Warning: include(rss.php): failed to open stream: No such file or directory in /var/sites/t/termisbpc.org/public_html/index.php on line 8

Warning: include(rss.php): failed to open stream: No such file or directory in /var/sites/t/termisbpc.org/public_html/index.php on line 8

Warning: include(): Failed opening 'rss.php' for inclusion (include_path='.:/usr/local/php-5.6.37-flock/lib/php') in /var/sites/t/termisbpc.org/public_html/index.php on line 8
Regenerate // The Global Cell & Gene Therapy Podcast https://termisbpc.org/ We aim to inspire and equip innovative early career researchers in TERM fields and accelerate the translation of their life-changing ideas from bench to market. Sharing the experience of senior industrial leaders and healthcare innovators. Tue, 02 Feb 2021 21:51:19 +0000 en-GB © 2018 Bokeh Media / Innocell Informative updates on developments within the Tissue Engineering and Regenerative Medicine Industry TERMIS Business Plan Competition episodic We aim to inspire and equip innovative early career researchers in TERM fields and accelerate the translation of their life-changing ideas from bench to market. Sharing the experience of senior industrial leaders and healthcare innovators. TERMIS Business Plan Competition info@termisbpc.org clean http://termisbpc.org/wp-content/uploads/2017/12/itunes-logo.png Regenerate // The Global Cell & Gene Therapy Podcast https://termisbpc.org/ TERMIS Business Plan Competition info@termisbpc.org We aim to inspire and equip innovative early career researchers in TERM fields and accelerate the translation of their life-changing ideas from bench to market. Sharing the experience of senior industrial leaders and healthcare innovators. No https://wordpress.org/?v=5.4.2 Customer Discovery and using the Business Model Canvas (Webinar #6) – June 2017 https://termisbpc.org/podcast/customer-discovery-webinar-6-june-2017/?utm_source=rss&utm_medium=rss&utm_campaign=customer-discovery-webinar-6-june-2017 Wed, 21 Jun 2017 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1871 full 6 1 Session 6: Customer Discovery and using the Business Model Canvas (Webinar)

This special session features Viktor Brandtneris, who is the Owner & Lean Startup Consultant at Brandtneris Consulting, USA.

While this session was only held a few weeks prior to the final round pitching, in order for the teams to incorporate some of the valuable insights. The two methodologies mentioned, ‘Customer Discovery’ and the ‘Business Model Canvas’, are widely used by lean startups at all growth stages. They are extremely valuable aids to help deliver an effective and concise pitch to potential investors.

Speakers:

Viktor Brandtneris, MBA
Owner & Lean Startup Consultant
Brandtneris Consulting, USA

Shiraz Ziya
TERMIS-EU BPC Committee
London, UK

Links mentioned:

———-

We would like to thank our sponsors, PROTiP Medical, Immodgel, J&J Innovation, and the Cell and Gene Therapy Catapult, UK.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 01:29:51 admin No no
How to prepare to meet investors in the TERM industry (Webinar #5) – Mar 2017 https://termisbpc.org/podcast/pap-2016-17-session-5-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-session-5-webinar Thu, 30 Mar 2017 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1816 full 5 1 Session 5: Investment in TERM (Webinar)

This webinar included talks from Matthew Durdy, MBA, Chief Business Officer (Cell & Gene Therapy Catapult) and Dr. Crystal Ruff, MBA, Business Development Consultant.

Developing a financial plan for your start-up can be a daunting task, especially for founders with a scientific or technical background. Forecasting your costs as accurately as possible, realistically valuing your product within the context of its market potential, and identifying your manufacturing cost-of-goods, are crucial prerequisites to securing an appropriate level of investment. Actually securing investment a whole new ball game- pitching to investors is a real art and often requires massive time commitments from company founders.

Speakers:

Matthew Durdy, MBA
Chief Business Officer
Cell & Gene Therapy Catapult, UK

Dr. Crystal Ruff, MBA
Business Development Consultant
8653224 Canada Inc.

———-

We would like to thank our sponsors, PROTiP Medical, Immodgel, J&J Innovation, Cell and Gene Therapy Catapult.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 01:07:27 admin No no
Fireside chat with Dr. Julian Hitchcock, Denoon Legal (London, UK) – Feb 2017 https://termisbpc.org/podcast/pap-2016-17-chat-hitchcock/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-chat-hitchcock Wed, 22 Feb 2017 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1867 bonus 3 1 Fireside chat with Dr. Julian Hitchcock, Denoon Legal (London, UK)

In this episode, Tracy and Oliver sit down with Dr. Julian Hitchcock to hear about his unique career path. This was recorded in Kings College London, UK.

Speakers:

Dr. Julian Hitchcock
Counsel
Denoon Legal

Miss Tracy Yu
Chair of TERMIS-EU BPC
London,UK

Mr. Oliver Ball
Committee Member,
London, UK

———-

We would like to thank our sponsors, PROTiP Medical & Immodgel.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 00:20:31 admin No no
Intellectual Property Strategy in TERM (Webinar #4) – Jan 2017 https://termisbpc.org/podcast/pap-2016-17-session-4-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-session-4-webinar Fri, 20 Jan 2017 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1814 full 4 1 Session 4: Intellectual Property Strategy in TERM (Webinar)

This talk was given by Dr. MacKenna Roberts, a Legal Consultant from IP Asset Ventures Ltd.

Think about intellectual property (IP) from the beginning involving all layers of management. Identify potentially valuable IP early on (patent, trade secret, know-how, copyright, and trade mark). Which part of you IP is most valuable is not always straightforward. Consider what you may want to patent and what to protect as confidential know-how or trade secrets. Control confidentiality carefully protecting against inadvertent disclosures. Disclosing your invention will damage/destroy your IP. Documents protecting you IP (e.g. NDA/CDAs, IP clauses in contracts) are essential from the beginning. Do an IP landscaping exercise early on to identify competitors, potential collaborators and infringers. Maintain a clear paper trail from the beginning recording the IP, its proposed method of protection, and its ownership. Sorting out IP ownership retrospectively is messy and expensive.

Speaker:

Dr. MacKenna Roberts
Legal Consultant
IP Asset Ventures Ltd.

———-

We would like to thank our sponsors, PROTiP Medical, Immodgel and J&J Innovation.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 01:27:13 admin No no
Speaking with Dr. Nihal Engin Vrana, VP Scientific Affairs at PROTiP Medical (Strasbourg, France) – Dec 2016 https://termisbpc.org/podcast/pap-2016-17-vrana-chat/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-vrana-chat Thu, 22 Dec 2016 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1865 bonus 2 1 Speaking with Dr. Nihal Engin Vrana, VP Scientific Affairs at PROTiP Medical (Strasbourg, France)

In this episode, Tracy Yu heads out to Strasbourg, France to speak with Nihal following his delivery of the second webinar.

Speakers:

Dr. Nihal Engin Vrana
VP of Scientific Affairs
PROTiP Medical, France

Miss. Tracy Yu
Chair of TERMIS-EU BPC
London, UK

———-

We would like to thank our sponsors, PROTiP Medical & Immodgel.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 00:08:40 admin No no
Fireside chat with Dr. Chris Gemmiti, Weiss Institute for Biologically Inspired Engineering – Dec 2016 https://termisbpc.org/podcast/pap-2016-17-chris-gemmiti-fireside/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-chris-gemmiti-fireside Mon, 19 Dec 2016 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1863 bonus 1 1 Fireside chat with Dr. Chris Gemmiti, Weiss Institute for Biologically Inspired Engineering

In this episode, Shiraz Ziya catches up with Chris following the first webinar in the PAP series.

Speakers:

Dr. Christopher Gemmiti
Business Development Lead
Wyss Institute, Harvard University, USA

Mr. Shiraz Ziya
TERMIS-EU PAP Lead
London, UK

———-

We would like to thank our sponsors, PROTiP Medical & Immodgel.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 00:34:35 admin No no
Regulation in the Regenerative Medicine Industry (Webinar #3) – Dec 2016 https://termisbpc.org/podcast/pap-2016-17-session-3-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-session-3-webinar Mon, 19 Dec 2016 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1812 full 3 1 Session 3: Regulation in the Regenerative Medicine Industry (Webinar)

The talks of this session were given by Dr Julian Hitchcock from Denoon Legal, and Dr Christopher Bravery from Consulting on Advanced Biologics.

The legal framework for market approval in Europe is provided by EU directives and regulations. There are two fundamental pieces of regulation for ATMPs: The European Tissue and Cells Directive (EUTCD) [Directive 2004/23/EC and implementing directives] and the Advance Therapy Medicinal Product (ATMP) Regulations (1394/2007 and 668/2009). European Medicines Agency and its Committee for Advanced Therapies (CAT) are the two most relevant regulatory bodies. A product may be an ATMP scientifically, but legally it may not be so. ATMP classification can be sought from CAT. Market authorisation can be sought nationally, through mutual recognition in a number of states, or centralised in the EU through the European Medicines Agency.

Speakers:

Dr. Julian Hitchcock
Counsel
Denoon Legal

Dr. Christopher Bravery
Director
Consulting on Advanced Biologicals Ltd

Links mentioned:

———-

We would like to thank our sponsors, PROTiP Medical & Immodgel.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 02:05:28 admin No no
Building an Evidence Base (Webinar #2) – Nov 2016 https://termisbpc.org/podcast/pap-2016-17-session-2-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-session-2-webinar Thu, 17 Nov 2016 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1810 full 2 1 Session 2: Building an Evidence Base (Webinar)

Dr Nihal Engin Vrana, PROTiP Medical, and Dr Mercedes Dragovits, Immodgel, discussed building an evidence base for advanced therapeutics in this webinar.
To provide a strong evidence base for an advanced therapeutic a following must be performed:

  • The proof of concept must be demonstrated both in vitro and in vivo.
  • The safety of each component in the therapeutic must be tested (risk assessment, possible side effects, stability).

Efficacy and ideal parameters of each component must be tested.

  • Fundamental research must be performed to understand the underlying science of the proposed mechanism of the therapeutic.
  • A systematic review of scientific literature should be performed.
  • Meta-analyses must be carried out: What kind of proof does your experimental work provide in light of the analysis of the aggregate results in the relevant field? Randomised control trials have to be performed: What is the clinical and pre-clinical scenario for your product/idea? What are the measures to prevent bias?

Speakers:

Dr. Nihal Engin Vrana
VP of Scientific Affairs
PROTiP Medical, France

Dr. Mercedes Dragovits
Project Manager and Coordinator
Immodgel, Germany

Links mentioned:

———-

We would like to thank our sponsors, PROTiP Medical & Immodgel.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 00:49:01 admin No no
Introduction to the Regenerative Medicine Industry (Webinar #1) – Oct 2016 https://termisbpc.org/podcast/pap-2016-17-session-1-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=pap-2016-17-session-1-webinar Tue, 18 Oct 2016 00:00:00 +0000 admin http://termisbpc.org/?post_type=podcast&p=1808 full 1 1 Session 1: Introduction to the Regenerative Medicine Industry (Webinar)

Lot of innovation. There has been plenty of innovation in the past 5-10 years in regenerative medicine. A traditionally overlooked, but essential, area of innovation is manufacturing: Without the ability to scale up for mass production, a new technology is highly likely to fail. Accordingly, a lot of innovation was put into this side of regenerative medicine recently by a diverse range of companies.

Financing is “white hot”, but cooling off. Most of the funds now come from public investment. The preferred way of raising funds is venture capital. Initial Public Offerings do not meet their targets.

Clinical trial success is mixed. 728 clinical trials are under way as per the second quarter of 2016 (Phase I: 223; Phase II: 439; Phase III: 66). Regenerative medicine therapies will have to demonstrate a much higher standard of care compared to alternatives to justify the high price point and to ensure the long-term success of the field.

Commercial success has not been achieved yet. More than 700 regenerative medicine companies have been set up worldwide. The majority of these are in North America (371), followed by Europe and Israel at 195, and Asia with 112. Cost has to be pushed down, the supply chain improved. Health-economic research is essential. A start-up should invest into demonstrating the health-economic benefit of its product, and also into better understanding the mechanism of action of its therapy as this has significant implications on how clinical trials will need to be designed and what patient groups must be targeted.

Some of the most common reasons for failure are: The discovery/invention does not fit well with industrial needs; the discovery/invention cannot be scaled up, the benefits that the discovery/invention provides is not worth the expenses of commercialisation. Not all interesting scientific solutions are fiscally worthwhile to pursue; target market, market analysis or business plan are not right due to lack of experience; and the “fish out of the water” effect: It is hard for a scientist to suddenly become a businessman.

Speakers:

Dr. Nihal Engin Vrana
VP of Scientific Affairs
PROTiP Medical, France

Dr. Christopher Gemmiti
Business Development Lead
Wyss Institute, Harvard University, USA

Links mentioned:

———-

We would like to thank our sponsors, PROTiP Medical & Immodgel.

Contact us at info@termisbpc.org
For more information, please visit http://www.termisbpc.org/pre-accelerator

]]>
clean no 01:24:05 admin No no