Archived Events – 2010
August 2, 2010 - 6:00 PM: Cato Research Presents at NC East SoCRA Chapter Meeting
Presentation Details: Informed Consent Content & Process Requirements
Presented by Amber Barnes, PhD, RAC
Regulatory Scientist, Cato ResearchDr. Barnes' presentation will focus on the elements of the informed consent document, and the components of the process. Industry specific scenarios will be presented to reinforce important concepts, for example: evaluating and documenting capacity to consent, voluntariness, HIPAA authorization, withdrawal of consent, and more. Discussions will also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research. CREDIT HOURS: This program offers 1.0 SoCRA CEUs
Venue: Cato Research
4364 S. Alston Avenue
Durham NC 27713
For more information: North Carolina (East) SoCRA Chapter News
July 28, 2010 - Cato Research Presents at BIOCOM CRO Workshop
Presentation Details: Pre-IND Meetings and IND Submissions: Lessons Learned
Presented by Sybille Sauter, PhD, RAC
Regulatory Scientist, Cato ResearchThis educational workshop will provide an overview of strategic regulatory considerations and lessons learned from early-stage drug development activities such as pre-IND meetings and IND submissions. Companies sometimes ponder whether or not to request a pre-IND meeting. During the seminar, we will discuss pros and cons related to pre-IND meetings and present some real-world examples. In addition, we will discuss advantages and challenges related to authoring INDs for electronic submissions, as well as the best practices for addressing each challenge in a time- and cost effective manner. To facilitate a smooth review process, authors must plan for current FDA reviewing styles and implement strategies for successful re-use of document content, style, and format for a consistent and clear message across the entire eCTD submission for ease-of-review by the FDA. Best practices and recommendations to address common problems with the generation of INDs will be presented. Last, we will briefly touch on similar regulatory processes for early-stage drug development activities in Europe such as clinical trial applications (CTAs), scientific advice, and protocol assistance. Following the presentation there will be a panel discussion with regulatory compliance and quality experts from the local biotech community
For more information: BIOCOM Event Calendar
July 22, 2010, 2:00 PM EDT: Free Educational Webinar
Presentation Details: Preclinical Drug Development: A Successful Path Forward
Join Cato Research for a free educational webinar. Presented by Sharon Daily, PhD, DABT, Sr. Toxicoogist at Cato Research
Developing a nonclinical strategy for a pharmaceutical or biopharmaceutical product can be very challenging. Interactions between the FDA and the developer can make or break the entire life cycle of the product. Cato will discuss the importance of the nonclinical program at each phase of the process and provide some recent examples of FDA interactions
For more information and to register: Cato Research Events
Presentation: Preclinical Drug Development: A Successful Path Forward
June 30 – July 3, 2010: Cato Research Presents at ESMO Conference: 12th World Congress on Gastrointestinal Cancer
Presentation Details: Inhibition of gastrin supports mechanism based efficacy in colorectal cancer
Presented by Lynda Sutton
Chief Operating Officer and Chief Regulatory Officer of Cato ResearchVenue: The International Convention Center of Barcelona
Centre de Convencions Internacional de Barcelona (CCIB)
Rambla de Prim 1-17
08019 Barcelona, Spain
For more information and to register: 12th World Congress on Gastrointestinal Cancer
June 29-30, 2010: Cato Research Presents at Cancer Vaccines Conference
Presentation Details: A prospective, randomized, double-blind, placebo controlled, group sequential trial of PAS for the treatment of advanced pancreatic cancer
Presented by Laura DiMichele, PhD, RAC
Clinical Scientist, Cato ResearchVenue: Le Meridien
20 Sidney Street
Cambridge MA, 02139
For more information and to register: Cancer Vaccines Conference
June 24, 2010, 2:00 PM EDT: Free Educational Webinar
Presentation Details: Past, Present and Future of REMS: Can We Mitigate With Restraint?
Join Cato Research for a free educational webinar. Presented by Jack Snyder, MD, JD, PhD, RAC, Clinical Research Physician and Assistant Managing Director, Cato Research Washington
Dr. Snyder will provide an overview and update on key aspects of REMS (risk evaluation and mitigation strategies) in the post-FDAAA world of product safety and risk management. He will discuss procedural and substantive issues, emphasizing the views and responses of public as well as private stakeholders. If you are wondering whether “safety has become the tail wagging the dog,” you won’t want to miss Dr. Snyder’s presentation.
For more information and to register: Cato Research Events
Presentation: Past, Present and Future of REMS: Can We Mitigate With Restraint?
June 23, 2010, 6:00-9:00 PM EDT: Cato Research Sponsors Women in Bio RTP Chapter Event
Presentation Details: Women In Bio RTP Beakers and Beer
Join us in celebrating the Research Triangle Park’s bioscience community! Women In Bio is once again joining the area sponsors in the community to celebrate RTP’s bioscience community. Here’s your opportunity to meet and make powerful connections with the leaders in bioscience – companies and research institutions - from across the State.
Sponsors for this event: Cato Research, Womble Carlyle Sandridge & Rice, PLLC, Acurian Patient Recuitment Services, Williams Mullen
Venue: Mez Contemporary Mexican
5410 Page Road
Durham, NC 27703
www.mezdurham.com
For more information and to register: Women in Bio Events
Contact: cwarrington@womeninbio.org
June 14-16, 2010: Cato Research Exhibits at ILSI-BioMed 2010 Conference
Presentation Details: Visit Cato Research Isreal at Booth 34 of the ILSI-BioMed 2010 Conference
The ILSI-BioMed 2010 Conference is one of the largest life sciences conferences held outside the USA. This year's conference will focus on innovation, and will feature world-class speakers in the areas of cardiology, vaccines, oncology, personalized medicine, metabolic diseases, and stem cell therapies. The exhibition area will feature 60 Israeli medical device and biopharma companies.
Venue: David InterContinental & Dan Panorama Hotels
Tel Aviv Israel, 69710Conference Brochure: ILSI-BioMed 2010 Brochure
For more information and to register: ILSI-BioMed 2010 Conference
June 15, 2010: Cato Research Presents at the 46th DIA Annual Meeting
Presentation Details: Challenges in Bringing Novel Cell-based Therapies from Experimental Studies into Successful Clinical Programs
Exciting progress has been made in the development of cell-based therapeutics, and experimental research has brought forward novel treatment opportunities of allogeneic or autologous cell-based products, in some cases optimized by gene modification. Clinical development is challenging, requiring understanding of controlled manufacturing, relevant nonclinical pharmacology and safety studies, and clinical risk factors. This session will include an overview of the current status from bench to bedside and illustrate the caveats and practical feedback to maximize success.
Session Chair: William Lee, PhD, RAC, Senior Regulatory Scientist at Cato Research
Also participating at this session:
Yin Huang, PhD, Pharmacologist, Office of Cellular, Tissue and Gene Therapies, CBER FDA
Deborah Ladenheim, PhD, Vice President, Regulatory Affairs, Athersys Inc.
Dr. Gopalan Narayanan, Head, Biologicals and Biotechnology Unit, MHRAVenue: Walter E. Washington Convention Center
801 Mount Vernon Place, NW
Washington, DC, 20001-3614
For more information and to register: DIA Annual Meeting
June 10, 2010, 7:30–10:30 AM EDT: Cato Research Participates in Panel Discussion at Tech Council of Maryland's BioBreakfast Series
Presentation Details: Creating Value through Outsourcing
Christine Warrington, Head of Global Sales and Marketing, Manager North America Sales at Cato Research will be participating
Increasingly, biopharma companies are turning to outsource providers for services including both non-clinical and clinical activities through final product manufacturing. For small companies, outsourcing decisions can become strategic drivers of business value and the achievement of a successful exit. Therefore, choosing the best contract services providers and developing successful programs are critical management challenges. This program will feature a panel of industry experts -- a bio-entrepreneur, a senior executive from a leading CRO, and a veteran biotech investor – who will share best practices and real life practical experiences with outsourcing and describe key ingredients that are necessary to find a suitable CRO. Our speakers will address issues related to what and when to outsource, how to establish an effective outsource program, avoid pitfalls, decrease risk, and drive the business value proposition.
Venue: Center for Advanced Research in Biotechnology
9600 Gudelsky Drive
Rockville MD 20850
For more information and to register: Tech Council MD BioBreakfast Series
June 2-3, 2010 - Cato Research Presents at 12th Annual NIH SBIR/STTR Conference, Triangulating Commercial Success: Knowledge, Partnerships, and Capital
Presentation Details: Women in Business — From the Trenches
Presented by Christine Warrington, Head of Global Sales and Marketing, Manager North America Sales at Cato Research
Conference attendees will learn the ins and outs of the NIH SBIR/STTR program, the funding opportunities available to small business researchers, and how the NIH SBIR/STTR program can be a valuable resource to help you start and/or grow your company.
Venue: Raleigh Convention Center
500 South Salisbury Street
Raleigh, NC 27601
For more information and to register: NIH SBIR/STTR Conference
May 23-26, 2010: Cato Research Presents at the MAGI Clinical Research Conference - 2010 East
Protocol Development: Science in Practice — Developing protocols that generate useful data, are practical for sites to implement, are acceptable to subjects, and work internationally.
Presented by Margaretha Oortgiesen, PhD, RAC, CCRP
Vice President, Drug Development
Managing Director of Cato Research, Durham NCMisconceptions About CROs — You've heard the complaints; now hear the reality.
Presented by Lisa Sanders, PhD, RAC
Clinical Strategy Scientist, Cato Research DurhamVenue: Sheraton Boston Hotel
39 Dalton Street
Prudential Center
Boston MA, 02199
For more information and to register: MAGI Clinical Research Conference
May 5, 2010, 10:00–11:30 AM CDT: Cato Research Participates in Panel Discussion at BIO 2010
Presentation Details: Accessing Capital Through Risk-Sharing Models Between Early-Stage Companies and CROs
Lynda Sutton, President of Cato Holdings will be participating. Breakout session chaired by Art Pappas, Managing Partner of Pappas Ventures.
This session will address clinical risk-sharing models and approaches that can help early-stage biotechnology and pharmaceutical companies access capital for clinical development. Contract research organizations and large pharmaceutical and biotechnology companies have well-established relationships. CROs have been developing more sophisticated models to allow themselves to do business with smaller, emerging compaines. The panel will discuss the structure of these new deals and define the pros and cons of these transactions to CROs, investors and the companies involved.
Venue: McCormick Place
2301 S. Lake Shore Drive
Chicago IL, 60616
For more information and to register: BIO International Convention 2010
April 29, 2010, 2:00 PM EDT: Free Educational Webinar
Presentation Details: Planning for FDA Clinical Site Inspections: Are You at Risk?
Join Cato Research for a free educational webinar. Presented by Cathy Anderson, PhD, RAC, Regulatory Scientist, Cato Research Durham.
The success or failure of investigational medicinal products is determined by data from clinical sites. FDA findings at a clinical site inspection can have a profound impact on the value of clinical data. This webinar will present an overview of regulatory responsibilities, the inspection process, and potential outcomes of clinical site inspections using case studies from actual FDA inspections. Recent trends in FDA inspection findings and methods for constructive inspection preparation will be addressed. Best practices for an effective response to FDA findings will also be presented.
For more information and to register: Cato Research Events
Presentation: Planning for FDA Clinical Site Inspections
April 29, 2010, 8:30 AM - 10:00 AM EDT: Cato Research Presents at the 26th Annual SQA Meeting and Quality College
Presentation Details: GG-1 Current Status and Future Directions of Pathology Peer Review
Presented by Jack Snyder, MD, JD, PhD, RAC
Clinical Research Physician
Assistant Managing Director, Cato Research WashingtonVenue: Duke Energy Convention Center
525 Elm Street
Cincinnati OH, 45202
For more information and to register: SQA Annual Meeting
April 25, 2010, 10 AM - 11 AM EDT: ACRP Global Conference and Exhibition 2010
Presentation Details: Cato Research presents "Data Quality and Integrity: From Monitoring to Approval" at the ACRP Global Conference and Exhibition 2010
Presented by Stéphanie Dubois, PhD, CCRP, RAC
Senior Clinical Scientist, Cato Research CanadaVenue: Tampa Convention Center
333 S. Franklin St.
Tampa FL, 33602
Directions
For more information: ACRP 2010
April 15, 2010, 8:30 AM - 9:30 AM PDT: Regulatory Intelligence: What is it and how can it accelerate your company's drug development?
Presentation Details: Cato Research presents "Regulatory Intelligence: What is it and how can it accelerate your company's drug development?"at the Pharmatek U Seminar Series
Presented by Sybille Sauter, PhD, RAC (US & EU)
Senior Regulatory Scientist, Cato Research San DiegoVenue: Pharmatek Laboratories
7330 Carroll Rd
San Diego CA, 92121
Directions
For more information: Pharmatek U
March 8-10, 2010 - 22nd Annual EuroMeeting
Presentation Details: Cato Research presents at the 22nd Annual EuroMeeting in Monaco, March 08-10, 2010 at the Grimaldi Forum.
Presented by Margaretha Oortgiesen, PhD, RAC, CCRP,
Vice President, Drug Development
Managing Director of Cato Research, Durham. NC.
February 25, 2010 2-3 PM EST: Free Educational Webinar
Presentation Details: Similarities and Differences between CMC Information required for EU IMPD CTA and US IND
Join Cato Research and Global Submit for a free educational webinar:
Information will be presented to understand the similarities and differences between the EMEA and FDA requirements for initial submission of new medicinal products. Useful practical suggestions and recommendations will be offered to assist with preparation of EU IMPD CTA and US IND submissions.
Presented by Randy Lane, Director, Pharmaceutical Development at Cato Research San Diego. Industry expert Kathie Clark of Global Submit will also be available for the Q&A session following the presentation.
For more information: Webinar Summary
To register: Cato Research Events
Presentation: Cato Research & Global Submit Webinar, February 2010
February 25, 2010 9:00 AM PST: BIOCOM's 7th Annual Counseling Workshop for Careers in Biotechnology and Medical Devices
Presentation Details: Cato Research presents "My Career at Cato Research" at BIOCOM's Counseling Workshop for Careers in Biotechnology and Medical Devices
Presented by: Kathy Grako, PhD, PMP
Clinical Strategy Scientist, Cato Research San DiegoVenue: Pfizer La Jolla
10777 Science Center Drive, Building CB2
La Jolla, CA, 92121For more information: BIOCOM Events
February 19, 2010 - Cato Research Presents at the 23rd Annual DIA Electronic Document Management Conference
Presentation Details: "Getting it Right the First Time: An Introduction to Document Authoring Best Practices for eCTD Submissions"
Presented by Sybille Sauter, Ph.D.
Regulatory Scientist at Cato Research San DiegoVenue: Gaylord National Resort & Convention Center
201 Waterfront St.
National Harbor MD, 20745For more information: DIA EDM Conference Brochure
January 28, 2010 2-3 PM: Free Educational Webinar
Presentation Details: Effective Project Management Techniques for the Creation of Marketing Applications in eCTD Format
Want to reduce delays and the need for additional outsourcing costs in preparing your eCTD marketing applications? Want to ensure high quality submissions in the upcoming year?
Join Cato Research and Global Submit for a free educational webinar:
Presented by Rachel Cooper, Project Manager and eCTD Specialist at Cato Research. Industry expert Kathie Clark of Global Submit will also be available for the Q&A session following the presentation.
For more information: Abstract
To register: Cato Research Events
Presentation: Cato Research and Global Submit Webinar January 2010
January 4, 2010 6 – 7 PM: SoCRA Chapter Meeting
Presentation Details: Clinical Trial Material: CTM Project Definition or, "why did they do it that way?" mini-workshop
Upon completion of this presentation the participants will have general understanding of:
- The factors to consider when defining CTM packaging projects
- The thought processes CTM professionals undertake to make packaging and shipment decisions
Presented by Margaret Schubert, B.A.,
Cato Research, Durham NC.Venue: Cato Research Ltd.
4364 South Alton Avenue
Durham NC 27713
DirectionsFor more information: North Carolina (East) SoCRA Chapter.