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

March 27, 2019- Clinical Protocol Development for Two Ultra-Rare Diseases

Date
12pm - 1pm

Clinical Protocol Development for Two Ultra-Rare Diseases

On Wednesday, March 27, the Regulatory Affairs Committee is hosting our next in-person. We are delighted to have Mark Hurtt, M.D. join us as our guest speaker. He will discuss clinical protocol development for two ultra-rare diseases. A conference line will be available. We encourage those in the San Diego area to attend in-person as we only host these meetings four times a year and it’s a great way to connect with the community.

If you are interested in attending, please contact Brittany Blocker, Manager of Regulatory Affairs at [email protected]

January 28, 2019-Pre-Clinical Efficacy Models for Immuno-Oncology Studies in Humanized Mice

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

Pre-Clinical Efficacy Models for Immuno-Oncology Studies in Humanized Mice

Pharmatest Services and Taconic Biosciences welcome everyone to a seminar titled “Preclinical efficacy models for immuno-oncology studies in humanized mice”. Humanized mouse models include functional human immune system, which allows testing efficacy of immunotherapies on human cancer cells in immunocompetent mice. The seminar also discusses the importance of using preclinical metastasis models to confirm efficacy before entering clinical trials.

- 8.00 – 8.30: Registration and networking
- 8.30 – 8.45: Introduction, by Jussi Halleen, CEO, Pharmatest Services
- 8.45 – 9.15: Humanized Immune System Models: Novel Models for Novel Immunotherapies, by Paul Volden, Associate Director of External Collaboration and Innovation at Taconic Biosciences
- 9.15 – 9.45: Humanized mouse models of bone metastasis, by Tiina Kähkönen, Research Director at Pharmatest Services
- 9.45 – 10.00: Q&A

Speakers:
Paul Volden, Associate Director of External Collaboration and Innovation, Taconic Biosciences
Tiina Kähkönen, Research Director, Pharmatest Services

December 4, 2018: Clinical Site Management: The Key to Successful Trials

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

Clinical Site Management: The Key to Successful Trials

Almost nine in ten clinical trials fail. While some failure is inevitable based on the development of the science, this figure is astoundingly, unacceptably high. Especially after spending over a billion dollars on average per trial and over a decade in development.

Why do so many clinical trials fail? There are many of the usual suspects ¬– excuses such as lack of efficacy, safety concerns, strategic reasons and economics, or some combination of these. Bull!

The real reasons: poor study design, increasingly complex protocols, poor trial management, lack of site involvement in study design, and weak teams. Awkward reasons managers don’t like to discuss, because they have to do with the quality of the clinical trial management and site selection. These are things you can do something about.

On December 4, the Biocom CRO group will present a panel of highly experienced and successful clinical trial managers, sponsors, monitors and site managers who will discuss their experiences, best practices and the lessons they have learned on the way to clinical trial success (and failure).

Lessons you can now learn for free…

Speakers: John Neal, Moderator, Founder and Chairman of PCRS Network, and Vice-Chairman of Association of Clinical Rresearch Professionals (ACRP)
Heidi Guthrie, Associate Director, CRO Services, ProSciento, Inc.
Claudia Shojai, Clinical Research Manager, DNA Electronics, Inc
Lisa Bjornestad, Director Site Alliance, the Americas at PAREXEL
Join us on December 4, 2018 at Biocom at 8am