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Workshop

[In-Person] Preclinical Development & IND Filing for Small Molecules: Nuts, Bolts and Best Practices


Speakers: Christine Wu, Arcus Bioscience; Werner Rubas, Sutro Biopharma; Anne Bonneville, Terns Pharmaceuticals; Jim Zhang, Olema Oncology; Peter Staehr, Consultant; William Schmidt, Ensysce; Tessie Alapatt, FDA
Organizers: Snow Ge, BridgeBio Pharma; Shichang Miao, Amgen
Date: 2023-04-24
Time: 8:45-17:30 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $125; Major Sponsorship: $3000 (sold out); Vendor Show: $675, On-site Registration:$500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (2)Bioivt; Veloxity Labs
Vendor show vendors registered to date: (20)Actylis; Altasciences; Alturas Analytics; BioAgilytix; BioTether Sciences; Curia; Dow Development Labs; Emery Pharma; Frontage Laboratories; IRBM; KCAS Bioanalytical & Biomarker Services; Meadowhawk Biolabs; Medicilon; PharmaBlock; Pharmaron; QPS, LLC; Quotient Sciences; ReechPharma; SOLVO/CRL; Worldwide Clinical Trials
Registration: http://www.PBSS.org
Registration deadline:2023-04-23  (it will close sooner if the seating cap is reached)

About the Topic

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. In this workshop, our speakers highly experienced with IND filings will discuss systemically the preclinical studies required for small molecule IND filings and the nuts, bolts, and best practices for putting together a high-quality IND package, as well as how to interact with various regulatory agencies.
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

Time

Topic

Presenter

8:45-9:00am

PBSS Welcome and Introduction 

Shichang Miao, PhD, Amgen; Snow Ge, PhD, BridgeBio Pharma

9:00-9:40am

1. IND Filing and Interaction With FDA 

Christine Wu, MS, RAC, Vice President and Head of Global Regulatory Affairs, Arcus Bioscience

9:40-10:45am

2. NonClinical Pharmacology & Pharmacokinetics

Werner Rubas, PhD, Vice President, Preclinical Development at SUTRO Biopharma, Inc.

10:45-10:55am  

Major Sponsor’s Presentation

BioIVT

10:55-11:10am

Break Period & Vendor Show

-

11:10am-12:10pm

3. Nonclinical Drug Safety

Anne Bonneville, PhD, Executive Director of Toxicology and DMPK at Terns Pharmaceuticals

12:10-1:00pm

Lunch

Sponsor (Celerion)

1:00-1:45pm

3. Nonclinical Drug Safety (cont’d)

Anne Bonneville, PhD, Executive Director of Toxicology and DMPK at Terns Pharmaceuticals

1:45-2:45pm       

4. Chemistry, Manufacturing, and Controls

Jim Zhang, PhD, VP of Chemistry, Manufacturing, and Controls, Olema Oncology

2:45-2:55pm

Major Sponsor’s Presentation

Veloxity Labs

2:55-3:10pm  

Break

-

3:15-4:15pm

5. Clinical Development

Peter Staehr, MD, Chief Medical Officer, Consultant

4:15-4:55pm

6. Preclinical Drug Development from a Regulatory Perspective (FDA)

Tessie Alapatt, PhD, Senior Pharmacology/Toxicology Reviewer in the Division of Anti-Infectives, Office of Infectious Diseases/OND/CDER, FDA

4:55-5:30pm

Panel Discussion

All Speakers

5:3-6:30 pm

Happy Hour

Sponsor (TBD)

 


About the Speakers

Christine Wu, MS, RAC, is the Vice President and Head of Global Regulatory Affairs at Arcus Bioscience, responsible for regulatory strategy and interactions with global regulatory agencies. Prior to Arcus, Ms. Wu was Vice President and Head of Regulatory Affairs at Nutcracker Therapeutics leading the development regulatory strategies to bring novel mRNA products into clinic. Before joining Nutcracker, Ms. Wu has held multiple Global Regulatory Affairs Lead roles with increasing responsibilities for all phases of drug and biologics development at Nektar Therapeutics, Allergan and Baxter Bioscience for over 15 years. During Ms. Wu’s regulatory career, she has successfully conducted various global regulatory meetings, has been responsible for multiple IND, CTA, BLA/NDA, and MAA submissions, and has been a key member of strategy teams. Ms. Wu received her BS degree in Biochemistry from Eastern China University of Science and Technology and her MS degree in Organic Chemistry from Florida Atlantic University.

Dr. Rubas joined SUTRO in September 2021, as Vice President Preclinical Development responsible for the bioanalytical and the nonclinical / clinical PK/ADMET strategy for all ADC and cytokine programs. Prior to joining SUTRO, Dr. Rubas built and oversaw the preclinical PK/ADME department at NEKTAR Therapeutics. During his tenure at NEKTAR he advanced multiple PEGylated Cytokines and small molecules into clinical development. Prior to NEKTAR, Dr. Rubas worked at SYNTEX, GENENTECH, COR Therapeutics, CHEMOCENTRYX, and F. Hoffman La-Roche in DMPK where he authored multiple IND’s. His pioneering work on in vitro transport studies (tissue and CACO-2) afforded him several invitations to speak at international meetings. He actively participates as advisor in the SPARK (Stanford University) and Catalyst (UCSF) Programs. Furthermore, Dr. Rubas is teaching a class on “Pharmacokinetics in Drug Development” as part of the Intensive Seminar on “The Drug Development Process” at UC Berkley extension. He received his pharmacist licensure from the ETH, Zurich and earned his Ph.D. from ETH Zurich, Switzerland.

Dr. Bonneville received her undergraduate Bachelor of Sciences in Avian Sciences (ornithology) at the University of California, Davis, and her Ph.D. in Pharmacology and Toxicology from the University of Arizona.  She did a postdoctoral fellowship at Eli Lilly and became board certified in toxicology (Diplomate of the American Board of Toxicology (DABT)) in 1997.

Dr. Bonneville has a substantial tenure in the pharmaceutical industry on the US west coast after leaving an academic position at Michigan State University.  Dr. Bonneville has shepherded the nonclinical development of many compounds from discovery through early development, IND-enabling toxicology, and clinical proof-of-concept, as well as leading the nonclinical efforts in late stage programs for new drug marketing applications in oncology, sleep disorders, and imaging, in the US and Europe.  She has spearheaded nonclinical drug development for pharmaceutical companies large and small such as Molecular Biosystems, Elan, Neurocrine Biosciences, Johnson and Johnson (Janssen), Impax, Medivation and ChemoCentryx.

Dr. Bonneville is currently Executive Director of Toxicology and DMPK at Terns Pharmaceuticals in Foster City, CA.

Peter Staehr, MD, is a senior executive medical doctor with 20+ years of global clinical development experience and executive management in Pharmaceutical/Biotech as well as Medical Drug-Device combination with EU board certification in Internal Medicine and Cardiology. He completed his postdoc fellowship at Stanford University. Dr. Staehr held demanding leadership roles in early- and late-stage clinical development with increasing responsibilities at small to large-size organizations (J&J, Theravance, CV Therapeutics, Gilead, Abbott Vascular, ChemoCentryx). He led or co-led clinical development programs and registrations for Pharmaceuticals (IND/NDA) as well as for Drug-Device combinations (IDE/PMA) in multiple therapeutic areas. 

Dr. Staehr is currently a consulting CMO for a start-up company. Prior to its acquisition, he was VP of Clinical Development and Translational Medicine at ChemoCentryx Inc., where he was leading several global clinical drug development programs in the orphan disease area, specifically for the treatment of immunology-related, dermatology and renal diseases. Dr Staehr is also the chairman of the San Francisco Bay Area chapter of the Pharmaceutical & BioScience Society (PBSS). 


2023-06-20, [Free Online] Highlights of 2022 FDA Approvals
2023-08-17, [Free Online] The Science and Stories of Promising Biotech Startups
2023-09-08, [In-person] Distribution and Disposition Studies for Biotherapeutics for IND / NDA Filings: Multi-specifics, ADCs, Nucleotides, Peptide conjugates, and Protein Degraders
2023-09-21, [In-Person] Advances in Cancer Therapeutics
2023-10-06, [In-Person] Human PK and Dose Prediction for Small Molecules
2024-01-15, [In-Person] ADME/DMPK Studies for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
┬ęPharmaceutical & BioScience Society, International; Last Modified: 6/3/2023; Admin Logon
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