WORKSHOP: Journey from Discovery to IND to Early Development

Date: November 9, 2024 @ 9:00 am – @ 3:00 pm
Location: 1633 Old Bayshore Hwy #280, Burlingame, CA 94010

Welcome to the “Journey from Discovery to IND to Early Development” workshop, taking place on November 9th, 2024, at Hanhai Biolabs, Burlingame, CA. This workshop brings together distinguished experts from the pharmaceutical and biotech industries to share their insights and experiences in drug discovery and development. Our esteemed speakers will delve into key aspects such as small-molecule lead optimization, DMPK, nonclinical safety assessments, and innovative approaches to high-throughput screening.

We are honored to have Dr. Zhonghua Pei of Neuron23, Dr. Shichang Miao of PBSS, Dr. Yang Tian of AusperBio Therapeutics, Dr. Xiaoting Wang of Amgen, and Dr. Ron Najafi of Emery Pharma, who will guide us through these topics. Their extensive backgrounds in oncology, inflammatory diseases, virology, immunotoxicology, and regulatory science promise a comprehensive and enriching experience for all attendees.

Let’s embark on this knowledge-packed journey together!

Speaker information:

1, Zhonghua Pei, Ph D., SVP of Chemistry & DMPK, Neuron23, Inc

Presentation titles:

(1) A Journey from Discovery to IND to Early Development, an overview; ~ 15 min;

(2) Small-Molecule Lead Optimization: the Joy and Challenges, ~ 35 min 

Brief bio: Dr. Zhonghua Pei serves as Senior Vice President of Chemistry at Neuron23. Zhonghua has rich and extensive small-molecule drug discovery experience in oncology, inflammatory diseases, metabolic disease (diabetes & obesity) and CNS diseases. After his Ph D studies at MIT, Zhonghua started his industrial career at Abbott Laboratories, then joined Genentech in 2007 and later Ideaya Biosciences in 2017. Over a period of more than 20 years he has made significant impact and contributions to the discovery of multiple clinical development candidates at Abbott, Genentech, Ideaya and Neuron23, either as an individual contributor or as a team leader. He has authored or co-authored more than 45 peer-reviewed papers, reviews and book chapters and 55 patents.
Zhonghua obtained his BS degree from University of Science and Technology in China (USTC), MS degree from Rensselaer Polytech Institute (RPI) and his Ph D. in chemistry from MIT. Zhonghua is the past president (2013-2014) and currently a member of the board of directors of the Chinese American Bio/Pharmaceutical Society (CABS).

2, Shichang Miao, Ph D., Founder and President of Pharmaceutical & BioScience Society International (PBSS)

Presentation title: Drug Metabolism and Pharmacokinetics (DMPK) in drug discovery and preclinical development: fundamentals and practical aspects

Bio: Shichang Miao, PhD, is a seasoned drug discovery scientist, drug developer and biotech investor / advisor / consultant. During his career, he worked at several biotech companies in the San Francisco Bay Area, including Tularik, ChemoCentryx and Amgen. At ChemoCentryx, as Vice President of Preclinical Development & Clinical Pharmacology, he led his team to conduct the preclinical assessment and clinical pharmacology studies for the development of Tavneos® (avacopan), which was approved in 2021 by the FDA for the treatment of ANCA-associated vasculitis, leading to the acquisition of ChemoCentryx by Amgen in 2022. He has also been a managing partner of Rivermount VC Fund, an advisor to Stanford University's SPARK translational medicine program, and a Bio Screening Committee member of Life Science Angels. He is also the founder and president of Pharmaceutical & BioScience Society International (PBSS), with chapters in the San Francisco Bay Area, San Diego, Boston, Vancouver, Korea, and soon Seattle. He received his PhD in organic chemistry and post-doctoral training in biochemistry at the University of British Columbia (Vancouver, Canada).

3, Yang Tian, Ph D., Senior VP of AusperBio Therapeutics

Presentation title: High-throughput screening, an overview

Bio: Dr. Yang Tian currently serves as Senior Vice President of AusperBio Therapeutics. Before joining AusperBio in 2022, he spent 10+ years at Gilead Sciences, taking responsibilities in assay development, high-throughput screening and early lead discovery cross drug discovery programs in Virology, Oncology and Inflammation. Dr. Tian obtained his PhD in Pharmacognosy from University of Illinois at Chicago.

4, Xiaoting Wang, Ph D., Director, Translational Safety & Bioanalytical Sciences, Amgen Inc.

Presentation title:Nonclinical safety assessment for pharmaceutics: general toxicology and safety pharmacology

Bio: Xiaoting Wang holds the position of director within the Translational Safety and Bioanalytical Sciences group at Amgen, located in South San Francisco. Her expertise lies in immunology and immunotoxicology, and she is a board-certified toxicologist. Xiaoting plays a pivotal role as the project lead toxicologist for inflammation and oncology programs. Additionally, she oversees a team of scientists dedicated to the development of various in vitro model systems. These systems are designed to predict and assess clinical safety concerns related to immunotoxicity and off-target effects. Xiaoting earned her PhD from the Viral Immunology and Pathology department at UMass Chan Medical School in Massachusetts. Following this, she completed her postdoctoral training in tumor immunology at the La Jolla Institute of Immunology in California

5, Ron Najafi, Ph D., Founder, President & CEO of Emery Pharma 

Presentation title: Nitrosamines in Pharmaceuticals? Tracing Root Cause and Navigating Risk Assessment

Bio: Dr. Ron Najafi is a highly accomplished scientist, entrepreneur, and leader in the pharmaceutical and biotechnology industries. With over 30 years of experience, Dr. Najafi has made significant contributions to drug development, analytical chemistry, and regulatory science. He is the Founder, Chairman, and CEO of Emery Pharma, a Contract Research Organization (CRO) specializing in preclinical support, bioanalysis, and regulatory compliance for early-stage biopharmaceutical companies.

Dr. Najafi established Emery Pharma in 2011 as a subsidiary of NovaBay Pharmaceuticals and transitioned it into a private entity under Najafi Pharma Inc. in 2015. Emery Pharma is an FDA-registered, DEA-licensed, and cGMP/GLP-compliant organization, renowned for its advanced analytical capabilities, including LC-MS and high-resolution mass spectrometry (HRMS). Under Dr. Najafi's leadership, Emery Pharma has developed customized solutions to accelerate life science innovation, supporting global clients in drug development.

One of Dr. Najafi’s key achievements is his leadership in uncovering the root cause of nitrosamine contamination in Zantac (ranitidine). Emery Pharma was the first lab to demonstrate that Zantac could generate N-nitrosodimethylamine (NDMA) over time, influenced by environmental factors such as temperature and moisture. This groundbreaking discovery, presented to the U.S. Food and Drug Administration, has made Dr. Najafi a recognized subject matter expert in nitrosamine contamination and its regulatory implications.

Prior to founding Emery Pharma, Dr. Najafi was the Founder, Chairman, and CEO of NovaBay Pharmaceuticals, where he led the company from its inception in 2000 to its Initial Public Offering (IPO) in 2007 on the NYSE and TSX under the ticker symbol NBY. During his tenure, he raised over $200 million in funding, formed international partnerships, and led the development of Avenova®, a leading treatment for blepharitis and meibomian gland dysfunction.

Dr. Najafi earned his Ph.D. in Organic Chemistry from the University of California, Davis, where he conducted research under the supervision of Professor George S. Zweifel. He also holds a B.S. and M.S. in Organic Chemistry from the University of San Francisco.

With a strong track record of innovation, Dr. Najafi continues to drive pharmaceutical development and regulatory advancements. His expertise spans drug development, clinical trials, regulatory compliance, and intellectual property creation, making him a pivotal figure in the biopharmaceutical industry.

Workshop lunch sponsor: 

Emery Pharma

1000 Atlantic Ave. Suite 110

Alameda, Ca 94501

www.emerypharma.com

NOTE: If you want to have other payment option, please go to our EVENTBRITE WEBSITE to register.