Evaluating your Therapeutics’ Performance Against Diet-Induced NAFLD/NASH Models

Date
8:00 AM - 10:00 AM
Location
McGraw Conference Room - Biocom 10996 Torreyana Rd. Suite 200, San Diego, CA 92121
Speakers:
Dr. Manindra Singh , Preclinical Scientist, Explora BioLabs , , Janell Richardson , Field Application Specialist, Taconic , , Aruna Somasiri , President and CEO, Wax-It Histology Services, Inc. , ,

Are you evaluating your therapeutics' performance against diet-induced NAFLD/NASH models? Are you in search of a timely preclinical solution that can generate high-quality data for quick go/no-go decision making?

With a global upswing in nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), with no readily available, FDA-approved therapeutic, many companies have prioritized NAFLD/NASH-related studies in hopes of expediting successful drug launches.
At this event, our expert panel will discuss commercially available in vivo mouse models and their related study design. Specific experimental procedures used to induce the desired disease phenotype will be explained in detail, and an actual case study data will be presented. In addition to in vivo procedures, our panelists will also discuss histological analysis of the liver pathology.

Transforming Regulatory Worries into Success Stories

Date
8:00 AM - 10:00 AM
Location
McGraw Conference Room - Biocom 10996 Torreyana Rd. Suite 200, San Diego, CA 92121
Speakers:
Andrea Young , Supervisor, Regulatory Compliance, Alcami Corporation , , Kristi Miller, PhD , Head of Regulatory Affairs, Regulatory Professionals, A Division of Premier Research , ,

Is your drug product development program keeping you up at night? Sleep easy by learning how to turn potential regulatory nightmares into successful FDA submissions.

Drug sponsors work closely with the FDA to bring their products to market. Along the way, there are a number of stumbling blocks that can thwart the development process thereby halting the progression of commercialization of even the most promising blockbuster drugs. While it is imperative to know what the agency requires, it is equally important to understand what can go wrong so that drug product information can be presented in the most comprehensive and complete manner.

We will discuss:
• Overview and definitions
• Tips for a successful pre-IND meeting
• FDA concerns with nonclinical and CMC information and how to avoid a clinical hold during the initial IND
• Important topics to discuss with FDA at end of phase meetings (nonclinical, clinical, and CMC concerns)
• Common agency questions resulting in deficiency letters
• Common agency questions resulting in complete response letters

Temperature Controlled Distribution of Biologics

Date
8:00 AM - 7:00 PM
Location
The Alexandria at Torrey Pines 10996 Torreyana Road, San Diego, CA 92121
Speakers:
Kevin Hickman , Senior Manager, Supply Chain Distribution, Gilead Sciences, Inc. , , Bob Seevers , Senior Advisor, Pearl Pathways & Member , , Heather Lane , Senior Supply Chain Specialist, Heron Tx , , Jeroen van Loo , Global Account Manager, ELPRO , , Denise Valentino , Director, Global Trade Compliance & Logistics, Neurocrine , ,

Temperature Controlled Distribution of Biologics

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Now in its second year, Biocom and ELPRO are delighted to bring cold chain practitioners our Leading Minds Seminar in San Diego on Tuesday, September 10th. The Temperature Controlled Distribution of Biologics seminar is designed for biotech companies, which are often virtual, rely heavily on partnerships, and have very specialized products.

Temperature sensitive biotech products, clinical supplies and active ingredients require more complex logistics handling in-transit and in-storage, especially across multi-national supply chains. While at the same time adhering to strict, and sometimes unclear, regulatory requirements.

Confirmed Speakers:
Denise Valentino, Director, Global Trade Compliance & Logistics, Neurocrine
Kevin Hickman, Senior Manager, Supply Chain Distribution, Gilead
Bob Seevers, Senior Advisor, Pearl Pathways & Member, USP <1079> Packaging and Distribution Committee
Heather Lane, Senior Supply Chain Specialist, HeronTx
Jeroen van Loo, Global Account Manager, ELPRO

​​​Topics include:
Knowing the ins/outs of import/export: Follow the rules while saving cost
Preparing for commercialization: What data will you put in the BLA?
GDP regulations updates across the globe
Biopharma and partners: Deeper dive into specific SOPs and contingencies
Qualification of shippers or thermal protection systems
Using temperature data for quality control and compliance
Quality and compliance GxP requirements for facilities

Why
Southern California’s Life Science community is a leader in novel drug discovery, genomics research and extensive clinical trial research. With a long history of innovation and trail already ablaze with next gen therapeutics, diagnostics and biologics, what level of consideration and investment is being allocated to the protection of in-process, clinical, active ingredient and finished good during distribution?

The distribution environment is challenging, even more so when distributing high-value temperature-sensitive products. To preserve the safety and efficacy of these products through each stage of the distribution process, they must be adequately and compliantly protected against thermal and physical stress.

The Seminar
This one-day seminar will discuss the many challenges facing Life Science organizations when distributing temperature sensitive products including types of stability testing; selecting the solution that is right for your product and its distribution environment; temperature data monitoring and management; quality agreements with partners; using multi-modal transport; clinical trial site quality control; and of course – how to best meet regulatory requirements with the resources you have.

Leading Minds Format
Leading Minds Seminars are unique in format and intent: we call it FUELS.
Fusion of
Useful
Experiences in
Logistics and
Storage

Experience sharing and problem solving are at the core of our seminars. Our Seminar programs are 65% discussion based. Step in, sit down, benchmark with other practitioners.

Collaborative and community-based learning at its best.

Who
All Life Science, Biologics, Pharma, and Medical Device practitioners who are faced with the challenges of preserving the safety and efficacy of their organization’s temperature-sensitive products are welcome to attend.

Job titles most likely to benefit in attending are:
Supply Chain, Logistics
Packaging Engineering
Cold Chain
Commercial operations or warehousing
Quality Control/Quality Assurance
Clinical Supply
Regulatory Affairs

Also, manufacturer’s partners:

CROs
CMOs
Freight forwarders, 3PLs, specialty couriers
Packaging supplier
Sponsors:

July 25th, 2019 – Are You Setting Your Molecule Up for Clinical Success?

Date
8:00 AM - 10:00 AM
Location
Biocom: McGraw Conference Room - 10996 Torreyana Rd. Suite 200, San Diego, CA 92121
Speakers:
Nikki Whitfield , Vice President of CDMO Services , Nikki has 25 years’ experience in the pharmaceutical industry and has previously held technical leadership positions in Vectura, Quadrant Drug Delivery and Elan where she was responsible for the development, transfer and scale up of both early phase and late phase products for the European and U.S. markets. In her previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product. Nikki’s current responsibilities at Quotient Sciences involve developing the global formulation and manufacturing capabilities. , Stephie Lee , Scientist , Stephie Lee, M.S., is a Scientist at Catalent in San Diego. She has a broad background in preclinical and clinical formulation, process development and GMP manufacturing of small molecule candidates, with a focus on early phase strategies for bioavailability enhancement of poorly soluble compounds. Stephie has managed more than 60 oral formulation programs, including spray dried dispersion, fluid bed processing, and micronization projects. Prior to joining Catalent, Stephie was a researcher in Dr. Richard Kaner’s laboratory at University of California, Los Angeles (UCLA), where she focused her research on the effects of various reaction conditions on the morphologies of nano conductive polymers such as polyaniline, polypyrrole and the fabrication of free-standing thin films of these materials. She received her Masters of Science in Chemistry and her Bachelor of Science in Biochemistry from UCLA. ,

Are You Setting Your Molecule Up for Clinical Success? How to Efficiently Bridge from First-in-Human Formulations to Scalable Dosage Forms for Proof-of-Concept Patient Trials

Cost, time, quality and dose flexibility are key considerations when developing first-in-human (FIH) dosage forms. Very often a simple pharmacy preparation may be sufficient to meet the requirements for Phase I clinical studies, but such products are likely to be unsuitable for Phase II patient trials which may take place at multiple clinical sites, in different countries and extend over a long period of time. Costly delays and budget overruns during product development and scale up can be prevented by carefully planning and integrating development activities and technology consideration from the outset. How do you develop a formulation that will be suitable for preclinical and FIH testing? How can you bridge from pharmacy preparations to GMP solid oral dosage forms that will be robust and scalable? How can you avoid common development pitfalls and ensure future success?

Quotient Sciences and Catalent Pharma Solutions, two leading drug development and manufacturing organizations, are coming together to share their expertise on phase appropriate formulation strategies and selecting the best technologies that will successfully transition your molecule into FIH clinical trials and then on through to your POC milestone and beyond.

Key considerations and strategies that will be covered include:
- Strategies on how to develop a phase-appropriate formulation
- Bridging drug products from preclinical to first-in-human and scaling for your POC trials
- Integrating pharmaceutical sciences & clinical testing to accelerate drug product development and reduces costs
- Assessing the challenges of poorly soluble molecules in early development and what technologies are best suited to enhance bioavailability
- Selecting scalable technologies to support your drug product’s needs and understanding the pros and cons

June 27, 2019- In vivo Imaging Applications for Improving the Precision of Discovery and Speed of Translation

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

This event will focus on in vivo imaging which has disrupted medical practice and the pharmaceutical industry from discovery to late phase clinical trials. Initial talks by industry experts will cover key translational and optical imaging technologies that have become highly prevalent in the pharmaceutical and biotech industry. Applications in in vivo imaging will be presented, including anatomical, pharmacodynamic (PD) biomarker and biodistribution assays. Examples using real datasets in research species from mice to NHP will be provided encompassing:
- PD biomarkers for diagnosis, stratification and response assessment
- the use of imaging agents as in vivo sensors and biomarkers
- target engagement and target validation
- therapeutics labeling and biodistribution imaging time courses
The presentations will focus primarily on neurology and oncology, but the principles described will directly apply to all major therapeutic areas, and presenters will be available to discuss applications outside these areas.

June 18, 2019- Designing Clinical Trials From the Patient’s Point of View

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

June 18, 2019- Designing Clinical Trials From the Patient’s Point of View
As leaders in biotech and life science industry, we strive to bring the most innovative treatments to the bedside. As professionals in clinical research, we strive to provide the best quality service and data to support life-changing studies. Clinical trends have forecasted methods to run trials more efficiently, as protocols become more complex. Throughout these changes, how do we keep the study patient focused?

Join Biocom’s CRO group as we host a discussion with patient advocacy groups on designing patient-centric studies. The event will highlight the current trends and new opportunities that both the biotech and clinical industry may adapt to lessen the burden of patient participation, increase patient enrollment and retention, and set the example as an industry that is truly putting their key customers, the patients, first .

Speakers:
Katie Croskrey – Executive Director, Alzheimer’s Association
Josh Bohannan – Public Policy Manager, Alzheimer’s Association
Tracy Dixon-Salazar, PhD - Director of Research & Strategy, LGS Foundation (Lennox-Gastaut Syndrome)

2019 Clinical Trials Research Showcase

Date
12pm - 5pm
Download Presentation Download

2019 Clinical Trials Research Showcase

Date & Location
Monday, May 20, 2019, 12:00 PM - 5:00 PM, Copley Conf Rms A-D, San Diego, CA

Overview
Sharp investigators will present their exciting research in a showcase format as part of Sharp’s inaugural participation in 2019’s Clinical Trials Day celebration!

The showcase will include displays from Sharp research sites, Sharp research vendors, partners, CROs, pharmaceutical and device manufacturers, local biotech and life sciences representatives and more

Objectives

Following this activity, participants should be able to:
Present innovative research conducted at Sharp HealthCare
Increase awareness of Sharp’s Research capabilities and requirements
Improve community outreach to potential research participants

Accreditation
Accreditation: Sharp HealthCare is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CME Credit: Sharp HealthCare designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.

May 7, 2019-Clinical Wanderlust: Where Should I Conduct My Clinical Trial and How Will the FDA Handle My Foreign Data?

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

Clinical Wanderlust: Where Should I Conduct My Clinical Trial and How Will the FDA Handle My Foreign Data?
Exploring the viability of Eastern Europe & Australia for First-in-Human Trials

US life science companies embarking on global clinical trials must consider how the FDA will handle foreign data generated. This discussion will introduce the FDA’s guidance on Acceptance of Foreign Clinical Studies, and how the FDA is addressing the challenge of processing the sheer volume of data and breadth of international inspections. The presenters will also present clinical, regulatory, import/export, and logistical benefits and challenges that you need to be aware of for your clinical trials in Australia, Czech Republic, Poland, and Slovakia.

Speakers:
Cameron Johnson, CEO, Nucleus Network
Jamie Weishaar, Business Development Executive, PCI Pharma Services
Mary Nguyen, PhD, Business Development Manager, Neox Clinical Research