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MichBio | 2023 Recap – MI Life Sciences Link

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Reflections on 2023

As 2023 ends, we’ve been reflecting on the impact our team made on Michigan’s life sciences industry.  

While there were certainly challenges along the way, we’re proud of the work done here at MichBio and hope you’ve noticed our efforts to convene, connect, inform, and advocate for the statewide life sciences cluster. Some reflections on activities over the past 12 months…

The year began with a well-attended reception for legislators and policymakers in late January where leaders from across the industry and state got a chance to raise awareness of their organizations and the impact they bring, along with that of the overall cluster, to Michigan’s economy. The event set the stage for MichBio’s subsequent advocacy efforts as elected officials and staff were generally better informed of our mission and priorities.

Not to rest solely on the success of that event, MichBio hosted several others around the state to better connect the life sciences ecosystem. Networking socials in Lansing, Grand Rapids, Royal Oak, Traverse City and Kalamazoo brought together old industry friends and created opportunities to make new acquaintances. Look for more schmoozing in 2024!

Late spring offered a unique chance for MichBio to engage the regional life sciences ecosystem by convening researchers and other stakeholders and respond to a federal solicitation towards establishing a Customer Experience Hub as part of the Advanced Research Projects Agency for Health (ARPA-H). The hub incorporates human-centered and design-thinking principles into ARPA-H initiatives, including reaching patient populations and engaging with providers. Through a series of Zoom gatherings and on an extremely short timeline, MichBio and others, including Corewell Health and the MSU Foundation, pulled together a submission. While we weren’t successful in being awarded the Hub, we learned a lot about the considerable partnerships already here in Michigan, and more importantly, the significant opportunity to expand such collaboration. 

In September, MichBio presented the Michigan Life Sciences Showcase, in part to celebrate our 30th anniversary as an organization. More importantly, it gave us a great opportunity to feature thought leadership from across our research, biopharma, medtech and healthtech sectors. Sessions showcased the latest in scientific discovery, sustaining a life sciences workforce, trends in healthcare innovation, advancements in product regulations, and so much more.

The highlight of 2023 most assuredly was hosting the Governor’s Roundtable on Growing Michigan’s Life Sciences Industry in late October. Industry executives from across the state gathered to discuss the opportunities and challenges facing their business growth and success. Governor Whitmer, along with leadership of the Biosciences Legislative Caucus and Michigan Economic Development Corporation engaged actively, asking numerous questions, and seeking perspectives on a variety of issues. It was a phenomenal gathering, and we were fortunate to have Governor Whitmer dedicate an hour of her valued time. The Roundtable served as a great foundation to jumpstarting an update to the statewide biosciences industry strategic plan in 2024.

“A five-alarm fire for the life sciences industry” …that’s how one legislator described the legislative policy landscape facing Michigan biosciences cluster. The year was unlike anything MichBio witnessed in a very long time as the industry was challenged relentlessly on numerous fronts – from attempts to regulate the use of animals in research, mandate drug price controls, institute data privacy directives and allow right-to-repair of medical devices. Much of the proposed legislation was anticipated as Democrats took control of the legislative and executive branches for the first time in decades and endeavored to pass their long-cherished policies. 

The likelihood of losing their majority in the House this fall along with having to shorten the legislative session to accommodate electoral timelines resulted in most legislation being accelerated without proper due diligence, discussion and improvement prior to deliberation and passage. Many legislators were (and remain) misinformed and misguided, and some cases, simply blinded by myths about how product development and biomedical innovation occur and what influences patient affordability and access. This caused MichBio to spend inordinate hours, often alongside statewide and national partners, trying to educate and better inform policymakers with independent data – a most time-consuming effort.

Nevertheless, MichBio’s efforts led to some legislative successes. For instance, passage of “Teddy’s Law” that would allow for adoption of research animals included features important to the life sciences industry (see Advocacy Watch for details). In addition, we were able to garner exemption for medical devices in the right-to-repair legislation and ensure that medical products are only worked on by FDA-certified and authorized personnel. Most importantly, MichBio was able to drive legislation that would reestablish a R&D Tax Credit (see Advocacy Watch for details) to the brink of final passage before the legislative calendar ran out. Talk about exhaustion and a myriad of emotions after all that!

We’d be remiss in not mentioning our great partnership with the MEDC. MichBio is privileged to support the agency’s efforts in retaining Michigan’s life science companies, as well as recruiting foreign direct investment to the state. In 2023, we collaborated on ensuring a State of Michigan presence at major industry events such as MD&M West, BIO International Convention, MEDICA and Select USA Investment Summit, where we hosted Michigan companies, showcased our life sciences assets, and met with interested parties from around the globe on the benefits of doing business with our cluster. In addition, MichBio has been leading in the creation of a comprehensive directory of company assets and capabilities, beginning with medical device suppliers and contract manufacturers, and expanding to OEMs and other sectors.

On the business side, MichBio’s Preferred Purchasing Program was utilized by well over a hundred members across almost 150 contractual arrangements that brought a net savings of almost $18 million. MichBio is heartened by our members’ engagement in the program that features over a dozen vendors and the tangible benefits it brings to their bottom line and long-term growth, whether they be an early-stage or large multi-national enterprise.

Organizationally, MichBio had its upheavals too. Long-time staff Elizabeth Foster and Alisha Brown departed for new endeavors in the late spring and mid-fall respectively. We welcomed Emily Brockman as our new Director, Member Relations this summer and she’s off to a great start in getting acquainted with our life sciences community, and are amid a search for a Director, Marketing and Industry Engagement. Through it all, we’ve tried our best to maintain a high level of service and support.

In closing, thank you to our members, without whom MichBio would not exist. We’re proud to deliver our business resources and benefits, advocacy and influence, education and programming, in support of our members, and generally informing and raising awareness of Michigan’s great life sciences cluster.

See you in 2024!

The MichBio Team

 
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This special edition BioMixer happens in conjunction with the Michigan Life Sciences Legislative Academy and will feature networking with life science industry professionals and enthusiasts along with Michigan Legislators who are attending the Academy.

The event is open to anyone – you do not need to be an attendee of the Legislative Academy.

Details:

  • Cost: $10.00, FREE for MichBio Members
  • Time: 5:00 – 7:00 PM
  • Location: Van Andel Research Institute

Exclusive Sponsorship Opportunity available – foster collaboration between the life sciences industry and Michigan’s policymakers by supporting this networking event. Contact emily@michbio.org for details.

REGISTER NOW

Federal 
FTC, DOJ Finalize Merger Guidelines that Could Impede Healthcare Deals

The Federal Trade Commission (FTC) and Department of Justice (DOJ) released new merger guidelines that have implications for the life sciences industry. The new guidelines may give regulators more ammunition to go after vertical and cross-market M&A that has historically been more difficult to challenge. Private equity “roll-ups” of multiple companies may also face heightened scrutiny.

The announcement reflects the agencies’ proposal earlier this year and raises significant concerns given the unique role that mergers & acquisitions play in innovation and the development of novel therapies. The guidelines dramatically expand the number and type of transactions that the agencies will consider presumptively unlawful. READ MORE

White House Announces New Efforts to Target Prescription Drug Prices

On December 7, the Biden Administration announced new efforts intended to lower prescription drug costs. While the announcement includes broader initiatives, one component would allow invoking March-In rights under the Bayh-Dole Act to license the patent rights of drugs to other biopharmaceutical manufacturers when the price of the drug is deemed to be too high.

MichBio has grave concerns regarding the Biden Administration’s proposed framework on March-In rights, which is a departure from previous interpretations of the Bayh-Dole Act and would enact price controls that will stifle biopharmaceutical innovation, reduce competition, and harm patients’ health. Bayh-Dole has been central to the creation of new and more effective therapeutics by incentivizing basic discoveries and research in the form of technology licensing and has engendered a commercialization and entrepreneurial ecosystem in Michigan and nationally for decades. READ MORE

Repeal of R&D Amortization

The America Innovation and R&D Competitiveness Act of 2023 or HB 2673 was reintroduced that would repeal current rules and allow a business to deduct of R&D costs in the tax year that they occur and thereby incentivize long-term investments in innovation. Such repeal has been a top policy priority for MichBio and the bio-industry generally as it would aid many early-stage companies who have suffered greatly by not being able to immediate qualified tax relief for their businesses. HB 2673 has broad support from the Michigan Congressional delegation with Reps. Huizenga, Moolenaar, Kildee, Scholten, Slotkin, and Stevens, having signed as co-sponsors. READ MORE

State
So Close on Reestablishing State R&D Tax Credit… 

Early fall 2023 saw a package of bills introduced that would reestablish a state research & development R&D) tax credit in Michigan – HBs 509951005101 and 5102. Ever since Michigan moved from the Michigan Business Tax regime to the current Corporate Income Tax regime twelve years ago, Michigan taxpayers have not been afforded a state tax credit for their R&D expenditures.

As proposed, taxpayers and authorized businesses with 250 or more employees could claim up to $2.0 million per taxpayer or business, respectively, per year. Taxpayers and authorized businesses with fewer than 250 employees (i.e., a “small” business) could claim up to $250,000 per taxpayer or business, respectively, per year. Additionally, taxpayers or employers could claim up to $200,000 in an additional credit for expenses from collaboration with a research university. The aggregate amount of R&D credits could not exceed $100.0 million (of which $25 million would be set aside solely for small businesses), and if they did, the Department of Treasury (DoT) would have to prorate the credits as prescribed by the bills. The bills would require the DoT to submit an annual report concerning the effectiveness and operation of the proposed R&D tax credits. READ MORE

Legislation to Enact Prescription Drug Price Controls

SB 483SB 484 and SB 485 were introduced in mid-September 2023 that would establish a new state board – a so-called Prescription Drug Affordability Board (PDAB) – that would determine how much pharmaceutical companies can charge for certain drugs by setting an “upper price limit”. According to PDAB supporters, such a body would lower out-of-pocket costs for Michigan patients struggling to afford their medicines.

Essentially, a PDAB is a mechanism for setting price controls on drugs. As proposed, the unelected, five-person board, MichBio, in partnership with its national partners BIO and PhRMA, along with many biopharma company members, is vehemently opposed to the notion of a PDAB. The legislation would not to lead to lower patient drug costs as those expenses are completely based on prescription benefit design through the pharmacy benefit managers and insurance companies. Moreoever, the concern is that imposition of price controls would chill biomedical innovation in Michigan and lead to fewer prescription drugs developed and reduced access to Michigan patients. READ MORE

Regulation of Dogs and Cats in Research

SB 148 and SB 149, sponsored by Sen. Polehanki and Sen. Hertel, respectively, sought to regulate the use/disposition of animals in research including mandatory reporting on numbers of animals owned, used, and released by research facilities, mandatory requirement for adoption of research animals post-use, and other restrictions and penalties.

The legislation arose after an outcry by the animal rights community over the 2019 disposition of more than 30 beagles including Teddy, who had been used in safety pharmacology and toxicology studies. At least 13 states, including Minnesota, Illinois, and Virginia, have passed similar laws. READ MORE

Rare Disease Advisory Council 

Legislation (HB 4167) to establish a Rare Disease Advisory Council (RDAC) in Michigan were progressing nicely through the summer following overwhelming bipartisan passage by the full House.

A RDAC would empower rare disease patients as partners in helping to shape policy development relevant to the unmet needs, common struggles, and concerns on equitable, quality, and affordable access to specialty treatment. The Council would have a diverse membership that includes academic researchers, health care providers and payers, industry members, and patients and caregivers. Twenty-four states have already implemented such a group, and others are poised to do so. READ MORE

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