BIO Comments on USDA-AMS National Bioengineered Food Disclosure Standard

Jul 3 2018
RE: Proposed Rule- National Bioengineered Food Disclosure Standard- Doc. No. AMS-TM-17-0050 83; Fed. Reg. 19860 (May 4, 2018)

Nonclinical: BIO Comments on FDA Draft Guidance Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals

Jun 25 2018

June 25, 2018


BIO Comments on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation

Jun 8 2018

June 8, 2018


Clinical Trials: Scientific and Ethical Considerations for Inclusion in Clinical Trials

Jun 8 2018

June 8, 2018


Benefit-Risk: BIO Comments on Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan

May 31 2018

May 31, 2018


Compounding: BIO comments on FDA Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

May 25 2018

May 25, 2018


BIO Written Testimony for House Financial Services Hearing on Legislative Proposals to Help Fuel Capital and Growth on Main Street

May 23 2018
Good morning Chairman Huizenga, Ranking Member Maloney, and Members of the Capital Markets, Securities, and Investment Subcommittee. My name is Brian Hahn, and I am the Chief Financial Officer of GlycoMimetics, Inc., a 48-employee public biotech company based in Rockville, Maryland. I am also the Co-Chair of the Finance and Tax Committee at the Biotechnology Innovation Organization (BIO), which represents GlycoMimetics and over 1,100 other growth-stage biotechs that are driving the search for the next generation of cures and breakthrough medicines. The ability of growing businesses to access the public markets, as supported by the JOBS Act, is of paramount importance to biotechnology innovation because investment capital is the lifeblood of scientific advancement. It costs over $1 billion to develop a single life-saving treatment, and most companies spend more than a decade in the lab before their first therapy is approved. During this long development process, virtually every dollar spent by an emerging biotech comes directly from investors. Expenses ranging from buy-in-bulk beakers to $150 million clinical trials are all funded by investment capital because biotechs remain pre-revenue through their entire time in the lab and the clinic.

BIO Submission to the China Section 301 Investigation - September 28, 2017

Apr 4 2018

BIO submitted comments to the Office of the United States Trade Representative (USTR) and the inter-agency Section 301 Committee regarding the investigation, initiated on August 18, 2017,...

BIO Comments on FDA Draft Guidance Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products

Mar 27 2018

March 27, 2018


BIO Comments on Proposed Settlement Agreement Between EPA and Philadelphia Energy Solutions on RFS Obligations

Mar 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.