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

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

8am - 10am
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

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

8am - 10am
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?

8am - 10am
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.

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

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

8am - 10am
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.

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


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.

October 25th, 2018- How is Artificial Intelligence Benefiting Biopharma?

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

Join us for an interactive discussion about the applications of AI in biopharma to accelerate drug discovery.

Pharmaceutical companies have been demonstrating a real interest in artificial intelligence (AI) applications for various research needs in solving more “traditional” tasks.
This seminar will provide access to experts in AI-related technologies, ways AI can increase accuracy, reproducibility, and scale in pathology, how the AI-based integration of pathology data with data from multiple sources can enhance analysis and the application of AI in target generation, identification of hits, and in the assessment of toxicology-related binding interactions.

Reveal Biosciences is a San Diego-based computational pathology company leveraging artificial intelligence (AI) to enable pathologists to make diagnostic decisions faster, more accurately, and with reproducibility at scale. Reveal is developing a pipeline of AI-based pathology decision support diagnostics to benefit patients. The company also supports drug development by combining traditional histopathology with AI to transform tissue biology into actionable data.

Immuneering’s technologies leverage advanced computational approaches and A.I. platforms to accelerate drug discovery and improve clinical outcomes. For diseases where the target is not known, the Cosiner algorithm identifies offsetting molecular profiles for disease and drug by yielding both a target and potential hits. Once a target is established, the Fluency A.I. algorithm eliminates the need for costly high throughput screens by efficiently modeling and predicting the binding interactions between a target and millions of compounds to identify hits for experimental assessment. Lastly, the Fluency-Tox A.I. algorithm models and projects toxicity-related drug binding interactions and can optimize molecules to be less toxic to humans.

Casey Laris, CTO, Reveal Biosciences
Rebecca Kusto, SVP and Head of R&D, Immuneering Corporation

Submission Survival Series: Navigating FDA Data Requirements- SD, LA, Bay Area presented by Accenture

Biocom offices: SD- LA- Bay Area

Getting your submission right the first time, within budget, is a strategic imperative for your organization. Without a clear and compliant clinical data strategy, many companies will struggle during the submission process.

The interactive discussion will include up-to-date information to better prepare your company for the rigors of organizing your clinical data packages in accordance with current guidance.

Join Accenture Clinical Data Operations Director, Brian Hermann, and Intelligent Data Flow (IDF) Operations Lead, George Stuts, for the Submission Survival Series: Navigating FDA Data Requirements. The 2 hour seminar will review how to plan for your clinical data submission readiness within Module 5.

Please choose a location from the list below that best suits your needs.

San Francisco
Tuesday, October 16, 2018
11:00 am - 1:00 pm

Los Angeles
Wednesday, October 17, 2018
11:00 am - 1:00 pm

San Diego
Thursday, October 18, 2018
11:00 am - 1:00 pm

​​​Topics will include:

Recent binding guidance from FDA (effective Dec 2016)
Study Data Technical Conformance Guide
Study Data Standardization Plan
Data Traceability and the FDA
Define files
Reviewers guides
Annotated CRFs
Pinnacle21 Data Validation
Submission Timelines

Who should attend:
Both early-stage companies who are new to the clinical data submission guidance’s, and portfolio builders who want to enhance their current clinical data submission knowledge, will benefit from attending the seminar.

Sherpa Summer Seminar

2pm - 6pm

Join Sherpa and the San Diego Clinical Supply Community for discussion, networking, and prizes!

Online registration closes Tuesday, July 17, noon PST. Onsite registration available.

Back by popular demand! Sherpa’s third annual Sherpa Summer Seminar brings the life sciences community together to explore ways to optimize clinical supply management. The 2018 edition will tackle common blind spots that exist between clinical operations, clinical supplies and the clinical site, and dive into the promises and challenges of direct to patient clinical trial designs. Be inspired by Sean Baumstark’s story, a warrior who is living with Friedreich’s Ataxia.

Come for the learnings, stay to connect with the life sciences community over good food (catered by Red Oven Pizza).


2:00 – 2:30pm

2:30 – 2:40pm

Mark Paiz, President, Sherpa Clinical Packaging

2:40 – 3:20pm

Harmonizing ClinOps, ClinSupplies, and the Clinical Site
For a clinical trial to go smoothly, the development and execution of clinical study design, clinical supply management, and patient enrollment must be in sync. Yet too often, this is the exception, not the rule. This panel will focus on common friction points and obstacles between clinical supplies, clinical operations, and clinical sites, and give suggestions on how to overcome them.

Moderator: Greg Kushla, PhD, RPh, Executive Director, Jeiven Pharmaceutical Consulting
Ron Carozza, C3 Research

3:20 – 4:00 pm

Direct to Patient Overview
The direct to patient (DTP) clinical trial design model is applauded for its focus on patient-centricity. For the sponsor company, this leads to shorter timelines, and less chance of costly patient drop-out. This panel will discuss the considerations that sponsor companies must be aware of when developing clinical supply strategies for DTP clinical trials such as the role of a nursing network, privacy concerns, and global regulations.

Moderator: Melissa Fassbender, US Editor, Outsourcing-Pharma
Sascha Sonnenberg, Vice President Commercial Operations Americas and EMEA, Marken
Kimberly Finn, VP Global Homecare & DTP US Services, Marken
4:00 – 4:30pm

Patient Perspective: The Importance of Clinical Trials
Sean Baumstark, Friedreich's Ataxia Survivor
4:30 – 4:40pm

Closing Remarks
Mark Paiz, President, Sherpa Clinical Packaging
4:40 – 6:00pm

Networking Hour & Tours
5:45 – 6:00pm