Jobs
View more job listings or post a job
Simcere of America Inc. VP of Boston Innovation Center
Simcere Pharma Group 制剂研发总监或以上 Drug Formulation Director  
Simcere of America Inc. Job Title: Senior Director, Toxicology    
Simcere of America Inc. Associate Director/Director, Regulatory Affairs  
Simcere of America Inc. Director of Business Development
Simcere of America Inc. Job Title: Business Development Intern  
Charles River Laboratories Research Associate
Genomics Institute of the Novartis Research Foundation Senior Investigator (Associate Director) in DMPK
Pliant Therapeutics, Inc. Description: Pliant Therapeutics is an early stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic th
Genentech ASSOCIATE SCIENTIST, DRUG METABOLISM AND PHARMACOKINETICS - BIOANALYSIS (DMPK-BA)
Post a job

Workshop

Small Molecule Formulation Development: Strategies for challenging APIs (jointly with AAPS-BADG)


Speakers: Tom Chiang (Genentech), Vahid Zia (Gilead), Andrew Phimister (Seaview Pharma Solutions), et al.
Organizers: Vibha Puri (Genentech), Edward Yost (Genentech), Lu Lu (WuXi AppTec), Rajiv Nayar (HTD Biosystems Inc.), Shichang Miao (ChemoCentryx)
Date: 9/27/2018
Time: 8:45-17:00
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)Catalent Pharma Solutions; Quotient Sciences
Vendor show vendors registered to date: (9)Absorption Systems; BioDuro; Concept Life Sciences; CoreRx, Inc.; Foster Delivery Science, Inc; Nitto Avecia Pharma Services; Pion Inc.; Q2 Solutions; Zef Scientific
Registration: http://www.PBSS.org
Registration deadline:9/26/2018  (it will close sooner if the seating cap is reached)

About the Topic

The pharmaceutical industry is focusing on more challenging biological targets to address unmet medical needs. These new targets are increasingly more difficult to drug due to their lipophilicity and complex mode of actions. Medicinal chemists are therefore creating new molecular entities that often have low solubility, permeability, or both low solubility and permeability. This requires scientists to challenge the current formulation development paradigm.  Identifying innovative strategies for drug development helps to shift the industry from empirical to more mechanistic approaches. The benefit is the ability to have flexible formulation strategies that can adjust to meet pre-clinical and clinical demands, while also meeting the requirements of a dynamic regulatory environment. This workshop will survey current formulation practices and how they are changing to address challenging APIs.  The evolving science includes knowing new technologies and how to take advantage of them.  Furthermore, discussions will focus on the mechanistic understanding of formulations which help to ensure successful drug products that meet quality-by-design (QbD) regulatory requirements.

This workshop will cover the following topics:

  • Overview of formulation development — pre-clinical to market image formulation
  • Essential DMPK concepts for the formulation scientists
  • New analytical tools and strategies for formulation development
  • Material sparing approaches to reduce cost and time while increasing formulation understanding
  • Particle engineering to address poor API PK properties
  • Regulatory and clinical requirements for a successful drug product

Workhop Agenda

8:00 – 8:45 am   Registration

8:45 – 9:00 am   Introduction

9:00 – 9:50 am   “Practical Application of Biopharmaceutical Tools to Guide Formulation Strategy” - Andrew Phimister – Seaview Pharma Solutions

9:50 – 10:40 am   “An integrated approach to evaluate the solubility target for salts for the oral drug delivery” - Tom Chiang - Genentech

10:40 – 11:00 am   Break

11:00 – 11:10 am   Sponsor presentation

11:10 – 12:00 pm   “Enhancing Biopharmaceutical Properties of Poorly Soluble Compounds: Formulation and Process Development” - Vahid Zia – Gilead

12:00 – 1:20 pm   Lunch

1:20 – 2:10 pm   “Formulation Strategies for High Dose Toxicology Studies” Dennis Leung – Genentech

2:10 – 3:00 pm   “Formulating Challenging API with Liposomal technologies:  Challenges, Limitations, and Opportunities” - Rajiv Nayar – HTD Biosystems

3:00 – 3:15 pm   Break

3:15 – 3:25 am   Sponsor presentation

3:25 – 4:15 pm   “Late-Stage Formulation Development Challenges” - Ravi Mahalingam – ReechPharma

4:15 – 4:45 pm   Panel Discussion

4:45 – 5:00 pm   Closing Remarks


2018-11-16, Hybrid LC-MS for Protein therapeutics and biomarkers: Recent developments in characterization and quantification
2018-12-04, Challenges in Peptide Drug Discovery & Development: Biology, Chemistry, PK, Delivery, Regulatory and Beyond
2019-02-07, Covalent Inhibitor Drug Discovery & Development: Biology, Chemistry, PK, Safety and Case Studies (Jointly with Bay Area PKPD Network)
2019-03-07, Promising therapeutic approaches and transnational medicine from SPARK: an academic-industry collaboration to advance novel therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
©Pharmaceutical & BioScience Society, International; Last Modified: 11/13/2018; Visited: 1314; Admin Logon
Ads (in random order)
Submit a Text Ad
($200 for 2 months)

Nektar Therapeutics Sr. Scientist - Bioanalytical Contributes to the development, validation, and implementation of ligand-binding assays. PhD and 5 years exp.
UC Davis UC Davis Liquid Chromatography/Mass Spectrometry and Confirmation Supervisor Apply Online: http://50.73.55.13/counter.php?id=139228 UC Davis i
Avecia Pharma Services Nitto Avecia Pharma provides GMP contract development and parenteral manufacturing services to the pharma/biotech industries. Visit our Irvine labs!
Pharmaron Our Vision: To become the world-leading small-molecule life science R&D service company, supporting our partners from discovery to commercialization
Protein Characterization Seminar hosted by Charles River Join us in San Diego on September 15, 2017 to discuss the analytical methods used to detect process residuals and determine biosimilarity.
Solid Form Solutions Ltd Solid Form Solutions Ltd CRO providing Solid State Crystallization and Analytical Testing Services to the pharma/biotech industries.
Zef Scientific California’s premier multi-vendor LC-MS/MS engineering firm with highest level of services & rapid onsite response on all major brands & models.
PHARMA INVENTOR Vancouver based Canadian Custom Synthesis Services Company, Offers Inventive & Cost-Effective Chemical Synthesis Services to Life Sciences Industries.
S-Matrix Fusion QbD® Software – Analytical Method Development & Validation, Formulation & Process R&D. Works with ChemStation, Chromeleon, and Empower.
Simulations Plus GastroPlus™ PBPK modeling workshops scheduled around the globe to train scientists on the new guidance documents from the FDA and EMA. Register today!
BIOTECH WEEK BOSTON - Sept. 4-7 Join us at Biotech Week Boston - Where Big Science and Bright Minds Meet. Sept. 4-7, 2018 at Hynes Convention Center.
Hypha Discovery Specialists in provision of drug metabolites at mg-g scale, including CYP/Non-CYP metabolites and conjugates such as glucuronides/sulfates.
Sirius Analytical Services and Automated Instruments for pKa, log P/D, solubility, dissolution. New Scissor instrument for sub-cutaneous injection site simulation.
Charles River 2nd Annual Viral Summit The 2-day summit unites industry experts in an interactive setting to share updates and discuss trends in viral safety and viral clearance.
MicroConstants MicroConstants is a GLP-compliant Contract Research Organization focused on performing regulated bioanalysis, drug metabolism and PK analysis.
Simulations Plus From sketching chemical structures, all the way through regulatory filings, Simulations Plus consulting experts can help. Over 20 years of experience!
Reaction Biology Corporation (RBC) RBC provides kinase & epigenetic assays and proteins for early-stage programs. Contact: kelvin.lam@reactionbiology.com
Pharm-Olam International Pharm-Olam is a midsize CRO offering a wide range of Phase I-IV comprehensive, clinical research services to the pharma, biotech & device industries.
Simulations Plus From the developers of GastroPlus™ comes PKPlus™. NCA & compartmental PK modeling for regulatory submissions. True "PlugNPlay" PK.
Origin Bioanalytical Laboratory A contract research organization for bioanalytical LC-MS/MS analysis specializing in ocular tissues/fluids located Rancho Cordova, CA
Nuventra Pharma Sciences With a background in clinical pharmacology and PK/PD, Nuventra enables our clients to make better strategic decisions.
Simulations Plus ADMET Predictor™ 9 - ADMET property estimation, HTPK Simulation, SAR elucidation, and QSAR model building software.
Clinverse Inc. A global technology company solely focused on automating the financial management of clinical trials.
Pacific BioLabs Offers toxicology,microbiology,analytical and bioanalytical services with a combination of technical expertise & rigorous quality systems.
INTERTEK PHARMACEUTICAL SERVICES Intertek, a bioanalytical CRO (drugs, biologics, proteins, ADCs, biosimilar, generics, peptide, biomarker, immunogenicity, ADA, Nab) in San Diego CA
Submit a Text Ad