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

8am - 10am
Biocom-10996 Torreyana Road, Suite 200, San Diego, CA 92121
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

Boston, MA
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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

8am - 10am
Biocom-10996 Torreyana Rd. Ste. 200, San Diego, CA 92121
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

4pm - 6pm
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!

February 8, 2017, Best Practice Series, IND-Enabling Studies

8am - 10am
4242 Campus Point Court San Diego, CA 92121
Joe Francisco, Ph.D. , Scientific Advisor, Charles River Lab , Essential Elements of an IND Application to Support Phase 1 Clinical Trials , Hua Yang, Ph.D. , CSO, Pharmaron Inc. , Specifics of what is included in IND-enabling studies and how to do it , Peter Rix, DABT. , President, Vector Pharma Advisors, Inc. , a) So you think you have a clinical candidate? b) Why do I need consultants anyway? ,

Is your company preparing an IND submission file? Gain critical insights from three industry experts. This presentation provides an overview of the preclinical drug development process, describing the range and scope of studies necessary to advance a new small molecule or biologic drug into and through the clinic. Three industry experts with extensive drug discovery and development experiences will present a deep dive into the best planning and practices for IND enabling studies. Case studies will be shared to stimulate in-depth discussions from both pharma and CRO perspectives. Come join this very informative session to learn how to prepare for a successful IND submission.

December 8, 2016-Structural & Functional Biosimilarity- Concepts & Technical Considerations

8am - 10am
Biocom-10996 Torreyana Rd. Suite 200 San Diego, CA 92121
Tod Lauerman, Ph.D , Corporate Development, Ajinomoto Althea, Inc. , , Dr. Bérangère Tissot , Subject Matter Expert, SGS , ,

Case Study: Protein Crystallization as a Strategy for Reducing Viscosity of High Concentration Protein Formulations
There are limited options for delivering the large quantity of therapeutic mAbs needed for clinical efficacy. Solubility, viscosity and potency limitations usually require IV infusions which are time consuming, costly, and require administration by a healthcare professional. Althea Technologies’ Crystalomics® platform produces high concentration (up to 350 mg/ml), low viscosity protein formulations suitable for SC administration. Crystalomics® formulations have completed Phase 2 human clinical trials. Formulation viscosity, potency and stability data will be presented.

The development pathway of a biosimilar is unlike that of a novel biotherapeutic. Many regulatory authorities reference a “step-by-step” approach to establishing biosimilarity.
A question which is often asked is – “how similar to the originator molecule must the biosimilar be”?
It is clear from most of the guidelines that the primary protein structure, the amino-acid sequence, must be the same, otherwise it will not be considered as a “Biosimilar”. The guidelines anticipate that minor differences in post-translational forms or product-related impurities may exist and that these should be investigated with regard to their potential impact on safety and efficacy. The US FDA has adopted a similar approach, in that the analytical characterization should show that it is “highly similar to the reference product notwithstanding minor differences in clinically inactive components”.
On the top of the primary structure and the PTMs, High Order Structure (HOS) characterization is a pre-requisite to any similarity study and all regulatory agencies require orthogonality in the methods selected to characterize these aspects of the innovator and the biosimilar products.
This presentation will include a brief review of the regulatory landscape, provide some insight on the structural and functional characterization techniques for biosimilarity assessment, and discuss comparability and similarity study design.

December 1, 2016-Partnering and Exiting for CROs: Tales from Founders and Investment Bankers

8am - 10am
Biocom 10996 Torreyana Rd, Suite 200, San Diego, CA 92121
Tim Scott , President, Pharmatek , , Ed Foster , President, Eurofins/Advantar , ,

Partnering and Exiting for CROs: Tales from Founders and Investment Bankers

What is the value of my service company? When and how do I exit and enjoy the fruits of my labor? Should I sell my baby to an investment banker (IB) or a private equity (PE) partner? How do I find strategic partners (for example, large CROs)? What are the pros and cons of working with an IB?

There have been many local seminars on company valuation, M&As and partnering. Most of them focus on companies developing therapeutics. The strategy, thinking and approach presented may not be applicable to CROs. Historically, smaller service companies are not the targets for M&A or private equity investment activities. However, with the continued trend towards outsourcing, and the robust growth in the entire service industry, CROs have become very attractive for both investors and strategic partners.

Please join us for this event where two local CRO founders will share the stories of their recent transactions. In addition, we will hear from a business advisor from an investment bank in the Bay Area to share his point of view of how service companies can position themselves for acquisition or investment, and how to work with investment bankers and private equity investors.

November 16th, 2016- Stem Cell Based Approaches to Muscular Disease Research

8am - 10am
Biocom (McGraw Boardroom) 10996 Torreyana Road, Suite 200, San Diego, CA 92121
Dr. Gustavo Dziewczapolski , Scientific Director at Cure CMD , , Dr. Anne Bang , Director, Cell Biology at Sanford Burhanm Prebys Medical Discovery Institute , , Dr. Joel Gottesfeld , Professor at TSRI , , Dr. Uli Schmidt , General Manager, Genea Biocells , ,

Muscular dystrophies and myopathies comprise an extensive number of disorders that primarily impact skeletal muscles and affect movement and mobility. These debilitating diseases are typically categorized as rare or orphan indications with high unmet clinical needs. Please join us for an informative session featuring local San Diego researchers and their approach to therapeutic drug discovery across a variety of skeletal muscle disorders.