Thursday, July 27th: 8am-10am Biocom CRO Presents: Pharma Outsourcing from Concept to Commercial: Strategies Addressing CMC Needs

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

Biocom CRO Presents: Pharma Outsourcing from Concept to Commercial:

Strategies Addressing CMC Needs

Outsourcing in Pharma has evolved from a tool to supplement internal activities to a necessary function designed to improve efficiencies and control costs within research and development organizations. This is particularly relevant to start-up pharmaceutical and biotechnology companies. However, realizing successful outcomes following engagement of CRO/CMO resources can be challenging - especially when working across large distances and without the ability to frequently monitor day-to-day activities. Through adoption of key strategies, efficiencies with CRO/CMO resources can be increased thus maximizing chances for successful project outcomes. This panel discussion brings together leading experts covering research, process development and manufacturing, and formulation development who will provide their insight on strategies for success in the CMC space.

Speakers:

• Research panelist – BioBlocks – Warren Wade

• Manufacturing panelist – Norac Pharma – Danny Levin

• Formulation panelist – Catalent Pharma Solutions – Bryan Knox

• Moderator – DEL BioPharma LLC – Daniel E. Levy

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When: Thursday, July 27th

8:00 a.m. - 10:00 a.m.

*This event is free for Biocom members

August 9th, 2017-Generic Products: Opportunities for Southern California Companies

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

Generic Products: Opportunities for Southern California Companies

"Generics - An Overview"
Giff Marzoni, Vice-President Global Pharmaceutical Development DavosPharma

"Navigating the Regulatory Paths for Generics"
Luman Wing, Director Executive Consultant, Cardinal Health

"Value Creation through Formulation of Generic Topicals"
John M Newsam, CEO Tioga Research

8 in 10 of the 4.5 billion US prescriptions in 2016 were for generic drugs. A generic drug is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. A generic drug is required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product, but need not contain the same inactive ingredients. It must, however, be proven to be bioequivalent to the brand name product.

If you are curious about the business drivers behind the generics industry, about the developmental and regulatory paths for a generic, about how bioequivalence can be proven, or about the strength of protection that a patent on an innovator product can provide, you might consider joining this event.

The event provides an introduction to the generics business in the US, overviewing business, technical, developmental and commercial aspects. Regulatory issues and requirements are summarized and strategies for realizing streamlined approvals outlined. And the event includes examples of where formulation creativity can establish a basis for a generic approval.