Seeing Around Corners – Anticipating and Avoiding Pitfalls in Drug and Product Development

REGISTRATION CLOSED - WALK INS WELCOME AT THE EVENT

Bringing new therapies to the market is more challenging than ever before.  In addition to rising costs, increasing regulatory complexity, market access, reimbursement concerns and manufacturing challenges, the science and technology is becoming exceedingly more complex.

Product development programs achieve higher levels of success when efficiently bringing together the multitude of functional activities such as nonclinical, CMC, clinical, statistics, and regulatory.

As the failure to “see around the corners” can lead to increased costs and delays in bringing new therapies to market, it’s important to take a holistic and integrated approach. Doing so helps developers to anticipate, minimize, and ideally, avoid pitfalls.

This event will address the intricacies and challenges of drug development, provide practical strategies for avoiding pitfalls and discuss the “how to” of most efficiently bringing new therapies to market.

Speaker: Mark Lane, PhD

Vice President, Development Consulting and Scientific Affairs, Pharmalex

Southern California Contact:

Piet Lesage, Regional Sales Director, Pharmalex

Agenda:

5:30 pm – 6:00 pm: Networking and light refreshments

6:00 pm – 6:10 pm: Introduction to Pharmalex, Piet Lesage

6:10 pm – 7:00 pm: Presentation and Q&A

7:00 pm – 8:00 pm: Further discussion with Mark

Post event March 22-24: Opportunity to schedule 1:1 meetings with Pharmalex

Cost: FREE

About the Presenters:

Mark Lane, PhD, Vice President, Development Consulting and Scientific Affairs, Pharmalex

Mark has extensive experience leading product development teams and functions accountable for product development across all phases. Unique expertise combining program, project and portfolio management expertise, deep understanding of drug development, and a strong working knowledge of cross-functional activities (R&D, clinical, medical affairs, manufacturing, marketing/market access, regulatory, etc.) with business & scientific acumen (110 publications).

Piet Lesage, Regional Sales Director, Pharmalex

Piet Lesage worked in Business Development for 20+ years. He joined Pharmalex less than a year ago, and since Jan 1st he is responsible for outreach to Pharma and BioTech companies on the West Coast. Previously, Piet focused on Medical Devices, IVD’s, Combination products and CDx. Before Joining Pharmalex, Piet worked as an independent consult with a focus on the development of a strategic market entry plan, encompassing regulatory, compliance, reimbursement and market access. He started his career supporting several US based pioneers in the Medical Ultrasound market.