Executive Medical Director coming directly from Janssen now at Geron....

[kmall]

Shyamala Navada - Executive Medical Director, Geron Corporation

Hired - January 2023

12/22/2022 - FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 867,130 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. Shyamala Navada is one of these newly hired employees.

Dr. Shyamala Navada's former employers include: Janssen, Mount Sinai Icahn School of Medicine, University of Michigan

Shyamala was at the Icahn School of Medicine from 2010 until 2021 before joining Janssen. Remember that P2 IMerge (MDS) and the P2 IMbark (MF) Clinical Trials of Imetelstat under the direction of Janssen, with Clinical Trial site location lead investigator Dr. John Mascarenhas, took place at the Ichan School of Medicine while Dr. Shyamala Navada was also employed there as well. The P3 IMerge (MDS) and P3 IMpact (MF) Clinical Trials - follow up's from P2 IMerge (MDS) and P2 IMbark (MF) are both currently underway at this same location.

https://icahn.mssm.edu/profiles/shyamala-navada

https://clinicaltrials.gov/ct2/show/NCT ... 0#contacts

https://clinicaltrials.gov/ct2/show/NCT ... 4#contacts



*Dr. Shyamala Navada's hiring at Geron now is QUITE SIGNIFICANT......her focus is on clinical and translational research in Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). She is the FIRST Geron employee we know of who was DIRECTLY INVOLVED with the P2 IMerge Clinical Trial (MDS) under Janssen's direction, who then went to work for Janssen almost 3yrs AFTER the Janssen/Geron Discontinuation and then in turn comes to be employed by Geron DIRECTLY FROM Janssen. This is HUGE folks. No need to read any tea leaves here.

Dr. Shyamala Navada has co-authored 24 publications since 2010. Many of these in conjunction with Dr. John Mascarenhas.

https://scholars.mssm.edu/en/persons/sh ... lications/

It appears that perhaps Dr. Shyamala Navada was involved in Clinical Trials involving both Luspatercept and Magrolimab. We would have to do a deep dive research wise for confirmation, however, this 2020 abstract co-authored by Dr. Shyamala Navada suggests just that:

https://www.tandfonline.com/doi/abs/10. ... ode=iery20


Of even greater importance moving forward for Geron, is her expertise in AML and this 2021 abstract, also co-authored by Dr. John Mascarenhas, on the "Safety and Efficacy: Clinical Experience of Venetoclax in Combination With Hypomethylating Agents in Both Newly Diagnosed and Relapsed/Refractory Advanced Myeloid Malignancies"

https://journals.lww.com/hemasphere/Ful ... _of.1.aspx

Remember that Geron is slated to launch the TELOMERE Clinical Trial in the very near future, which should get the greenlight from the FDA once data from the upcoming IMpress Clinical Trial is submitted:

"TELOMERE is a planned Phase 1/2 clinical trial evaluating imetelstat in patients with relapsed/refractory AML. The trial is designed to test two distinct combinations of imetelstat and venetoclax or imetelstat and azacitidine. The primary objective of the Phase 1 portion is to identify a safe dose of each of the combinations. The primary objective of the Phase 2 portion of the study is overall response rate for each of the combination regimens. TELOMERE is expected to begin after an appropriate dose for single agent imetelstat in AML has been identified in the IMpress study."

https://www.geron.com/research-and-deve ... al-trials/

If all of the above wasn't enough, Dr. Shyamala Navada has extensive experience with "Special considerations in the management of adult patients with acute leukaemias and myeloid neoplasms in the COVID-19 era" as this abstract 2020 clearly demonstrates.

https://www.thelancet.com/journals/lanh ... 2/fulltext

Take the time to read the authors of this abstract. We are all very familiar with the majority of them by now: Dr. David P. Steensma, Dr. Pierre Fenaux, Dr. Uwe Platzbecker, Dr. Valeria Santini, Dr. Amer M. Zeidan and Dr. John Mascarenhas have all been deeply involved with Imetelstat as KOL's (Key Opinion Leaders) and Clinical Trial lead investigators.

Dr. Shyamala Navada's addition to the Geron roster just may be the MOST SIGNIFICANT to the company and forward direction of Imetelstat since both Dr. Rizo and Dr. Feller joined the team in 2019. Today is a rather important day in the history of Geron.....and that may be putting it quite mildly.

I think this "recommendation" on her LinkedIn page sums it up best.....

"A superior physician. She is a hematologist -oncologist extraordinaire." -James Holland, Professor at Mount Sinai

Things are certainly starting to get exciting around here! -Kmall

[kmall]

Known current Geron Employees as of 1/28/2022 and their initial hiring dates –
* Former Janssen employee
** Former JNJ employee
+ Part-time or Consultant

Management:
1 - CEO – Dr. John A. Scarlett, MD - 2011
2 - CFO – Olivia K. Bloom - 1994
3 - CAO – Melissa A. Kelly Behrs – 1998
4 - CBO – Edward Koval - 2021
5 - COO – Andrew J. Grethlein - 2012
6 - CCO* – Anil Kapur - 2019
7 - CMO* – Faye Feller, MD - 2019
8 - CLO – Stephen N. Rosenfield - 2011

Clinical – Operations, Science, Development:
Faye Feller*(7), MD – CMO – 2019
9 - Shyamala Navada* - Executive Medical Director, MD
10 - Laurie Sherman* – VP Clinical Operations – 2019
11 - Souria Dougherty* - Ex Director Clinical Science - 2019
12 - Tymara Berry – Ex Director Clinical Development - 2020
13 - Dr. Vivian Rodolf - Medical Director - 2022
14 - Sheetal Shah – Sr Director – 2020
15 - Denise Redding – Director - 2021
16 - Jeff Ryel – Director Clinical Operations - 2020
17 - Brandie Jonas – Sr Director, Clinical Program Management – 2019
18 - F Matthew Bakthasekaran - Sr Manger, Clinical Program Management - 2022
19 - Miranda Chrisp - Associate Director, Clinical Program Management - 2023
20 - Judy Ho - Sr Manager - 2022
21 - Natasha M - Associate Director, Clinical Research - 2021
22 - Manoj Jivani - Director Clinical Operations - 2022
23 - Kate Turner - Associate Director Clinical Operations - 2022
24 - Jennifer Riggs* - Associate Director Clinical Science - 2022
25 – Carolina Jacobs – Sr Project Manager - 2012
26 - Daria Zielinska – Sr Scientist – 2001
27 - Ron Pruzan – Principal Scientist – 2010
28 – Yelena Polonskaya – Sr Research Associate - 2001
29 - Barbara Mandelkow (Germany) Lab Assistant - 2017
30 - Janet Ahern(+) - Clinical Research Consultant - 2022
31 - Dr. Aleksandra Rizo*(+) - Sr. Medical and Regulatory Advisor - 2019
(currently employed at Vividion and Geron)
32 - Mebratu Gebreyesus(+) - Sr Development Associate - 2010
(currently employed at Bayer, Celltheon and Geron)
33 - Kerry Mundt(+) – CT Assistant – 2010
(currently employed by Pharmacyclics/Abbvie and Geron)

Pharmacovigilance and Drug Safety/Information:
34 - Patti N. – Ex Director Drug Safety – 2020
35 - Annat Ikin - Director Medical Writing – 2021

Business Development:
Melissa A. Kelly Behrs (3) – Chief Alliance Officer – 2014
Edward Koval (4) – CBO - 2021
Anil Kapur* (6) - COO - 2019
36 - Jason Grossman - Ex Director, Commercial Operations - 2022
37 - Nishan Sengupta** - VP, Market-Access, Pricing, Evidence Strategy - 2021
38 - Scott Hutson** - VP Sales - 2022
39 - Denise Meyer – VP Medical Affairs – 2022
40 - Peter A. Avalos** - VP Trade & Channel Relations - 2022
41 - Oliver Gessner* - Sr. Director, Business Insights and Analytics, Hematology - 2022
42 - Lorraine Shui** - VP Marketing - 2022
43 - Christopher Cornell - Sr. Field Medical Liaison - 2022
44 - Natasha Moningka, Ph.D - Senior Medical Field Liason
45 - Helen Lee – Sr. Reporting Analyst - 2012
46 - Anthony Kuczynski – Business System Manager - 2019
47 - Aron Feingold - VP Investor Relations & Corporate Communication - 2022

Finance:
Olivia K. Bloom (2) – CFO – 1994
48 - Karen Boyce – VP -2008
49 - Andrew Good – Ex Director – 2006
50 - Gilian Fong – Director – 2021
51 – Iasko Cable – Sr. Clinical Trial Accountant – 2019
52 – Dave Clark – CPA, Corporate Controller - 2022
53 - Katherine Harmon, CPA, Assistant Controller - 2022

Data Management:
54 - Ben Thorp - Head of Clinical Data Management - 2022
55 - Sarfraz Haroon - Associate Director, Clinical Data Management - 2022
56 - Rana F.* – Director, Statistical Programming - 2020
57 - Sridevi Sridhar, CCDM – Associate Director – 2021
58 - Aswin Jayaraman - Director, IT Applications - 2022

Manufacturing:
59 - Patrick Murphy – VP Manufacturing – 2019
60 - Eric Mueller – Director – 2019
61 - Leslie C. – CMC Director - 2021
62 - Bharat Baral* – CMC Manager – 2021 & 2011
63 - William Garzon-Rodriguez* - Associate Director Drug Product Manufacturing – 2021
64 - Tim Tickner – Director, Supply Chain Management – 2022

Regulatory:
65 - Sharon McBain* - VP Global - 2019
66 - Shirin Mirshamsi* – Director EU – 2019
67 - Ilesh Sanathra* - Director Global – 2020
68 - Nick Lyon** –Sr Director – 2020
69 – Ronan Balicanta* Sr Manager, Submissions - 2022
70 - Tarin Araujo** - Sr Manager US - 2022
71 - Joyce Reader** - Sr Regulatory Consultant (+) - 2022

Biostatistics:
72 - Ying Wan* – VP - 2019
73 - Libo Sun* – Director - 2019

Quality Assurance and Quality Control:
74 - Denise Grippo – VP Quality and Compliance – 2019
75 - Samantha Taylor – QA Manager, Document Control – 2007
76 - Joe Denton – Director – 2019
77 - Damanjit Singh – Sr Manager – 2018
78 - Willie Mobley – Materials/Document Specialist - 2007
79 - Leah Wood – Manager – 2021
80 - Murugappa Vedachalam (+) – QA/QC/CMC Consultant - 2019

Legal and Intellectual Property:
Stephen L. Rosenfield (8) – CLO – 2011
81 - Pamela Smith – Associate General Counsel - 1999
82 - Christopher Johnson – Director - 2019
83 - Laura Reederson – Director - 2020
84 - Leslie Mooi – VP IP – 2007
85 - Abby B. – Sr Patent Paralegal - 2014
86 - Cheryl Northern – Sr. Contracts Manager – 2007

Facilities Operations and Information Technology:
87 - Michael Yamada – VP -2007
88 - Jyoti Shetty – Sr Director IT – 2021
89 - John Albert - Director Information Technology Infrastructure - 2022
90 - Tim W - Associate Director, IT Business Systems - 2022
91 - Miguel Hundelt – Systems Administrator – 2018
92 – Julian Cornejo - Systems Administrator - 2021
93 - Briana Martinez – Ex Assistant - 2006
94 - Julia Mensing – Ex Assistant – 2011
95 - Stacie W. – Ex Assistant - 2020
96 - Mia Pham – Office Manager - 2020

Human Resources:
97 - Shannon Odam – HR Executive -2019
98 - Stephanie Dellari – Director - 2004
99 - Susan Finan – Employee Benefits – 2021
100 - Marisa Cerniglia - Manager, People Operations – 2021
101 – Jennifer Allen - Associate Director, Talent Acquisition – 2022
102 – Fiona McAuliffe – Talent Acquisition Associate - 2022

***This latest "known" Geron employee roster reflects the most recent additions of:

9 - Shyamala Navada* - Executive Medical Director, MD
19 - Miranda Chrisp - Associate Director, Clinical Program Management
40 - Peter A. Avalos** - VP Trade & Channel Relations
41 - Oliver Gessner* - Sr. Director, Business Insights and Analytics
44 - Natasha Moningka, Ph.D - Senior Medical Field Liason

++ -Departure of (87)Brittney Hernandez - Contracts Manager


Former Janssen and JNJ employees now at Geron:

Janssen -
1. Dr. Aleksandra Rizo - Sr. Medical and Regulatory Advisor - 2019
2. Dr. Faye Feller, MD – CMO – 2019
3. Shyamala Navada, MD - Executive Medical Director - 2023
4. Laurie Sherman – VP Clinical Operations – 2019
5. Souria Dougherty - Ex Director Clinical Science - 2019
6. Jennifer Riggs - Associate Director Clinical Science - 2022
7. Anil Kapur - COO - 2019
8. Oliver Gessner - Sr. Director, Business Insights and Analytics, Hematology - 2022
9. Rana F. – Director, Statistical Programming - 2020
10. Bharat Baral – CMC Manager – 2021 & 2011
11. William Garzon-Rodriguez - Associate Director Drug Product Manufacturing – 2021
12. Sharon McBain - VP Global Regulatory - 2019
13. Shirin Mirshamsi – Director EU, Regulatory – 2019
14. Ilesh Sanathra - Director Global, Regulatory – 2020
15. Ronan Balicanta - Sr Manager, Regulatory Submissions - 2022
16. Ying Wan – VP, Biostatistics - 2019
17. Libo Sun – Director, Biostatistics - 2019


JNJ
1. Nishan Sengupta - VP, Market-Access, Pricing, Evidence Strategy - 2021
2. Scott Hutson - VP Sales - 2022
3. Lorraine Shui - VP Marketing - 2022
4. Nick Lyon - Sr Director UK, Regulatory - 2020
5. Tarin Araujo - Sr Manager US, Regulatory - 2022
6. Joyce Reader - Sr Regulatory Consultant UK, Regulatory - 2022
7. Peter A. Avalos - VP Trade & Channel Relations - 2022

***As of now, this is the current list of "known" ex-Janssen and ex-JNJ employees now working at Geron. Most likely more to come. -Kmall

[kmall]

*Sidenote - I failed to mention that Dr Shyamala Navada - Executive Medical Director, Geron Corporation has an MD, MSCR from the Icahn School of Medicine.

An MSCR is a Master of Clinical Research title.

https://icahn.mssm.edu/education/dual-specialty/md-mscr

There is quite a bit of information associated with today's announcement, so apologies for passing this over earlier. -Kmall

[biopearl123]

And you’re apologizing??This is a fantastic post and a fabulous piece of news. Geron’s telegraph machine seems to be working well. So is J and J ‘s.

[kmall]

Bp- it would be very interesting to know how Dr. Shyamala Navada ended up going from the Icahn School of Medicine over to Janssen? So many coincidences and "cross contamination" between these three companies - Geron/Janssen/JNJ - even I'm starting to lose track. At this point I think that it's just about as evident as you can get, that JNJ is still firmly involved here at some level.

Of course, with the exception of death and taxes, nothing is guaranteed, but I have a hard time believing that they don't re-enter the picture here. -Kmall

[biopearl123]

It looks pretty clearly like there will be a division of labor with Dr. Feller carrying the torch for NDA and ongoing MF PIII and Dr. Nevada perusing her specialty in the area of AML, supervising the higher risk MDS/AML and the AML combo studies that are about to start. I always wondered if Dr. Mascarenhas would be the one to go to industry as did Dr. Steensma in his transition to Novartis. I am sure very close relationships with industry develop as large, highly important clinical studies develop and progress with industry very happy to poach the best talent from academia.

[Hoosier Investor]

Thanks for the great research & observations. Exciting times for sure.

As my all-time favorite superhero (Al Bundy) would say.....lets rock!