Meet Us

SDEE has a number of truly fantastic events that range from our monthly happy hours to expert-led workshops and networking events.

Want to sponsor an event or happy hour? Please visit https://sdee.nationbuilder.com/sponsor-sdee

  • Friday, January 17, 2020 at 08:30 AM · $30.00 USD
    BDO in San Diego, CA

    Latest Trends on Global Registrations for Pharmaceutical Products

    Friday, January 17, 2020
    8:30 am – 11:30 am

    Location:

    BDO
    3570 Carmel Mountain Road, Suite 400
    San Diego, CA 92130

     

    Sponsored By:

    Sponsor logos

    If your company is planning clinical trials for pharmaceutical products, then this workshop will provide valuable insights for your clinical strategy.  The workshop will provide an update on the latest programs being developed and piloted by regulators the Australian Government expedite approvals for Pharmaceutical products. The program will also cover best practices for global clinical trials, and how to leverage the incentives in Australia to expedite and accelerate market access globally.

    The program will cover:

    • Case studies on parallel reviews (including regulator feedback)
    • How to leverage Australian approvals to gain approval in other APAC territories
    • How to lay the foundations, and special considerations that should be addressed early-on in order to execute global regulatory approvals and participate on these types of programs.

    Background:

    Historically, most major global regulators have undertaken a de-novo comprehensive evaluation of pharmaceutical applications regardless of whether they have been reviewed and approved by other major regulators, leading to duplication of efforts and delays to patient access.

    During this presentation we will outline the recent programs pilots in Australia to truncate the evaluation activities and timelines through the recognition of product evaluations and approvals by comparable international regulators. These programs are being piloted between the EU, Canada, FDA and Australia.

    The utilization of this approach can accelerate companies to market access in these key geographies and as an extension to expand to broader regions.

    The success of these programs may open a new paradigm for international registration of pharmaceutical products. 

    Objectives:

    • Describe the opportunity to obtain a simplified regulatory evaluation and an accelerated regulatory approval by leveraging approvals in the other regulated markets (USA, EU, Canada, Australia).
    • Outline new regulatory approval pathways for international registrations using Australia as a case study.
    • Outline best practices on how to leverage clinical data for international registrations.
    • Identify how regulatory approvals in Australia can serve as a steppingstone to regulatory approvals in the Asia Pacific region.

    Agenda:

    8:30 – 9:00am: Networking and light breakfast

    9:00 – 10:30am: Presentations

    10:30 – 11:00am: Discussion & Q & A

    11:00 – 11:30am: Networking

     

    Speakers

    Robert StringerRobert Stringer, Director of Pharma Services, Brandwood CKC

    Robert Stringer has more than 25 years of experience in the Australian and New Zealand pharmaceutical industry.

    Prior to establishing Capital K Consulting, Robert was a member of the leadership team at AstraZeneca Australia, having managed the Regulatory Affairs, Clinical Research and Strategic Planning & Business Development teams. His career also includes the green fields market entry into Australia of Sandoz (the generic arm of Novartis), ultimately holding the role of Research and Development Manager. In this role his responsibilities included leading the regulatory, product development, and quality assurance functions, along with joint leadership of the product sourcing and partnering arrangements. At Sandoz, Robert achieved the world-first market approval of a biosimilar.

     

    Grant Bennett

    Grant Bennett, CEO, Brandwood CKC

    Grant Bennett has a deep and practical experience of regulatory affairs gained through medical devices industry roles across the Asia Pacific. His prior experience includes roles as Regional Regulatory Affairs Manager Asia Pacific and Australia/New Zealand Quality Assurance Manager with a US-headquartered, multinational supplier of professional Medical Devices.

    An internationally respected industry leader, Grant chairs both the Regulatory Affairs Expert Panel and National Advisory Council for Australian industry peak body AusMedtech. He is an adviser to the Asian Harmonization Working Party (AHWP), supporting regulatory guidance development in pre-market assessments, labelling and UDI implementation

  • Tuesday, February 04, 2020 at 06:00 PM through February 07, 2020

    North American Protein Degradation Conference

    North American Protein Degradation Conference

    Plus Pre-conference deep dive into ‘Drugging the Proteasome’

    February 4-6, 2020

    San Diego, USA

    “The entire bandwidth of the protein degradation field was covered with excellent, carefully prepared presentations” -  Peter von Matt, Novartis

    With Arvinas’ PROTAC therapy entering phase 1 clinical trials, Kymeras’ IRAK4 degrader racing through pre-clinical, and Bristol-Myers Squibb approaching complete acquisition of Celgene, it has never been a more exciting time to be working in the field of targeted protein degradation.

    Following the global response to the inaugural European Congress earlier this year, the North American Protein Degradation Congress will bring together pharma, biotech, and academic researchers to expand upon one of the hottest drug discovery platforms within the pharmaceutical industry. Delegates will have the opportunity to learn from experts and key thought leaders within the protein degradation space, allowing ideas to be exchanged, partnerships to be built, and difficulties to be addressed in expanding the space of protein degraders beyond our current knowledge.

    At the congress, you can expect to hear the following:

    • The latest pre-clinical and clinical data in PROTAC therapy and molecular glues
    • Emerging strategies outside of PROTACs and molecular glues to induce TPD
    • Assessing rates of protein synthesis, degradation, and quantifying protein homeostatic in vivo
    • Insights into protein degrader PK/PD from mechanistic modelling

    To register: https://go.kisacoresearch.com/l/678123/2019-10-31/svzg

  • Tuesday, February 11, 2020 at 05:00 PM

    Bootcamp

  • Thursday, February 20, 2020 at 05:30 PM
    New English Brewing Company in San Diego, CA

    February Happy Hour

    Come network with your fellow San Diego entrepreneurs at Happy Hour held at the New English Brewing Company in Sorrento Valley. SDEE members - stop by the SDEE table, make a name tag, and collect one free drink ticket and one free food ticket. This month's food truck is Angry Pete's Pizza. You must be an SDEE member to receive food and drink tickets. 

    Not a member yet? Just ask SDEE about the benefits of joining and/or ask members at the event about the benefits they've received from joining. Our members are happy to spread the word! 

    Everyone is welcome (registration is free!), SDEE members get 10% drinks discount.

  • Monday, March 02, 2020 at 12:00 PM through March 05, 2020
    Loews Coronado Resort

    Festival of Biologics USA, March 2 - 4, 2020

    The Festival of Biologics brings together senior biologics professionals to showcase their research, collaborate on challenges, forge new connections and ultimately advance the industry to improve patient health.

    It is the meeting place for the life science community to bridge the gap between academia and industry. With three events in one, the Festival of Biologics encourages conversation across the entire industry so you can inspire change, champion innovation, and address complex challenges.

    Purchase tickets here: www.terrapinn.com/fobsd/sdee

  • Tuesday, March 10, 2020 at 05:00 PM

    Bootcamp

  • Thursday, March 19, 2020 at 05:30 PM
    New English Brewing Company in San Diego, CA

    March Happy Hour

    Come network with your fellow San Diego entrepreneurs at Happy Hour held at the New English Brewing Company in Sorrento Valley. SDEE members - stop by the SDEE table, make a name tag, and collect one free drink ticket and one free food ticket. This month's food truck is Angry Pete's Pizza. You must be an SDEE member to receive food and drink tickets. 

    Not a member yet? Just ask SDEE about the benefits of joining and/or ask members at the event about the benefits they've received from joining. Our members are happy to spread the word! 

    Everyone is welcome (registration is free!), SDEE members get 10% drinks discount.

  • Tuesday, April 07, 2020 at 05:00 PM

    Bootcamp

  • Thursday, April 16, 2020 at 05:30 PM
    New English Brewing Company in San Diego, CA

    April Happy Hour

    Come network with your fellow San Diego entrepreneurs at Happy Hour held at the New English Brewing Company in Sorrento Valley. SDEE members - stop by the SDEE table, make a name tag, and collect one free drink ticket and one free food ticket. This month's food truck is Angry Pete's Pizza. You must be an SDEE member to receive food and drink tickets. 

    Not a member yet? Just ask SDEE about the benefits of joining and/or ask members at the event about the benefits they've received from joining. Our members are happy to spread the word! 

    Everyone is welcome (registration is free!), SDEE members get 10% drinks discount.

  • Thursday, May 21, 2020 at 05:30 PM
    New English Brewing Company in San Diego, CA

    May Happy Hour

    Come network with your fellow San Diego entrepreneurs at Happy Hour held at the New English Brewing Company in Sorrento Valley. SDEE members - stop by the SDEE table, make a name tag, and collect one free drink ticket and one free food ticket. This month's food truck is Angry Pete's Pizza. You must be an SDEE member to receive food and drink tickets. 

    Not a member yet? Just ask SDEE about the benefits of joining and/or ask members at the event about the benefits they've received from joining. Our members are happy to spread the word! 

    Everyone is welcome (registration is free!), SDEE members get 10% drinks discount.


Attend SDEE Events Donate | Sponsor SDEE Become a Member

Connect with SDEE

Sign Up for SDEE Newsletter


SDEE PLATINUM SPONSORS

Morrison Foerster Alexandria

Struthers Family
Trust

SDEE GOLD SPONSORS

BioMed Realty

Ted Jacobs
Executive Managing Director
Global Life Sciences Practices Group

Brex logo

SDEE SILVER SPONSORS

Takeda San Diego Union Bank JP Morgan logo

SDEE BRONZE SPONSORS

Duane Morris MaxCyte Wagenknecht Barney and Barney Longfellow

SDEE is a nonprofit 501(c)(3) organization founded by local San Diego entrepreneurs
in order to provide a voice for the early stage start-up, to support new entrepreneurs and their companies,
and to sponsor networking and educational events
to help develop the skills necessary to bring funding, business, and jobs to the San Diego area.

© 2015 San Diego Entrepreneurs Exchange. All Rights Reserved