This week, we have a conversation with DIA chief science and regulatory officer, Maria Vassileva, and Medicus Pharma CEO, Raza Bokhari.

Times:

02:53 Medicus Pharma

29:13 DIA

DIA

DIA (Drug Information Association) is a global organisation that assists life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow.

Starting with the controversy over the drug Thalidomide, DIA’s founders - a group of 30 pharmaceutical professionals, medical writers, and academics - came together to create a platform for necessary global communication and collaboration to solve a healthcare threat to unborn children worldwide.

Today, professionals from 80 countries engage with DIA through its membership network, educational offerings, and professional development opportunities.

Medicus Pharma

Medicus Pharma Ltd. has submitted an Orphan Drug Designation (ODD) application to the U.S. Food and Drug Administration for SkinJect (D-MNA) for the treatment of basal cell carcinoma (BCC) in patients with Gorlin syndrome, a rare genetic disorder characterised by the development of multiple, recurrent skin cancers. There are no FDA-approved therapies specifically for BCC in Gorlin Syndrome.

The submission represents a strategic expansion of the SkinJect programme into a high unmet need orphan indication, where current treatment options are limited and often involve repeated surgical procedures associated with cumulative morbidity and disfigurement.

Medicus believes SkinJect can address this through a localised, repeatable, non-surgical treatment approach. It is a doxorubicin-containing dissolvable microneedle array designed for direct intradermal delivery into BCC lesions.

SkinJect has been evaluated in phase 1 and 2 clinical studies in patients with basal cell carcinoma.

To get in touch with guest suggestions, or to sponsor or advertise on the podcast, please email jim@deeptechdigest.com

This week, we have a conversation with congenital myotonic dystrophy patient advocacy consultant Lisa Harvey-Duren, who was the founding Myotonic Dystrophy Foundation executive director in 2008, and Michael Snape, CEO and CSO of AMO Pharma, which is developing a treatment for the disease.

AMO Pharma

AMO Pharma is a clinical-stage specialty biopharmaceutical company working to identify and advance promising therapies for the treatment of serious and debilitating diseases in patient populations with significant areas of unmet need, including rare and severe childhood onset neurogenetic disorders with limited or no treatment options.

In addition to developing AMO-02 for congenital myotonic dystrophy, the company is also progressing AMO-02 as a clinical stage treatment for arrhythmogenic right ventricular cardiomyopathy.

AMO-01 is being investigated for treatment of Phelan-McDermid syndrome and AMO-04 as a clinic-ready potential medicine for Rett syndrome and related disorders.

To get in touch with guest suggestions, or to sponsor or advertise on the podcast, please email jim@deeptechdigest.com

This week, our conversations are with Uwe Diegel, CEO of Lifeina, about their cooling technologies, and with Dirk Beher, CEO of FundaMental Pharma, about treatment resistant depression.

Times:

02:37 FundaMental Pharma

23:56 Lifeina

FundaMental

FundaMental Pharma is a preclinical biopharmaceutical company focused on developing new treatments for treatment‑resistant depression (TRD).

The company’s platform centres on proprietary dual‑acting modulators of the N‑methyl‑D‑aspartate receptor (NMDAR). These molecules simultaneously disrupt the pathological complex formed between NMDAR and the TRPM4 ion channel, while also acting as potent NMDAR antagonists. This dual mechanism is designed to intervene upstream in the neurobiological processes associated with excitotoxicity and impaired neuronal signalling, offering a differentiated strategy compared with existing antidepressant classes.

FMP374 is the company’s lead candidate and has demonstrated strong antidepressant‑like effects at low nanomolar concentrations in preclinical proof‑of‑concept studies. Importantly, these studies have not shown dissociation‑related behaviours, ataxia or hyperactivity at efficacious doses, supporting the potential for an at‑home therapeutic profile. The molecule is orally bioavailable and is progressing toward IND‑enabling studies.

The company’s goal is to deliver new therapeutic options for patients with severe unmet medical needs, where current treatments often fail to provide adequate relief.

Lifeina

Lifeina is a French health‑tech company focused on portable, connected medical‑device solutions for people who rely on temperature‑sensitive medications. Its flagship product, LifeinaBox, is a compact, battery‑powered mini‑fridge designed to keep biologics such as insulin, growth hormones and certain injectable therapies within a safe temperature range during travel or daily use.

The device pairs with a mobile app that monitors temperature, battery status and usage patterns, providing alerts if the medication is at risk.

The company positions its technology as a way to give patients greater independence and mobility. Lifeina works with patient groups, clinicians and pharmaceutical partners to refine its devices and expand compatibility with a wider range of biologic medicines.

To get in touch with guest suggestions, or to sponsor or advertise on the podcast, please email jim@deeptechdigest.com