Pharmaceutical Pathways

Drug Discovery, Development, & FDA Regulations

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STATKING
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BioOhio presents two events about Drug Discovery, Development, & FDA Regulations in partnership with NEOMED, Squire Patton Boggs, REDIzoneSTATKING 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

8 am – 5 pm

Location

Backstage Event Center

625 Walnut Street

Cincinnati, OH 45202

Sponsored by

Wood-Herron-Evans-2015-250
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STATKING

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

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

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

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

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

11:00 – Other Federal & Ohio Drug Discovery Resources

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

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.