IHIF Launching Public Policy Forum
 
IHIF’s Policy Forum will work with the IHIF board and leadership to address state and federal policy issues that affect the life sciences business community and Hoosier patients' access to therapies. Based on survey feedback from our Roadmap 2020 Strategic Plan, our members would like IHIF to increase awareness of current, industry-related public policy activities and issues and facilitate opportunities for industry engagement with state and federal legislators. The Policy Forum will work on both of those recommendations and build a more robust public policy conversation in support of life sciences in the state.
 
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 Public Policy Forum. Not a member? Sign up today!
 
COVID Updates and all the latest additions to the IHIF COVID-19 Toolkit

Great news on vaccine efficacy from Pfizer and Moderna!!

Lilly Antibody Treatment Lands FDA Emergency Use Authorization
The U.S. Food and Drug Administration has granted an Emergency Use Authorization for a COVID-19 antibody therapy developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The treatment, known as bamlanivimab or LY-CoV555), is authorized for the treatment of mild-to-moderate COVID-19 in patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to a more severe case of the disease and/or hospitalization. Lilly says the EUA is based on a Phase 2 study involving recently-diagnosed, mild-to-moderate COVID-19 in an outpatient setting. 
For your vaccine storage needs: Eppendorf’s CryoCube -80C freezers, are all in stock and on a promotion that includes racks. 

  • Cryocube F570/h (400 box capacity)
  • CryoCube F740/hi (~600 box capacity)
  • Model includes free external monitoring software

Contact Nick Yonts to learn more!
Member News
Advanced Accelerator Applications (AAA) Breaks Ground in Indy
Executives from New Jersey-based Advanced Accelerator Applications USA Inc. broke ground on a new, $72 million manufacturing facility in Indianapolis. The company, a subsidiary of Switzerland-based Novartis AG (NYSE: NVS), says the plant will produce radioligand therapies used to treat cancer. 



Gov. Eric Holcomb remarks at AAA groundbreaking
FAST BioMedical Sets Up Space at 16 Tech
Indianapolis-based FAST BioMedical has set up operations inside the 16 Tech Innovation District on the city's near north side. The late clinical-stage medical technology company says locating its wet lab operations at the district's state-of-the-art laboratory facility will accelerate its clinical technology development. 
The Hercules 100 Transnasal Esophageal Balloon, used during transnasal esophageal procedures, has been released in the US by Cook Medical.
Are you interested in using single-cell analysis in your research study? 
Fios Genomics' brand-new whitepaper "Single-Cell Analysis: Applications and Resolutions for Research" is now available on our website. In it, we discuss the applications, challenges, and resolutions of using single-cell data in research, alongside what is expected in the future in this area of analysis.
 
Single-cell research has a number of applications including:
  • identification of gene expression profiles for novel subpopulations
  • identification of cell populations with altered states, associated with survival or drug response
the comparison of cell type composition of samples across different condition

Need a bioreactor? Rent a Cellmaker! - Find out how our new flexible rental options work and try before you buy!
Learn more (Twitter video)

Year end discounts also available on purchase.
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
GMI is a team of experienced and dedicated owner-employees focused on customer service, quality, and on-time delivery of high-precision, complex, CNC machined components, meticulous assemblies, and value-added services. We are ISO 13485:2016 Certified, FDA Registered, and ITAR Compliant. As a contract manufacturer, we serve the needs of many diverse and demanding industries. Our certifications require us to deliver high-value parts and assemblies within the stringent quality requirements of the Medical Device, RF/Microwave Communication, and other specialty product segments. Additionally, we serve the Medical Gas, Agriculture, Defense, Aerospace, and Optical industries. We would be happy to collaborate on your project regardless of the industry.
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
  • Joined sign-on letter to coalition letter to House and Senate re: PTAB and IP Rights
  • Joined AdvaMed letter supporting Medicare Coverage of Innovative Technology (MCIT)
BIO Launches New Strategic Vision
The Biotechnology Innovation Organization (BIO) today announced a new, strategic direction that will help guide it to achieving long-term goals while maintaining responsiveness to changing political headwinds.
The FDA and medtech industry groups held a virtual public meeting to begin negotiations for the fifth iteration of the Medical Device User Fee Amendments program. "As MDUFA IV continues for the next two years, and in order to support the commitments in the final two years of the program, we urge FDA to complete the hiring of all MDUFA-funded [full-time equivalents] as soon as possible, including those from MDUFA III," said Janet Trunzo, AdvaMed's senior executive VP of technology and regulatory affairs.
Full Story: MedTech Dive (10/28)  
Breakthrough drugs are no accident
Good Day BIO - 10/9/20
They’re possible thanks to the deliberate innovation ecosystem we’ve built in the United States—which includes strong intellectual property protections. We take a look at some of them in a new blog post.

Of the nearly 750 unique active compounds in development to fight COVID-19, more than half are being researched and developed in U.S. labs. 

And it’s not just COVID: More than half of the roughly 8,000 treatments in development globally are byproducts of U.S. labs. This includes 1,200 therapies to fight cancer, 566 medicines targeting rare diseases, and 200 treatments for heart disease and stroke.

“America’s innovation ecosystem is no accident. It’s a direct and intentional result of decades of smart, forward-thinking policies that incentivize and reward innovation,” we write.

These include policies like patent protections as well as legislation such as the Hatch-Waxman Act, which has advanced new discoveries and competition that drives down costs, and the Bayh-Dole Act, which helps private companies turn early-stage federally funded research into tangible medicines and products.

Bayh-Dole is more important than ever, as we’ve explained, as drug manufacturers are pouring billions of dollars into turning basic science from federally funded research into potential COVID-19 vaccines, treatments, and diagnostics. 

But some want the federal government to wrongly use it to “march in” and seize the patents on these drugs, sending “a chilling message to companies in every industry—don’t bother investing billions of R&D dollars to turn federally funded inventions into real-life, market-ready products, since the government will just steal the fruit of your labor,” explains David Winwood, an expert in university technology transfer, in The Washington Times.

Laws and protections like Bayh-Dole have helped us “live healthier, more prosperous lives,” concludes Winwood. “We should nurture this innovation—not squash it by inappropriate use of march-in rights.” 

Upcoming Events
Save the Date
WEBINAR
Tuesday, December 15, 2020
11:00 am – noon

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a seminar series on critical issues in the life sciences. Each month, a panel in the field of life sciences will be available to discuss the topic and answer questions concerning the major challenges and opportunities in the industry. We hope you will join us.

COVID and Cold Chain Distribution Challenges


There is no charge to attend.
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. 

December 2-4, 2020
Collaborate and partner with top life science companies to combat viral and bacterial infections and bring lifesaving treatments to patients faster. BIO Members* benefit from an exclusive 20% discount on all registration categories (General Delegate and Academia/Small Company/Investor). View the BIO member directory to confirm your company's status.

January 11-15, 2021
Affordable access to BIO One-on-One Partnering, with an integrated video conferencing system, to provide a seamless partnering experience for all attendees, regardless of whether you are registered for a specific event during JPM week. BIO Members* partner for free/ Non-Member companies partner for $150.

February 16-18, 2021
For more than 20 years, the BIO CEO & Investor Conference has fueled biotech industry networking with premier investor and banking communities, focused on established and emerging publicly traded and select private biotech companies. For the discounted rate of $795 (20% savings), use code BIOCEO12.

With a robust landscape of BD and investors events taking place over the next six months, now is the time to develop a strategic sponsorship platform that allows you access to BIO’s global network of biopharma leaders. BIO Members* receive the greatest discounts to attend BIO events. Email us at biomember@bio.org to request your discount code or join today!

*Please note, IHIF Membership does not qualify for the BIO Member discounts.
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

Special Notice: Due to requests we're extending our Empowering Female Founders initiative.
We're offering an additional 150 Female Founders 70% off tickets to attend Venture Summit \ Virtual Connect being held on November 17th - 19th, 2020.
If you know of female founders that can benefit, they can register here using discount code: empowerFF

Come meet, interact and network online with more than 1,500 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.


Register Today & Save - Click here. (Use promo code “IHIFVIP”)
Take Your Project to Market with I-Corps at NIH

We are now accepting applications for the first 2021 cohort of I-Corps at NIH! Apply for I-Corps at NIH to receive real-world training that prepares you for the next chapter of your commercialization efforts. The first 2021 cohort will run from February through April, 2021.
 
I-Corps at NIH is an entrepreneurship training program offered to small businesses with an ACTIVE Phase I SBIR/STTR award from 24 participating institutes and centers within the NIH and CDC. The program is designed specifically for NIH- and CDC-funded small businesses, with experts and seasoned entrepreneurs from biotech industries. Eligible grantees should submit their application on NIH ASSIST by Tuesday, November 17, 2020. Eligible contractors may reach out to their Contract Officer for application details.
 
I-Corps at NIH program centers around Customer Development. By conducting 100 interviews over 8 weeks, small businesses refine their target customer, key product, and market needs. The interviews help participants make new networks, establish partnerships, and build commercialization plans that accurately address the needs of their target market.
 
To learn more about I-Corps at NIH, visit https://sbir.cancer.gov/icorps. For inquiries, please contact I-Corps at NIH program experts at icorps@mail.nih.gov.

I-Corps at NIH

To apply, submit your application on NIH ASSIST by Tuesday, November 17, 2020, 5:00 p.m. your local time.
We are excited to announce our new FDA Resources page!
 
We worked with experts at the FDA to provide entrepreneurs with a set of curated links that are relevant for early-stage companies developing oncology-related technologies. We have the latest information from the FDA’s Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) to help you find the right resource at the right stage of development.
 
If you are not sure about which center to choose, we have detailed information on what each of the three centers to regulate on the main page for your reference. For any questions regarding the FDA resources page, please contact us at ncisbir@mail.nih.gov.
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.
NEW FOR THIS YEAR....
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!
Advances in Behavioral/Mental Health Treatments
February 19, 2021
Virtual
Lessons Learned from the Pandemic
April 30, 2021
Format TBD
IMDMC Annual Meeting
December 3, 2020
1:30 - 3:00 pm

Post-election: What does it mean for medical devices and healthcare?

Join us virtually at the IMDMC Annual Meeting for a post-election presentation by Ralph Hall of Leavitt Partners focusing on the impact to the medical device and health care industries. The presentation will cover topics such as the impact of the election on key health care issues, the impact of the election on FDA (specifically CDRH and senior leadership), and insights into anticipated 2021 FDA initiatives.

Leavitt Partners is a family of health care focused intelligence businesses whose mission is to improve lives by advancing value-based care, striving to make health care more accessible, effective, and sustainable.

Ralph Hall, principal at Leavitt Partners, provides consulting services to clients in the areas of FDA statutes and regulations, regulatory compliance, as well as health care policy and legislation, and particularly the application of those regulatory systems to the medical device industry.
Industry News
Biopharma Startup to Set Up Shop in Fishers
A biopharmaceutical manufacturing services startup has announced plans to build its global headquarters and first manufacturing facility in Hamilton County. INCOG BioPharma Services says it will invest about $60 million to construct and equip the 60,000-square-foot facility in Fishers and create up to 150 jobs by the end of 2024. 
Read More (Source: Inside Indiana Business)
Pandemic Boosts Business for Antimicrobial Innovation
It won't be long until Americans see antimicrobial tray tables on their flights, antimicrobial seats at sports stadiums and antimicrobial features in their car's interior--and it all centers on a technology invented at Purdue University, commercialized in southeast Indiana and soon manufactured there as well. The germ-killing molecular technology, called Nouvex, can be embedded in a long list of end products to make them antimicrobial, and the pandemic has created a tsunami-sized wave of interest that a small Hoosier startup is riding to the marketplace.
By Ben Adams
After snapping up contract research organization Covance for $6.5 billion five years ago, LabCorp is now looking to change the makeup of its drug development business.
Read more (Source: Fierce Biotech)
Healthcare Technology Company Diagnotes Secures Funding to Drive Growth
Diagnotes, an Indianapolis-based company focused on healthcare communication and collaboration, today announced it has raised a new round of funding with participation from Elevate VenturesIU Ventures and Purdue Ventures.
Learn More (Source: Elevate Ventures)
New Simon Comprehensive Cancer Center Director Named
The Indiana University School of Medicine has named a new director of the IU Melvin and Bren Simon Comprehensive Cancer Center, while also marking a $15 million gift from the Walther Cancer Foundation. Dr. Kelvin Lee will succeed Dr. Patrick Loehrer, who has served as cancer center director since 2009. 
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
New Business Solutions Program Partner - Research Solutions

Open to Eligible IHIF Members
15% Off: On-Demand Document Retrieval
BIO's newest partner, Research Solutions, is trusted by more than 70% of the world's top pharmaceutical companies and emerging life science businesses. Through our partnership, we're pleased to offer our members an exclusive 15% discount on its award-winning SaaS platform, Article Galaxy, for simplified and lowest-cost access to the latest scientific content.

Highlights include:
• On-demand access to 70M+ journal articles
• Full-text PDFs delivered within minutes
• Integrated search with 70+ discovery websites
• Lowest-cost filtering, including Open Access
• PDF tracking and duplicate order alerts
• 20% savings on journal article spend

Exclusive benefits for BIO/IHIF members:
• 15% off annual Article Galaxy subscription
• 14 day, risk-free trial
New from PSC Biotech
ACE Essentials Promotion
PSC has launched a limited time offer exclusively for BIO members: Now through January 31, 2021, members can receive 50% off the initialization fee of their eQMS, ACE Essentials™, which equates to savings of $9,500! 
Expanded Professional Service Offerings
PSC now offers a 10% discount on all their professional services to BIO members. This includes services such as:
·     Computer System Validation
·     Commissioning
·     Qualification and Validation
·     Regulatory Affairs
·     Audits
·     Quality Assurance
·     Quality Control
·     Engineering
·     Technical Writing
·     Calibration
·     Project Management
·     and more
Regulatory Affairs Survey
PSC Software, your compliance partner, with BIO Business Solutions ® is launching a free webinar series in January of 2021 focusing on Regulatory Affairs! PSC anticipates building a series that dives deep into regulatory topics to ensure your products make it to patients. We would appreciate your feedback and cooperation. 
Unifirst Offers Alternative Solutions for Workwear Needs

About Humboldt
Humboldt Storage and Moving, a United Van Lines agent, is your one-stop for all your moving and storage needs including employee relocation, moving an office or lab, or an entire company – across town, across the USA, or across the world. Humboldt provides custom moving, relocation and storage services, and has a strong focus on customer service and has a unique expertise with serving the biotech industry.
IHIF Member Benefits 

  • Preferred discounts on all moving needs for members
  • Local, long-distance, and international moving solutions
  • Laboratory, office, and employee relocations
  • Regulatory compliant, climate-controlled specimen relocation for laboratory moves
  • Single source who will coordinate all relocation aspects
  • Guaranteed pickup and delivery minimizes downtime on all relocations
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!