December 1, 2016-Partnering and Exiting for CROs: Tales from Founders and Investment Bankers

Date
8am - 10am
Location
Biocom 10996 Torreyana Rd, Suite 200, San Diego, CA 92121
Speakers:
Tim Scott , President, Pharmatek , , Ed Foster , President, Eurofins/Advantar , ,

Partnering and Exiting for CROs: Tales from Founders and Investment Bankers

What is the value of my service company? When and how do I exit and enjoy the fruits of my labor? Should I sell my baby to an investment banker (IB) or a private equity (PE) partner? How do I find strategic partners (for example, large CROs)? What are the pros and cons of working with an IB?

There have been many local seminars on company valuation, M&As and partnering. Most of them focus on companies developing therapeutics. The strategy, thinking and approach presented may not be applicable to CROs. Historically, smaller service companies are not the targets for M&A or private equity investment activities. However, with the continued trend towards outsourcing, and the robust growth in the entire service industry, CROs have become very attractive for both investors and strategic partners.

Please join us for this event where two local CRO founders will share the stories of their recent transactions. In addition, we will hear from a business advisor from an investment bank in the Bay Area to share his point of view of how service companies can position themselves for acquisition or investment, and how to work with investment bankers and private equity investors.

November 16th, 2016- Stem Cell Based Approaches to Muscular Disease Research

Date
8am - 10am
Location
Biocom (McGraw Boardroom) 10996 Torreyana Road, Suite 200, San Diego, CA 92121
Speakers:
Dr. Gustavo Dziewczapolski , Scientific Director at Cure CMD , , Dr. Anne Bang , Director, Cell Biology at Sanford Burhanm Prebys Medical Discovery Institute , , Dr. Joel Gottesfeld , Professor at TSRI , , Dr. Uli Schmidt , General Manager, Genea Biocells , ,

Muscular dystrophies and myopathies comprise an extensive number of disorders that primarily impact skeletal muscles and affect movement and mobility. These debilitating diseases are typically categorized as rare or orphan indications with high unmet clinical needs. Please join us for an informative session featuring local San Diego researchers and their approach to therapeutic drug discovery across a variety of skeletal muscle disorders.

November 1-2, 2016- Outsourced Pharma West-San Francisco

Dates
7am - 6pm
7am - 4pm
Location
Hyatt Regency 1333 Old Bayshore Highway | Burlingame, CA

Outsourced Pharma is produced throughout the U.S. in areas with contribution to pharmaceutical development and manufacturing. With events across the country, attendees can stay close to home and save on travel time. As with a local cuisine, the Outsourced Pharma "recipe" (its mission, its structure) remains true-to-form everywhere we go, but each meeting is naturally flavored by the distinctive interests of the region.

September 22, 2016-CRO Best Practice Series- Optimized & Active Asset Management

Date
8am - 10am
Location
Biocom-10996 Torreyana Road, Suite 200 San Diego, CA 92121
Speakers:
Gary Ostermiller , Stability Storage Process Consultant, Nagano Sciences , , Taylor Moyer , CEO, Managed Laboratory Services , ,

With the rising cost of getting a drug to market, it is more important now than ever to carefully manage your budget and ensure that you are allocating spend appropriately. One area that frequently has a mis, or NON managed budget, is an organization’s asset management program. In a mid-sized biotech, hundreds of thousands, if not millions of dollars, are spent on purchasing new equipment, keeping high dollar assets under service contract, and managing the break/fix, PM, calibration of existing assets; and this does not even consider the soft costs associated with the administrative burden of keeping your assets functioning.

What about your organization? Do you know what the percent utilization of your key equipment is? Do you know what assets are covered under service contract, do you know if those assets SHOULD be under contract? Do you know how well your assets are performing? Percent downtime? Length of life cycle? How that affects productivity in your lab?
Explore why these, and so many more questions are important in defining a functional, useful, and valuable asset management plan that will not only improve the efficiency and operation of your lab, but will most likely save you money.

August 31, 2016-CRO Educational Event- Ins and outs of Patient Derived Xenograft (PDX): an important tool for preclinical cancer drug discovery

Date
8am - 10am
Location
Biocom 10996 Torreyana Road, Suite 200 San Diego, CA 92121
Speakers:
Thomas B. Broudy, Ph.D., GM & CSO, Crown Bioscience San Diego , Using PDX Models for Preclinical Trials of Oncology Therapeutics: Immuno-oncology and Beyond , , Brian W. Soper, Ph.D., Senior Technical Information Scientist, The Jackson Laboratory , Onco-HuTM Mice for Immunotherapeutic Drug Discovery , , Beth Bauer, DVM, DACLAM, Head of IDEXX BioResearch Genetic and Necropsy Services , PDX, Tumor Stocks & Cell Line Authentication: The Link Between Legacy Data and Reproducibility , ,

Join us on August 31st at 8 a.m. as our presenters, Crown Biosciences and IDEXX BioResearch share insights about the promise, opportunity and possible pitfalls of patient-derived xenograft models.

• Crown Biosciences: Using PDX Models for Preclinical Trials of Oncology Therapeutics: Immuno-oncology and Beyond
• IDEXX BioResearch: PDX, Tumor Stocks & Cell Line Authentication: The Link Between Legacy Data and Reproducibility

Ins and outs of Patient Derived Xenograft (PDX): an important tool for preclinical cancer drug discovery

With PDX models becoming more and more popular in preclinical cancer research, it’s prime time to explore the topic. Have you considered using PDX models in your preclinical cancer research? What are the challenges and the advantages? What are the methods? Why use a PDX model over a traditional xenograft model? What is the clinical relevance? What models are available? How do you know if your PDX is really just a mouse tumor? What’s an effective method to link phenotypic characterization data and identity confirmation to better assure reproducibility?

Explore answers to these questions. Learn how PDx models are being used, what challenges others have faced and how these models may have application in your research.

San Diego is a major oncology research center and we have CROs that can advance oncology drug programs from concept all the way through Phase 2 and 3 clinical trials.

Using PDX Models for Preclinical Trials of Oncology Therapeutics: Immuno-oncology and Beyond
Thomas B. Broudy, Ph.D., GM & CSO, Crown Bioscience San Diego
Dr. Tommy Broudy is General Manager and CSO of Crown Bioscience’s translational oncology-focused site in San Diego. Prior to this, Tommy was co-founder and CSO of Molecular Response, a premier oncology CRO whose patient derived xenograft (PDX) services business was acquired by CrownBio in Feb 2015. As CSO of CrownBio San Diego, Tommy is leading the establishment of the world’s largest and most diverse portfolio of fully characterized PDX models to help successfully translate novel anti-cancers into the clinic. Tommy’s team are also focused on stratifying the clinical selection process via strategic design of HuTrials (‘mouse clinical trials’), and development of the next generation of immuno-oncology models.

Onco-HuTM Mice for Immunotherapeutic Drug Discovery
Brian W. Soper, Ph.D., Senior Technical Information Scientist, The Jackson Laboratory
Brian has worked at The Jackson Laboratory for more than 20 years. He conducted research on hematopoietic stem cell biology, bone marrow transplantation, immune tolerance and treatment strategies for a mouse model of human enzyme deficiency. He currently provides scientific consultation services to the research community. Brian's areas of expertise include mouse models of human type 1 and type 2 diabetes, and research with immunodeficient mice. Brian has extensive knowledge in the immunobiology of mice reconstituted with human hematopoietic cells and tumor bearing humanized mice used in immuno-oncology.

PDX, Tumor Stocks & Cell Line Authentication: The Link Between Legacy Data and Reproducibility
Beth Bauer, DVM, DACLAM, Head of IDEXX BioResearch Genetic and Necropsy Services
Since 2004 Dr. Bauer has worked at IDEXX BioResearch, (formerly known as RADIL) and currently serves as Head of the Genetics and Necropsy Laboratories. Dr. Bauer’s leadership in Cell Line Authentication has been recognized by the Global Biological Standards Institute where she serves in their Leadership Circle as well as serving on the Standards Development Organization for ATCC. Beth is an experienced Geneticist who gained extensive hands-on experience in Mouse Genetics and Colony Management during her tenure as the operations manager of the Mutant Mouse Resource Research Center (MMRRC) in Columbia, Missouri.

August 23-24, 2016- Outsourced Pharma West

Dates
7:00AM
4:00PM
Location
Hyatt Regency La Jolla- 3777 La Jolla Village Dr, San Diego, CA 92122

Outsourced Pharma West
August 23-24, 2016 | Hyatt Regency La Jolla

Attendees at Outsourced Pharma West 2016 in San Diego can expect a program of similar caliber to last year's event. The educational focus is the business of outsourcing for pharmaceutical development and manufacturing, incorporating the unique considerations for Southern California's biomedical, biotech and pharmaceutical research, development, and manufacturing industries.

While conveniently situated for attendees in San Diego and neighboring La Jolla, the content will have implications for an international audience. The conference is designed for life science professionals in the following job functions and company types:

Job function:
Executive Leadership
Manufacturing
Development
Technical Operations
Supply Chain
Quality
Supplier Management
Outsourcing
CMC
Funding

Company type:
Early Stage pharm/biopharm
Clinical Stage pharm/biopharm
Small to midsized pharm/biopharm
Large pharm/biopharm
Virtual pharm/biopharm
VC or Investment Companies
Consultants

June 16, 2016-SureClinical eTMF Best Practices Lunch and Learn at Biocom

Date
11:30 am - 1:30 pm
Location
Biocom 10996 Torreyana Rd. Suite 200 San Diego, CA 92121
Speakers:
SureClinical eTMF Best Practices Lunch and Learn at Biocom , SureClinical eTMF Best Practices Lunch and Learn at Biocom , Please join us for an electronic Trial Master File (eTMF) best practice seminar. The seminar will be given in a Lunch and Learn format and highlight how clinical research organizations and sponsors are leveraging the power of cloud-based eTMF solutions and digital signing to eliminate paper, save time and simplify clinical trial document management. In this seminar you will learn best practices for implementing an eTMF within a clinical study team of remote study team members and investigators, and how study teams can manage their documents from the office and on the go. Study startup is accelerated through the use of templates, while study documents can be electronically uploaded and signed. ,

Please join us for an electronic Trial Master File (eTMF) best practice seminar. The seminar will be given in a Lunch and Learn format and highlight how clinical research organizations and sponsors are leveraging the power of cloud-based eTMF solutions and digital signing to eliminate paper, save time and simplify clinical trial document management.

In this seminar you will learn best practices for implementing an eTMF within a clinical study team of remote study team members and investigators, and how study teams can manage their documents from the office and on the go. Study startup is accelerated through the use of templates, while study documents can be electronically uploaded and signed.

Guest Speakers Include:
Brett Ewald, PhD, Vice President, Development, DNAtrix
Zack Schmidt, Founder & CEO, SureClinical

The seminar will be held at Biocom offices and also aims to increase relationship building and collaboration in the San Diego Bio-tech and Device community through industry networking.

Please contact Lou Chappuie, [email protected] or (916) 265-2008 for more information.

This event is for professionals in the Life Sciences industry. SureClinical reserves the right to confirm your attendance and legitimate interest in attending this informative seminar. All registered attendees will be verified upon check-in.

April 27, 2016-CRO Breakfast: Skin-Applied Products: From Concept to Approvals in San Diego

Date
8am - 10am
Location
Biocom 10996 Torreyana Road, Suite 200 San Diego, California 92121
Speakers:
Pieter Dorrestein , Director , Collaborative Mass Spectrometry Innovation Center (UCSD) New Learnings and Potential Treatments from Scrutiny of the Skin Microbiome , Avadhesh Kushwaha , Pharmaceutical Formulation Scientist (Tioga Research) , Opportunities for Innovation in Skin-Applied Formulations , Kevin Rosenthal , Director, Manufacturing Business Development (Pharmatek Laboratories) , Advancing a topical product into GMP production , Dan Piacquadio , CEO (Therapeutics Inc) , Challenges in the Clinical Development of Topical Products ,
Moderator: John M Newsam , CEO (Tioga Research)
Download Presentation Download

Why are dermatology programs so much in favor with investors? Does it really take less time to advance a topical drug program through clinical trials and approvals? What has happened in formulation science that has created such opportunities for new topical products? Why would I favor a transdermal mode of administration over others? What is special about the skill sets required to advance a skin-applied product program?

Hear answers to these questions. Learn how skin-applied product challenges are being addressed. Be prepared to quiz our expert panel on which classes of therapeutics lend themselves best to a skin-applied format, when a transdermal delivery route is preferred, and on how simple or complex a topical or transdermal development program can be.San Diego is developing as a major international center for skin-directed activities. We are fortunate to have a constellation of CROs and CMOs that can advance a topical drug program from concept all the way through Phase 2 and 3 clinical trials.

The nature of the San Diego CRO community is such that it encourages inter-company cooperation. A client can then benefit from ‘best of breed’ strengths being brought to bear, while avoiding discontinuities that can arise elsewhere when technology transfer is needed. And these local strengths extend also to non-pharmaceutical beauty and hygiene products.