The Road to the Clinic for Small Molecule

May 10 2017https://www.eventbrite.co.uk/e/the-road-to-the-clinic-for-small-molecule-registr...

Johnson & Johnson Innovation, JLABS, and Janssen Discovery Sciences invite you to an in-depth look into the process of filing a CTA.

Whether your goal is to develop a pipeline through commercial launch or partner as early as possible, submitting a CTA is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a clear blueprint for CTA approval, and we want you to be ready.

Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful small molecule CTA submission. The presentations will highlight the following:

  • Janssen Research & Development - a brief overview
  • Preclinical Development strategies for pharmacokinetics, drug metabolism and toxicology
  • Key CMC strategies to balance cost, time and quality risks
  • Designing First-in-Human trials to highlight the qualities of your molecule
  • Regulatory strategy, CTA requirements, and Pre-CTA meetings



Event Partners:
         


    


Agenda:

13:00 | Registration Opens, Networking, Lunch and Coffee
13:30 | Welcome and Introduction
14:00 | Preclinical Development Strategies
  - Designing drugable molecules with appropriate potency, selectivity, efficacy, solubility, kinetics and metabolism
- The importance of estimated low Dose to Man and high bioavailability
- Mitigate in vivo toxicology by in vitro toxicology screening
- Preclinical toxicology incl CV tox and mutagenicity evaluations before and during GLP toxicology
- Considerations for typical First-in-Human (FIH) Program
- Validation and translational aspects for positive human PoC (cellular - in vivo PKPD/Disease models)
- Predictive biomarker strategy and validation
- Budgetary aspects for this phase
14:45 | Chemistry, Manufacturing and Controls Strategies
  - Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
- The challenge of chiral APIs
- Drug product formulations for FIH
- Budgetary aspects for this phase
15:30 | Break and Coffee
15:45 | Clinical Pharmacology
  - Designing FIH trials
- Understanding PK/PD
- Biomarkers of safety and efficacy
- Budgetary aspects for this phase
16:30 | Regulatory Overview
  - Data requirements: CMC, safety, clinical plan
- eCTD
- Pre-CTA meetings and regulatory authority (EMA,FDA, MPA) support
- Regulatory Strategy
- Budgetary aspects for this phase
17:15 | Reception
18:30 | Programme Close




Speakers
Klaus Suwelack | New Venture Lead Germany, Janssen Germany/Johnson & Johnson Innovation read bio»
Ann Lampo | Head Preclinical Project Development EU, Janssen R&D read bio»
Sigrid Stokbroekx | Scientific Director, Janssen R&D read bio»
Erik Mannaert | Senior Scientific Director, Janssen R&D read bio»
Birge Berns | Senior Director, Global Regulatory Affairs Immunology, Janssen R&D read bio»


Fees:
FREE | Technologiepark Heidelberg Affiliate
‎€30 | General Public
‎€15 | Other Student/Academic
€40 | Onsite


Location:
Marsilius Arkaden
Im Neuenheimer Feld 130
69120 Heidelberg
Germany


Speakers' Biographies:

Klaus Suwelack, Ph.D. | New Venture Lead Germany, Janssen Germany/Johnson & Johnson Innovation
Klaus Suwelack is New Venture Lead Germany and in New Business Development and Innovation Management at Janssen Germany (a Johnson & Johnson Company) responsible for search and development of innovative Health Outcome Solutions, new Business Models, e-Health, m-Health and partnering with Startup- companies in the field of Biotech and Digital Health. He is working closely together with the Johnson & Johnson Innovation Center in London ( jnjinnovation.com). Klaus has a Ph. D. in Pharmacology from University of Bonn and a Certificate of Business Excellence from Columbia University
Connect with Klaus: Connect on LinkedIn



Ann Lampo | Head Preclinical Project Development EU, Janssen R&D
Ann Lampo, DVM, EU Head of Preclinical Project Development and Single Point of Contact Infectious Diseases & Vaccines, Neuroscience and Global Public Health, obtained the degree of Doctor in Veterinary Medicine at the University of Ghent Belgium in 1987. She was certified in European Regulatory Affairs at the Institute for Pharmaceutical Business Administration in the Netherlands (1996) and is a Eurotox Registered Toxicologist since 1998. Ann joined Janssen in 1988 as a Scientific writer and has taken several leadership roles since that time. In 2000, she was appointed Director in Toxicology and became more broadly involved in Preclinical Development (PCD) projects, which led to the approval of REMINYL and the submission of the registration file of Risperdal ConstaTM. From 2001 to 2007, she headed up a group of scientific experts responsible for Genetic and In Vitro Toxicology, GLP safety pharmacology and General Toxicology in In the Drug Evaluation organization. As a member of several early development teams, she was responsible for the toxicological contribution of more than 50 First-in Human packages. In 2007, Ann became the Pre-Clinical Single Point of Contact for the Research & Early Development (RED) EU unit. Since 2010, she is the Therapeutic Area Point of Contact for Neuroscience, Oncology (until 2013), Infectious Diseases including Vaccines, and, since 2013, Global Public Health. In this function, she heads up the Preclinical Project Leaders group based in Beerse. This team also provides Preclinical Submission support for projects from NS, IDV and GPH. Within PD&S, she is also the Single Point of Contact for the London Innovation Center.
Connect with Ann: Connect on LinkedIn



Sigrid Stokbroekx | Scientific Director, Janssen R&D
Sigrid Stokbroekx is currently heading up Pharmaceutical Sciences, in addition she is Small Molecule preNME Single Point of Contact for all Therapeutic Areas. She graduated as Master in Chemistry from the University of Leuven, Belgium. She joined Janssen R&D in 1988 as Scientist in Physico-chemical characterization of Active Pharmaceutical Ingredients. In 2000 she joined Pharmaceutical Sciences where she established a strong Preformulation and Characterization team, responsible for the pharmaceutical assessment of potential drug candidates, preformulation activities, physical form selection of the drug substance, defining the formulation trajectory, and understanding both drug substance and drug product behavior. In that role she enabled with her team the discovery Therapeutic Areas (TA) to progress their programs. A number of new innovative technologies were assessed and implemented that are key in the selection and understanding of the solid state properties of APIs and complex formulation platforms. Sigrid also co-developed and implemented the Pharmaceutical Sciences Automated Research Lab, contributed to national and international scientific congresses and patents for Janssen. She represented Pharmaceutical Sciences on various pre-NME, early development and late development programs. She also took on an assignment of early CMC leader. In 2011 she became Drug Product Technical Integrator (DP-TI), where she lead the development of oral, injectable and inhalation formulations for various projects, mainly early development. In 2014 she became the head of the DP-TI team. In 2015 she returned to Pharmaceutical Sciences to lead the department which is responsible for developability assessments, preformulation and PBPK modelling, form selection and physical understanding of API's and formulations, material sciences and particle and powder characterization at all stages of development.



Erik Mannaert | Senior Scientific Director, Janssen R&D
Erik Mannaert graduated from the K.U.Leuven, Belgium, as a Pharm D and obtained a PhD in Pharmaceutical Sciences at the same university, after a residency in the Department of Toxicology. He joined Janssen R&D in 1996, and held positions of increasing responsibility in the area of clinical pharmacology. Most of his experience is as a Clinical Pharmacology Leader overseeing the clinical pharmacology development aspects of compounds in internal medicine, CNS and oncology, both in early and late stages of clinical development. His most recent assignment is as Biopharmaceutics Leader, Global Clinical Pharmacology, at Janssen R&D. In addition, he is an invited professor at the University of Antwerp, Belgium.
Connect with Erik: Connect on LinkedIn



Birge Berns, M.D., MRCP, FFPM | Senior Director, Global Regulatory Affairs Immunology, Janssen R&D
Dr Berns is a physician with > 20 years experience in early and late stage drug development including strategic, regulatory and operational aspects, therapeutic area focus on rheumatology, oncology and anti-infectives within Janssen/Centocor, Eisai and Aventis. Currently, she is leading multiple global regulatory biologic teams within the Janssen Immunology group, integrating inputs from regional and functional Regulatory Team members to create a coherent and unified global regulatory strategy across our Immunology portfolio. In her role, she is responsible for negotiations with Health Authorities around the world. She received her medical qualification from the University of Erlangen Nuernberg, Germany where she also received her MD in Forensic Immunology. She gained her clinical experience in the UK NHS. She obtained her MRCP(UK) and Fellowship of the Faculty of Pharmaceutical Medicine in the UK.
Connect with Birge: Connect on LinkedIn


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