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.
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!
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.
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.
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.
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.
Outsourced Pharma is produced throughout the U.S. in areas with contribution to pharmaceutical development and manufacturing. With events across the country, attendees can stay close to home and save on travel time. As with a local cuisine, the Outsourced Pharma "recipe" (its mission, its structure) remains true-to-form everywhere we go, but each meeting is naturally flavored by the distinctive interests of the region.
With the rising cost of getting a drug to market, it is more important now than ever to carefully manage your budget and ensure that you are allocating spend appropriately. One area that frequently has a mis, or NON managed budget, is an organization’s asset management program. In a mid-sized biotech, hundreds of thousands, if not millions of dollars, are spent on purchasing new equipment, keeping high dollar assets under service contract, and managing the break/fix, PM, calibration of existing assets; and this does not even consider the soft costs associated with the administrative burden of keeping your assets functioning.
What about your organization? Do you know what the percent utilization of your key equipment is? Do you know what assets are covered under service contract, do you know if those assets SHOULD be under contract? Do you know how well your assets are performing? Percent downtime? Length of life cycle? How that affects productivity in your lab?
Explore why these, and so many more questions are important in defining a functional, useful, and valuable asset management plan that will not only improve the efficiency and operation of your lab, but will most likely save you money.