Larry Norder | VP Manufacturing, Tryp Therapeutics

Larry Norder has over 30 years of experience in the pharmaceutical and biotech industry. He has led chemistry aspects of early stage R&D, preclinical and clinical development programs for such products as naproxen, mycophenylate mofetil, gancyclovir, ketorolac tromethamine, nafarelin acetate, palonosetron, and topical corticosteroids. He has also been responsible for top line revenues for contract research and manufacturing, cheminformatic and bioinformatic software and associated services. Most recently, Larry has turned to the application of these set of skills to innovation and manufacturing in the nutraceuticals and natural supplements world. He has developed novel technologies to increase transdermal delivery of BCS Class II molecules, oral formulations to increase bioavailability and inhalation formulations for increased safety and efficacy. He has also developed novel methods of extraction, isolation and characterization of desirable phytochemicals.

Larry earned his BS in chemistry from the University of Illinois, a certificate in Network Software Technology Management from University of California, Santa Cruz. Larry is a member of the American Chemical Society (ACS), the American Association of Pharmaceutical Scientists (AAPS) and the International Society of Pharmaceutical Engineers (IPSE).
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You have three decades of experience in pharmaceuticals and biotech. What first attracted you to the world of psychedelics?

I have worked in both drug discovery and development and I have developed a healthy respect for the ability of Nature to provide novel compounds that can be developed into effective treatments.  By looking at what is being used in traditional, non-Western medicine and the ethnobotany of indegenous peoples, one can find many starting points for drug discovery and development.  From this experience, it was a very short path to an interest in psychedelics.

What made you feel compelled to actually want to pursue novel drug discovery around psychedelic derived medicines?

I see this as a unique opportunity, almost a perfect storm of breakthrough therapeutic potential, a dramatically shortened path to approval and a change in societal perception of the value of these molecules.

From your perspective, how do you see the potential of therapeutics with psychedelics?

I see high potential as a therapeutic and more importantly as a tool to understand and treat the role of the CNS (central nervous system) and consciousness in neuropsychiatric diseases.  Great progress is made in therapy when a molecular understanding of the disease is made. 

Can you share a bit about what TRYP is working on with psilocybin?

Our strategy with chemical synthesis and manufacturing of drug substances & drug products is to follow a virtual pharma model where we engage best in class contract development and manufacturing organizations (CDMO) to conduct R&D, process scale up and manufacturing.  During these engagements, any intellectual property created is captured and becomes part of the TRYP IP estate.  By using a CDMO which operates under cGMP, we will meet the requirements set forth by FDA under 21CFR part 211 for development and manufacture of clinical supplies for our clinical trials.  Additionally our CDMO holds licenses from DEA so that we can legally have schedule 1 controlled drug produced.

You have developed novel technologies to increase transdermal delivery and also developed oral formulations that increase bioavailability. Can you share why that is important and how it can help patients?

The general theory of how drugs work to effect changes in disease states is that a drug interacts with a biochemical system in the body and thereby causes a change in that system which affects a change in the disease state.  Looking deeper at this concept, there are two parts, first being does the drug get to the location of the biochemical machinery in the body and secondly, once there does it interact with the machinery and affect the desired change.  The first part is where bioavailability is important.  

What do you see as some of the major challenges in developing a novel psychedelic derived medicine and how has TRYP planned to overcome them?

There are two categories of challenges with psychedelics, first being the category of challenges any new drug faces.  These are well known and the pharmaceutical industry has a set playbook of strategies to address these challenges.  At TRYP, our team has deep expertise and experience in discovery and development.  The second category is a societal one.  Psychedelics fell out of favor during the war on drugs and virtually all research stopped in their uses as therapeutics despite their being promising results in the treatment of alcohol addiction and the body of ethnobotanical evidence of their uses by indegenous peoples.  Society has decided that psychedelics are worthy again for investigation as therapeutics and we at TRYP are bringing the right resources to the right place at the right time with the right people to be successful.

Can you share what you are most excited about when you think about the work you are doing at Tryp?

I am most excited by our path to a potential treatment.  Psilocybin has a depth of clinical evidence for its safety in humans and we expect to leverage that information to expedite our clinical development to Phase 2 instead of at Phase 1.  This will significantly reduce our time & expense to develop the necessary data for a new drug application (NDA).  

What has been something you have learned about the science of psychedelics since getting involved in TRYP Therapeutics? Are there any misconceptions you had that were challenged or changed in any way?

I was pleasantly surprised to learn about the low addiction potential of psychedelics and the amount of research that was done in the 50’s and early 60’s.  I also am quite pleased to see the potential for clinical utility and as a tool for understanding the CNS role in some diseases.  

When you think about the future of healthcare, how big of a role do you see psychedelics playing in the lives of patients? 

I see a potentially large role in the future of healthcare. Not only in the better known neuropsychiatric indications, but in central nervous system (CNS) diseases without effective first line treatments.  Lastly I think psychedelics can be a very specific tool for the understanding of consciousness and how it arises from the biochemical working  of the brain, this will inevitably lead to additional indications and disease areas as the current rate of R & D continues to gain interest in the pharmaceutical community.

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