COVID Updates and all the latest additions to the IHIF COVID-19 Toolkit

The FDA released a 24-page guidance update on its website for drugmakers that aim to adapt their COVID-19 products, such as vaccines, diagnostics and therapeutics, to emerging coronavirus variants. "By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts," said acting FDA Commissioner Janet Woodcock.
Full Story: CNN (2/22), CNBC (2/22)  
Another Bloomington Facility to Produce COVID Vaccine
The city of Bloomington is further growing its role as a critical site for the mass production of the COVID-19 vaccine. Massachusetts-based Moderna Inc. (Nasdaq: MRNA) says it has selected Baxter International Inc. (NYSE: BAX) to fill and finish approximately as many as 90 million doses of its vaccine in the Monroe County city. Read More (Source: Inside Indiana Business)
Lilly Touts New Trial Results for COVID Antibody Therapies
Indianapolis-based Eli Lilly and Co. says the combination of two of its COVID-19 antibody therapies continues to reduce hospitalizations and death in high-risk patients recently diagnosed with the disease, according to a new clinical trial. The company says data from the Phase 3 study support the use of... Read More (Source: Inside Indiana Business)
Catalent Ready to Ship More COVID Vaccines from Bloomington
More COVID-19 vaccine doses will soon be made available to Americans, and they will come from a production facility in Bloomington. New Jersey-based Catalent Inc. (NYSE: CTLT) has been manufacturing the Johnson & Johnson vaccine for more than a month and is now awaiting regulatory approval to begin distributing the vaccine from the Monroe County facility. The company has also been producing the Moderna vaccine for several months and Denis Johnson, general manager of the Bloomington plant, says they are on pace to meet the commitments for both vaccines. Read More (Source: Inside Indiana Business)
With the possibility of COVID-19 vaccines becoming available soon, get the facts on vaccine development. Learn more about the scientific rigor that goes into developing a vaccine, and how the vaccine process is safe and effective.
Member News
Worth a read
From BioCrossroads: The Brookings Institution recently released a report, sponsored by the Central Indiana Corporate Partnership, State of renewal: Charting a course for Indiana’s economic growth and inclusion, which features a deep analysis of Indiana’s workforce and economy. 

From Elevate Ventures: The report from Indianapolis-based Elevate Ventures shows VC deals throughout the state increased nearly 20%, the majority of which were pre-seed investments of $500,000 or less. Read More (Source: Inside INdiana Business)

From the National Cancer Institute: National Cancer Institute has one of the largest Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs in the U.S. In 2017, NCI SBIR Development Center hired TechLink, an organization specializing in economic impact studies of SBIR programs, to conduct an economic impact study to quantify the program’s overall contribution to the national economy.
Purdue-Affiliated Company Inks Research Agreement
A Purdue University-affiliated company is working to reduce mortality and morbidity resulting from injuries on the battlefield through the development of new life-saving strategies. OYE Therapeutics Inc., located in the Purdue Research Park, has entered into a Cooperative Research and Development Agreement with the Uniformed Services University of the Health Sciences. Read More (Source: Inside Indiana Business)
Lilly Touts Positive Results for Diabetes Treatment
Indianapolis-based Eli Lilly and Co. is reporting positive results from two Phase 3 clinical trials of a drug designed to help people with type 2 diabetes. Lilly says tirzepatide led to "significant A1C and body weight reductions" in adults with the disease during the trials. Read More (Source: Inside Indiana Business)
Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. Read More (Source: Medical Tubing and Extrusion)

Welcome New IHIF Members!
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Featured New Member
Femtera Laboratories LLC strives to innovate next-generation diagnostics for severe diseases, especially for simultaneous detection of multiple types of early-stage cancers. The accurate, non-invasive and affordable laboratory-developed tests (LDTs) the company works on are based on the cutting-edge metabolomics and high-resolution accurate mass spectrometry (HRAM) techniques. In addition, the company has been providing certain high-end research-use-only (RUO) testing services to support related research institutions/ hospitals.

Founded in March 2016, the company is currently located in the Biotechnology Research & Training Center of the Indiana University School of Medicine (IUSM) in Indianapolis, Indiana. Its technical team is comprised of highly skilled researchers hailing from multidisciplinary backgrounds. With unique combined expertise in academic research, industrial R&D and commercial testing services, the team is able to bridge the gap between scientific findings and commercialization. Femtera further enhances its strengths by working with a group of highly qualified consultants and collaborators.

IHIF's Policy Corner
What We're Following at Home and on the Hill

Upcoming Events
BioForward Wisconsin, BioKansas, BioOhio, Bio Nebraska, iBIO, Indiana Health Industry Forum (IHIF), MichBio, Missouri Biotechnology Association (MOBIO), South Dakota Biotech, and PSC Biotech’s joint webinar, “How to Select an eQMS for the Medical Device Industry”, goes live on 4/1/21 at 9AM (CST)/10AM (EST). This webinar provides guidance on how to select an eQMS and goes over the benefits of Quality Management Systems for Medical Device Companies.

Items Discussed: 
-Pain Points of Startup Medical Device Companies
-Medical Device Regulations
-How to Build Out a Successful QMS for a Startup
-Electronic Quality Management Systems
-Benefits of an eQMS
APRIL 30, 2021
Registration for The Digital MedTech Conference is open! Taking place virtually on May 6, The Digital MedTech Conference is a great opportunity to gain insights from leading industry experts and partake in discussion about current and future challenges, opportunities and trends in the digital health and medical device sectors. Learn more.
With the industry preparing for increased activity around partnering events in 2021, due in part to the virtual and hybrid nature of hosted meetings, it will be critical to establish a strategic roadmap for engagement that accelerates the effectiveness of your business development efforts. 

Elevate your presence at BIO’s established portfolio of independent investor and partnering events and attract the attention of hundreds of business development leaders, licensing professionals and investors from across the globe. 

*Please note, IHIF Membership does not qualify for the BIO Member discounts.
BIO Digital
June 10-11, 14-18, 2021

Ready to expand your company's visibility and partnership opportunities beyond borders in 2021? Join the Innovation Stage, BIO Digital's new interactive forum showcasing the hottest companies in biotech!
How does it work? Fast-paced presentations and networking allow you to showcase your company, biotech region, or technology to a global audience of prospective partners ahead of BIO Digital Week. Early access programming June 10-11 includes the new can't-miss Global Marketplace, allowing state and international delegations to tell their stories, plus other exciting tracks that will help your company rise to new heights!
With several options to participate, explore the new Innovation Stage and how your company or organization can get involved.

Announcing the 2020 - 2021 IN Life Sciences Collaboration Conference Series!

Since 2006, CBLS has been presenting the Indiana Life Sciences Collaboration Conference Series, providing a forum for professionals in healthcare and life sciences to consider, discuss, and debate key business strategy issues. The conferences bring together leaders from industry, academia, government, and economic development communities. Join us in exploring business solutions and making new connections in the life sciences.
This year's series will begin virtually, building upon great subjects and quality presenters just as in previous years. The November format is modified for a half-day schedule over a two day span. We are excited to leverage the highly ranked Kelley School of Business' online learning resources for educational and networking opportunities for the series!
Lessons Learned from the Pandemic
April 30, 2021
Format TBD
WEBINAR: Reverse Mergers and SPACs: Are APOs the New Norm for Biotechs Going Public?
Date/Time: THURS. MAR 18, 2021 | 9 AM – 10 AM PT
2020 was an unprecedented year for Special Purpose Acquisition Corps (SPACs), an alternative public offering (APO) financing vehicle for listing on a public stock exchange. SPACs raised $82 billion, a figure greater than all previous years combined and representing nearly half of all capital raised in U.S. listed initial public offerings (IPOs). And the momentum continues to grow in 2021 as evidenced by 225 SPACs raising roughly $71 billion—a figure that accounts for more than 70% of all public stock sales and putting it on track to shatter last year’s record. 

Join us on Thursday, March 18th for a webinar as Scott Jordan leads a distinguished panel of experts to discuss the SPAC landscape from those immersed in the sector including sponsors, a leading attorney representing SPACs, and an investment banker facilitating concurrent financings.
During the webinar, panel members will provide an overview of the financing structure, capital raised to date, case studies of closed transactions, and answers to the following questions:
• Is my company a candidate for a SPAC?
• Should my board evaluate SPACs as a viable alternative to an IPO?
• How do I position my company to attract a SPAC and raise concurrent financing?
• What are the advantages / disadvantages of going public via a SPAC, IPO, or Reverse Merger?
• What are the key success factors for closing a SPAC and achieving post-close success?
Panel members include:
David Strupp – Co-Chief Executive Officer, Ignyte Acquisition Corp
Scott Janssen – Managing Director, LS Associates
Stephen Alicanti – Partner, DLA Piper
Mike Montgomery – Managing Partner, Effectus Group
Moderator: Scott Jordan – Founder / CEO, S. Jordan Associates (SJA)
BREXIT: What you need to know NOW!
March 18, 2021, 12:00 PM-1:00 PM

The United Kingdom officially left the European Union on January 31, 2020 and on December 24, 2020, the UK and EU concluded a Trade and Cooperation Agreement (TCA) that set out terms for the U.K.’s departure from the E.U.’s single market and customs union on January 1, 2021.

Join the Indiana District Export Council and the U.S. Department of Commerce for a BREXIT webinar on March 18th, 2021.

Hear from experts from the British Consulate General in Chicago on the impact that the TCA has on Indiana companies doing business with the UK, and on companies looking to use the UK as a gateway to the EU market. We will also learn about the progress of the Free Trade Agreement being negotiated between the UK and the US, and the opportunities that a successful negotiation will create for local companies.

COMPANY PERSPECTIVE: Berry Global is a plastic packaging company with over 290 locations around the world based in Evansville, Indiana. Learn how Berry Global is navigating BREXIT and how it’s impacting their UK operations.

  • Rob McNeill | Regional Director for the Midwest & Colorado | British Consulate-General Chicago
  • Frances Moffett-Kouadio | British Consulate-Chicago, Department for International trade’s Director for Exports in North America
  • Ryan Middendorf | Director of Global Trade at Berry Global, Inc. |
Ryan has over 20 years of import and export experience managing customs compliance and international freight for large retailers and manufacturers. He is responsible for trade compliance policies for all of Berry’s global businesses and oversees import and export operations in the US and Canada. He is a licensed US Customs Broker and has a degree in International Business from Northern Kentucky University.
Industry News
Academy Launched for Medical Device Development
Indianapolis-based management software company Greenlight Guru has created an online educational platform to help medical device companies through regulatory and product development challenges. Greenlight Guru Academy says it intends to help medical device professionals train their employees to effectively design, develop and market safer, more effective medical devices for patients. Read More
BIO Business Solutions - Special Discounts for IHIF Members
BIO Business Solutions provides cost-savings offers to eligible IHIF Members. To learn more about the programs and services available, please click here. Not an IHIF member? Join today! See the latest deals and offers from our BIO Business Solutions partners here
Featured Program
About ShareVault
ShareVault offers secure, cloud-based document sharing solutions, also known as virtual data rooms, that are frequently used by organizations of all types to securely share highly confidential documents with outside parties. In contrast to consumer-grade file sharing services, ShareVault allows organizations to easily share documents with third parties, while monitoring access and maintaining control.
IHIF Member Benefits

  • Minimum 20% discount on ShareVault's primary products
  • Minimum 30% savings off the standard pricing of ShareVault for SharePoint
  • At least 5% additional discount on subscriptions with terms of two or more years
  • eCTD tag structure available at no cost
  • Creation of document index available at no cost
  • Migration services from existing VDRs at no cost
  • Assistance with high-performance uploads at no cost
About IHIF Membership

Now is a great time to become a member of the Indiana Health Industry Forum! Join your voice to over 150 current member companies to impact the strategic direction of Indiana's health science sector.

Membership in IHIF offers a number of solutions:
  • Promote your business, locally, nationally, and globally.
  • Support the industry in the state and contribute directly to its growth and direction.
  • Find others who share your interests and build your business network.
  • Lend your voice to public policies that support innovation.
  • Directly impact your bottom line with significant savings and discount programs exclusively for IHIF members.

To complete a membership application, click here. 
Time to renew? Try it on-line! It's quick and easy! IHIF members can renew their memberships on-line at any time and update information in the Member Directory. Not an IHIF Member? Apply on-line or download an application packet now!