The Southern California Pharmaceutical Discussion Group (SCPDG) Announces our May 2025 Meeting:
Optimizing Drug Development: A Strategic Approach to CMC and
Phase-Appropriate Execution
Presented By
REZA OLIYAI, Ph.D.
President and CEO
Oliyai Consulting Corporation (OCC)
Abstract:
This presentation will explore the critical elements of a successful drug development strategy, focusing on key aspects such as an end-to-end CMC strategy, phase-appropriate drug development, and strategic partnerships with CROs and CDMOs, along with collaboration with consulting firms. A successful CMC strategy integrates pre-clinical studies, clinical development plans, regulatory frameworks, and the target product profile for commercialization. Phase-appropriate drug development emphasizes tailoring the process to each stage, optimizing resources, timelines, and costs. Partnering with CROs and CDMOs provides specialized resources for manufacturing, while collaborating with skilled consulting firms offers valuable insights to create a fully integrated, end-to-end drug product development strategy and execution. Together, these elements form a cohesive approach that accelerates drug development, mitigates risks, and enhances clinical outcomes. Additionally, considerations around tariff implications and the BioSecure Act will be discussed in relation to the design of an effective and resilient supply chain.
Biography:
Dr. Oliyai is a seasoned pharmaceutical executive with over 30 years of leadership experience, currently serving as the President and CEO of Oliyai Consulting Corporation, which he founded in 2022. His extensive career includes a notable tenure as Senior Vice President of Pharmaceutical and Biologics Operations at Gilead Sciences, where he oversaw the development of more than 200 drug candidates and successfully brought 27 products to market, underscoring the depth and vision that drive Oliyai Consulting.
Oliyai Consulting is a premier pharma and biotech consulting firm, distinguished by the real-world expertise of its subject matter experts. The company specializes in accelerating drug development from lead optimization through commercialization, with a core focus on CMC. The firm crafts tailored solutions to tackle scientific, technical, regulatory, and operational challenges, delivering exceptional value through a data-driven, phase-appropriate approach and sound regulatory strategies.
Oliyai Consulting offers unparalleled support and insights to its clients. Every team member is selected based on the ability to provide the highest caliber of service. The team's expertise spans a variety of modalities, including small molecules, polypeptides, biologics, antibody-drug conjugates (ADCs), cell therapies, and combination drug-device products. Oliyai Consulting brings deep understanding and regulatory expertise to a wide range of drug delivery routes, including oral, intravenous, subcutaneous, long-acting injectable, intravitreal, and inhalation, with specialized proficiency in pediatric formulations. In addition to CMC, Oliyai Consulting excels in medicinal chemistry, prodrug design, toxicology, ADME/PK, clinical pharmacology, regulatory strategy, and patent litigation support.
Oliyai Consulting serves over 90 diverse organizations, including major pharmaceutical companies, biotech firms, startups, venture capital groups, AI-driven enterprises, and law firms.
Date: Thursday, May 8, 2025
Agenda: 4:00-4:30 PM PT, Check-In, Networking and Refreshments, 4:30-5:30 PM PT, Presentation and Discussion.
Location: Waters District Office, 3540 Howard Way, Suite 100, Costa Mesa, CA 92626 or join us online. You must register to attend live or receive the link to attend virtually. General admission is $20.00 (to cover the cost of refreshments), Students with ID and Retirees are $5.00.
Registration: Please register by Noon, Tuesday, May 6, using the link below or copy and type into your browser:
https://www.eventbrite.com/e/optimizing-cmc-and-drug-development-using-cdmos-and-consultants-tickets-1324590207969?aff=oddtdtcreator
Note: Must register to receive Zoom Link.
------------------------------
Ke Wu Ph.D.
Associate Director
Abbvie
Irvine CA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------