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MichBio | BioLink - July 2022

Michigan Business Network
July 12, 2022 7:00 AM

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Michigan Medical Device Summit Registration is Now Open!
NEW THIS YEAR - SUPPLIER SHOWCASE
 
The Michigan Medical Device Summit is the annual gathering of the statewide medtech community. It is designed for attendees to learn about the latest in medical device technologies, regulations, and marketplace, and especially what Michigan’s cluster has to offer to those developing and manufacturing innovative medical products. Hear the state’s most outstanding medtech and related thought leaders share their perspectives on topics of the day.
 
Meet and network with medtech sector professionals, academic researchers, healthcare providers and clinicians, suppliers and contract manufacturers, professional services firms, investors, business leaders, government officials, and disruptive companies across all growth stages.
 
The Summit is intended to better connect and raise the visibility of Michigan’s large medtech cluster including its significant innovation and supply chain assets that are contributing to its steady growth and economic impact. New in 2022 is a showcase of Michigan firms supplying and serving the medtech community.
 
AGENDA INFORMATION IS COMING SOON!
Small Business Opportunities from the NIH
SBIR/STTR AWARD ASSESSMENT, FUNDING OPPORTUNITY & COMMERCIALIZATION PROGRAMMING
 
Phase I Technical and Business Assistance (TABA) Program Launches for 2022-2023: Request a Needs Assessment Report for Your SBIR or STTR Award
The NIH TABA Program helps small businesses identify and address their most pressing product development needs. And now, if eligible, you can submit a request for a FREE Needs Assessment Report that provides a third party, unbiased assessment of your project’s progress in four technical and business areas that are critical to success in the competitive healthcare marketplace.
 
Your company is eligible to participate if your Phase I NIH SBIR or STTR (grant, contract, or Fast-Track) 
  • is active or was active within the past two years, AND 
  • was not awarded TABA funding within the Phase I award budget, AND
  • has not already received a TABA Needs Assessment Report or NICHE Assessment for the same Phase I project.
Selection will be made on a first come, first serve basis.
 
Questions? Email the NHLBI Small Business Team at nhlbi_sbir@mail.nih.gov. To learn more, visit the NIH TABA Needs Assessment Website
 
Concept to Clinic: Commercializing Innovation (C3i) Program
Medical device innovators with active NHLBI small business grants are invited to apply to the National Institute for Biomedical Imaging and Bioengineering (NIBIB) C3i program! The 24-week C3i program provides participants with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Participants will learn how to:
  • Evaluate whether a compelling unmet market need exists for their proposed solution
  • Assess whether there is a viable business opportunity that can be built to meet this need
  • Build a compelling pitch presentation to secure support from potential investors and other business partners.
The teams will be guided through a series of lectures and interactive exercises, where they will pressure-test the commercial viability of ideas using universal business criteria as well as the unique requirements of medical device commercialization. Participants also work with experienced business advisors and subject matter experts who provide insights into the market sector, intellectual property, regulatory, and reimbursement requirements specific to their projects.
 
Applications for this year’s C3i cohort are due August 5th, 2022. For more information, visit the NIBIB C3i Program website
 
Administrative Supplements for Providing Technical and Business Assistance (TABA) Funding to SBIR/STTR Awardees (NOT-OD-21-062)
All NHLBI grantees with an active Phase I (R41/R43) small business award or a Fast-Track (R42/R44) award in the Phase I stage are now eligible to request up to $6,500 to support subcontracts or consultants that provide specific TABA services. Normally, small businesses include this budget request as part of the application and provide a detailed budget justification. However, small businesses may become aware of technical or business needs after receiving their Notice of Award that necessitate requesting TABA Funding through an Administrative Supplement.
 
Examples of technical and business services that can be supported by TABA Funding include, but are not limited to:
  • Assistance with product sales
  • Intellectual property protections
  • Market research and/or validation
  • Development of regulatory plans
  • Development of manufacturing plans
Eligibility is limited to grantees whose awards are not in a no-cost extension and did not already request TABA funding through their grant application.
 
Grantees who are interested in requesting an administrative supplement through NOT-OD-21-062 are strongly encouraged to contact Dr. Stephanie Davis at nhlbi_sbir@mail.nih.gov before applying.
 
 
New Funding Opportunity from the NIH: Small Business Transition Grant For Early Career Scientists
SIGN UP NOW
 
The National Cancer Institute (NCI) recently released a new funding opportunity for biotech companies and university researchers! The new Small Business Transition Grant funds the translation of technology from university to small business, as well as the transition of early career researchers from academia to industry. This award uses the Small Business Technology Transfer (STTR) and Small Business Innovation Research (SBIR) funding mechanisms, so you must be a small business concern at the time of application. If you are not familiar with the mechanisms, please refer to the attached overview factsheet for information on the two mechanisms.
If you are interested in applying for this Fast-track opportunity with a budget of up to $2.4 million, sign up for an informational webinar on July 21, 2022. READ MORE
 
 
 
 
 
 
 
 
 
 
 
 
FEDERAL ADVOCACY NEWS
 
UFAs Advance Slowly
Reauthorization of the FDA user fee agreement (UFA) package – that sets terms, conditions and costs for review of prescription drug (PDUFA), medical device (MDUFA), generic drug (GDUFA), and biosimilar (BsUFA) applications – is inching forward in Congress. In addition to codifying the agreements, these bills are often vehicles for other FDA policy changes. READ MORE
 
Senate Committee Advances PBM Transparency Legislation
The Senate Commerce Committee passed legislation, Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) , that is designed to address how PBMs control drug prices and can potentially reduce the amount independent pharmacies and consumers pay for medicine. READ MORE
 
Cybersecurity Front and Center for Feds
Congress is considering several pieces of legislation requiring the FDA to regularly update cybersecurity guidance and better coordinate efforts with other agencies to better safeguard of medical and healthcare technologies from digital threats.
 
A bipartisan proposal, the Strengthening Cybersecurity for Medical Devices Act, would require the agency to review and update premarket medical device cybersecurity guidance every two years. A second bill, S. 3904, Healthcare Cybersecurity Act, would mandate closer collaboration between the Department of Health and Human Services and the Cybersecurity and Infrastructure Security Agency in addressing threats. READ MORE
 
Multi-Cancer Early Detection Screening Coverage Act
MichBio is among over 400 groups from all 50 states that have signed the Prevent Cancer Foundation’s letter to Congress encouraging passage of the Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946 / S. 1873). The legislation has reached an exciting milestone with over half of the U.S. House of Representatives having co-sponsored the bill. 
 
As a reminder, the Medicare Multi-Cancer Early Detection Screening Coverage Act aims to overcome the access barriers that exist for Medicare beneficiaries by creating a pathway for timely coverage of multi-cancer early detection (MCED) tests once they are approved by the Food and Drug Administration (FDA). 
 
PODCAST: Accelerated Approval Study and Implications for Rare Disease Patients
This podcast discusses the results of Vital Transformation's latest research study outlining the impact of proposed changes to the Accelerated Approval pathway, and what this would mean for patients with rare conditions. READ MORE
 
Recent White House Proposals on Cancer Research Would be Counterproductive
Earlier this year, the Biden Administration aimed to reignite the Cancer Moonshot through its proposed federal budget and an objective to reduce cancer mortality by 50% over the next 25 years. The White House proposes to increase public funding for cancer research and at the same time control the price of cancer treatments. READ MORE
 
 
STATE ADVOCACY NEWS
 
Rare Disease Advisory Council
The wait for Senate approval continues for HB 4654 that if enacted would establish a Rare Disease Advisory Council to address challenges and issues facing patients and caregivers. As we’ve described before, the legislation is pending before the Senate Health Policy Committee. MichBio recently suggested some changes to the language and makeup of the proposed RDAC in an attempt to address concerns raised by several legislators.
 
Indications from key legislators were that the bill was to be voted out of Committee and Senate before the summer recess. But the session just ended and so HB 4654 will not be taken up until the early fall.
 
Telemedicine Policies to be Highlighted in State Sessions
The Michigan Department of Health and Human Services (MDHHS) has issued many COVID-19 Response Medicaid Policy Bulletins and L-Letters as a result of the federal Public Health Emergency (PHE) and the continued consequences of the Coronavirus Disease 19 (COVID-19) pandemic. Many of the COVID-19 Response policy bulletins and L-Letters were intended to be time-limited.
 
With the end of the PHE in sight, MDHHS would like to welcome providers to upcoming virtual sessions to learn about the proposed post-PHE telemedicine policies and how to comment or share input on proposed policies. 
 
To participate, select one of the following meeting options to register (both will contain the same information).
  • July 11, 2022, 10:00 to 11:00 am EST - REGISTER
  • July 19, 2022, 10:00 to 11:00 am EST - REGISTER
 
A confirmation email with a link to the meeting will be sent to the email address used to register. For questions or problems registering email ProviderOutreach@Michigan.gov.
 
Charles River is Hiring For Over 75 Positions in Mattawan!
SEE ALL OPEN POSITIONS ON CHARLES RIVER'S CAREER PAGE
 
 
Compliance Specialist
 
Responsibilities of the Compliance Specialist include but are not limited to: managing the Company’s global policy management program; supporting government contracts compliance; overseeing management of the Company’s records management program; assisting with risk assessment, monitoring and auditing; providing Legal Compliance leadership, and supporting other important Legal Compliance (I-Comply) program initiatives.
 
Veterinary Pathologist
 
Responsible for independently performing gross and microscopic evaluation of tissues, recording results, preparing reports delineating pathological findings, and assisting with necropsy supervision. With minimal supervision, work with customers as needed to market company services and to assure customer satisfaction.
 
 
 
 
EMMA International is Hiring For Positions in Detroit!
SEE ALL OPEN POSITIONS ON EMMA INTERNATIONAL'S CAREER PAGE
 
 
Quality Engineer
 
Responsible for the development, maintenance, and implementation of specifications and standards for processes, materials, and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System and in compliance with FDA regulations, ISO 13485, and other regulatory requirements as applicable.
 
Research Analyst
 
The Research Analyst collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.
 
 
 
Director of Regulatory Affairs
 
  • Develop and implement global regulatory strategies for development, submission, registration, and maintenance of in vitro diagnostic (IVD) products.
  • Lead submissions, communications, and meetings with Regulatory Authorities.
  • Support Franchise to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks.
  •  
 
Associate Director of Quality Control
 
Responsible for the day-to-day management of Quality Control Supervisor, Scientists, and Technicians. Ensures that relevant regulations (including but not limited to QSR, ISO, OSHA, IVDD/R, MDD) are met and the timely output of testing data. Analyzes work processes to ensure appropriate staffing and that staff and equipment utilization are maximized. Responsible for managing documentation, complaint, audit and assay improvement activities. Able to effectively collaborate with peers to obtain favorable results.
 
Visit the MichBio BioConnections Career Center
MEMBERS RECIEVE FREE POSTS!
 
Bio-industry organizations can post open positions on the new and improved MichBio career center. MichBio members receive an annual allotment of free postings based on their company size and membership level. Internships are always free to post.
 
 
 
BIO Impact Agriculture and Environment Conference
September 19-21, 2022, Omaha, NE
 
After almost two years, BIO is bringing together the agricultural and environmental biotech industry in person once again. The BIO Impact Agriculture & Environment Conference heads back to the Midwest, September 19-21, 2022 in Omaha, NE! BIO Impact brings together biotech leaders working to address today's global challenges for three days of dynamic programming, networking, and BIO One-on-One Partnering™. 
 
 
REGISTRATION NOW OPEN!
 
Michigan Medical Device Summit
September 20, Kalamazoo, MI
 
The Summit is intended to better connect and raise the visibility of Michigan’s large medtech cluster including its significant innovation and supply chain assets that are contributing to its steady growth and economic impact. New in 2022 is a showcase of Michigan firms supplying and serving the medtech community.
 
Meet and network with medtech sector professionals, academic researchers, healthcare providers and clinicians, suppliers and contract manufacturers, and others.
 
 
RESCHEDULED
 
Michigan Forum for Digital Health
October 4, 2022, Virtual
 
Follow-up to 2021's inaugural Digital Health Forum to continue the conversation on essential topics related to growing the Informatics and Health IT sector in Michigan.
 
The event will bring together industry professionals, academics, and stakeholders for programming, virtual exhibitor meetings, and networking.
 
 
MPO Summit
October 18-19, 2022, Austin, TX
 
Focusing on the world of outsourcing for medical device manufacturing coupled with a keen awareness of innovation in the space, Medical Product Outsourcing’s conference series—the MPO Summit—has provided the medtech industry with the most comprehensive programs for more than 15 years. These highly informative symposiums address critical issues impacting multiple stakeholders within the industry. In 2022, the MPO Summit returns to Austin, Texas, home to the event previously in 2016.
 
 
MedTech Conference
October 24-26, Boston, MA
 
The MedTech Conference will bring together the world's top medtech executives and innovators for three days of programs, networking and business development opportunities. The Conference will be held in person in Boston, MA! Options for virtual participation will also be made available to ensure maximum participation from the global medtech community. No matter how you participate, you are guaranteed to experience the same quality programming and networking that you’ve come to expect from The MedTech Conference.
 
MedTech Committee Continues Planning for Fall Medical Device Summit
 
At its quarterly meeting, the MedTech committee discussed the value of including a vendor/supplier showcase in this fall's Michigan Medical Device Summit, as well as, possible topics for the agenda, issues the sector is facing that could be addressed at such an event and other topics.
 
Join a MichBio Committee and Help Direct the Future of Your Sector.
 
MichBio committees are made up of member employees who meet quarterly to discuss issues related to their area of expertise. Together, the committees examine current industry trends, legislative concerns, and consider events or educational opportunities that would benefit their sector. All committees are accepting new members.
 
Available committees:
 
 
  • BioEconomy - MEETING TBD
  • BioTech and Pharma - MEETING TBD
  • Cannabis Science - MEETS 8/18
  • Digital Health - MEETS 8/25
  • Diversity Network - MEETS 8/4
 
  • I.P. and Legal Affairs - MEETS 8/11
  • MedTech - MEETING TBD
  • Patient Advocate - MEETS 7/21
  • Workforce and Education - MEETING TBD
 
New Perspectives provides support and leadership for emerging biotechnology and pharmaceutical companies by helping to maximize your developmental assets in the commercial setting.
 
New Perspectives helps companies build a take-to-market strategy, obtain investment, or package an asset for licensure or sale. The company's experience encompasses NCE, 505b2, orphan drugs, BPLA, generics, devices and biosimilars. Whether you are developing your product for licensing or planning on commercializing it yourself, New Perspectives is focused on its success. The team partners with your team to establish your product’s value proposition, differentiate it from the competition and shape your product’s ultimate strategic direction for launch and commercial success.
 
 
Talent Source was founded to provide clients with a personalized approach (boutique) to identify top talent. We limit the number of active clients to ensure 100% success rate. Our focus is to build partnerships with our clients.
 
We build relationships with candidates which allows us to find top talent with proven soft skills. If you treat people, the way you want to be treated they will remember you. We call ourselves collaborators, connectors, and networkers.
 
Talent Source has the distinct advantage of understanding the biotechnology, engineering and technical recruiting market and a rich understanding of the needs and requirements of our clients.
 
 
 
 
 
 
 
 
 
 
 
 
 
PhRMA
 
 
 

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