BIO Early-Stage Resources Hub

Access a range of exclusive resources, including cost-saving programs, educational webinars and stay up-to-date with the latest BIO Emerging Companies Section (ECS) events with our comprehensive resource center, designed to empower early-stage companies and help them thrive.

Please find below a list of digital resources available to you covering several critical topics in the capital formation and funding space for early-stage biotechs. BIO members can access additional content here.
BIO Member Resources

BIO members can access additional content by clicking here and entering a password. If you’re a BIO member and need to access the page, please email bioemergingcompanies@bio.org.

Tax Policy Issues
 

BIO is focused on advancing tax policy that recognizes early-stage biotech companies as fundamental to the long-term economic growth of the United States. An overview of BIO’s tax policy priorities are below.

6/6/2023
Statement for the Record: "American Ingenuity: Promoting Innovation Through the Tax Code"

BIO letter to House Small Business Committee outlining 7 tax policy recommendations for supporting biotechs.

5/4/2023
Letter to House & Senate Leaders: R&D Amortization

BIO and BIO members urge immediate legislative action to repeal the harmful R&D amortization provision that went into effect in 2022.

6/15/2022
Letter to House & Senate Leaders: R&D Amortization

BIO, BIO members, and State affiliates urge immediate legislative action to repeal the harmful R&D amortization provision that went into effect in 2022.

7/6/2023
BIO Tax Priorities Overview

An overview of BIO’s tax policy priorities.

4/21/2023
Talking Points: Impact of Domestic R&D Amortization on the Biotechnology Community

Talking points on the background, impact on the biotechnology community and solution.

SBIR
 

The SBIR program plays an important role in financing promising early-stage innovation. Here are some resources to help you draft applications and track critical submission deadlines.

Grant Application Timeline

A three-month schedule for completing an SBIR/STTR grant application including key activities to complete.

BIO Office Hours: Grant Writing Slides

A PowerPoint presentation on the grant application process. An overview of how to identify opportunities, how to compose a proposal, and project management tips.

PSC Biotech: Grant Writing White Paper

A white paper on regulatory grant writing, best practices for developing proposals, success factors, and tackling grant writing challenges.

SBIR Application Key Decision Points Flowchart

A grant application flowchart from start to finish. Includes decision points and scenarios to help determine which agencies and grants to apply to.

Raising Investor Capital
 

Partnerships between small biotechs and large pharma companies can drive scientific advancements and expedite drug development. Our goal is to provide the tools needed to facilitate these collaborations.

BIO Large Biopharma Therapeutic Focus Guide

This resource provides guidance to assist early-stage companies in identifying potential large biopharma partners.

Capital Formation Policy Issues
 

BIO’s comments on legislative and regulatory tax issues, securities law issues, accounting, and other capital formation policy initiatives.

6/17/2022
The Enhancement and Standardization of Climate-Related Disclosures for Investors

Comments on proposed rule to require information about a registrant’s climate-related risks that are reasonably likely to have a material impact on its business, results of operations, or financial condition.

5/5/2022
Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure

Comments on proposed rule to enhance and standardize disclosures regarding cybersecurity risk management, strategy, governance, and incident reporting by public companies.

3/30/2023
Order Competition Rule

Comments on proposed rule to amend regulations governing the national market system (NMS).

4/25/2022
Short Position and Short Activity Reporting

Comments on proposed rule to require money managers to disclose within 14 calendar days after month-end certain gross short positions on companies.

3/30/2023
Minimum Pricing Increments, Access Fees, and Transparency of Better Priced Orders

Comments on proposed rule to adapt a variable minimum pricing increments for the quoting and trading of NMS stocks, reduce access fee caps, and enhance transparency of better priced orders.

6/13/2021
Request for Comment on Climate Risk Disclosures

Comments on SEC request for information on climate risk disclosures.

12/23/2021
Request for Comment on Proposed Amendments to Rules Governing Proxy Voting Advice

Comments on proposed rule governing proxy voting advice.

6/13/2021
Request for Comment on Pharmaceutical Task Force, Project No. P212900

Comments in response to Federal Trade Commission’s Pharmaceutical Task Force’s request for public comment.

4/15/2022
Request for Information on Merger Enforcement

Comments to FTC on merger enforcement.

5/5/2022
Business Practices of PBMs and Their Impact on Independent Pharmacies and Consumers

Comments in response to FTC Solicitation for Public Comments on the Business Practices of PBMs and Their Impact on Independent Pharmacies and Consumers.

4/23/2023
"A Roadmap for Growth: Reforms to Encourage Capital Formation and Investment Opportunities for All Americans"

Statement for the Record to House Financial Services Committee, Subcommittee on Capital Markets.

12/15/2021
"The Impact of Consolidation and Monopoly Power on American Innovation"

Testimony of BIO’s Chief Policy Officer before the Senate Subcommittee on Competition Policy, Antitrust, and Consumer Rights on consolidation and monopoly power.

7/29/2021
Short Sale Transparency and Market Fairness Act

BIO Support of H.R. 4618, to amend short sale reporting requirements.

9/22/2022
Committee on Foreign Investment in the United States (CFIUS)

An overview of CFIUS and how the Administration’s focus on protecting the U.S. Biotech Industry could cause unintentional harm by impeding foreign investment and collaborations.

3/28/2021
Proposals to Foster Capital Formation and Economic Growth in the Bioeconomy

BIO Letter to Senate Banking Committee in support of proposals to foster capital formation for biotechs.

Industry Analysis
 

See below for a collection of recent reports from BIO’s Industry Analysis team. To view the full collection of reports, visit bio.org/ia-reports. To view BIO data on emerging therapeutic company investment and deal trends. click here. To view BIO data on FDA Approval Trends and clinical development pipeline, click here.

Emerging Therapeutic Company Investment and Deal Trends

New BIO Industry Analysis trend data have been released for Emerging Therapeutic Company Investment, R&D-Stage Out-licensing, and Acquisitions.

IRA's Impact on the Biopharma Ecosystem

New research released by Vital Transformation (VT) shows that the Inflation Reduction Act (IRA) will stifle the ability of companies to continue research and development across a broad range of therapeutic areas.

FDA Approvals & Clinical Development Pipeline

BIO’s Industry Analysis Team presents FDA Approval Trends that are filterable by various attributes including: size of company, molecule size, disease area, and various expedited approval pathways.

The State of Innovation in Antibacterial Therapeutics

This report investigates recent investment into antibacterial innovation and the current clinical pipeline that will help bridge the gaps in the antibacterial armamentarium.

The State of Innovation in Vaccines and Prophylactic Antibodies for Infectious Diseases

This report focuses on vaccine innovation and success at the clinical stage, as well as the innovation of prophylactic antibodies in clinical trials.

BIO Office Hour Materials
 

BIO Office Hours allow you to schedule one-on-one meetings with subject matter experts. Below are materials from past office hours. For more information, visit bio.org/save/office-hours.

Chubb Cyber Index

Contains graphs and charts on cyber threat trends. View data on assets affected, annual claims, and more by industry and revenue size.