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MichBio | August BioLink

Michigan Business Network
September 3, 2020 10:00 AM

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MichBio Welcomes Two New Board Members.

We are pleased to welcome Uma Sharma, PhD Chief Scientific Officer at MMS Holdings and Ron Perry Vice President and General Manager at Emergent BioSolutions to the Board of Directors.
 
Dr. Sharma and Mr. Perry become part of a seventeen-member Board that in late June 2020, elected Ken Massey, PhD, Director of Venture Development at Wayne State University as Chair, and Kevin McLeod, CEO of C2Dx as Vice Chair. Robert Donofrio, PhD, Vice President of Food Safety R&D at Neogen and Sandra Pennell, Controller at Vericel, were elected into non-voting Officer roles as Secretary and Treasurer, respectively.
 
We are thrilled to have such capable and dedicated leadership as part of the MichBio team and look forward to their contributions to our continued effort to drive bio-industry growth.
 
Biotech Votes 2020
Verify. Register. Learn.
 
The 2020 election season is full of candidates and issues of importance to the bio-industry. BIO - the Biotechnology Innovation Organization - is leading a nationwide campaign to verify, register, and educate the bio-industry community in local and national issues. Michigan voters can find out if they are registered to vote and what's on their local ballot in a Michigan specific website created in partnership with MichBio.
 
Webinar: Biotech Votes 2020
September 14 - 1:00 to 2:00 pm
 
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.
 
The 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
 
MichBio joins Partnership for Chronic Disease to Award Representative John Moolenaar the "2020 Champion for Healthy Seniors Award"
 
The award recognizes Rep. Mollenaar for his leadership in protecting seniors and those with chronic conditions by protecting access to affordable medications and in-home treatments.
 
Advocacy at the Federal Level
 
MichBio Provides Perspectives on SBIR/STTR Programs. MichBio was invited to present its perspectives on the utility of the SBIR/STTR programs. The National Academy of Sciences, Engineering and Medicine was charged to conduct a nationwide assessment and is hosting various interviews with relevant stakeholders across the U.S.
 
Stephen Rapundalo, PhD, President and CEO, participated in an online meeting alongside Randy Myer, an entrepreneur and Professor of the Practice of Strategy and Entrepreneurship, University of North Carolina, and Josh Makower, MD MBA, Co-Founder & Advisor, Stanford Biodesign, Chairman & Founder, ExploraMed Development LLC and General Partner, New Enterprise Associates.
 
The 75-min discussion focused on how applicants/beneficiaries viewed benefits and drawbacks of the SBIR/STTR program, what investors (VCs, angels and corporates) thought, and what changes/improvements could be implemented to strengthen the programs and make them more impactful.
 
MichBio Raises Alarm Over New Convalescent Plasma EUA. MichBio sought quick action from Michigan Congressional officials for clarity from the FDA on the labeling requirements for units of Covid-19 convalescent plasma (CCP) available for transfusion into patients. 
 
MichBio became aware a major unintended consequence of the FDA’s recent issuance of an EUA covering use of Covid-19 convalescent plasma (CCP). Specifically, as spelled out in the "Fact Sheet for Health Care Providers", requirements called for display of the antibody titer on each unit of CCP. These labeling requirements were significantly different than previously in use for CCP collected and distributed for the Expanded Access Program (EAP) led by the Mayo Clinic. Since the EAP was closed upon EUA issuance, no existing units were eligible for use under the auspices of that protocol.  
 
MichBio immediately raised the incongruencies in requirements to the attention of Rep. Fred Upton (R-MI) and Rep. Debbie Dingell (D-MI), both members of the U.S. House Energy & Commerce Committee that oversees the FDA. The legislators expeditiously communicated our concerns in a letter to FDA Commissioner Stephen Hahn for his timely response and action. 
 
The new labeling requirements meant that transfusion services at health systems across Michigan and nationally could not legally transfuse existing CCP units to any patients who presented to a provider institution and qualified for transfusion. In addition, the change caught blood suppliers like the American Red Cross unaware, and so procurement of CCP from their inventories was impacted too. 
 
This past weekend, we received word that the FDA acknowledged the unintended consequences, identified workarounds for the short term, while it worked to issue an amended guidance. As a result, the first EUA patient was transfused using existing CCP supplies.
 
Thank you Reps. Dingell and Upton for quick action!
 
CMS Issues Proposed Rule That 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, its member companies and state affiliates like MichBio, would make significant changes to streamline Medicare coverage for FDA-designated breakthrough technologies that have market authorization. 
 
The proposed rule would create a new, voluntary Medicare Coverage of Innovative Technologies (MCIT) pathway that would provide immediate, national Medicare coverage of any FDA-market authorized breakthrough device if the device meets certain criteria. This automatic coverage would begin on the date of FDA-market authorization and would last for four years, after which time coverage would be determined through existing processes (national or local coverage determinations, or claim-by-claim adjudication).
 
The full text of the proposed rule can be accessed here. CMS is seeking comments on the proposed MCIT pathway. Comments are due October 29th.
 
Advocacy at the State Level
 
MichBio Hosts Legislative Briefing on Covid Testing. MichBio hosted a legislative briefing on “Covid-19 Testing: Fundamentals, Utility, Challenges and Policy Implications”. Five member companies served as expert presenters with the aim of educating legislative offices on the types of tests, whom to test, testing timing and frequency, interpretation of test results, testing supply chain, clinical uses and utility, as well as the regulatory, payment and policy impediments standing in the way of implementing an efficient and broadly available testing system for Michigan citizens.
 
Presenters included Mike Pisano, PhD, Vice President of Business Development and Contract Research at Cayman Chemical, Brandon McNaughton, PhD, Co-Founder and CEO at Akadeum Life Sciences, Anna Langerveld, PhD, Founder and CSO at Genemarkers, Alan Mack, CEO at NxGen MDx, and Phil Levy, MD, Vice President of Translational Sciences and Clinical Research Innovation at Wayne State University. Stephen Rapundalo, PhD, President and CEO of MichBio, moderated the session and spoke to the policy implications.
 
The briefing was recorded and is available here.
 
 
Correction
The following revision corrects misstatements in the original article whereby we referenced opposition to HB 5944. First, we should have cited HB 5943 as the “accumulators bill” to which we were opposed in its original form, not as HB 5944. A substitution was introduced to HB 5943 to which the bio-industry is now amenable. Secondly, and instead, we should have indicated our opposition to HB 5940 as corrected below.
 
Drug and Medical Price Transparency. Chairman Frank Vaupel (R-Howell) held a hearing of House Health Policy Committee, wherein a legislative package of nine bills targeting various facets of the pharmaceutical costs supply chain was discussed. Substitutes to the bills were introduced.
 
MichBio, as well as BIO, PhRMA and various drug manufacturer companies are opposed to HB 5937, the so-called “drug manufacturer data reporting act” or “manufacturer transparency bill” that would require drug manufacturers to submit annual reports that detail the aggregate list price, total R&D cost to bring to market, total manufacturing, distribution and marketing/advertising costs, and rebates and other incentives applied, for the period of time that the prescription is available on the market. Such costs would have to be tracked even by early stage biotechs in case their products are ultimately marketed or sold to another company who would market them.
 
In addition, the bio-industry opposes HB 5940, as it seeks to regulate drug manufacturer sales representatives through the Board of Pharmacy. The bill is typically referred to as the “gift ban bill” but its pricing disclosure and sales rep regulation is most concern.
 
The House Health Policy Committee will continue to convene on this package of bills in the coming weeks. Stay tuned.
 
Your Voice is Important
 
You can help keep decision-makers informed on the needs of the bio-industry and help support business-friendly policies that allow for continued growth and development of tools and technologies that improve and save lives. Use the link below to send us an email and find out how you can help.
 
 
 
MichBio Member Subsidiary of the MSU Foundation:
 
 
MSU Foundation - Investment Analyst
 
The MSU Foundation looks to hire an Investment Analyst to work closely with the Executive Director, Director of Finance, and Chair of the MSU Foundation’s Investment Committee to assist with the management of the investment portfolio.
 
To apply, please construct a single PDF document that includes a cover letter and resume. Please send the document to resumes@msufoundation.org no later than October 9, 2020
 
 
 
 
 
 
 
 
 
 
 
 
These August events are available for digital download!
 
PLEASE NOTE: MichBio is transitioning to a new database system. When you access any of the events below, you will be directed to that new database.
 
IF YOU ARE A MEMBER please find the "Sign In" link at the top right of the screen and tell the system "You Have Forgotten Your Username and Password." If you enter the same email you have used to access your account in our current system, the new system will send you login information. Once you have logged in, the events below that have member pricing will automatically show up at the member price when you add them to your cart.
 
IF YOU ARE NOT A MEMBER you have the option of using the "Sign In" link at the top right to "Create a Profile" or simply adding the event to your cart and checking out.
 
 
Five Ways to Stop FDA Recalls - Presented by Menlo Park Associates
 
MichBio Member Company Menlo Park Associates presented 5 Ways to Stop FDA Recalls: 
  • Detection to the rescue
  • Knowledge Synergy
  • Sharing Synergy
  • Precise Probabilities
  • Anchoring Standards
 
Cost: FREE for Members, $19 for Nonmembers
 
 
Using a Forecast to Drive Biopharma Decision Making for Products of all Stages
 
Download this webinar for an expert discussion on the benefits of having a forecast, what goes into making one, and learn about the tools and tactics available to build a forecast for your product or company - no matter the size or stage.
 
Cost: FREE for Members, $19 for Nonmembers
 
 
 
 
Legislative Briefing on COVID Testing: Fundamentals, Utility, Challenges, and Policy Implications
 
This briefing covered what types of tests are available, how they are conducted, what results may mean and the issues that have emerged with implementation. MichBio members NxGen MDx, Genemarkers LLC, Akadeum Life Sciences, Wayne State University and University of Michigan spoke.
 
COST: FREE
 
 
Influenza and COVID19: Planning and Implementation for the 2020/21 Influenza Season
September 9, 2020, 4:00 pm
 
This discussion will explore learnings from the current Southern Hemisphere winter, where responses to both influenza and coronavirus are occurring simultaneously, offer insights as to how governments, providers and public health stakeholders in the Northern Hemisphere can prepare for the upcoming season.
 
 
Genomic Medicine Briefing: Transformative Treatments for Patients and Providers
September 14, 2020, 10:00 - 11:00 am
COST: FREE
 
In this webcast, we will explore how genomic technologies are currently being applied in the research lab and clinically to characterize and treat rare diseases, cancer, and other conditions. In addition, you will hear patient perspectives on the promise of these technologies.
 
 
 
A2 BioSocial
September 15, 2020, 5:00 - 7:00 pm
COST: FREE
 
Welcome back a new season of bio-socializing with fellow Michigan bio-industry professionals and Sococo. Sococo is a virtual platform that creates an "office" for to gather in. You can use the platform to connect in the ways you find the most beneficial - either private conversations or group chats.
 
 
The Art and Science of Scientific Storytelling: Perspectives from a Medical Communications Expert
September 16, 2020, 12:00 - 1:00 pm
Cost: FREE for Members, $19 for Nonmembers
 
Data are much more than numbers – they’re indicators of actual human experience, and interwoven into every number and every outcome, is a patient’s story. Scientific storytelling enables us to take data and weave it into impactful messaging that empowers HCPs to act in the best interests of their patients
 
 
Current Status of 3D Printing for Polymer Medical Device Components
September 16, 2020, 12:00 - 12:30 pm
Cost: FREE
 
MichBio Member aMDI, with MediSurge, presents this webinar featuring a review of common polymer additive manufacturing (AM) processes - Advances in liquid photopolymer AM - An overview of digital light processing (DLP)
 
 
 
Bio Impact Digital
September 21 - 22, 2020
 
BIO IMPACT Digital is focused on bringing together the global agriculture and environment community to share critical industry insights, form valuable partnerships, and spotlight new innovations making our world more resilient. 
 
 
Tech on the Edge
September 24, 2020, 11:00 am - 5:00 pm
Cost: FREE
 
As a part of a2tech360, we are excited to virtually celebrate the technologies, innovation, and talent of 40+ companies (from the “edge” of the Ann Arbor area) showcasing their unique products and projects.
 
 
Regional Postdoc Symposium
October 7 - 9, 2020
Cost: FREE
 
MichBio members Michigan State and Wayne State Universities, and the University of Michigan partner with Van Andel Institute to bring you the 2020 Michigan Regional Postdoc Symposium featuring career panel, informational sessions, and a keynote address on "Navigating Negotiations".
 
 
BIO Investor Forum Digital
October 13 - 15, 2020
 
MEMBERS SAVE ON REGISTRATION UNTIL SEPT. 10. CONTACT ALISHA BROWN FOR INSTRUCTIONS
 
BIO Investor Forum Digital will showcase drug development programs that are ready for partnering or venture funding and to accelerating the progress of new therapeutic technologies into commercialization and treating patients.
 
 
Virtual MedTech Conference
On-demand and Partnering
September 8 - October 23, 2020
 
Live Stream
October 5 - 7, 2020
 
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.
 
MichBio and Aon have teamed up to bring comprehensive coverage for Executive Liability and Cyber Insurance programs. Aon has undertaken an extensive request for proposal process to vet and select an elite group of insurers based on their ability to deliver distinctive value to life sciences clients. Through these programs, MichBio members can access and benefit from expansive coverage of offerings, and competitive pricing utilizing broad Aon-negotiated policy language, along with a unique array of defined services, all designed to enhance program efficiency and effectiveness through these reputed insurance carriers.
 
MichBio Member Benefits:
  • Members will benefit from multiple carriers competing for their business, without sacrificing coverages or enhancements.
  • Superior claims handling by experience attorneys and claims professionals with extensive life science experience
  • Managed by dedicated Life Science and Professional Risk Solutions team members within Aon industry
  • Industry-leading global resources, technical expertise and industry knowledge are delivered locally through more than 500 offices in more than 120 countries
 
PrEFERRED PURCHASING PROGRAM & BIO BUSINESS SOLUTIONS
MichBio members have access to a group of preferred vendors who provide discounts on their products or services. Vendors include VWR, Chubb, Office Depot, Scientist.com, and more. For the full list of included providers, or information on how to sign up, contact elizabeth@michbio.org.
 
DID YOU KNOW?
Most members involved in the Preferred Purchasing Program save in excess of 10 TIMES the cost of their membership on everything from everyday business expenses, lab supplies, and insurance.
 
 
Welcome Iris Dx!
 
Iris Dx is a Grand Rapids based company creating a precision approach to oncology diagnostics.
 
 
Welcome Science DrillHouse!
 
Science DrillHouse, Inc. is a non-profit organization associated with Science DIBS, LLC. Similarly to Science DIBS, Science DrillHouse’s goal is to help students on their way to a science career by providing students with scholarships to assist in the expenses associated with a summer research experience.
 
Get to Know Member Consultant - Performance Validation!
 
Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
 
Performance Validation is not a virtual company, a staffing agency, or a “body shop.” The company's projects are managed and staffed by its own employees who live by their Mission, to provide clients with peace of mind, which they have been doing so for more than 30 years.
 
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