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STEM 2017 Venue: Hotel Royal Orchid Resort, Allalsandra, Yelehanka,Bangalore. Focusing on latest trend in Stem Cells, Regenerative Medicine and Tissue Engineering. PANEL DISCUSSION: “ Cellular Therapies in India: The way forward” Regulatory norms and solutions. Guest Of Honor: Dr. Pragnya Rao, Associate Dean, Kasturba Medical College, Manipal University. Dr. C.M.HABIBULLAH MEMORIAL Symposium: Padmabhushan Dr. Shiva kumar Sarin, Director, Institue of Liver and Biliary Sciences, Delhi. Speakers: Panelists: Moderator: Dr. Gururaj.A.Rao Dr. Vivek.Tanavade. Dr. S.G.Ananda.Rao Dr. R.S.Verma. Dr. R.R.Bhonde. Dr. Anupam Kumar. Dr. Gopal. Pande. Dr. Rakhi Pal. Dr. Soma.Guharthakartha. Dr. Anujit.Kumar. Dr. B.M. Gandhi Dr. Aejaz. Habeeb. 2004 2005 2006 2007 2009 2010 2011 2012 2013 2014 2015 2016 2017 13th Annual Meeting : STEM 2017 4th Febraury 2017 STEM 2017 SRMTE SOCIETY FOR REGENERATIVE MEDICINE AND TISSUE ENGINEERING (SRMTE) Phone: 080-65652220 E-mail: [email protected] Society for Regenerative Medicine and Tissue Engineering (SRMTE) STEM 2017 STEM 2017

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STEM 2017 Venue: Hotel Royal Orchid Resort, Allalsandra, Yelehanka,Bangalore. Focusing on latest trend in Stem Cells, Regenerative Medicine and Tissue Engineering. PANEL DISCUSSION: “ Cellular Therapies in India: The way forward” Regulatory norms and solutions. Guest Of Honor: Dr. Pragnya Rao, Associate Dean, Kasturba Medical College, Manipal University. Dr. C.M.HABIBULLAH MEMORIAL Symposium: Padmabhushan Dr. Shiva kumar Sarin, Director, Institue of Liver and Biliary Sciences, Delhi. Speakers: Panelists: Moderator: Dr. Gururaj.A.Rao Dr. Vivek.Tanavade. Dr. S.G.Ananda.Rao Dr. R.S.Verma. Dr. R.R.Bhonde. Dr. Anupam Kumar. Dr. Gopal. Pande. Dr. Rakhi Pal. Dr. Soma.Guharthakartha. Dr. Anujit.Kumar. Dr. B.M. Gandhi Dr. Aejaz. Habeeb.

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13th Annual Meeting : STEM 2017 4th Febraury 2017

STEM

2017

SRMTE

S O C I E T Y F O R R E G E N E RA T I V E M E D I C I N E A N D T I S S U E E N G I N E E R I N G ( S RM T E )

Phone: 080-65652220

E-mail: [email protected]

S o c i e t y f o r R e g e n e r a t i v e M e d i c i n e a n d T i s s u e E n g i n e e r i n g ( S R M T E )

STEM 2017

STEM 2017

Society for Regenerative Medicine &Tissue Engineering (SRMTE) (Non Profit Society Registered in Maharashtra under Societies Act. 1860)

STEM 2017

13th Annual Conference

4th February 2017

Venue: Royal Orchid Resort, Allalsandra, Yelahanka, Bangalore.

Program Schedule

Registration 8:30 – 9:30

Inaugural Session: 9.30 to 11.00

Opening Remarks Dr. Gopal Pande, Professor and Dean

School of Regenerative Medicine, Manipal University, Bangalore. Dr. S. G. A. Rao, Founder Trustee, SRMTE.

Presidential Address: Dr. Manoj Mojamdar, President, SRMTE.

Chief Guest: Vice Chancellor, Manipal University.

Guest of Honor: Dr. Pragna Rao, Associate Dean,

Kasturba Medical College, Manipal University.

Habibullah Memorial Oration: Padma Bhushan Dr. Shiv Kumar Sarin, Director, Institute of Liver and Biliary Sciences, Vasanth Kunj, New Delhi.

Title: “Liver Regeneration in Health & Disease”

Vote of Thanks: Dr. Jyothsna Rao, Secretary, SRMTE.

Tea Break: 11:00 to11:30

Session I: 11:30 - 12.30

Dr. Vivek Tanavade, Ahmedabad University.

Title: “Use of Next Generation Sequencing Technologies in Understanding Development

& Differentiation.”

Prof. R. S. Verma, IIT, Madras.

Title: “Cardiogel - A Novel Biomatrix for cardiac regeneration”

Panel Discussion: 12.30 to 1.30

Topic: “Cellular Therapies in India– The way forward”.

Panelist:

Dr. Gopal Pande, Professor and Dean, School of Regenerative Medicine, Bangalore.

Dr. S. G. A. Rao, Founder Trustee, SRMTE.

Dr. Md. Aejaz Habeeb, Professor, Deccan College of Medical Sciences, Hyderabad.

Dr. B. M. Gandhi, Former Advisor, Ministry of Science and Technology, New Delhi.

Dr. Shiv Kumar Sarin, Professor, Institute of Liver and Biliary Science (ILBS), Delhi.

Dr. Ramesh Bhonde, DY Patil University, Pune.

Dr. Soma Guhathakurtha, Synkromax Biotech and IIT Madras.

Moderated by: Dr. Gururaj A Rao, Research Director, International Stemcell Services Ltd, Bangalore.

Lunch Break 1:30 to 2.30

Session II: 2.30 - 4.00

Dr. Anupam Kumar, ILBS, Delhi.

Title: “Bone marrow in liver development and regeneration: bench to bed side”.

Dr. Rakhi Pal, inStem, Bangalore.

Title: “Neuro-Glial characterization in a humanized neuro developmental diseased model

system”.

Dr. Anujith Kumar, SORM, Bangalore.

Title: “Paradoxical role of Zic3 in self-renewal and differentiation of stem cells: A player

in the dual zone”.

Tea Break: 4:00 to 4.30

Session III: 4.30 – 6:00 (Student Presentation)

Ms. Swathi Sridhar, BMS College of Engineering, Bangalore.

Title: “Platelet Rich Plasma in Knee Pain”.

Ms. Ankita Umrao, Sri Raghavendra Biotechnologies Pvt Limited, Bangalore.

Title: “Chemopreventive action of Swastharakshak® in cancer”.

Ms. Ranjitha. A and Ms. Sathyashree. P. V., Maharani Lakshmi Ammanni College, Bangalore.

Title: “Identification of proteins in Human Umbilical Cord Blood (HUCB) as a validated

biomarker”.

Ms. Sowmya Jahnavi, SORM, Bangalore.

Title: “IFNg mediated lineage choice perturbations in Mesenchymal stem cells: Impli-

cations in reestablishing connective tissue homeostasis during stress”.

Ms. Bhavana Chandravamsi, SORM, Bangalore.

Title: “MSC protect Islets against hypoxia and inflammation milieu”.

Valedictory and concluding remarks.

Associates:

This year the annual conference of SRMTE was held in association with School of Regenerative Medicine (SORM) in

Royal Orchid Resorts, Bangalore and boasts of an impressive clutch of speakers in the space of Stem cell and Regen-

erative Medicine. The conference started on a positive note with the conveners: Dr. S. G. Ananda Rao, Founder

SRMTE, and Dr. Gopal Pande, Dean, SORM, who went on to set the stage with the content focus matter of the meet-

ing. This year the focus was:

Cellular Therapies in India: The way forward.

The conference, as in its tradition saw eminent scientists from the field of stem cells and Tissue Engineering. The

opening remarks were by the conveners Dr. S. G. Ananda Rao, Stem Foundation and Dr. Gopal Pande, Dean, SORM,

which set the stage for the other eminent speakers to present their views in the conference. Dr. Rao spoke of his asso-

ciation with Dr. Habbibullah and reminisced his strong desire to work in the clinical applications of stem cells espe-

cially in liver patients. Dr. Pande also spoke about their association in the past.

The Guest of Honor for this year was Dr. Pragnya Rao, Associate Dean, Kasturba Medical College, Manipal Univer-

sity. She touched upon the status of research in India and expressed strengthening of our research activities in the field

of Stem cells and Regenerative Medicine.

The Padmashri C.M. Habibullah memorial lecture was delivered by Dr. Shiv Kumar Sarin, Director, Institute of Liver

and Biliary Sciences, Delhi, titled “Liver Regeneration in Health and Disease”. Dr. Sarin delivered a very informative

lecture on the biology of liver and the pathogenesis associated with liver failure. He spoke about his studies and ex-

perience in treating liver diseases and the modalities to be adopted to get positive clinical outcome. He showed the

stem cells could be an important treatment modality which could lead to better clinical outcome.

Dr. Vivek Tanavade, University of Ahmedabad, and spoke about Next Generation Sequencing as a tool in understand-

ing the role of miRNA in development and differentiation using a zebrafish model. Prof. R. S. Verma spoke about

Cardiogel, a novel biomatrix for cardiac regeneration.

The proceedings of “STEM – 2017” 13th Annual Meeting

Society for Regenerative Medicine and Tissue Engineering (SRMTE).

The Panel Discussion was centered on the topic of the way forward for Cellular Therapies in India. The panel was

moderated by Dr. Gururaj Rao, International Stem Cell Services, who initiated the discussion by presenting the current

state regulatory affairs. The panelists comprised of distinguished scientists, including Dr. S. G. Ananda Rao Founder-

Trustee, SRMTE, Dr. Gopal Pande, Dean, SORM, Dr. B.M. Gandhi, Former Advisor to DBT, Dr. R. R. Bhonde, For-

mer Dean, SORM, Dr. Soma Guhathakurtha, Synkromax and Dr. Md. Aejaz Habib, CLRD, Deccan College, Hydera-

bad. The experts expressed concern over the lack of clarity in regulations. The general consensus was that guidelines

to ensure quality assurance and quality control of stem cell processing must be implemented. Recommendations from

the panel members in the SRMTE meeting was to create a referendum comprising of all stake holders in the stem cell

space including clinical scientists, doctors and hospitals and representing this to the government for further delibera-

tions with definite time frame. A balanced approach will be needed to nurture this field and prevent unscrupulous

profiteering at the expense of patients. Since cellular therapy has already entered the generic space, what is required is

a structure that allows therapeutic use of cells with appropriate oversight. Also, members of the panel advocated the

support of social media to accelerate the process. (This coming from a power house panel comprising of Dr. S.G. An-

anda Rao, Dr. Gopal Pande, Dr. Ramesh Bhonde, Dr. B. M. Gandhi and similar stalwarts in the area should be taken

up seriously).

The major concern was how to regulate the clinical procedures involving stem cells, rampantly practiced by

doctors, without proper quality control on the stem cells. The panelists were critical about the lack of frame-

work and guidelines in this domain, which allowed doctors and physicians to circumvent the system and prac-

tice stem cell therapy in their operating theatres and clinics. This they observed was very akin to the IVF indus-

try which is offered by many doctors without proper training, QA/QC, registered processing centre and proper

infrastructure.

The general consensus was to have proper guidelines for the stem cell processing cGMP unit which could function

under a proper frame work under the jurisdiction of an independent regulatory body. The centre could process autolo-

gous and allogeneic stem cells and the doctors will abide to the frame work and source their cells in this manner. Stem

cell processing centers must be closely working with clinical treatment centers which are also registered before al-

lowed to offer cellular therapies. One option is to provide the option of centralized facility that can provide standards

for quality. Such units, preferably one in every region, will help in maintaining quality standards for stem cell process-

ing. This system is akin to registration required for ART (Assisted Reproductive Technology) clinics and banks as per

the proposed ART bill.

Data obtained from clinical trials (India and worldwide) in adult stem cells must be considered and there is an urgent

need to expedite the process of using adult stem cells as standard of care in certain conditions where there is sufficient

clinical data. In areas which need further validation, clinical research must be encouraged and results must be collated

to determine their efficacy. A clear end point must be to evaluate the mode in which these therapies can be incorpo-

rated in routine clinical practice. The panel agreed that there must be a mechanism to fast-track stem cell applications

for certain conditions and on the whole a constructive step must be taken to ensure the timely adoption of cellular

therapies in the clinic. The panel agreed that growth in the regenerative medicine sector has been stunted due to lack

of clear regulatory guidelines. A positive step will boost this field by eradicating ambiguity and spurring job opportu-

nities in this field. The panel consensus was to apply to the Government of India with an urgent appeal to redress the

concerns of all stakeholders in this field.

PANEL urges the Health Ministry to constitute a new independent body which will oversee cellular therapies

which will include adult stem cells and related cells in the clinical realm. This should be implemented like the

ART bill and the regulatory process must akin to the ART bill.

The conference ended on a positive note to continue the tradition of research and learning.

The 13th meeting SRMTE heralded a new step in the direction of public policy in the area of stem cell clinical applica-

tions. Based on the recommendations of our panelists and a cumulative policy decision deliberated for 13 years

SRMTE has come up with a referendum to the government for a change in public policy regarding stem cell therapy

and would like to fast track the process in the government to accelerate clinical trials which will in turn make them

more acceptable in our medical community to be put to practice.

Dr. Jyothsna Rao facilitating Dr. Pragnya Rao Dr. S G A Rao

Dr. Shiv Kumar Sarin : Dr.C.M. Habibullah Memorial Lecture.

SRMTE Team

Panel Discussion At lunch

Dr. S G A Rao and fellow Delegates

Student Presentations

Dr. Gururaj Rao facilitating Dr. Verma Dr. Gururaj Rao facilitating Dr. Vivek Tanavade Dr. Rakhi Pal.

Dr. Gururaj Rao facilitating Dr. Bhonde Dr. Gururaj Rao facilitating Dr. Gopal Pande Panel Discussion

O ur Cherished Moments Over the years……...