Skip to main content
Category

News Archive

Pathfinder Innovation Flyer 113018 a

Join us December 13, 2018 for PATHFINDER INNOVATION PROGRAM

By News Archive

Pathfinder Innovation Flyer 113018 a

Explore Legal Issues for Early Stage Companies

Business formation and governance • Advisory Board vs. Board of Directors Equity incentive plans • NDA’s (w/ potential co-owners/joint ventures/investors and employees) • Worker classifications (exempt vs. non-exempt; W2 or 1099) Employment contracts • Lease and distributor agreements • Customer agreements (for beta testing and beyond) • CRADA’s and technology transfer agreements

Schedule

1 p.m – Networking Lunch

1:30 – Panel Discussion with Q&A 

2:45-4:15 – One-on-one  with Attorneys*

RSVP by noon, December 12 at BHI@BioHealthInnovation.org

No charge to attend • Attend in person or by videoconference

BioHealth Innovation, 1 Church Street, Suite 801, Rockville, MD 20876

creatv-microtech-logo

Creatv MicroTech Receives Japanese Patent for Cancer Screening

By News Archive

creatv-microtech-logo

Creatv MicroTech, Inc. (Creatv) has received notice from the Japanese Patent Office that its patent covering numerous clinical applications for the detection of cancer associated macrophage-like cells (CAMLs) in cancer patient blood samples has been issued. Clinical applications of the CAML biomarker include cancer screening, various cancer diagnostics, and early detection of disease recurrence. Approved claims cover all solid tumors. Similar patents have been issued in Europe and Australia.

Read More
rooster-bio-logo

RoosterBio Submits U.S. FDA Master Files for CliniControl™ Line of Human Mesenchymal Stem/Stromal Cell Products

By News Archive

rooster-bio-logo

RoosterBio Inc, a leading supplier of human Mesenchymal Stem/Stromal Cell (hMSC) working cell banks and hMSC-specific bioprocess systems, announces today it has submitted a U.S. Food and Drug Administration (FDA) Type II Master File (MF) for its CliniControl™ line of cGMP hMSC working cell banks. This MF complements the MF for the CliniControl RoosterNourish™-MSC-CC bioprocess media that was filed in 2017. The MFs contain confidential information on the products including their chemistry, manufacture, and controls. This enables RoosterBio to protect proprietary product information yet allows the FDA to review the information in support of an investigator’s submission. Upon request, RoosterBio will grant a customer authorization to cross reference the stated MF(s) to support their own regulatory filing, such as an Investigational New Drug (IND) application to the FDA. INDs are filed with the FDA prior to beginning clinical evaluation of new therapeutic products in human subjects.

Read More
crispr-therapeutics-logo

The Untold CRISPR Story

By News Archive

crispr-therapeutics-logo

The recent shocking reports about a human genome editing experiment have led to increased murmurings about the potential pitfalls of improved access to molecular technologies. Sharing speeds science. That’s been the driving concept behind Addgene since its founding. Nowhere has this proved more prescient than in the acceleration of basic research using CRISPR-Cas9 genome editing tools. It would be a tremendous loss of efficiency and funding if this rogue experiment resulted in a reduction in repository deposits and the sharing of research materials.

Read More

Search

You have successfully subscribed to the newsletter

There was an error while trying to send your request. Please try again.

BioHealth Innovation will use the information you provide on this form to be in touch with you and to provide updates and marketing.