BioOhio presents two events about Drug Discovery, Development, & FDA Regulations in partnership with NEOMED, Squire Patton Boggs, REDIzone, STATKING Clinical Services, Camargo Pharmaceutical Services, and the US Economic Development Administration (EDA).
CLE Credits
CLE credit is pending for both events:
5/21 – 6.00 total hours; including 1.50 ethics
5/22 – 3.00 hours; including 1.50 ethics
Price
- BioOhio Members (1-10 employees) – $125.00
- BioOhio Members (11+ employees) – $175.00
- Non Members – $275.00
- Student Members- $50.00
- City and State Government – $125.00
Southwest Ohio
Monday, May 21
Sponsored by
Agenda
8:00 am – Breakfast and Registration
8:30 – Welcome from John F. Lewis Jr., President & CEO, BioOhio
Morning Program
8:35 – Advancements in Drug Discovery & Development – Academia
- Moderated by Elliot Reed, EIR, Faculty – College of Graduate Studies | REDIzone Program Manager, Northeast Ohio Medical University
- Pankaj Desai, PhD, Professor and Director, Drug Development Graduate Program, College of Pharmacy, University of Cincinnati
- Bruce Halpryn, PhD, Chief Operating Officer, Myonexus Therapeutics
- Takanori Takebe, MD, Associate Director of Commercial Innovation, Department of Pediatrics, Cincinnati Children’s
This panel will discuss predictive toxicology, the changing landscape in drug discovery from a technological perspective, compound lead generation, drug manufacturing techniques, including 3D printed drugs, and de-identified vs. identified data.
10:00 – Networking Break
10:15 – Other Federal & Ohio Drug Discovery Resources
- Elliot Reed, EIR, Faculty – College of Graduate Studies | REDIzone Program Manager, Northeast Ohio Medical University
10:40 – Advancements/Showcase in Drug Discovery & Development – Industry
- Moderated by John F. Lewis Jr., President & CEO, BioOhio
- Kevin Peters, PhD, Chief Scientific Officer, Aerpio
- Jan Rosenbaum, PhD, Chief Scientific Officer, Airway Therapeutics
- Isaiah Shalwitz, VP of Business Development and Operations, Invirsa
12:00 – Lunch
Afternoon Program: FDA Pharmaceutical Regulatory Forum
12:30 – Pre-IND Meeting Tasks
- Ken Phelps, President & CEO, Camargo Pharmaceutical Services
This session will discuss defining regulatory strategy, writing a clinical development plan and investigator brochure, and preparing for an FDA meeting
1:00 – Writing INDs
- Overview: Dennis King, President and Founder, STATKING Clinical Services
- Pre-Clinical Animal Section: Donald G. Stump, PhD, DABT, Senior Director, Toxicology, Charles River Laboratories
- Chemistry, Manufacturing and Control Section: Douglas W. Balogh, PhD, Director, Navigant Consulting
- Clinical Section: Keith Moore, PharmD, FCCP, BCPS, Chief Scientific Officer and Founder, ICIOMICS Life Sciences
2:30 – Accelerating Drug Clinical Development
- Steven Johnson, Vice President, Regulatory Affairs, Medpace
2:45 – Networking Break
3:00 – Legal, Ethical, Regulatory and Public Policy Concerns About New Advancements in Drug Discovery
- Moderated by Leah Brownlee, Of Counsel, Global Corporate Practice, Life Sciences Industry Group, Squire Patton Boggs (US) LLP
- James Reed, Senior Patent Counsel, Squire Patton Boggs (US) LLP
- Sarah Stec, Associate, Squire Patton Boggs (US) LLP
- Vyacheslav Vasilyev, Corporate Counsel, Zoetis
4:30 – Networking Reception
Northeast Ohio
Tuesday, May 22
9 am – 3:30 pm
Location
The NEW Center at Northeast Ohio Medical University (NEOMED)
4211 Ohio St Rt 44
Rootstown, OH 44272
Agenda
9:00 am – Breakfast and Registration
9:30 – Welcome from John F. Lewis Jr., President & CEO, BioOhio
Morning Program
9:35 – Legal, Ethical, Regulatory and Public Policy Concerns About New Advancements in Drug Discovery
- Moderated by Leah Brownlee, Of Counsel, Global Corporate Practice, Life Sciences Industry Group, Squire Patton Boggs (US) LLP
- James Reed, Senior Patent Counsel, Squire Patton Boggs (US) LLP
- Sarah Stec, Associate, Squire Patton Boggs (US) LLP
- Vyacheslav Vasilyev, Corporate Counsel, Zoetis
11:00 – Other Federal & Ohio Drug Discovery Resources
- Angela W. Corona, PhD, Director, Business development, BioMotiv
- Brad Lang, PhD, Executive in Residence, BioEnterprise
- Elliot Reed, EIR, Faculty – College of Graduate Studies | REDIzone Program Manager, Northeast Ohio Medical University
11:30 – Lunch
Afternoon Program
12:15 – Advancements/Showcase in Drug Discovery & Development – Industry
- Stephen A Charles, PhD, Executive in Residence, BioEnterprise
- Adam Davis, PhD, Director of Manufacturing, Abeona Therapeutics
- Carl Hulit, Vice President of Research and Development, Nortis
1:30 – Advancements in Drug Discovery & Development – Academia
- Moderated by Elliot Reed, EIR, Faculty – College of Graduate Studies | REDIzone Program Manager, Northeast Ohio Medical University
- Anthony J. Berdis, PhD, Associate Professor of Chemistry and Biology, Cleveland State University | Chief Scientific Officer, Co-Founder, Red5 Pharmaceuticals
- Stephanie Ham, PhD, CEO & Co-Founder, OncoSolutions
- Moo-Yeal Lee, PhD, Associate Professor, Cleveland State University
This panel will discuss predictive toxicology, the changing landscape in drug discovery from a technological perspective, compound lead generation, drug manufacturing techniques, including 3D printed drugs, and de-identified vs. identified data.
3:00 – Networking Reception
Sponsorship
Interested in sponsoring Pharmaceutical Pathways? Sponsorship is $1,500 per event, or $2,500 for both.
First-time event sponsors will receive a 5% discount, and if you wish to combine annual BioOhio membership and event sponsorship, we will reduce your annual dues by $200.
Event sponsorship benefits include:
- Exhibit space at event
- On-site logo presence
- Premium logo placement on all print and electronic conference material & signage
- Text acknowledgement of support on social media and the BioOhio LinkedIn Group
- Organization name, logo, and description listed in event materials
- One complimentary event registration
- Attendee list with contact information, pre- and post-event
- Company representative name badges tagged as “Sponsor” at event
To become a sponsor, contact Jen Goldsberry (614) 675-3686 x 1004, jgoldsberry@bioohio.com.
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