EAST COAST CARDIOVASCULAR THERAPEUTICS XCHANGE
Boston
December 5, 2023

Welcome to hubXchange’s Cardiovascular Therapeutics East Coast 2023 Xchange, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in the cardiovascular drug discovery space, through a series of roundtable discussions.

Discussion topics will cover Novel Targets, Lead Optimization, Preclinical Studies, Novel Endpoints.

Take advantage of this unique highly interactive meeting format designed for maximum engagement and collaboration with your peers.

Please note this is an In-Person meeting.

VENUE DETAILS: Hilton Boston Woburn Hotel, 2 Forbes Road, Woburn MA 01801

SNAPSHOTS OF DISCUSSION TOPICS

Track 1: Novel Targets

Targeting inflammation in cardiovascular disease: novel therapies and mechanisms
Precision medicine in cardiovascular disease and new therapeutic strategies

Track 2: Lead Optimization

Optimization of delivery systems for cardiovascular drugs
Multi-targeted drug design for cardiovascular disease

Track 3: Preclinical Studies

Animal models of cardiovascular disease: selection, characterization, and translatability
Biomarkers for preclinical cardiovascular research: current status and future directions

Track 4: Novel End Points

Creating a cardiovascular target product profile: identification and selection of targeted endpoints
Pioneering new endpoints for cardiovascular drug discovery

Full Xchange Agenda

Click on each track for detailed agenda

Novel Targets

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation

09:05 – 10:05

Precision medicine in cardiovascular disease and new therapeutic strategies

How can we identify and validate novel targets for CV therapeutics?
What are the barriers to clinical development of precision medicines in CV?
How will regulatory changes affect development of novel CV therapeutics?
Will novel precision medicines in CV face unique reimbursement and market access challenges?
Where are the best indication opportunities for novel CV therapies?

Samuel Murphy

Chief Executive Officer, Salubris

Sam is currently CEO of Salubris Biotherapeutics, a clinical stage biotech focused on the development of complex biologics for heart failure, neurodegenerative disease and cancer. Sam previously worked for twelve years in strategy consulting and transaction advisory across several global firms, most recently as a Senior Principal at IMS/IQVIA. Sam completed his PhD in Virology at University of Pennsylvania and his Post-Doc in Gene Therapy and Translational Medicine at CHOP. Sam currently serves as Board Chair at GO Therapeutics, and Board Director at MedAlliance and Viracta. He is an author of >20 peer-reviewed publications and inventor on several issued patents.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor Roundtable Discussion

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Sponsor Poster Session

15:35 – 16:35

Targeting inflammation in cardiovascular disease: novel therapies and mechanisms

Christopher O'Donnell

Global Head Cardiovascular and Metabolism Translational Medicine, Novartis

16:35 – 17:35

Evening Drinks Reception

Lead Optimization

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation

09:05 – 10:05

Optimization of target discovery and validation, dosages and delivery systems for cardiovascular drugs

Druggable targets validated in animal models may lack human relevance, especially for complex non-monogenic diseases
Identifying a human disease target is only the first step; optimal dosages must be fine-tuned for effectiveness and minimal side effects
FDA Modernisation Act 2.0 ends the animal mandate and promotes the use of more superior human-based technologies
Targeted heart delivery, not systemic administration, offers potential to enhance efficacy and reduce adverse events in virus-mediated gene therapy

Ronald Li

Chief Executive Officer, Medera Biopharmaceutical

Ronald Li, an accomplished academic-turned-entrepreneur, leads MederaBiopharmaceutical as CEO and Founder. Medera focuses on advanced gene therapies for challenging diseases, with three subsidiaries: Novoheartfor (disease modeling), Sardocor (gene therapy trials), and Xellera Therapeutics (cGMP-compliant manufacturing). Dr. Li, an expert in cardiac electrophysiology and stem cells, boasts 200+ peer-reviewed publications. Formerly a professor at esteemed institutions like Johns Hopkins and Icahn School of Medicine, he earned recognition and awards, including Young Investigator and Best Study honors. Notably, he directed the Ming-Wai Lau Centre for Reparative Medicine and gained distinctions from University of Toronto and University of Waterloo.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor Roundtable Discussion

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Sponsor led Poster Session

15:35 – 16:35

Multi-targeted drug design for cardiovascular disease

Novartis

16:35 – 17:35

Evening Drinks Reception

Preclinical Studies

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation

09:05 – 10:05

Biomarkers for preclinical cardiovascular research: current status and future directions

What are the major obstacles in identifying and validating reliable biomarkers for predicting cardiovascular disease in preclinical models?
How can researchers overcome the inherent heterogeneity and variability in preclinical models to establish robust and reproducible biomarkers for cardiovascular research?
What are the key challenges in translating promising preclinical biomarkers into clinically actionable tools for early detection and prevention of cardiovascular diseases in humans?

Michael Dunn

Director, Clinical Sciences General Medicine, Regeneron

Michael Dunn, PhD is a Director in Regeneron’s General Medicine Therapeutic Area, supporting the strategic and tactical clinical development of a broad portfolio of therapeutics in disease areas including cardiovascular, metabolism, infectious disease, and ophthalmology. Prior to his current clinical role, Dr. Dunn worked in the Cardiovascular Research Group at Regeneron. He led teams in the discovery and development of therapeutic antibodies for the treatment of heart failure and systemic hemodynamic disorders. He was the founding and lead scientist on the novel membrane bound guanylate cyclase activating antibody, REGN5381 that is currently in Phase 2 clinical development for heart failure. Dr. Dunn received his PhD in Pharmaceutical Sciences from the University of Rhode Island, College of Pharmacy and B.S. in Biological Sciences from the University of Vermont.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55– 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Sponsor led Poster Session

15:35 – 16:35

Animal models of cardiovascular disease: selection, characterization, and translatability

How are animal models chosen to test a novel therapeutic?
What does the design look like? Readouts? Groups? Blinding? Statistics?
Is age of the animals ever considered? How about gender? How about rodent versus non-rodent?
How about multi-etiology – for example, cardiovascular disease on top of renal disease; or diabetic or non-diabetic.

Jeff Madwed

Executive Director/ Juvenescence; CEO/ Selah Therapeutics

Jeff Madwed is an executive director at Juvenescence, where he is currently CEO of two portfolio companies: (1) Souvien, a company creating innovative medicines to address neurodegenerative diseases by targeting the epigenetic mechanisms, and (2) Selah, a company developing novel ketone-based therapies for the treatment of age-related diseases such as heart failure, chronic kidney disease, migraine, epilepsy and others. Jeff is a pharmacologist, a research project leader and played a major pre-clinical pharmacology role in the development of Flomax (tamsulosin) and Micardis (telmisartan).

Jeff joined Juvenescence in July 2020, after stops in Big Pharma at Boehringer Ingelheim Pharmaceutics, Inc in Ridgefield, CT, Merck in Rahway/Kenilworth NJ and Mitsubishi-Tanabe in Jersey City, NJ. Jeff completed his Ph.D. at Harvard University in Physiology and Biophysics. He proceeded to do post-doctoral work at the St. Luke’s Hospital/Kansas U Medical School in Kansas City, MO, and then worked at Physio-Control/U. Washington in Seattle before beginning his pharmaceutical career.

16:35 – 17:35

Evening Drinks Reception

Novel Endpoints

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation

09:05 – 10:05

Creating a cardiovascular target product profile: identification and selection of targeted endpoints

What are approaches to identify the optimal target patient and/or sub-population?
How do we select efficacy and safety endpoints that inform decision-making during early clinical development?
How do we develop a research strategy for a novel therapeutic based on the target product profile, including differentiation from standards of care?

Kersten Small

Head of Preclinical and Translational Sciences, Selah Therapeutics

Kersten Small, PhD is Head of Preclinical and Translational Sciences at Selah Therapeutics, a startup drug discovery company within Juvenescence, a healthcare organization focused on developing products for cardiovascular diseases and healthy aging. Kersten is an exceptional pharmaceutical scientist, drug hunter and translational research leader with over 18 years of experience in drug and biomarker discovery at Merck, Mitsubishi-Tanabe and Cohen Veterans Biosciences in multiple therapeutic areas. Currently at Selah Therapeutics, Kersten partners with industry leaders, contract research organizations, clinical and basic research scientists to discover and advance candidate ketone therapeutics into clinical development for treatment of heart failure.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor Roundtable Discussion

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 15:30

Sponsor Poster Session

15:35 – 16:35

How to accelerate the introduction of novel clinically relevant and HA acceptable endpoints into clinical trials

How we define “novel endpoints” in the present era
What work needs to be done to develop and validate novel endpoints
How to work with HAs to develop novel endpoints that are biologically and clinically relevant
How to accelerate the introduction of novel endpoints in clinical trials

Cristina Quarta

Senior Medical Director, MeTA+ Clinical Development & Translational Sciences, Alexion Pharmaceuticals

Cristina is a Senior Medical Director and Global Clinical Lead at Alexion, AstraZeneca Rare Disease, working on Rare cardiomyopathies for the past 20 years and leading clinical research for cardiac amyloidosis.

16:35 – 17:35

Evening Drinks Reception

EAST COAST CARDIOVASCULAR THERAPEUTICS XCHANGE
Boston
December 5, 2023