Thursday, April 19th, 2pm-4pm- South San Francisco-Modified Release Solid Oral Dosage Formulations and Regulatory Considerations

Date
2pm - 4pm
Location
Genesis Tower, One Tower Place, South San Francisco, CA 94080

Join Biocom and RECRO Gainesville for a seminar regarding "Modified Release Solid Oral Dosage Formulations and Regulatory Considerations." RECRO Gainesville is a CDMO pioneering the development of extended release technologies.

The presentations will review the technical formulation differences between immediate release and controlled (modified) release solid oral formulations with an emphasis on formulation approaches for modified release, including reasons for changing from immediate to modified release and how to go about this change from a technical perspective. Discussions will provide Regulatory considerations for Modified Release formulations including the most common regulatory pathways for approval with comparison and contrast for each option.

https://www.biocom.org/s/EventDetail?event=CRO-RECRO

Wednesday, April 18, 2018: Modified Release Solid Oral Dosage Formulations and Regulatory Considerations

Date
8am - 10am
Location
Biocom: McGraw Boardroom- 10996 Torreyana Rd. Suite 200, San Diego, CA 92121

Join Biocom and RECRO Gainesville for a seminar regarding "Modified Release Solid Oral Dosage Formulations and Regulatory Considerations." RECRO Gainesville is a CDMO pioneering the development of extended release technologies.

The presentations will review the technical formulation differences between Immediate release and Controlled (modified) release solid oral formulations with an emphasis on formulation approaches for Modified Release, including reasons for changing from immediate to modified release and how to go about this change from a technical perspective. Discussions will provide Regulatory considerations for Modified Release formulations including the most common regulatory pathways for approval with comparison and contrast for each option.

Speakers:
Dr. Myke Scoggins, Process Development manager at RECRO Gainesville, LLC.
R. Wayne Wiley, Senior Director of Regulatory Affairs at RECRO Gainesville LLC.

Thursday, April 12, 2018 in South Francisco -Humanized Mouse Models and Their Use in Preclinical Bone Metastasis Studies

Date
12pm - 2pm
Location
Larkspur Landing-690 Gateway Blvd. South San Francisco, CA 94080

Pharmatest Services and Taconic Biosciences welcome you to an educational seminar titled “Humanized Mouse Models and Their Use in Preclinical Bone Metastasis Studies." This seminar addresses In vivo models for immuno-oncology research and novel bone metastasis models in humanized mice.

Speakers:

Jussi Halleen, CEO, Pharmatest Services
Tiina Kähkönen, Research Director, Pharmatest Services
Azusa Tanaka, Product Manager for Precision Research Models, Taconic Biosciences

Agenda:

10:00 - 10:30am Registration and networking

10:30 - 10:45am Introduction by Jussi Halleen, CEO, Pharmatest Services

10:45 - 11:15am "In vivo Models for Immuno-Oncology Research: Human Immune System Engrafted Mouse Models," by Azusa Tanaka, Product Manager for Precision Research Models, Taconic Biosciences

11:15 - 11:45am "Novel Bone Metastasis Models in Humanized Mice," by Tiina Kähkönen, Research Director, Pharmatest Services

11:45 - 12:00pm Q&A

February 14, 2018: How to develop a clear and compliant clinical data submission strategy

Date
8am - 10am
Location
Biocom 10996 Torreyana Rd. Suite 200 San Diego, CA 92121

How to develop a clear and compliant clinical data submission strategy
Accenture’s Clinical Data Operations Director, Brian Hermann will host a seminar focusing on how to plan and prepare your clinical data for submission readiness within Module 5. The seminar discusses up-to-date information that will better prepare your company for the rigors of preparing your clinical data packages in accordance with current guidance. Learn how to develop a clear and compliant clinical data submission strategy based on studies showing where many companies struggle during the submission process.

Both early-stage companies who are new to the clinical data submission guidance’s, and portfolio builders who want to enhance their current clinical data submission knowledge, will benefit from attending the seminar.

We plan to cover the following topics:
• CDISC
• Recent binding guidance from FDA (effective Dec 2016)
o Waivers
o Exemptions
o Timelines
• Study Data Technical Conformance Guide
• Study Data Standardization Plan
• Data Traceability and the FDA
• Define files
• Reviewers guides
• Annotated CRFs
• Pinnacle21 Data Validation
• Coding
• Pooling
• Submission Timelines

Important Event Details
________________________________________
When: Wednesday, February 14th
8:00 a.m. - 10:00 a.m.

Where: Biocom (McGraw Boardroom)
10996 Torreyana Road
San Diego, California 92121

*This event is free for Biocom members

Tuesday, January 23, 2018-Humanized Mouse Models in Preclinical Efficacy Studies in Oncology

Date
8am - 10am
Location
Biocom, McGraw Boardroom, 10996 Torreyana Road Suite 200 San Diego, CA 92121
Download Presentation Download

Pharmatest Services and Crown Bioscience welcome everyone to an educational seminar titled “Humanized mouse models in preclinical efficacy studies in oncology”. Humanized mouse models include a functional human immune system, which allows the efficacy testing of immunotherapies on human cancer cells in immunocompetent mice. The seminar also discusses the importance of using preclinical metastasis models to confirm novel agent efficacy before entering clinical trials.

Speakers:
Jussi Halleen, CEO, Pharmatest
H. Toni Jun, Director Scientific Engagement, CrownBio
Mari Suominen, Research Director, Pharmatest

Tuesday, November 7th, 2017-Biocom CRO Networking Mixer

Date
5pm - 7pm
Location
Biocom-McGraw Boardroom- 10996 Torreyana Rd. Suite 200, San Diego CA 92121

Please join us on Tuesday, November 7th, from 5pm-7pm in the McGraw Boardroom at Biocom for a hosted CRO Networking Mixer specially designed for our CRO Members. With over a hundred CRO’s in our membership, this is an opportunity to gain a better understanding of your colleagues expertise in order to foster more collaboration within the CRO Community. We invite you to make valuable connections while enjoying hors d'oeuvres and cocktails, with the opportunity to share a brief pitch about your CRO’s unique offerings.

We look forward to seeing you then!

October 21, 2017- FSH Society is hosting a Family Day Conference in Los Angeles

Date
Download Presentation Download

The FSH Society is hosting a Family Day Conference in Los Angeles on Saturday, October 21, 2017. Join FSH muscular dystrophy patients, families, researchers and clinicians to learn about cutting-edge research. Expert clinicians will discuss best practices for managing FSHD, including physical therapy and exercise. Leading researchers will present the latest work on drug development, stem cells, and clinical trials. Amanda Rickard, Senior Scientist at Genea Biocells in San Diego, will be one of the featured speakers giving a talk at 2:55pm entitled, “Using Stem Cells for FSHD Modeling and Treatment.” Registration must be completed by October 16th and information for the event and registration can be found at:

https://www.fshsociety.org/fsh-events/2017-fsh-society-family-day-los-angeles/ and FSH Society _LA Family-Day-Flyer.

Thursday, October 12th- Medical Device Breakfast: Designing and Implementing Effective Clinical Trials

Date

Medical Device Breakfast: Designing and Implementing Effective Clinical Trials

Running effective and efficient clinical trials for medical device and diagnostic companies has become increasing complex as our access to patient data, novel surgical devices and biomarkers has increased. Please join us as Jeff Anderson from Reva Medical and Art Weber from Banyan Biomarkers present their experience with designing and implementing clinical trials that leverage creative ways to navigate the rapidly evolving medical landscape. Greg Dombal from Halloran Consulting will share some additional perspective on a few strategies to be creative in clinical without breaking the bank.

REGISTER HERE

Speakers:
Moderator:
Greg Dombal, COO, Halloran Consulting Group, Inc.

Presenters:
Jeff Anderson, SVP of Clinical/Regulatory Affairs, Reva Medical

Art Weber, Director of Clinical Affairs, Banyan Biomarkers

Event Details:

When: Thursday, October 12th | 8:00 am to 10:00 am
Where: Biocom Boardroom | 10996 Torreyana Road, Suite 200, San Diego, CA 92121

REGISTER HERE

*Please note: Biocom events are now closed to non-member service providers.

We Can Help
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Biocom is the largest, most experienced leader and advocate for California’s life science sector. We work on behalf of more than 950 members to drive public policy, build an enviable network of industry leaders, create access to capital, introduce cutting-edge STEM education programs, and create robust value-driven purchasing programs.

Biocom | 10996 Torreyana Road #200, San Diego CA 92121 | 858.455.0300
www.biocom.org