Barnett Releases IND Submissions: A Primer

Barnett Releases IND Submissions: A Primer

Barnett International, a division of Cambridge Healthtech Institute, has announced the release of IND Submissions: A Primer, an in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments. IND Submissions: A Primer is the only comprehensive IND manual of its kind.

Needham, MA (PRWEB) February 25, 2009 -- IND Submissions: A Primer provides a "hands-on" approach that teaches regulatory professionals - novice and veteran alike - to work with the regulations, guidance documents, content templates, contributing authors, and style guides necessary to write an IND. The book's writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book is a CD filled with electronic examples.

The 600-page, spiral-bound, hardcover book is easy to use, providing step-by-step instructions on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is divided by easy-to-read tabs.

IND Submissions: A Primer is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional. This comprehensive "how-to" guide contains:

•    Regulations and guidance document references

•    Overview and background of why the submission is required

•    Structure of the submission itself

•    Details on who should contribute to the submission

•    Where to pull, re-use, or start as a basis for information needed in a submission

•    Tips and lessons learned from the author's experience

•    Different perspectives on how a submission can be approached

•    Applicable FDA Form 1571 information for each submission

•    Paper publishing tips

•    Electronic CTD publishing sections for each submission, where applicable

•    Real life examples taken from the press and approved NDAs when available

•    Electronic examples and content templates to utilize so that an RA professional can begin immediately working on a submission

IND Submissions: A Primer is available for $295 per copy by calling 800-856-2556, or by ordering online at www.barnettinternational.com. Estimated shipping date is February 27, 2009.

About the author:

IND Submissions: A Primer was written by Meredith Brown-Tuttle, RAC, a regulatory consultant whose background incorporates all aspects of drug, device, and biologics development including clinical research, data management, medical writing, and regulatory affairs. She served for six years on the Board of Editors for the Regulatory Affairs Professional Society's journal, "Focus," and has published numerous articles, edited books and book chapters, and presented at professional meetings on a variety of clinical research and regulatory topics. Ms. Brown-Tuttle also teaches about regulatory submissions, intelligence, strategy, and agency interactions for the Regulatory Affairs Certificate program at UC Santa Cruz.

About Cambridge Healthtech Institute

Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI's portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech's Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.

Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business.

About Barnett International

Founded in 1979, Barnett International is widely recognized for its superior consulting services and its targeted education and training programs. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. The "Barnett Difference" is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.

We help pharmaceutical, biotechnology and medical device companies maximize the speed and quality of their product development efforts. With an international presence and with many staff members working from the client site for increased benefits, Barnett is able to apply a global expertise to its projects.

Our services include educational programs and products and consulting.

The source of our expertise:

•    Exclusively focused on the pharmaceutical/biopharmaceutical industry for more than 20 years

•    A team of talented professionals (150+) with deep-rooted industry insight and expertise

•    An in-depth understanding of different cultures and unique organizations

•    Experience working with major pharmaceutical companies around the world

•    Global resources with offices in the US and Europe

Media Contact:

Barnett International

Kate Bliss

Marketing Communications Manager

781-972-5435

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Contact Information Tracey Fielding

7814-972-5429

American TeleCare, Inc. (ATI) Appoints Michael A. Brodeur as Chief Financial Officer

American TeleCare, Inc. (ATI) Appoints Michael A. Brodeur as Chief Financial Officer

American TeleCare, the Leader in Technology-Enabled Telehealth Solutions, Adds Accomplished Financial Executive to its Senior Management Team

Minneapolis (PRWEB) February 25, 2009 -- American TeleCare, Inc. (ATI) announced that Michael A. Brodeur has joined the company as its chief financial officer. ATI is the leader in the development and application of video-based telehealth solutions to advance patient care.

"Mike is a seasoned executive with more than 25 years of high-level financial management experience in the health care, medical device, biotechnology and clinical laboratory industries," said Randy Moore, M.D., M.B.A., chairman and chief executive officer, American TeleCare (ATI). "He brings ATI exceptional expertise in corporate finance, business development and the capital markets."

"With solutions that combine telecommunications technology with unmatched clinical functionality, ATI is at the forefront of the telehealth industry," said Brodeur. "Managing the costs of caring for patients with complex, chronic conditions is a fundamental challenge in health system reform. ATI is positioned to lead the way to establish new models of telehealth-supported care that connect high-risk patients to essential clinical expertise."

Immediately before joining ATI, Brodeur was the chief financial officer of Medical CV, Inc. (NASDAQ:MDCV), developer and manufacturer of laser-based surgical devices. He has also served as CFO of McKesson Medical Management (a $500 million pharmacy outsource provider to hospitals) and Meris Laboratories, Inc. (a $50 million clinical laboratory testing company). He previously held other senior financial leadership positions with EPS Solutions Corporation and WellPoint Health Networks, Inc., now WellPoint, Inc. (NYSE:WLP), which today is the nation's largest health insurer by member numbers. Brodeur was a managing partner at Prairieview CFO Partners, LLP, a CFO services firm for public and pre-IPO emerging and middle-market businesses. And as senior partner at Tatum CFO Partners, LLP, another national CFO services firm, he served as CFO of Molecular Diagnostics, Inc., now CytoCore, Inc. (OTCBB:CYTO) and Aastrom Biosciences, Inc. (NASDAQ:ASTM).

Brodeur is a certified public accountant who began his career at Ernst & Young. He earned a bachelor's of science degree in business administration and accountancy at California State University, Long Beach, Calif.

About American TeleCare, Inc. (ATI)

Founded in 1993, American TeleCare (ATI) is the pioneer of intelligent monitoring and video-based telehealth technology. With proven experience in clinical process re-engineering, ATI works with leading healthcare organizations to put their patients at the center of care teams and supports them with best-in-class solutions. ATI systems connect continuous healing relationships and deliver essential information for clinical and self care. Ongoing monitoring and constant care of patients at home keeps them connected to clinical expertise and may help prevent acute events. The results: 100-200 percent increases in provider productivity and 65-95 percent reductions in emergency room and inpatient costs - achieved as care teams help physicians watch over, improve and maintain their patients' health. For more information, visit www.americantelecare.com. Then call 800-323-6667.

NOTE: American TeleCare will exhibit at the American Telemedicine Association (ATA) Annual International Meeting & Exposition, which will be held on April 26-28, 2009 at the Rio All-Suites Hotel and Casino, Las Vegas, Nev. American TeleCare will be at booth #300.

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Contact Information DAVID AQUILINA

American TeleCare, Inc. (ATI)

http://www.americantelecare.com

612.922.5551

Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials

Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials

Stemedica Cell Technologies, Inc. announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U.S.-based Phase I and Phase II Clinical Trials.

San Diego, CA (PRWEB) February 25, 2009 -- Stemedica Cell Technologies (http://www.stemedica.com), Inc. ("Stemedica") announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U.S.-based Phase I and Phase II Clinical Trials. Readiness for manufacture includes obtaining a California Drug Manufacturing License for the Stemedica facility in San Diego, California.

"Completion of this certification will allow us to manufacture stem cells under contract for clinical trials for Stemedica as well as for other companies and research centers in California and across the United States. This marks a significant milestone along the journey toward the future availability of stem cell treatment for patients who so urgently need it," said Dr. Maynard Howe, Vice Chairman and CEO at Stemedica.

To prepare for inspection, Stemedica fully reconstructed its facility according to FDA requirements, which had previously focused on research and development. Stemedica's manufacturing facility now includes a fully compliant manufacturing wing with entry-level gowning rooms, two ISO class 8 sterile gowning suites, an ISO Class 7 Manufacturing Clean Room, an ISO Class 7 Processing Clean Room, a Good Manufacturing Process compliant materials warehouse and a controlled-access Quality Control testing laboratory.

"As soon as Stemedica secures its license from the State of California's Department of Public Health, we plan on filing for one or more IND's (Investigative New Drug) for specific indications with the FDA using our proprietary technology. The final major step by the Food and Drug Branch within the Department of Public Health is an in-depth, in-person inspection by their personnel. We're particularly proud of the fact that we are ready for, and capable of, seeking licensing in California, which has exceptionally stringent standards," said Dr. Alex Kharazi, Vice President, Research & Manufacturing at Stemedica.

"Becoming a Licensed Manufacturer of clinical grade adult stem cells is a significant scientific and medical step forward for the Company," said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer. "Securing this status will allow us to become a primary CMO (Contract Manufacturing Organization) for other for-profit companies and the many research organizations interested in advancing stem cell research through clinical application. Additionally, achieving this regulatory status within the manufacturing world will provide Stemedica with the foundation to advance its own Phase I and Phase II Clinical Studies once approved by the FDA."

About Stemedica Technologies, Inc.

Stemedica Cell Technologies Inc. (www.stemedica.com (http://www.stemedica.com)) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan -- dmcguigan (at) stemedica.com.

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Contact Information Dave McGuigan

Stemedica Cell Technologies Inc

http://www.stemedica.com

+1 858 658 0910