San Diego
San Diego Marriott La Jolla
4240 La Jolla Village Dr
La Jolla, CA 92037
expertXchange Seminars: Two connected events, one shared conversation.
Consultant Lunch and Learn
Too Hard to Handle Seminar
November 12th in San Diego, CA | November 19th in Boston, MA
Boston
Royal Sonesta
40 Edwin H Land Blvd
Cambridge, MA 02142
Consultant Lunch and Learn
10:30 am - 1:30 pm
Lunch for both events
12:30pm - 1:30pm
Too Hard to Handle Seminar
12:30 pm - 6:30 pm
Developing complex oral therapies requires critical decisions at every stage, from navigating early formulation challenges and accelerating first-in-human studies to managing highly potent compounds and preparing for commercial launch.
Future-proof your program
Join us for an expert-led seminar exploring how integrated, phase-appropriate strategies can help overcome development challenges, reduce risk and build a more efficient path from molecule to market.
Through practical insights and real-world considerations, attendees will gain a broader perspective on designing oral drug development programs with speed, scalability and long-term success in mind.
Helping You Navigate Your Clients’ Next Challenge – A Consultant Lunch & Learn – Agenda Consultants Only
Patricia Krainski, VP Business Development, D&M, PCI Pharma Services
Pharmaceutical and biotech programs are increasingly complex, and consultants play a critical role in helping clients navigate challenges, evaluate options and make the right decisions at the right time.
This focused Lunch & Learn will provide an overview of PCI’s integrated capabilities across drug product development and manufacturing, sterile fill-finish and lyophilization, clinical trial services, commercial manufacturing and packaging, advanced drug delivery and global supply.
Designed specifically for consultants, the session will help you understand where PCI can support you and your clients, the challenges our experts can help solve, and when it makes sense to bring us into the conversation. We’ll explore how our capabilities connect across the product lifecycle, giving you access to trusted expertise and experienced teams that can help simplify complexity, reduce risk and keep your clients’ programs moving forward.
Ultimately, it’s about making it easier for you to support your clients, with the confidence that when you bring PCI to the table, their program is in experienced and trusted hands
Open to all attendees
Too Hard to Handle - Agenda Open to All
Anshul Gupte, Ph.D. RAC Drugs, Vice President, Pharmaceutical Development, PCI Pharma Services
Dr. Firouz Asgarzadeh, President, OSD Pharmaceutical Solutions LLC
This session will focus on how sponsors can move complex oral therapies into first-in-human studies quickly and intelligently, especially when working with scarce API, potent compounds or limited early data. It is intended to frame the early development decisions that shape speed, scientific robustness and future scalability.
Key subjects discussed:
- How to turn early molecule properties (potency, solubility, dose, PK/PD, tox uncertainty) into a realistic path to FIH
- What “phase appropriate” formulation and process design really looks like for FIH and early proof of concept
- Practical tactics (including specialised dispensing and smart FIH design) to reduce API usage and accelerate decision in clinic
- How to recognise development choices that can scale into later phases – and spot the ones that will create technical debt
Rebecca Coutts, Senior Director, Pharmaceutical Development, PCI Pharma Services
Lieselotte De Smet, Chief Technology Officer, XeDev (Boston, MA)
TJ Higley, CEO, Microsize (San Diego, CA)
This session will explore how development teams can select the most appropriate solubility-enabling strategy for poorly bioavailable and technically challenging molecules. The emphasis is on product-first, platform-agnostic decision-making that balances bioperformance, manufacturability and long-term development fit.
Key learning points:
- A structured framework for choosing between micronisation, spray drying, hot melt extrusion, nano enabled and lipid based approaches
- How different enabling technologies affect downstream manufacturability: compressibility, flow, stability, segregation and closed handling
- Case studies showing where specific technologies have succeeded or failed, and which early data should drive go/no go decisions
- How route selection today shapes your options for future dosage forms and product presentation
David O’Connell, Director of Scientific and Technical Affairs, PCI Pharma Services
Dean Calhoun, President and CEO, Affygility
This session will address the specific development and manufacturing challenges associated with ultrahigh potent oral dose forms, with a focus on containment, operability and scale-up. It is designed to show how formulation and process choices must adapt when products become harder to handle safely and reproducibly.
Key topics covered:
- How OELs, PDEs and industrial hygiene expectations translate into practical constraints on process and facility design
- Techniques for achieving robust low dose blends, controlling segregation and designing effective closed transfer and cleaning strategies
- Formulation and process choices that support dose uniformity and operator protection as batch sizes grow
- How to ensure your dosage form and process design stay compatible with necessary blinding, comparator use and hazard communication
Kevin Kue, Senior Manager, Global Technical Sales, PCI Pharma Services
Brian Sheridan, VP Sales Global Adherence & Clinicals, Westrock
This session will look at how clinical and commercial supply strategies can be aligned earlier to reduce friction, rework and launch risk for complex oral therapies. It will distinguish clearly between clinical and commercial requirements while showing the value of planning both in a coordinated way.
Key areas explored:
- Clinical supply: designing Phase 2b/3 kits and blinding strategies that anticipate future commercial formats and avoid uncontrolled SKU growth
- Commercial packaging: planning the shift from near commercial clinical packs to final market packs, including serialisation, aggregation and artwork
- Sustainability and regulation: what upcoming packaging and packaging waste requirements mean for oral solid dose design and change control
- Supply chain resilience: how to use FTZs, qualified depots and (where feasible) dual sourcing to absorb forecast error and regulatory change
Our seminar partners
Register for the Lunch and Learn or Seminar by completing the form below.
Consultants: If you are interested in attending the Lunch & Learn, please select “Consultant” under the “I am associated with:” field in the registration form below. Consultants are welcome to attend both the Lunch & Learn and the “Too Hard to Handle” Seminar. Please note that all registrations are subject to review. Registrations for the consultants lunch and learn that do not meet the event’s attendee criteria may be declined.
Learn more about our non-sterile capabilities and how we deliver safe, reliable, and scalable solutions across a broad range of oral dosage forms.
Contact us today and talk to our expert customer services team about how we can support you with sterile drug formulation services.
Inspired by tomorrow, and with over 8000 people in 38 global GMP facilities, we support you from early-stage development through commercialization and beyond.