directive to Allow Sales of E15 Fuel Year-Round
Press Release  •  October 9, 2018
The following statement may be attributed to Brent Erickson, BIO’s Executive Vice President, Industrial and Environmental Section, in response to President Donald Trump’s directive allowing the sale of E15 fuels year-round. 
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BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment
Letters, Testimony & Comments  •  October 8, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment. The draft guidance is an important step in clarifying the FDA’s view of endpoints to demonstrate efficacy of therapies to treat opioid use disorder (OUD). It’s important to expand primary and secondary endpoints in clinical trials for medications to treat opioid use disorder, including the outcomes patients and clinicians said were important to them at the public meeting on patient-focused drug development for opioid use disorder. BIO requests clarification on how the FDA defines relapse to illicit opioid use, and requests FDA consider other possible endpoints to demonstrate effectiveness of drugs. BIO recommends the FDA provide additional detail on Phase III studies for medication assisted treatments.
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BIO Statement on the United States-Mexico-Canada Agreement
Press Release  •  October 4, 2018
Washington, D.C. (October 4, 2018) – Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the United States-Mexico-Canada Agreement (USMCA):“BIO supports the USMCA and appreciates the Administration’s efforts to prioritize biotechnology innovation, including provisions that update intellectual property protections and agricultural market access to 21st century standards.“Strong and dependable intellectual property standards are critical to fueling innovation, attracting investment, and ensuring that patients, farmers, and consumers around the globe have access to the next generation of biotechnology breakthroughs. The USMCA represents an important step in bringing Mexico and Canada closer to high U.S. standards that have made us the world leader in biotechnology innovation.“The U.S., Mexico and Canada also have a long history of cooperation in the area of agricultural biotechnology, the USMCA builds on this by advancing provisions to facilitate trade and ensure cooperation on future innovation in biotechnology.“Thanks to the Administration’s leadership, the U.S. and our neighboring countries will continue to drive global innovation, ingenuity and ground-breaking science.“The USMCA sets important new standards for U.S. trade policy by ensuring trading partners establish policies that protect, respect, and advance the hard work and investment needed to bring new biotechnology innovations from the lab to the marketplace.”
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