Speakers: Aziz Alam, Alterome Therapeutics; Elisabeth Gardiner, EMMG Consulting; Sanjeev Thohan, SARx Consulting; Preetanshu Pandey, Boundless Bio; Ken Kobayashi, Pyxis Oncology; Grace Furman, Paracelsus, Inc.
Organizers: Robyn Rourick, MSc (Genentech), MSc and Sanjeev Thohan, PhD (SARx Consulting)
Date: 2024-04-30
Time: 8:45-17:30 Pacific Time
Registration fee: Regular attendees: $295; Academic/Paying out of Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Hilton San Diego/Del Mar, 15575 Jimmy Durante Blvd, Del Mar, CA 92014
Major Sponsor: (1)AustinPx
Vendor show vendors registered to date: (23)Adare Pharma Solutions; Almac; Altasciences; Alturas Analytics; Ardena; Attentive Science; BA Sciences; BioAgilytix; BioIVT; Celerion; Charles River Labs; CMIC, Inc.; Cowan Health Consulting; Crystal Pharmatech Inc; Discovery Life Sciences; Ellegaard BioResearch; Inotiv; ITR Laboratories; Meadowhawk Biolabs; Pharmaron; Quotient Sciences; Veloxity Labs; WuXi Apptec
Registration: http://www.PBSS.org
Registration deadline:2024-04-29  (it will close sooner if the seating cap is reached)

About the Topic

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Investigational new drug (IND) application is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations, and processes of assembling and filing an IND is the key to not only a successful filing but also a promising clinical development path forward. Often, there are cases where too many nice-to-have studies crowd in the package but critical studies/issues are not addressed, and this can lead to significant delays in clinical development. Additionally, the regulatory environment is changing as rapidly as the industry. Therefore, keeping up to date on the regulatory requirements and the industry’s best practices in different aspects including non-clinical safety, PK, CMC, and clinical plan is paramount.

Below are the topics to be covered:

· Overview of preclinical development and IND filing for small molecules
· Key preclinical studies required (Safety, DMPK & CMC)
· Clinical Development plans
· Regulatory strategies
· Interacting with regulatory agencies

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Aziz Alam: Aziz Alam, Senior Director of Regulatory Affairs at Alterome, is a seasoned pharmaceutical regulatory affairs leader with a strong background in global regulatory strategy across the US, EU, and APAC regions. Aziz specializes in oncology and non-oncology therapeutics in virtual, small, and large pharma environments. He has successfully led over 20 INDs through FDA authorization and 2 global drug approvals through FDA and EMA approval. Aziz specializes in securing expedited designation approvals from the FDA, including Orphan, Fast Track, and Breakthrough designations. Aziz is active with Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA), contributing to industry thought leadership. 

Elisabeth Gardiner: Elisabeth is President of EMMG Consulting in San Diego, CA. She holds MS and PhD degrees in Entomology from Texas A&M University and University of Wisconsin, Madison. Her post graduate experiences have given her in-depth knowledge of small molecule and biologic drug discovery, with an emphasis on targeted assay builds, strategic pharmacology planning; technology evaluation and biomarker exploration.  Over the past 25 years, Elisabeth has held positions with increasing responsibility covering the disciplines of Biology, Pharmacology and Translational Medicine. She is a preclinical SME for both small and large molecule modalities at Alterome Tx, Aravive Biologics, Fount Therapeutics (became Kinnate), Meditope Biosciences, aTyr Pharma, Novartis (GNF), and Kalypsys.

Sanjeev Thohan: Sanjeev has been a very active member and leader and founder of many preclinical teams. He holds MS and PhD degrees in Pharmacology and Toxicology from the University of Arizona and University of Maryland with concentrations in interspecies drug metabolism mechanisms, bioactivation, and systems toxicology. He personally generated and oversaw ADME/TOX/Safety IND-enabling studies to facilitate Phase I-II clinical study design for both small molecules and antibody drug conjugates (ADC) in the Anti-viral, Anti-infective, Anti-inflammatory, Biodefense, Cardiovascular/ Metabolic and Oncology, therapeutic areas. He is an active mentor with the Centers for advancing Innovation (NIH collaboration) as well as a Scientific Advisory Board member and founder for a number of startup companies. 

Preet Pandey:  Preet is the Head of CMC at Boundless Bio, with over 18 years of experience in the pharmaceutical industry. Preet's academic background includes a Bachelor’s in chemical engineering from IIT Kanpur and M.S. and Ph.D. degrees from West Virginia University.  His career journey spans from large pharma, Merck and Bristol-Myers Squibb in New Jersey, to multiple early-stage biotechs in San Diego. Actively engaged in organizations like AAPS and AICHE, Preet has chaired symposiums and served as a reviewer for multiple journals. He has over 40 peer-reviewed publications, multiple patents, and is the chief editor of a book on predictive modeling in pharmaceutical manufacturing. 

Ken Kobayashi: Ken is the Chief Medical Officer at Pyxis Oncology, is an experienced medical oncologist, clinical pharmacologist, and senior global life sciences executive. He earned his MD from Northwestern University Medical School and trained in medical oncology and clinical pharmacology at the University of Chicago. He has a deep background as a clinician-scientist, regulator, scientific diplomat and drug developer across the US, Europe, Latin America, and Japan/Asia. As a senior executive in large and mid-size pharmaceutical companies including Pfizer, Daiichi Sankyo, AstraZeneca, Janssen, and Novartis, he has successfully overseen the introduction of more than 28 investigational agents into the clinic and been directly involved with 60 programs across multiple solid tumor and hematologic malignancy indications.

Grace Furman: As President & CEO of Paracelsus, Inc., Grace has been providing professional toxicology services to the pharmaceutical industry since 2007. Grace received her B.S. in toxicology, is a Diplomate of the American Board of Toxicology and received her Ph.D. in toxicology from Northeastern University in Boston, MA.  Grace’s area of expertise relates to regulatory toxicology as applied to development of novel small molecule therapeutics. Grace’s professional provenance includes positions in both Small Pharma and Big Pharma environments. Grace led the group which provided the functional interface between the La Jolla Drug Safety and Worldwide Regulatory Affairs departments.