25 April 2024

Workshop: Expediting Your Biopharmaceutical to IND

Babraham Hall, Cambridge CB22 3AT

Expediting Your Biopharmaceutical to IND Workshop

Join Abzena & OncoDesign Services for a half-day workshop on Thursday, 25th April in Cambridge, UK focused on strategies for streamlining large molecule drug programs to IND and beyond.

Hear from industry experts from NGT Biopharma Consultants, Trio Pharmaceuticals, OncoDesign Services and Abzena, as they share insights and real-world case studies that cover regulatory, design and developability considerations that drug developers should take into account when bridging a molecule from discovery to the clinic.

Lunch, poster presentations and a networking reception will be included, along with an optional facility tour of Abzena’s Cambridge facility.  The workshop will be held in The Petersfield Lecture Theatre in the Cambridge Building on the Babraham Research Campus. *Registration deadline for our event is Tuesday, April 23rd.

What You’ll Learn:

-Gain insights on preclinical processes for of new therapeutic compounds

-Technical expectations & regulatory process for a successful CTA/IND application.

-De-risking is a continual process that starts long before you’ve identified a lead candidate

-Nonclinical science (g., toxicology & pharmacology) requirements for transitioning from candidate selection into preclinical development and ultimately first in human (FIH) studies.

-How an integrated early development strategy can reduce development times, cost and risk

-Global regulatory and quality expectations.

-How to leverage the ecosystem to enable successful drug development

Agenda for Thursday, 25th April

  • 12:00 to 13:30 pm – Lunch & Optional Facility Tour of Abzena’s site
  • 13:30 pm  to 13:45 pm – Opening Address by Dr Campbell Bunce, CSO at Abzena
  • 13:45 pm to 14:15 pm – “Navigating the Regulatory Landscape to Large Molecule CTA/IND Applications” by NGT Biopharma Consultants
  • 14: 15 pm to 14:45 pm – “Integrated Approach for Streamlining Development” with Drive Bio
  • 15:00 pm to 15:30 pm – “Perspective on evaluating different therapeutic strategies to demonstrate proof of concept with preclinical in vitro and in vivo studies” with OncoDesign Services
  • 15:30 pm to 16:00 pm – “Principles and Practice of derisking lead drug candidate discovery, design and selection” with Abzena
  • 16:00 pm to 16:45 pm – “Antibody Program Case Study” with Trio Pharmaceuticals
  • 16:45 pm- 18:00 pm – Networking Reception with Scientific Posters, Beverages & Canapes*Registration deadline for our event is Tuesday, April 23rd.

Register Using Our Form Below:


Our Speakers:

Dr Campbell Bunce, CSO at Abzena

Campbell Bunce as CSO and Cambridge Site Head leads a talented team of scientists across a diverse range of expertise and capabilities to support drug discovery, design, and developability; and cell line development. He ensures that Abzena’s strong innovation focus and depth of scientific expertise is maintained through technological developments and works in partnership with clients to design and deliver solutions that support their program needs. Campbell has over 25 years of experience working in the biotech and diagnostics sectors. Before joining Abzena in 2015, he held multiple positions of increasing responsibility in Biotech including Head of Cellular Immunology at Cantab Pharmaceuticals, Director of Programs at Piramed Pharma, and R&D Director at Immune Targeting systems. Throughout his career he has applied innovative solutions for the design, manufacture and clinical evaluation of novel products including vaccines, biologics, and small molecules in multiple therapeutic areas. These include inflammation, cancer, infectious disease, and addiction. Campbell has a Ph.D. in Immunology from the University of Manchester, UK, an Executive MBA from Judge Business School, Cambridge University, UK and has published a number of papers on cell-mediated immunity, immunotherapy and vaccines.

Dr Nicolas Legrand, Dir. of Translational Pharmacology at OncoDesign Services

Nicolas Legrand is the head of the translational pharmacology department  (Paris area site) where he currently leads a team of over 40 project leads and technical staff.  His department provides expertise in combining In Vitro and In Vivo capabilities in a variety of therapeutic areas for Biochemical & cellular assays, Acute and chronic inflammation (skin, lung, gut, liver, kidney, systemic, autoimmune), Infectious diseases (including COVID), Pharmacokinetics, Oncology & immuno-oncology.  His expertise lies in Pre-clinical R&D project design and management (internal and outsourced) for academic and industrial partners, scientific consulting and support for project reviewing, Model & service portfolio development and management, Translational immunology (rodents, humanized animal models, non-human primates), Scientific expertise in mouse and human immunology, immuno-oncology, hematopoiesis, gene therapy, infectious diseases (HIV, SARS-CoV-2), Certifications: animal experimentation / radio-protection. He has his PhD in Immunology from the Pierre and Marie Curie University.

Graham Cook, B. Pharm., Ph.D., Consultant from NGT Biopharma 

Graham is a pharmaceutical consultant with over 37 years experience in pharmaceutical CMC development, quality, regulatory and external advocacy. Most recently he led Pfizer’s Quality Intelligence and Compliance Information team supporting Pfizer Global Supply. He was the chair of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing and Quality Expert Group (MQEG) from 2016-2021 and was the EFPIA Topic Lead for ICH Q12 Product Lifecycle Management guideline. He was appointed to the British Pharmacopoeia Commission between 2010 and 2021 and currently chairs the MC2 Expert Advisory Group and AQbD Working Party. Between 2012-2018 he was Chairman of the ASTM International E55 Technical Committee developing pharmaceutical manufacturing standards. He was a past chair of Pfizer’s QbD Council and previous roles include Technical Director supporting Wyeth Europa Manufacturing and External Supply, and Director Formulation Development for Wyeth Consumer Healthcare (Richmond, VA, USA), with over 40 product launches, 4 NDAs, and 2 patent applications. Graham is a pharmacist with a Ph.D. in pharmaceutics.

Shiva Bhowmik,  Founder & COO from Trio Pharmaceuticals

Shiva Bhowmik is the founder and COO of Trio Pharmaceuticals, a biotech company focused on making antibody drugs with dual action to enhance tumor immunity.

Trio Pharmaceuticals, Inc. (TRIO) is a privately held cancer therapeutics company incubating at QB3, University of California San Francisco. TRIO is developing first-in-class dual action antibody drug conjugates, TRIObody Drug Conjugate (TDC), and dual action antibody drugs, TRIObody, that stops both tumor growth and immunosuppression with and without payload delivery, respectively. TRIObody™ and TDC can synergize with current cancer drugs to improve efficacy.

About our sponsors:

Oncodesign Services is a Contract research organization (CRO) specializing in drug discovery and preclinical services.
From target identification to IND filing, the company contributes to the development of innovative therapies in oncology, inflammation and infectious diseases, with high medical needs. Through integrated capabilities in medicinal chemistry, DMPK, pharmaco-imaging, bioanalysis, in vivo/in vitro pharmacology, Oncodesign Services support the R&D programs of customers with a global footprint. Based in Dijon, France, in the heart of the university and hospital cluster and within the Paris-Saclay cluster, Oncodesign Services has 230 employees in France, Canada and the United States. Learn more at  www.oncodesign-services.com

 


Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK.