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BIO Announces Keynote and Returns to Boston June 4-7 to Celebrate 25 Years of History-Making Innovation
Press Release  •  April 3, 2018
TV's Robin Roberts will deliver the keynote address at the upcoming BIO International Convention which returns to Boston June 4-7. Celebrating its 25 year anniversary, BIO will host the event expected to attract more than 16,000 attendees and 1,800 exhibitors from 74 countries.
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BIO Comments on FDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act Products
Letters, Testimony & Comments  •  March 27, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products. The Prescription Drug User Fee Act (PDUFA) meeting structure fosters robust communication between the FDA and industry and promotes biomedical innovation. Formal, face-to-face meetings – along with other types of communication like well-written responses, phone calls, and emails – are critical for aligning on complex scientific matters throughout the drug development process. With clarifications, this guidance could be a helpful tool for sponsors to engage in more productive discussions with the FDA. BIO requests clarifications on surrogate endpoint/biomarker Type C meetings, background package contents, whether FDA welcomes discussion of emerging data sources (patient experience data, novel trial designs, real-world evidence), preliminary responses to sponsors, and meeting timelines, among other issues.  
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BIO Comments on DOJ’s Environmental Settlement Agreement with Philadelphia Energy Solutions
Press Release  •  March 26, 2018
BIO today submitted comments to the U.S. Department of Justice on the proposed Consent Decree and Environmental Settlement Agreement with the United States Bankruptcy Court for the District of Delaware in the case of Philadelphia Energy Solutions Refining and Marketing LLC and PES Holdings LLC (PES).
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BIO Comments on Proposed Settlement Agreement Between EPA and Philadelphia Energy Solutions on RFS Obligations
Letters, Testimony & Comments  •  March 26, 2018
BIO is greatly concerned by the Department of Justice's and Environmental Protection Agency's proposed Settlement Agreement to resolve a dispute about the PES Holdings' obligations under the Renewable Fuel Standard.
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BIO Applauds Introduction of the Advancing Emergency Preparedness Through One Health Act of 2018
Press Release  •  March 23, 2018
The Biotechnology Innovation Organization (BIO) applauds the introduction of the “Advancing Emergency Preparedness Through One Health Act of 2018” by Senators Tina Smith (D-MN) and Todd Young (R-IN).
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BIO Statement on Growing American Food Exports Act of 2018
Press Release  •  March 23, 2018
The Biotechnology Innovation Organization (BIO) today released the following statement in response to the introduction of the “Growing American Food Exports Act of 2018” by Representatives Neal Dunn (FL-02) and Jimmy Panetta (CA-20).
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BIO Comments on FDA Draft Guidance on Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
Letters, Testimony & Comments  •  March 22, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. BIO supports the FDA’s efforts to update and replace the 1997 version of this guidance, and suggests the FDA revise the guidance entitled Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products, which is also dated July 1997. BIO appreciates the inclusion of cellular, gene, and cell-based gene therapy products in the scope but notes some of these products are excluded as exceptions in certain examples in the appendix. BIO’s comments include suggested changes to promote the longevity of the guidance, make terminology more consistent, and promote continuity and consistency across various guidelines.
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USDA Biobased Economy Report Indicates Potential for Rural Prosperity with Renewable Chemicals
Press Release  •  March 20, 2018
BIO today welcomed USDA’s release of a new report, Indicators of the U.S. Biobased Economy, which measures substantial economic growth, job creation, and household income from biofuel and bioenergy production and future growth in renewable chemicals and biobased products.
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BIO Comments on Promoting the Use of Complex Innovative Designs in Clinical Trials
Letters, Testimony & Comments  •  March 20, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials. BIO supports the development and launch of this initiative. BIO shares the FDA’s goals for the pilot program to promote public learning about Innovative Clinical Trial Design (ICTD) and to demonstrate the use of novel designs to increase the efficiency and/or feasibility of clinical development. The pilot program will present multiple opportunities for public learning and the advancement of ICTD. To advance the successful implementation of the ICTD Pilot Program, BIO developed recommendations on the timelines, communication, and disclosure of information, among other issues. BIO’s comments also include high-level case studies of innovative clinical trial designs which have historically shown low levels of regulatory, in an effort to provide insight into the general types of innovative clinical trial designs BIO would like to see in the pilot program.
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BIO Statement of Support for the STRONGER Patents Act
Press Release  •  March 20, 2018
Washington, D.C. (March 20, 2018) – The following statement on the House introduction of the STRONGER Patents Act by Representatives Steve Stivers (R-OH-15) and Bill Foster (D-IL- 11) may be attributed to Tom DiLenge, BIO’s President, Advocacy, Law & Public Policy Division:“BIO supports balanced reforms to reduce abusive patent practices – both by patent owners and against patent owners.  But we also must strengthen the incentives needed to sustain our nation’s global leadership in biotechnology innovation and the creation of high-wage, high-value jobs throughout our country. With the introduction of the STRONGER Patents Act, Congress has begun the process of achieving that critical balance.“I commend Representatives Stivers and Foster for their leadership in introducing legislation that will reform the inter partes review and post-grant review processes, bringing fairness and finality to these Patent Office proceedings. The bill also will enhance patent quality by ensuring that all fees paid to the Patent Office are used for their intended purposes, and will crack down on abusive patent demand letters.“Strong patents are the lifeblood of the biotechnology industry. They are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines and more sustainable sources of energy and agricultural products. And they are essential to the technology transfer process that leads from inventions in the lab to products on the shelves.“The majority of biotechnology companies are small companies that have no products on the market, and thus their research and development activities are funded through massive amounts of private sector investment over many years, sometimes even decades. Without strong, predictable and enforceable protections for patented inventions, investors will shy away from investing in biotechinnovation, degrading the ability to provide solutions to the most pressing medical,…
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