In-house promotion....a harbinger of things to come?

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kmall
Posts: 753
Joined: Thu Mar 21, 2019 3:57 pm

In-house promotion....a harbinger of things to come?

Post by kmall » Wed Oct 05, 2022 4:08 am

Nick Lyon - Director Regulatory CMC, Geron Corporation since August 2020 has recently been promoted........

Nick Lyon - Senior Director, Head of CMC Regulatory, Geron Corporation - October 2022

CMC: Chemistry, Manufacturing and Controls (CMC) of a medicinal product is the body of information that defines not only the manufacturing process itself but also the quality control release testing, specifications and stability of the product together with the manufacturing facility and all of its support utilities, including their design, qualification, operation and maintenance. CMC regulatory affairs and compliance is seen as a process of governance which ensures CMC practices are carried out in agreement with regulatory agencies requirements and expectations. Since such requirements and expectations change with time, a function of CMC regulatory compliance is to ensure that all CMC practices are updated accordingly.

https://www.genpact.com/insight/an-intr ... ontrols%20(CMC,all%20of%20its%20support%20utilities%2C

Nick Lyon has over 25yrs of Regulatory experience in Europe, the US and Japan.

Prior to joining Geron, Mr. Lyon has been employed by Pfizer, JNJ, GlaxoSmithKline, DuPont Pharmaceuticals, Ineos Healthcare, Chugai Pharma Europe Ltd amongst others.

Nick Lyon:
(a) Track record of 25+ years experience in EU, US and Japanese regulatory affairs having worked in UK, US and Japan
(b) Hands-on working at big pharma and biotechnology companies with strengths in CMC, clinical, regulatory strategy.
(c) Lead Centralised, MRP/DCP, National and US NDA approvals for products from early phase.
(d) Developed robust registration/risk mitigation strategies plus CTD dossiers for small molecules and biologicals notably monoclonal abs, vaccines, antisera
(e) Written and reviewed variety of CTD modules e.g. Module 1, Module 2 QOS, Clinical Summaries, CSRs, Module 3s for both NCE and biologicals, Module 5.
(f) Produced and managed CTAs, IMPDs (6+) and US INDs for Phase 1-3 trials and managed life-cycles
(g) In depth knowledge of EU directives, CHMP guidelines, CT directive, 21 CFRs, INDs, ICH
(h) Worked in oncology, vaccine, viral, immunology, CNS, CVS, renal areas
(i) Successfully completed EMEA scientific advice procedures, FDA EOPII/SPAs for NDAs and Orphan drugs.
(j) Managed PIPs and US paediatric waiver applications
(k) Expert in e-CTD and 'NeeS'
(l) Written variety of SOPs eg. SAE reporting or IMP release.

*Having Nick Lyon as an integral member of #teamawesome is not only an advantage towards Geron's future success, but a harbinger of things to come...???? -Kmall

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: In-house promotion....a harbinger of things to come?

Post by biopearl123 » Wed Oct 05, 2022 6:35 pm

Greetings Kmall, I hope you and your worthy seacraft escaped the wrath of Ian. I have two questions for you. First is in regard to Nick Lyons’s promotion. Is this just a fancier title associated with a salary boost or does it make room for the addition of an “assistant” to fill his previous position and add to his department. Secondly, with regard to John McDonald JD, MBA. Is Geron his only non Novo Nordisk board position? Sometimes as you know people of his stature serve on several boards at once (including our own esteemed Dr. Scarlett). If however it looks like Geron is a singular focus for Mr. McDonald this might be of importance. Thanks for sharing your thoughts as always. Hope you are well. bp

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: In-house promotion....a harbinger of things to come?

Post by biopearl123 » Wed Oct 05, 2022 6:43 pm

Interestingly, Novo Nordisk does not have much of a footprint (none) in oncology. There are programs in heme disorders (hemophilia and sickle cell disease.). Perhaps they are looking to diversify. If so they will probably be up against some giants with deep pockets.

kmall
Posts: 753
Joined: Thu Mar 21, 2019 3:57 pm

Re: In-house promotion....a harbinger of things to come?

Post by kmall » Thu Oct 06, 2022 1:32 am

Bp - Thanks for the well wishes. Luckily I'm up in the Northeast at the moment, so Ian was merely an inconvenience these past few days. Prayers go out to all of those who suffered the wrath of a storm we haven't seen the likes of in quite a while. It will take some time for things to get back to "normal" for all of those affected.

As for your questions regarding Nick Lyon, all I can offer is pure speculation on my behalf. He was hired by Geron in August 2020 as Director Regulatory CMC and is part of the UK Regulatory team. Reading through his resume highlights you'll notice - "regulatory strategy." Within 14 months (Oct 25, 2021) of his employment with Geron, a PR was issued concerning the Innovation Passport Designation Awarded to Imetelstat for the Treatment of Lower Risk Myelodysplastic Syndromes. This designation as you know is intended to "Expedite the Regulatory Review Process."

https://ir.geron.com/investors/press-re ... fault.aspx

Taking a look at Nick Lyon's experience and his skillset with Regulatory strategy, one would assume that he was a major catalyst for the UK Innovation Passport Designation bestowed upon Imetelstat.

It certainly appears to be a promotion with an upgraded title, however, the CMC in his job title in conjunction with being a Regulatory Specialist, implies to me that manufacturing is well on its way towards the advancement for commercialization. Of course that would be putting the cart before approval, but remember ST Pharma passed FDA PAI at their Banwol, Korea oligonucleotide plant back in August of this year. Also keep in mind that this is first time in Asia the FDA has granted it's Good Manufacturing Practice (cGMP) certification upon such a facility.

http://www.koreabiomed.com/news/article ... dxno=14300

From what I can tell, Nick Lyon's promotion is well deserved and he appears to be the crucial bridge connecting Regulatory and Manufacturing, which has tripped up many Big Pharma and Biotechs in the past as they near the finish line.

Pt. 2 of your question regarding Nick Lyon. There was an additional hire in the UK with a Regulatory position who has yet to be announced. That is most likely the additional position you inquired about, and rest assured, as soon as I can find out who that is, you and your readers will be the first to know.

Finally, doing a quick check on John F McDonald it seems that he was appointed to Nouscom's BOD in 2018.

https://www.prnewswire.com/news-release ... 36339.html

http://www.nouscom.com/team/john-f-mcdonald-jd-mba/

"Nouscom is a next-generation immunotherapy company developing engineered viral vectored vaccines for treatment of cancer. The company has offices in Basel, Switzerland and Rome, Italy."

http://www.nouscom.com/

Mr. McDonald seems to be an enormous asset to Geron's BOD and as you astutely pointed out, Novo Nordisk may be looking to expand their Hematological pipeline. What better way to do it than with the addition of Imetelstat?

Hope this shines a little more light on a thing or two while we wait for MD Anderson and January 2023. -Kmall


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