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[Beerse, BE] The Road to the Clinic for Small Molecule

Johnson & Johnson Innovation, JLABS

Tuesday, 12 June 2018 from 08:30 to 13:00 (CEST)

[Beerse, BE] The Road to the Clinic for Small Molecule

Registration Information

Registration Type Sales End Price * Fee Quantity
General Public 11 Jun 2018 €30.00 €3.17
Other Students/Academic 11 Jun 2018 €15.00 €2.18
Media/Press   more info 2 May 2018 Free €0.00
* Prices include VAT

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Event Details

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:

08:30 | Registration Opens, Networking, Lunch and Coffee
09:00 | Welcome and Introduction
09:15 | 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
10:00 | 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
10:45 | Break and Coffee
11:00 | Clinical Pharmacology
  - Designing FIH trials
- Understanding PK/PD
- Biomarkers of safety and efficacy
- Budgetary aspects for this phase
11:45 | 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
12:30 | Networking Lunch
13:00 | Programme Close




Speakers:
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»
Jens Heile | Director EMEA Regulatory, Janssen read bio»


Fees:
‎€30 | General Public
‎€15 | Other Student/Academic
€40 | Onsite


Location:
JLABS @ BE
Beerse 1
Turnhoutseweg 30
2340 Beerse, BE


Speakers' Biographies:


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



Jens Heile | Director EMEA Regulatory, Janssen 


Do you have questions about [Beerse, BE] The Road to the Clinic for Small Molecule? Contact Johnson & Johnson Innovation, JLABS

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When & Where


JLABS @ BE
Beerse 1
Turnhoutseweg 30
2340 Beerse
Belgium

Tuesday, 12 June 2018 from 08:30 to 13:00 (CEST)


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Organiser

Johnson & Johnson Innovation, JLABS

About Johnson & Johnson Innovation, JLABS
Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and digital health sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to eight locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto and a ninth location, New York City, launching in 2018. For more information please visit jlabs.jnjinnovation.com.

About Johnson & Johnson Innovation
Johnson & Johnson Innovation Limited focuses on accelerating all stages of innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson's global healthcare businesses. Johnson & Johnson Innovation provides scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical device and consumer companies of Johnson & Johnson. Under the Johnson & Johnson Innovation umbrella of businesses, we connect with innovators through our regional Innovation Centers, Johnson & Johnson Innovation | JLABS, Johnson & Johnson Innovation - JLINX, Johnson & Johnson Innovation - JJDC, and and our Business Development teams to create customized deals and novel collaborations that speed development of innovations to solve unmet needs in patients. For more information please visit www.jnjinnovation.com or follow @JNJInnovation.

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[Beerse, BE] The Road to the Clinic for Small Molecule
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