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News and Press: MichBio News

March 'On the Road' with Stephen Rapundalo

Friday, March 20, 2015   (0 Comments)
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 Stephen Rapundalo

The last month has been a mixture of efforts, visits, and events.

We entered into the data gathering phase of the Bio-Industry Strategic Roadmap 2015 effort – more on that in a separate article – that has required considerable time with hosting of focus group sessions and 1:1 interviews. We’ve received great responses and the perspectives have been diverse. There’s been no shortage of ideas and commentaries. To no surprise, some themes have emerged. In other instances, we’ve been amazed at the conflicting perceptions and prevailing attitudes. But I suppose some of that is to be expected… it’d be no fun if it were all uniform and straightforward.

At the tail end of January, I had the opportunity to attend a meeting of the National Advisory Council (NAC) for the Community College Consortium for Bioscience Credentials (C3BC) in Winston-Salem, NC. I‘m honored to serve as NAC co-chair and help lead the committee’s oversight C3BC program and its participant’s efforts. 

The C3BC consortium includes 12 colleges from across the country, with its focus on meeting the workforce needs for bioscience training. The strategies include: I) development of standardized core skills across the biosciences subsectors and II) introduction of stackable, portable, industry-recognized credentials. C3BC is funded by a $15M grant from the federal Department of Labor and its Trade Adjustment Assistance Community College and Career Training (TAACCCT) program. The initiative is comprised of several key hubs: bio-manufacturing, medical devices, lab skills, and learning technologies.

Specifically, the NAC serves to:

  • Ensure that consortium colleges not only have access to local input but also to advice from regional and national industry groups (such as BIO, NAM) to better understand new credentialing opportunities to meet evolving bioscience workforce needs
  • Identify and validate the necessary skills and competencies of workers; advise on program design and delivery; and assist with curriculum development
  • Ensure that consortium members working with industry, will be understanding current and anticipating future business needs, so that members can quickly adapt to changes in the environment, particularly in hiring
  • Ensure that consortium members are working with Industry partners directly to help provide internships, apprenticeships or jobs

The NAC and C3BC partners met over two and a half days and in the midst of a snowstorm that dumped 8” in a region that knows little about how deal with such conditions – think shutdown. But it was worthwhile meeting and really opened my eyes to what other regions are doing to develop their bioscience talent and meet the industry’s workforce needs for the future.

March began with back-to-back trips to Lansing to deal with two continuing legislative issues: biosimilars substitution legislation and the so-called “Drug Compounding” law. 

All states have to amend their pharmacy laws to allow for the impending access to interchangeable biologics and biosimilars. Many have already passed similar legislation over the last year – VA, CO, IN, and others. MichBio, as part of a coalition of biotech companies, BIO, GPhA, Express Scripts, patient and physician advocacy groups, and others, is working to ensure that the following principles are included in any final legislation:

  • Substitution should occur only when the FDA has designated a biologic product as interchangeable.
  • The prescribing physician should be able to prevent substitution.
  • The prescribing physician should be notified of the substitution.
  • The patient, or the patient’s authorized representative, should, at a minimum, be notified of the substitution.
  • The pharmacist and the physician should keep records of the substitution.

Opponents are primarily against physician notification and want to substitute at will. Several meetings have been held between the coalition and the legislative sponsor, Rep. Yonker (R-Caledonia). The most recent included stakeholders from all sides of the matter that turned out to be somewhat frustrating given a rather fundamental misunderstanding of the complexity of these drugs. We are continuing our advocacy efforts on behalf of the biopharma companies.

As for the Pharmacy Practice and Drug Compounding Act, the law requires pharmaceutical and medical device companies to hire a “pharmacist-in-charge” (PIC) to be responsible for their product supply chain. Recently, the Licensing & Regulatory Agency (LARA) held a meeting to address pharmaceutical stakeholder concerns about the PIC requirement. On the device front, MichBio is working with key companies, AdvaMed, and the Medical Device Manufacturers Association, to ensure that manufacturers will be exempted from the regulations, or at the very least can identify a “facility manager” or “designated official” as the responsible party. A meeting with the Licensing & Regulatory Agency (LARA) is planned in the near future to discuss the matter. So stay tuned on that.

Then, it was off to Washington, DC and the annual AdvaMed Capital Hill Fly-In. Despite the inclement weather, 7” of snow and a government shutdown on the 2nd day, I managed to fit in visits with 11 of the MI delegation offices… not bad. Repeal of the medical device tax was the main issue discussed, along with the 21st Century Cures discussion draft and patent abuse legislation.

Last week, I did my monthly jaunt up to Genesys Health for continued strategic discussions about growing their life sciences cluster concept. Mid-week I was in Lansing for a quarterly meeting of the Michigan SmartZones and Support Service Providers – always a great opportunity to catch up on what various groups are doing to support company launches, commercialization, and growth. Later that same day, I paid a visit to Endra Life Sciences, Inc. here in Ann Arbor. The company is commercializing a breakthrough photoacoustic technology to enable advanced medical imaging at a fraction of the cost of traditional imaging modalities. Michael Thornton, President and CEO, showed me their commercial product, Nexus 128, a preclinical photoacoustic CT scanner that is being utilized around the globe for molecular imaging applications. Some really cool stuff.

This week, David McGuire, Director of Membership & Operations, and I visited Molecular Imaging, Inc. The facility is the former Charles River Discovery and Imaging Services (and before that, MIR Pre-Clinical Services). A consortium of investors purchased the majority of fixed assets and tangible property from Charles River in 2011 to form the new entity. We had a great meeting with Tom Ludlam, President and CEO, and Dick Leopold, the original founder and VP, Oncology. The company has seen good growth and now has a facility in La Jolla, CA too. It has a full suite of imaging technologies, and while it has expanded its services to other therapeutic areas, it remains the only CRO with proven specialty in the oncology arena.

Lastly, we just concluded another BioArbor session, this one focused on Big Data and led by John Freshley, President and CEO, ONL Therapeutics. Look for the next event in April. And don’t forget our upcoming MichBio U webinar on “Reimbursement Strategy and Business Plans” set for March 25th, as well as the “Medical Technologies: Strategies for Growing in the Global Marketplace” event on March 31 in East Lansing at the MSU Henry Center. Catch up with me next month.


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