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If you could ask your antibody therapeutics regulatory authority one question, what would it be?

Posted by on 20 March 2019
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We recently (Aug 2018) surveyed 174 antibody engineering and therapeutic professionals from pharma and biotech, academia, service providers, CDMOs and CROs on the current state of the antibodies industry. Experts from North America (51%), Europe (36%) and Asia (11%) offered there insights on a range of important topics and here we dive into the responses around regulations, revealing what they really think of the regulatory agencies governing the industry.

Download the full State of the Antibody Therapeutics Industry Report here

Regulatory authority impact

We asked survey respondents about the impact that regulatory agencies have had on their company’s success in the antibody therapeutics field and results were generally positive. Overall, 47% said that agencies had a Moderately or Major Positive impact, whilst just 8% said there had been a Moderately or Major Negative impact.

With different regulatory agencies obviously present in different parts of the world, comparing answers across locations offered some interesting results. As the chart below shows, European respondents are happier with regulatory authorities, with 54% saying they had a positive impact on their company, versus just 38% of North American respondents. Indeed, when numerical values are given to the responses - where 1= Major Negative and 5 = Major Positive impact - European agencies come out on top with a score of 3.74/5, with North American (3.42) and Asian (3.32) trailing behind.

Antibody Regulatory Impact

Results also showed some interesting variance when splitting respondents by the organization they represent. Respondents from CROs, CDMOs and service providers were overwhelmingly positive towards regulatory authorities, with 69% saying they had a Moderately or Major Positive impact and none at all saying they'd seen a negative effect - giving an average score of 4.23. Conversely, when looking at pharma and biotech respondents, they were far more ambivalent about the impact that regulatory agencies had, with almost half (48%) saying there effect was neutral.

One anonymous question

The single question that generated the most discussion in the whole survey was when we asked respondents: 'If you could ask the regulatory authority one question anonymously, what would it be?' The questions covered a whole host of topics as the results show below:

  • Which goes first, efficacy or safety?
  • How do you look at advances in in vitro culture technology as a predictor of in human efficacy, i.e. would you believe in reduction of the need for animal models for both efficacy and safety?
  • How can we better plan for the future of our drugs, making sure we address any potential issues experimentally early on in our process?
  • What are the enzyme source requirements?
  • What are the important check list items during facility qualification and inspection that you don't mention to us?
  • Could you offer streamlined guidelines for individualized vaccines?
  • Is there any effort to make the GMP process less expensive?
  • Do you have case studies for each disease area?
  • Before drug discovery, what issues should we consider and evaluate in advance?
  • How ethical is it to perform immunotherapy outside a patient’s body with antibodies or CAR-T?
  • Why is there a reluctance to develop more modern and faster approval pathways based on supplementary modelling data?
  • Can pathways become more nimble?
  • How can we get more input on the expectations regarding the design and usage of biological assays?
  • Could you provide three scenarios in which you would accept an IND for an antibody therapeutic without in vivo tox data?
  • Can we introduce a Safe Harbour law to enable greater innovation in antibody technology?
  • Methods to analyse and describe mechanism of action by bifunctional antibodies or similar constructs.
  • Why are your software and methods to regulate so outdated?
  • How can I optimise approval of combinations therapies (checkpoint inhibitors + A.N.Other)
  • What are the regulatory trends for ADCs?
  • How to control the lab safety strictly?
  • How can we move from a tumor-by-tumor registration to a mechanism-based approval process?
  • What are the major new challenges for medical diagnosis through antibody products?
  • How much political pressure is there on accelerated approvals to remain on market despite mediocre post-approval trials?
  • Could more experts be assigned to review the applications?
  • How can we design clinical trials more effectively?
  • Transition in manufacturing of critical raw material to API manufacturing.
  • Why is the process so slow?
  • How long it will take for IND SUBMISSION FOR ADC?
  • What area of clinical development is most important to a successful BLA filing on a protein analog?
  • How does composition of the drug/therapeutic impact FDA approval?
  • Can you guide in more detail how to gain approval for new products including innovative products?
  • What tests are necessary to show equivalence between a product in solution vs a dry formulated?
  • What is the best way to guarantee breakthrough designation for a drug?
  • What are the most critical profiles of therapeutic antibodies for FDA approval?
  • As protein engineering advances and antibody therapeutics become less germline-like, what factors will you take into consideration when deciding whether or not to approve?
  • How can you make it easier to get a drug into clinical trial?
  • What is the future of animal testing?
  • Is there any non-conventional point that you would like to see to facilitate the regulatory process, apart from the conventional known path?
  • Why does the new drug review process take so long? What are the approaches (procedures) that are currently considered to speed up overall review process?
  • What’s the hold up on new technologies? Is there a trade-off between too fast to adopt and too slow to adapt?
  • Is it acceptable to include polysorbate 80 in the formulation of a lyophilized therapeutic?
  • Which areas / functions can we expedite further?
  • What is absolutely required in terms of testing candidate therapeutics in animal models of disease?
  • The FDA sees large amounts of positive and negative data, yet very few parties publish negative data. Is there a way the FDA can publish de-identified negative data so others don’t repeat the same studies?
  • How pure is the protein and how well preserved?
  • How deeply do we have to figure out anti-drug antibody issues for biologics in clinical studies?
  • How can we accelerate the IND process?
  • Can you reduce regulations on monoclonal antibodies in the clinic?
  • How do we innovate and align on immunogenicity cut points?
  • Are GMO microbes GMOs?
  • Can we reduce primate use in biotherapeutic development?
  • How can we optimize biosimilars to reduce clinical trials?
  • Could we get advanced notice of planned inspections?
  • What is the future landscape for biosimilar product approval? Are CMC or clinical study requirements likely to change?
  • Can we skip Phase III clinical trials for a biosimilar product if the analytical similarity data is really solid and comprehensive?
  • Why is it so expensive just to get to Phase I?
  • How is Brexit going to impact the relationship?
  • How do we have trials locally?

Overall, the results of the survey show that whilst antibody engineering and therapeutics industry professionals are generally fairly positive towards the regulatory framework, there is inevitably still a broad range of concerns and questions over the guidelines and how the agencies enforce them.

Download the full State of the Antibody Therapeutics Industry Report here

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