*Photo credit from Nucleate Singapore

It’s a wrap for our collaborations with Nucleate Singapore to run their flagship educational series “Nucleate Ignite” aimed to convey an in-depth technical understanding of crucial roles in the biotech world.

The blurb of the 4 sessions as below:

🔰 Session 1 | Introduction to Biotherapeutic Development, by Dr Cheuk Ka Tong from Tikva Allocell Pte Ltd

Dr Tong covered how the FDA regulatory process came to be, and how it has changed with the times to accommodate newer modalities like biologics 💉 in addition to traditional small molecules 💊 She also explained how the process has shaped the profile of medicines approved today following the introduction of expedited review programmes like the fast track designation, breakthrough designation, accelerated approval and priority review 📋.

⚖ Session 2 | Basics for IP Strategy for Biotherapeutic Companies, by Dr Adam Gregory and Mr Richard Clegg from Mewburn Ellis

The patent attorneys walked us through why IP is critical to research (even early stage research) and how it is never too soon for scientists to think about their project direction in the context of patents 📜

Mewburn Ellis has been intimately involved with Singapore’s Biotech Ecosystem since its infancy and has helped many of the best-known, homegrown biotechs strategise, build and manage their patent portfolios. Tapping on their wealth of knowledge, they covered:

1️⃣ Characteristics of an invention that can be patented: industrial utility, novelty, non-obviousness ✅

2️⃣ Strategies to protect the core of an invention (eg. your discovery platform), yet hide the crown jewel (eg. your lead asset arising from your discovery platform) from competition 🛡

3️⃣ The importance of timing: how does one balance thoroughness versus speed in a first-to-file (that supplanted first-to-invent) system? When should one file to maximise patent life and how can one extend it? ⏳

💊 Session 3 | The IND Application and TPP, by Dr Dipti Thakkar and Mr Carlo Polo from Hummingbird Bioscience

Dr Thakkar and Mr Polo of Hummingbird Bioscience shared ways to craft a ideal profile of your brand new therapeutic, and what you need to build a data package to reach that coveted “Investigational New Drug” milestone 🏆

Hummingbird Bioscience is a clinical-stage biotechnology company with a proprietary, multidisciplinary platform that generates novel biologics against biologically validated targets. Tapping on their experience taking their lead asset HMBD-001 (anti-HER3) through the IND stage, they broke down the complex, nuanced process into easily digestible lessons:

1️⃣ You need an essential target profile and an ideal product profile 🎯

 But don’t set your TPP parameters based on your gut, talk to your KOLs 🗣️

2️⃣ What does the Chemistry, Manufacturing and Controls (CMC) process checklist comprise of, and how an intimate understanding of the TPP is necessary for a robust CMC control strategy 🧾

3️⃣ Work alongside regulatory agencies rather than viewing them solely as gatekeepers: they can be your partner from IND to New Drug Application (NDA)/Biologics License Application (BLA) 🏢

📜 Session 4 | The Clinical Development Plan and Considerations for Early Stage Clinical Trials, by Dr Veronica Diermayr from Experimental Drug Development Centre (EDDC)

Dr. Diermayr rounded off the series by leading us in a comprehensive discussion on how to design early stage clinical trials to give your therapeutic its best chance of success in patients who need it most 💊.

The Experimental Drug Development Centre is a national platform for drug discovery and development, where Dr. Diermayr, an asset development leader with 15+ years of clinical development experience under her belt, quarterbacked two of EDDC’s homegrown, flagship assets (ETC-159 and EBC-129) into closely watched clinical trials. In this session, she covered:

1️⃣ The distinction between non-parametric algorithm-based (eg. 3+3), Bayesian algorithm-based (eg. up and down, isotonic) and parametric model-based (eg. continual reassessment method, Bayesian optimal interval design) clinical trial designs 📜

2️⃣ The objectives of Phase 0 to 4 clinical trials 💉

3️⃣ A detailed explanation of the types of endpoints involved in trial readouts: direct, composite, surrogate, patient-reported and digital 🎯

Source: Nucleate Singapore