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March 2015
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On the Road 
Stephen Rapundalo, PhD 
President & CEO

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 (see more below) 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. [Read more 'On the Road']

Input Gathering Stage of Strategic Roadmap Effort
The Michigan Bio-Industry Strategic Roadmap 2015 is a statewide effort led by MichBio to develop a five-year strategic plan for growing our biosciences industry. The initiative is being executed in partnership with the Business Leaders for Michigan and the University Research Corridor.

Outreach to bio-industry stakeholders is in full swing with numerous data-gathering sessions completed already, and more planned. Anyone involved with the bio-industry can participate in two ways:
  1. Complete a 10-minute online survey
  2. Participate in a focus group
In addition, we are conducting 1:1 interviews with select bio-industry thought leaders.

Data gathered will validate key strategic themes and areas, identify new unmet needs and growth opportunities, and help develop policy proposals for action. We are seeking input based on sector, market , and functional areas.

Be a part of the Michigan biosciences industry strategic planning effort! Questions or comments? Contact Stephen Rapundalo at srapundalo@michbio.org.

FDA Seeks External Collaborations to Support Regulatory Science Needs
This report identifies drug safety-related regulatory science needs, priorities related to the mission of CDER that would benefit from external collaborations and resources. [More]

Draft Guidance on Formal Meetings Between Applicants and FDA
This document provides recommendations on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products, and revises the guidance for industry published in 2009. [More]

Electronic Informed Consent (IC) Guidance Issued
Electronic IC can employ one or more forms of electronic media, including "text, graphics, audio, video, podcasts, and interactive Web sites, biological recognition devices, and card readers." They may also use interactive computer-based technology, such as "diagrams, images, graphics, video technology, and narration," which may include questions at the end of each section to assess the subject's understanding. [More]

Rules for Disinfecting Reusable Medical Devices Finalized by FDA
This document will help device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection, and includes recommendations manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. [More]
Advertise in BioMatters, go to BIO
BioMatters is getting a makeover just in time for the 2015 BIO International Convention in Philadelphia! 

Ad space is still available, with discounted rates for MichBio members. Among other places, it will be distributed at BIO where 15,000 bioscience professionals from around the world gather for four days! 

MichBio is proudly partnering with the Global Business Club of Mid-Michigan for this half-day event in Lansing for new and experienced exporters to discuss market entry approaches and regulatory and supply chain issues. Registration is only $35 ($15 for students).
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