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

5pm - 7pm
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

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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


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.


Greg Dombal, COO, Halloran Consulting Group, Inc.

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


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

We Can Help
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

October 11th, 2017- Concept to Commercial: A Clinical and Regulatory Outlook, 8am-10am

8am - 10am
Biocom McGraw Boardroom-10996 Torreyana Suite 200, San Diego, CA 92121

Biocom CRO Presents: Concept to Commercial: A Clinical and Regulatory Outlook

Imagine that you’re the CEO of a biotechnology company developing a pipeline of novel drugs. What do you do to prepare your team and your product to succeed in the clinic? Please join us as we hear from three industry veterans about the critical success factors for clinical development at three transition points: discovery to non-clinical development, non-clinical development to Phase 1 clinical studies, and Phase 1 to Phase 2 clinical studies.

Bob Gauthier, MS
Vice President, Product Development, Therapeutics, Inc.

Bob Gauthier is responsible for Product Development at Therapeutics, including all aspects of planning, managing, and executing product development, with an emphasis on leading cross-functional project teams to deliver novel products to the dermatology marketplace.

Louis Scotti
Vice President, Business Development, IriSys

Mr. Scotti joined IriSys in 2015 after previously serving on its Board of Directors from 2007 until 2012. He has headed business development, marketing, new products and investor/public relations functions during a long career in the bio/pharma industry both in the U.S. and internationally. His responsibilities at IriSys include business development, commercial planning and managing contracts with clients and partners.

Stan McDermott, PharmD, MS, RPh
Managing Director, Clinical Research, Cardinal Health
Dr. McDermott has managerial responsibilities for a team of clinical research consultants providing clinical strategy, operations and medical writing services. He is also a technical leader for clinical development programs. He has experience with regulatory strategies; clinical development planning, execution and reporting; clinical trial design, management and reporting and operational responsibilities.


Mark Hurtt, MD
Clinical Research and Translational Medicine Consultant

Dr. Hurtt provides hands-on assistance to companies preparing for Phase 1 and Phase 2 clinical trials and critical interactions with FDA and EMA.

Thursday, September 28, 2017-Digital Marketing Success for CRO’s

8am - 10am
Biocom- 10996 Torreyana Rd. Suite 200, San Diego, CA 92121
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Digital Marketing Success for CRO’s

An introduction to creating strategic, targeted, and measurable online campaigns
Today’s social and technology environment is turning traditional marketing for CROs on its head. Instead of telling the customer what to think, you need to find out what they already think and go from there, continually adjusting your approach based on real interactions with real customers every day. Digital marketing operates within its own paradigm requiring an adept use of analytical tools.

The evolution of digital marketing isn't really about the brands; it's about consumers exercising more control over their choices. This seminar demonstrates how using this single realization as a starting point helps you build and implement more effective campaigns.

Experienced marketing executives from Allurdata (a noted healthcare analytics company from Denver) and Mentus (San Diego’s most experienced biotech marketing firm) will provide insight on how to rapidly respond to change in consumer behavior with brand evolution and positioning with a digital marketing strategy.
Learn about Brand Staging utilizing your brand image and messaging. Determine the Data Model best suited to your objectives, and then tune it to the most effective consumer and business response.


Analytics Panelist – Allurdata – Bob Durham, President
Brand Panelist – Mentus – Guy Iannuzzi, President

Please register here: https://www.biocom.org/s/EventDetail?event=September-CRO

Friday, September 22- 5th American Alternative Muscle Club Meeting

The Sanford Consortium For Regenerative Medicine 2880 Torrey Pines Scenic Dr. La Jolla, California 92037
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Friday, September 22, 2017
5th American Alternative Muscle Club Meeting
The Sanford Consortium For Regenerative Medicine
2880 Torrey Pines Scenic Dr.
La Jolla, California 92037

Genea Biocells is proud to be sponsoring the Young Investigator Awards and poster prizes for the 2017 Alternative Muscle Club Meeting this Friday, September 22, 2017 at the Sanford Consortium for Regenerative Medicine.
This meeting is an opportunity for young investigators early in their research careers from academia, industry and medical sectors to present their work in a relaxed environment. The free daylong meeting will cover a wide range of research areas, reflecting the diverse types of cutting-edge muscle research undertaken today. Topics will include Muscle Structure and Signaling, Biomechanics and Biophysics of Muscle Contraction, Muscle Development, Muscle Regeneration and Cardiac vasculature.

The AMC has always been a meeting for young scientists with a strong emphasis on career support and networking and will again include the ‘Translational Medicine Workshop’ along with
‘Interviewing for Industry’ workshop and a ‘Funding Opportunities Panel.'

For more information on AMC please visit: Alternative Muscle Club. For more information on Genea Biocells please visit: Genea Biocells.

Thursday, August 10-How Will Brexit Impact Your Clinical Supply Strategy? | How Can You Prepare for the QP Process? | Hear the Patient’s Perspective on the Importance of Clinical Trials

2pm - 6pm

How Will Brexit Impact Your Clinical Supply Strategy? | How Can You Prepare for the QP Process? | Hear the Patient's Perspective on the Importance of Clinical Trials

What: Sherpa Summer Seminar
For: Anyone managing clinical supply, global or domestic

When: Aug 10 | 2 – 6 pm
Where: Sherpa Clinical Packaging,
6166 Nancy Ridge Drive
San Diego CA 92129

By popular demand, Sherpa will be hosting the 2nd annual Sherpa Summer Seminar on August 10th, and you are cordially invited!

With Brexit scheduled to be finalized by March 2019, now is the time to understand how this major political shift could impact your clinical study design, cost, and efficiencies.
Attendees will hear from industry thought leaders on:
• The impact of Brexit on European clinical studies and global depots
• How sponsor companies can best prepare for the QP Process
• The Importance of clinical trials from the patient's perspective

Afterwards, join us and San Diego's life sciences community for BBQ during our open house and tour our new 2017 facilities addition!

Learn more and register for this complimentary event with Sherpa Clinical Packaging

August 9th, 2017-Generic Products: Opportunities for Southern California Companies

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

Generic Products: Opportunities for Southern California Companies

"Generics - An Overview"
Giff Marzoni, Vice-President Global Pharmaceutical Development DavosPharma

"Navigating the Regulatory Paths for Generics"
Luman Wing, Director Executive Consultant, Cardinal Health

"Value Creation through Formulation of Generic Topicals"
John M Newsam, CEO Tioga Research

8 in 10 of the 4.5 billion US prescriptions in 2016 were for generic drugs. A generic drug is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. A generic drug is required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product, but need not contain the same inactive ingredients. It must, however, be proven to be bioequivalent to the brand name product.

If you are curious about the business drivers behind the generics industry, about the developmental and regulatory paths for a generic, about how bioequivalence can be proven, or about the strength of protection that a patent on an innovator product can provide, you might consider joining this event.

The event provides an introduction to the generics business in the US, overviewing business, technical, developmental and commercial aspects. Regulatory issues and requirements are summarized and strategies for realizing streamlined approvals outlined. And the event includes examples of where formulation creativity can establish a basis for a generic approval.