In Support of FDA’s Authority to Regulate Medicines
Shehnaaz Suliman, CEO, ReCode Therapeutics
On Friday, April 7, a federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American.
District Judge Matthew Kacsmaryk issued a decision that overturns the FDA’s 23-year-old approval of mifepristone, the primary medicine used in abortion and miscarriage care, and which has been proven by decades of data to be safer than Tylenol, nearly all antibiotics and insulin.
Amanda Banks, MD
The decision ignores decades of scientific evidence and legal precedent. Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.
As an industry, we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.
Jeremy Levin, CEO, Ovid Therapeutics
Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.
While the drug development, approval and monitoring process is not perfect, the Agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.
As an industry dedicated to improving human health, and as members of the biopharma industry, we add our signatures to this letter and stand together to unequivocally support the continued authority of the FDA to regulate new medicines.
Paul Hastings, CEO, Nkarta Therapeutics
In the face of laws and rulings that aim to undermine the evidence-based and legislatively sanctioned authority of federally mandated institutions such as FDA to protect public interests, and by putting an entire industry focused on medical innovation at risk, we cannot stay quiet.
We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place.
Click here to join us.
| Shehnaaz Suliman, MD
CEO ReCode Therapeutics |
Amanda Banks, MD
Advisor, Board Member Co-founder and former CEO, Blackfynn
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Jeremy Levin, MD
CEO Ovid Therapeutics
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| Paul Hastings
CEO |
John Maraganore
Former founding CEO at Alnylam Pharmaceuticals
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Julia Owens, PhD
CEO Ananke Therapeutics
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| Peter Kolchinsky, PhD
Managing Partner RA Capital Management
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Ted Love, MD President & CEO Global Blood Therapeutics |
Eric Dube, PhD
CEO |
| Dr. Albert Bourla
Chairman and Chief Executive Officer Pfizer
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Deborah Dunsire MD
President and CEO H. Lundbeck A/S
|
Alisha Alaimo
President Biogen |
| Robert Langer, PhD
Professor MIT |
Daniel Swisher
President and COO |
Christopher Tan
Exec Director, BD&L, Infectious Diseases & Vaccines Merck & Co, Inc
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| Paula Soteropoulos
Chairman of the Board Ensoma
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Steven Holtzman
Chair Camp4 Therapeutics |
Peter J Pitts
President Center for Medicine in the Public Interest |
| Angie You
CEO Architect Therapeutics |
Jon Martin
Associate Vice President Organon
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Jeb Keiper
CEO Nimbus Therapeutics |
| Paul J Sekhri
President and CEO Lyv Advisors LLC |
Grace E. Colón, Ph.D.
Former CEO, InCarda Therapeutics; Board member, Voyager Therapeutics, CareDx, BIO, MIT
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Michelle Werner
CEO |
| Rene Russo
CEO Xilio Therapeutics
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Barbara Duncan
Director Ovid Therapeutics |
Ramani Varanasi
Managing Director ReVive Advisors |
| Maria Soloveychik
CEO SyntheX
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Nancy Whiting, PharmD
CEO Recludix Pharma |
Rekha Hemrajani
Board Member BioAge Labs |
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| Hanadie Yousef
CEO Juvena Therapeutics
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Deborah Geraghty
CEO Anokion |
Patrice Milos
Board Member, VP Scientific Operations Proof Diagnostics |
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| Yvonne Linney PhD
Board Director Linney Bioconsulting
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Julie Krop
Chief Medical Officer PureTech Health |
Rhonda F. Farnum
CBO, SVP Commercial & Medical Affairs Theravance Biopharma, Inc. |
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| Stephanie Oestreich
CBO Galecto
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Sylvia McBrinn
Former CEO Axerion Therapeutics |
Christine Miller
Biopharma Executive |
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| Wendye Robbins, MD
Independent Red Tower Partners
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Meg Alexander
Chief Corporate Affairs Officer Ovid Therapeutics
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Melita Sun Jung
CBO Structure Therapeutics |
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| Katherine Bowdish
CEO & President PIC Therapeutics
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Joanne Dove Kotz
CEO Jnana Therapeutics |
Jenny Herbach
CEO Adventris Pharmaceuticals |
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| Lavi Erisson
CEO Gensaic |
Bob Coughlin
Board Member, Former CEO MassBio
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Kristine C. Mechem
Chief Corporate Development Officer Craif Inc |
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| Jason Tardio
Chief Operating Officer Ovid Therapeutics
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Nina Kjellson
General Partner Canaan Partners
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Tara Nickerson
Biopharma Executive
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| John Kolljins
President & CEO Satsuma Pharmaceuticals
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Ashley Zehnder
CEO Fauna Bio Incorporated |
Mark Frohlich
CEO Indapta Therapeutics |
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| Cristina Ghenoiu
Principal RA Capital
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Emily Minkow
CEO Stylus Medicine |
Rajeev Shah
Managing Partner RA Capital |
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| Lori Lyons-Williams CEO, Abdera Therapeutics |
Ron Cohen, MD
President and CEO Acorda Therapeutics
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Elizabeth Jeffords
CEO Iolyx Therapeutics |
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| Emily Drabant Conley, PhD
CEO Federation Bio |
Amit Rakhit
CEO
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Ken Drazan
Chairman & CEO Arsenal Biosciences |
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| Bernard Coulie
President and CEO Pliant Therapeutics
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Sabrina Martucci Johnson
CEO Daré Bioscience
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Zachary Hornby
President & CEO Boundless Bio, Inc. |
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| Eric Easom
Founder & CEO AN2 Therapeutics
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Mark Lappe
CEO and Chairman Inhibrx |
Kevin Pojasek
CEO Enara Bio |
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| Srini Akkaraju
Managing General Partner Samsara BioCapital
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Jack Elands
CEO Emergence Therapeutics |
Kristen Fortney
CEO BioAge Labs |
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| JJ Kang, PhD
CEO Appia Bio |
Elena Itskovich
President Nest Catalyst
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David Meeker
Chairman and CEO Rhythm Pharmaceuticals
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| Bonnie H Anderson
CEO PinkDx Inc
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Michael Gladstone
Partner Atlas Venture |
Ivana Magovcevic-Liebisch
President & CEO Vigil Neuroscience |
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| Polly Murphy
CBO UroGen Pharma
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Matthew Hammond
Partner RA Capital Management |
Linda Phelan Dyson
Founder and Principal Dunn Street Strategies |
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| Marcelo E. Bigal
CEO Ventus Therapeutics
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David Grayzel
Partner Atlas Venture |
ShiYin Foo
CEO |
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| Jason Braun
SVP Nkarta
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Jason Rhodes
Partner Atlas Venture |
Bruce Booth
Partner Atlas Venture |
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| Erika Smith
CEO ReNetX Bio
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Kevin Bitterman
Partner Atlas Venture |
Joao Siffert
CEO Design Therapeutics
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| Peter Strumph
CEO Parvus Therapeutics
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Daphne Zohar
CEO Puretech |
Alex Harding, MD
Head of Business Development CRISPR Therapeutics |
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| Zach Scheiner
Principal RA Capital |
Camille D Samuels
Partner Venrock
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Faraz Ali
CEO Tenaya Therapeutics |
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| Gisela A. Paulsen, MPharm
Former President & COO, Oncocyte Corporation EIR, DigitalDX
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Nicolas Tilmans
CEO Anagenex |
Michael Gilman
CEO Arrakis Therapeutics |
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| Pearl Freier
President Cambridge BioPartners
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Alan Fuhrman
Chief Financial Officer Tyra Biosciences |
Christy Oliger
Board Director Reata |
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| Katherine Vega Stultz
CEO Ocelot Bio
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Paul D Rennert
CEO Aleta Biotherapeutics |
Thomas J. McGahren, MD JD
Managing Director Griffin Securities
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| Yael Weiss
CEO Mahzi Therapeutics
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Kenneth A. Berlin
President & CEO Ayala Pharmaceuticals, Inc. |
Rob Shaffer
Chief Operations Officer Vrata Therapeutics |
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| Patrick Heron
Managing Partner Frazier Life Sciences
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C Gordon Beck III
Founder and Managing Director Princeton Biomedical Consulting LLC
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Rebecca Frey
President and CEO Siduma Therapeutics |
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| Doug Drysdale
CEO Cybin
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Nerissa Kreher, MD
Chief Medical Officer Entrada Therapeutics |
Sarah Boyce
CEO Avidity Biosciences |
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| Safia Rizvi
CEO CILA Therapeutics
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Zen Chu
Faculty MIT Healthcare Ventures |
Bruce Goldsmith
Consultant Aureum Bio |
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| Nabil Uddin
Corporate Development Concert Pharmaceuticals, Inc.
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Paul Peter Tak, MD PhD
President & CEO Candel Therapeutics |
Catherine J. Mackey, Ph.D
Retired Sr. VP R&D Pfizer |
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| Samuel D Waksal
CEO and President Graviton BioScience Corporation |
Gautam Kollu
CEO D2G Oncology |
Sun Altbach
Advisor LVF |
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| Nima Farzan
CEO Kinnate Biopharma
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David de Graaf
President & CEO Reverb Therapeutics |
Brook Byers
Biotech Founder and Board Member Byers Capital
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| Peter Barrett
Partner Atlas Venture
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Art Krieg
Adjunct Professor University of Massachusetts Chane Medical School
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Peter Smith
CEO Remix Therapeutics |
| Holly Weng
President HW MedAdvice |
Michael Raab
President & CEO Ardelyx, Inc. |
Jean-Francois Formela
Partner Atlas Venture
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| Todd Harris
CEO Tyra Biosciences
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Richard Colvin, MD, PhD
Chief Medical Officer bluebird bio |
Ronald A. DePinho, MD
Professor & Past President UT MD Anderson Cancer Center |
| Steve Derby
Chairman General Ventures Inc.
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David Campbell
President and CEO Janux Therapeutics |
Amir Nashat
CEO Paratus Sciences |
| Nick Mordwinkin
Chief Business Officer Kezar Life Sciences
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Heather Turner
CEO Carmot Therapeutics, Inc. |
Leslie Williams
CoFounder President & CEO hC Bioscience, Inc |
| Mark Benjamin
President & EVP Business Development Cyrus Biotechnology
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Douglas Fisher, MD
Partner Revelation Partners |
Gerald Commissiong
CEO Todos Medical |
| Diala Ezzeddine
Co-founder & COO Differentiated Therapeutics
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Daphne Koller
Founder and CEO insitro |
Hannah Brie Gordon
VP, Product Enveda Biosciences |
| Sanjeev Redkar
President & CoFounder Apollomics Inc.
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Rick Lundberg
President and CEO Eikonizo Therapeutics |
Rajesh Devraj
President & CEO Rectify Pharmaceuticals |
| Raul Oliva
CEO & Co-Founder Sidekick Bio, Inc.
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Ty Howe
Biotech advisor Marsh USA |
Jeff Jonker
CEO Belharra Therapeutics |
| Adel Nada
CEO GentiBio
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Tess Cameron
Principal RA Capital |
Florian Brand
CEO & Co-Founder atai Life Sciences |
| Daniel Bradbury
Executive Chairman Equillium, Inc
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Robert Hughes
EVP Rectify
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Rohan Palekar
CEO 89bio Inc
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| Chris Francis
SVP Wave Life Sciences
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Stephen Benoit
President & CEO MDI Therapeutics |
Mary Rozenman
CFO/CBO insitro |
| Derek DiRocco
Partner RA Capital
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Hong Wan
President & CEO Tallac Therapeutics |
Aoife Brennan
CEO Synlogic |
| James McArthur
President & CEO PepGen
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Glenn Rockman
Managing Partner Adjuvant Capital, L.P. |
Daniel Bensen
COO Tyra Biosciences
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| Ali Fawaz
General Counsel Tyra Biosciences
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William S. Marshall
Chief Scientific Officer Elsie Biotechnologies |
Laura Stoppel
Principal RA Capital |
| Allison Kemner
VP Clinical Sciences and Operations Tyra Biosciences
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Piyush Patel
Chief Development Officer Tyra Biosciences |
Ronald Swanson
CSO Tyra Biosciences |
| Ben Wang
Cofounder and COO Chimera Bioengineering
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Jessica Sagers
Head of Engagement RA Capital |
Michael Mendelsohn
Board Chairman Cardurion Pharmaceuticals |
| Imran Nasrullah
VP and US Head Collaborate to Cure Hub, BD&L/OI Bayer Pharmaceuticals
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Karen LaRochelle
CBO Aleta Biotherapeutics |
Clifford Stocks
CEO OncoResponse |
| Xiaobing Li
Chief Development Officer Rectify Pharmaceuticals
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Ram Aiyar
CEO Korro Bio
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Sarah Honig
VP Corporate Development and Strategy Tyra Biosciences
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| Stephanie Engels
SVP, HR Korro Bio, Inc
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Eli Berlin
Chief Financial and Operating Officer Terray Therapeutics
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Micah Benson
CSO KSQ Therapeutics |
| Robert Hudkins
CTO Tyra Biosciences
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Laura Shawver
CEO Capstan Therapeutics |
Adam Kolom
CEO Related Sciences |
| Jonathan Moore
CSO Rectify Pharmaceuticals
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William J. Newell
CEO Sutro Biopharma
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Reid Huber
Partner Third Rock Ventures |
| Arthur T. Suckow
CEO DTx Pharma
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Suha Jhaveri
CBO Leyden Labs |
Viswa Colluru
CEO Enveda Biosciences |
| William J. Rieflin
Chairperson NGM Biopharmaceuticals
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Michael Rosenblatt, M.D.
Senior Advisor Several life science funds and boards |
Eileen McCullough
Board member, CEO, and Company Builder Stealth-stage Biotechs
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| Jing Liang
Managing Partner Umbrex
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Bassil Dahiyat
CEO Xencor |
Isan Chen, MD
CEO MBrace Therapeutics, Inc. |
| Kabeer Aziz
Partner Adjuvant Capital
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Adam Gridley
President & CEO Allay Therapeutics |
Ryan Daws
CFO Obsidian Therapeutics, Inc. |
| Emilie Besnard
Senior Scientist Dorian Therapeutics
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Drew Volpe
Managing Partner First Star Ventures |
Sheila Gujrathi
Chair of Ventyx, ADARx and ImmPACT Bio |
| John Hood
CEO Endeavor Biomedicines
|
Mary Ann Gray
President Gray Strategic Advisors, LLC |
Roger Frechette
Principal and Founder New England PharmAssociates, LLC |
| Karim Dabbagh
President/CEO Second Genome, Inc
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Blake Mandell
CEO and Co-Founder Transcend Therapeutics |
Brian Gallagher
Managing Partner Trekk Venture Partners |
| Ginger Cooper
VP Sales Artificial, Inc
|
Wendy Nelson
President & Founder Boston Biotech Forum |
Amit Jolly
Investor Self
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| Jacqueto Zephyr
Scientist Nimbus Therapeutics |
Alan Horsagee
President & CEO Duet BioTherapeutics |
Bharatt Chowrira
President PureTech |
| Jens Eckstein Ph. D.
Managing Partner Jens Eckstein Ph. D.
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Dominique Verhelle
CEO NextRNA Therapeutics |
Arthur Klausner
Executive Chairman Concarlo Therapeutics, Inc. |
| Anna French
Partner Qiming Venture Partners USA
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Aetna Wun Trombley
CEO Lycia Therapeutics |
Sean McClain
Founder & CEO Absci |
| Jessica O’Leary
VP, Corporate Development 76Bio
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Hiroomi Tada MD PhD
Chief Medical Officer Tyra Biosciences |
Glenn Schulman
SVP, Investor Relations ProKidney Corp |
| Loren Beck
Chief Legal Officer HDT Bio Corp.
|
Andrew Farnum
CEO Variant Bio |
Kenny Storch
Vice President BTIG |
| Benny Sorensen
CEO & President Hemab Therapeutics
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Jason Lettmann
General Partner Lightstone Ventures |
Philippe Lopes-Fernandes
EVP, Chief Business Officer Ipsen |
| Cedric Francois
CEO Apellis
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Leslie Stolz
Senior Vice President, Regulatory Affairs
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Renato Skerlj
CEO Expansion Therapeutics |
| Chi-Ting Huang
Vice President CMC Pheon Therapeutics
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Samantha Truex
CEO Upstream Bio |
Jeff Marrazzo
Co-founder and former CEO Spark Therapeutics |
| Hilary Malone
CEO Certego Therapeutics |
Greg Naeve
Chief Business Officer RootPath Genomics |
Alicia J. Hager
Chief Legal Officer Nkarta
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| Nadir Mahmood
CFO & CBO Nkarta |
Mark Leuchtenberger
CEO Spybiotech |
Catherine Stehman-Breen
CEO |
| J. Mike Smith
Managing Principal Back West, Inc
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Robert Michael Poole PresidentNW Biomedical Consulting, Inc. |
Kenneth Moch
President Euclidean Life Science Advisors, LLC
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| Matthew Gall
CFO iTeos Therapeutics, Inc. |
Linda Rockett
General Counsel Wave Life Sciences
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Laura Tadvalkar
Managing Director RA Capital |
| Bernat Olle
CEO Vedanta Biosciences
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Eric Marcusson
Co-Founder, Providence Therapeutics & Northern RNA Marcusson Consulting
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Marcos Milla
Venture Partner Samsara BioCapital, LLC |
| Michele Libonati
COO Pacylex Pharmaceuticals, Inc.
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Dolca Thomas
Venture Partner, BOD Samsara, Ventus, Chinook |
Susan Dillon CEOAro Biotherapeutics |
| Flavia Borellini
Biotech Executive, Board Director
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Nancy Simonian
CEO Syros Pharmaceuticals |
Svetlana Lucas CBOScribe Therapeutics Inc. |
| Eef Schimmelpennink
President and CEO LENZ Therapeutics
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Sumant Ramachandra
President and CEO ImmPACT Bio |
Fredrik Wiklund
CEO Bright Peak Therapeutics |
| Simon Read
CEO and Founder Mariana Oncology
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Sarah Kurz
Executive Vice President Partner Therapeutics |
Debanjan Ray
CEO Synthekine |
| Michele Libonati
COO Pacylex Pharmaceuticals, Inc.
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Dolca Thomas
Venture Partner, BOD Samsara, Ventus, Chinook |
Susan Dillon CEOAro Biotherapeutics |
| Flavia Borellini
Biotech Executive, Board Director
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Nancy Simonian
CEO Syros Pharmaceuticals |
Svetlana Lucas CBOScribe Therapeutics Inc. |
| Simon Read
CEO and Founder Mariana Oncology
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Sarah Kurz
Executive Vice President Partner Therapeutics |
Debanjan Ray
CEO Synthekine |
| Jeffrey Smith
VP, Program Management Nkarta |
Eric Dobmeier
President & CEO Chinook Therapeutics, Inc.
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Thomas J Novak
Chief Scientific Officer Autobahn Labs, Inc. |
| Stefani Wolff
COO Nurix
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David M. Epstein
President & CEO Black Diamond Therapeutics |
Tawni Koutchesfahani
Executive Director, Manufacturing Nkarta
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| Chris Varma
CEO
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David-Alexandre Gros
CEO Eledon Pharmaceuticals |
Patrick Trojer
CEO TRIANA Biomedicines |
| Behzad Khosrowshahi
President & CEO DRI Healthcare
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Theron Odlaug, Ph.D.
Operating Partner Signet Healthcare Partners |
Saif Rathore, MD PhD
Former SVP Strategy, Cellarity |
| Andrew Hirsch
President & CEO C4 Therapeutics
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Laura Lande-Diner CBOSatellite Bio |
Amy Hummel
Associate Director, IND/IDE Management Yale Center for Clinical Investigation
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| George Vlasuk
Board Member Nimbus Therapeutics
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Cara Tenenbaum
Principal Strathmore Health Strategy |
Daniel van der Lelie
CSO and CEO Gusto Global LLC. |
| Philip R. Johnson
CEO Interius Biotherapeutics
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Dave McDonald
Head of Life Sciences Investment Banking Lake Street Capital Markets |
Joseph Horvat
US General Manager MorphoSys US, Inc. |
| Matt Ottmer
CEO & President Kisbee Therapeutics, Inc
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Seth Ettenberg
President and CEO BlueRock |
Edwin H Gordon
Founder 4c Advisors, llc |
| Andrew Funderburk
Managing Director Kendall Investor Relations
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Rita Balice-Gordon
CEO Muna Therapeutics |
Jonathan Leff
Partner Deerfield Management |
| Mary Kay Fenton
Chief Financial Officer Talaris Therapeutics
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Kieren Marr
CEO Pearl Diagnostics |
Ananya Zutshi
CEO Guardian Bio |
| Susan Sobolov
President RIGImmune Inc
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Amy Conrad
CEO Juniper Point |
Jacob Stangl
Founder and Director OrisDx, Inc. |
| Mario David Saltarelli MD PhD CEOGABA Therapeutics Inc
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Ellen Leinfuss
SVP, Commercial Certara |
Ed Burgard PhD
President Dignify Therapeutics |
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