ADVOCATE. CONNECT. INNOVATE.

What, Why, Where, When and How to hold your first First-In-Human trial

San Diego, CA

9/25/2018

2:00pm - 5:30pm

You’ve answered some basic science questions about a drug’s safety and are ready to move to the clinic… There is a lot to consider including study design, cost/incentives, speed, quality, the participant pool, communication/language, partners, your market, standard of medical care, data integrity and more! To answer these questions, we've assembled a group of experts to help you prepare before you take the next steps.

This clinical trial workshop will bring together experts in the field from Johnson & Johnson, CROs and agencies to discuss advantages, challenges and experiences in running trials around the globe.

Topics will include:

Preparing for your FIH, Phase 1B trials

The questions you should be asking – what, why, where, when and how?
High level considerations when planning clinical trials
The importance of proactive planning and the right partner
Partner/vendor/country selection
Regulatory environment
Study populations and design
Safety considerations
Study location considerations

What are the real differences/advantages for a young company that has limited resources going to other locations for clinical trials?
Standard of medical care and data integrity in THAT country
Timelines & costs If you are thinking about your clinical trials, attend this session to gain key insights into the details of executing your first trials. There will be plenty of time for group Q & A and meeting 1-on-1 with providers.

Speakers:
Gene Richardson | Director Early Development and Clinical Pharmacology, Janssen R&D read bio»
Bruce Morimoto | Vice President, Scientific Affairs, Celerion read bio»
Larry Ereshefsky | Chief Scientific Officer, Hassman Research Institute, and CNS Network | Owner/CSO, Follow the Molecule read bio»
Stan Jhee | Corporate VP Scientific Affairs, Parexel read bio»
Barry Murphy | Executive Director Business Development, Novotech read bio»

Agenda:
2:00 PM | Registration and Networking
2:15 PM | Early development and clinical pharmacology
2:45 PM | Q&A
3:00 PM | Nuts and bolts of early clinical research
3:30 PM | Panel discussion - Messes and successes of preparing and executing your first trial
4:15 PM | Q&A
4:30 PM | Reception and Gallery Walk - Meet the providers
5:30 PM | Program close

Fees:
$25 | General Public
$15 | Student/Academic
$35 | At the door

Location:
JLABS
3210 Merryfield Row
San Diego, CA

Speakers' Biographies:

Gene Richardson | Director Global Development and Clinical Operations, Early Development & Clinical Pharmacology, Janssen Research & Development
Gene Richardson is Head, Global Development and ED&CP Clinical Operations at Janssen, a Pharmaceutical Company of Johnson & Johnson. In a career that expands over 43 years in Clinical Research & Development, 8 with Schering-Plough and the past 35 years with Johnson & Johnson, Gene has progressed through multiple levels of responsibility in Clinical Research from Bench Science to Clinical Research Site Monitoring to US Head Janssen Global Clinical Operations ED&CP to his current role where he oversees the conduct of 50 to 60 Janssen Clinical Pharmacology studies per year, across 5 different Therapeutic Areas globally. Gene completed his B.S. degree in Biochemistry at Seton Hall University.

Bruce Morimoto | Vice President, Scientific Affairs, Celerion, Inc., USA
Bruce is the Vice President, Scientific Affairs, a key leadership position at Celerion and is directly responsible for developing and deploying scientific, regulatory and medical expertise and advice to various biotech and emerging pharmaceutical companies. Prior to joining Celerion, he was Vice President of Drug Development at Allon Therapeutics, where his responsibilities included management of early clinical research, nonclinical and manufacturing activities for therapeutic programs in various neurological and psychiatric conditions (Alzheimer’s & Parkinson’s disease, frontotemporal dementia, and schizophrenia). Bruce also directed the chronic and neuropathic pain program at NeuroMed Technologies.

Bruce earned his doctorate in biochemistry from the University of California, Los Angeles (UCLA), and completed post doctorate research at University of California, Berkeley. He was on the faculty in the Chemistry department at Purdue University before moving into industry. Bruce serves on a number of advisory committees including scientific review for the Michael J Fox Foundation, TIDES (oligonucleotide & peptide conference series) and the Safety Pharmacology Society.

Larry Ereshefsky | Chief Scientific Officer, Hassman Research Institute, and CNS Network | Owner/CSO, Follow the Molecule. Retired Regents Professor, The University of Texas Health Science Center
Larry has over 40 years of experience as a clinician, scientist and PI, developing treatments and innovative clinical methodologies to make a difference in the lives of patients with Neurodegenerative and Psychiatric Disorders. He has contributed significantly to several drug approvals spanning neurology and psychiatry, including drug development planning, PK/PD evaluation, and methodological innovation for numerous indications. He has designed, implemented, supervised, and conducted more than 100 CNS clinical trials ranging from first into human and into patient populations, through to proof of concept. He is a leader in the use of signal detection strategies to minimize placebo response and insuring study designs preserve statistical power while preserving the blinding.

He has been a leader in the application of translational drug development tools including neurocircuitry/biomarker based (RDoC) strategies, i.e., continuous CSF sampling, QEEG, ERP, PSG, MRI, fMRI, PET, and cognitive and behavioral paradigms. He has worked with Michael J Fox Foundation on validating inflammatory markers and alpha-synuclein in PD, and with Washington University and the NIH in validating CSF Amyloid and Tau targets. He has particular expertise and skill in supporting complex, integrated (umbrella) and adaptive Phase I-II studies, including extensive experience using enriched and first generation Asian population.

Stan Jhee, Corporate VP Scientific Affairs, Parexel
Dr. Jhee has expertise in a wide range of early drug development studies from First-in-Human through Proof-of-concept (emphasis on clinical pharmacology/Phase I studies) and works collaboratively with pharmaceutical industry colleagues in the strategic planning, protocol development, clinical conduct, data analysis and reporting of clinical studies.

In 2000, Dr Jhee pioneered the concept of gathering Japanese data in the US and UK to help pharmaceutical companies in support of Asian drug development, coining the term Ethnobridging. Under his leadership, we have now conducted over 180 Asian studies, expanding the service to include Chinese and Korean subjects in addition Japanese. Dr Jhee has authored over 50 peer reviewed scholarly articles and has written three books on Ethnobridging as the lead author.


Barry Murphy | Executive Director Business Development, Novotech
Barry has been in the clinical research industry for 10 years now, having begun his career as a pharmacist, after graduating with an MSc (Pharmacy) from Trinity College Dublin. First moving into the industry with ICON in their Dublin headquarters in 2009, a passion for cross functional team building, strategic thinking and problem solving saw Barry excel in proposal development, contract management and client relationship management roles. Moving to Sydney, Australia in 2012, his Asia-Pacific expertise and knowledge was honed, before moving to an Asia-Pacific specialist CRO, Novotech at the beginning of 2015 in a business development role. Barry has serve Novotech’s main client base. Novotech now boast 3 staff in each of San Francisco and Boston and Barry took over as Global Head of Business Development in November 2017.

Click Here for More Information

Contact: Brittney Sabbah
Contact Email: bsabbah@its.jnj.com

Event Address:

JLABS in San Diego
3210 Merryfield Row
San Diego, CA 92121