Friday, September 22- 5th American Alternative Muscle Club Meeting

Date
Location
The Sanford Consortium For Regenerative Medicine 2880 Torrey Pines Scenic Dr. La Jolla, California 92037
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Friday, September 22, 2017
5th American Alternative Muscle Club Meeting
The Sanford Consortium For Regenerative Medicine
2880 Torrey Pines Scenic Dr.
La Jolla, California 92037

Genea Biocells is proud to be sponsoring the Young Investigator Awards and poster prizes for the 2017 Alternative Muscle Club Meeting this Friday, September 22, 2017 at the Sanford Consortium for Regenerative Medicine.
This meeting is an opportunity for young investigators early in their research careers from academia, industry and medical sectors to present their work in a relaxed environment. The free daylong meeting will cover a wide range of research areas, reflecting the diverse types of cutting-edge muscle research undertaken today. Topics will include Muscle Structure and Signaling, Biomechanics and Biophysics of Muscle Contraction, Muscle Development, Muscle Regeneration and Cardiac vasculature.

The AMC has always been a meeting for young scientists with a strong emphasis on career support and networking and will again include the ‘Translational Medicine Workshop’ along with
‘Interviewing for Industry’ workshop and a ‘Funding Opportunities Panel.'

For more information on AMC please visit: Alternative Muscle Club. For more information on Genea Biocells please visit: Genea Biocells.

Thursday, August 10-How Will Brexit Impact Your Clinical Supply Strategy? | How Can You Prepare for the QP Process? | Hear the Patient’s Perspective on the Importance of Clinical Trials

Date
2pm - 6pm

How Will Brexit Impact Your Clinical Supply Strategy? | How Can You Prepare for the QP Process? | Hear the Patient's Perspective on the Importance of Clinical Trials

What: Sherpa Summer Seminar
For: Anyone managing clinical supply, global or domestic

When: Aug 10 | 2 – 6 pm
Where: Sherpa Clinical Packaging,
6166 Nancy Ridge Drive
San Diego CA 92129

By popular demand, Sherpa will be hosting the 2nd annual Sherpa Summer Seminar on August 10th, and you are cordially invited!

With Brexit scheduled to be finalized by March 2019, now is the time to understand how this major political shift could impact your clinical study design, cost, and efficiencies.
Attendees will hear from industry thought leaders on:
• The impact of Brexit on European clinical studies and global depots
• How sponsor companies can best prepare for the QP Process
• The Importance of clinical trials from the patient's perspective

Afterwards, join us and San Diego's life sciences community for BBQ during our open house and tour our new 2017 facilities addition!

Learn more and register for this complimentary event with Sherpa Clinical Packaging

August 9th, 2017-Generic Products: Opportunities for Southern California Companies

Date
8am - 10am
Location
Biocom-McGraw Boardroom-10996 Torreyana Rd. Suite 200, San Diego, 92121

Generic Products: Opportunities for Southern California Companies

"Generics - An Overview"
Giff Marzoni, Vice-President Global Pharmaceutical Development DavosPharma

"Navigating the Regulatory Paths for Generics"
Luman Wing, Director Executive Consultant, Cardinal Health

"Value Creation through Formulation of Generic Topicals"
John M Newsam, CEO Tioga Research

8 in 10 of the 4.5 billion US prescriptions in 2016 were for generic drugs. A generic drug is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. A generic drug is required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product, but need not contain the same inactive ingredients. It must, however, be proven to be bioequivalent to the brand name product.

If you are curious about the business drivers behind the generics industry, about the developmental and regulatory paths for a generic, about how bioequivalence can be proven, or about the strength of protection that a patent on an innovator product can provide, you might consider joining this event.

The event provides an introduction to the generics business in the US, overviewing business, technical, developmental and commercial aspects. Regulatory issues and requirements are summarized and strategies for realizing streamlined approvals outlined. And the event includes examples of where formulation creativity can establish a basis for a generic approval.

Thursday, July 27th: 8am-10am Biocom CRO Presents: Pharma Outsourcing from Concept to Commercial: Strategies Addressing CMC Needs

Date
8am - 10am
Location
Biocom, 10996 Torreyana Rd, Suite 200, San Diego, CA 92121

Biocom CRO Presents: Pharma Outsourcing from Concept to Commercial:

Strategies Addressing CMC Needs

Outsourcing in Pharma has evolved from a tool to supplement internal activities to a necessary function designed to improve efficiencies and control costs within research and development organizations. This is particularly relevant to start-up pharmaceutical and biotechnology companies. However, realizing successful outcomes following engagement of CRO/CMO resources can be challenging - especially when working across large distances and without the ability to frequently monitor day-to-day activities. Through adoption of key strategies, efficiencies with CRO/CMO resources can be increased thus maximizing chances for successful project outcomes. This panel discussion brings together leading experts covering research, process development and manufacturing, and formulation development who will provide their insight on strategies for success in the CMC space.

Speakers:

• Research panelist – BioBlocks – Warren Wade

• Manufacturing panelist – Norac Pharma – Danny Levin

• Formulation panelist – Catalent Pharma Solutions – Bryan Knox

• Moderator – DEL BioPharma LLC – Daniel E. Levy

________________________________________

When: Thursday, July 27th

8:00 a.m. - 10:00 a.m.

*This event is free for Biocom members

June 14, 2017- Concept to Commercialization : Why the Current CRO Model May Be Failing Developers, Investors and Patients

Date
8am - 10am
Location
Biocom-10996 Torreyana Road, Suite 200, San Diego, CA 92121
Speakers:
James Nolan , CEO, InClinica , ,

“Concept to Commercialization : Why the Current CRO Model May Be Failing Developers, Investors and Patients”

The first in a series of “Concept to Commercialization” presentations, this lecture will examine why the current CRO model may be failing developers, investors and patients. Does a new model CRO need introduction to the industry? Yes, according to pharmaceutical leader James Nolan, one that includes these four, key elements and available at the earliest stages of development:

• A reimbursement strategy
• Regulatory experts
• Pre-IND evaluation capabilities
• Patient access experts.

These added capabilities will allow CROs to separate themselves in a highly competitive industry. Mr. Nolan will also detail key issues complicating the concept to commercialization path for drug developers.

Drug Delivery Experts and Protea Biosciences to present a poster at the 13th Annual Protein Engineering Summit in Boston MA on May 1-5, 2017

Dates
Location
Boston, MA
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DRUG DELIVERY EXPERTS AND PROTEA BIOSCIENCES AT PEGS BOSTON 2017

San Diego, CA – May 2, 2017 Drug Delivery Experts and Protea Biosciences to present a poster at
the 13th Annual Protein Engineering Summit in Boston MA on May 1-5, 2017. The poster, entitled
“Sequencing of Polyethylene Glycol Conjugation Site on a Protein by High-Resolution Mass
Spectrometry”, will be presented at Session A.
This work represents a collaboration between Drug Delivery Experts and Protea Biosciences to
determine the specific site of PEG attachment using HPLC with high-resolution mass spectrometric
analysis. DDE designs PEG-protein conjugates to provide prolonged half-lives and improved efficacy
due to the ability of the PEG moiety to reduce renal clearance, improve stability to proteases, and alter
immunogenicity for polypeptide therapeutics. Site-specific PEGylation is essential to produce a
homogenous biotherapeutic agent. For this project, DDE conjugated 20KDa PEG to a defined site and
provided the purified PEGylated protein as a substrate for demonstration of a new methodology to
unequivocally determine the site of PEGylation. Protea Biosciences utilized high resolution mass
spectrometry analysis of PEG conjugates by in-source collision induced dissociation and higher
energy collisional dissociation mass spectrometry to sequence the tryptic peptide and determine the
definitive location of PEG conjugation.
About Drug Delivery Experts
Drug Delivery Experts (DDE) is a drug product development firm that specializes in the research,
development, and translation of drug delivery systems from preclinical to clinical development and
commercialization. DDE has specific expertise with peptides, proteins, oligonucleotides, formulation,
process, and development of combination drug products. Leveraging over 200 years of pharmaceutical
development experience, the team at DDE has worked across nearly all routes of administration, from
injection devices to non-invasive delivery technologies, at a broad range of companies. Drug Delivery
Experts brings a unique perspective to drug product programs and understands the value proposition
for each stakeholder, from startup company, delivery technology provider, to pharmaceutical
company, along with investors and board members. Christopher A. Rhodes, Ph.D., founded the DDE
in 2014 after his 22-year tenure in pharmaceutical, biotechnology, and drug delivery industries,
translating delivery technologies from R&D to product development. Drug Delivery Experts is located
in San Diego, California.
About Protea Biosciences
Protea Biosciences is an innovative bioanalytics technology organization offering Mass Spectrometry
Imaging and LC-MS services focused on protein characterization, proteomics, metabolomics, and
small molecule analysis. Using state-of-the-art instrumentation including high resolution, accurate
mass (HRAM) mass spectrometry systems, MALDI, and the LAESI®DP-1000 Direct Ionization
System, Protea supports researchers’ projects by providing information to accelerate drug discovery
and development. Protea’s infrastructure and workflows enable the identification, quantification,
characterization, and spatial distribution of biomolecules such as proteins, metabolites, and lipids from
biological matrices. Protea’s analyses include proprietary sample preparation methods, method
development, and data analysis, with applications in the fields of pharmaceutical, clinical, academic,
and industrial research. Protea also offers a line of mass spectrometry standards and protein sample
preparation products, which include Progenta Acid Labile Surfactants, Ultrapure MALDI Matrices and
mass spec grade protein standards. Protea is located in Morgantown, West Virginia.

April 19, 2016-Chemistry Outsourcing: Helping Small Companies Achieve Big Goals

Date
8am - 10am
Location
Biocom-10996 Torreyana Rd. Ste. 200, San Diego, CA 92121
Speakers:
Daniel E. Levy, Ph.D. , Consultant, DEL Biopharma, LLC , , Peter Pallai, Ph.D , CEO, BioBlocks , , Warren S. Wade, Ph.D , Vice President, Chemistry , ,

Chemistry outsourcing has evolved from a tool to supplement internal activities to a necessary function designed to improve efficiencies and control costs within research and development organizations. This is particularly relevant to start-up pharmaceutical and biotechnology companies. However, realizing successful outcomes following engagement of CRO/CMO resources can be challenging - especially when working across large distances and without the ability to frequently monitor day-to-day activities. Through adoption of key strategies, efficiencies with CRO/CMO resources can be increased thus maximizing chances for successful project outcomes.

March 16, 2017-CRO Networking Mixer

Date
4pm - 6pm
Location
Biocom, 10996 Torreyana Road, Suite 200 San Diego, CA 92121

Please join us on Thursday, March 16th, from 4pm-6pm on the Biocom Patio for a hosted networking reception specially designed for our CRO Members. With over a hundred CRO’s in our membership, this is an opportunity to gain a better understanding of your colleagues expertise in order to foster more collaboration within the CRO Community. We invite you to make valuable connections while enjoying sunset hors d'oeuvres and cocktails on our terrace while listening to a brief pitch about each participating CRO and the services they offer. We hope to see you there!