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
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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

November 13th, 8am-10am: Clinical Trials in the Asia Pacific Region: The Competitive Edge?

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

Clinical Trials in the Asia Pacific Region: The Competitive Edge?
Join leaders from Nucleus Network, CoSec and Novotech as they discuss incentives for undertaking clinical research down under as well as the opportunities for the entire Asia Pacific region.

Learn about Australia’s clinical trial regulatory system and process, which enables quicker approvals within 4-5 weeks of IRB submissions ( no IND or IMP required). Australian data is accepted for regulatory submissions by both the FDA & EMA offering significant savings in clinical study costs. Find out how to navigate the landscape of Australia’s internationally-accessible R&D scheme, while learning more about incentive opportunities.

Discover how Australia can serve as a soft landing for conducting early phase clinical studies in the Asia Pacific region offering access to patient naïve populations in a variety of therapeutics areas. Come learn if biotech companies are turning more to the Asia Pacific region to recruit patients quicker while reducing recruitment and study timelines.

Speakers:
Cameron Johnson, CEO Nucleus Network, Australian Phase 1
Stewart Walker, Vice-President, CoSec,
Aditya Kotta, Business Development, Novotech

Bios:
Cameron Johnson, CEO Nucleus Network - Cameron Johnson joined Nucleus Network in August 2013 as the Chief Operating Officer before moving into the position of Managing Director. Prior to joining Nucleus Network, Cameron held the position of Chief Executive Officer at a Phase 1 Clinical Trials Organization and was also the inaugural CEO of the company. Cameron has worked in early phase clinical trials organizations conducting phase I first in human clinical studies for over 15 years across Australia and Europe.

Stewart Walker- CoSec - With nearly a decade of hands-on experience in corporate governance and compliance, Stewart Walker has a strong record of supporting US-based executives to navigate various regulatory landscapes. Stewart understands that a complex web of regulatory and reporting requirements can demand more time from executives than actually running their businesses, and he is happy to represent CoSec--a company that is committed to understanding its clients’ compliance and governance needs, fulfilling their regulatory obligations, and optimizing every opportunity that the Australian market has to offer.
Aditya Kotta - Novotech – Aditya has been in the Life Science industry for 10 years serving in a variety of roles from lab research to clinical operations, and now currently, business development. He also has experience working in both US focused and Global CROs, with clients ranging from biotech to big pharma. Aditya is passionate about putting together the time and cost efficient clinical development plans for Biotechs who are entering the clinical stage of development.

November 8, 2018- Cyber Security Risk Management for the 21st Century

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

Cyber threats are evolving and expanding at an astonishing pace. The attack surface has expanded to every area of modern life. Protecting a business’ critical assets has become of paramount importance; however, just as threats have evolved, so must our approach to managing these risks. Aligning security with business priority can elevate cybersecurity risk management from a technology management headache to a competitive advantage. Learn how to assess your risk, prioritize your remediation strategy, and build a security program that effectively minimizes risk to levels commensurate with your business’ risk appetite.

Speakers:
Michael Henry, Department of Homeland Security
Sean Walls, Vice President, Eurofins Cyber Security, North America, Inc.
Sem Ponnambalam, President, Xahive

Bios:

Sem Ponnambalam, co-founder and President of xahive, is primarily responsible for global operations including cybersecurity governance, education and regulatory reviews. With 18 plus years’ experience in both private, and public sectors, Sem has been instrumental in building relationships between xahive and US, Canadian and UK clinical research institutions. She has lectured and facilitated introduction to cybersecurity governance workshops and courses for businesses including healthcare institutions, Fortune 500 companies and associations. She has also co-authored articles about the importance of cybersecurity in international medical journals, and drafted a manual on cybersecurity steps to protect small, medium, enterprises and not-for-profits from cyberbreaches. Sem was a panelist at the World Economic Forum in NYC speaking about the importance of cybersecurity, in March 2017. Sem was selected as a delegate and panelist to represent Canada at the G20 Youth Summit in Berlin, in 2017. Sem has a Bachelor of Arts Honors in Political Science: International Relations, and a Master of Arts in Legal Studies, specializing in international law both from Carleton University.

Mr. Walls is currently the Vice President of the Cyber Security division at Eurofins, a multi-billion dollar international QA and standards testing organization. He has over 20 years of experience in cybersecurity and information technology. Sean has held executive leadership positions with several national security consulting and IT integration companies. He has been a strategic advisor to hundreds of fortune 500 and 100 companies over the years and speaks regularly on cybersecurity subjects.