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BIO-MANUFACTURING INNOVATION SUMMIT

Summit took place 7 - 8 July 2022
See highlights below

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Insight - Access - Engagement
Innovation & Partnering in Bio-Manufacturing


Past event: 7 - 8 July 2022
Thanks to our Partners, Speakers & Participants for making the launch edition such a success.

See you back at Rutgers,
in the new venue,
 
July 13 - 14, 2023


Here are a few snaps from the pilot edition
Alberto Cuitiño

Alberto Cuitiño

Interim Dean, Rutgers School of Engineering Department Chair, Professor Mechanical & Aerospace Engineering, Rutgers University

Chris Yochim

Chris Yochim

Head of Business Development, National Institute for Innovation in Manufacturing BioPharmaceuticals - NIIMBL

Timothy T. Belski, MS, PMP

Timothy T. Belski, MS, PMP

Branch Chief, BioMaP PCI, ​Biomedical Advanced Research & Development Authority (BARDA)

Stelios C. Tsinontides

Stelios C. Tsinontides

Director Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration

Shiv Krishnan & Rahul Singhvi

Shiv Krishnan & Rahul Singhvi

Shiv Krishnan of Lonza, and Rahul Singhvi, CEO of Resilience; questions from the audience.

Rahul Singvhi

Rahul Singvhi

Co-Founder & CEO Resilience

Rahul Singhvi

Rahul Singhvi

Co-Founder & CEO Resilience

Mark Emalfarb

Mark Emalfarb

CEO & Founder, Dyadic International Inc.

Sarfaraz Niazi

Sarfaraz Niazi

Co-Founder & CSO, Novel351K

Alastair Florence

Alastair Florence

Director, Future Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub

Alastair Florence

Alastair Florence

Director, Future Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub

Vipul Davé

Vipul Davé

Senior Engineering Fellow, ​Strategy, Innovation & Deployment, Johnson & Johnson Supply Chain

Fernando Muzzio

Fernando Muzzio

Distinguished Professor of Chemical and Biochemical Engineering, Rutgers University

Donald Zinn

Donald Zinn

Vice President, US Business Crossject

Investor Panel

Investor Panel

Justin Sperry, Pfizer Stephen Chambers, SOSV & IndieBio Tim Rollender, NJEDA Evergreen Fund

Driving meaningful innovation, impact and value creation in Bio-Manufacturing and ensuring resilient, adaptable supply chains, efficient re-shoring, on-shoring and cutting edge pharma manufacturing solutions to meet demand and accelerate the development and production of essential novel therapeutics and vaccines, in the US and globally.
 
The Bio-Manufacturing Summit and partnering forum is co-organized by Broadreach Global and Host Partners Rutgers University, with support from NIIMBL - the National Institute for Innovation in Manufacturing Biopharmaceuticals, and our Global Innovation Partners MBHB LLC, Patent Docs, Mazards, and the BiotechGate Partnering Platform.
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What solutions can technology transfer from the world-leading institutions and most innovative private companies provide? Which partners can provide the expertise to move these innovations to the market? How can industry and private companies reduce costs and accelerate their own programs? How to re-shore on on-shore rapidly and efficiently? What are the intellectual property and regulatory considerations? Engage with leading Bio-Manufacturing Innovators, selected projects, leading start-ups and growth companies, government, Investors, Industry, and leading innovation stakeholders and KOLs.

 

  • Hear from KOLs and leading experts.

  • See innovative technologies and company presentations.

  • Understand the strategic interests of key government agencies

  • Connect with leading investors

  • Engage with industry KOLs and decision-makers

  • Meet directly with key potential partners via the BiotechGate partnering platform and in-person meetings.

 

The one summit which brings together all key stakeholder groups in bio-manufacturing, matching transformational technologies and pioneering companies from around the world with KOL insight and the key industry and investors.

Speakers

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Justin Sperry

Vice President, Transformational Technology for Biotherapeutics & Vaccines,

Pfizer

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Mark Emalfarb

CEO & Founder,

Dyadic International Inc.

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Mauricio Futran

VP of Advanced Technology, Global Tech Services, Janssen Supply Chain, Johnson & Johnson

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Rahul Singhvi

Co-Founder & CEO

Resilience

Co-Founder & CEO

Resilience

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Michael P. Angelastro

Director, Division of Pharmaceutical Countermeasures Infrastructure (PCI) Biomedical Advanced Research & Development Authority (BARDA)

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Stelios C. Tsinontides

Director    
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration

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Chris Yochim

Head of Business Development,

National Institute for Innovation in Manufacturing BioPharmaceuticals - NIIMBL

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Alberto Cuitiño

Interim Dean, Rutgers School of Engineering
Department Chair, Professor
Mechanical & Aerospace Engineering
,

Rutgers University

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Stephen Chambers

General Partner,

SOSV, &

Managing Partner,

IndieBio NY

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Timothy B. Rollender

Director – Venture Programs
New Jersey Economic Development Authority (NJEDA)

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Cedric Bisson

Partner,

Teralys Capital,

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Shiv Krishnan

Head, External Innovation, Biologics R&D,

Lonza

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Frank Gupton

Co-Founder, Phlow Corp., &

CEO, Medicines for All

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Sarfaraz Niazi

Adj. Professor of Pharmaceutical Sciences, University of Illinois,

&

CSO, Novel351K

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Parviz A. Shamlou

VP & Executive Director, Jefferson Institute of Bioprocessing

(JIB)

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Fernando Muzzio

Distinguished Professor of Chemical and Biochemical Engineering,

Rutgers University

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Christian Hinrichs

Chief, Cancer Immunotherapy Section at Rutgers Cancer Institute of New Jersey

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Renata Pasqualini

Chief Scientific Officer and Founder,

PhageNova Bio

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Don Liu

Chief Science Officer,

Naki Therapeutics

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 Hemanth Kaligotla

Director External Innovation, Bio R&D,

Lonza

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Diane Burgess

Board of Trustees Distinguished Prof. of Pharmaceutics, Pfizer Distinguished Endowed Chair in Pharmaceutical Technology, Dept. of Pharmaceutical Sciences, University of Connecticut 

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Timothy T. Belski, MS, PMP

Branch Chief, BioMaP
PCI ,

Biomedical Advanced Research & Development Authority (BARDA)

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Vince Smeraglia

Executive Director, 

Strategic Alliances

The Office For Research

Rutgers University

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Vipul Davé, Ph.D.

Senior Engineering Fellow,

Strategy, Innovation & Deployment, Johnson & Johnson Supply Chain

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Haro
Hartounian

CEO,

BioCentriq

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Alastair Florence

Director, Future Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub

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Doug Hausner

Senior Manager Business Development, Continuous Manufacturing, 

Thermofisher Scientific

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Donald Zinn

Vice President,

US Business

Crossject

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Jens Bukrinsky

Head of Research,

SB 3000

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Kevin Noonan

Partner, Chair of the Biopharmaceuticals Practice Group, McDonnell Boehnen Hulbert & Berghoff LLP

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Roop Chandwani

Chief Executive Officer,

Mazards

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Leah Stilwell

Senior Director Business Development

Asymchem Group

Program
Day I     -  Thursday July 7 

08:00       Registration & Coffee

09:00 EDT

  • Welcome & Opening Remarks 

    • Christian J. Suojanen, CEO, Broadreach Global

    • Alberto Cuitiño, Interim Dean, Rutgers School of Engineering Department Chair, Professor, Mechanical & Aerospace Engineering, Rutgers University

    • Chris Yochim, Head of Business Development, National Institute for Innovation in Manufacturing Biopharmaceuticals - NIIMBL 
      Judith Sheft, Executive Director New Jersey Commission on Science, Innovation and Technology

09:15 EDT

  • Meeting vaccine & pharmaceutical demand, nationally & worldwide. Needs, Challenges & Strategies.

    • KEYNOTE - Timothy T. Belski, MS, PMP, Branch Chief, BioMaP, ​Division of Pharmaceutical Countermeasures Infrastructure (PCI) Biomedical Advanced Research & Development Authority (BARDA), Assistant Secretary for Preparedness & Response (ASPR), U.S. Department of Health & Human Services

      • PANEL DISCUSSION

      • Cedric Bisson, Partner, Teralys Capital, Co-Chairman of the Canadian Emergency Covid Therapeutics Task Force, Member of the Bio-Manufacturing Emergency Task Force

      • Derron Stark, Partner, Transaction Strategy & Execution, Supply Chain, Health Sciences & Wellness, EY Parthenon

10:15 EDT

  • CDER efforts on enabling pharmaceutical advanced manufacturing. ​

    • Stelios C. Tsinontides, Ph.D., FAIChE, Director, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration - FDA

10:45        Coffee Break

11:15 EDT

  • Reinventing biologic vaccine and drug development & production.​

    • Mark Emalfarb, Founder, CEO & Board Member, Dyadic International (NASDAQ:DYAI)

11:35 EDT

  • Acceleration biosimilars development & approvals. 

    • Sarfaraz Niazi, Adjunct Professor of Pharmaceutical Sciences, University of Illinois, Chicago, Co-founder & CSO, Novel351k

12:00        Networking Lunch

13:00 EDT

  • Continuous API Manufacturing.

    • Alastair Florence, Director, Future Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub, University of Strathclyde  

13:20 EDT

  • Building Resilience through Excellence in Biomanufacturing.

    • Rahul Singhvi, Co-Founder & CEO, Resilience

13:50 EDT

  • IP Issues: Driving innovation & preserving global access in light of the covid IP waiver. 

    • ​Kevin Noonan, Partner, Head of the Biopharmaceutical Practice Group, MBHB LLP, Co-Editor, Patent Docs

14:20 EDT

  • INNOVATION SESSIONS 

    • NAKI Therapeutics - Don Liu, Chief Science Officer

    • ​PhageNova Bio - Renata Pasqualini, Chief Scientific Officer and Founder​

      • Q&A Panel​

        • Shiv Krishnan, Head, External Innovation, Biologics R&D,, Lonza

        • Roop Chandwani, Chief Executive Officer,, Mazards

15:00        Coffee Break

15:30 EDT

  • Building for Success in Bio-Manufacturing Spinouts

    • Moderator: Chris Yochim, Director of Business Development, National Institute for Innovation in Manufacturing Biopharmaceuticals – NIIMBL

      • Haro Hartounian, CEO, BioCentriq

      • Fernando Muzzio, Distinguished Professor of Chemical & Biochemical Engineering, Rutgers University 

      • Alastair Florence, Director, Future Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub, University of Strathclyde

      • Vince Smeraglia, Executive Director, Strategic Alliances, The Office for Research, Rutgers University

16:15 EDT

  • Industry perspectives: innovation and partnering in advanced manufacturing. 

    • Justin Sperry, Vice President – Transformational Technology for Biotherapeutics and Vaccines, Worldwide Research, Development and Medical, Pfizer

    • Hemanth Kaligotla, Director External Innovation, Bio R&D, Lonza

    • Leah Stilwell, Senior Director of Business Development, Asymchem Group

    • Douglas Hausner, Senior Manager, Continuous Manufacturing Business Development, Thermo Fisher Scientific 

17:15        End of Day I Program - Reception (to 19:00 / 7:00PM)

Day II    -   Friday July 8

08:15        Registration & Coffee 

09:00 EDT

  • Opening remarks

09:15 EDT

  • Driving innovation in advanced manufacturing through industry-university collaborations - getting it right. 

    • Vipul Davé, Ph.D., Senior Engineering Fellow,​Strategy, Innovation & Deployment, Johnson & Johnson Supply Chain

    • Fernando Muzzio, Distinguished Professor of Chemical & Biochemical Engineering, Rutgers University

09:45 EDT

  • Fostering brain capital to drive the bio-manufacturing revolution - industry training.

    • Parviz A. Shamlou, Vice President & Executive Director, Jefferson Institute of Bioprocessing (JIB), Thomas Jefferson University

10:00        Coffee Break

10:30 EDT

  • End to end continuous manufacturing of liquid products.

    • Diane Burgess, Board of Trustees Distinguished Professor of Pharmaceutics, Pfizer Distinguished Endowed Chair in Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Connecticut 

10:50 EDT

  • Innovation in cell & gene therapy.

    • Christian Hinrichs, Chief, Cancer Immunotherapy Section at Rutgers Cancer Institute of New Jersey

11:15 EDT

  • Needle free delivery of biologics - Crossject & the $60 to $155m BARDA deal.

    • Donald Zinn, Vice President, US Business, Crossject

11:30 EDT

  • VC, Corporate & Public Investment in advanced bio-manufacturing - Models & Interest.

    • Justin Sperry, Vice President – Transformational Technology for Biotherapeutics and Vaccines, Worldwide Research, Development and Medical, Pfizer

    • Stephen Chambers, General Partner – SOSV, & Managing Director, IndieBio NY

    • Tim Rollender, Director - Venture Programs at New Jersey Economic Development Authority (NJEDA)

12:30        Closing Remarks (12:45 End of Program - Networking)

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Addressing Key issues including:

 

  • Ensuring stable, resilient supply chains,

  • Ensuring sufficient supply of innovative medicines and vaccines?

  • How to efficiently re-shore production

  • On-shoring for the first time and rapidly building capacity.

  • Co-development & partnering models, manufacturing & therapeutics development

  • Partnering with industry

  • Transformational new technologies 

  • Technology leapfrogging with innovative technologies and turn-key solutions?

  • Breakthrough innovations in continuous manufacturing of API, end to end production of liquid products, continuous production of biologicals, from peptides to mRNA.

  • Technology and Partnering interests of pharma and industry.

  • Investor interests & opportunities.

  • Working with regulators to enable re-shoring via advanced manufacturing?

  • IP issues with regard to protecting and driving innovation, and ensuring global access?

  • The best models for transferring knowledge and industrial know-how.

  • Effective workforce development for scale up.

  •  

VENUE

Rutgers University Busch Campus Center
Bartholomew Road 604
Piscataway, New Jersey
United States
Co-Organized with Host Partners
Supported by
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Thanks to our Global Innovation Partners
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