Business Development Forum Kickoff - SAVE THE DATE

IHIF's new Business Development Forum will kick off with a webinar on October 21 from 10:30 - 11:30 am on, "Innovative Discovery Spaces Past, Present & Future – 3 Cases Studies”. Invitation and Registration information will be forwarded to Forum members soon.

Your company or organization must be an IHIF member to participate in Forum discussions. If you are already a member, please sign-up here to join the Business Development Forum. Not a member? Sign up today!

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

The FDA has released a list of medical devices that have been discontinued or are in shortage due to the COVID-19 pandemic. The move is part of a new authority under the Coronavirus Aid, Relief, and Economic Security Act, which requires manufacturers of certain devices to report interruptions and discontinuations and requires the FDA to maintain lists of that information.
Full Story: Regulatory Focus (8/14)  Source: BIO Smartbrief

Catalent announced Monday that its commercial gene therapy manufacturing facility in Maryland was chosen to produce the viral vector to be used in AstraZeneca and the University of Oxford's experimental COVID-19 vaccine by the latter portion of the third quarter. AstraZeneca's vaccine candidate is one of the leading options in the vaccine development race.
Full Story: Reuters (8/24)   Source: BIO Smartbrief
Centralized distribution of a COVID-19 vaccine will be managed by medical supplier McKesson, according to the Trump administration. The company will follow CDC guidance for shipping vaccines to administration sites, and planning is underway to ensure rapid distribution if a vaccine is approved.
Local health officials in the US aren't sure how they'll pay for and organize the delivery of a COVID-19 vaccine to some 330 million people. "It's probably going to be even worse than the problems with testing and PPE," said Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials.
Notre Dame Researchers Launch COVID Registry
Researchers at the University of Notre Dame are leveraging the university’s membership in the Indiana Clinical and Translational Sciences Institute and one of its key programs to launch the Indiana COVID-19 Registry. Notre Dame says the registry is an effort to track the spread and impact of the coronavirus and better inform decision makers at the state and local levels. Read More
IU School of Medicine Chosen for COVID Vaccine Trial
The Indiana University School of Medicine in Indianapolis has been selected as one of dozens of sites for a COVID-19 vaccine trial. United Kingdom-based AstraZeneca plc (NYSE: AZN) is conducting the Phase III clinical trial of the vaccine, which researchers at Oxford University began developing in January. The IU School of Medicine is the only site in Indiana to be selected for the trial, and the university says the participants will be a representative sample of the population demographics of Indianapolis. Read More Source: Inside Indiana Business
Member News
$1.5M Grows Impact for Parkinson's Speech Device
A Purdue University professor believes the device she invented years ago is now on the doorstep of helping potentially one million people overcome a hardship of Parkinson's disease. SpeechVive, a small device that resembles a hearing aid, is worn over one ear to help the wearer overcome speech issues caused by Parkinson's. Boosted by a recent $1.5 million funding round--and a major triumph within the Medicare system--SpeechVive's creator says the device is now more affordable and poised to help a million patients find their voice again. Full Story
Joint Venture to Manage IU Health Campus Design
Through a joint venture, three Indianapolis firms are working together to design the new Indiana University Health campus in downtown Indianapolis. CSO and RATIO Architects, along with healthcare design company BSA LifeStructures, have formed CURIS Design LLC. 
IU, Purdue Collaborate on Potential Kidney Cancer Test
Indianapolis-based Walther Cancer Foundation Inc. has awarded two grants totaling $240,000 to help researchers who are working to develop a urine test to help detect a type of kidney cancer. The goal is to create a simple test that would help patients avoid an invasive biopsy as doctors look for renal tumors. 
Ten Saint Mary’s student workers will be hired to work as analysts and startup coaches at the IDEA Center and will be involved every step of the way in the commercialization process. 
Cellexus begins growth drive
Scotland, Dundee biotech, Cellexus, started on a growth drive this quarter with the addition of two new team members, an office expansion as well as closing their latest share round. Cellexus welcomed Dr Adam Ostrowski to a newly created Technical Application Specialist role. With a background in Microbiology, Adam’s role will focus on supporting new and existing customers to ensure they are using the CellMaker system in the most effective way. This includes providing technical expertise and advice on optimising their bioprocesses. Craig Walker also joined the Technical Team, increasing in-house production capabilities. 
Foreign Investment in the U.K.: A Proposed New Framework for Increased Scrutiny

The U.K. has historically adopted a relatively liberal approach to foreign investment and remains one of the top recipients of foreign investment in the world. In contrast to its neighbours in Europe and the United States, the U.K. does not currently operate a separate framework for the review of foreign investment transactions that raise national security considerations. Instead, it forms part of the U.K.’s wider legal framework on merger control in a competition context, presided over by the U.K. Competition and Markets Authority (CMA).

Indy Commercial Real Estate Firms Announce Merger
Two Indianapolis-based commercial real estate firms are joining forces. Bradley Co. and RESOURCE Commercial Real Estate have announced plans to merge, though financial details are not being disclosed. 
IBRI Names New President and CEO
The Indiana Biosciences Research Institute has named Dr. Alan Palkowitz president and chief executive officer. IBRI says the research scientist will continue his work at the Indiana University School of Medicine as a professor of medicine. Read More
Sotera Health’s Sterigenics Announces Acquisition of Iotron Industries
Sotera Health, the world’s leading, fully integrated protector of global health, announced today that it has acquired Canadian-based Iotron Industries. The acquisition expands the company’s electron beam (EBeam) footprint and adds new expertise to its Sterigenics business. Iotron Industries is a leading outsourced provider of EBeam sterilization in North America.
Catalent Investing $50M in Bloomington
New Jersey-based Catalent Inc. (NYSE: CTLT) is continuing to grow its operation in Monroe County. The company says it is investing $50 million to install a third high-speed vial filling line at its Bloomington facility by April of next year. Read More
Welcome New IHIF Members!
Follow IHIF on Twitter to keep up with all of the latest news, events, and exclusive member benefits!

Featured New Member
Networks Connect is a technical staffing solutions company serving the short-term, long-term contract, temporary-to-hire, and direct-hire staffing service needs of all companies and professionals in the areas of IT, Engineering, Scientific, Manufacturing & Supply Chain, Civil Engineering & Architecture.
IHIF's Policy Corner
What We're Following at Home and on the Hill

  • Find your legislators and keep up with IHIF's advocacy efforts - here
IHIF Actions
  • Signed on to multi-state letter to HHS opposing the use of March In Rights for Remdesivir and supporting Bayh/Dole and the importance of protecting innovation.

  • Supported letter to the President from the Council of State Bioscience Associations opposing the "Most Favored Nation" executive order.

New Voter Registration Tool - Biotech Votes 2020
Science is the way out of this pandemic and voting is the way you can help.

With Biotech Votes 2020, you can:
1) VERIFY polling/mail-in ballot information
2) REGISTER to vote
3) LEARN about the candidates & key biotech policies

Your voice is critical!

EVENT: Biotech Votes 2020 – Webinar
Sep 14, 2020 1:00PM—2:00PM
Free of Charge – REGISTER HERE

With the elections just weeks away, BIO is providing an in-depth discussion on the political races that matter most, from the top-of-the-ticket, through the Senate and House, and down the ballot to pivotal state races. Attendees will hear analysis on the presidential election, the hurdles between now and election day, “must-pass” legislation, a potential Congressional COVID relief package, and the post-presidential conventions landscape.

Our expert panel will provide additional insight into:
  • Likely events that might shape the election’s final outcome
  • The policy outlooks under both a second Trump term or a Biden presidency
  • How the balance of power in Congress may impact those within the biotech industry
  • How the Covid-19 pandemic has affected the strategies of this year’s campaign
CMS Issues Proposed Rule on Medicare Coverage of Innovative Technology – Provides Immediate, National, 4-year Coverage for Breakthrough Devices
The Centers for Medicare & Medicaid Services (CMS) released the long-awaited proposed rule on "Medicare Coverage of Innovative Technologies." The proposed rule, which is the result of many years of hard work and advocacy on the part of AdvaMed and its member companies, would make significant changes to streamline Medicare coverage for FDA-designated breakthrough technologies that have market authorization.  

Big Issue: What you Need to Know During National Immunization Awareness Month and Beyond
Source: Good Day BIO Newsletter- 8/21/2020
Every August, the Centers for Disease Control and Prevention (CDC) highlights the importance of vaccination for people of all ages. This year, it’s more important than ever to stay up to date on routine immunizations—and understand the implications for not getting them.

Due to lockdowns and resources diverted to the coronavirus response, we’ve seen “fresh explosions of illness and death from other diseases—ones that are readily prevented by vaccines,” The New York Times reported earlier this summer

As a result, we’ve seen surges in preventable illnesses around the world, including diphtheria, cholera, measles, tuberculosis, and poliovirus in dozens of countries, the report continued

In the U.S., demand for some vaccines plummeted as much as 95%, according to the National Foundation for Infectious Diseases (NFID)—which is bad news as the pandemic continues to rage on ahead of flu season.

While COVID-19 certainly played a role, U.S. vaccination rates were falling even before the pandemic—and the United States almost lost its measles elimination status in 2019

But pandemic or not, routine vaccinations are safe—and it’s critically important that children and adults catch up on vaccines now. 
To increase awareness and access, the U.S. Department of Health and Human Services (HHS) is ensuring parents are aware of the importance of vaccinations and COVID-19 safety precautions at providers’ offices. The American Academy of Pediatrics (AAP) urges parents to find out about what safety procedures are in place at their practice and to make an appointment for routine immunizations—which is good advice for adults too. This week, HHS also issued an emergency directive allowing pharmacists in all 50 states to give childhood vaccinations, reported NBC News.

HHS has offered a number of ways for people to get involvedand spread the word about catching up on routine immunizations.

Don’t forget! Make a plan to get your flu vaccine in the fall, so we can all do our part to make sure our loved ones are protected, and help ensure health care systems aren’t overwhelmed during the flu season and the ongoing pandemic.

Vaccines are vital for protecting public health. “Infectious diseases are global and they don’t care about boundaries and borders, everyone is affected from childhood all the way through seniors,” as Phyllis Arthur, BIO’s VP of Infectious Diseases and Diagnostics Policy recently said.
Excerpts. Source: Good Day BIO 9/9/20
Nine biopharmaceutical companies pledge “to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines,” according to a joint statement.
This follows the example set by BIO leadership which released an open letter to the biopharmaceutical industry, articulating principles to ensure the “integrity, transparency, and objective assessment” of COVID-19 clinical data and secure public trust in new medical products developed in response to the pandemic.  
And this is in line with the FDA’s guidance—which “requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations."
Upcoming Events
The Fundamentals of Disinfectant Efficacy Testing
BIO and IHIF’s newest partner PSC Biotech™ is hosting a webinar on September 24th at 1:00 PM EST, hosted by PDA Best Selling Author and PSC Regional Manager, Crystal Booth, to cover the application, development, and performance of assays. 

We’ll discuss the following topics and host a Q&A session.
  • What is the test used for?
  • Regulations governing the test
  • Reviewing regulatory observations regarding Disinfectant Efficacy
  • Examining various testing methods
  • Development and Performance of the testing method

Our host, Crystal Booth, is a seasoned, award-winning technical writer and best-selling author of “Method Development and Validation for the Pharmaceutical Microbiologist.” She has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance.
Venture Summit\Virtual Connect 3
IHIF is pleased to invite you to attend Venture Summit \ Virtual Connect

Venture Summit \ Virtual Connect 3
Where Innovation Meets Capital
November 17-19, 2020

Come meet, interact and network online with more than 1,300 VCs, Corporate VCs, angel investors, industry execs and founders of venture backed, emerging and early stage Lifesciences/healthcare companies at the prestigious Venture Summit Virtual Connect 3 being held virtually on November 17th-19th 2020, featuring a dedicated Lifesciences/ Healthcare Track.

Whether you’re a Lifesciences/Healthcare startup seeking capital and exposure, or an investor seeking new deals, Venture Summit Virtual Connect 3.0 presented by youngStartup Ventures – is the event of the year you won’t want to miss.

A highly productive venture conference, Venture Summit Virtual Connect 3.0 is dedicated to showcasing VCs, Corporate VCs and angel investors committed to funding venture backed, emerging and early stage Lifesciences/Healthcare companies.

Special Offer:
IHIF has made special arrangement for our network to receive a special discount of 20% off the existing “early bird” savings. This conference will be attended by the best people in the industry. Please register early to avoid disappointment.

Register Today & Save - Click here. (Use promo code “IHIFVIP”)

This year's The MedTech Conference, originally set to be held in Toronto, will take place on a virtual platform with the 2022 conference to be held in Toronto. "The theme of this year's conference -- United by Purpose -- has never been more appropriate. While we may be unable to meet in person in Toronto, the show will go on! We'll have all the great opportunities our attendees have come to expect to connect and learn about the key issues that affect our industry," said AdvaMed President and CEO Scott Whitaker.

The Virtual MedTech Conference will bring together the world's top medtech executives and innovators to network, conduct business, gain access to capital and share insights in an engaging digital environment.

IHIF Member discount available. Save 10% on current registration fees.

Special offer for IHIF Members!
The BIO Investor Forum Digital is expanding into a three-day virtual education and partnering event, October 13-15, for investors and business development professionals. Find investors and strategic partners to advance your biotech innovation and move into the next stage of the business life cycle.

Request your exclusive discount and receive 20% off the non-member rate when you opt-in by September 10, 2020. Request your discount code below, and register anytime leading up to the event!

What’s Included in Your Registration 

BIO is committed to driving your business partnerships via our enhanced and effective BIO One-on-One Partnering System. Communicate directly with prospective investors, business executives or service providers with maximum flexibility across time zones. 

Explore the interactive education platform featuring expert-level panel sessions and Fireside Chats focused on the most pressing topics in biotech and pharma today. 

Company presenters tend to receive double the number of BIO One-on-One Partnering™ requests than non-presenters, and schedule twice as many meetings than non-presenting companies. >>Learn More

New Company Visibility Opportunities Available
There are many ways to promote your company at BIO Investor Forum Digital. Explore new opportunities to increase your visibility, enhance your existing business relationships, and fosters new collaborations. View all opportunities here.
BioCrossroads Indiana Life Sciences Summit 2020

This year we will focus on COVID-19's impact on our life sciences companies and research institutions, and will highlight the critical role Indiana’s life sciences ecosystem has played in fighting the global health crisis. Don't miss the conversation!
Registration, schedule, and sponsorship details are now live! 
IBJ Virtual Life Science Power Breakfast
Date: Friday, October 9, 2020 - 8:30 am
Cost: Individual Tickets & Corporate Rooms
RSVP by October 7, 2020

Featured Panelists:
  • Richard DiMarchi, PhD, Distinguished Professor of Chemistry, Linda & Jack Gill Chair in Biomolecular Sciences, Indiana University
  • Fritz French, Chairman, On Target Laboratories, Inc.
  • Rob Lyles, President, COOK Regentec, Vice President, COOK Group
  • Patricia Martin, President & CEO, BioCrossroads
  • Todd Saxton, Associate Professor, Strategy & Entrepreneurship, Indiana Venture Faculty Fellow, IU Kelley School of Business, Vice President of Business Development, Regenstrief Institute, Co-author, The Titanic Effect

Moderated By: John Russell, Health Care & Life Sciences Reporter, Indianapolis
Business Journal

Register online at:
2020 AURP International Conference Pre-Session
Date: September 15, 2020 ~ 1:00 - 4:00 PM
Cost: $99 for non members and $75 for AURP members

Brought to you by AURP BIO Health Caucus
The Covid-19 Pandemic vividly demonstrates the need for rethinking ways to manufacture biological materials and create sustainable medical product supply lines for the United States. New program funding, new regulatory schemes and new community engagement are all solutions as we witness the renaissance of life science manufacturing in the US from Delaware to Alabama to California. Join a discussion of best bio and pharma manufacturing practices, public policies and programs to help the US respond to the Covid-19 Pandemic and create a more resilient manufacturing infrastructure.

Industry News
Learn more about the NCI SBIR Contract Solicitation

We invite cancer technology innovators to submit proposals for the 2021 NCI SBIR Contract Solicitation. This year’s contract solicitation includes 17 topics proposed by the institute.

As a reminder, proposals must be submitted by Monday, October 26, 2020, by 5 p.m. EDT, through the electronic Contract Proposal Submission (eCPS) website. For more information about the FY2021 NCI SBIR Contract Solicitation, visit the NCI SBIR current contracts page or contact Rosemary Hamill at
The Applicant Assistance Program (AAP) accepting applications for those who are participating in the January 2021 SBIR/STTR application cycle.
This is a FREE program geared toward helping small businesses apply for Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) funding. AAP provides participants with services such as application needs assessment, mentoring, application preparation support, and application review. If you are interested, apply by Thursday, September 24, 2020 on the AAP Application Portal.
Program eligibility is limited to small businesses who have not previously won an SBIR or STTR award from the NIH.

If you are interested in participating in AAP, join us for an informational webinar on Tuesday, September 15, 2020, 3-4 p.m. EDT.

Topics to be covered include:
  • SBIR/STTR program basics
  • Eligibility criteria
  • AAP information
  • How to write an application for AAP
Under the Medical Device User Fee Act IV, the FDA has raised its user fees to 7.2% for fiscal 2021. From October 1 to September 30, 2021, the standard fee for 510(k) applications will increase to $12,432, while the premarket approval fees will increase to $365,657.
Full Story: FDAnews (8/18)  
Indy Logistics Companies Acquired
Ohio-based Nippon Express USA Inc. has acquired a pair of logistics companies in Indianapolis. Nippon, a subsidiary of Nippon Express Co. Ltd. in Japan, says the MD Logistics LLC and MD Express LLC brands and organizational structure will remain the same. Read More
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
Nikon BioPipeline – High Content Imaging System
BIO and IHIF's preferred partner, Nikon, is pleased to introduce BioPipeline Live, your answer for automated high throughput and high content imaging of live samples, such as cells and organoids. Nikon offers BIO and IHIF members 15% off select BIO customized microscope packages.

With BioPipeline Live, Nikon seeks to provide seamless integration of the highest performance and most reliable technologies from top manufacturers as part of a unified platform for high content imaging of live samples. The system holds up to 44 wellplates, features robotics for automated exchange, and comes with complete incubation coverage.
BioPipeline Live is configured on the Nikon Ti2-E inverted microscope, which features an industry-leading 25mm field of view (FOV) for maximizing throughput. Users have access to the full range of detectors and illuminators compatible with the Ti2-E, including Nikon’s A1R HD25 confocal system, which features a matching 25mm FOV. BioPipeline Live is completely integrated using Nikon’s NIS-Elements software. 

Scale Therapies Faster and Safer
Avantor makes innovative and life-changing therapies a reality via our offerings in cGMP chemicals, single-use solutions, cell culture media and sera, and laboratory services.

Attend our on-demand webinar to learn how cGMP chemicals make a difference in cell and gene therapy scale up.

Click on the link below and select Day 4 on the Sign Up Form. 

Understanding the critical roles of cGMP chemicals and single-use technologies in cell & gene therapy manufacturing

Get Started With Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in news release distribution and regulatory disclosure. Investor relations, public relations, public policy and marketing professionals rely on Business Wire for secure and accurate distribution of market-moving news and multimedia.
IHIF Member Benefits 

  • Special Bundled Services (discounts wire, multimedia, and BIO SmartBrief Distributions)
  • 10% discount off Business Wire’s standard published rates on news distribution services (domestic, specialty or international circuits)
  • 10% discount off Business Wire’s standard published rates on EDGAR products
  • Distribution to biotechnology and related trade publications at no additional charge with any circuit selected
  • Posting of your company’s logo included with your news releases at no additional charge
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!