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The Ten Mistakes That Senior Management Teams Make with Investigational New Drug Applications
All About Science Series
Tuesday, March 2, 2010


Agenda
12:00 PM - 12:30 PM   Registration, Lunch, and Networking
12:30 PM - 1:20 PM     Interactive Presentation
1:20 PM - 2:00 PM       Panel Discussion & Q&A;

The achievement of a cleared Investigational New Drug application (IND) is a critical milestone for most small to mid-sized companies. Senior Management teams face many challenges when working on these applications. These are not easy applications to create, and there are many potential pitfalls.

During this presentation the pitfalls that CEOs and senior management teams need to be aware of will be identified. A panel session will follow the main presentation at which time the audience will be able to address questions to members of the panel.

For the first time at the BioCenter, Webinar link-up is available for those who are not able to participate on-site.

This event is produced in partnership with Liquent and Speid & Associates, Inc.


Speakers
• Panel Chair: Debra Gosling, Account Executive, Regulatory & Clinical Services, Liquent Inc.
• Lead Speaker: Lorna Speid, M.R.Pharm.S., Ph.D., RAC., President, Speid & Associates, Inc.
Sarah Powell, Executive Director of Regulatory Strategies, Liquent Inc.
Jim Hilferty, Operations Manager, Regulatory & Clinical Services, Liquent Inc.


Venue
The San Jose BioCenter
5941 Optical Court
San Jose, CA 95138
Click here for venue directions»


Speakers Bios

Panel Chair: Debra Gosling, Account Executive, Liquent Regulatory & Clinical Services, Liquent Inc.
Debra is an Account Executive with Liquent Regulatory & Clinical Services. She is a key contributor to new business development of Liquent Services & Software Solutions offerings, including Submission Published Outsourcing, Regulatory Writing, Medical Communications, and Custom Literature Searches. In addition, she is responsible for maintaining ongoing client relationships. Previous new business development experience includes: Covance Clinical Services (IVRS technology), Roche Diagnostics (Applied Science Division) and Dade Behring (MicroScan). Debra began her career as a BS, MT (ASCP) graduate of Rochester Institute of Technology with practical experience managing a Clinical Microbiology Laboratory. Debra has been living and working in the San Francisco Bay Area biotech community since 1988.


Lorna Speid, M.R.Pharm.S., Ph.D., RAC., President, Speid & Associates, Inc.
Lorna Speid, B.Pharm.(Hons). M.R.Pharm.S., Ph.D., RAC is President of Speid & Associates, Inc. a regulatory and drug development consultancy based in San Diego, California. She works with small and large pharmaceutical companies, assisting them at the various stages of the drug development process, including US, European, international and global strategic regulatory affairs. Dr. Speid has an excellent track record of success in regulatory affairs, and is considered an expert in her field. She has registered therapeutics internationally, and has experience with all the major regulatory authorities. She has experience with many therapeutic areas including oncology, diabetes and pulmonary.
Dr. Speid began her career as a pharmacist in the UK, after which she completed a Ph.D. at the Centre for Medicines Research International, into the Safety Assessment of Medicines, Pre and Post Marketing. She has worked for large as well as small pharma companies, including Sanofi Winthrop in the UK (now Sanofi-Aventis), Ciba Geigy and Novartis in Switzerland (at Headquarters). Small companies that she has worked for include Valentis, Inc. (Director of Regulatory Affairs), NewBiotics (Vice President Regulatory Affairs and Project Management), and Avera, Inc. (Vice President of Regulatory Affairs). Dr. Speid was an officer at the last two companies. She has a Bachelor of Pharmacy degree from the University of London, UK (Kings College), and a Ph.D. from the University of Wales, College Cardiff, United Kingdom.


Sarah Powell, Executive Director of Regulatory Strategies, Liquent Inc.
Ms. Powell is the Executive Director of Regulatory Strategies for Liquent. Sarah has 22 yrs of experience in pharma and related regulated industries. For the last 8 years Sarah has worked on a variety of projects related to implementation of regulatory solutions and has contributed to defining product strategies for industry leading software solutions. While in industry, Sarah performed a variety of roles within the Clinical, Quality, Regulatory Affairs and Regulatory Operations groups. Sarah has extensive experience with preparing regulatory submission for biologic products for submission in the US and EU. She also has detailed knowledge on the requirements for the electronic submissions, including eCTD, and the recently established requirements for electronic submission of labeling information (SPL and PIM).


Jim Hilferty, Operations Manager, Regulatory and Clinical Services, Liquent Inc.
As an Operations Manager, Jim Hilferty is responsible for the design and implementation of regulatory processes to support the additional business development required for expansion and growth of Regulatory and Clinical Services (RCS) at Liquent. Jim is responsible for RCS business development planning, day to day business process analysis and management, articulating procedures and solutions to multi-level teams, internal and external training, strong documentation skills, and an in-depth understanding of multiple regulatory software applications, dossier formats, and agency requirements.
Jim has performed system installations, validation, user and administration training, report and submission level publishing using CoreDossier, EZsubs, and InSight Publisher applications. He has the flexibility and comfort level to utilize CoreDossier, EZsubs, InSight Manager, and InSight Publisher with the clients’ business processes on-site or remotely while meeting time sensitive deliverables. Jim has been a member of multiple teams that have published large and time critical IND, NDA, BLA, CTD, and supplemental dossiers to both the CDER and CBER divisions of the FDA, the EMEA, and Canadian agencies in both electronic and paper formats. Jim has worked on projects for clients such as Alcon, Allergan, Amgen, AstraZeneca International, Bayer, Corus Pharmaceuticals, Discovery Labs, Endo Pharmaceuticals, McNeil, OSI Pharmaceuticals, Neurocrine Biosciences, Novalar, and ZymoGenetics as well as providing training and support to a number of other large and small Biotech and Pharmaceutical companies.
Jim has been responsible for creating comprehensive validation packages for the majority of Liquent’s systems and applications, assisted in the development of company-wide document management standards, best practices, processes, document templates, and standard operating procedures. In addition, Jim has published eCTDs with all of Liquent’s publishing products, provided technical and process support for document management systems, and spent time helping Technical Support resolve outstanding client application and process issues.
Prior to Liquent, Jim’s responsibilities have included electronic publishing for multiple pharmaceutical and biotechnology companies, project proposals and management, developing a quality assurance management application, developing VBA macros for authoring templates, publishing system and Acrobat plug-in analysis, clinical system and Acrobat plug-in validation, SOP and process development, technical and operational publishing support lead for a major pharmaceutical company’s regulatory operations department managing technical support for dossier submittals, operating system platform upgrades, and system validation projects.


About Liquent
Liquent, Inc., located in Horsham, PA, provides a complete spectrum of software solutions and Regulatory and Clinical outsourcing services to meet the needs of Regulatory organizations in the Life Sciences industry.
Fore more information about Liquent, please visit www.liquent.com.

About Speid & Associates, Inc.
Speid & Associates, Inc. is a privately held regulatory affairs and drug development consultancy based in San Diego, California. Speid & Associates assists life science companies move new chemical entities to the finish line expeditiously by developing effective global regulatory strategies. The Company works at all phases of drug development and has experience working with all major regulatory authorities. Speid & Associates also conducts due diligence for investors and companies.
Fore more information about Speid & Associates, Inc., please visit www.sndtm.com.


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