MichBio | Seasonal Message and BioLink

MichBio December update

Happy New Year!

2020 has been a year unlike any other - in many ways it has felt like both the longest and shortest year in recent memory and has tested our industry's collective resolve to keep moving forward while so many others have been asked to sit still.

While so much has been uncertain, one thing is clear - the life science industry the world over, with sizeable and significant contributions from our great State, has stepped up to solve a historic problem with innovative and life-saving technologies, devices, treatments, and vaccines. The urgency with which our industry took up this challenge is a testament to the talent, passion, and dedication of the individual people who make up our colleagues and industry friends.

We have learned much in 2020, but nothing more important than the knowledge that when the world was watching, we delivered.

Without a doubt, 2021 will bring more new discoveries, technologies, drugs, devices, and collaborations to tackle some of the most difficult and life-altering diseases and conditions. Throughout, the staff at MichBio will be here to support you in your important work.

Thank you and we wish you the happiest New Year!

Make sure to include MichBio in your 2021 plans - Join or Renew.

LEARN MORE ABOUT MICHBIO MEMBER BENEFITS

SAVE THE DATE! Michigan Forum for Digital Health Coming March 31st!

A transformation in healthcare is underway with digital technologies playing a central role. Digital health envisions a world where innovation supports improved health and contributes to better quality, accessibility, and inclusivity for patients, and improves the patient-provider interface to provide more efficient services and inter-operability while leading to more impactful outcomes.

However, the challenges facing innovators and the healthcare system to attain such a lofty goal should not be underestimated. Regulatory barriers, economic hurdles, difficulties in effectively digitizing patient data, privacy, and security concerns, are just a few of the issues that must be overcome to achieve marketplace adoption and success.

This inaugural Forum will have engaging sessions to connect digital health technologists from across the biosciences industry, researchers, implementers, and field experts from across Michigan and beyond. It will feature an FDA Town Hall, panel discussions, solo presentations, and opportunities to network and showcase organizations and/or technologies.

FEATURED SPEAKER

Bakul Patel, MSEE, MBA

Director, Digital Health Center of Excellence

Director, Digital Health Division

Center for Devices and Radiological Health

Food and Drug Administration

Mr. Patel is responsible for providing leadership in development, implementation, execution, management, and establishment of strategic direction and regulatory policy, and coordinating scientific efforts for digital health, software, and emerging technologies. This includes responsibilities in leading the development of policies for mobile health, health information technology, cybersecurity, medical device interoperability, and medical device software.

MichBio Welcomes Dr. Lola Eniola-Adefeso to the Board!

Lola Eniola-Adefeso, PhD is a University Diversity and Social Transformation Professor of Chemical Engineering at the University of Michiganand holds joint appointments in Biomedical Engineering and Macromolecular Science & Engineering and serves on the steering committee of the UM Biointerfaces Institute. She holds a PhD from the University of Pennsylvania and served two years as a NIH Postdoctoral Fellow at the Baylor College of Medicine before coming to Michigan. Dr. Eniola-Adefeso is a co-founder of Asalyxa Bio - a recently-founded company making progress on a treatment for Acute Respiratory Distress Syndrome (ARDS), including the variety found in COVID-19 patients.

We are thrilled to have Dr. Eniola-Adefeso join the Board and know that she will provide the strategic vision necessary to support MichBio as we continue to drive bio-industry growth.

Advocacy at the Federal Level

President Trump Signs COVID Relief, Omnibus Appropriations Package. President Trump finally signed off on a $2.3 trillion Omnibus package that includes $900 billion in COVID relief funding (read the text of the legislation here) to millions of Americans during the holiday season. The package will extend aid through stimulus checks, federal unemployment benefits, funds for small businesses, schools, and childcare, as well as for vaccine distribution. A summary of the details is provided in this Washington Post article.

In addition, the legislation continues the federal government's commitment to research and public health with funding for BARDA, HIV prevention and treatment, and a four-year extension of the critical Rare Pediatric Disease Priority Review Voucher Program to help deliver cures to patients with unmet medical needs.

Thank you Senators Stabenow and Peters, Reps. Upton, Dingell, and Walberg on the Energy & Commerce Committee, and all the other members of the Michigan House delegation for efforts to getting all aspects of this important legislation completed.

Introduction of HR 8845 - From Our Friends at Trusscott Rossman.

Advances in early detection research are on the cusp of significantly improving our ability to find cancer earlier, with a simple blood draw. Multi-cancer early detection tests have the ability to detect many cancers – before patients show symptoms. This technology holds great promise, but there are major barriers to Medicare coverage. We’re encouraged to see House and Senate leaders driving action now to make sure seniors and their doctors will have access to this important innovation. Learn more about the Multi-Cancer Early Detection Screening Coverage Act.

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.

JOIN THE ADVOCACY EFFORT

Pfizer and BioNTech Recieve Authorization in the European Union for COVID-19 Vaccine

India-based CDMO Piramal sketches out $32M upgrade to Michigan drug ingredient facility

Kalamazoo region takes center stage as COVID-19 vaccine distribution commences

New Website Will Combat Vaccine Myths, Boost Public Confidence, Increase Acceptance

Stryker Closes Wright Medical buy, Closes some Businesses to DJO

Pfizer's Coronavirus Vaccine is Being Made in Michigan

NeuMoDx Molecular: Lab develops test that can detect COVID-19, flu strains

University of Michigan: Hair without harm: 2 UM graduates use invasive plant species to create healthier extensions

Cayman Chemical: Cayman Receives SBIR Grant for Alzheimer’s Research

Pfizer Receives FDA Fast Track Designation for Duchenne Muscular Dystrophy Investigational Gene Therapy

NSF - Plumbing Standard Revisions Tighten Lead Leaching Criteria in Drinking Water

NEOGEN launches improved test for gluten

Pfizer - US FDA Approves Pfizer's Xeljanz (Tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis

Swift Biosciences and BillionToOne Partner Together for Commercialization and Manufacturing of EUA Approved COVID-19 Test

University of Michigan - FDA Grant Will Help Bring Complex Generic Drugs to Market Faster

These recent 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 have any trouble please contact us at alisha@michbio.org and we will help.

Diversity Network: When Hiring the Best Means Hiring a Non-Citizen

With sponsor EMMA International , the Diversity Network hosted legal and HR immigration and employment experts as they demystified the international hiring process to equip you with the knowledge you need to confidently search the globe for the most qualified candidates for your company.

COST: FREE for members, $19 for nonmembers

DOWNLOAD THIS WEBINAR

Patient Advocacy Forum

Presented with BIO and Bristol Myers Squibb, the Patient Forum brought together patient groups, industry representatives, and law-makers to identify ways to empower the patient voice. Featuring Eric Dube, PhD President and CEO of Travere Therapeutics discussing his role as both a patient of two rare cancers and an industry leader.

COST: $35 for members, $75 for nonmembers

VIEW RECORDED SESSIONS

BIOTECH SHOWCASE - January 11 - 15, 2021

DIGITAL MEDICINE AND MEDTECH SHOWCASE - January 11 - 15, 2021

SEED SHOWCASE - January 13, 2021

MichBio Members Save! Email alisha@michbio.org for your discount code.

Biotech Showcase™ Digital is an investor and networking conference devoted to providing private and small- and mid-cap biotechnology companies an opportunity to present to and meet with investors and biopharmaceutical executives. The event has gone fully digital and has been expanded to five 24-hour days to accommodate partnering meetings all over the world. See event timeline here.

LEARN MORE AND REGISTER

A2 BioSocial

January 12, 2020, 5:00 - 7:00 pm

COST: FREE

"Stop by" for some bio-socializing with fellow Michigan bio-industry professionals and Sococo. Sococo is a virtual platform that creates an "office" to gather in. You can use the platform to connect in the ways you find the most beneficial - either private conversations or group chats.

RSVP FOR THIS EVENT

Diversity Network Presents:

Making 2021 the Year to Reconcile Life and Work?

January 13, 2021

Cost: FREE - Nonmember registrations courtesy of sponsor, EMMA International!

MichBio welcomes Professor Katleen De Stobbeleir for a presentation and Q&A session on future plans, career aspirations, work-life balance, and the importance for under-represented groups in understanding the "big picture of you".

All member registrants will be entered into a raffle for a copy of Katleen's new book "Making Your Way: The (Wobbly) Road to Success and Happiness in Life and Work"

LEARN MORE AND REGISTER

A2Y Chamber Virtual Early Edition - State of the Biosciences Industry – Perspectives from Area Leaders

January 20, 2021, 9:00 am

Michigan’s biosciences industry has evolved strongly in recent years thanks to a health-care industry desperate for cost-saving innovation, as well as a supportive ecosystem with great research universities, skilled talent, and a focus on commercialization. Industry leaders will talk about their companies’ growth and what it’ll take to ensure an even brighter future for the state’s bio-industry.

MichBio U: Environmental, Health & Safety Regulation Overview for Labs

January 20, 2021, 11:00 am - 12:00 pm

Cost: FREE for members, $19 for nonmembers

Join us for a high-level overview of the regulations that might be applicable to laboratories. Expert speaker from Kestrel Televate has deep understanding of various waste management options and regulations, including RCRA, TSCA, and DOT, as well a working knowledge of the Canadian requirements and transshipment.

Michigan BioTalent Summit

February 3, 2021

The Michigan bio-industry has proven to be a vital component of the national pandemic response. This event is an important element in connecting the many facets of the industry, identifying what’s going well with our overall talent strategy, what can be improved, raising the visibility of existing talent-related resources and efforts, and ensuring that the collaborations seen in last eight months can continue even in the absence of a global pandemic.

LEARN MORE AND REGISTER

Michigan Forum for Digital Health

March 31, 2021 -

Intersecting research, big data, AI, and care management: the future of healthcare is digital. This inaugural Forum will have engaging sessions to connect digital health technologists from across the biosciences industry, researchers, implementers, and field experts from across Michigan and beyond. It will feature an FDA Town Hall, panel discussions, solo presentations, and opportunities to network and showcase your organizations and/or technologies.

**Registration Opens February 1st**

PSC Biotech™ is a life science accelerator, focused on serving as a seamless extension of companies through consulting services. PSC Biotech™ supports all FDA regulated industries through Regulatory Affairs, Technical Writing, Audit, Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV) and IT, Calibration, Engineering, and Project Management Support. PSC aims to be your trusted partner, bringing your company to compliance with our global team of Subject Matter Experts, by providing high quality and reliable consulting services at a cost-effective price.

MichBio Member Benefits:

10% discount on Professional Consulting Services for Regulatory Affairs; Technical Writing; Audit; Commissioning, Qualification, and Validation (CQV); Computer System Validation (CSV) and IT; Calibration; Engineering; and Project Management Support
15% discount on the Initialization Fee and User Licenses for PSC Software™ (Adaptive Compliance Engine® (ACE™), ACE Essentials™, and AuditUtopia®). Subscriptions include the hosting, cloud storage, technical support, and upgrades to future versions of software
45-day free trial ofACE™, ACE Essentials™and AuditUtopia®.Social Media

Learn more are www.bio.org/save/psc-biotech or email save@bio.org.

THROUGH JANUARY 31 - 50% off ACE Essentials initialization fee ($9,500 savings)

ACE Essentials™ is a pre-configured, turn-key, cloud-based quality management software solution for startups, and small to mid-sized life science companies. ACE Essentials™ is a plug-and-play solution that comes with pre-configured, validated workflows and includes a wide range of policies and SOPs that allows companies to move from a paper-based system to a fully functional and operating electronic quality management system in a week’s implementation time.

CONTACT YOUR MICHIGAN PSCBIOTECH TEAM

Preferred Purchasing Program and 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.

Michigan-based Dewpoint provides project management, agile, application, infrastructure, security, and a range of tailored professional and managed services solutions utilizing local resources with global experience. The company is distinguished by its depth and quality of delivery experience, focus on client success, ease of doing business, and track record of consistently delivering for clients.

Get to Know Member Consultant - Intent Venture Management!

Intent Venture Management was founded and directed by Lindsay E. Klee to advise life science, healthcare & investor clients nationally.

Lindsay has extensive experience in life science investment and commercialization and has consulted for VC investors and numerous start-ups, worked as part of the Belle Michigan LP General Partnership, consulted with numerous hospitals, and served as Commercialization Director for the University of Michigan Medical Innovation Center where she was directly responsible for pioneering and managing a Concept to Commercialization product development gap fund for healthcare, medical device, therapeutic, IT, and diagnostic technologies.

She secured competitive capital for and managed an FDA-sponsored device consortium and has assisted teams and companies working toward product milestones, funding, and FDA submissions/compliance. Lindsay’s previous work experience also includes consulting for small, medium, and large enterprises (both independently and within the Healthcare and Life Science Divisions of PricewaterhouseCoopers, LLC). Her consulting efforts have focused on M&A/expansion decisions, deal structuring, feasibility studies, financial and business/commercial planning, and regulatory compliance. She also has worked in technology transfer and in drug discovery with Pfizer Global Research and Development.

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MichBio | Seasonal Message and BioLink - December 2020

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