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
|8:00 | Registration Opens, Networking, and Breakfast|
|8:30 | Welcome and Introduction|
|9:00 | 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
|9:30 | 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
|10:00 | Q&A and Break|
|10:30 | Clinical Pharmacology|
|- Designing FIH trials
- Understanding PK/PD
- Biomarkers of safety and efficacy
- Budgetary aspects for this phase
|11:00 | Regulatory Overview|
|- Data requirements: CMC, safety, clinical plan
- Pre-CTA meetings and regulatory authority (EMA,FDA, MPA) support
- Regulatory Strategy
- Budgetary aspects for this phase
|11:30 | Discussion and Q&A|
|12:00 | Lunch and Networking|
|13:00 | Programme Close|
Kristof Van Emelen | Director, Emerging Sciences and Innovation, Janssen Discovery Sciences, Janssen R&D read bio»
Ann Lampo | Head Preclinical Project Development EU, Janssen R&D read bio»
Peter D'hoore | Senior 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»
FREE | UCLPartners affiliate
£25 | General Public
£15 | Other Student/Academic
£30 | Onsite
170 Tottenham Court Rd
London W1T 7HA
Kristof Van Emelen, Ph.D. | Director, Emerging Sciences and Innovation, Janssen Discovery Sciences, Janssen R&D
Kristof Van Emelen obtained his Ph.D. degree in Organic Chemistry and worked from 1997 to 2006 at the Medicinal Chemistry Department of Johnson and Johnson Pharmaceutical R&D in Belgium. In 2004, Kristof was appointed Program Leader and assumed responsibility for the development and implementation of an integrated kinase-platform that served several applications across various therapeutic areas. Between 2007 and 2011, he held the position of Director of Medicinal Chemistry at Tibotec, a daughter company of the J&J Family of Companies, overseeing Medicinal Chemistry activities in the area of Infectious Disease. From April 2011 onwards, he served as Scientific Director Advanced Chemical Sciences, applying chemical expertise in a cross-disciplinary fashion at the interface of Discovery and Development. Since 2013, he is serving as Director Emerging Sciences and Innovation, liaising the Janssen small molecule drug discovery organization with the J&J Innovation Centers. In this role, he is responsible for identifying, forming and enabling productive collaborations with leading external innovators and developing new partnering models.
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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.
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Peter D'hoore | Senior Scientific Director, Janssen R&D
Peter D'hoore has over 25 years of experience in the pharmaceutical industry. In 1987 he graduated as a Pharmacist at the University of Leuven and was certified as an Industrial Pharmacist two years later. Shortly thereafter, he joined the International Quality Department at Janssen Pharmaceutica, Belgium. In 1996 Peter moved to the Operations side of the business where he was responsible for scale-up, process validation and launch readiness of several new products as part of the New Product Introductions group. Three years later,he returned to R&D as CMC leader where he was responsible for the CMC development and launch of several new products such as the long-acting injectable antipsychotics Risperdal® Consta®, Xeplion® and Trevicta®, as well as the oral solid formulations Invega® and Risperdal Quicklet®. He further manages an international group of CMC Leaders and acts as the CMC Single Point of Contact with the Janssen Neuroscience Therapeutic Area and the London Innovation Center.
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.
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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.
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Johnson & Johnson Innovation, JLABS
About Johnson & Johnson Innovation, JLABS
JLABS, part of Johnson & Johnson Innovation, Limited, is a network of life science incubators providing emerging companies many of the advantages of being in a big company, without the capital investment. JLABS offers singular bench tops, modular wet lab units and office space on a short-term basis, allowing companies to pay only for the space they need, with an option to quickly expand when they have the resources to do so. Companies residing at JLABS also have access to core research labs hosting specialized capital equipment and shared administrative areas. JLABS is an open innovation model, and the agreement for space does not grant JLABS or Johnson & Johnson Innovation any stake or rights in the companies, nor will the companies have a guaranteed future affiliation with JLABS. The flagship facility is located in San Diego at Janssen's West Coast Research Center, and JLABS has now two established locations in San Francisco - one through a collaboration with the California Institute for Quantitative Biosciences (QB3) and a second standalone facility - one in Boston through a collaboration with Lab Central, one in Houston through a collaboration with TMC, and one in Toronto through a collaboration with MaRS. 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, JLABS, Johnson & Johnson Innovation - JJDC, Inc. 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.