Regulatory Team In The UK Continues To Grow.......

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kmall
Posts: 398
Joined: Thu Mar 21, 2019 3:57 pm

Regulatory Team In The UK Continues To Grow.......

Post by kmall » Tue Nov 15, 2022 12:05 pm

Joyce Reader - Senior Regulatory Consultant, Geron Corporation (contract)

Hired - Nov 2022

10/20/2022 - FOSTER CITY, Calif.- (BUSINESS WIRE)- Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 843,260 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. Joyce Reader is one of these newly hired employees.

Joyce Reader's former employers include: Jazz Pharmaceuticals (UK), GW Pharmaceuticals (UK), Gilead (UK), Biogen (UK), Pfizer (UK), Abbott Laboratories (UK), GlaxoSmithKline (UK), Sanofi-Aventis (UK), UCB (UK), Reader Regulatory LTD (UK), Regulatory Live (UK).......

*Detect a pattern here (UK) ?????

Joyce Reader is a "CMC Regulatory Expert" (her words):

"Joyce Reader has over 30 years’ CMC regulatory affairs experience in several leading global pharmaceutical companies working on a wide range of dosage forms for clinical trial, MAA/NDA and post approval aspects for regulatory submissions. expert knowledge of the requirements of all global regions."

1 - "Regulatory Manager (CMC Biologics)
UCB
Jan 2018 - Jun 2019 1 yr 6 mos
Slough, United Kingdom
Strategic support for Phase 3 Clinical Trial CMC submission preparation (EU, Canada, US and ROW countries), including Response to Questions and Phase 3 post approval changes. CMC documentation preparation for MAA/BLA submissions and response to questions."


2 - "Interim Manager, Regulatory Affairs, CMC
Gilead Sciences
Aug 2015 - Sep 2017 2 yrs 2 mos
Cambridge, United Kingdom
Provision of regulatory submission support for registrations to the Commercial & Access Emerging Markets Team.

Provision of continued interim management support for new registrations and support on-going post-approval maintenance activities in Emerging Markets.

Support preparation of new ROW modules for new products as required and to support new CTA filings in ROW markets."


3 - "Regulatory Affairs Manager - Emerging Markets
Biogen Idec
May 2014 - Aug 2015 1 yr 4 mos
Maidenhead (UK) Office
Interim Associate Director - A member of the Global Emerging Markets Leadership Team specifically managing MENA markets including South Africa.

Product Lead for Interferon franchise of products; providing strategy and management for new regulatory submissions and life cycle management.

Team management in support of Biogen portfolio of products in the region, including CMC, artwork/labelling and safety/indication updates.

Cross functional management; working with local distributor, commercial, artwork division, to align business decision and strategy for the region.

Member of MERN working in partnership EFPIA and Regulatory in the Middle East to develop legislation and regulatory best practices."

4 - "AfME Conformance Lead
Pfizer
Apr 2011 - Apr 2014 3 yrs 1 mo
Maidenhead and Walton Oaks (UK) Offices
• Responsible for managing a team of regulatory professionals (5 UK and 4 Dubai
based) in support of lifecycle submissions for all Pfizer products specifically for
Africa and Middle East (AfME) markets and EU emerging markets (+ 85 countries)
• Lead the provision of submission strategy and project management for all CMC
changes originating at plant or Pfizer country offices (PCOs - affiliates) to maximize
efficiencies, quality and rate of submission approvals at BoH
• Provide regional/local management of lifecycle submissions in markets under
responsibility, including: Market Application amendments, variations, renewals,
response to HA questions
• Ensure CMC change and documentation management electronic database systems are
updated and maintained to align with the regulatory information submitted/approved
externally by a Board of Health or internally by the appropriate functional area
• Maintain regulatory requirements intelligence for AfME region relating to all post
approval changes/renewals
• Creation of training material and delivery for new systems management, roles and
responsibilities to direct reports and PCO (country affiliates)."


**Detect a pattern here.....UK, US, EU, Canada, Middle East, Africa, South Africa, (+85 countries) ???


***WOW !!!! All I can say is, Dr. Scarlett and Sharon McBain ain't messing around.


****Expect a PR concerning UK Regulatory submission at any time now. -Kmall

kmall
Posts: 398
Joined: Thu Mar 21, 2019 3:57 pm

Re: Regulatory Team In The UK Continues To Grow.......

Post by kmall » Tue Nov 15, 2022 12:31 pm

My post on the YMB directing readers to go to Imetelchat for details on the Joyce Reader hire was immediately "flagged" for "approval" and waiting to be "reviewed"........

"Your comment may have been sent for review for one of the following reasons:
All comments on the site require manual approval (so nothing personal)
Certain comments are sent to an internal product performance review (it’s not you, it’s us)
Your comment has been automatically flagged as It may not align with our Community Guidelines (You can revise your comment at any time)
We let registered users know as soon as their comment has been reviewed."

Someone sure doesn't want FACTUAL information being posted over there. Apparently you can promote pump and dump stocks all day long and submit spam messages for Elite Club, but don't dare inform readers on recent hires by Geron on the GERN board without review.......huh???? -Kmall

biopearl123
Posts: 1105
Joined: Fri Jul 20, 2018 5:13 pm

Re: Regulatory Team In The UK Continues To Grow.......

Post by biopearl123 » Tue Nov 15, 2022 3:35 pm

Kmall, another great dig. The UK “separatist” approach to drug approval post Brexit has been intriguing. Re your YMB experience, I don’t think its a “someone” but a something, e.g. bots that flag some defined catch phrase and thus makes posting a challenge sometimes.

kmall
Posts: 398
Joined: Thu Mar 21, 2019 3:57 pm

Re: Regulatory Team In The UK Continues To Grow.......

Post by kmall » Wed Nov 16, 2022 9:26 am

Bp - Joyce Reader appears to be a powerhouse in UK Regulatory submissions. I think her resume speaks for itself. Joyce Reader is one of the recent hires I personally have been looking forward to seeing for the past few months. I've also pointed out a few details with regards to global Regulatory Agencies while she was working with Big Pharma based in the UK. She obviously has the credentials and experience to see Imetelstat through the approval process around the world. From what I've seen, she seems to be as top tier as it gets. Kudos to Dr. Scarlett and Sharon McBain for getting her onboard.

On the other end of the spectrum, the "new" and "improved" YMB is proving to be nothing more than a hypocritical censored platform rife with the same old shenanigans we have grown accustomed to. I tried directing readers to Imetelchat for details on the Joyce Reader hire by Geron on the GERN board and my post was immediately flagged for "review." It was never posted. These are the 3 posts that were "rejected" for violating the YMB terms of conditions and have subsequently sidelined me from posting apparently. Here is the message I now receive for 3 "violations":

"Unfortunately, you are unable to take part in this conversation right now as your comments have been blocked too many times. Learn More...."

It's not quite clear what violations I triggered, but I was directed to a list of rules that ranged from death threats and child endangerment to copyright infringement and everything in-between.......you be the judge:

1 - Nov 6, 2022 - Your comment on Geron Corporation (GON.F) Stock Forum & Discussion - Yahoo Finance violates the community guidelines and has been rejected:

"kmall
Geron planning to add up to an additional 10% employee base by the end of the year (2022). That is quite bullish considering they are still over a year away from commercialization expectations. -Kmall"

This was in response to the Geron company PR which was released prior to the Q3 CC last week. I think "bullish" was the violation here? Kind of ironic since they have a "bullish" button to distinguish poster positions on the stock. Again not certain since my violation from Yahoo was not specified.


2 - Nov 13, 2022 - Your comment on Geron Corporation (GON.F) Stock Forum & Discussion - Yahoo Finance violates the community guidelines and has been rejected:

"kmall
From Imetechat - "Go Big Or Go Home - Pt. 3 (3)" - June 1, 2020 "In conclusion, from the 3 indications mentioned (MDS, MF, AML) here we can now project anywhere from a $5.7 - $15.6 Billion or more annual Global market. I would feel comfortable placing this estimate roughly in the middle at around $8 - $10 Billion. As stated earlier, how much of this can be carved out for Imetelstat is still shrouded in mystery, however, if the enthusiasm reflected in last Thursdays CC is any indication – I would stake my claim that it’s quite a fair share." -Kmall'

This was in response to Martin for pointing out future potential revenue stream projections to another poster on the GERN YMB board. Again, not quite sure what triggered this violation since nothing was specified, but those were not some pie in the sky figures I pulled out of thin air, as we all know many others do on that forum. I did extensive research on global patient population estimates for 3 indications (MDS, MF and AML) and current (2020) BAT costs in those indications for patient care/drug costs associated with, on both ends of the scale - high and low, for a basis on that final analysis/conclusion.


3 - Nov 15, 2022 - Your comment on Geron Corporation (GON.F) Stock Forum & Discussion - Yahoo Finance violates the community guidelines and has been rejected:

"kmall
1 share of JNJ for 2 shares of GERN. -Kmall"

This of course is pure speculation on my end based on researching this company and the newly hired employees (post JNJ collaboration) associated with. Just a hunch/guess on my part, and a reply hidden deep in a thread while responding to another posters inquiry on a future partner/acquisition. If opinions are a violation, then guilty as charged.

*From what I can tell, it seems to be a violation to post factual information, opinions based on actual research, or even opinions for that matter. It appears that the "new and improved' YMB is following the playbook of pre-Elon Musk Twitter......what a sad commentary on our 1st Amendment rights as Americans these days. -Kmall

kmall
Posts: 398
Joined: Thu Mar 21, 2019 3:57 pm

Re: Regulatory Team In The UK Continues To Grow.......

Post by kmall » Sun Nov 20, 2022 12:57 pm

Reviewing the 3/2018 10k filing recently, I stumbled upon this little nugget, which is a peak at the future Regulatory strategy enacted by Geron:

Pg. 44:

"In addition, in June 2016, the electorate of the United Kingdom voted to exit the European Union, and in March 2017 the Government of the United Kingdom initiated the formal procedure of withdrawal from the European Union. While the exit of the United Kingdom from the European Union is to be completed in 2019, the exact timing of the withdrawal and the resulting effect of withdrawal will not be known for some time, which could lead to a period of considerable uncertainty relating to our ability to obtain and maintain Supplementary Protection Certificates (SPCs) of our products based on our United Kingdom patents and our ability to establish and maintain European trademarks in the United Kingdom."

https://fintel.io/doc/sec-gern-geron-10 ... h-16-17947

It's no wonder that Geron hired Sharon McBain to set-up shop in the UK to start developing a Regulatory team and an office there. Dr. Scarlett had quite a bit on his plate at that time, and that decision moving forward may prove to be more insightful than many realize.

There's quite a bit more eye-opening crystal ball moments in that 10k if anyone cares to review. -Kmall

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