eCTD Global Submission Planners Case Study Presented by Auditgraph

Posted by BioOhio on Aug. 11, 2014

Contributor-MMarcussenBioOhio is glad to introduce a new contributor to micrOHscope, Mauricha F. Marcussen, CEO of BioOhio member company Auditgraph. Mauricha has extensive experience in the life sciences industry working with over 20 of the industry’s top pharmaceutical and biotechnology companies. She is known for her expert business, technology, and project management services related to many areas of regulatory affairs, including global product labeling and electronic international submission processes and requirements.

What if you had country specific submissions requirements at your fingertips?

Auditgraph200webAuditgraph, a pharmaceutical and life sciences partner delivering technology in regulatory, has developed a portal with eCTD global submission requirements. With over 160 countries, many with unique submission requirements, the manual task of maintaining this information is extremely inefficient and difficult to manage. Auditgraph undertook the process of creating a platform where country-specific submission information would be maintained and made available with the click of a button. Auditgraph’s eCTD Global Submission Planners Case Study reveals valuable information about the scope, process and result of one client’s use of the platform.

In this case study you’ll learn:

  • The scope of global submissions and filing requirements
  • The process Auditgraph took to create an online platform for clients to access a tremendous amount of submission information
  • The result of using Auditgraph’s powerful platform, its specific capabilities and the efficiencies realized by the featured client.

BIO Washington Update, August 2014

Posted by BioOhio on Aug. 06, 2014

CSBA BIO and Republic Consulting

August 6, 2014

Legislators wrapped up their summer work in July before leaving town for the August recess, but not without some last minute drama over the Highway Trust Fund (HTF) and the border supplemental bill. Ultimately, lawmakers passed a funding extension for the Highway Trust Fund (HTF), staving off a financial crisis. Congress also moved forward on several tax items and continued to hold oversight hearings on the Affordable Care Act (ACA) implementation.

CONGRESSIONAL OUTLOOK

When lawmakers return after Labor Day, they will have a host of issues to confront in the short period of time before they resume full-time campaign activity leading up to the mid-term election. Congress is currently scheduled to be in session the week of September 29 for last minute items, but they are expected to wrap up federal funding legislation and other expiring items by September 19.

There are several must-pass items that both chambers are expected to address upon their return. At the top of the list is government funding. Congress will need to move quickly to pass a continuing resolution (CR) to fund the government past the current authority which expires on September 30. The final CR may also include a temporary extension of the Export-Import (Ex-Im) Bank, which would allow for additional time to debate the controversial reauthorization. Finally, legislators are expected to act on the internet tax moratorium, which is set to expire in the fall.

In addition to these pressing items, the Senate may also take up several other bills designed to motivate the Democratic base, including possible votes on college affordability, a minimum wage increase, and bills reversing the Supreme Court decisions on employer contraception coverage and campaign finance disclosure.

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The summer of partnerships and discovery in Ohio’s bioscience community

Posted by BioOhio on Jul. 30, 2014

Expo-Logo-for-CTA-230As we prepare for the Ohio Bioscience Expo & Showcase next week, bringing together bioscience companies and professionals from all over the state, we wanted to take a moment and recognize the impressive list of partnerships and collaborations in the news this summer. From device & drug development, patient care initiatives, commercialization efforts and research partnerships, it’s all coming together in Ohio.

The Neurotechnology Innovations Translator, with principal investigator Dr. Ali Rezai, backed by the Ohio Third Frontier and partners throughout Ohio industry and academia to the tune of $161M was announced in June.

The Ohio Clinical Trials Collaborative, part of Governor John Kasich’s Ohio Medical Corridor, held a public launch of the statewide IRB, connecting Ohio’s clinical resources, at the BIO International Convention in San Diego. OCTC seeks to establish Ohio as one of the most efficient and effective states in which to develop new therapeutics, diagnostics and medical devices.

The Austen BioInnovation Institute in Akron recently announced an agreement with ADB International Group to bring the E-QURE BST would healing device to the U.S. market. Navidea Biopharmaceuticals formed a joint venture named R-Nav with startup Rheumco to target rheumatologic and arthritic diseases. Backed by the National Science Foundation, UC San Francisco and University of Toledo formed the Center for Disruptive Musculoskeletal Innovations.

Akron Children’s Hospital, is leading research with 23 children’s hospitals around the country to improve the safety and care of patients during shift changes or hand-offs to new care providers. The University of Cincinnati, The Ohio State University and Indiana University formed the Midwest Consortium for Cancer Survivorship to enhance the quality of life for cancer survivors through patient-centered care beginning at the time of diagnosis.

The Wright State University and Premier Health Neuroscience Institute has added Dayton Children’s Hospital to its research program. The University of Cincinnati announced it is one of the founding members of the Midwest Pain Consortium, along with Eli Lilly and Co., which will work to develop next generation pain medications.

We’re excited to see so much activity around Ohio, connecting the amazing resources in our state. Great things happen when people work together.

We hope you can make it to the Expo next week, a free event designed to build even more exciting partnerships in Ohio’s bio community!

BioOhio BioBulletin, July 2014

Posted by BioOhio on Jul. 18, 2014
BioBulletin John Lewis

Welcome to the July BioBulletin.

Trivia for this month: Charles Francis Brush, born and raised in Euclid, worked as an analytical and consulting chemist in Cleveland. His interest in electricity eventually led to his advancement of the electric arc light. Brush installed his first commercial arc lamp on the balcony of a doctor’s residence in Cincinnati. 12 arc lamps were later used to light the public square in Cleveland. This type of lighting changed life in American cities, making nighttime activities more popular and safe. Ohio-born pioneers continued to innovate light, including Thomas Edison from Milan, inventor of electric light, and Arthur Compton from Wooster and graduate from the College of Wooster, inventor of the florescent lighting tube.

Ohio Bioscience Expo & Showcase presented by BioOhio

An event focused on Ohio-based resources, business and innovation, August 5, 10am-5pm

Discover and connect with established & start-up bioscience companies, suppliers, service providers, and innovators. Meet companies who are moving bioscience technologies and products from concept to market, and the innovators who are on the idea-market path. Exhibitors and attendees alike will connect with new customers, find new collaborators and partners, meet colleagues in the industry, discover companies making cutting edge products and delivering quality services.

47 exhibitors and 200 attendees are currently registered, and growing steadily. Click here for more info on exhibiting, or click here to register as an attendee (free to attend).

Educational workshops, hosted by event sponsors, will be held throughout the day, and a networking reception will take place from 4-5.

The event will be held in Aurora, located between Cleveland and Akron, at the Bertram Inn & Conference Center.

Sponsored by

University of Cincinnati Professional Practice | MAGNET | Offenberger & White, Inc. (OffWhite) | McFlusion | NanoLogix | BioEnterprise | Britton Gallagher | Taylor Strategy Partners

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Workshop content to shine at the Ohio Bioscience Expo & Showcase

Posted by BioOhio on Jul. 16, 2014

Expo-Logo-for-CTA-230The Ohio Bioscience Expo & Showcase is less than a month away! We have an amazing group of sponsors and exhibitors from around Ohio. The event is free to attend, and we still have space for new exhibitors!

Companies represent the fields of medical devices, pharmaceuticals, clinical research, contract manufacturing, agricultural biotechnology, product design, professional services, manufacturing services, workforce development, quality control, information technology, economic development, and more!

We are also delighted to present a series of exceptional (and free!) workshops to all Expo attendees. Workshops will run throughout the day alongside the exhibitor floor. Click here for the schedule and workshop details.

  • University of Cincinnati ProPEL will discuss how to integrate internships into your business, finding value for both students and employers.
  • MAGNET & BioEnterprise present Additive Manufacturing and its Impact on Medical Products, featuring experts in the industry.
  • NanoLogix presents Dr. Sebastian Faro, who will discuss the N-Assay Multiwell Microplate Assay technology.
  • McFlusion presents the science of clean-in-place (CIP) technology – TACCT (Time, Action, Coverage, Chemistry and Temperature) and the practical application of these critical cleaning parameters.
  • Offenberger & White presents Brand Science 101 & Social Science 101, two sessions designed to improve your branding and social media presence.
  • Taylor Strategy Partners presents a program to help participants understand the Millennial/Gen Y generation, relevant demographic trends, and the importance of assimilating them fully into the workforce.

The Ohio Bioscience Expo & Showcase will be held on August 5th, at the Bertram Inn & Conference Center, 10am – 5pm. See you there!

 

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